Process evaluation of a participatory ergonomics programme to prevent low back pain and neck pain among workers Population-based smoking cessation in women post partum: adherence to motivational interviewing in relation to client characteristics and behavioural outcomes. A complex multimodal activity intervention to reduce the risk of dementia in mild cognitive impairment–ThinkingFit: pilot and feasibility study for a randomized controlled trial Editorial: an author's checklist for measure development and validation manuscripts. Adherence to guidelines on cervical cancer screening in general practice: programme elements of successful implementation. The effectiveness and ineffectiveness of complex behavioral interventions: impact of treatment fidelity. A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods. A heart failure self-management program for patients of all literacy levels: A randomized, controlled trial [ISRCTN11535170] Investigating theoretical explanations for behaviour change: The case study of ProActive No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial The peaceful mind program: a pilot test of a cognitive-behavioral therapy-based intervention for anxious patients with dementia. Implementation of a cancer prevention program for working class, multiethnic populations. Secondary prevention in coronary heart disease: a randomised trial of nurse led clinics in primary care Effects of an exercise adherence intervention on outcomes in patients with heart failure. Training dietitians in basic motivational interviewing skills results in changes in their counseling style and in lower saturated fat intakes in their patients. Motivational Interviewing to Improve Adherence to a Behavioral Weight-Control Program for Older Obese Women With NIDDM: A pilot study Randomized controlled trial of a psychoeducation program for the self-management of chronic cardiac pain. Adherence to the principles of Motivational Interviewing, clients' characteristics and behavior outcome in a smoking cessation and relapse prevention trial in women postpartum. The efficacy of home based progressive strength training in older adults with knee osteoarthritis: a randomized controlled trial. Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial. Motivational interviewing delivered by diabetes educators: does it improve blood glucose control among poorly controlled type 2 diabetes patients? Effects of nurse counseling on walking for exercise in elderly primary care patients. ‘On Your Feet to Earn Your Seat’, a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial Systematic evaluation of implementation fidelity of complex interventions in health and social care Effects of multicomponent exercise on cognitive function in older adults with amnestic mild cognitive impairment: a randomized controlled trial Dealing with missing data in a multi-question depression scale: a comparison of imputation methods Implementation and effectiveness of a community-based health promotion program for older adults. Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis. The Fitness Arthritis and Seniors Trial (FAST). Diabetes nurse case management and motivational interviewing for change (DYNAMIC): results of a 2-year randomized controlled pragmatic trial. Motivational interviewing (MINT) improves continuous positive airway pressure (CPAP) acceptance and adherence: a randomized controlled trial. Development and evaluation of a sleep education program for older adults with dementia living in adult family homes. Educational outreach visits to improve nurses' use of mechanical venous thromboembolism prevention in hospitalized medical patients. Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial. Design and implementation of a home-based exercise program post-hip fracture: the Baltimore hip studies experience. A randomized trial to improve self-management practices of adults with asthma. Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project. A randomized controlled trial of an intervention designed to improve the care given in general practice to Type II diabetic patients: patient outcomes and professional ability to change behaviour. Process evaluation of a problem solving intervention to prevent recurrent sickness absence in workers with common mental disorders. Process evaluation of a clinical preventive nutrition intervention. Problem solving to improve adherence and asthma outcomes in urban adults with moderate or severe asthma: a randomized controlled trial. Effectiveness of the Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) Dissemination Project: A Science to Prenatal Care Practice Partnership Effectiveness of pharmacist care for patients with reactive airways disease: a randomized controlled trial. Framework for design and evaluation of complex interventions to improve health The role of gender in moderating treatment outcome in collaborative care for anxiety. Implementing a Dietary Intervention in Primary Care Practice: A Process Evaluation Effectiveness of multifaceted educational programme to reduce antibiotic dispensing in primary care: practice based randomised controlled trial
