Specific Intervention Components Research Articles

Specific and Nonspecific Psychological Interventions for PTSD Symptoms: A Meta‐Analysis With Problem Complexity as a Moderator

The necessity of specific intervention components for the successful treatment of patients with posttraumatic stress disorder is the subject of controversy. To investigate the complexity of clinical problems as a moderator of relative effects between specific and nonspecific psychological interventions. We included 18 randomized controlled trials, directly comparing specific and nonspecific psychological interventions. We conducted moderator analyses, including the complexity of clinical problems as predictor. Our results have confirmed the moderate superiority of specific over nonspecific psychological interventions; however, the superiority was small in studies with complex clinical problems and large in studies with noncomplex clinical problems. For patients with complex clinical problems, our results suggest that particular nonspecific psychological interventions may be offered as an alternative to specific psychological interventions. In contrast, for patients with noncomplex clinical problems, specific psychological interventions are the best treatment option.

One size does not fit all: evaluating an intervention to reduce antibiotic prescribing for acute bronchitis

BackgroundOveruse of antibiotics for upper respiratory tract infections (URIs) and acute bronchitis is a persistent and vexing problem. In the U.S., more than half of all patients with upper respiratory tract infections and acute bronchitis are treated with antibiotics annually, despite the fact that most cases are viral in etiology and are not responsive to antibiotics. Interventions aiming to reduce unnecessary antibiotic prescribing have had mixed results, and successes have been modest. The objective of this evaluation is to use mixed methods to understand why a multi-level intervention to reduce antibiotic prescribing for acute bronchitis among primary care providers resulted in measurable improvement in only one third of participating clinicians.MethodsClinician perspectives on print-based and electronic intervention strategies, and antibiotic prescribing more generally, were elicited through structured telephone surveys at high and low performing sites after the first year of intervention at the Geisinger Health System in Pennsylvania (n = 29).ResultsCompared with a survey on antibiotic use conducted 10 years earlier, clinicians demonstrated greater awareness of antibiotic resistance and how it is impacted by individual prescribing decisions—including their own. However, persistent perceived barriers to reducing prescribing included patient expectations, time pressure, and diagnostic uncertainty, and these factors were reported as differentially undermining specific intervention components’ effectiveness. An exam room poster depicting a diagnostic algorithm was the most popular strategy.ConclusionsFuture efforts to reduce antibiotic prescribing should address multi-level barriers identified by clinicians and tailor strategies to differences at individual clinician and group practice levels, focusing in particular on changing how patients and providers make decisions together about antibiotic use.

An analysis of teacher practices with toddlers during social conflicts

Employing a quasi-experimental design, this pilot study on teacher practices with toddlers during social conflicts was conducted in the southeastern USA. Four child-care classrooms, teachers (n = 8) and children (n = 51) were assessed with the Classroom Assessment Scoring System – Toddler [CLASS-Toddler; La Paro, K., Hamre, B. K., & Pianta, R. C. (2011). Classroom Assessment Scoring System – Toddler (CLASS). Baltimore, MD: Brookes], an author-developed problem-solving measure, a measure of child temperament and teacher interviews. Teachers in intervention classrooms were provided professional development in three areas: (a) teacher self-regulation and stress management, (b) child self-regulation of emotions and behaviours, and (c) social problem solving. For intervention classrooms, results showed growth in several CLASS dimensions including positive climate, teacher sensitivity, and classroom guidance, while the problem-solving measure revealed an unanticipated increase in problems. Additional research is needed on toddler social problem-solving skills and supportive teacher practices. Further refinement of the problem-solving measure and delineation of specific professional development intervention components that indicate positive classroom change is needed.

Combining computerized social cognitive training with neuroplasticity-based auditory training in schizophrenia.

