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C Hewitt, S Gilbody,
S Brealey,
M Paulden,
S Palmer,
R Mann,
J Green,
J Morrell,
M Barkham,
K Light,
D Richards
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ABSTRACT: To provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research.
Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists.
A generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies.
The Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model.
In light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking. Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify postnatal depression. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness.
Health technology assessment (Winchester, England). 08/2009; 13(36):1-145, 147-230.
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ABSTRACT: Studies of cognitive behavioural therapy delivered by computer (cCBT) show clinical efficacy for treating anxiety and depression, but have not focused on barriers to uptake. Potential barriers include adverse consequences, accessibility and acceptability.
An integrated systematic review was conducted of quantitative and qualitative studies and surveys from multiple electronic databases where computers delivered cCBT for anxiety or depression.
Substantial numbers of potential participants are lost prior to trials commencing with little explanation. Among trial participants, drop-outs may be higher in the cCBT groups (odds ratio 2.03, 95% confidence interval 0.81-5.09). Only a median of 56% completed a full course of cCBT and personal circumstance was a more common cause of drop-out than difficulties with the technology or social background. Risk was rarely assessed in the majority of programs. Significant staff time was needed to support clients. Therapists were more negative about cCBT than clients.
While cCBT is likely to be an effective and acceptable intervention for some people, there are barriers to its uptake that will substantially limit its impact if not addressed. These included investigating the outcome and attitudes of those who do not make it as far as cCBT trials and why so few finish a full course of cCBT.
Psychological Medicine 10/2008; 39(5):705-12. · 6.16 Impact Factor
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ABSTRACT: To assemble and to appraise critically the current literature on tests and measures of therapist-patient interactions in order to make recommendations for practice, training and research, and to establish benchmarks for standardisation, acceptability and routine use of such measures.
Major electronic databases (including PsycINFO) were searched from inception to 2002.
A comprehensive conceptual map of the subject area of therapist-patient interactions was developed through data extraction from, and analysis of, studies selected from the literature searches. The results of these searches were assessed and appraised to produce a set of possible therapist-patient measures. These measures were then evaluated.
The contextual map included the various concepts and domains that had been used in the context of the literature on therapist-patient interactions, and was used to guide the successive stages of the review. Three developmental processes were identified as necessary for the provision of an effective therapeutic relationship: 'establishing a relationship', 'developing a relationship' and 'maintaining a relationship'. Eighty-three therapist-patient measures having basic information on reliability and validity were identified for critical appraisal. The areas of the conceptual map that received most coverage (i.e. over 50% measures associated with them) were framework, therapist and patient engagement, roles, therapeutic techniques and threats to the relationship. These areas relate to the three key developmental processes outlined above. Of the 83 measures matching the content domain, 43 met the minimum standard. A total of 30 measures displayed adequate responsiveness or precision. None of the 43 measures that met the minimum standard was fully addressed in terms of acceptability and feasibility evidence. The majority of these measures had three or fewer components described. Therefore, out of a total of 83 measures matching the content domain, no measure could be said to have met an industry standard.
The findings indicate that the therapist-patient interaction can be measured using a wide range of instruments of varying value. However, due care should be taken in ensuring that the measure is suitable for the context in which it is to be used. Following on from this work, it is suggested that specific research networks for the development of therapist-patient measures should be established, that research activity should prioritise investment in increasing the evidence base of existing measures rather than attempting to develop new ones, and that research activity should focus on improving these existing measures in terms of acceptability and feasibility issues.
Health technology assessment (Winchester, England) 07/2008; 12(24):iii, ix-47. · 4.26 Impact Factor
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ABSTRACT: Depression is a common, disabling condition for which psychological treatments, in particular cognitive behavioural therapies are recommended. Promising results in recent randomized trials have renewed interest in behavioural therapy. This systematic review sought to identify all randomized trials of behavioural therapy for depression, determine the effect of such interventions and examine any moderators of such effect.
Randomized trials of behavioural treatments of depression versus controls or other psychotherapies were identified using electronic database searches, previous reviews and reference lists. Data on symptom-level, recovery/dropout rate and study-level moderators (study quality, number of sessions, severity and level of training) were extracted and analysed using meta-analysis and meta-regression respectively.
