Predicting and preventing relapse of depression in primary care: a mixed methods study

BackgroundMost people with depression are managed in primary care. Relapse (reemergence of depression symptoms after improvement) is common and contributes to the burden and morbidity associated with depression. There is a lack of evidence-based approaches for risk-stratifying people according to risk of relapse and for preventing relapse in primary care.MethodsIn this mixed methods study, I initially reviewed studies looking to predict relapse of depression across all settings. I then attempted to derive and validate a prognostic model to predict relapse within 6-8 months in a primary care setting, using multilevel logistic regression analysis on individual participant data from seven studies (n=1244). Concurrently, a qualitative workstream, using thematic analysis, explored the perspectives of general practitioners (GPs) and people with lived experience of depression around relapse risk and prevention in practice.ResultsThe systematic review identified eleven models; none could currently be implemented in a primary care setting. The prognostic model developed in this study had inadequate predictive performance on internal validation (Cstatistic 0.60; calibration slope 0.81). I carried out twenty-two semi-structured interviews with GPs and twenty-three with people with lived experience of depression. People with lived experience of depression and GPs reflected that a discussion around relapse would be useful but was not routinely offered. Both participant groups felt there would be benefits to relapse prevention for depression being embedded within primary care.ConclusionsWe are currently unable to accurately predict an individual’s risk ofdepression relapse. The longer-term care of people with depression ingeneral practice could be improved by enabling continuity of care, increased consistency and clarity around follow-up arrangements, and focussed discussions around relapse risk and prevention. Scalable, brief relapse prevention interventions are needed, which would require policy change and additional resource. We need to better understand existing interventions and barriers to implementation in practice

Predicting and preventing relapse of depression in primary care: a mixed methods study

Background Most people with depression are managed in primary care. Relapse (re-emergence of depression symptoms after improvement) is common and contributes to the burden and morbidity associated with depression. There is a lack of evidence-based approaches for risk-stratifying people according to risk of relapse and for preventing relapse in primary care. Methods In this mixed methods study, I initially reviewed studies looking to predict relapse of depression across all settings. I then attempted to derive and validate a prognostic model to predict relapse within 6-8 months in a primary care setting, using multilevel logistic regression analysis on individual participant data from seven studies (n=1244). Concurrently, a qualitative workstream, using thematic analysis, explored the perspectives of general practitioners (GPs) and people with lived experience of depression around relapse risk and prevention in practice. Results The systematic review identified eleven models; none could currently be implemented in a primary care setting. The prognostic model developed in this study had inadequate predictive performance on internal validation (C-statistic 0.60; calibration slope 0.81). I carried out twenty-two semi-structured interviews with GPs and twenty-three with people with lived experience of depression. People with lived experience of depression and GPs reflected that a discussion around relapse would be useful but was not routinely offered. Both participant groups felt there would be benefits to relapse prevention for depression being embedded within primary care. Conclusions We are currently unable to accurately predict an individual’s risk of depression relapse. The longer-term care of people with depression in general practice could be improved by enabling continuity of care, increased consistency and clarity around follow-up arrangements, and focussed discussions around relapse risk and prevention. Scalable, brief relapse prevention interventions are needed, which would require policy change and additional resource. We need to better understand existing interventions and barriers to implementation in practice

