[Show abstract][Hide abstract] ABSTRACT: Clinical practice guidelines for the treatment of major depressive disorder (MDD) recommend antidepressants for patients with moderate-severe depression and active monitoring for patients with mild-moderate symptoms. The feasibility and efficiency of active monitoring has not been proven conclusively. The aim of this study is to evaluate the cost-effectiveness of active monitoring in comparison to antidepressants for primary care patients with mild-moderate MDD.
This is a 12-month follow-up multicenter observational prospective controlled trial. Patients are enrolled in 12 primary care centers in Barcelona (Spain). Eligible patients are adults (≥18 years-old) with a new episode of MDD that sign a written consent to participate. This is a naturalistic study in which general practitioners (GPs) use their professional judgment to allocate patients into active monitoring or antidepressants groups. GPs treat the patients following their clinical criteria. At baseline, GPs complete a questionnaire (sociodemographic/job characteristics, training, attitude towards depression, interest on mental health and participation in communication groups). Patients’ measurements take place at baseline and after six and 12 months. Main outcome measures include severity of depression (PHQ-9), health-related quality of life (EuroQol-5D) and use of healthcare and social care services (Client Service Receipt Inventory). Secondary outcomes include diagnosis of MDD according to DSM-IV diagnostic criteria (SCID-I), disability (WHO-DAS), anxiety (BAI), comorbidities, medication side-effects and beliefs about medicines (BMQ).
The analysis will be done according to the intention to treat analysis. Missing data will be imputed using multiple imputation by chained equations. To minimize the bias resulting from the lack of randomization, a propensity score will be used. Incremental effects and costs between groups will be modelled in each of the imputed databases using multivariate generalized linear models and then combined as per Rubin’s rules. Propensity scores will be used to adjust the models. Incremental cost-effectiveness ratios will be calculated by dividing the difference in costs between groups by the difference in effects. To deal with the uncertainty, resampling techniques with bootstrapping will be used and cost-effectiveness planes and cost-effectiveness acceptability curves will be constructed. A series of sensitivity analyses will be performed.
Given the high burden and costs generated by depressive disorder, it is important that general practitioners treat major depression efficiently. Recent evidence has suggested that antidepressants have low benefits for patients with mild to moderate major depression. For such cases of depression, active monitoring exists as a treatment option, but it is not without difficulties for implementation and its effectiveness and efficiency have not been demonstrated conclusively. The results of the study will provide information on which is the most efficient approach to treat patients with mild to moderate major depression in primary care.
[Show abstract][Hide abstract] ABSTRACT: Background:
Care closer to home is being explored as a means of improving patient experience as well as efficiency in terms of cost savings. Evidence that community cancer services improve care quality and/or generate cost savings is currently limited. A randomised study was undertaken to compare delivery of cancer treatment in the hospital with two different community settings.
Ninety-seven patients being offered outpatient-based cancer treatment were randomised to treatment delivered in a hospital day unit, at the patient's home or in local general practice (GP) surgeries. The primary outcome was patient-perceived benefits, using the emotional function domain of the EORTC quality of life (QOL) QLQC30 questionnaire evaluated after 12 weeks. Secondary outcomes included additional QOL measures, patient satisfaction, safety and health economics.
There was no statistically significant QOL difference between treatment in the combined community locations relative to hospital (difference of −7.2, 95% confidence interval: −19·5 to +5·2, P=0.25). There was a significant difference between the two community locations in favour of home (+15·2, 1·3 to 29·1, P=0.033). Hospital anxiety and depression scale scores were consistent with the primary outcome measure. There was no evidence that community treatment compromised patient safety and no significant difference between treatment arms in terms of overall costs or Quality Adjusted Life Year. Seventy-eight percent of patients expressed satisfaction with their treatment whatever their location, whereas 57% of patients preferred future treatment to continue at the hospital, 81% at GP surgeries and 90% at home. Although initial pre-trial interviews revealed concerns among health-care professionals and some patients regarding community treatment, opinions were largely more favourable in post-trial interviews.
Patient QOL favours delivering cancer treatment in the home rather than GP surgeries. Nevertheless, both community settings were acceptable to and preferred by patients compared with hospital, were safe, with no detrimental impact on overall health-care costs.
