Stepped care for depression and anxiety: from primary care to specialized mental health care: a randomised controlled trial testing the effectiveness of a stepped care program among primary care patients with mood or anxiety disorders

Background

There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption on the physical, psychological and social health of the population. There also exists a substantial evidence base for the efficacy of brief interventions aimed at reducing alcohol consumption across a range of healthcare settings. Primary research conducted in emergency departments has reinforced the current evidence regarding the potential effectiveness and cost-effectiveness. Within this body of evidence there is marked variation in the intensity of brief intervention delivered, from very minimal interventions to more intensive behavioural or lifestyle counselling approaches. Further the majority of primary research has been conducted in single centre and there is little evidence of the wider issues of generalisability and implementation of brief interventions across emergency departments.

Methods/design

The study design is a prospective pragmatic factorial cluster randomised controlled trial. Individual Emergency Departments (ED) (n = 9) are randomised with equal probability to a combination of screening tool (M-SASQ vs FAST vs SIPS-PAT) and an intervention (Minimal intervention vs Brief advice vs Brief lifestyle counselling). The primary hypothesis is that brief lifestyle counselling delivered by an Alcohol Health Worker (AHW) is more effective than Brief Advice or a minimal intervention delivered by ED staff. Secondary hypotheses address whether short screening instruments are more acceptable and as efficient as longer screening instruments and the cost-effectiveness of screening and brief interventions in ED. Individual participants will be followed up at 6 and 12 months after consent. The primary outcome measure is performance using a gold-standard screening test (AUDIT). Secondary outcomes include; quantity and frequency of alcohol consumed, alcohol-related problems, motivation to change, health related quality of life and service utilisation.

Discussion

This paper presents a protocol for a large multi-centre pragmatic factorial cluster randomised trial to evaluate the effectiveness and cost-effectiveness of screening and brief interventions for hazardous alcohol users attending emergency departments.

Trial Registration

ISRCTN 93681536     

Effectiveness of psychoeducational support on quality of life in early-stage breast cancer patients: a systematic review and meta-analysis of randomized controlled trials

Purpose

Most breast cancer patients receive psychosocial support interventions. However, the effectiveness of these interventions has not yet been clarified. Quality of life (QOL) was an important construct that should be considered when assessing these interventions. The purpose was to evaluate the effectiveness of psychosocial and especially psychoeducational support interventions for early-stage breast cancer patients since the follow-up was bound up to 6 months after finishing the intervention.

Methods

We conducted a systematic review and meta-analysis to identify randomized controlled trials with early-stage breast cancer patients receiving psychosocial (psychoeducational and other) support in which QOL was measured as a treatment outcome. We compared mean differences at less than 6 months post-intervention with a control group. The primary outcome was Global Health Status/QOL scale (Global QOL), and secondary outcomes were the subscales of QOL.

Results

No significant effect was observed for Global QOL; however, individuals receiving psychosocial support scored higher on the Breast Cancer Symptoms subscale. For psychoeducational support in the psychosocial support, significant effect was observed on the Emotional subscale.

Conclusions

Our analysis strengthens the evidence of the effectiveness of psychosocial support in improving breast cancer symptoms and psychoeducational support in improving emotional well-being within 6 months post-intervention.     

Cost effectiveness of tobacco control policies in Vietnam

Background

Tobacco smoking is one of the leading public health problems in the world. It is also possible to prevent and/or reduce the harm from tobacco use through the use of cost-effective tobacco control measures. However, most of this evidence comes from developed countries and little research has been conducted on this issue in developing countries.

Objective

The objective of this study was to analyse the cost effectiveness of four population-level tobacco control interventions in Vietnam.

Methods

Four tobacco control interventions were evaluated: excise tax increase; graphic warning labels on cigarette packs; mass media campaigns; and smoking bans (in public or in work places). A multi-state life table model was constructed in Microsoft® Excel to examine the cost effectiveness of the tobacco control intervention options. A government perspective was adopted, with costing conducted using a bottom-up approach. Health improvement was considered in terms of disability-adjusted life-years (DALYs) averted. All assumptions were subject to sensitivity and uncertainty analysis.

Results

All the interventions fell within the definition of being very cost effective according to the threshold level suggested by the WHO (i.e. Conclusions All four interventions to reduce the harm from tobacco use appear to be highly cost effective and should be considered as priorities in the context of Vietnam. The government may initially consider graphic warning labels and tax increase, followed by other interventions.     

Steady state trials: another valid substitution of counterfactual ideal to measure causal effects

Objectives

Many traditionally established medical interventions are not examined with randomized trials especially in emergency medicine. We researched what is the scientific basis of the measurement of the causal effect in these interventions and proposed another trial to measure causal effects.

