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Interventions to implement prevention in primary care.

BACKGROUND: Primary care physicians hold a strategic position in delivering preventive services. However discrepancies exist between evidence based guidelines and practice. OBJECTIVES: To assess the effects of interventions to improve the delivery of preventive services in primary care. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group specialised register (November 1995; August 1999), MEDLINE (1980 to 1995) and hand searched relevant journals. SELECTION CRITERIA: Randomised trials, controlled before and after studies, and interrupted time series analyses of interventions to improve preventive services by primary care professionals responsible for patient care. DATA COLLECTION AND ANALYSIS: Two researchers independently extracted data and assessed study quality. MAIN RESULTS: Fifty-five studies were included, involving more than 2000 health professionals and 99,000 people, with 83 comparisons between intervention and control groups. Post intervention differences between intervention and control groups varied widely within and across categories of interventions. Most interventions were found to be effective in some studies, but not in others. Five comparisons of group education versus no intervention showed absolute change of preventive services varying between -4% and +31%. Nine comparisons of physician reminders versus no intervention showed absolute change of preventive services varying between 5% and 24%. Fourteen comparisons of multifaceted interventions versus no intervention showed absolute change of preventive services varying between -3% and +64%. Six comparisons of multifaceted interventions versus group education reported absolute changes varying between -31% and +28%. All these comparisons used randomised groups. Ten comparisons of multifaceted interventions versus no intervention used non-randomised groups and showed absolute change of preventive services varying between -5% and +21%. The remaining planned comparisons within categories of interventions contained less than five comparisons. REVIEWER'S CONCLUSIONS: There is currently no solid basis for assuming that a particular intervention or package of interventions will work. Effective interventions to increase preventive activities in primary care exist, but there is considerable variation in the level of change achieved, with effect sizes usually small or moderate. Tailoring interventions to address specific barriers to change in a particular setting is probably important. Multifaceted interventions may be more effective than single interventions, because more barriers to change can be addressed. Future research should analyse barriers to change and interventions to implement preventive services in more detail, to clarify how interventions relate to specific barriers. Since more complex interventions are likely to be more effective but also more costly, economic evaluations should also be included.

Humans↗

Improving the referral process for familial breast cancer genetic counselling: findings of three randomised controlled trials of two interventions.

OBJECTIVES: To evaluate the effectiveness and cost-effectiveness of two complementary interventions, using familial breast cancer as a model condition. The primary care intervention consisted of providing computerised referral guidelines and related education to GPs. The nurse counsellor intervention evaluated genetic nurses as substitutes for specialist geneticists in the initial assessment and management of referred patients. DESIGN: The computerised referral guidelines study was a pragmatic, cluster randomised controlled trial (RCT) with general practices randomised to intervention or control groups. The nurse counsellor intervention was tested in two concurrent RCTs conducted in separate UK health service locations, using predetermined definitions of equivalence. SETTING: The computerised referral guidelines trial took place in general practices in Scotland from November 2000 to June 2001. The nurse counsellor intervention took place in a regional genetics clinic in Scotland, and in two health authorities in Wales served by a single genetics service during 2001. PARTICIPANTS: The computerised referral guidelines study involved GPs and referred patients. Both nurse counsellor intervention trials included women referred for the first time, aged 18 years or over and whose main concern was family history of breast cancer. INTERVENTIONS: The software system was developed with GPs, presenting cancer genetic referral guidelines in a checklist approach. Intervention GPs were invited to postgraduate update education sessions, and both intervention and control practices received paper-based guidelines. The intervention period was November 2000 to June 2001. For the nurse counsellor trial, trial 1 ran outpatient sessions with the same appointment length as the standard service offered by geneticists, but the nurse counsellor saw new patients at the first appointment and referred back to the GP or on to a clinical geneticist according to locally developed protocol, under the supervision of a consultant geneticist. The control intervention was the current service, which comprised an initial and a follow-up appointment with a clinical geneticist. In trial 2, a nurse counsellor ran outpatient sessions with the same appointment length as the new consultant-based cancer genetics service and new patients were seen at the first appointment and referred as in trial 1. The control intervention was a new service, and comprised collection of family history by telephone followed by a consultation with a clinical assistant or a specialist registrar, supervised by a consultant. The intervention was implemented between 1998 and 2001. MAIN OUTCOME MEASURES: In the software system trial, the primary outcome was GPs' confidence in their management of patients with concerns about family history of breast cancer. For the nurse counsellor trial, the primary outcome was patient anxiety, measured using standard scales. RESULTS: In the software system trial, 57 practices (230 GPs) were randomised to the intervention group and 29 (116 GPs) to the control group. No statistically significant differences were detected in GPs' confidence or any other outcomes. Fewer than half of the intervention GPs were aware of the software, and only 22 reported using it in practice. The estimated total cost was GBP3.12 per CD-ROM distributed (2001 prices). For the two arms of the nurse counsellor trial, 289 patients (193 intervention, 96 control) and 297 patients (197 intervention and 100 control) consented, were randomised, returned a baseline questionnaire and attended the clinic for trials 1 and 2 respectively. The analysis in both cases suggested equivalence in all anxiety scores, and no statistically significant differences were detected in other outcomes in either trial. A cost-minimisation analysis suggested that the cost per counselling episode was GBP10.23 lower in intervention arm than in the control arm and GBP10.89 higher in the intervention arm than in the control arm (2001 prices) for trials 1 and 2, respectively. Taking the trials together, the costs were sensitive to the grades of doctors and the time spent in consultant supervision of the nurse counsellor, but they were only slightly affected by the grade of nurse counsellor, the selected discount rate and the lifespan of equipment. CONCLUSIONS: Computer-based systems in the primary care intervention cannot be recommended for widespread use without further evaluation and testing in real practice settings. Genetic nurse counsellors may be a cost-effective alternative to assessment by doctors. This trial does not provide definitive evidence that the general policy of employing genetics nurse counsellors is sound, as it was based on only three individuals. Future evaluations of computer-based decision support systems for primary care must first address their efficacy under ideal conditions, identify barriers to the use of such systems in practice, and provide evidence of the impact of the policy of such systems in routine practice. The nurse counsellor trial should be replicated in other settings to provide reassurance of the generalisability of the intervention and other models of nurse-based assessment, such as in outreach clinics, should be developed and evaluated. The design of future evaluations of professional substitution should also address issues such as the effect of different levels of training and experience of nurse counsellors, and learning effects.

Breast Neoplasms↗

Psychological and/or educational interventions for the prevention of depression in children and adolescents.