Social cognitive deficits are an important treatment target in schizophrenia, but it is unclear to what degree they require specialized interventions and which specific components of behavioral interventions are effective. In this pilot study, we explored the effects of a novel computerized neuroplasticity-based auditory training delivered in conjunction with computerized social cognition training (SCT) in patients with schizophrenia. Nineteen clinically stable schizophrenia subjects performed 50 hours of computerized exercises that place implicit, increasing demands on auditory perception, plus 12 hours of computerized training in emotion identification, social perception, and theory of mind tasks. All subjects were assessed with MATRICS-recommended measures of neurocognition and social cognition, plus a measure of self-referential source memory before and after the computerized training. Subjects showed significant improvements on multiple measures of neurocognition. Additionally, subjects showed significant gains on measures of social cognition, including the MSCEIT Perceiving Emotions, MSCEIT Managing Emotions, and self-referential source memory, plus a significant decrease in positive symptoms. Computerized training of auditory processing/verbal learning in schizophrenia results in significant basic neurocognitive gains. Further, addition of computerized social cognition training results in significant gains in several social cognitive outcome measures. Computerized cognitive training that directly targets social cognitive processes can drive improvements in these crucial functions.

Component analysis of adherence in a family intervention.

Most studies of adherence use a single global measure to examine the relation of adherence to outcomes. These studies inform us about effects of overall implementation but not about importance of specific program elements. Previous research on the Strengthening Families Program 10-14 has shown that outcomes were unrelated to global adherence. The purpose of the present study was to determine whether adherence to specific components of SFP was related to outcomes, even though global adherence was not. The authors micro-coded data from an observational study of 11 instances of SFP (N = 47 facilitators, 151 participants) into specific process and content components. Using multilevel analysis, they examined the relation of each component to program outcomes, accounting for individual- and program-level variables. Most associations of adherence with outcome were negligible for European-Americans but significant for minority participants. Global assessments of implementation are insufficient for complex, multi-component prevention programs and may obscure relations of implementation to outcomes. Additionally, program components may function differently based on participant characteristics. Facilitators would benefit from understanding the function of individual program components, particularly when programs are delivered to diverse audiences. Program developers should provide detailed logic models of program theory to guide facilitators' decisions about adaptation. This is one of only a few studies to examine the relation of adherence to specific intervention components to outcomes in a real-world setting. Results show the utility of component analysis and the importance of considering individual characteristics for implementation assessment.

Workplace pedometer interventions for increasing physical activity

The World Health Organization and the World Economic Forum have recommended further research to strengthen current knowledge of workplace health programmes, particularly on effectiveness and using simple instruments. A pedometer is one such simple instrument that can be incorporated in workplace interventions. To assess the effectiveness of pedometer interventions in the workplace for increasing physical activity and improving subsequent health outcomes. Electronic searches of the Cochrane Central Register of Controlled Trials (671 potential papers), MEDLINE (1001), Embase (965), CINAHL (1262), OSH UPDATE databases (75) and Web of Science (1154) from the earliest record to between 30th January and 6th February 2012 yielded 3248 unique records. Reference lists of articles yielded an additional 34 papers. Contact with individuals and organisations did not produce any further records. We included individual and cluster-randomised controlled trials of workplace health promotion interventions with a pedometer component in employed adults. The primary outcome was physical activity and was part of the eligibility criteria. We considered subsequent health outcomes, including adverse effects, as secondary outcomes. Two review authors undertook the screening of titles and abstracts and the full-text papers independently. Two review authors (RFP and MC) independently completed data extraction and risk of bias assessment. We contacted authors to obtain additional data and clarification. We found four relevant studies providing data for 1809 employees, 60% of whom were allocated to the intervention group. All studies assessed outcomes immediately after the intervention had finished and the intervention duration varied between three to six months. All studies had usual treatment control conditions; however one study's usual treatment was an alternative physical activity programme while the other three had minimally active controls. In general, there was high risk of bias mainly due to lack of blinding, self reported outcome measurement, incomplete outcome data due to attrition, and most of the studies had not published protocols, which increases the likelihood of selective reporting.Three studies compared the pedometer programme to a minimally active control group, but the results for physical activity could not be combined because each study used a different measure of activity. One study observed an increase in physical activity under a pedometer programme, but the other two did not find a significant difference. For secondary outcomes we found improvements in body mass index, waist circumference, fasting plasma glucose, the quality of life mental component and worksite injury associated with the pedometer programmes, but these results were based on limited data from one or two small studies. There were no differences between the pedometer programme and the control group for blood pressure, a number of biochemical outcomes and the quality of life physical component. Sedentary behaviour and disease risk scores were not measured by any of the included studies.One study compared a pedometer programme and an alternative physical activity programme, but baseline imbalances made it difficult to distinguish the true improvements associated with either programme.Overall, there was insufficient evidence to assess the effectiveness of pedometer interventions in the workplace.There is a need for more high quality randomised controlled trials to assess the effectiveness of pedometer interventions in the workplace for increasing physical activity and improving subsequent health outcomes. To improve the quality of the evidence available, future studies should be registered in an online trials register, publish a protocol, allocate time and financial support to reducing attrition, and try to blind personnel (especially those who undertake measurement). To better identify the effects of pedometer interventions, future studies should report a core set of outcomes (total physical activity in METs, total time sitting in hours and minutes, objectively measured cardiovascular disease and type II diabetes risk factors, quality of life and injury), assess outcomes in the long term and undertake subgroup analyses based upon demographic subgroups (e.g. age, gender, educational status). Future studies should also compare different types of active intervention to test specific intervention components (eligibility, duration, step goal, step diary, settings), and settings (occupation, intervention provider). There was limited and low quality data providing insufficient evidence to assess the effectiveness of pedometer interventions in the workplace for increasing physical activity and improving subsequent health outcomes.