Seventeen randomized controlled trials including 1109 subjects were included in this meta-analysis. A random-effects meta-analysis of symptom-level post-treatment showed behavioural therapies were superior to controls [standardized mean difference (SMD) -0.70, 95% CI -1.00 to -0.39, k=12, n=459], brief psychotherapy (SMD -0.56, 95% CI -1.0 to -0.12, k=3, n=166), supportive therapy (SMD -0.75, 95% CI -1.37 to -0.14, k=2, n=45) and equal to cognitive behavioural therapy (SMD 0.08, 95% CI -0.14 to 0.30, k=12, n=476).
The results in this study indicate behavioural therapy is an effective treatment for depression with outcomes equal to that of the current recommended psychological intervention. Future research needs to address issues of parsimony of such interventions.
Psychological Medicine 06/2008; 38(5):611-23. · 6.16 Impact Factor
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D A Richards,
K Lovell, S Gilbody,
L Gask,
D Torgerson,
M Barkham,
M Bland,
P Bower,
A J Lankshear,
A Simpson,
J Fletcher,
D Escott,
S Hennessy,
R Richardson
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ABSTRACT: Collaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial.
We undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to 'collaborative care' - case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication - or a usual care control. The primary outcome was symptoms of depression (PHQ-9).
We recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (-2.99, 95% CI -7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (-4.64, 95% CI -7.93 to -1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00-0.32).
Collaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.
Psychological Medicine 03/2008; 38(2):279-87. · 6.16 Impact Factor
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ABSTRACT: To determine the clinical effectiveness and cost-effectiveness of pharmacological and/or psychosocial interventions for the prevention of relapse in people with bipolar disorder.
Major electronic databases were searched up to September 2005.
Systematic reviews were undertaken on the clinical and economic effectiveness of treatments. An analysis was performed using the methods of mixed treatment comparison (MTC) to enable indirect comparisons to be made between the treatments. An economic model of treatments for the prevention of relapse in bipolar disorder was developed.
Forty-five trials were included in the clinical effectiveness review; all but one studied adults. This review found that for the prevention of all relapses, lithium, valproate, lamotrigine and olanzapine performed better than placebo, with lithium and lamotrigine having the strongest evidence. For depressive relapse prevention, valproate, lamotrigine and imipramine performed better than placebo, with evidence strongest for lamotrigine and weakest for imipramine. For manic relapses, lithium and olanzapine performed significantly better than placebo. The MTC found that the best treatment for bipolar I patients with mainly depressive symptoms was valproate, followed by lithium plus imipramine. For bipolar I patients with mainly manic symptoms, olanzapine was the best treatment. From the studies investigating psychosocial interventions, there were few data for each comparison and outcome. The evidence suggests that cognitive behaviour therapy (CBT), in combination with usual treatment, is effective for the prevention of relapse. Group psychoeducation and possibly family therapy may also have roles as adjunctive therapy for preventing relapse. The results from the decision analytic model developed on the cost-effectiveness of long-term maintenance treatments of bipolar I patients suggest that the choice of treatment is dependent upon a number of factors: the previous episode history of a patient and the mortality benefit assumed for lithium strategies. The results from the base-case analysis for patients with a recent history of depression suggest that valproate, lithium and the combination of lithium and imipramine are potentially cost-effective depending upon the amount that a decision-maker is willing to pay for additional health gain. Using conventional amounts that the NHS is prepared to pay for health gain, then the lithium-based strategies appear to be potentially cost-effective for this group. For patients with a recent history of mania, the choice of pharmacological intervention appears to be between olanzapine and lithium monotherapy. Again using conventional threshold as a reference point, the results suggest that lithium is the most cost-effective therapy. Excluding the additional mortality benefit associated with lithium-based strategies resulted in all treatments for patients with a recent history of a depressive episode being dominated by valproate and, in the case of patients with a recent history of a manic episode, by olanzapine.
Lithium, valproate, lamotrigine and olanzapine are effective as maintenance therapy for the prevention of relapse in bipolar disorder. Olanzapine and lithium are efficacious for the prevention of manic relapses and valproate, lamotrigine and imipramine for the prevention of depressive relapse. There is some evidence that CBT, group psychoeducation and family therapy might be beneficial as adjuncts to pharmacological maintenance treatments. Insufficient information is available regarding the relative tolerability of the treatments or their relative effects on suicide rate and mortality. For patients with a recent depressive episode, valproate, lithium monotherapy and the combination of lithium and imipramine are potentially cost-effective. For patients with a recent manic episode, olanzapine and lithium monotherapy are potentially cost-effective. The cost-effectiveness estimates in both groups of patients were shown to be sensitive to the assumption of a reduced suicidal risk associated with lithium-based strategies. Further research is needed into the adverse effects of all treatments and the differential effects of agents. Good-quality trials of valproate, of combination therapy, e.g. lithium plus a selective serotonin reuptake inhibitor antidepressant, of psychosocial interventions and of the disorder in children are also required.