Background Both low back pain ( LBP ) and neck pain ( NP ) are major occupational health problems . In the workplace , participatory ergonomics ( PE ) is frequently used on musculoskeletal disorders . However , evidence on the effectiveness of PE to prevent LBP and NP obtained from r and omised controlled trials ( RCTs ) is scarce . This study evaluates the process of the Stay@Work participatory ergonomics programme , including the perceived implementation of the prioritised ergonomic measures . Methods This cluster- RCT was conducted at the departments of four Dutch companies ( a railway transportation company , an airline company , a steel company , and a university including its university medical hospital ) . Directly after the r and omisation outcome , intervention departments formed a working group that followed the steps of PE during a six-hour working group meeting . Guided by an ergonomist , working groups identified and prioritised risk factors for LBP and NP , and composed and prioritised ergonomic measures . Within three months after the meeting , working groups had to implement the prioritised ergonomic measures at their department . Data on various process components ( recruitment , reach , fidelity , satisfaction , and implementation components , i.e. , dose delivered and dose received ) were collected and analysed on two levels : department ( i.e. , working group members from intervention departments ) and participant ( i.e. , workers from intervention departments ) . Results A total of 19 intervention departments ( n = 10 with mental workloads , n = 1 with a light physical workload , n = 4 departments with physical and mental workloads , and n = 4 with heavy physical workloads ) were recruited for participation , and the reach among working group members who participated was high ( 87 % ) . Fidelity and satisfaction towards the PE programme rated by the working group members was good ( 7.3 or higher ) . The same was found for the Stay@Work ergocoach training ( 7.5 or higher ) . In total , 66 ergonomic measures were prioritised by the working groups . Altogether , 34 % of all prioritised ergonomic measures were perceived as implemented ( dose delivered ) , while the workers at the intervention departments perceived 26 % as implemented ( dose received ) . Conclusions PE can be a successful method to develop and to prioritise ergonomic measures to prevent LBP and NP . Despite the positive rating of the PE programme the implementation of the prioritised ergonomic measures was lower than expected . Trial registration Current Controlled Trials IS RCT AIMS quantitative description of adherence to motivational interviewing ( MI ) in smoking cessation sessions ; and examination of the relationships between client characteristics and adherence to MI , and between adherence to MI and future smoking status . METHODS 84 sessions were conducted during a r and omised controlled trial to test the effectiveness of a  population -based smoking intervention in women during the postpartum period . Demographic and behaviour-related variables were included in a logistic regression to predict adherence to MI . MEASUREMENTS adherence was measured using the MI Treatment Integrity Scale . FINDINGS 38.1 % of sessions showed good adherence to MI . Receiving a good MI session was not related to any demographic or behavioural variables . The relationship between adherence and intervention outcome after six months was not statistically significant ( chi(2)=0.355 , p=0.551 ) . CONCLUSIONS the smoking cessation sessions examined in this study failed to adhere to MI . There was no relationship between adherence to MI and behavioural outcome six months after the intervention , indicating that women who smoke post partum may be a high-risk group for whom specific smoking cessation interventions need to be developed Background Dementia affects 35 million people worldwide and is currently incurable . Many cases may be preventable because regular participation in physical , mental and social leisure activities during middle age is associated with up to 47 % dementia risk reduction . However , the majority of middle-aged adults are not active enough . MCI is therefore a clear target for activity interventions aim ed at reducing dementia risk . An active lifestyle during middle age reduces dementia risk but it remains to be determined if increased activity reduces dementia risk when MCI is already evident . Before this can be investigated conclusively , complex multimodal activity programmes are required that ( 1 ) combine multiple health promoting activities , ( 2 ) engage people with MCI , and ( 3 ) result in sufficient adherence rates . Methods We design ed the ThinkingFit programme to engage  people with MCI  in a complex intervention comprised of three activity components : physical activity , group-based cognitive stimulation ( GCST ) and individual cognitive stimulation ( ICST ) . Engagement and adherence was promoted by applying specific psychological techniques to enhance behavioural flexibility in an early pre-phase and during the course of the intervention . To pilot the intervention , participants served as their own controls during a 6- to 12-week run-in period , which was followed by 12 weeks of activity intervention . Results Out of 212 MCI patients screened , 163 were eligible , 70 consented and 67 completed the intervention ( mean age 74 years ) .  