United We Stand: Emphasizing Commonalities Across Cognitive-Behavioral Therapies

Cognitive behavioral therapy (CBT) has a rich history of alleviating the suffering associated with mental disorders. Recently, there have been exciting new developments, including multicomponent approaches, incorporated alternative therapies (e.g., meditation), targeted and cost-effective technologies, and integrated biological and behavioral frameworks. These field-wide changes have led some to emphasize the differences among variants of CBT. Here, we draw attention to commonalities across cognitive-behavioral therapies, including shared goals, change principles, and therapeutic processes. Specifically, we offer a framework for examining common CBT characteristics that emphasizes behavioral adaptation as a unifying goal and three core change principles, namely (a) context engagement to promote adaptive imagining and enacting of new experiences; (b) attention change to promote adaptive sustaining, shifting, and broadening of attention; and (c) cognitive change to promote adaptive perspective taking on events so as to alter verbal meanings. Further, we argue that specific intervention components, including behavioral exposure/activation, attention training, acceptance/tolerance, decentering/defusion, and cognitive reframing, may be emphasized to a greater or lesser degree by different treatment packages but are still fundamentally common therapeutic processes that are present across approaches and are best understood by their relationships to these core CBT change principles. We conclude by arguing for shared methodological and design frameworks for investigating unique and common characteristics to advance a unified and strong voice for CBT in a widening, increasingly multimodal and interdisciplinary, intervention science.

Brief FASD prevention intervention: physicians’ skills demonstrated in a clinical trial in Russia