Health technology assessment (Winchester, England) 11/2007; 11(39):iii-iv, ix-206. · 4.26 Impact Factor
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D K Raynor,
A Blenkinsopp,
P Knapp,
J Grime,
D J Nicolson,
K Pollock,
G Dorer, S Gilbody,
D Dickinson,
A J Maule,
P Spoor
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ABSTRACT: To establish the role and value of written information available to patients about individual medicines from the perspective of patients, carers and professionals. To determine how effective this information is in improving patients' knowledge and understanding of treatment and health outcomes.
Electronic databases searched to late 2004, experts in information design, and stakeholder workshops (including patients and patient organisations).
Data from selected studies were tabulated and the results were qualitatively synthesised along with findings from the information design and stakeholder workshop strands.
Most people do not value the written information they receive. They had concerns about the use of complex language and poor visual presentation and in most cases the research showed that the information did not increase knowledge. The research showed that patients valued written information that was tailored to their individual circumstances and illness, and that contained a balance of harm and benefit information. Most patients wanted to know about any adverse effects that could arise. Patients require information to help decision-making about whether to take a medicine or not and (once taking a medicine) with ongoing decisions about the management of the medicine and interpreting symptoms. Patients did not want written information to be a substitute for spoken information from their prescriber. While not everyone wanted written information, those who did wanted sufficient detail to meet their need. Some health professionals thought that written information for patients should be brief and simple, with concerns about providing side-effect information. They saw increasing compliance as a prime function, in contrast to patients who saw an informed decision not to take a medicine as an acceptable outcome.
The combination of a quantitative and qualitative review, an exploration of best practice in information design, plus the input of patients at stakeholder workshops, allowed this review to look at all perspectives. There is a gap between currently provided leaflets and information which patients would value and find more useful. The challenge is to develop methods of provision flexible enough to allow uptake of varying amounts and types of information, depending on needs at different times in an illness. This review has identified a number of areas where future research could be improved in terms of the robustness of its design and conduct, and the use of patient-focused outcomes. The scope for this research includes determining the content, delivery and layout of statutory leaflets that best meet patients' needs, and providing individualised information, which includes both benefit and harm information. In particular, studies of the effectiveness and role and value of Internet-based medicines information are needed.
Health technology assessment (Winchester, England) 03/2007; 11(5):iii, 1-160. · 4.26 Impact Factor
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ABSTRACT: Direct to consumer advertising is increasingly used by the pharmaceutical industry, but its benefits and harms have yet to be summarised in a comprehensive and rigorous manner.
A systematic review was conducted of robust evaluations of the impact (positive and negative) of direct to consumer advertising. A broad range of databases and data sources (including Cinahl, Embase, HMIC, HSRProj, Medline, PsycInfo, and the internet) were searched from inception to 2004.
From 2853 citations only four reports were found that met the strict inclusion criteria and provided usable results. Direct to consumer advertising is associated with increased prescription of advertised products and there is substantial impact on patients' request for specific drugs and physicians' confidence in prescribing. No additional benefits in terms of health outcomes were demonstrated.
Direct to consumer advertising is banned in most countries, and the research evidence tends to support the negative impact that is feared by those who support a legislative ban. Further research is needed into the clinical and economic impact of direct to consumer advertising in healthcare systems.
Quality and Safety in Health Care 09/2005; 14(4):246-50. · 1.68 Impact Factor
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ABSTRACT: Screening or case finding instruments have been advocated as a simple, quick and inexpensive method to improve detection and management of depression in non-specialist settings, such as primary care and the general hospital. However, screening/case finding is just one of a number of strategies that have been advocated to improve the quality of care for depression. The adoption of this seemingly simple and effective strategy should be underpinned by evidence of clinical and cost effectiveness.
