Cost-effectiveness of behavioral activation compared to treatment as usual for depressed older adults in primary care: A cluster randomized controlled trial.

INTRODUCTION: Depression in older adults is associated with decreased quality of life and increased utilization of healthcare services. Behavioral activation (BA) is an effective treatment for late-life depression, but the cost-effectiveness compared to treatment as usual (TAU) is unknown. METHODS: An economic evaluation was performed alongside a cluster randomized controlled multicenter trial including 161 older adults (≥65 years) with moderate to severe depressive symptoms (PHQ-9 ≥ 10). Outcome measures were depression (response on the QIDS-SR), quality-adjusted life-years (QALYs) and societal costs. Missing data were imputed using multiple imputation. Cost and effect differences were estimated using bivariate linear regression models, and statistical uncertainty was estimated with bootstrapping. Cost-effectiveness acceptability curves showed the probability of cost-effectiveness at different ceiling ratios. RESULTS: Societal costs were statistically non-significantly lower in BA compared to TAU (mean difference (MD) -€485, 95 % CI -3861 to 2792). There were no significant differences in response on the QIDS-SR (MD 0.085, 95 % CI -0.015 to 0.19), and QALYs (MD 0.026, 95 % CI -0.0037 to 0.055). On average, BA was dominant over TAU (i.e., more effective and less expensive), although the probability of dominance was only 0.60 from the societal perspective and 0.85 from the health care perspective for both QIDS-SR response and QALYs. DISCUSSION: Although the results suggest that BA is dominant over TAU, there was considerable uncertainty surrounding the cost-effectiveness estimates which precludes firm conclusions.

Behavioural Activation versus Treatment as Usual for Depressed Older Adults in Primary Care: A Pragmatic Cluster-Randomised Controlled Trial.

INTRODUCTION: Effective non-pharmacological treatment options for depression in older adults are lacking. OBJECTIVE: The effectiveness of behavioural activation (BA) by mental health nurses (MHNs) for depressed older adults in primary care compared with treatment as usual (TAU) was evaluated. METHODS: In this multicentre cluster-randomised controlled trial, 59 primary care centres (PCCs) were randomised to BA and TAU. Consenting older (≥65 years) adults (n = 161) with clinically relevant symptoms of depression (PHQ-9 ≥ 10) participated. Interventions were an 8-week individual MHN-led BA programme and unrestricted TAU in which general practitioners followed national guidelines. The primary outcome was self-reported depression (QIDS-SR16) at 9 weeks and 3, 6, 9, and 12-month follow-up. RESULTS: Data of 96 participants from 21 PCCs in BA and 65 participants from 16 PCCs in TAU, recruited between July 4, 2016, and September 21, 2020, were included in the intention-to-treat analyses. At post-treatment, BA participants reported significantly lower severity of depressive symptoms than TAU participants (QIDS-SR16 difference = -2.77, 95% CI = -4.19 to -1.35), p < 0.001; between-group effect size = 0.90; 95% CI = 0.42-1.38). This difference persisted up to the 3-month follow-up (QIDS-SR16 difference = -1.53, 95% CI = -2.81 to -0.26, p = 0.02; between-group effect size = 0.50; 95% CI = 0.07-0.92) but not up to the 12-month follow-up [QIDS-SR16 difference = -0.89 (-2.49 to 0.71)], p = 0.28; between-group effect size = 0.29 (95% CI = -0.82 to 0.24). CONCLUSIONS: BA led to a greater symptom reduction of depressive symptoms in older adults, compared to TAU in primary care, at post-treatment and 3-month follow-up, but not at 6- to 12-month follow-up.

"Constructing a health assessment questionnaire for people with intellectual disabilities: A cognitive interview study".

INTRODUCTION: Health assessment instruments can help to raise awareness among general practitioners of specific health problems in people with intellectual disabilities (PID). The present authors developed a health assessment questionnaire using the cognitive interview technique (CI) to improve the comprehensibility. The utility of this approach to questionnaire development involving PID is assessed. METHOD: A qualitative approach using the CI was employed. The study included PID and their caregivers. The present authors interviewed 14 participants in 5 subsequent rounds. After each round, the questionnaire was adjusted until saturation was reached. RESULTS: Three hundred and sixty three identified problems led to 316 changes to the questionnaire. Most problems (102) concerned the comprehension of the question, followed by problems in the "missing answer categories" and "inaccurate instruction" section. CONCLUSION: The comprehensible health assessment questionnaire can help PID to take an active role in communication with their GP. The use of CI helped to improve the questionnaire. CI is a usable and valuable procedure for PID.