BACKGROUND: Depression is the fourth most important disease in the estimation of the burden of disease Murray 1996 and is a common problem with prevalence rates estimated to be as high as 8% in young people. Depression in young people is associated with poor academic performance, social dysfunction, substance abuse, suicide attempts, and completed suicide (NHMRC 1997). This has precipitated the development of programmes aimed at preventing the onset of depression. This review evaluates evidence for the effectiveness of these prevention programmes. OBJECTIVES: To determine whether psychological and/or educational interventions (both universal and targeted) are effective in reducing risk of depressive disorder by reducing depressive symptoms immediately after intervention or by preventing the onset of depressive disorder in children and adolescents over the next one to three years. SEARCH STRATEGY: The Cochrane Depression, Anxiety and Neurosis Group trials register (August 2002), MEDLINE (1966 to December Week 3 2002), EMBASE (1980 to January Week 2 2003), PsychInfo (1886 to January Week 2 2003) and ERIC (1985 to December 2002) were searched. In addition, conference abstracts, the reference lists of included studies, and other reviews were searched and experts in the field were contacted. SELECTION CRITERIA: Each identified study was assessed for possible inclusion by two independent reviewers based on the methods sections. The determinants for inclusion were that the trial include a psychological and/or educational prevention programme for young people aged 5 to 19 years-old, who did not meet DSM or ICD criteria for depression and/or did not fall into the clinical range on standardised, validated, and reliable rating scales of depression. DATA COLLECTION AND ANALYSIS: The methodological quality of the included trials was assessed by two independent reviewers according to a list of pre-determined criteria, which were based on quality ratings devised by Moncrieff and colleagues (Moncrieff 2001). Outcome data was extracted and entered into Revman 4.2. Means and standard deviations for continuous outcomes and number of events for dichotomous outcomes were extracted where available. For trials where the required data were not reported or could not be calculated, further details were requested from first authors. If no further details were provided, the trial was included in the review and described, but not included in the meta-analysis. Results were presented for each type of intervention: targeted or universal interventions; and educational or psychological interventions and if data were provided, by gender. Where possible data were combined in meta-analyses to give a treatment effect across all trials. Sensitivity analysis were conducted on studies rated as "adequate" or "high" quality, that is with a score over 22, based on the scale by Moncrieff et al (Moncrieff 2001). The presence of publication bias was assessed using funnel plots. MAIN RESULTS: Studies were divided into those that compared intervention with an active comparison or placebo (i.e. a control condition that resembles the intervention being investigated but which lacks the elements thought to be active in preventing depression) and those that used a "wait-list" or no intervention comparison group. Only two studies fell into the former category and neither showed effectiveness although one study was inadequately powered to show a difference and in the other the "placebo" contained active therapeutic elements, reducing the ability to demonstrate a difference from intervention. Psychological interventions were effective compared with non-intervention immediately after the programmes were delivered with a significant reduction in scores on depression rating scales for targeted (standardised mean difference (SMD) of -0.26 and a 95% confidence interval (CI) of -0.40 to -0.13 ) but not universal interventions (SMD -0.21, 95% CI -0.48, 0.06), with a significant effect maintained on pooling data (SMD -0.26, 95% CI -0.36, -0.15). While small effect sizes were reported, these were associated with a significant reduction in depressive episodes. The overall risk difference after intervention translates to "numbers needed to treat" (NNT) of 10. The most effective study is the targeted programme by Clarke (Clarke 2001) where the initial effect size of -0.46 is associated with an initial risk difference of -0.22 and NNT 5. There was no evidence of effectiveness for educational interventions. Reports of effectiveness for boys and girls were contradictory. The quality of many studies was poor, and only two studies made allocation concealment explicit. Sensitivity analysis of only high quality studies did not alter the results significantly. The only analysis in which there was significant statistical heterogeneity was the sub-group analysis by gender where there was variability in the response to different programmes for both girls and boys. For the most part funnel plots indicate findings are robust for short term effects with no publication bias evident. There are too few studies to comment on whether there is publication bias for studies reporting long-term (12-36 month) follow-up. REVIEWER'S CONCLUSIONS: Although there is insufficient evidence to warrant the introduction of depression prevention programmes currently, results to date indicate that further study would be worthwhile. There is a need to compare interventions with a placebo or some sort of active comparison so that study participants do not know whether they are in the intervention group or not, to investigate the impact of booster sessions to see if effectiveness immediately after intervention can be prolonged, ideally for a year or longer, and to consider practical implementation of prevention programmes when choosing target populations. Until now most studies have focussed on psychological interventions. The potential effectiveness of educational interventions has not been fully investigated. Given the gender differences in prevalence, and the change in these that occurs in adolescence with a disproportionate increase in prevalence rates for girls, it is likely that girls and boys will respond differently to interventions. Although differences have been reported in studies in this review the findings are contradictory and a more definitive delineation of gender specific responses to interventions would be helpful.

Adolescent↗

Effectiveness of Caregiver-Mediated Spoken Language Interventions for Children Under Five at Risk of Developmental Language Disorder: A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: Caregiver-mediated interventions are commonly used by Speech and Language Therapists to support early language development. Developmental Language Disorder (DLD) is associated with reduced quality of life throughout the lifespan. Understanding factors that predict intervention success is essential for developing appropriate, cost-effective therapy provision for the approximately 12% of preschool children who present with early markers for Developmental Language Disorder (DLD). This systematic review and meta-analysis examined the effectiveness of caregiver-mediated spoken language interventions for under-fives at risk of DLD, and factors influencing intervention effectiveness. METHODS: A systematic review following PRISMA guidelines was conducted. Five electronic databases were searched to identify experimental studies comparing caregiver-mediated spoken language interventions to control conditions in under-fives presenting with risk factors for DLD. Risk factors included prematurity, socioeconomic factors, caregiver language development concerns, and formal or informal language screening or assessment scores. Twenty-six experimental studies with 1407 child participants were included in qualitative synthesis. Meta-analysis was performed on nine Randomised Controlled Trials involving 947 children. RESULTS: Effectiveness was examined for outcomes including child language gains, child wellbeing, inclusion and attainment. Meta-analysis indicated a significant effect of caregiver-mediated spoken language interventions on language outcomes compared to treatment-as-usual, non-language intervention or waitlist control conditions. Non-language outcomes were evaluated via qualitative synthesis. Interventions significantly improved language development trajectories for under-fives presenting with risk factors or early markers for DLD. CONCLUSION AND IMPLICATIONS: This review contributes to the growing evidence base demonstrating that caregiver-mediated interventions can positively impact language development and wellbeing outcomes for children under five at risk of DLD. These findings support the implementation of caregiver-mediated environmental language interventions in clinical practice to maximise accessibility and cost-effectiveness while delivering optimal outcomes for vulnerable populations. WHAT THIS PAPER ADDS: What is already known on this subject Previous research on caregiver-mediated spoken language interventions has highlighted gaps in the evidence regarding the impact of risk factors, demographic characteristics, dosage and intervention components on child language outcomes. Developmental Language Disorder has relatively high population prevalence, estimated at 7%. Prevalence is associated with risk factors including low household socioeconomic status (SES), prematurity and late language emergence. In contrast to its prevalence, there is low public and professional awareness of DLD and a low diagnostic rate. Therefore, a strengthened evidence base and additional insights into the factors affecting success of family-based interventions is important in order to increase the effectiveness of service provision and care planning for this underserved population. Timely and effective intervention with young children presenting with early markers for DLD has the potential to offer lifelong improvement to their wellbeing, inclusion and attainment outcomes. Recent systematic reviews of the effectiveness of caregiver-mediated language interventions had differences in population age range and diagnostic inclusion criteria. What this paper adds to existing knowledge Our review examines the effectiveness of caregiver-mediated early spoken language interventions on child language, attainment and wellbeing, and on caregiver self-efficacy and adherence to language support strategies. Our population was children under five presenting with risk factors for Developmental Language Disorder, in the absence of other neurodevelopmental or genetic conditions such as intellectual disability or autism. This review adds depth and detail to the evidence base supporting the effectiveness of caregiver-mediated spoken language interventions in improving outcomes for this population of young children, and factors that influence their success. What are the potential or actual clinical implications of this work? The high prevalence of Developmental Language Disorder, estimated at around 7% of the population, and the strong association with risk factors including low SES, prematurity and late language emergence, coupled with the low awareness of DLD and low diagnostic rate, mean that a strengthened evidence base and additional insights into the factors affecting success of family-based interventions can increase the effectiveness of service provision and care planning for this population. Timely and effective intervention in this group of young children has the potential to improve wellbeing and attainment outcomes across the lifespan. This review contributes to our understanding of how to implement cost-effective, socially valid and maximally engaging partnership working with families of young children at risk for DLD.