British Journal of Cancer 08/2013; 109(6). DOI:10.1038/bjc.2013.414 · 4.82 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background Cost of illness (COI) studies are carried out under conditions of uncertainty and with incomplete information. There are concerns regarding their generalisability, accuracy and usability in evidence-informed care. Aims A hybrid methodology is used to estimate the regional costs of depression in Catalonia (Spain) following an integrative approach. Methods The cross-design synthesis included nominal groups and quantitative analysis of both top-down and bottom-up studies, and incorporated primary and secondary data from different sources of information in Catalonia. Sensitivity analysis used probabilistic Monte Carlo simulation modelling. A dissemination strategy was planned, including a standard form adapted from cost-effectiveness studies to summarise methods and results. Results The method used allows for a comprehensive estimate of the cost of depression in Catalonia. Health officers and decision-makers concluded that this methodology provided useful information and knowledge for evidence-informed planning in mental health. Conclusions The mix of methods, combined with a simulation model, contributed to a reduction in data gaps and, in conditions of uncertainty, supplied more complete information on the costs of depression in Catalonia. This approach to COI should be differentiated from other COI designs to allow like-with-like comparisons. A consensus on COI typology, procedures and dissemination is needed.
Journal of Mental Health 01/2013; 22(2). DOI:10.3109/09638237.2012.745185 · 1.01 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background Economic evaluation analyses can be enhanced by employing regression methods, allowing for the identification of important sub-groups and to adjust for imperfect randomisation in clinical trials or to analyse non-randomised data. Aims To explore the benefits of combining regression techniques and the standard Bayesian approach to refine cost-effectiveness analyses using data from randomised clinical trials. Method Data from a randomised trial of anti-depressant treatment were analysed and a regression model was used to explore the factors that have an impact on the net benefit (NB) statistic with the aim of using these findings to adjust the cost-effectiveness acceptability curves. Exploratory sub-samples' analyses were carried out to explore possible differences in cost-effectiveness. Results The analysis found that having suffered a previous similar depression is strongly correlated with a lower NB, independent of the outcome measure or follow-up point. In patients with previous similar depression, adding an selective serotonin reuptake inhibitors to supportive care for mild-to-moderate depression is probably cost-effective at the level used by the English National Institute for Health and Clinical Excellence to make recommendations. Conclusions This analysis highlights the need for incorporation of econometric methods into cost-effectiveness analyses using the NB approach.
Journal of Mental Health 01/2013; 22(2). DOI:10.3109/09638237.2012.745186 · 1.01 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE:: To determine the effectiveness of adding psychoeducational treatment implemented in general practice to usual care for patients with fibromyalgia (FM), and to analyze the cost-utility of the intervention from health care and societal perspectives. METHODS:: Twelve-month randomized controlled trial. A total of 216 primary care patients meeting the American College of Rheumatology criteria for FM participated in the study. The intervention included 9, 2-hour sessions of psychoeducation (5 sessions of education about the illness+4 sessions of autogenic relaxation) added to usual care provided by a multidisciplinary group in general practice was compared to usual care in the public health system. RESULTS:: At 12-month follow-up, patients who received psychoeducation showed greater improvement in global functional status (Cohen d=0.36; -2.49 to 3.81), physical functioning (Cohen d=0.56; 0.08 to 1.00), days feeling well (Cohen d=0.40; -0.16 to 1.02), pain (Cohen d= 0.35; -0.04 to 0.80), morning fatigue (Cohen d=0.24; -0.20 to 0.76), stiffness (Cohen d=0.34; -0.10 to 0.87), and depression (Cohen d=0.30; -0.26 to 0.93). Mean incremental cost per person receiving the intervention was &OV0556;-215.49 (-615.13 to 287.81) from the health care perspective, and &OV0556;-197.32 (-785.12 to 395.74) from the societal perspective. The incremental gain in quality-adjusted life-years per person was 0.12 (0.06 to 0.19), yielding a "dominant" intervention from both perspectives. The sensitivity analysis suggested that the intervention was cost-effective even imputing all missing data. DISCUSSION:: Our findings demonstrate the long-term clinical effectiveness of a psychoeducational treatment program for FM implemented at primary care level and the cost-utility from a health care and societal perspective. TRIAL REGISTRATION:: NCT00550966.