Affecting patients with work-related problems by educational training of their GPs: a cost-effectiveness study.

BACKGROUND: Assessing the cost effectiveness of training aimed at increasing general practitioners' (GP) work awareness and patients' work-related self-efficacy and quality of life. METHODS: A cluster randomized controlled trial in twenty-six GP practices in the southeast of the Netherlands with 32 participating GPs. GPs working in an intervention group practice received training and GPs working in a control group practice delivered usual care. The training intervention consisted of lectures and workshops aimed at increasing GPs' work awareness and more proactive counseling for patients with work-related problems (WRP). Subjects were working age patients with paid work for at least 12 h per week, who visited one of the participating GPs during the study period. As outcome measures we used the Return to Work Self Efficacy scale to assess patients' work-related self-efficacy and the Euroquol to assess quality of life. We also measured health care costs and productivity costs. With a 4-item questionnaire we asked patients to assess their GPs' work awareness. Data were collected at baseline, after 6 and 12 months. RESULTS: Data of 280 patients could be analyzed. The patient related outcomes did not improve after GP training. The change in GP work awareness and the overall mean cost difference (of €770) in favor of the intervention group were not significant. CONCLUSIONS: The training intervention presented in this paper was not cost-effective. Training which is further personalized and targeted at high risk groups with respect to WRP, is more likely to be cost effective.

Alpha-glucosidase inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk of developing type 2 diabetes mellitus.

BACKGROUND: Alpha-glucosidase inhibitors (AGI) reduce blood glucose levels and may thus prevent or delay type 2 diabetes mellitus (T2DM) and its associated complications in people at risk of developing of T2DM. OBJECTIVES: To assess the effects of AGI in people with impaired glucose tolerance (IGT), impaired fasting blood glucose (IFG), moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of systematic reviews, articles and health technology assessment reports. The date of the last search of all databases was December 2017. SELECTION CRITERIA: We included randomised controlled trials (RCTs), with a duration of one year or more, comparing AGI with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with IFG, IGT, moderately elevated HbA1c or combinations of these. DATA COLLECTION AND ANALYSIS: Two review authors read all abstracts and full-text articles or records, assessed quality and extracted outcome data independently. One review author extracted data, which were checked by a second review author. We resolved discrepancies by consensus or involvement of a third review author. For meta-analyses we used a random-effects model with assessment of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall quality of the evidence by using the GRADE instrument. MAIN RESULTS: For this update of the Cochrane Review (first published 2006, Issue 4) we included 10 RCTs (11,814 participants), eight investigating acarbose and two investigating voglibose, that included people with IGT or people "at increased risk for diabetes". The trial duration ranged from one to six years. Most trials compared AGI with placebo (N = 4) or no intervention (N = 4).Acarbose reduced the incidence of T2DM compared to placebo: 670 out of 4014 people (16.7%) in the acarbose groups developed T2DM, compared to 812 out of 3994 people (20.3%) in the placebo groups (RR 0.82, 95% CI 0.75 to 0.89; P < 0.0001; 3 trials; 8008 participants; moderate-certainty evidence). One trial including participants with coronary heart disease and IGT contributed 64% of cases for this outcome. Acarbose reduced the risk of T2DM compared to no intervention: 7 out 75 people (9.3%) in the acarbose groups developed T2DM, compared to 18 out of 65 people (27.7%) in the no-intervention groups (RR 0.31, 95% CI 0.14 to 0.69; P = 0.004; 2 trials; 140 participants; very low-certainty evidence).Acarbose compared to placebo did not reduce or increase the risk of all-cause mortality (RR 0.98, 95% CI 0.82 to 1.18; P = 0.86; 3 trials; 8069 participants; very low-certainty evidence), cardiovascular mortality (RR 0.88; 95% CI 0.71 to 1.10; P = 0.26; 3 trials; 8069 participants; very low-certainty evidence), serious adverse events (RR 1.12, 95% CI 0.97 to 1.29; P = 0.13; 2 trials; 6625 participants; low-certainty evidence), non-fatal stroke (RR 0.50, 95% CI 0.09 to 2.74; P = 0.43; 1 trial; 1368 participants; very low-certainty evidence) or congestive heart failure (RR of 0.87; 95% CI 0.63 to 1.12; P = 0.40; 2 trials; 7890 participants; low-certainty evidence). Acarbose compared to placebo reduced non-fatal myocardial infarction: one out of 742 participants (0.1%) in the acarbose groups had a non-fatal myocardial infarction compared to 15 out of 744 participants (2%) in the placebo groups (RR 0.10, 95% CI 0.02 to 0.53; P = 0.007; 2 trials; 1486 participants; very low-certainty evidence). Acarbose treatment showed an increased risk of non-serious adverse events (mainly gastro-intestinal events), compared to placebo: 751 of 775 people (96.9%) in the acarbose groups experienced an event, compared to 723 of 775 people (93.3%) in the placebo groups (RR 1.04; 95% CI 1.01 to 1.06; P = 0.0008; 2 trials; 1550 participants). Acarbose compared to no intervention showed no advantage or disadvantage for any of these outcome measures (very low-certainty evidence).One trial each compared voglibose with placebo (1780 participants) or diet and exercise (870 participants). Voglibose compared to placebo reduced the incidence of T2DM: 50 out of 897 participants (5.6%) developed T2DM, compared to 106 out of 881 participants (12%) in the placebo group (RR 0.46, 95% CI 0.34 to 0.64; P < 0.0001; 1 trial; 1778 participants; low-certainty evidence). For all other reported outcome measures there were no clear differences between voglibose and comparator groups. One trial with 90 participants compared acarbose with diet and exercise and another trial with 98 participants reported data on acarbose versus metformin. There were no clear differences for any outcome measure between these two acarbose interventions and the associated comparator groups.None of the trials reported amputation of lower extremity, blindness or severe vision loss, end-stage renal disease, health-related quality of life, time to progression to T2DM, or socioeconomic effects. AUTHORS' CONCLUSIONS: AGI may prevent or delay the development of T2DM in people with IGT. There is no firm evidence that AGI have a beneficial effect on cardiovascular mortality or cardiovascular events.