Activity adherence rates were high : physical activity = 71 % ; GCST = 83 % ; ICST = 67 % . Significant treatment effects ( p < .05 ) were evident on physical health outcomes ( decreased BMI and systolic blood pressure , [ pre/post values of 26.3/25.9 kg/m2 and 145/136 mmHg respectively ] ) , fitness ( decreased resting and recovery heart rate [ 68/65 bpm and 75/69 bpm ] ) , and cognition ( improved working memory [ 5.3/6.3 items ] ) . Conclusions We found satisfactory recruitment , retention and engagement rates , coupled with significant treatment effects in elderly MCI patients . It appears feasible to conduct r and omized controlled trials of the dementia prevention potential of complex multimodal activity programmes like ThinkingFit . Trial registration Clinical Trials.gov registration nr : NCT01603862 ; date : 17/5/2012 A recent special issue of the Journal of Pediatric Psychology included papers focused on evidence -based assessment across several broad domains of assessment in pediatric psychology ( e.g. , adherence , pediatric pain , and quality of life ) . In one of these papers , Holmbeck et al. ( 2008 ) review ed strengths and limitations of existing measures of psychosocial adjustment and psychopathology , concluding that many measures lacked supporting psychometric data ( e.g. , basic indices of reliability and validity ) that would permit a complete evaluation of these measures . Given that measure development and validation papers are frequently published in JPP ( Brown , 2007 ) , it is important that we attend to guiding psychometric principles when developing and disseminating data on new measures to be employed with pediatric population s ( Nunnally & Bernstein , 1994 ) . Thus , the purpose of this paper is to present and describe a checklist for authors to use when su bmi tting measure development papers to JPP . This checklist is included in the Appendix and is also included at the following link on the JPP website : http://www.oxfordjournals.org/our_journals/jpepsy/for _ authors /measure%20development%20checklist.pdf Findings presented by Holmbeck et al. ( 2008 ) indicated that 34 of the 37 measures review ed met pre-established “ evidence -based assessment ” ( EBA ) criteria for “ well-established ” measures ( Cohen et al. , 2008 ) . To be considered “ well-established , ” a measure had to have been presented in at least two peer- review ed journal articles by different investigatory teams , have demonstrated adequate levels of reliability and validity , and be accompanied by supporting information ( e.g. , a measure manual ) . Although most measures that we review ed met these criteria , we also found that most of the 34 “ well-established ” measures were hampered by at least one major psychometric flaw and /or lacked important psychometric data . We concluded that a more fine-grained EBA classification system is needed . One important distinction in this literature relates to differences between empirically supported assessment and evidence -based assessment . This type of distinction was first discussed in the literature on clinical interventions ( e.g. , Spring , 2007 ) . An empirically supported intervention is one that has demonstrated efficacy in r and omized clinical trials or clinic-based effectiveness trials . An evidence -based intervention has empirical support in the manner just described , but also “ integrates research evidence , clinical expertise , and patient preferences and characteristics … empirically-supported treatments  ( ESTs )  are an important component of evidence -based practice ( EBP ) , but EBP can not be reduced to ESTs ” ( Spring , 2007 , p.611 ) . Applying these terms to the field of assessment and measure development efforts , an empirically supported assessment measure would be one that demonstrates satisfactory psychometric characteristics , broadly defined . To be evidence based , the measure should also demonstrate utility in clinical setting s , be useful in making diagnoses , be sensitive to treatment effects , and /or provide incremental validity above and beyond other similar measures . Although papers in the special issue of JPP frequently referred to “ evidence -based assessment ” ( Cohen et al. , 2009 ) , the articles included in the issue tended to evaluate the degree to which the measures were empirically-supported rather than evidence based . To be “ evidence -based , ” our review s would have needed to integrate an evaluation of clinical utility , diagnostic utility , and treatment sensitivity with the empirical psychometric data presented in each review . As noted , the published review s were more likely to focus on the latter rather than on the former . As suggested by Mash and Hunsley ( 2005 ) , detailed EBA profiles would provide a complete evaluation of evidence across each of several psychometric and clinical ly relevant dimensions , including : ( a ) internal consistency , ( b ) test – retest reliability , ( c ) the availability of normative data , ( d ) content validity , ( e ) construct validity , ( f ) convergent and discriminant validity , ( g ) criterion-related validity , ( h ) incremental validity , ( i ) clinical utility , ( j ) diagnostic utility , and ( k ) treatment sensitivity . The focus on incremental validity and clinical and diagnostic utility raises the bar from a focus on “ empirical support ” ( i.e. , where the focus would tend to be primarily on psychometric data ) to a broad focus on the “ evidence base ” for a measure . In developing the checklist that is the focus of this article , we attempted to provide a list of criteria relevant to establishing the evidence base ( and not just empirical support ) for a measure . In addition to shifting the focus from providing “ empirical support ” for a measure to providing an “ evidence base ” for our instruments , a checklist for measure development papers would permit JPP review ers to evaluate such papers in the same way that review ers of r and omized clinical trials make use of the Consoli date d St and ards of Reporting Trials ( CONSORT ) checklist and flowchart ( Altman et al. , 2001 ) . The CONSORT checklist contains reporting st and ards with respect to method ological features of and the manner in which results are reported in clinical trials . Moreover , authors are required to provide a flowchart that describes details of sample recruitment and attrition during the course of the study . Thus , a checklist for measure development papers would serve two interrelated purpose s : ( a ) it would provide guidance to authors as they embark on the measure development process and would provide a list of criteria authors can use as they develop an evidence base for their measures , and ( b ) it would begin to st and ardize the manner in which psychometric and other assessment -related data are presented in measure development papers for this journal . Before providing a more detailed overview of the checklist , it is important to note that this checklist is rather exhaustive ( see Appendix ) . As such , it represents what would “ ideally ” be expected for a measure development or validation manuscript rather than minimal criteria for such papers . No one paper can provide a complete evaluation of all important psychometric and clinical ly relevant dimensions that will establish once- and -for-all the evidence base for a measure . Instrument refinement is part of a measure development process that gradually builds an evidence base for a scale ( see Smith & McCarthy , 1995 , for suggestions on measure refinement ) . Indeed , the validation of any measure is a cumulative process that occurs across many different types of research studies and across research programs BACKGROUND There is still only limited underst and ing of whether and why interventions to facilitate the implementation of guidelines for improving primary care are successful . It is therefore important to look inside the ' black box ' of the intervention , to ascertain which elements work well or less well . AIM To assess the associations of key elements of a nationwide multifaceted prevention programme with the successful implementation of cervical screening guidelines in general practice . DESIGN OF STUDY A nationwide prospect i ve cohort study . SETTING A r and om sample of one-third of all 4,758 general practice s in The Netherl and s ( n = 1,586 ) . METHOD General practitioners ( GPs ) in The Netherl and s were exposed to a two- and -a-half-year nationwide multifaceted prevention programme to improve the adherence to national guidelines for cervical cancer screening . Adherence to guidelines at baseline and after the intervention and actual exposure to programme elements were assessed in the sample using self-administered question naires . RESULTS Both baseline and post-measurement question naires were returned by 988 practice s ( response rate = 62 % ) . No major differences in baseline practice characteristics between study population , non-responders , and all Netherl and s practice s were observed . After the intervention all practice s improved markedly ( P<0.001 ) in their incorporation of nine out of 10 guideline indicators for effective cervical screening into practice . The most important elements for successful implementation were : specific software modules ( odds ratios and 95 % confidence intervalsfor all nine indicators ranged from OR = 1.85 [ 95 % CI = 1.24 - 2.77 ] to OR = 10.2 [ 95 % CI = 7.58 - 14.1 ] ) ; two or more ' practice visits ' by outreach visitors ( ORs and 95 % CIs for six indicators ranged from OR = 1.46 [ 95 % CI= 1.01 - 2.12 ] to OR = 2.35 [ 95 % CI = 1.63 - 3.38 ] ) ; and an educational programme for practice assistants ( ORs and 95 % CIs for four indicators ranged from OR = 1.57 [ 95 % CI = 1.00 - 1.92 ] to OR = 1.90 [ 95 % CI = 1.25 - 2.88 ] ) . CONCLUSION A multifaceted programme targeting GPs , including facilitating software modules , outreach visits , and educational sessions for PAs , contributes to the successful implementation of national guidelines for cervical screening There is often wide variability in the reported effects of complex behavioral interventions . Effectiveness can vary across studies , sites , and providers . A factor that has been insufficiently considered is the fidelity of the behavioral