BackgroundAlcohol consumption during pregnancy can result in a range of adverse pregnancy outcomes including Fetal Alcohol Spectrum Disorders (FASD). Risky drinking among Russian women constitutes a significant risk for alcohol-exposed pregnancies (AEP). Russian women report that obstetrics and gynecology (OB/GYN) physicians are the most important source of information about alcohol consumption during pregnancy and developing effective prevention interventions by OB/GYNs is indicated. This is the first study focused on implementation of an AEP prevention intervention at women’s clinics in Russia.MethodThe paper describes the intervention protocol and addresses questions about the feasibility of a brief FASD prevention intervention delivered by OB/GYNs at women’s clinics in Russia. Brief physician intervention guidelines and two evidence-based FASD prevention interventions were utilized to design a brief dual-focused physician intervention (DFBPI) appropriate to Russian OB/GYN care. The questions answered were whether trained OB/GYN physicians could deliver DFBPI during women’s routine clinic visits, whether they maintained skills over time in clinical settings, and which specific intervention components were better maintained. Data were collected as part of a larger study aimed at evaluating effectiveness of DFBPI in reducing AEP risk in non-pregnant women. Methods of monitoring the intervention delivery included fidelity check lists (FCL) with the key components of the intervention completed by physicians and patients and live and audio taped observations of intervention sessions. Physicians (N = 23) and women (N = 372) independently completed FCL, and 78 audiotapes were coded.ResultsThe differences between women’s and physicians’ reports on individual items were not significant. Although the majority of physician and patient reports were consistent (N = 305), a discrepancy existed between the reports in 57 cases. Women reported more intervention components missing compared to physicians (p < 0.001). Discussing barriers was the most difficult component for physicians to implement, and OB/GYN demonstrated difficulties in discussing contraception methods.ConclusionsThe results supported the feasibility of the DFBPI in Russia. OB/GYN physicians trained in the DFBPI, monitored, and supported were able to implement and maintain skills during the study. In addition to the alcohol focus, DFBPI training needs to have a sufficient component to improve physicians’ skills in discussing contraception use.

Improving Patient Handovers From Hospital to Primary Care

Evidence shows that suboptimum handovers at hospital discharge lead to increased rehospitalizations and decreased quality of health care. To systematically review interventions that aim to improve patient discharge from hospital to primary care. PubMed, CINAHL, PsycInfo, the Cochrane Library, and EMBASE were searched for studies published between January 1990 and March 2011. Randomized, controlled trials of interventions that aimed to improve handovers between hospital and primary care providers at hospital discharge. Two reviewers independently abstracted data on study objectives, setting and design, intervention characteristics, and outcomes. Studies were categorized according to methodological quality, sample size, intervention characteristics, outcome, statistical significance, and direction of effects. Of the 36 included studies, 25 (69.4%) had statistically significant effects in favor of the intervention group and 34 (94.4%) described multicomponent interventions. Effective interventions included medication reconciliation; electronic tools to facilitate quick, clear, and structured summary generation; discharge planning; shared involvement in follow-up by hospital and community care providers; use of electronic discharge notifications; and Web-based access to discharge information for general practitioners. Statistically significant effects were mostly found in reducing hospital use (for example, rehospitalizations), improvement of continuity of care (for example, accurate discharge information), and improvement of patient status after discharge (for example, satisfaction). Heterogeneity of the interventions and study characteristics made meta-analysis impossible. Most studies had diffuse aims and poor descriptions of the specific intervention components. Many interventions have positive effects on patient care. However, given the complexity of interventions and outcome measures, the literature does not permit firm conclusions about which interventions have these effects. The European Union, the Framework Programme of the European Commission.

A Required Third-Year Medical Student Palliative Care Curriculum Impacts Knowledge and Attitudes

Despite broad support for palliative and end-of-life care training in medical schools, required clinical palliative care and end-of-life experiences are rare. In this study, we assess the impact of a required palliative care educational intervention on medical students' palliative care pain knowledge and end-of-life attitudes. In this wait-list control crossover design, third-year medical students from two sequential classes (n=157) completed a palliative care workshop at the beginning of a required year-long course. Students then completed a patient experience, online pain management module, and reflective essay in either the first or second half of the course. Fifteen validated multiple choice palliative care pain management items and the Thanatophobia Scale (7 items) were administered to measure knowledge and attitudes for all students at baseline, 5.5 months, and 11 months. Multivariate repeated measures ANOVA was used to determine differences between groups and across time. Analysis found statistically significant increases in knowledge and improvements in attitudes (p<0.001) across the time points as well as a statistically significant interaction effect between time and groups (p=0.006). These changes correspond to specific curricular intervention components in which attitudinal improvements are seen after the workshop, and knowledge increases are seen after the patient experience, online pain module, and reflective essay. A modest, required palliative care curriculum can yield improvements in medical student knowledge and attitudes. However, expansion of the experiential component and palliative care skills training and assessment are needed for students to have more meaningful outcomes and to ultimately contribute to better patient outcomes.