Development of a health assessment instrument for people with intellectual disabilities: a Delphi study.

Background: People with intellectual disabilities (IDs) experience health inequalities. Applying health assessments is one way of diminishing these inequalities. A health assessment instrument can support general practitioners (GPs) in providing better medical care to people with ID. Objectives: The aim of this study was to determine which items should be part of a health assessment instrument for people with ID to be used in primary care. Methods: This Delphi consensus study was conducted among 24 GP experts and 21 ID physicians. We performed three anonymous sequential online questionnaire rounds. We started with 82 'general' items and 14 items concerning physical and additional examinations derived from the international literature and a focus group study among Dutch GPs. We definitely included items if more than 75% of the GP experts agreed on their inclusion. Results: The participation rate in all rounds was above 88%. The expert groups proposed 10 new items. Consensus was reached on 64 'general' items related to highly prevalent diseases, public health and health promotion. Consensus was also reached on 18 physical and additional examination items. Conclusions: For the first time, experts in a Delphi study were able to arrive at a selection of items for a health assessment instrument for people with ID. The overall agreement among the GPs and ID physicians was good. Because the experts prefer that patients complete the health assessment questionnaire at home, questions that cover these items must be formulated clearly.

Behavioural activation by mental health nurses for late-life depression in primary care: a randomized controlled trial.

BACKGROUND: Depressive symptoms are common in older adults. The effectiveness of pharmacological treatments and the availability of psychological treatments in primary care are limited. A behavioural approach to depression treatment might be beneficial to many older adults but such care is still largely unavailable. Behavioural Activation (BA) protocols are less complicated and more easy to train than other psychological therapies, making them very suitable for delivery by less specialised therapists. The recent introduction of the mental health nurse in primary care centres in the Netherlands has created major opportunities for improving the accessibility of psychological treatments for late-life depression in primary care. BA may thus address the needs of older patients while improving treatment outcome and lowering costs.The primary objective of this study is to compare the effectiveness and cost-effectiveness of BA in comparison with treatment as usual (TAU) for late-life depression in Dutch primary care. A secondary goal is to explore several potential mechanisms of change, as well as predictors and moderators of treatment outcome of BA for late-life depression. METHODS/DESIGN: Cluster-randomised controlled multicentre trial with two parallel groups: a) behavioural activation, and b) treatment as usual, conducted in primary care centres with a follow-up of 52 weeks. The main inclusion criterion is a PHQ-9 score > 9. Patients are excluded from the trial in case of severe mental illness that requires specialized treatment, high suicide risk, drug and/or alcohol abuse, prior psychotherapy, change in dosage or type of prescribed antidepressants in the previous 12 weeks, or moderate to severe cognitive impairment. The intervention consists of 8 weekly 30-min BA sessions delivered by a trained mental health nurse. DISCUSSION: We expect BA to be an effective and cost-effective treatment for late-life depression compared to TAU. BA delivered by mental health nurses could increase the availability and accessibility of non-pharmacological treatments for late-life depression in primary care. TRIAL REGISTRATION: This study is retrospectively registered in the Dutch Clinical Trial Register NTR6013 on August 25th 2016.