treatment that was provided . Low quality practice could be likened to partial doses of a vaccine or antibiotic : the right idea but insufficient strength . Using  motivational interviewing ( MI ) as an example , the authors describe three quality conditions that should be present for a study to be regarded as a trial of a complex behavioral intervention : ( 1 ) The treatment should clearly contain the components that are theoretically or empirically related to its efficacy ; ( 2 ) providers should be trained to an adequate and specified criterion of proficiency before treating trial patients ; and ( 3 ) the fidelity of treatment should be documented by reliable coding of practice throughout the study and reported in a manner that permits comparison with skill levels in other trials . The authors also discuss bona fide intervention failures despite strong clinical trial methodology , offering recommendations for future outcome research BACKGROUND More evidence is needed on the potential role of ' booster ' interventions in the maintenance of increases in physical activity levels after a brief intervention in relatively sedentary population s. OBJECTIVES To determine whether objective ly measured physical activity , 6 months after a brief intervention , is increased in those receiving physical activity ' booster ' consultations  delivered in a motivational interviewing ( MI ) style , either face to face or by telephone . DESIGN Three-arm , parallel-group , pragmatic , superiority r and omised controlled trial with nested qualitative research fidelity and geographical information systems and health economic sub studies . Treatment allocation was carried out using a web-based simple r and omisation procedure with equal allocation probabilities . Principal investigators and study statisticians were blinded to treatment allocation until after the final analysis only . SETTING Deprived areas of Sheffield , UK . PARTICIPANTS Previously sedentary people , aged 40 - 64 years , living in deprived areas of Sheffield , UK , who had increased their physical activity levels after receiving a brief intervention . INTERVENTIONS Participants were r and omised to the control group ( no further intervention ) or to two sessions of MI , either face to face ( ' full booster ' ) or by telephone ( ' mini booster ' ) . Sessions were delivered 1 and 2 months post-r and omisation . MAIN OUTCOME MEASURES The primary outcome was total energy expenditure ( TEE ) per day in kcal from 7-day accelerometry , measured using an Actiheart device ( CamNtech Ltd , Cambridge , UK ) . Independent evaluation of practitioner competence was carried out using the Motivational Interviewing Treatment Integrity assessment . An estimate of the per-participant intervention costs , re source use data collected by question naire and health-related quality of life data were analysed to produce a range of economic models from a short-term NHS perspective . An additional series of models were developed that used TEE values to estimate the long-term cost-effectiveness . RESULTS In total , 282 people were r and omised ( control = 96 ; mini booster = 92 , full booster = 94 ) of whom 160 had a minimum of 4 out of 7 days ' accelerometry data at 3 months ( control = 61 , mini booster = 47 , full booster = 52 ) . The mean difference in TEE per day between baseline and 3 months favoured the control arm over the combined booster arm but this was not statistically significant ( -39 kcal , 95 % confidence interval -173 to 95 , p = 0.57 ) . The autonomy-enabled MI communication style was generally acceptable , although some participants wanted a more paternalistic approach and most expressed enthusiasm for monitoring and feedback components of the intervention and research . Full boosters were more popular than mini boosters . Practitioners achieved and maintained a consistent level of MI competence . Walking distance to the nearest municipal green space or leisure facilities was not associated with physical activity levels . Two alternative modelling approaches both suggested that neither intervention was likely to be cost-effective . CONCLUSIONS Although some individuals do find a community-based , brief MI ' booster ' intervention supportive , the low levels of recruitment and retention and the lack of impact on objective ly measured physical activity levels in those with adequate outcome data suggest that it is unlikely to represent a clinical ly effective or cost-effective intervention for the maintenance of recently acquired physical activity increases in deprived middle-aged urban population s. Future research with middle-aged and relatively deprived population s should explore interventions to promote physical activity that require less proactive engagement from individuals , including environmental interventions . STUDY REGISTRATION Current Controlled Trials IS RCT N56495859 , Clinical Trials.gov NCT00836459 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 18 , No. 13 . See the NIHR Journals Library website for further project information Background Self-management programs for patients with heart failure can reduce hospitalizations and mortality . However , no programs have analyzed their usefulness for patients with low literacy . We compared the efficacy of a heart failure self-management program design ed for patients with low literacy versus usual care .  