The Clinical journal of pain 01/2013; DOI:10.1097/AJP.0b013e318270f99a · 2.70 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Fatigue is common and has been shown to result in high economic costs to society. The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET) and counselling (COUN) with usual care plus a self-help booklet (BUC) for people presenting with chronic fatigue.
A randomised controlled trial was conducted with participants consulting for fatigue of over three months' duration recruited from 31 general practices in South East England and allocated to one of three arms. Outcomes and use of services were assessed at 6-month follow-up. The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale. Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves.
Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54. Those receiving the active therapies (GET and COUN) had more contacts with care professionals and therefore higher costs, these differences being statistically significant. COUN was more expensive and less effective than the other two therapies. The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement. However, there was much uncertainty around this result.
This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue. It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC.Clinical Trial Registration number at ISRCTN register: 72136156.
BMC Health Services Research 08/2012; 12:264. DOI:10.1186/1472-6963-12-264 · 1.66 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background.Increasing therapeutic inpatient activities may improve the quality and outcomes of care. Evaluation of these interventions is necessary including assessment of cost-effectiveness. The aim of this paper is to describe the development and reliability of a tool to collect information on care contacts and therapeutic activities of patients on inpatient wards.Method.The development of the tool consisted of: 1) literature review, 2) interviews with staff, 3) expert consultation, 4) feasibility study, 5) focus groups with staff members, and 6) reliability tests. Service use data were collected with the tool and costs calculated.Results.Service users' reported more use of activities than that contained in case notes during a 7-day period. This resulted in a cost difference of £10 per person. Case notes had more one-to-one nursing contacts, with a cost difference of £4 per person. One-day data showed less nurse contact time reported by participants compared to observational data (p < 0.001) but similar use of activities. Costs were £46 for the tool and £67 for the observational data.Conclusions.This tool is a good source of information on the number of activities attended by service users and contacts with psychiatrists. There is some disagreement with other sources of information on interactions between service users and nurses, possibly reflecting different definitions of a 'meaningful contact'. This does not have a major impact on cost given that for much of the care received there is reasonable agreement.
[Show abstract][Hide abstract] ABSTRACT: Community studies reveal people with coronary heart disease (CHD) are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions. There is evidence for the efficacy of collaborative care and case management for depression treatment, and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological, pharmacological, or combined treatments, these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care settings.
This pilot randomised controlled trial will evaluate whether a simple intervention involving a personalised care plan, elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients. The comparator group will be usual general practitioner (GP) care.81 participants have been recruited from CHD registers of 15 South London general practices. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale (HADS-D) together with symptomatic CHD identified using the Modified Rose Angina Questionnaire.Consenting participants are randomly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant's physical and mental health needs which are documented in a care plan, followed by regular telephone reviews by the case manager over a 6-month period. At each review, the intervention participant's mood, function and identified problems are reviewed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient's self efficacy to solve their problems.Depressive symptoms measured by HADS score will be collected at baseline and 1, 6- and 12 months post randomisation. Other outcomes include CHD symptoms, quality of life, wellbeing and health service utilisation.
This practical and patient-focused intervention is potentially an effective and accessible approach to the health and social care needs of people with depression and CHD in primary care.
[Show abstract][Hide abstract] ABSTRACT: Objective: Mental health conditions are associated with a significant burden on individuals. Using data from a large population health survey, the present study aimed to quantify the burden of emotional disorders (depression and anxiety) on health-related quality of life (HRQoL) in the region of Catalonia (Spain) for evidence-informed policy making. Methods: Regression models were used to estimate the impact of emotional disorders on HRQoL, controlling by socioeconomic factors and somatic health problems. The rate of emotional disorders was based on the General Health Questionnaire (GHQ-12) and quality of life scores were based on the EQ-5D. Results: The impact of emotional disorders on HRQoL was equal to a reduction of 0.17 in the EQ-5D score. Translation of this individual impact to population figures yielded a total loss of 78,742 quality-adjusted life years (QALYs) for 2006. This strong impact highlights the need for global policies aiming to reduce this burden. Conclusion: The negative relation between emotional disorders and the HRQoL of individuals was confirmed and quantified for the population of Catalonia. The use of quality of life scales such as the SF or EQ-5D, combined with data on quasi-specific health conditions provides substantial information for prioritizing and planning health programs.