Practice, progress and future directions for physical therapies in Huntingtons disease.

Physical therapies and exercise may have potential as a disease modifying agent in Huntington's disease (HD) and in recent years, there have been several small scale feasibility studies that have shown benefit as a result of physical interventions. When evaluating complex physical interventions, a phased approach using mixed methodology designs that report specific intervention components, adherence, acceptability, adverse events and defined intervention protocols is important for replication and planning of future trials and to ensure potential for implementation in clinical practice. A narrative review of the available literature related to physical activity, physical therapy and exercise in people with HD was performed using a population, intervention, comparison and outcome (PICO) approach. Eight studies met specific inclusion criteria and were reviewed in terms of their systematic conduct and reporting standards. All of the studies (n = 8) provided details of intervention including location and duration. The majority of interventions included balance training activities in combination with other complex activities of daily living that required therapist supervision. Two of the interventions were home based, the remainder were facility or hospital based. None of the studies reported adverse events whilst only 3/8 reported adherence rates which were ranging from 60-80%. In general, limited detail was provided on the specific individual components of the interventions. This review of primary publications and conference proceedings, suggests that researchers working in the field need to focus on clearer reporting of intervention protocols so as to generate a clearer understanding of the impact of exercise and physical therapies on the symptoms of HD, as well as any potential synergistic role alongside the impending disease-modifying interventions.

Depression: a modifiable factor in fearful older fallers transitioning to frailty?

Fear of falling is one of the most common fears among community-dwelling older people and is as serious a health problem as falls themselves. Understanding fear of falling in fallers transitioning to frailty may help us identify effective strategies to reduce it in this already vulnerable group of older people. Our aim was to evaluate the psychological factors associated with fear of falling in a group of fallers transitioning to frailty when compared with robust or non-frail fallers. Cross-sectional design where 301 fallers underwent assessment at the Technology Research for Independent Living Clinic in Dublin (http://www.trilcentre.org/) is seen. Fear of falling was measured using the Modified Falls Efficacy Scale, and frailty was measured using the Biological Syndrome Model. Psychological measures included assessment of anxiety, depression, loneliness, personality factors and cognition. Frailer fallers had increased fear of falling when compared with robust fallers (p < 0.001). Age, female gender and lower cognitive scores were associated with greater fear of falling in the robust group. For frailer fallers, higher depression score was the only factor associated with fear of falling on multivariate analysis. The odds ratio of having case level depressive disorder (CESD-8 ≥ 4) if you were a frailer faller was significantly higher than if you were robust (OR = 2.6, CI 1.3-5.2, p = 0.006). Fallers at a transitional level of frailty may represent a particularly vulnerable group psychologically who would benefit most from interventional strategies with specific intervention components addressing depressive symptoms.

A multilevel meta-analysis of single-case and small-n research on interventions for reducing challenging behavior in persons with intellectual disabilities

The effectiveness of different interventions for challenging behavior (CB) in persons with intellectual disabilities (ID) was reviewed by means of a two-phase study. First, a systematic review of 137 meta-analyses and reviews on group-study interventions for CB in persons with ID was conducted. Based on this review, hypotheses concerning the effectiveness of divergent interventions for CB and concerning the impact of variables moderating treatment effectiveness were systematically generated. Second, these hypotheses were tested by means of a multilevel meta-analysis of single-case and small-n research. Two hundred and eighty-five studies reporting on 598 individuals were examined. The average treatment effect was large and statistically significant. However, this effect varied significantly over the included studies and participants. Compared to the meta-analyses and reviews focusing on group-studies in this research domain, the results of the present multilevel meta-analysis of single-case and small-n intervention research provided more detailed knowledge on which specific CB and intervention components moderate the interventions' effectiveness.