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial

Background: South Africa is among the 7 highest tuberculosis (TB) burden countries. Harmful lifestyle behaviours, such as smoking and alcohol, and poor medication adherence can affect clinical outcomes. Modification of these behaviours is likely to improve TB treatment outcomes and has proven possible using motivational interviewing (MI) techniques or use of short message service (SMS) text messaging. There have been no studies assessing the effect of combined MI and SMS interventions on multiple lifestyle factors and TB treatment outcomes. Methods: This is a prospective, multi-centre, two-arm individual randomised controlled trial looking at the effectiveness and cost-effectiveness of a complex behavioural intervention (the ProLife programme) on improving TB and lifestyle-related outcomes in 3 provinces of South Africa. The ProLife programme consists of an MI counselling strategy, delivered by lay health workers, augmented with subsequent SMS. We aim to recruit 696 adult participants (aged 18 years and over) with drug-sensitive pulmonary TB who are current smokers and/or report harmful or hazardous alcohol use. Patients will be consecutively enrolled at 27 clinics in 3 different health districts in South Africa. Participants randomised individually to the intervention arm will receive 3 MI counselling sessions 1 month apart. Each MI session will be followed by twice-weekly SMS messages targeting treatment adherence, alcohol use and tobacco smoking, as appropriate. We will assess the effect on TB treatment success, using standard World Health Organization (WHO) treatment outcome definitions (primary outcome), as well as on a range of secondary outcomes including smoking cessation, reduction in alcohol use and TB medication and anti-retroviral therapy adherence. Secondary outcomes will be measured at 3 and 6 months follow-up. Discussion: This trial aligns with the WHO agenda of integrating TB care with the care for chronic diseases of life-style, such as provision of smoking cessation treatments, and with the use of digital technologies. If the ProLife programme is found to be effective and cost- effective, the programme could have significant implications for TB treatment globally and could be successfully implemented in a wide range of TB treatment settings

New metrics for the Lancet Standing Commission on Liver Disease in the UK

Health Polic

Effect of a brief motivational interview and text message intervention targeting tobacco smoking, alcohol use, and medication adherence to improve tuberculosis treatment outcomes in adult patients with tuberculosis : A multicentre, randomised controlled trial of the ProLife programme in South Africa

Objectives: To investigate the effectiveness of a complex behavioural intervention, ProLife, on tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking. Design: Multicentre, individual, randomised controlled trial where participants were assigned (1:1) to the ProLife intervention or usual care. Setting: 27 primary care clinics in South Africa. Participants: 574 adults starting treatment for drug-sensitive pulmonary TB who smoked tobacco or reported harmful/hazardous alcohol use. Interventions: The intervention, delivered by lay health workers (LHWs), consisted of 3 brief motivational interviewing (MI) sessions, augmented with Short Message Service (SMS) messages, targeting medication adherence, alcohol use and tobacco smoking. Outcome measures: The primary outcome was successful versus unsuccessful TB treatment at 6 to 9 months, from TB records. Secondary outcomes were biochemically confirmed sustained smoking cessation, reduction in the Alcohol Use Disorder Identification Test (AUDIT) score, improved TB and antiretroviral treatment (ART) adherence and ART initiation, each measured at 3 and 6 months by questionnaires; and cure rates in patients who had bacteriology-confirmed TB at baseline, from TB records. Results: Between 15 November 2018 and 31 August 2019, 574 participants were randomised to receive either the intervention (n=283) or usual care (n=291). TB treatment success rates did not differ significantly between intervention (67.8%) and control (70.1%; OR=0.9 (95% CI: 0.64,1.27)). There was no evidence of an effect at 3- and 6-months respectively on continuous smoking abstinence (OR=0.65 (95% CI: 0.37,1.14); OR=0.76 (95% CI: 0.35,1.63)), TB medication adherence (OR=1.22 (95%CI: 0.52,2.87); OR=0.89 (95%CI: 0.26,3.07)), taking ART (OR=0.79 (0.38,1.65), OR=2.05 (0.80,5.27)) or AUDIT scores (mean score difference 0.55 (95% CI: -1.01,2.11); -0.04 (95% CI: -2,1.91); and adjusting for baseline values. Cure rates were not significantly higher (OR=1.16 (0.83,1.63)). Conclusions: Simultaneous targeting of multiple health risk behaviours with MI and SMS using LHWs may not be an effective approach to improve TB outcomes

Unacceptable failures: the final report of the <em>Lancet</em> Commission into liver disease in the UK