Methods

We deduced steady state trials from the counterfactual model and used Bayesian approaches to estimate causal effects statistically.

Results

When the state of the observed person is fairly steady before an exposure, the ratio of the after-period to the before-period of the exposure is sufficiently small, and changes are obtained in relatively short time, it is possible to postulate that the state of the counterfactual person to be compared is almost equal to the state of the real person before the exposure. Bayesian approaches show that the causal effect of the exposure is estimated even in only one-person steady state trials, when large changes are observed.

Conclusions

Steady state trials are valid methods to measure causal effects and can measure causal effects even in one-person trials. When we can measure the causal effect of interventions with steady state trials, these interventions should be regarded as scientific without use of randomized trials.     

Effectiveness of workplace health promotion and primary prevention interventions: a review

Background

Workplace health promotion and primary prevention interventions are highly prevalent. However, their effectiveness remains mostly unclear.

Aim

This article compiles and summarizes the results of current reviews concerning the effectiveness of health promotion and primary prevention interventions in the workplace.

Subjects and methods

Studies were selected from four electronic databases on the basis of the following criteria: (1) Meta-analysis or systematic reviews, (2) published in international peer-reviewed journals (3) between 1 January 2004 and 30 June 2008 (4) in English or German (5) that examined the effectiveness of workplace health promotion and primary prevention interventions.

Results

Seventeen reviews met the inclusion criteria and were subsequently categorized into the following areas of intervention: stress, physical activity and nutrition, organizational development, smoking, and ergonomics and back pain. Singular interventions showed limited effectiveness. Workplace interventions aimed at helping individuals reported substantially greater effects than workplace interventions aimed at the workforce as a whole; here, methodological influences play an important role.

Conclusions

The greatest results are achievable through comprehensive multimodal (or systemic) programs including relational and behavioral elements. Future research is needed in the conception of methodologically sound and setting-appropriate study designs.     

Gesundheitsbezogene Interventionen in der Arbeitswelt

Background

The effectiveness of workplace health promotion programs is mostly unclear.

Methods

This article summarizes the results of current reviews concerning the effectiveness of health promotion and primary prevention interventions in the workplace. Studies were selected from 4 databases on the basis of the following criteria: meta-analysis or systematic reviews published in international peer-reviewed journals between 01/01/04 and 30/06/08 in English or German that examined the effectiveness of workplace health promotion and primary prevention interventions.

Results and conclusions

Seventeen reviews met the inclusion criteria. Singular interventions show limited effectiveness. Workplace interventions aimed at helping individuals report substantially greater results than workplace interventions aimed at the workforce as a whole; here, methodological influences play an important role. With comprehensive programs – including relational and behavioral elements – the greatest results can be achieved. Future research is needed in the conception of methodologically sound and setting-appropriate study designs.     

Equity-focused knowledge translation: a framework for “reasonable action” on health inequities

Objectives

To identify gaps in procedural approaches to knowledge translation and outline a more relational approach that addresses health inequities based on creating collaborative environments for reasonable action.

Methods

A literature review encompassing approaches to critical inquiry of the institutional conditions in which knowledge is created combined with a process for encouraging reflexive professional practice provide the conceptual foundation for our approach, called equity-focused knowledge translation (EqKT).

Results

The EqKT approach creates a matrix through which teams of knowledge stakeholders (researchers, practitioners, and policymakers) can set common ground for taking collaborative action on health inequities.

Conclusions

Our approach can contribute to the call by the WHO Commission on the Social Determinants of Healths for more reasonable action on health inequities by being incorporated into numerous public health settings and processes. Further steps include empirical applications and evaluations of EqKT in real world applications.     

Disease prevention and health promotion programs: benefits, implementation, quality assurance and open questions??a summary of the evidence

Aim

Disease prevention and health promotion programs are standardized behavioral interventions that may be combined with contextual interventions. With optimized methods, they offer proven efficacy, efficiency, transparency, manageability, and rapid transfer of knowledge.

Subject and methods

This review summarizes their central barriers and success factors based on current research.

Results

Important barriers to effective use of disease prevention and health promotion programs are low implementation fidelity, exaggerated flexibility subject to political change, inadequately trained and overworked personnel, disregard of context, change of implementation frameworks, lack of supportive contextual interventions, a plethora of programs, scarce resources and weak organizational support, resistance to social technologies, choices based on marketing criteria instead of effectiveness, and research gaps. Solutions include robust intervention plans, clear and comprehensive manuals, definition of intervention core and periphery, organizational and leadership support, qualification of users, systematic adaptation to local conditions, and quality assurance/monitoring of acceptance and effectiveness.