[Show abstract][Hide abstract] ABSTRACT: Exposure to war can negatively affect health and may impact on healthcare costs. Estimating these costs and identifying their predictors is important for appropriate service planning. We aimed to measure use of health services in an adult population who had experienced war in the former-Yugoslavia on average 8 years previously, and to identify characteristics associated with the use and costs of healthcare.
War-affected community samples in Bosnia-Herzegovina, Croatia, Kosovo, FYR Macedonia, and Serbia were recruited through a random walk technique. Refugees in Germany, Italy and the UK were contacted through registers, organisations and networking. Current service use was measured for the previous three months and combined with unit costs for each country for the year 2006/7. A two-part approach was used, to identify predictors of service use with a multiple logistic regression model and predictors of cost with a generalised linear regression model.
3,313 participants were interviewed in Balkan countries and 854 refugees in Western European countries. In the Balkan countries, traumatic events and mental health status were related to greater service use while in Western countries these associations were not found. Participants in Balkan countries with post traumatic stress disorder (PTSD) had costs that were 63% higher (p = 0.005) than those without PTSD. Distress experienced during the most traumatic war event was associated with higher costs (p = 0.013). In Western European countries costs were 76% higher if non-PTSD anxiety disorders were present (0.027) and 63% higher for mood disorders (p = 0.006).
War experiences and their effects on mental health are associated with increased health care costs even many years later, especially for those who stayed in the area of conflict. Focussing on the mental health impact of war is important for many reasons including those of an economic nature.
PLoS ONE 01/2012; 7(1):e29603. DOI:10.1371/journal.pone.0029603 · 3.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Mental health conditions are associated with a significant burden on individuals. Using data from a large population health survey, the present study aimed to quantify the burden of emotional disorders (depression and anxiety) on health-related quality of life (HRQoL) in the region of Catalonia (Spain) for evidence-informed policy making.
Regression models were used to estimate the impact of emotional disorders on HRQoL, controlling by socioeconomic factors and somatic health problems. The rate of emotional disorders was based on the General Health Questionnaire (GHQ-12) and quality of life scores were based on the EQ-5D.
The impact of emotional disorders on HRQoL was equal to a reduction of 0.17 in the EQ-5D score. Translation of this individual impact to population figures yielded a total loss of 78,742 quality-adjusted life years (QALYs) for 2006. This strong impact highlights the need for global policies aiming to reduce this burden.
The negative relation between emotional disorders and the HRQoL of individuals was confirmed and quantified for the population of Catalonia. The use of quality of life scales such as the SF or EQ-5D, combined with data on quasi-specific health conditions provides substantial information for prioritizing and planning health programs.
[Show abstract][Hide abstract] ABSTRACT: The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP) surgeries.
Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm), or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire), as well as secondary end points: patient satisfaction, safety and health economics.
The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key stakeholders regarding potential costs and benefits of transferring clinical services from hospital to the community.
BMC Cancer 10/2011; 11:467. DOI:10.1186/1471-2407-11-467 · 3.32 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To estimate the cost of depression for the adult population in Catalonia (Spain) for 2006.
The total adult population of Catalonia for the reference year was close to 6 million. A cross-design synthesis study was conducted, combining "top-down" and "bottom-up" data from secondary data sources, as well as expert opinion (nominal groups). A societal perspective was adopted. Estimates included direct health costs (hospital, primary, specialised and pharmacological care) and the indirect costs derived from the productivity lost due to morbidity and mortality. Sensitivity analyses were carried out for primary and specialised care resource utilisation. A Monte Carlo simulation model was developed to handle the uncertainty of the unit costs of primary care, specialised care and hospital visits.
The total annual cost of depression in Catalonia for 2006 was 735.4 million Euros. Of this figure, 21.2% corresponded to direct costs, including 41 million Euros in primary care (5.6%), 8.1 million Euros in mental health specialised care (1.1%), 5.6 million Euros due to hospitalisation (0.8%) and 101.1 million Euros due to pharmacological care (13.7%); and 78.8% to indirect costs due to productivity loss. 3.7 million work days were lost to temporary disability for depression with a cost of 199.6 million Euros (27.1%), and 353.3 million Euros due to permanent disability (48%). Mortality attributed to suicide accounted for 26.9 million Euros (3.7%). The average annual cost of an adult with depression was close to 1800 Euros.