This final report of the Lancet Commission into liver disease in the UK stresses the continuing increase in burden of liver disease from excess alcohol consumption and obesity, with high levels of hospital admissions which are worsening in deprived areas. Only with comprehensive food and alcohol strategies based on fiscal and regulatory measures (including a minimum unit price for alcohol, the alcohol duty escalator, and an extension of the sugar levy on food content) can the disease burden be curtailed. Following introduction of minimum unit pricing in Scotland, alcohol sales fell by 3%, with the greatest effect on heavy drinkers of low-cost alcohol products. We also discuss the major contribution of obesity and alcohol to the ten most common cancers as well as measures outlined by the departing Chief Medical Officer to combat rising levels of obesity—the highest of any country in the west. Mortality of severely ill patients with liver disease in district general hospitals is unacceptably high, indicating the need to develop a masterplan for improving hospital care. We propose a plan based around specialist hospital centres that are linked to district general hospitals by operational delivery networks. This plan has received strong backing from the British Association for Study of the Liver and British Society of Gastroenterology, but is held up at NHS England. The value of so-called day-case care bundles to reduce high hospital readmission rates with greater care in the community is described, along with examples of locally derived schemes for the early detection of disease and, in particular, schemes to allow general practitioners to refer patients directly for elastography assessment. New funding arrangements for general practitioners will be required if these proposals are to be taken up more widely around the country. Understanding of the harm to health from lifestyle causes among the general population is low, with a poor knowledge of alcohol consumption and dietary guidelines. The Lancet Commission has serious doubts about whether the initiatives described in the Prevention Green Paper, with the onus placed on the individual based on the use of information technology and the latest in behavioural science, will be effective. We call for greater coordination between official and non-official bodies that have highlighted the unacceptable disease burden from liver disease in England in order to present a single, strong voice to the higher echelons of government

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase&nbsp;1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation&nbsp;disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age&nbsp; 6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score&nbsp; 652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc&nbsp;= 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N&nbsp;= 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in&nbsp;Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in&nbsp;Asia&nbsp;and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Identifying the top research priorities in medically not yet explained symptoms (MNYES): A James Lind Alliance priority setting partnership

Objectives: This study establishes research priorities for medically not yet explained symptoms (MNYES), also known as persistent physical symptoms or medically unexplained symptoms, from the perspective of patients, caregivers and clinicians, in a priority setting partnership (PSP) following the James Lind Alliance (JLA) approach. Research into such symptoms in general has been poorly funded over the years and so far has been primarily researcher-led with minimal input from patients, caregivers and clinicians; and sometimes has been controversial. Design: JLA PSP method. The PSP termed these symptoms MNYES. Methods: The study was conducted according to the JLA’s detailed methodology for conducting priority setting exercises. It involved five key stages: defining the appropriate term for the conditions under study by the PSP Steering Group; gathering questions on MNYES from patients, caregivers and clinicians in a publicly accessible survey; checking these research questions against existing evidence; interim prioritisation in a second survey; and a final multi-stakeholder consensus meeting to determine the top 10 unanswered research questions using the modified nominal group methodology. Results: Over 700 responses from UK patients, caregivers and clinicians were identified in the two surveys and charities contributed from a broad range of medical specialties and primary care. The final top 10 unanswered research questions cover, among others: treatment strategies, personalisation of treatment, collaborative care pathways, training for clinicians and outcomes that matter to patients. Interpretation: The top 10 unanswered research questions are expected to generate much needed, relevant and impactful research into MNYES

Effect of a brief motivational interview and text message intervention targeting tobacco smoking, alcohol use and medication adherence to improve tuberculosis treatment outcomes in adult patients with tuberculosis : a multicentre, randomised controlled trial of the ProLife programme in South Africa

