Adele Ring

Primary Care Consultations About Medically Unexplained Symptoms: Patient Presentations and Doctor Responses That Influence the Probability of Somatic Intervention

Objective: In primary care, many consultations about physical symptoms that the doctor thinks are not explained by physical disease nevertheless lead to somatic interventions. Our objective was to test the predictions that somatic intervention becomes more likely a) when doctors provide simple reassurance rather than detailed symptom explanations and do not help patients discuss psychosocial problems and b) when patients try to engage doctors by extending their symptom presentation. Methods: Consultations of 420 patients presenting physical symptoms that the doctor considered unexplained by physical disease were audio-recorded, transcribed, and coded. Analysis modeled the probability of somatic intervention as a function of the quantity of specific types of speech by patients (symptomatic and psychosocial presentations) and doctors (normalization, physical explanations, psychosocial discussion). Results: Somatic intervention was associated with the duration of consultation. Controlling for duration, it was, as predicted, associated positively with symptom presentations and inversely with patients’ and doctors’ psychosocial talk. The relationship with doctors’ psychosocial talk was accounted for by patients’ psychosocial talk. Contrary to predictions, doctors’ normalization was inversely associated with somatic intervention and physical explanations had no effect. Conclusion: Somatic intervention did not result from the demands of patients. Instead, it became more likely as patients complained about their symptoms. Facilitating patients’ psychosocial talk has the potential to divert consultations about medically unexplained symptoms from somatic interventions. To understand why such consultations often lead to somatic interventions, we must understand why patients progressively extend their symptom presentations and why doctors, in turn, apparently respond to this by providing somatic intervention. MUS = medically unexplained symptoms; GP = general practitioner.

Randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of selective serotonin reuptake inhibitors plus supportive care, versus supportive care alone, for mild to moderate depression with somatic symptoms in primary care: the THREAD (THREshold for AntiDepressant response) study

OBJECTIVES To determine (1) the effectiveness and cost-effectiveness of selective serotonin reuptake inhibitor (SSRI) treatment plus supportive care, versus supportive care alone, for mild to moderate depression in patients with somatic symptoms in primary care; and (2) the impact of the initial severity of depression on effectiveness and relative costs. To investigate the impact of demographic and social variables. DESIGN The study was a parallel group, open-label, pragmatic randomised controlled trial. SETTING The study took place in a UK primary care setting. Patients were referred by 177 GPs from 115 practices around three academic centres. PARTICIPANTS Patients diagnosed with new episodes of depression and potentially in need of treatment. In total, 602 patients were referred to the study team, of whom 220 were randomised. INTERVENTIONS GPs were asked to provide supportive care to all participants in follow-up consultations 2, 4, 8 and 12 weeks after the baseline assessment, to prescribe an SSRI of their choice to patients in the SSRI plus supportive care arm and to continue treatment for at least 4 months after recovery. They could switch antidepressants during treatment if necessary. They were asked to refrain from prescribing an antidepressant to those in the supportive care alone arm during the first 12 weeks but could prescribe to these patients if treatment became necessary. MAIN OUTCOME MEASURES The primary outcome measure was Hamilton Depression Rating Scale (HDRS) score at 12-week follow-up. Secondary outcome measures were scores on HDRS at 26-week follow-up, Beck Depression Inventory, Medical Outcomes Study Short Form-36 (SF-36), Medical Interview Satisfaction Scale (MISS), modified Client Service Receipt Inventory and medical record data. RESULTS SSRIs were received by 87% of patients in the SSRI plus supportive care arm and 20% in the supportive care alone arm. Longitudinal analyses demonstrated statistically significant differences in favour of the SSRI plus supportive care arm in terms of lower HDRS scores and higher scores on the SF-36 and MISS. Significant mean differences in HDRS score adjusted for baseline were found at both follow-up points when analysed separately but were relatively small. The numbers needed to treat for remission (to HDRS > 8) were 6 [95% confidence interval (CI) 4 to 26)] at 12 weeks and 6 (95% CI 3 to 31) at 26 weeks, and for significant improvement (HDRS reduction > or = 50%) were 7 (95% CI 4 to 83) and 5 (95% CI 3 to 13) respectively. Incremental cost-effectiveness ratios and cost-effectiveness planes suggested that adding an SSRI to supportive care was probably cost-effective. The cost-effectiveness acceptability curve for utility suggested that adding an SSRI to supportive care was cost-effective at the values of 20,000 pounds-30,000 pounds per quality-adjusted life-year. A poorer outcome on the HDRS was significantly related to greater severity at baseline, a higher physical symptom score and being unemployed. CONCLUSIONS Treatment with an SSRI plus supportive care is more effective than supportive care alone for patients with mild to moderate depression, at least for those with symptoms persisting for 8 weeks and an HRDS score of > or = 12. The additional benefit is relatively small, and may be at least in part a placebo effect, but is probably cost-effective at the level used by the National Institute for Health and Clinical Excellence to make judgements about recommending treatments within the National Health Service. However, further research is required.