To determine the clinical and cost effectiveness of screening and case finding instruments in: (1) improving the recognition of depression; (2) improving the management of depression, and (3) improving the outcome of depression.
The researchers undertook electronic searches of The Cochrane Library (Issue 4, 2004); The Cochrane Depression, Anxiety and Neurosis Group's Register [2004); EMBASE (1980-2004); MEDLINE (1966-2004); CINAHL (to 2004) and PsycLIT (1974-2004). References of all identified studies were searched for further trials, and the researchers contacted authors of trials.
Randomised controlled trials of the administration of case finding/screening instruments for depression and the feedback of the results of these instruments to clinicians, compared with no clinician feedback. Trials had to be conducted in non-mental health settings, such as primary care or the general hospital. Studies that used screening strategies in addition to enhanced care, such as case management and structured follow up, were specifically excluded.
Citations and, where possible, abstracts were independently inspected by researchers, papers ordered, re-inspected and quality assessed. Data were also independently extracted. Data relating to: (1) the recognition of depression; (2) the management of depression and (3) the outcome of depression over time were sought. For dichotomous data the Relative Risk (RR), 95% confidence interval (CI) were calculated on an intention-to-treat basis. For continuous data, weighted and standardised mean difference were calculated. A series of a priori sensitivity analyses relating to the method of administration of questionnaires and population under study were used to examine plausible causes of heterogeneity.
Twelve studies (including 5693 patients) met our inclusion criteria. Synthesis of these data gave the following results:(1) the recognition of depression: according to case note entries of depression, screening/case finding instruments had borderline impact on the overall recognition of depression by clinicians (relative risk 1.38; 95% confidence interval 1.04 to 1.83). However, substantial heterogeneity was found for this outcome. Screening and feedback, irrespective of baseline score of depression has no impact on the detection of depression (relative risk 1.00; 95% confidence interval 0.89 to 1.13). In contrast, three small positive studies using a two stage selective procedure, whereby patients were screened and only patients scoring above a certain threshold were entered into the trial, did suggest that this approach might be effective (relative risk 2.66; 95% confidence interval 1.78 to 3.96). Separate pooling according to this variable reduced the overall level of heterogeneity. Publication bias was also found for this outcome.(2) the management of depression: according to case note entries for active interventions and prescription data, a selected subsample of all studies reported this outcome and found that there was there was an overall trend to showing a borderline higher intervention rate amongst those who received feedback of screening/case finding instruments (relative risk 1.35; 95% confidence interval 0.98 to 1.85), although substantial heterogeneity between studies existed for this outcome. This result was dependant upon the presence of one highly positive study.(3) the outcome of depression: few studies reported the impact of case finding/screening instruments on the actual outcome of depression, and no statistical pooling was possible. However, three out of four studies reported no clinical effect (p<0.05) at either six months or twelve months. No studies examined the cost effectiveness of screening/case finding as a strategy.
There is substantial evidence that routinely administered case finding/screening questionnaires for depression have minimal impact on the detection, management or outcome of depression by clinicians. Practice guidelines and recommendations to adopt this strategy, in isolation, in order to improve the quality of healthcare should be resisted. The longer term benefits and costs of routine screening/case finding for depression have not been evaluated. A two stage procedure for screening/case finding may be effective, but this needs to be evaluated in a large scale cluster randomised trial, with a prospective economic evaluation.
Cochrane database of systematic reviews (Online) 02/2005; · 5.72 Impact Factor
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Health technology assessment (Winchester, England) 02/2003; 7(13):1-193. · 4.26 Impact Factor
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Quality in Health Care 04/2000; 9(1):73-9.
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Health technology assessment (Winchester, England) 02/2000; 4(10):1-115. · 4.26 Impact Factor
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BMJ 11/1999; 319(7214):917-8. · 14.09 Impact Factor
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The British Journal of Psychiatry 11/1999; 175:303-5. · 6.62 Impact Factor
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Journal of Epidemiology & Community Health 08/1999; 53(7):442-3. · 3.19 Impact Factor
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BMJ 03/1998; 316(7129):471. · 14.09 Impact Factor
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Quality in Health Care 01/1998; 6(4):219-25.
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The Health service journal 08/1997; 107(5563):32-3.
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BMJ 04/1997; 314(7083):828-9. · 14.09 Impact Factor
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BMJ 12/1995; 311(7015):1303-4. · 14.09 Impact Factor