OBJECTIVE: To investigate the effectiveness of a complex behavioural intervention, ProLife, on tuberculosis (TB) treatment success, medication adherence, alcohol use and tobacco smoking. DESIGN: Multicentre, individual, randomised controlled trial where participants were assigned (1:1) to the ProLife intervention or usual care. Setting: 27 primary care clinics in South Africa. Participants: 574 adults starting treatment for drug-sensitive pulmonary TB who smoked tobacco or reported harmful/hazardous alcohol use. INTERVENTIONS: The intervention, delivered by lay health workers (LHWs), consisted of three brief motivational interviewing (MI) sessions, augmented with short message service (SMS) messages, targeting medication adherence, alcohol use and tobacco smoking. OUTCOME MEASURES: The primary outcome was successful versus unsuccessful TB treatment at 6-9 months, from TB records. Secondary outcomes were biochemically confirmed sustained smoking cessation, reduction in the Alcohol Use Disorder Identification Test (AUDIT) score, improved TB and antiretroviral therapy (ART) adherence and ART initiation, each measured at 3 and 6 months by questionnaires; and cure rates in patients who had bacteriology-confirmed TB at baseline, from TB records. RESULTS: Between 15 November 2018 and 31 August 2019, 574 participants were randomised to receive either the intervention (n=283) or usual care (n=291). TB treatment success rates did not differ significantly between intervention (67.8%) and control (70.1%; OR 0.9, 95% CI 0.64% to 1.27%). There was no evidence of an effect at 3 and 6 months, respectively, on continuous smoking abstinence (OR 0.65, 95% CI 0.37 to 1.14; OR 0.76, 95% CI 0.35 to 1.63), TB medication adherence (OR 1.22, 95% CI 0.52 to 2.87; OR 0.89, 95% CI 0.26 to 3.07), taking ART (OR 0.79, 95% CI 0.38 to 1.65; OR 2.05, 95% CI 0.80 to 5.27) or AUDIT scores (mean score difference 0.55, 95% CI -1.01 to 2.11; -0.04, 95% CI -2.0 to 1.91) and adjusting for baseline values. Cure rates were not significantly higher (OR 1.16, 95% CI 0.83 to 1.63). CONCLUSION: Simultaneous targeting of multiple health risk behaviours with MI and SMS using LHWs may not be an effective approach to improve TB outcomes.SA-Medical Research/Newton Foundationhttp://bmjopen.bmj.comSchool of Health Systems and Public Health (SHSPH

The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care : protocol for the PREDICTR study

BACKGROUND: Most patients who present with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common (at least 50% of patients treated for depression will relapse after a single episode) and leads to considerable morbidity and decreased quality of life for patients. The majority of patients will relapse within 6 months, and those with a history of relapse are more likely to relapse in the future than those with no such history. GPs see a largely undifferentiated case-mix of patients, and once patients with depression reach remission, there is limited guidance to help GPs stratify patients according to risk of relapse. We aim to develop a prognostic model to predict an individual’s risk of relapse within 6–8 months of entering remission. The long-term objective is to inform the clinical management of depression after the acute phase. METHODS: We will develop a prognostic model using secondary analysis of individual participant data drawn from seven RCTs and one longitudinal cohort study in primary or community care settings. We will use logistic regression to predict the outcome of relapse of depression within 6–8 months. We plan to include the following established relapse predictors in the model: residual depressive symptoms, number of previous depressive episodes, co-morbid anxiety and severity of index episode. We will use a “full model” development approach, including all available predictors. Performance statistics (optimism-adjusted C-statistic, calibration-in-the-large, calibration slope) and calibration plots (with smoothed calibration curves) will be calculated. Generalisability of predictive performance will be assessed through internal-external cross-validation. Clinical utility will be explored through net benefit analysis. DISCUSSION: We will derive a statistical model to predict relapse of depression in remitted depressed patients in primary care. Assuming the model has sufficient predictive performance, we outline the next steps including independent external validation and further assessment of clinical utility and impact. STUDY REGISTRATION: ClinicalTrials.gov ID: NCT0466666