Humans↗

Psycho-educational interventions in the treatment of arthritis.

Patient education has a long history as an integral part of clinical practice; however, controlled clinical trials of psycho-educational interventions for the rheumatic disorders emerged in significant numbers over the last 15 to 20 years. In this chapter, the efficacy of these interventions was reviewed in 34 reports (54 separate treatment arms) published in the last 10 years. Psycho-educational interventions included both traditional educational or teaching activities and psychological interventions. The most common types of intervention were self-management programmes ((21 treatment arms) and cognitive-behavioral therapy (10 treatment arms). Both approaches emphasize learning new skills helpful in managing one's disease. Self-management programmes are broadly focused on using information, problem-solving and coping skills for symptom management. Cognitive-behavioural therapy usually emphasizes control of pain by understanding the interaction of emotions and cognition with the physical and behavioral aspects of pain. Other interventions, tested either individually or as comparisons for self-management or cognitive-behavioural therapy interventions, included traditional classroom-type programmes (four treatment arms), 'materials' including pamphlets, books and computerized instruction (seven treatment arms), individualized instruction (five treatment arms), psychotherapy (one), and support groups (three treatment arms). Sixty per cent of studies used clinic samples, 52% rheumatoid arthritis and 8% with osteoarthritis. The remaining studies recruited from community samples where the exact diagnosis was not always clear, though most had either RA or OA. The majority of self-management interventions used community samples. The average effect size for treatment compared to non-intervention controls (weighted for sample size) for RA patient pain, functional ability and depression at post intervention was 0.13, -0.16 and 0.01 compared with 0.44, 0.28 and 0.56 for OA patients and 0.21, 0.08 and 0.12 for community samples. At 3 months follow-up, self-management programmes demonstrated improvement compared to controls for self-efficacy (effect sizes 0.22 to 0.29) with community patients while cognitive-behavioural therapy interventions demonstrated similar improvements in active coping skills (effect sizes 0.09 to 0.18) with RA patients. Effect sizes ranged from 0.6 to 1.1 for exercise compliance following self-management interventions. In the few studies with follow-up evaluations extending beyond 3 months post-intervention, effects generally weaken. As expected, psycho-educational interventions do not alter physical functioning with functional abilities continuing to decline over time. Lorig and colleagues have demonstrated in 4-year outcome studies important reductions in the use of health care services for participants in self-management programmes despite the progression of functional disability. Psycho-educational interventions are difficult to evaluate because of the differences in interventions, methods of assessment and varying follow-up times. Studies of these interventions differ in quality, patient population, etc., precluding a useful meta analysis. Overall, there is improvement in pain, depressive symptoms, self-efficacy, coping abilities, and self-management behaviours such as exercise compliance following psycho-educational interventions, with a trend to greater improvement for OA than RA patients. Utilization of health care services may be reduced following educational interventions. Although the overall improvement is small, it is probably of the order of that seen with therapy with NSAIDs and is independent of medical treatment. Psycho-educational interventions are a useful additional modality in the management of rheumatic diseases and may improve treatment effects and patient quality of life.

Arthritis↗

Prevention of stroke in urban China: a community-based intervention trial.

BACKGROUND AND PURPOSE: Stroke has been the second leading cause of death in large cities in China since the 1980s. Meanwhile, the prevalences of hypertension and smoking have steadily increased over the last 2 decades. Therefore, a community-based intervention trial was initiated in 7 Chinese cities in 1987. The overall goal of the study was to evaluate the effectiveness of an intervention aimed at reducing multiple risk factors for stroke. The primary study objective was to reduce the incidence of stroke by 25% over 3.5 years of intervention. METHODS: In May 1987 in each of 7 the cities, 2 geographically separated communities with a registered population of about 10 000 each were selected as either intervention or control communities. In each community, a cohort containing about 2700 subjects (>/=35 years old) free of stroke was sampled, and a survey was administered to obtain baseline data and screen the eligible subjects for intervention. In each city, a program of treatment for hypertension, heart disease, and diabetes was instituted in the intervention cohort (n approximately 2700) and health education was provided to the full intervention community (n approximately 10 000). A follow-up survey was conducted in 1990. Comparisons of intervention and control cohorts in each city were pooled to yield a single summary. RESULTS: A total of 18 786 subjects were recruited to the intervention cohort and 18 876 to the control cohort from 7 cities. After 3.5 years, 174 new stroke cases had occurred in the intervention cohort and 253 in the control cohort. The 3.5-year cumulative incidence of total stroke was significantly lower in the intervention cohort than the control cohort (0.93% versus 1.34%; RR=0.69; 95% CI, 0.57 to 0.84). The incidence rates of nonfatal and fatal stroke, as well as ischemic and hemorrhagic stroke, were significantly lower in the intervention cohort than the control cohort. The prevalence of hypertension increased by 4.3% in the intervention cohort and by 7.8% in the control cohort. The average systolic and diastolic blood pressures increased more in the control cohort than in the intervention cohort. Among hypertensive individuals in the intervention cohort, awareness of hypertension increased by 6.7% and the percentage of hypertensives who regularly took antihypertensive medication increased 13.2%. All of these indices became worse in the control cohort. The prevalence of heart diseases and diabetes increased significantly in the both cohorts (P<0.01). The prevalence of consumption of alcohol increased slightly, and that of smoking remained constant in both cohorts. CONCLUSIONS: A community-based intervention for stroke reduction is feasible and effective in the cities of China. The reduction, due to the intervention, in the incidence of stroke in the intervention cohort was statistically significant after 3.5 years of intervention. The sharp reduction in the incidence of stroke may be due to the interventions having blunted the expected increase in hypertension that accompanies aging as well as to better and earlier treatment of hypertension, particularly borderline hypertension. Applied health education to all the residents of the community may have prevented some normotensive individuals from developing hypertension and improved overall health awareness and knowledge.