Conclusion

Both users and decision-makers should demand proof of effectiveness of program choices and should adhere to quality assurance procedures during implementation. Program development and evaluation should ensure (1) the definition of core intervention components, (2) instructions for adaptation of programs to specific contexts, (3) basic data on resources required for implementation, and (4) evidence of program effectiveness.     

Studies with staggered starts: multiple baseline designs and group-randomized trials

Objectives. Multiple baseline designs (MBDs) have been suggested as alternatives to group-randomized trials (GRT). We reviewed structural features of MBDs and considered their potential effectiveness in public health research. We also reviewed the effect of staggered starts on statistical power.Methods. We reviewed the MBD literature to identify key structural features, recent suggestions that MBDs be adopted in public health research, and the literature on power in GRTs with staggered starts. We also computed power for MBDs and GRTs.Results. The features that have contributed to the success of small MBDs in some fields are not likely to translate well to public health research. MBDs can be more powerful than GRTs under some conditions, but those conditions involve assumptions that require careful evaluation in practice.Conclusions. MBDs will often serve better as a complement of rather than as an alternative to GRTs. GRTs may employ staggered starts for logistical or ethical reasons, but this will always increase their duration and will often increase their cost.The randomized controlled trial (RCT) is the gold standard for causal inference for individual-level interventions.¹ When interventions are applied at the group level and outcomes are measured at the individual level, the cluster- or group-randomized trial (GRT) is the gold standard for causal inference.^2,3 However, GRTs are often costly and time-consuming, prompting researchers to look for alternatives. One alternative that has been suggested is the multiple baseline design (MBD), which has a venerable history in education and applied behavior research with individual-level interventions but is relatively new in public health research with group-level interventions.^4–6 The MBD makes repeated measurements over a period of time and introduces a sustained intervention on a staggered schedule; intervention effects synchronized with the staggered start times provide evidence for causal inference. Hawkins et al. described the MBD as “a viable alternative to the RCT” and suggested that it will be lower cost, use smaller sample sizes, and still be statistically rigorous.⁵ Biglan et al. suggested complementary roles, with MBDs used to “develop and sort through potentially effective intervention methods, followed by evaluation in RCTs both to test efficacy and to determine the extent of generalizability.”⁴ We review the structural features that have made MBDs useful in other fields and consider whether similar success is likely in public health. We also compare the statistical power of MBDs and GRTs.     

Improving prescribing of antihypertensive and cholesterol-lowering drugs: a method for identifying and addressing barriers to change

Background

We describe a simple approach we used to identify barriers and tailor an intervention to improve pharmacological management of hypertension and hypercholesterolaemia. We also report the results of a post hoc exercise and survey we carried out to evaluate our approach for identifying barriers and tailoring interventions.

Methods

We used structured reflection, searched for other relevant trials, surveyed general practitioners and talked with physicians during pilot testing of the intervention. The post hoc exercise was carried out as focus groups of international researchers in the field of quality improvement in health care. The post hoc survey was done by telephone interviews with physicians allocated to the experimental group of a randomised trial of our multifaceted intervention.

Results

A wide range of barriers was identified and several interventions were suggested through structured reflection. The survey led to some adjustments. Studying other trials and pilot testing did not lead to changes in the design of the intervention. Neither the post hoc focus groups nor the post hoc survey revealed important barriers or interventions that we had not considered or included in our tailored intervention.

Conclusions

A simple approach to identifying barriers to change appears to have been adequate and efficient. However, we do not know for certain what we would have gained by using more comprehensive methods and we do not know whether the resulting intervention would have been more effective if we had used other methods. The effectiveness of our multifaceted intervention is under evaluation in a randomised controlled trial.     

Patient-important activity and participation outcomes in clinical trials involving children with chronic conditions

Purpose

Children with chronic conditions experience medical issues over long-term periods of time which can have lasting emotional and social consequences impacting daily life and functioning. Activities and participation outcomes are needed in order to comprehensively assess child-important health in clinical trials. Our objective was to review the extent to which activity and participation outcomes are included in clinical trials of childhood chronic disease and to determine what trial characteristics are associated with their use.

Methods

A review of a large clinical trial registration database (clinicaltrials.gov) was conducted over the 2010 calendar year. The measures used to assess primary and secondary endpoints were coded according to the ICF classification system. Trial characteristics that might be associated with activity and participation outcome use such as sponsorship type, intervention type, health condition, whether the trial was focused on pediatric patients, phase of trial and sample size were also extracted and explored with univariable and multivariable regressions.