Methods We performed a 12-month r and omized controlled trial . From November 2001 to April 2003 , we enrolled participants aged 30–80 , who had heart failure and took furosemide .  Intervention patients received education on self-care emphasizing daily weight measurement , diuretic dose self-adjustment , and symptom recognition and response . Picture-based educational material s , a digital scale , and scheduled telephone follow-up were provided to reinforce adherence . Control patients received a generic heart failure brochure and usual care . Primary outcomes were combined hospitalization or death , and heart failure-related quality of life . Results 123 patients ( 64 control , 59 intervention ) participated ; 41 % had inadequate literacy . Patients in the intervention group had a lower rate of hospitalization or death ( crude incidence rate ratio ( IRR ) = 0.69 ; CI 0.4 , 1.2 ; adjusted IRR = 0.53 ; CI 0.32 , 0.89 ) . This difference was larger for patients with low literacy ( IRR = 0.39 ; CI 0.16 , 0.91 ) than for higher literacy ( IRR = 0.56 ; CI 0.3 , 1.04 ) , but the interaction was not statistically significant . At 12 months , more patients in the intervention group reported monitoring weights daily ( 79 % vs. 29 % , p < 0.0001 ) . After adjusting for baseline demographic and treatment differences , we found no difference in heart failure-related quality of life at 12 months ( difference = -2 ; CI -5 , + 9 ) . Conclusion A primary care-based heart failure self-management program design ed for patients with low literacy reduces the risk of hospitalizations or death Developing more effective behavioural interventions requires an underst and ing of the mechanisms of behaviour change , and methods to rigorously test their theoretical basis . The delivery and theoretical basis of an intervention protocol were assessed in ProActive , a UK trial of an intervention to increase the physical activity of those at risk of Type 2 diabetes ( N = 365 ) . In 108 intervention sessions , behaviours of facilitators were mapped to four theories that informed intervention development and behaviours of participants were mapped to 17 theoretical components of these four theories . The theory base of the intervention specified by the protocol was different than that delivered by facilitators , and that received by participants . Of the intervention techniques delivered , 25 % were associated with  theory of planned behaviour ( TPB )  , 42 % with  self-regulation theory ( SRT )  , 24 % with  operant learning theory ( OLT )  and 9 % with  relapse prevention theory ( RPT ) .  The theoretical classification of participant talk showed a different pattern , with twice the proportion associated with OLT ( 48 % ) , 21 % associated with TPB , 31 % with SRT and no talk associated with RPT . This study demonstrates one approach to assessing the extent to which the theories used to guide intervention development account for any changes observed Abstract Objective . To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care . Design and setting . Cluster r and omised trial in general practice s. Intervention . Nurse-led structured diabetes care with a protocol , record keeping , reminders , and feedback , plus training in motivational interviewing and agenda setting . Subjects . Primary care nurses in 58 general practice s and their 940 type 2 diabetes patients with an HbA1c concentration above 7 % , and a body mass index ( BMI ) above 25 kg/m2 . Main outcome measures . HbA1c , diet , and physical activity ( medical records and patient question naires ) . Results . Multilevel linear and logistic regression analyses adjusted for baseline outcomes showed that despite active nurse participation in the intervention , the comprehensive programme was no more effective than usual care after 14 months , as shown by HbA1c levels ( difference between groups = 0.13 ; CI 20.8–0.35 ) and diet ( fat ( difference between groups = 0.19 ; CI 20.82–1.21 ) ; vegetables ( difference between groups = 0.10 ; CI-0.21–0.41 ) ; fruit ( difference between groups = 20.02 ; CI 20.26–0.22 ) ) , and physical activity ( difference between groups = 21.15 ; CI 212.26–9.97 ) , or any of the other measures of clinical parameters , patient 's readiness to change , or quality of life . Conclusion . A comprehensive programme that integrated lifestyle counselling based on motivational interviewing principles integrated into structured diabetes care did not alter HbA1c or the lifestyle related to diet and physical activity . We thus question the impact of motivational interviewing in terms of its ability to improve routine diabetes care in general practice OBJECTIVES To assess feasibility and to conduct a preliminary evaluation of outcomes following Peaceful Mind , a cognitive-behavioral therapy-based intervention for anxiety in dementia , relative to usual care . DESIGN Pilot r and omized controlled trial including assessment s at baseline and 3 and 6 months . SETTING Houston , TX . PARTICIPANTS Thirty-two out patients diagnosed with mild ( 47 % ) or