Cerebrovascular Disorders↗

From concept to application: the impact of a community-wide intervention to improve the delivery of preventive services to children.

OBJECTIVE: To improve health outcomes of children, the US Maternal and Child Health Bureau has recommended more effective organization of preventive services within primary care practices and more coordination between practices and community-based agencies. However, applying these recommendations in communities is challenging because they require both more complex systems of care delivery within organizations and more complex interactions between them. To improve the way that preventive health care services are organized and delivered in 1 community, we designed, implemented, and assessed the impact of a health care system-level approach, which involved addressing multiple care delivery processes, at multiple levels in the community, the practice, and the family. Our objective was to improve the processes of preventive services delivery to all children in a defined geographic community, with particular attention to health outcomes for low-income mothers and infants. DESIGN: Observational intervention study in 1 North Carolina county (population 182 000) involving low- income pregnant mothers and their infants, primary care practices, and departments of health and mental health. An interrupted time-series design was used to assess rates of preventive services in office practices before and after the intervention, and a historical cohort design was used to compare maternal and child health outcomes for women enrolled in an intensive home visiting program with women who sought prenatal care during the 9 months before the program's initiation. Outcomes were assessed when the infants reached 12 months of age. INTERVENTIONS: Our primary objective was to achieve changes in the process of care delivery at the level of the clinical interaction between care providers and patients that would lead to improved health and developmental outcomes for families. We selected interventions that were directed toward major risk factors (eg, poverty, ineffective care systems for preventive care in office practices) and for which there was existing evidence of efficacy. The interventions involved community-, practice-, and family-level strategies to improve processes of care delivery to families and children. The objectives of the community-level intervention were: 1) to achieve policy level changes that would result in changes in resources available at the level of clinical care, 2) to engage multiple practice organizations in the intervention to achieve an effect on most, if not all, families in the community, and 3) to enhance communication between, among, and within public and private practice organizations to improve coordination and avoid duplication of services. The objective of the practice-level interventions was to overcome specific barriers in the process of care delivery so that preventive services could be effectively delivered. To assist the health department in implementing the family-level intervention, we provided assistance in hiring and training staff and ongoing consultation on staff supervision, including the use of structured protocols for care delivery, and regular feedback data about implementation of the program. Interventions with primary care practices focused on the design of the delivery system within the office and the use of teamwork and data in an "office systems" approach to improving clinical preventive care. All practices (N = 8) that enrolled at least 5 infants/month received help in assessing performance and developing systems (eg, preventive services flow sheets) for preventive services delivery. Family-level interventions addressed the process of care delivery to high-risk pregnant women (<100% poverty) and their infants. Mothers were recruited for the home visiting intervention when they first sought prenatal care at the community health center, the county's largest provider of prenatal care to underserved women. The home visiting intervention involved teams of nurses and educators and involved 2 to 4 visits per month through the infant's first year of life to provide parental education on fetal and infant health and development, enhance parents' informal support systems, and link parents with needed health and human services. We included training in injury prevention and discipline, and home visitors assisted mothers in obtaining care from one of the primary care offices. RESULTS: There were high levels of participation, changes in the organization of the delivery system, and improvements in preventive health outcomes. Agencies cooperated in joint contracting, staff training, and defining program eligibility. All 8 eligible practices agreed to participate and 7/8 implemented at least 1 new office system element. Of eligible women, 89% agreed to participate, and outcome data were available on 80% (180/225). After adjusting for differences in baseline characteristics, intervention group women were significantly more likely than comparison group women to use contraceptives (69% vs 47%), not smoke tobacco (27% vs 54%) and have a safe and stimulating home environment for their children. Intervention group children were more likely to have had an appropriate number of well-child care visits (57% vs 37%) and less likely to be injured (2% vs 7%). Intervention mothers also received Aid to Families with Dependent Children for fewer months after the birth of their child (7.7 months vs 11.3 months). CONCLUSIONS: We observed a number of positive effects at all 3 levels of intervention. Policy-level changes at the state and community led to lasting changes in the organization and financing of care, which enabled changes in clinical services to take place. These changes have now been expanded beyond this community to other communities in the state. We were also able to engage multiple practice organizations, reduce duplication, and improve the coordination of care. Changes in the process of preventive services delivery were noted in participating practices. Finally, the outcomes of the family-level intervention were comparable in direction and magnitude to the outcomes of previous randomized trials of the intervention. All the changes were achieved over a relatively brief 3-year study period, and many have been sustained since the project was completed. Tiered, interrelated interventions directed at an entire population of mothers and children hold promise to improve the effectiveness and outcomes of health care for families and children.

Adult↗

Effects of educational and psychosocial interventions for adolescents with diabetes mellitus: a systematic review.

