Embedding effective depression care: using theory for primary care organisational and systems change

Background: depression and related disorders represent a significant part of general practitioners (GPs) daily work. Implementing the evidence about what works for depression care into routine practice presents a challenge for researchers and service designers. The emerging consensus is that the transfer of efficacious interventions into routine practice is strongly linked to how well the interventions are based upon theory and take into account the contextual factors of the setting into which they are to be transferred. We set out to develop a conceptual framework to guide change and the implementation of best practice depression care in the primary care setting.Methods: we used a mixed method, observational approach to gather data about routine depression care in a range of primary care settings via: audit of electronic health records; observation of routine clinical care; and structured, facilitated whole of organisation meetings. Audit data were summarised using simple descriptive statistics. Observational data were collected using field notes. Organisational meetings were audio taped and transcribed. All the data sets were grouped, by organisation, and considered as a whole case. Normalisation Process Theory (NPT) was identified as an analytical theory to guide the conceptual framework development.Results: five privately owned primary care organisations (general practices) and one community health centre took part over the course of 18 months. We successfully developed a conceptual framework for implementing an effective model of depression care based on the four constructs of NPT: coherence, which proposes that depression work requires the conceptualisation of boundaries of who is depressed and who is not depressed and techniques for dealing with diffuseness; cognitive participation, which proposes that depression work requires engagement with a shared set of techniques that deal with depression as a health problem; collective action, which proposes that agreement is reached about how care is organised; and reflexive monitoring, which proposes that depression work requires agreement about how depression work will be monitored at the patient and practice level. We describe how these constructs can be used to guide the design and implementation of effective depression care in a way that can take account of contextual differences.Conclusions: ideas about what is required for an effective model and system of depression care in primary care need to be accompanied by theoretically informed frameworks that consider how these can be implemented. The conceptual framework we have presented can be used to guide organisational and system change to develop common language around each construct between policy makers, service users, professionals, and researchers. This shared understanding across groups is fundamental to the effective implementation of change in primary care for depressio

Systematic review of factors associated with quality of life of asylum seekers and refugees in high-income countries

The stressful experiences that many asylum seekers and refugees (AS&R) are exposed to during forced migration, and during resettlement in host countries, can have a profound impact on their mental health. Comparatively less research attention has been allocated to exploring other indices of quality of life (QoL) in AS&R populations. This review aimed to (i) synthesize the predictors and correlates of QoL of AS&R populations in high-income countries, and (ii) to identify the methodological strengths and weaknesses of this body of research. Fourteen databases were systematically searched (Medline, PsychINFO, CINAHL, Cochrane Library, Health Technology Assessment, National Health Service Economic Evaluation, Educational Resource Index and Abstracts, BiblioMap, Scopus, Social Sciences Citation Index, Evidence Aid, DARE, Web of Science and PubMed). Eligibility criteria included: adults seeking asylum or refuge in a high-income country, primary quantitative data, the use of a measure based on the WHO's definition of QoL, published in a peer-reviewed journal. A narrative synthesis approach was used, and the quality was assessed using the AXIS tool for cross-sectional studies and the CASP tool for longitudinal studies. Of the 13.656 papers identified, 23 met the eligibility criteria. A wide range of factors were found to have significant associations with QoL. Both positive and negative correlates of QoL were largely dominated by social (e.g. social networks) and mental health factors (e.g. depression). Although all of the cross-sectional studies met over half of the quality criteria, only 12 met 75% or more of these criteria. For the longitudinal studies, for all but one study lacked statistical precision and the results cannot be applied to the local population. Key findings across the various forms of QoL (overall, physical, psychological, social and environmental) were that having established social networks and social integration were associated with higher QoL, whereas having mental disorders (i.e. PTSD or depression) was strongly associated with reduced QoL. More research is needed into physical and environmental predictors and correlates of QoL. The findings of the review can be used to inform policies and interventions aimed at supporting AS&R and promoting the integration and wellbeing of these populations

Process evaluation for complex interventions in primary care: understanding trials using the normalization process model