GPs' opinions of health assessment instruments for people with intellectual disabilities: a qualitative study.

BACKGROUND: GPs provide health care to people with intellectual disabilities (ID). People with ID find it difficult to express themselves concerning health-related matters. Applying health assessments is an effective method to reveal health needs, and can play a role in prevention and health promotion. AIM: The aim of this qualitative study was to explore GPs' considerations about applying a health assessment for people with ID. DESIGN AND SETTING: This focus group study was conducted among a selection of Dutch GPs. METHOD: An interview guide was developed. All discussions were audiorecorded and transcribed. Analysis was performed using the framework analysis approach. Two researchers independently applied open coding and identified a thematic framework. This framework and the summaries of views per theme were discussed in the research team. RESULTS: After four focus groups, with 23 GPs, saturation was reached. Three main themes evolved: health assessments in relation to GPs' responsibility; the usefulness and necessity of health assessments; and barriers to using health assessments on people with ID. A health assessment instrument for people with ID can help GPs to focus on certain issues that are not so common in the general population. GPs are motivated to use such a tool if it is scientifically tested, and results in significant health gains. However, GPs identify barriers at the level of GP, patient, and organisation. CONCLUSION: Most GPs in the focus groups consider providing medical care to people with ID their responsibility and indicate that a health assessment instrument could be a valuable tool. In order to deliver good care, they need education and support. Many barriers need to be overcome before a health assessment instrument can be implemented.

Why patients self-refer to the Emergency Department: A qualitative interview study.

RATIONALE, AIMS, AND OBJECTIVES: There have been multiple studies investigating reasons for patients to self-refer to the Emergency Department (ED). The majority made use of questionnaires and excluded patients with urgent conditions. The goal of this qualitative study is to explore what motives patients have to self-refer to an ED, also including patients in urgent triage categories. METHODS: In a large teaching hospital in the Netherlands, a qualitative interview study focusing on reasons for self-referring to the ED was performed. Self-referred patients were included until no new reasons for attending the ED were found. Exclusion criteria were as follows: not mentally able to be interviewed or not speaking Dutch. Patients who were in need of urgent care were treated first, before being asked to participate. Interviews followed a predefined topic guide. Practicing cyclic analysis, the interview topic guide was modified during the inclusion period. Interviews were recorded on an audio recorder, transcribed verbatim, and anonymized. Two investigators independently coded the information and combined the codes into meaningful clusters. Subsequently, these were categorized into themes to build a framework of reasons for self-referral to the ED. Characteristic quotes were used to illustrate the acquired theoretical framework. RESULTS: Thirty self-referred patients were interviewed. Most of the participants were male (63%), with a mean age of 46 years. Two main themes emerged from the interviews that are pertinent to the patients' decisions to attend the ED: (1) health concerns and (2) practical issues. CONCLUSIONS: This study found that there are 2 clearly distinctive reasons for self-referral to the ED: health concerns or practical motives. Self-referral because of practical motives is probably most suitable for strategies that aim to reduce inappropriate ED visits.

Social characteristics and care needs of older persons with medically unexplained symptoms: a case-control study.