A meta-analysis of the efficacy of HIV/AIDS prevention interventions in Asia, 1995–2009

The HIV/AIDS epidemic continues to grow in pockets across Asia, despite early successes at curtailing its spread in countries like Thailand. Recent evidence documents dramatic increases in incidence among risk groups and, alarmingly, the general population. This meta-analysis summarizes the sexual risk-reduction interventions for the prevention of HIV-infection that have been evaluated in Asia. Sexual risk-reduction outcomes (condom use, number of sexual partners, incident sexually transmitted infections [STI], including HIV) from 46 behavioral intervention studies with a comparison condition and available by August 2010 were included. Overall, behavioral interventions in Asia consistently reduced sexual risk outcomes. Condom use improved when interventions sampled more women, included motivational content, or did not include STI testing and treatment. Incident HIV/STI efficacy improved most when interventions sampled more women, were conducted more recently, or when they included STI counseling and testing. Sexual frequency efficacy improved more in interventions that were conducted in countries with lower human development capacities, when younger individuals were sampled, or when condom skills training was included. Behavioral interventions for reducing sexual risk in Asia are efficacious; yet, the magnitude of the effects co-varies with specific intervention and structural components. The impact of structural factors on HIV intervention efficacy must be considered when implementing and evaluating behavioral interventions. Implications and recommendations for HIV/AIDS interventions are discussed.

Effectiveness of nonpharmacological secondary prevention of coronary heart disease

To summarize the current evidence with regard to the effectiveness of nonpharmacological secondary prevention strategies of coronary heart disease (CHD) and to investigate the comparative effectiveness of interventions of different categories, specific intervention components and the effectiveness in patient subgroups. A structured search of databases and manual search were conducted. Clinical trials and meta-analyses published between January 2003 and September 2008 were included if they targeted adults with CHD, had a follow-up of at least 12 months, and reported mortality, cardiac events or quality of life. Two researchers assessed eligibility and methodological quality, in which appropriate, pooled effect estimates were calculated and tested in sensitivity analyses. Of 4798 publications 43 met the inclusion criteria. Overall study quality was satisfactory, but only about half of the studies reported mortality. Follow-up duration varied between 12 and 120 months. Despite substantial heterogeneity, there was strong evidence of intervention effectiveness overall. The evidence for exercise and multimodal interventions was more conclusive for reducing mortality, whereas psychosocial interventions seemed to be more effective in improving the quality of life. Rigorous studies investigating dietary and smoking cessation interventions, specific intervention components and important patient subgroups, were scarce. Nonpharmacological secondary prevention is safe and effective, with exercise and multimodal interventions reducing mortality most substantially. There is a lack of studies concerning dietary and smoking cessation interventions. In addition, intervention effectiveness in patient subgroups and of intervention components could not be evaluated conclusively. Future research should investigate these issues in rigorous studies with appropriate follow-up duration to improve the current poor risk factor control of CHD patients.

Design and conduct of a pragmatic randomized controlled trial to enhance smoking-cessation outcomes with exercise: The Fit2Quit study

Background Most smokers want to stop smoking and many try to quit. However abstinence rates are low and most smokers do not manage to abstain for even a week. Relapse to smoking can be related to the occurrence of tobacco withdrawal symptoms (e.g., sleep disturbance, irritability, and craving) and weight gain. If regular exercise mitigates these effects it could have potential as an aid to smoking cessation. The aim of the Fit2Quit study is to determine the effects of a home and community-based exercise intervention on smoking abstinence at six months when used as an adjunct to usual care (telephone smoking-cessation counseling and nicotine replacement therapy; NRT). Methods/design A prospective parallel two-arm randomized controlled trial. Participants (n = 1400, 700 per arm) will be randomized to a structured home and community-based exercise program plus usual care (behavioral counseling and NRT) or to usual-care alone. It is targeted that at least 25% of the sample will be of Māori ethnicity (New Zealand indigenous). Outcomes to be measured using intention-to-treat analysis include: seven-day point prevalence of smoking abstinence verified by salivary cotinine (primary outcome); 6 months continuous abstinence; body mass index (BMI); cardio-respiratory fitness; physical activity levels; and cost effectiveness. Discussion The Fit2Quit study is an example of a large, pragmatic randomized controlled trial in a community setting. Specific components of the exercise intervention are outlined in detail. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609000637246.