Why do primary care physicians propose medical care to patients with medically unexplained symptoms? A new method of sequence analysis to test theories of patient pressure.

Objective: We test predictions from contrasting theories that primary care physicians offer medical care to patients with medically unexplained symptoms in response to a) patients’ attribution of symptoms to disease and demand for treatment or b) their progressive elaboration of their symptoms in the attempt to engage their physicians. Methods: Primary care physicians identified consecutive patients who consulted with symptoms that the physician considered unexplained by physical disease. Four hundred twenty consultations with 36 physicians were audio recorded and transcribed, and physician and patient speech was coded turn by turn. Hierarchical logistic regression analysis modeled the probability of the physician proposing medical care as a function of the quantity of patients’ speech of specific kinds that preceded it. Results: Whether physicians proposed medical care was unrelated to patients’ attributions to disease or demands for treatment. Proposals of explicitly somatic responses (drugs, investigation or specialist referral) became more likely after patients had elaborated their symptoms and less likely after patients indicated psychosocial difficulties. Proposals of a further primary care consultation were responses simply to lengthening consultation. Conclusions: The findings are incompatible with the influential assumption that physicians offer medical care to patients with unexplained symptoms because the patients demand treatment for a physical disease. Instead, the reason why many of these patients receive high levels of medical care should be sought by investigating the motivations behind physicians’ responses to patients’ symptom presentation. MUS = medically unexplained symptoms.

Factors predictive of resilience and vulnerability in new-onset epilepsy

Purpose:  Epilepsy has been associated with reduced quality of life (QOL), but QOL outcomes are heterogeneous. Some people are able to maintain a good QOL despite poorly controlled epilepsy and others report poor QOL despite well‐controlled epilepsy. Maintaining a good QOL in the face of adversity is embodied by the concept of resilience. We explored the factors associated with having a resilient outcome in people with epilepsy (PWE). Our definition of adversity included socioeconomic disadvantage as well as continuing seizures.

Does the concept of resilience contribute to understanding good quality of life in the context of epilepsy

A significant body of research highlights negative impacts of epilepsy for individual quality of life (QOL). Poor seizure control is frequently associated with reporting of poor QOL and good seizure control with good QOL; however, this is not a universal finding. Evidence suggests that some people enjoy good QOL despite ongoing seizures while others report poor QOL despite good seizure control. Understanding the factors that influence QOL for people with epilepsy and the processes via which such factors exert their influence is central to the development of interventions to support people with epilepsy to experience the best possible QOL. We present findings of a qualitative investigation exploring influences and processes on QOL for people with epilepsy. We describe the clinical, psychological, and social factors contributing to QOL. In particular, we focus on the value of the concept of resilience for understanding quality of life in epilepsy. Based on our analysis, we propose a model of resilience wherein four key component sets of factors interact to determine QOL. This model reflects the fluid nature of resilience that, we suggest, is subject to change based on shifts within the individual components and the interactions between them. The model offers a representation of the complex influences that act and interact to either mitigate or further compound the negative impacts of epilepsy on individual QOL.

Soft governance, restratification and the 2004 general medical services contract: the case of UK primary care organisations and general practice teams

In the UK National Health Service, primary care organisation (PCO) managers have traditionally relied on the soft leadership of general practitioners based on professional self-regulation rather than direct managerial control. The 2004 general medical services contract (nGMS) represented a significant break from this arrangement by introducing new performance management mechanisms for PCO managers to measure and improve general practice work. This article examines the impact of nGMS on the governance of UK general practice by PCO managers through a qualitative analysis of data from an empirical study in four UK PCOs and eight general practices, drawing on Hoods four-part governance framework. Two hybrids emerged: (i) PCO managers emphasised a hybrid of oversight, competition (comptrol) and peer-based mutuality by granting increased support, guidance and autonomy to compliant practices; and (ii) practices emphasised a broad acceptance of increased PCO oversight of clinical work that incorporated a restratified elite of general practice clinical peers at both PCO and practice levels. Given the increased international focus on the quality, safety and efficiency in primary care, a key issue for PCOs and practices will be to achieve an effective, contextually appropriate balance between the counterposing governance mechanisms of peer-led mutuality and externally led comptrol.