BACKGROUND: Research in younger patients with medically unexplained symptoms (MUS) has shown impairments in social functioning, such as loneliness and a reduced quality of the patient-doctor relationship. As far as we know, no studies have been performed on social functioning in older MUS patients; self-reported care needs of older MUS patients remain unknown. OBJECTIVE: To explore social characteristics and care needs of older persons with chronic MUS, when compared to older persons with chronic medically explained symptoms (MES). METHODS: Patient characteristics of 107 older persons (>60 years) with chronic MUS were compared to 150 older persons with chronic MES in a case-control design. Participants were recruited via advertisements, general practices and a specialized clinic. All participants completed questionnaires on social functioning; the Camberwell Assessment of Need for the Elderly was used to draw up care needs. Linear regression analyses were performed to explore the association between social characteristics and group (MUS/MES), adjusted for demographic and physical determinants. Multiple chi-square tests were performed to detect between-group differences regarding care needs. RESULTS: After adjustments, older MUS patients were slightly but significantly lonelier, reported a somewhat lower quality of their patient-doctor relationship, but reported equal social support levels when compared to MES patients. MUS patients more often reported unmet care needs regarding health and information provision about their health status. CONCLUSION: Only small differences in social functioning were found between older MUS and MES patients. Possibly, training future doctors in giving acceptable explanations for the patient's complaints could improve the unmet care need of information provision in older MUS patients.

[Take the time: primary healthcare for people with intellectual disabilities]. / Neem de tijd: zorg voor mensen met verstandelijke beperkingen in de eerste lijn.

People with intellectual disabilities (ID) have a higher prevalence of health problems than the general population and their health needs are often unrecognized and unmet. In this article we present three cases of patients with ID to illustrate some specific problems. A 22-year-old man, severely intellectually disabled, presented with an unsteady gait. He had recently been diagnosed with Cohen Syndrome. Since he was unable to express himself, it took some time to discover that he had additional symptoms, e.g. frequent infections. Eventually, all his complaints fit with his syndrome. A 54-year-old woman, severely to moderately intellectually disabled, presented with new behaviour, i.e. loss of appetite, weakness in her legs and excessive thirst. Although she was able to speak, she was unable to explain what was wrong with her. Since we were aware of the etiology of her disability, Prader Willi syndrome, we were more aware of the possibility of diabetes mellitus. A 56-year-old man, mildly intellectually disabled, presented with hearing voices for which he received antipsychotic medication. After a conversation in simple language, we discovered that he heard humming sounds rather than voices. He was ultimately diagnosed with tinnitus rather than psychosis. It takes time to discover the health issues that affect patients with ID. This is due to communication problems, the inability to understand bodily functions, symptoms and diseases, multi-morbidity, the atypical presentation of disease at times and the different prevalence rates for certain diseases when compared with the general population.

Cost-utility analysis of a treatment advice to discontinue inappropriate long-term antidepressant use in primary care.

BACKGROUND: Antidepressant prescriptions have increased exponentially, burdening health care costs. OBJECTIVE: To evaluate the costs and effects of an antidepressant cessation advice in case of inappropriate long-term use in primary care, i.e. long-term usage without a (current) indication. METHODS: A economic evaluation during 1-year follow-up was performed, from a societal perspective, as part of a cluster-randomised controlled clinical trial (PANDA). Costs were assessed using the Trimbos/iMTA questionnaire for costs associated with psychiatric illness. Health-related quality of life was measured using the EuroQol 5D. Outcome was costs per quality adjusted life year (QALY). Missing values were estimated using multiple imputation, bootstrap simulations were performed to address the uncertainty surrounding the incremental cost-effectiveness ratios (ICERs). RESULTS: There was no difference in average QALYs between the intervention (0.70) and control group (0.72) [difference -0.02 (95% CI -0.05 to 0.10)]. The intervention group, however, was less expensive than the control group (total costs €3636 versus €5267, respectively). Most cost-effectiveness pairs were located in the south-west quadrant of the cost-effectiveness plane, implying the intervention was less effective but also less costly. The ICER of the pooled data was €70,180, meaning that for one QALY lost, €70,180 is saved. CONCLUSIONS: This study shows that an antidepressant cessation advice given to patients (and their FPs) with inappropriate long-term antidepressant usage, albeit not effective, does seem to result in a reduction of societal costs. This reduction in costs is mostly due to reduction of productivity losses, possibly due to patient empowerment and loss of stigma.

Generalist solutions to complex problems: generating practice-based evidence--the example of managing multi-morbidity.