Improving the Reporting of Interventions in Clinical Trials of Acupuncture: The Updated and Revised STRICTA

The revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) are being published with free online access to all users and prospective authors. The original STRICTA were co-published in five journals and also translated and published in Chinese, Korean and Japanese. STRICTA were written in response to published reports of acupuncture trials that reported insufficient information on the interventions themselves, compromising the interpretation of trial results and any possible replications. The aim of STRICTA is to provide precise guidelines for prospective authors of clinical trials to report clearly the specific components of acupuncture interventions used within an acupuncture trial, so as to enable other researchers to to reproduce the reported research protocol accurately and reliably or to appraise the findings critically. Poor reporting of interventions within trials is not confined to the field of acupuncture or complementary medicine. In the conventional medical field, approximately onehalf of trials scrutinized in one study were found to describe interventions inadequately. The whole subject of the quality of reporting in clinical trials has been addressed by the CONSORT (CONsolidated Standards Of Reporting Trials) Group. First published in 1996, and then revised in 2001 and 2010, the CONSORT Statement set out guidelines designed to improve the reporting of parallel-group randomized controlled trials. The CONSORT 2010 Statement consists of a 25-item checklist and a flow diagram, along with a set of explanations and examples of good reporting. When first developed in 2001, the STRICTA guidelines were designed to replace the one item in the CONSORT checklist related to interventions, which is Item 5 in the current version of CONSORT. STRICTA expanded this item with an additional 6 sub-items. The intention from the outset was that authors reporting acupuncture trials should follow CONSORT for all items except the one related to interventions, and, for this item, the STRICTA checklist with six subitems should be followed. In parallel with the updating of CONSORT, the STRICTA Group has also revised and updated the STRICTA guidelines. The details of this 2-year revision process, which included an extensive literature review a survey of authors of previous trials, the collation of opinions elicited from a group of 47 experts, and a consensus meeting in Freiburg, in Germany in 2008, have been set out elsewhere. The newly revised STRICTA criteria will be published online in this journal as an official extension to CONSORT. The revised STRICTA has retained the six sub-items as before, but has refined the criteria, removing those details identified by the international group of collaborators as redundant, ambiguous, lacking in clarity, and needing reworking to achieve improvement. These guidelines now comprise not only a sixitem checklist, but also explanatory text with examples of good reporting. All the the Editorial team of the Journal exhort all authors reporting trials of acupuncture to use both STRICTA and CONSORT when writing up studies for publication, and, equally, to use these guidelines as Gold Standards for the evaluation of published work. This will facilitate higherquality reporting, which, in turn, will enhance the impact of research conducted in the field. We believe that the online publication of the revised version of STRICTA will prove extremely useful not only to researchers worldwide, but also to millions of patients the world over who should be the beneficiaries of such improved research.

Information–motivation–behavioral skills barriers associated with intentional versus unintentional ARV non-adherence behavior among HIV+ patients in clinical care

Since the arrival of antiretroviral (ARV) therapy, HIV has become better characterized as a chronic disease rather than a terminal illness, depending in part on one's ability to maintain relatively high levels of adherence. Despite research concerning barriers and facilitators of ARV adherence behavior, relatively little is known about specific challenges faced by HIV-positive persons who report “taking a break” from their ARV medications. The present study employed the Information–Motivation–Behavioral Skills Model of ARV adherence as a framework for understanding adherence-related barriers that may differentiate between non-adherent patients who report “taking a break” versus those who do not report “taking a break” from their ARV medications. A sample of 327 HIV-positive patients who reported less than 100% adherence at study baseline provided data for this research. Participants who reported “taking a break” from their HIV medications without first talking to their healthcare provider were classified as intentionally non-adherent, while those who did not report “taking a break” without first talking with their healthcare provider were classified as unintentionally non-adherent. Analyses examined differences between intentionally versus unintentionally non-adherent patients with respect to demographic characteristics and responses to the adherence-related information, motivation, and behavioral skills questionnaire items. Few differences were observed among the groups on demographics, adherence-related information, or adherence-related motivation; however, significant differences were observed on about half of the adherence-related behavioral skills items. Implications for future research, as well as the design of specific intervention components to reduce intentionally non-adherent behavior, are discussed.