BACKGROUND: Insulin-dependent diabetes mellitus, also known as type 1 diabetes, is a life-threatening condition and is the third most common chronic illness among young people. As a result of minimal or non-existent insulin production, people with diabetes must take over the normally automatic task of regulation of blood glucose levels. This is achieved by a complex regimen involving multiple, daily administrations of insulin coordinated with dietary intake and energy expenditure and monitored by blood glucose testing. OBJECTIVES: To examine the effectiveness of educational and psychosocial interventions for adolescents with type 1 diabetes designed to improve their diabetes management. Specifically, it addressed the following research questions: (1) Do educational and psychosocial interventions for adolescents with type 1 diabetes have beneficial effects on biological and psychosocial outcomes? (2) Are there types or features of interventions that have been shown to be more effective than others? (3) What evidence is there of the cost-effectiveness of interventions? METHODS: A search strategy was formulated, piloted and refined. Three journals were handsearched, 11 electronic databases were searched and personal contacts, flyers, conferences and websites were used to notify the research community of the review to access further literature. This process generated 10,535 abstracts, which, after screening, resulted in 367 articles identified for retrieval. This number was augmented by hand-searching, personal contact and exploding references, and a final total of 457 articles were scrutinised. Of these, 64 reports describing 62 studies were identified as empirical papers evaluating educational or psychosocial interventions. The relevant data were extracted from the papers and summary tables for each study were prepared. Where possible, effect sizes were computed for outcomes from studies that included a randomised control group (CG) and other relevant information. RESULTS: A descriptive analysis of the 62 studies was undertaken. Most studies (67.7%) were conducted in the USA and 41% were randomised controlled trials (RCTs), none of which were UK-based. Only 48% of the reports provided an explicit theoretical rationale for the intervention. The mean number of participants was 53.8. The studies took place in various settings, evaluated a variety of interventions, involved various interventionists, addressed various components and assessed the effects by a range of outcomes, including measures of metabolic control and psychological and behavioural outcomes. Follow-up assessments were relatively rare. RESULTS - THE EFFECTIVENESS OF INTERVENTIONS: The 25 RCTs were examined in more detail and three of the most effective were described in depth. Effect sizes could be calculated for 14 studies. The mean (pooled) effect size for psychosocial outcomes was 0.37 and 0.33 for glycated haemoglobin with outliers (0.08 without outliers), indicating that these interventions have small to medium beneficial effects on diabetes management outcomes. A narrative review of the 21 pre-post studies with no CG was performed, including evaluations of interventions conducted at summer camps, interventions for poorly controlled patients and educational interventions. All studies reported beneficial effects. RESULTS - COST-EFFECTIVENESS: Few studies addressed economic considerations associated with interventions, and the lack of information on costs and the diversity of outcomes included by investigators impeded cost- effectiveness comparisons. Shorter hospitalisation at diagnosis is at least as effective in achieving control and avoiding complications in adolescence as longer stays. Home care may result in improved outcomes but may not be cheaper than hospital care at diagnosis. Targeting poorly controlled subjects may reduce adverse events and hospitalisations and may be more cost-effective than generic interventions. There is a need for rigorous cost-effectiveness studies of educational and psychosocial interventions for adolescents with type 1 diabetes that include longer-term considerations. CONCLUSIONS: The following conclusions were drawn from this review: (1) Educational and psychosocial interventions have small to medium beneficial effects on various diabetes management outcomes. (2) Well-designed trials of such interventions are needed in the UK (no completed RCTs of educational or psychosocial interventions for adolescents with type 1 diabetes conducted in the UK were found). (3) The evidence, arising primarily from studies in the USA, provides a starting point for the design of interventions in the UK. (4) Quantitative and narrative analysis of the evidence suggested that interventions are more likely to be effective if they demonstrate the inter-relatedness of the various aspects of diabetes management. (ABSTRACT TRUNCATED)

Adolescent↗

Efficacy and cost-effectiveness of the first generation of HIV prevention interventions for people with severe and persistent mental illness.

BACKGROUND: People with serious mental illness are at elevated risk for human immunodeficiency virus (HIV) infection. A small body of published research has evaluated the efficacy of HIV prevention interventions that aim to help persons with mental illness modify sexual behaviors that place them at risk for HIV infection. Additional research has evaluated the economic efficiency ('cost-effectiveness') of these interventions. AIMS OF THE STUDY: We provide a detailed and critical review of the efficacy and cost-effectiveness of randomized, controlled trials of HIV prevention interventions for this population. We present a brief overview of the epidemiology of HIV among men and women with serious mental illness and describe HIV risk factors for members of this population. The efficacy literature is critically reviewed, and the results of the available studies are compared using a common effect size metric. The cost-effectiveness of HIV prevention interventions for mentally ill adults is then reviewed. METHODS: The efficacy of interventions at reducing risk behaviors and increasing preventive behaviors was summarized using effect size estimation techniques. First, we reviewed interventions that have been evaluated in randomized clinical trials and published in the peer-reviewed scientific literature so as to summarize the interventions that have been subjected to the most rigorous evaluation. For each of the five studies that met the inclusion criteria, we briefly described the methodology and intervention content, summarized the evidence for intervention efficacy, and calculated appropriate effect size estimates. A narrative review of two cost-effectiveness studies published to date was included. RESULTS: The review of intervention efficacy indicated that the risk reduction interventions evaluated to date have had only limited success at helping people with severe mental illness reduce their HIV risk behavior. Most effect sizes indicating successful condom use increases were in the small or small to moderate range. Overall, studies with the largest sample sizes, and presumably the most generalizable results, produced smaller intervention effect sizes than studies with smaller samples. The cost-effectiveness literature revealed similarly mixed results: economic efficiency varied from not cost-effective to highly cost-effective. DISCUSSION: Limited information is presently available regarding the efficacy and cost-effectiveness of HIV prevention interventions for people with severe and persistent mental illness. Encouraging results were obtained in some, but not all studies. Methodological limitations will need to be addressed in the next generation of HIV risk reduction intervention studies for this population. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Persons with severe mental illness warrant attention from health care providers due to elevated risk for HIV infection. Interventions discussed herein, focusing on information and behavioral skills training, can be employed until strategies with stronger results are developed. IMPLICATIONS FOR HEALTH POLICIES: Effective and cost-effective HIV risk reduction interventions are available for adults with mental illness and should be more widely implemented. The cost-effectiveness of these interventions could be further enhanced by screening potential participants for high-risk sexual behaviors. IMPLICATIONS FOR FURTHER RESEARCH: To advance the field, the next generation of intervention research for people with severe mental illness will need to improve upon the designs and intervention strategies of the first generation, include larger samples, and devote increased attention to the life circumstances and particular mental health issues of intervention participants.

Acquired Immunodeficiency Syndrome↗

Interventions for prevention of drug use by young people delivered in non-school settings.