Using discrete choice experiments to define patient preferences for outcomes in trials

Methods Web-based survey, containing discrete choice experiments (DCEs) to elicit preferences of three pre-defined groups of adults with epilepsy (n=750): (i) early epilepsy, (ii) established epilepsy, (iii) women of childbearing age (WOCBA). The DCEs contains five attributes, with two levels, defined using: semi-structured interviews with patients (n=56), a focus group with AED prescribers (n=8), and trial data. Each used the same fractional factorial design, folded into eight binary choices: Which medication would you prefer to take? Target sample size is 750 respondents, recruited via the Epilepsy Action website. Data will be analysed in STATA using a random effects logit model.

The health impacts of women's low control in their living environment: A theory-based systematic review of observational studies in societies with profound gender discrimination.

Abstract We conducted a systematic review of observational evidence on the health impacts of womens low control/autonomy in the living environment in societies with profound gender discrimination and gender bias. Thirty observational studies of varying methodological quality were included. Overall, the evidence suggests that womens lower control or autonomy (for example lack of freedom of movement outside the home, lack of authority to access healthcare for sick children) was associated with poorer mental and physical health for women and higher morbidity and mortality for their children, after adjusting for their socioeconomic circumstances. Further studies are needed to disentangle and understand the pathways between low control and health outcomes in contexts of profound gender discrimination. This systematic review has highlighted the general low quality of the evidence base on this research question. It identifies the pressing need for high quality, longitudinal studies in the future. HighlightsTheory posits that restricted autonomy of women in societies with profound gender discrimination may lead to poorer health.Lower control over health determinants in their living environment may lead to poorer health outcomes for women and children.This theory‐based systematic review examined the impact of womens low control in the living environment on health outcomes.The evidence suggests that womens low control in their living environment is associated with adverse health outcomes.There are adverse effects on the health of women and their children in societies with profound gender discrimination.Further high quality longitudinal studies are needed to disentangle and understand these pathways in greater depth.

Patient‐Focused Drug Development Methods for Benefit–Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs

Regulatory decisions may be enhanced by incorporating patient preferences for drug benefit and harms. This study demonstrates a method of weighting clinical evidence by patients’ benefit–risk preferences. Preference weights, derived from discrete choice experiments, were applied to clinical trial data to estimate the expected utility of alternative drugs. In a case study, the rank ordering of antiepileptic drugs (AEDs), as indicated from clinical studies, was compared with ordering based on weighting clinical evidence by patients’ preferences. A statistically significant change in rank ordering of AEDs was observed for women of childbearing potential who were prescribed monotherapy for generalized or unclassified epilepsy. Rank ordering inferred from trial data, valproate > topiramate > lamotrigine, was reversed. Modeling the expected utility of drugs might address the need to use more systematic, methodologically sound approaches to collect patient input that can further inform regulatory decision making.

1151 Patients’ preferences for anti-epileptic drugs (aeds)

Objectives To identify preferences for outcomes of antiepileptic drugs (AEDs) that patients consider important and, to investigate the impact of patient preferences on the ranking of AEDs, as indicated by a clinical trial. Methods Adult patients with epilepsy completed a web-based questionnaire containing a discrete choice experiment. Patients made choices between hypothetical pairs of AEDs described by varying levels of clinical efficacy and treatment-related adverse events (AEs). Data were analysed using a random effects logit model. Women with the potential to become pregnant were analysed separately. Utility and probability of uptake for existing AEDs were derived using preference weights and published clinical event data. Results Patients (n=414) had stronger preferences for reducing the risk of AEs than improving treatment benefit. In return for a 1% improvement in 12 month remission, the maximum acceptable risk of adverse events was: depression 0.31%, memory problems 0.30%, aggression 0.25%; and for women with the potential to become pregnant: depression 0.56%, memory problems 0.34%, and foetal abnormality 0.20%. The rank ordering of AEDs differed when patient preferences were considered. Conclusion Exploring what patients consider important in measuring AED effectiveness will assist in supporting adherence, and ensure clinical services are focused on patient-defined needs.