BACKGROUND: A growing proportion of people are living with long term conditions. The majority have more than one. Dealing with multi-morbidity is a complex problem for health systems: for those designing and implementing healthcare as well as for those providing the evidence informing practice. Yet the concept of multi-morbidity (the presence of >2 diseases) is a product of the design of health care systems which define health care need on the basis of disease status. So does the solution lie in an alternative model of healthcare? DISCUSSION: Strengthening generalist practice has been proposed as part of the solution to tackling multi-morbidity. Generalism is a professional philosophy of practice, deeply known to many practitioners, and described as expertise in whole person medicine. But generalism lacks the evidence base needed by policy makers and planners to support service redesign. The challenge is to fill this practice-research gap in order to critically explore if and when generalist care offers a robust alternative to management of this complex problem. We need practice-based evidence to fill this gap. By recognising generalist practice as a 'complex intervention' (intervening in a complex system), we outline an approach to evaluate impact using action-research principles. We highlight the implications for those who both commission and undertake research in order to tackle this problem. SUMMARY: Answers to the complex problem of multi-morbidity won't come from doing more of the same. We need to change systems of care, and so the systems for generating evidence to support that care. This paper contributes to that work through outlining a process for generating practice-based evidence of generalist solutions to the complex problem of person-centred care for people with multi-morbidity.

Mindfulness-based cognitive therapy for patients with medically unexplained symptoms: a cost-effectiveness study.

OBJECTIVE: Our aim was to assess cost-effectiveness of mindfulness-based cognitive therapy (MBCT) compared with enhanced usual care (EUC) in treating patients with persistent medically unexplained symptoms(MUS). METHODS: A full economic evaluation with a one year time horizon was performed from a societal perspective. Costs were assessed by prospective cost diaries. Health-related Quality of Life was measured using SF-6D. Outcomes were costs per Quality-Adjusted Life Year (QALY). Bootstrap simulations were performed to obtain mean costs, QALY scores and incremental cost-effectiveness ratios (ICERs). RESULTS: MBCT participants (n=55) had lower hospital costs and higher mental health care costs than patients who received EUC (n=41). Mean bootstrapped costs for MBCT were €6269, and €5617 for EUC (95% uncertainty interval for difference: -€1576; €2955). QALYs were 0.674 for MBCT and 0.663 for EUC. MBCT was on average more effective and more costly than EUC, resulting in an ICER of €56,637 per QALY gained. At a willingness to pay of €80,000 per QALY, the probability that MBCT is cost-effective is 57%. CONCLUSION: Total costs were not statistically significantly different between MBCT and EUC. However, MBCT seemed to cause a shift in the use of health care resources as mental health care costs were higher and hospital care costs lower in the MBCT condition. Due to the higher drop-out in the EUC condition the cost-effectiveness of MBCT might have been underestimated. The shift in health care use might lead to more effective care for patients with persistent MUS. The longer-term impact of MBCT for patients with persistent MUS needs to be further studied.

Prescribing ANtiDepressants Appropriately (PANDA): a cluster randomized controlled trial in primary care.

BACKGROUND: Inappropriate use of antidepressants (AD), defined as either continuation in the absence of a proper indication or continuation despite the lack of therapeutic efficacy, applies to approximately half of all long term AD users. METHODS/DESIGN: We have designed a cluster randomized controlled clinical trial to assess the (cost-) effectiveness of an antidepressant cessation advice in the absence of a proper indication for maintenance treatment with antidepressants in primary care.We will select all patients using antidepressants for over 9 months from 45 general practices. Patients will be diagnosed using the Composite International Diagnostic Interview (CIDI) version 3.0, extended with questions about the psychiatric history and previous treatment strategies. General practices will be randomized to either the intervention or the control group. In case of overtreatment, defined as the absence of a proper indication according to current guidelines, a cessation advice is given to the general practitioner. In the control groups no specific information is given. The primary outcome measure will be the proportion of patients that successfully discontinue their antidepressants at one-year follow-up. Secondary outcomes are dimensional measures of psychopathology and costs. DISCUSSION: This study protocol provides a detailed overview of the design of the trial. Study results will be of importance for refining current guidelines. If the intervention is effective it can be used in managed care programs. TRIAL REGISTRATION: NTR2032.

The quality dilemma.

In the language and logic of the free market, providers of health care will have to demonstrate the quality of their work. However, in this setting quality is only interpreted in quantitative ways and consequently does not necessarily do justice to good physicians. Moreover, both outcome measures and process measures have serious drawbacks. An emphasis on outcome measures will disadvantage physicians working in deprived areas and doctors managing more complicated cases. Although process measures give the most direct information on the physician's performance, their evidence base is not always as straightforward as commonly supposed. Finally, measurement of quality indicators is complicated and time consuming. Physicians should be aware of the drawbacks of quality measurement and of the poor effects of quality improvement strategies on patient outcomes.