BACKGROUND: Interventions intended to prevent or reduce use of drugs by young people may be delivered in schools or in other settings. This review aims to summarise the current literature about the effectiveness of interventions delivered in non schools settings. OBJECTIVES: (1) - To summarise the current evidence about the effectiveness of interventions delivered in non-school settings intended to prevent or reduce drug use by young people under 25;(2) - To investigate whether interventions' effects are modified by the type and setting of the intervention, and the age of young people targeted;(3) - To identify areas where more research is needed. SEARCH STRATEGY: We searched Cochrane Central Register of Controlled Trials (CENTRAL - The Cochrane Library Issue 4, 2004), MEDLINE (1966-2004), EMBASE (1980-2004), PsycInfo (1972-2004), SIGLE (1980-2004), CINAHL (1982-2004) and ASSIA (1987-2004). We searched also reference lists of review articles and retrieved studies. SELECTION CRITERIA: Randomised trials that evaluated an intervention targeting drug use by young people under 25 years of age, delivered in a non-school setting, compared with no intervention or another intervention, that reported substantive outcomes relevant to the review. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. Results were tabulated, as studies were considered too dissimilar to combine using meta-analysis. MAIN RESULTS: Seventeen studies, 9 cluster randomised studies, with 253 clusters, 8 individually randomised studies with 1230 participants, evaluating four types of intervention: motivational interviewing or brief intervention, education or skills training, family interventions and multi-component community interventions. Many studies had methodological drawbacks, especially high levels of loss to follow-up. There were too few studies for firm conclusions. One study of motivational interviewing suggested that this intervention was beneficial on cannabis use. Three family interventions (Focus on Families, Iowa Strengthening Families Program and Preparing for the Drug-Free Years), each evaluated in only one study, suggested that they may be beneficial in preventing cannabis use. The studies of multi component community interventions did not find any strong effects on drug use outcomes, and the two studies of education and skills training did not find any differences between the intervention and control groups. AUTHORS' CONCLUSIONS: There is a lack of evidence of effectiveness of the included interventions. Motivational interviewing and some family interventions may have some benefit. Cost-effectiveness has not yet been addressed in any studies, and further research is needed to determine whether any of these interventions can be recommended.

Adolescent↗

Design issues addressed in published evaluations of adolescent HIV-risk reduction interventions: a review.

OBJECTIVE: This study was conducted to determine: (1) issues in intervention design that have been addressed in behavioral interventions targeting human immunodeficiency virus (HIV)-risk behaviors among adolescents; (2) specific choices made in intervention design; (3) historic changes in the likelihood that issues in intervention design will be addressed; and (4) if an association exists between quality of evaluation design and the number of intervention design issues addressed. DESIGN: Literature search employing five electronic databases and 11 journals for articles published from January 1983 through December 1993 reporting evaluations of adolescent HIV-risk reduction interventions. MAIN OUTCOMES MEASURES: The frequency with which 12 issues in intervention design were addressed: basing the intervention on a theory of behavioral change; specifying a target population; involving the targeted community in the formulation of the intervention; addressing developmental issues; providing facts; strengthening interpersonal skills; describing the media (format) for delivering the intervention; specifying potentially relevant characteristics of the interventionists; describing the duration of the intervention; providing boosters; pilot testing the intervention; and including other potentially augmentative elements. RESULTS: Twenty-eight published intervention articles were included in these analyses. The median number of intervention design issues addressed in any study was six (range three to nine), although this number increased significantly over time (p < .01). There was substantial variability in the frequency with which each individual design issue was addressed, with some design issues (e.g., inclusion of specific facts and the description of the channel employed) being addressed in all studies. Other design issues were addressed in less than one-quarter of studies [e.g., basing the intervention on a theory of behavioral change (18%) and addressing developmental issues (21%)]. The targeted community was involved in one-third of studies. More recent studies and studies employing a randomized evaluation design with both preintervention and postintervention assessments addressed more intervention design issues than did earlier studies and studies employing other evaluation designs (p = .01 and p = .03, respectively). CONCLUSION: The majority of published adolescent HIV-risk reduction studies have not addressed important issues in intervention design. However, more recent studies and studies employing a strong evaluation design have addressed a greater number of these issues. Frameworks to guide intervention efforts (e.g., to serve as "practice guidelines") are needed to allow for both accurate replication and meaningful comparison of differing intervention approaches.

Adolescent↗

Meta-analysis of trials of interventions to improve medication adherence.

The effect of tools and methods designed to enhance medication adherence that have been evaluated in randomized controlled trials was studied. A literature search was performed with MEDLINE, International Pharmaceutical Abstracts, PsychLIT, ERIC, and EMBASE for the period from 1966 to December 2000. Only randomized, controlled trials with at least 10 subjects per intervention group were included. Of 484 articles evaluated, only 61 met the criteria for the meta-analysis. Multiple interventions or study samples were identified in 23 of the articles. Each intervention was counted as a separate study, yielding 95 cohorts totaling 18,922 subjects. Of these subjects, 9,604 (51%) received interventions and 9,318 served as controls. Cohorts reported between 1990 and 1999 accounted for 53% of the sample; 56% of all cohorts were based in physician offices and 26% involved hypertensive patients. Behavioral interventions accounted for 41 cohorts (8,885 subjects), educational interventions for 22 cohorts (6,392 subjects), and combined interventions for 32 cohorts (3,645 subjects). Homogeneity of groupings and effect sizes (ESs) were calculated for each type of intervention. Overall, the data were not homogeneous, so conclusions could not be derived from the entire body of data. The educational intervention and combined intervention cohorts were nonhomogeneous (p < 0.001 and p < 0.01, respectively); however, the behavioral intervention cohort was homogeneous (Q = 42.48, d.f. = 40, p = 0.36). The overall ES for behavioral interventions was 0.07 (95% confidence interval [CI] = 0.04-0.09). There were no significant differences among the behavioral interventions. Educational interventions had an overall ES of 0.11 (95% CI = 0.06-0.15); there were no significant differences among the educational interventions. The overall ES of the combined interventions was 0.08 (95% CI = 0.04-0.12). When stratifying the combined intervention group by type of behavioral intervention, mail reminders had the largest impact (ES = 0.38). Meta-analysis of studies of interventions to improve medication adherence revealed an increase in adherence of 4-11%. No single strategy appeared to be best.

Adult↗

Tobacco control activities of primary-care physicians in the Community Intervention Trial for Smoking Cessation. COMMIT Research Group.

OBJECTIVE: To compare tobacco control practices of physicians and their staff in Intervention communities with those in Comparison communities of the Community Intervention Trial for Smoking Cessation (COMMIT). DESIGN: COMMIT was a randomised trial testing community-based intervention for smoking cessation carried out over four years. SETTING: Eleven matched pairs of communities assigned randomly to Intervention and Comparison conditions. PARTICIPANTS AND INTERVENTIONS: Physicians in the Intervention communities participated in continuing medical education (CME). Training for office staff focused on tobacco control and office intervention "systems". OUTCOME MEASURES: Smoking control attitudes and practices reported by primary-care physicians in the 22 communities, smoking policies, and practices of 30 randomly selected medical offices in each community, and patient reports of physician intervention activities. RESULTS: Response rates to the physicians' mail survey were 45% and 42% in Intervention and Comparison communities, respectively. Telephone interviews of office staff had response rates of 84% in both conditions. Physicians in Intervention communities were more likely to attend training than those in Comparison communities (53% and 26%, respectively (P<0.0005)). In both conditions, training attendees perceived themselves as being better prepared to counsel smokers than non-attendees (P < or = 0.01) and reported more activity in smoking intervention. Intervention communities carried out more office-based tobacco control activities (P = 0.002). Smokers in Intervention communities were more likely to report receiving reading material about smoking from their physicians (P = 0.026). No other differences in physician intervention activities were reported by smokers between the Intervention and Comparison communities. CONCLUSIONS: The COMMIT intervention had a significant effect on some reported physician behaviours, office practices, and policies. However, most physicians still did not use state-of-the-art smoking intervention practices with their patients and there was little, or no, difference between patient reports of intervention activities of physicians in the Intervention and Comparison communities. Better systems and incentives are needed to attract physicians and their staff to CME and to encourage them to follow through on what they learn. The recently released Agency for Health Care Policy and Research clinical practice guideline for smoking cessation and other standards and policies outline these systems and offer suggestions for incentives to facilitate adoption of these practices by physicians.