Results

Four hundred and ninety-nine trials met inclusion criteria, 495 of which had complete information about hypothesized predictors. Only 36 out of 495 trials included an activity and participation outcome as part of the trial evaluation process. Both univariable and multivariable regression models showed that non-drug trials and late phase of trial (phase IV) showed the strongest likelihood with whether a trial would include an activity and participation outcome.

Discussion

Most registered clinical trials for children with chronic or ongoing medical conditions do not include a comprehensive approach to health outcomes assessment, especially drug trials and early phase trials. Outcome measures in pediatric clinical trials are lagging relative to World Health Organization standards for comprehensive health evaluation.     

Gesundheitsförderung durch Organisationsentwicklung

Background

The Ottawa Charter presents with its setting approach a strategy for health promotion and prevention, which reacts to specific living conditions in the late modern world society.

Aims

This contribution analyses, by using systems theoretical concepts and assumptions, the understanding of health and health promotion of the Ottawa Charter. It discusses characteristics of settings relevant for health promotion, especially those of organisations and regional political units.

Results

Strategic options for influencing health are provided by using a simple model of action which identifies different entry points for health promoting interventions in organisations. How organisations influence the health of different stakeholders and how they can alter these influences by implementing sustainable health promotion interventions is demonstrated.

Conclusions

General transformation strategies for organisations can be used and adapted successfully for implementing health promotion, as the WHO Network of Health Promoting Hospitals e.g. shows.     

The promising application of health technology assessment in public health: a review of background information and considerations for future development

Introduction

Health technology assessment (HTA) is a multidisciplinary approach to the evaluation of health-care technologies, which aims to support the decision-making process by driving medical, technical and economic knowledge. It is characterised by the contextual examination of epidemiological, clinical, economic, social, ethical and organisational implications.

Main part

Even if it was born in fields other than medicine, HTA has progressively spread as an innovative tool to assess health-care technologies such as drugs, medical devices and surgical procedures. Through a scientific literature review the purpose of applying HTA to public health was explained and discussed. Tackling interventions to control health determinants has great potential for reducing the burden of disease and for promoting health in the general population. Anyway health expenditure for public health is low: this could threaten interventions and damage the role of public health itself. HTA could represent a guide to best invest in this field and to gain in efficacy and effectiveness in line with current strategies to implement health services in all sectors.

Conclusion

HTA could represent a good tool to address all topics and problems pertaining to choices in public health and could allow decision-makers to best invest scarce available resources.     

The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

Background

There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people's mental health. The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors.

Methods and design

The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR), awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes.

Discussion

Although it has been reported that suicide-preventive interventions can be effective in decreasing suicidal behavior, well-documented and randomized studies are lacking. The effects of such interventions in terms of combating unhealthy lifestyles in young people, which often characterize suicidal individuals, have never been reported. We know that unhealthy and risk-taking behaviors are detrimental to individuals' current and future health. It is, therefore, crucial to test well-designed, longitudinal mental health-promoting and suicide-preventive interventions by evaluating the implications of such activities for reducing unhealthy and risk behaviors while concurrently promoting healthy ones.

Trial registration

The German Clinical Trials Register, DRKS00000214.     

The influence of (public) health expenditure on longevity

Objectives

We report new evidence on the contribution of health expenditure to increasing life expectancy in OECD countries, differentiating the effects of public and private health expenditures.

Methods

A theoretical model is presented and estimated though a cross-country fixed effects multiple regression analysis for a sample of OECD countries over the period 1980–2000.

Results

Although the effect of aggregate health expenditure is not conclusive, public health expenditure plays a significant role in enhancing longevity. However, its influence diminishes as the size of the public health sector on GDP expands, reaching a maximum around the 8 %.

Conclusions

With the influence of public health expenditure being positive, the ambiguous effect of the aggregate expenditure suggests that the weight of public and private health sectors matters, the second having a lower impact on longevity. This might explain the poor evolution of the life expectancy in countries with a high amount of private resources devoted to health. In such cases, an extension of public services could give rise to a better outcome from the overall health investment.     

The Italian health surveillance (SiVeAS) prioritization approach to reduce chronic disease risk factors

Objective

Because public health funds are limited, programs need to be prioritized.

Methods

We used data on 15 risk factors from Italy’s public health surveillance to inform prioritization of programs. We ranked risk factors using a score based on the product of six criteria: deaths attributable to risk factors; prevalence of risk factors; risk factor prevalence trend; disparity based on the ratio of risk factor prevalence between low and high education attainment; level of intervention effectiveness; and cost of the intervention.