The heterogeneity of the data sources, the uncertainty in several estimates (i.e. proportion of psychotropic expenditure attributed to the treatment of depression, suicide rate attributed to depression), and the difficulty in disaggregating anxiety and depressive disorders in a number of databases are study limitations.
The burden of depression for the Catalan public health system and society as a whole due to the consumption of resources and, more importantly, the loss of productivity is significant. Inefficiencies may be found in the overuse of pharmaceuticals and in the eligibility criteria of disability for work.
[Show abstract][Hide abstract] ABSTRACT: Multiple sclerosis (MS) is a disorder that incurs high costs to individuals, health systems and society as a whole. A growing number of studies have measured the costs of MS and assessed the cost effectiveness of different treatments. This review summarizes the evidence from these studies. Electronic databases were searched and a total of 51 studies were included, 32 of which were cost-of-illness studies. The cost-of-illness studies took different perspectives (health service or societal) and the annual costs per person with MS ranged between $US6511 and $US77,938 (year of cost 2008). Economic evaluations of interferon (IFN)-beta-1a, IFNbeta-1b, glatiramer acetate, natalizumab, mitoxantrone and cyclophosphamide were identified. The results of the cost effectiveness of drug interventions were mixed. Most results comparing a drug with placebo related to IFNbeta-1b and the results usually revealed cost-effectiveness ratios that were above usual willingness-to-pay thresholds of public decision makers. The limited evidence on glatiramer acetate suggests that this may be cost effective. Head-to-head drug comparisons produced varying results, although the findings for natalizumab appear favourable compared with other drugs. Further trial-based comparisons are required to increase the evidence base regarding drug treatments for MS.
[Show abstract][Hide abstract] ABSTRACT: Despite major developments in community mental health services, inpatient care remains an important yet costly part of the service system and patients who are admitted frequently spend a long period of time in hospital. It is, therefore, crucial to have a good understanding of activities that take place on inpatient wards.
To review studies that have measured nursing and patient activity and interaction on psychiatric inpatient wards.
This literature review was performed by searching electronic databases and hand-checking reference lists.
The review identified 13 relevant studies. Most used observational methods and found that at best 50% of staff time is spent in contact with patients, and very little time is spent delivering therapeutic activities. Studies also showed that patients spend substantial time apart from staff or other patients.
On inpatient psychiatric wards, evidence over 35 years has found little patient activity or patient social engagement. The reasons for this trend and recommendations for the future are discussed.
International journal of nursing studies 04/2010; 47(7):909-17. DOI:10.1016/j.ijnurstu.2010.03.012 · 2.25 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Nearly 1 in 10 in the population experience fatigue of more than six months at any one time. Chronic fatigue is a common reason for consulting a general practitioner, and some patients report their symptoms are not taken seriously enough. A gap in perceptions may occur because doctors underestimate the impact of fatigue on patients' lives. The main aim of the study is to explore the economic impact of chronic fatigue in patients seeking help from general practitioners and to identify characteristics that explain variations in costs.
The design of study was a survey of patients presenting to general practitioners with unexplained chronic fatigue. The setting were 29 general practice surgeries located in the London and South Thames regions of the English National Health Service. Use of services over a six month period was measured and lost employment recorded. Regression models were used to identify factors that explained variations in these costs.
The mean total cost of services and lost employment across the sample of 222 patients was 3878 pounds for the six-month period. Formal services accounted for 13% of this figure, while lost employment accounted for 61% and informal care for 26%. The variation in the total costs was significantly related to factors linked to the severity of the condition and social functioning.
The economic costs generated by chronic fatigue are high and mostly borne by patients and their families. Enquiry about the functional consequences of fatigue on the social and occupational lives of patients may help doctors understand the impact of fatigue, and make patients feel better understood.
BMC Health Services Research 03/2010; 10:56. DOI:10.1186/1472-6963-10-56 · 1.66 Impact Factor