Health Promotion Program on Reduction of Cardiovascular Disease Risk Factors for Adults with Intellectual Disabilities

Disease prevention for persons with intellectual disabilities (ID) has been recognized as an under researched area. Health promotion programs integrating structured and multiple approaches to reduce cardiovascular disease (CVD) risk factors for persons with ID are imperative and greatly needed. PURPOSE: The purpose of this study was to examine the effect of a 12-week theoretical-based health promotion program in reduction of cardiovascular disease (CVD) risk factors for older adults with ID. METHODS: A total of 33 older adults with ID (Age in yr.: M = 39.18, SD = 9.49, Range = 30 to 70; Gender, Males = 33.3%, Females = 66.7%) was recruited to participate in a 12-week health promotion program (3 day per week and 90 minutes per day) at a local educational and vocational center in Taiwan. The 12-week health promotion program included health education and exercise components using Transtheoretical Model (TTM) as a framework. The direct caregivers of participants with ID were closely involved throughout the intervention program. Pre- and post-measures include weight, height, waist circumference, resting blood pressure, skinfolds, as well as fasting plasma triglycerides, total cholesterol, and glucose. A multivariate analysis of variance (MANOVA) for repeated measures was computed to examine statistically significant differences between pre and post measures. RESULTS: The findings of the repeated MANOVA revealed significant differences in the outcome measures (Pillai's Trace =.681, F(5,23) =7.844, p=.000). The univariate tests indicated that weight, waist circumferences, as well as fasting plasma triglycerides, total cholesterol, and glucose levels were significantly decreased after the intervention program. CONCLUSIONS: The reductions of CVD risk factors as results of the health promotion program are concluded. The impacts of specific intervention components (i.e., health education and exercise) contributing to the changes in diet and physical activity patterns that indirectly influence the reduction of CVD risk factors were not further examined in this study. Longitudinal research examining changes in health and CVD risk factors as a result of behavioral changes (i.e., diet and physical activity behavior changes) following a TTM approach intervention is needed.

Using theory to synthesise evidence from behaviour change interventions: The example of audit and feedback

Evidence syntheses are used to inform health care policy and practice. Behaviour change theories offer frameworks for categorising and evaluating interventions and identifying likely mechanisms through which effects are achieved. Yet systematic reviews rarely explicitly classify intervention components using theory, which may result in evidence syntheses and health care practice recommendations that are less than optimal. This paper outlines a method for applying theory to evidence syntheses of behaviour change interventions. We illustrate this method with an analysis of 'audit and feedback' interventions, based on data from a Cochrane review. Our analysis is based on Control Theory, which suggests that behaviour change is most likely if feedback is accompanied by comparison with a behavioural target and by action plans, and we coded interventions for these three techniques. Multivariate meta-regression was performed on 85 comparisons from 61 studies. However, few interventions incorporated targets or action plans, and so meta-regression models were likely to be underfitted due to insufficient power. The utility of our approach could not be tested via our analysis because of the limited nature of the audit and feedback interventions. However, we show that conceptualising and categorising interventions using behaviour change theory can reveal the theoretical coherence of interventions and so point towards improvements in intervention design, evaluation and synthesis. The results demonstrate that a theory-based approach to evidence synthesis is feasible, and can prove beneficial in understanding intervention design, even where there is insufficient empirical evidence to reliably synthesise effects of specific intervention components.