Results

We identified seven priorities: physical inactivity; cigarette smoking (current smoking); ever told had hypertension; not having blood pressure screening; ever told had high cholesterol; alcohol (heavy drinking); not eating five fruits and vegetables a day; and not having a fecal occult blood test.

Conclusions

This prioritization method should be used as a tool for planning and decision making.     

Using randomized controlled trials to evaluate socially complex services: problems, challenges and recommendations

BACKGROUND: Following the lead of evidence-based medicine, practice based on effectiveness research has become the new gold standard of contemporary public policy. Studies of this sort are increasingly demanded to evaluate services provided by mental health, social services and criminal justice systems. AIMS: The paper questions whether the simple randomized controlled trial (RCT) paradigm as applied in clinical trials can be used "off the rack" to evaluate socially complex service (SCS) interventions. These are services that are characterized by complex, diverse and non-standardized staffing arrangements; ambiguous protocols; hard-to-define study samples and unevenly motivated subjects and dependence on broader social environments. The difficulty of ensuring precise protocols, equivalent groups (tied to a meaningful target population) and neutral and equivalent trial environments under real world conditions are explored, as are the implications of not achieving standardization and equivalence. METHODS: Limitations of effectiveness research as a research tool and information source are examined by comparing the assumptions underpinning the simple RCT to the characteristics of SCS interventions, as illustrated by programs targeted to mentally disordered offenders in Britain. RESULTS: SCSs violate the assumptions underpinning the simple RCT model in ways that draw into sharp question the validity, reliability and generalizability of inferences of SCS trials. DISCUSSION: The RCT is not a panacea. Effectiveness research of SCS interventions that is based on the RCT model is unlikely to yield valid, reliable and generalizable inferences without becoming more complex in design and more sensitive to issues of selection bias, unmeasured variables and endogeneity. Ten recommendations are offered for stylizing the RCT design to the characteristics of socially complex services. IMPLICATIONS: It remains an empirical issue whether RCT-based services effectiveness research can inform mental health policy. Without major design innovations, it is more likely that the information generated by this research will have limited practical use, especially if the RCT model is unable to control for the effect of social complexity and the interaction between social complexity and dynamic systemic change. Scientific evaluations of services make clinical and economic sense so long as they are designed to meet the challenges of the services of which they promise greater knowledge.     

Eine rationale Strategie f��r Pr?vention und Gesundheitsf?rderung

Background

Prevention and health promotion can improve the performance of the health care system. However, the numerous interventions in Germany show a lack of evidence base and inexplicit responsibilities.

Aims

On the basis of knowledge about quality assurance, effectiveness, and target groups, we deduce criteria for a rational prevention strategy. Obstacles to the implementation of a rational prevention strategy are described.

Results

Empirically proven health inequalities provide indications of outcome measures. Effectiveness of interventions should be analyzed and compared in a competitive context.

Conclusion

Concerning the institutional setting, we recommend a prevention trust which regulates planning, controlling, and financing of the interventions in terms of an evidence-based care plan.     

The effectiveness of psychosocial interventions designed to improve health-related quality of life (HRQOL) amongst asthmatic children and their families: a systematic review

Purpose

Asthmatic children are at risk of compromised health-related quality of life (HRQOL) compared with their healthy peers. This systematic review reports the range and effectiveness of psychosocial interventions designed to improve HRQOL amongst asthmatic children, adolescents, and their families.

Method

Data sources included The Cochrane Airways Group Trials Register of trials, PubMed database, and reference lists from review articles.

Results

Eighteen studies of psychosocial interventions were identified. Interventions were designed to improve HRQOL amongst a range of psychosocial, health care, school-related and clinical outcomes, and were delivered in numerous settings and formats. Four studies reported that interventions were effective for significant improvements in child overall HRQOL scores. These include asthma education (n?=?2), asthma education plus problem solving (n?=?1), and art therapy (n?=?1).

Conclusions

Most interventions focussed on the delivery of asthma education to children, with the purpose of improving knowledge about asthma and disease management. There is limited evidence to suggest that interventions currently available are effective for significantly improving HRQOL amongst asthmatic children, adolescents, and their families. Most interventions lacked a theoretical basis and did not focus on family functioning variables. Multi-component interventions that incorporate asthma education along with strategies to assist families with implementing behaviour change towards improved asthma management are required. Future interventions should also attempt to address the wider context of family functioning likely to contribute to the family??s ability to engage in successful asthma management in order to improve HRQOL.