Background: the Normalization Process Model is a conceptual tool intended to assist in understanding the factors that affect implementation processes in clinical trials and other evaluations of complex interventions. It focuses on the ways that the implementation of complex interventions is shaped by problems of workability and integration.Method: in this paper the model is applied to two different complex trials: (i) the delivery of problem solving therapies for psychosocial distress, and (ii) the delivery of nurse-led clinics for heart failure treatment in primary care.Results: application of the model shows how process evaluations need to focus on more than the immediate contexts in which trial outcomes are generated. Problems relating to intervention workability and integration also need to be understood. The model may be used effectively to explain the implementation process in trials of complex interventions.Conclusion: the model invites evaluators to attend equally to considering how a complex intervention interacts with existing patterns of service organization, professional practice, and professional-patient interaction. The justification for this may be found in the abundance of reports of clinical effectiveness for interventions that have little hope of being implemented in real healthcare setting

Considering the case for an antidepressant drug trial involving temporary deception: a qualitative enquiry of potential participants

<p>Abstract</p> <p>Background</p> <p>Systematic reviews of randomised placebo controlled trials of antidepressant medication show small and decreasing differences between pharmacological and placebo arms. In part this finding may relate to methodological problems with conventional trial designs, including their assumption of additivity between drug and placebo trial arms. Balanced placebo designs, which include elements of deception, may address the additivity question, but pose substantial ethical and pragmatic problems. This study aimed to ascertain views of potential study participants of the ethics and pragmatics of various balanced placebo designs, in order to inform the design of future antidepressant drug trials.</p> <p>Methods</p> <p>A qualitative approach was employed to explore the perspectives of general practitioners, psychiatrists, and patients with experience of depression. The doctors were chosen via purposive sampling, while patients were recruited through participating general practitioners. Three focus groups and 12 in-depth interviews were conducted. A vignette-based topic guide invited views on three deceptive strategies: post hoc, authorised and minimised deception. The focus groups and interviews were tape-recorded and transcribed. Transcripts were analysed thematically using Framework.</p> <p>Results</p> <p>Deception in non-research situations was typically perceived as acceptable within specific parameters. All participants could see the potential utility of introducing deception into trial designs, however views on the acceptability of deception within antidepressant drug trials varied substantially. Authorized deception was the most commonly accepted strategy, though some thought this would reduce the effectiveness of the design because participants would correctly guess the deceptive element. The major issues that affected views about the acceptability of deception studies were the welfare and capacity of patients, practicalities of trial design, and the question of trust.</p> <p>Conclusion</p> <p>There is a trade-off between pragmatic and ethical responses to the question of whether, and under what circumstances, elements of deception could be introduced into antidepressant drug trials. Ensuring adequate ethical safeguards within balanced placebo designs is likely to diminish their ability to address the crucial issue of additivity. The balanced placebo designs considered in this study are unlikely to be feasible in future trials of antidepressant medication. However there remains an urgent need to improve the quality of antidepressant drug trials.</p

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

Normalisation of unexplained symptoms by general practitioners: a functional typology.

BACKGROUND: Patients often present in primary care with physical symptoms that doctors cannot readily explain. The process of reassuring these patients is challenging, complex and poorly understood. AIM: To construct a typology of general practitioners' (GPs') normalising explanations, based on their effect on the process and outcome of consultations involving patients with medically unexplained symptoms. DESIGN OF STUDY: Qualitative analysis of audiotaped consultations between patients and GPs. SETTING: Seven general practices in Merseyside, United Kingdom. METHODS: Transcripts of audiotaped consultations between 21 GPs and 36 patients with medically unexplained symptoms were analysed inductively, to identify types of normalising speech used by GPs. RESULTS: Normalisation without explanation included rudimentary reassurance and the authority of a negative test result. Patients persisted in requesting explanation and elaborated or extended their symptoms, rendering somatic management more likely. Normalisation with ineffective explanation provided a tangible physical explanation for symptoms, unrelated to patient's expressed concerns. This was also counterproductive. Normalisation with effective explanation provided tangible mechanisms grounded in patients' concerns, often linking physical and psychological factors. These explanations were accepted by patients; those linking physical and psychological factors contributed to psychosocial management outcomes. CONCLUSIONS: The routine exercise of normalisation by GPs contains approaches that are ineffective and may exacerbate patients' presentation. However, it also contains types of explanation that may reduce the need for symptomatic investigation or treatment. These findings can inform the development of well-grounded educational interventions for GPs