Adult↗

Effects of social intervention on detection and efficacy of treatment for arterial hypertension. Main results of the Polish Four Cities Programme.

BACKGROUND: Cardiovascular diseases are the main cause of death in the adult Polish population. Beside lipid disorders and cigarette smoking, hypertension represents the most important risk factor leading to cardiovascular complications. Representative studies conducted in Poland in 1994-2002 showed that in 2002 the number of respondents in the survey who stated they knew their own blood pressure values dropped by 3.5 million, compared with 1994. This decrease was predominantly seen in small towns and in the countryside. Preventive programmes should therefore be addressed mainly to the most vulnerable communities. Modern methods of social marketing may play a substantial role in the creation of a healthy lifestyle. AIM: The aim of the Polish Four Cities Programme (PP4M), conducted in 2000-2001, was to develop the most effective methods of detection of and improvement in treatment for hypertension among the residents of small towns and rural areas. One of the programme tasks was to compare the effectiveness of a standard medical screening intervention with a similar approach combined with the use of social marketing methods.Methods. The programme was conducted by an interdisciplinary team in three small Polish towns -- Kartuzy, Oborniki Wlkp. and Braniewo, as well as in one of the districts of a large city Łódź -- Olechów. Medical intervention combined with social marketing (community intervention) took place in Oborniki Wlkp. whereas the residents of Kartuzy and Łódź were subjected only to the traditional medical intervention. Braniewo served as a control location -- neither medical nor community intervention was implemented. Community intervention with elements of social marketing consisted of a three-month, intensive education and information campaign, initiated four weeks prior to the start of medical intervention. Epidemiological situation was assessed in all the four cities before and after the completion of the preventive interventions (screening), using representative surveys, with the objective to assess the changes in the awareness of one's own blood pressure values, detection of hypertension and knowledge concerning cardiovascular risk factors.Results. In two survey locations -- Kartuzy and Łódź - awareness of one's own blood pressure values after the medical intervention did not significantly change (61% and 67.6% at baseline versus 62.1% and 71.6% after the intervention, respectively). In contrast, social marketing activities conducted in Oborniki significantly increased this parameter from 61.5% to 79.8% (p<0.01). While medical intervention did not change the proportion of non-diagnosed hypertension in a small town (a non-significant decrease from 49% to 45% in Kartuzy), its effect in a large city was clearly visible (a decrease from 46% to 28% in Łódź). In Oborniki Wlkp. (medical intervention combined with social marketing) the effects were the most noticeable -- a reduction from 50% to 27% was achieved. The efficacy of hypertension treatment at baseline was low (4.7% in Kartuzy, 6.6% in Oborniki, and 6.5% in Łódź), but it then improved significantly (a twofold increase in Kartuzy and Oborniki, and more than twofold increase in Łódź). When the target value of blood pressure was set at 160/95 mmHg, the highest efficacy of hypotensive therapy was observed directly after the completion of medical and community intervention in Oborniki (an almost twofold increase in treatment efficacy). CONCLUSIONS: 1. Medical intervention combined with a community intervention and marketing campaign leads to a statistically significant improvement in self-awareness of blood pressure values among residents of small towns. 2. Medical intervention combined with community intervention brings the detection rate of hypertension in small towns up to the level observed in large cities. 3. Medical intervention, especially when combined with community intervention, improves the efficacy of the treatment of hypertension, regardless of the size of agglomeration.

Adult↗

The effectiveness of sex education and HIV education interventions in schools in developing countries.

OBJECTIVE: To review the impact of sex education and HIV education interventions in schools in developing countries on both risk behaviours for HIV and the psychosocial factors that affect them. METHODS: We conducted a systematic review. Searches identified studies in developing countries that evaluated interventions using either experimental or strong quasi-experimental designs and measured the impact of the intervention on sexual risk behaviours. Each study was summarized and coded, and the results were tabulated by type of intervention. FINDINGS: Twenty-two intervention evaluations met the inclusion criteria: 17 were based on a curriculum and 5 were not, and 19 were implemented primarily by adults and 3 by peers. These 22 interventions significantly improved 21 out of 55 sexual behaviours measured. Only one of the interventions (a non-curriculum-based peer-led intervention) increased any measure of reported sexual intercourse; 7 interventions delayed the reported onset of sex; 3 reduced the reported number of sexual partners; and 1 reduced the reported frequency of sexual activity. Furthermore, 16 of the 22 interventions significantly delayed sex, reduced the frequency of sex, decreased the number of sexual partners, increased the use of condoms or contraceptives or reduced the incidence of unprotected sex. Of the 17 curriculum-based interventions, 13 had most of the characteristics believed to be important according to research in developed and developing countries and were taught by adults. Of these 13 studies, 11 significantly improved one or more reported sexual behaviours, and the remaining 2 showed non-significant improvements in reported sexual behaviour. Among these 13 studies, interventions led by both teachers and other adults had strong evidence of positive impact on reported behaviour. Of the 5 non-curriculum-based interventions, 2 of 4 adult-led and the 1 peer-led intervention improved one or more sexual behaviours. CONCLUSIONS: A large majority of school-based sex education and HIV education interventions reduced reported risky sexual behaviours in developing countries. The curriculum-based interventions having the characteristics of effective interventions in the developed and developing world should be implemented more widely. All types of school-based interventions need additional rigorous evaluation, and more rigorous evaluations of peer-led and non-curriculum-based interventions are necessary before they can be widely recommended.

Adolescent↗

HIV/STD risk reduction interventions for African American and Latino adolescent girls at an adolescent medicine clinic: a randomized controlled trial.

BACKGROUND: Adolescent girls in the United States and around the world are at a heightened risk for sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV). OBJECTIVE: To determine the efficacy of a skill-based HIV/STD risk-reduction intervention in reducing self-reported unprotected sexual intercourse among African American and Latino adolescent girls. DESIGN: Randomized controlled trial with 3-, 6-, and 12-month follow-ups. SETTING AND PARTICIPANTS: Sexually experienced African American and Latino adolescent girls recruited from the adolescent medicine clinic of a children's hospital serving a low-income inner-city community (N = 682, mean age, 15.5 years); 88.6% were retained at the 12-month follow-up. INTERVENTIONS: Three 250-minute interventions based on cognitive-behavioral theories and elicitation research: an information-based HIV/STD intervention provided information necessary to practice safer sex; a skill-based HIV/STD intervention provided information and taught skills necessary to practice safer sex; or a health-promotion control intervention concerned with health issues unrelated to sexual behavior. MAIN OUTCOME MEASURES: Primary outcome measure was self-reported frequency of unprotected sexual intercourse; secondary outcomes included the frequency of sexual intercourse while intoxicated, the number of sexual partners, biologically confirmed STDs, and theoretical mediator variables, including the intention to use condoms, beliefs about using condoms, and condom-use knowledge. RESULTS: No differences between the information intervention and the health control intervention were statistically significant. Skills-intervention participants (mean [SE], 2.27 [0.81]) reported less unprotected sexual intercourse at the 12-month follow-up than did information-intervention participants (mean [SE], 4.04 [0.80]; P = .03), or health control-intervention participants (mean [SE], 5.05 [0.81]; P = .002). At the 12-month follow-up, skills-intervention participants (mean [SE], 0.91 [0.05]) reported fewer sexual partners (P = .04) compared with health control-intervention participants (mean [SE], 1.04 [0.05]) and were less likely to test positive for STD (mean [SE], 10.5% [2.9%]) than were health control-intervention participants (mean [SE], 18.2% [2.8%]; P = .05). No differences in the frequency of unprotected sexual intercourse, the number of partners, or the rate of STD were observed at the 3- or 6-month follow-up between skill-intervention participants and information-intervention or health control-intervention participants. CONCLUSION: Skill-based HIV/STD interventions can reduce sexual risk behaviors and STD rate among African American and Latino adolescent girls in clinic settings.

Adolescent↗

Interventions to improve antibiotic prescribing practices in ambulatory care.

BACKGROUND: The development of resistance to antibiotics by many important human pathogens has been linked to exposure to antibiotics over time. The misuse of antibiotics for viral infections (for which they are of no value) and the excessive use of broad spectrum antibiotics in place of narrower spectrum antibiotics have been well-documented throughout the world. Many studies have helped to elucidate the reasons physicians use antibiotics inappropriately. OBJECTIVES: To systematically review the literature to estimate the effectiveness of professional interventions, alone or in combination, in improving the selection, dose and treatment duration of antibiotics prescribed by healthcare providers in the outpatient setting; and to evaluate the impact of these interventions on reducing the incidence of antimicrobial resistant pathogens. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care Group (EPOC) specialized register for studies relating to antibiotic prescribing and ambulatory care. Additional studies were obtained from the bibliographies of retrieved articles, the Scientific Citation Index and personal files. SELECTION CRITERIA: We included all randomised and quasi-randomised controlled trials (RCT and QRCT), controlled before and after studies (CBA) and interrupted time series (ITS) studies of healthcare consumers or healthcare professionals who provide primary care in the outpatient setting. Interventions included any professional intervention, as defined by EPOC, or a patient-based intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed study quality. MAIN RESULTS: Thirty-nine studies examined the effect of printed educational materials for physicians, audit and feedback, educational meetings, educational outreach visits, financial and healthcare system changes, physician reminders, patient-based interventions and multi-faceted interventions. These interventions addressed the overuse of antibiotics for viral infections, the choice of antibiotic for bacterial infections such as streptococcal pharyngitis and urinary tract infection, and the duration of use of antibiotics for conditions such as acute otitis media. Use of printed educational materials or audit and feedback alone resulted in no or only small changes in prescribing. The exception was a study documenting a sustained reduction in macrolide use in Finland following the publication of a warning against their use for group A streptococcal infections. Interactive educational meetings appeared to be more effective than didactic lectures. Educational outreach visits and physician reminders produced mixed results. Patient-based interventions, particularly the use of delayed prescriptions for infections for which antibiotics were not immediately indicated effectively reduced antibiotic use by patients and did not result in excess morbidity. Multi-faceted interventions combining physician, patient and public education in a variety of venues and formats were the most successful in reducing antibiotic prescribing for inappropriate indications. Only one of four studies demonstrated a sustained reduction in the incidence of antibiotic-resistant bacteria associated with the intervention. AUTHORS' CONCLUSIONS: The effectiveness of an intervention on antibiotic prescribing depends to a large degree on the particular prescribing behaviour and the barriers to change in the particular community. No single intervention can be recommended for all behaviours in any setting. Multi-faceted interventions where educational interventions occur on many levels may be successfully applied to communities after addressing local barriers to change. These were the only interventions with effect sizes of sufficient magnitude to potentially reduce the incidence of antibiotic-resistant bacteria. Future research should focus on which elements of these interventions are the most effective. In addition, patient-based interventions and physician reminders show promise and innovative methods such as these deserve further study.

Ambulatory Care↗

Randomized controlled trials of socially complex nursing interventions: creating bias and unreliability?

BACKGROUND: The randomized controlled trial is viewed by many researchers as the 'gold standard' research design. It is used increasingly to evaluate the effectiveness of socially complex activities such as nursing interventions. This use is seen by many commentators as problematic, while others are concerned about the quality of many published trial reports. One area of concern is that of intervention bias: the impact that a sentient intervention, such as a nursing one, may have consciously or unconsciously on study outcomes. This paper reports on an analysis of intervention definitions and possible intervention bias in 47 reports of randomized controlled trials of nursing interventions published in 2000 or 2001. AIMS: This study evaluates four characteristics of the included reports: intervention sample size, intervention definition, involvement of intervention nurses in other aspects of the trial, and the claimed generalizability of results. METHODS: Reports of randomized controlled trials published in 2000 or 2001 were identified. Full-text versions of 47 papers were obtained and information about the four characteristics was extracted and analysed. RESULTS: Problems relating to possible intervention bias were identified in each of the papers. Inadequate intervention definition was the commonest problem, leading to difficulties in calculating the 'intervention dose' and in replicating or generalizing from the studies. DISCUSSION: None of the included studies met the requirements of the Consolidated Standards of Reporting Trials. Four types of intervention bias were identified, and their possible implications for the reporting of trials of nursing interventions are discussed. This was a small-scale study, limited by time and resources. Its results are suggestive of a major problem of intervention bias but larger-scale investigations are necessary to quantify its extent. CONCLUSIONS: Intervention bias is potentially a problem in randomized controlled trials. Lack of detail about interventions in published papers could be corrected by stricter adherence to guidelines such as the Consolidated Standards of Reporting Trials, but this will not correct the underlying problem of inadequate study design that appears to be widespread in randomized controlled trials of nursing interventions.

Bias↗