moderate ( 53 % ) dementia receiving care through outpatient clinics at the Veterans Affairs medical center , Baylor College of Medicine , Harris County Hospital District , and community day centers for dementia , and their collaterals , who spent at least 8 hours a week with them . INTERVENTION Peaceful Mind included up to 12 weekly in-home sessions ( mean : 8.7 , SD : 2.27 ) during the initial 3 months and up to eight brief telephone sessions ( mean : 5.4 , SD : 3.17 ) during months 3 - 6 , involving self-monitoring for anxiety , deep breathing , and optional skills ( coping self-statements , behavioral activation , and sleep management ) . Patients learned skills , and collaterals served as coaches . In usual care , patients received diagnostic feedback , and providers were informed of inclusion status . MEASUREMENTS Neuropsychiatric Inventory-Anxiety subscale , Rating Anxiety in Dementia scale , Penn State Worry Question naire-Abbreviated , Geriatric Anxiety Inventory , Geriatric Depression Scale , Quality of Life in Alzheimer disease , Patient Health Question naire , and Client Satisfaction Question naire . RESULTS Feasibility was demonstrated with regard to recruitment , attrition , and treatment characteristics . At 3 months , clinicians rated patients receiving Peaceful Mind as less anxious , and patients rated themselves as having higher quality of life ; collaterals reported less distress related to loved ones ' anxiety . Although significant positive effects were not noted in other outcomes or at 6-month follow-up , the pilot nature of the trial prohibits conclusions about efficacy . CONCLUSIONS Results support that Peaceful Mind is ready for future comparative clinical trials BACKGROUND This paper describes the implementation of the Healthy Directions-Health Centers intervention and examines the characteristics of participants associated with completion of intervention activities . Healthy Directions-Health Centers was design ed to address social context ual factors relevant to cancer prevention interventions for working class , multi-ethnic population s. METHODS Ten community health centers were paired and r and omly assigned to intervention or control .  Patients who resided in low income , multi-ethnic neighborhoods were approached for participation . This study targeted fruit and vegetable consumption , red meat consumption , multi-vitamin intake , and physical activity . The intervention components consisted of : ( 1 ) a brief study endorsement from a clinician ; ( 2 ) an in-person counseling session with a health advisor ; ( 3 ) four follow-up telephone counseling sessions ; and ( 4 ) multiple distributions of tailored material s. RESULTS Among the 1,088 intervention group participants , 978 participants ( 90 % ) completed at least five out of six intervention activities . Participants who missed clinical appointments were less likely to complete all components of the intervention . Participant characteristics that predicted receipt of clinician endorsement differed from characteristics that predicted completion of health advisor activities . Low acculturation did not present a barrier to delivery of the intervention once the participant was enrolled . CONCLUSIONS Collection and reporting on process evaluation results can help explain variations in program implementation Objective To evaluate whether  nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound .  Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions  Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevention and , for them , future cardiovascular events and mortality could be reduced by up to a third The purpose of this study was to determine how an exercise adherence intervention affects the physiological , functional , and quality of life outcomes of patients with heart failure ( HF ) . Sixteen HF patients were r and omly assigned to an  exercise-only group  ( n = 8) or to an  exercise-with-adherence group ( n = 8) . Two of the 16 people  died from nonexercise related causes during the study and were not included in the analysis . The intervention was tested over a 24-week period in which patients participated in a 12-week supervised exercise program ( Phase 1 ) followed by 12 weeks of unsupervised home exercise ( Phase 2 ) . The intervention format was one of individualized graphic feedback on exercise goals and participation and problem-solving support by nurses . Results indicate that patients who received the intervention exercised more frequently and experienced improved outcomes during both phases . The adherence intervention may encourage HF patients to continue to exercise and thereby maintain the health benefits gained in both phases of an exercise program OBJECTIVE To test if basic training for  dietitians  in motivational interviewing ( MI ) result ed in changes in dietitians ' counseling style and improvements in their patients ' diet and risk parameters . DESIGN A r and omized controlled trial . SETTING 9 home-care organizations in the Netherl and s. PARTICIPANTS 37 dietitians , 209 baseline patients , and 142 follow-up diabetes patients . INTERVENTION Dietitians were r and omly allocated to receive basic training in motivational interviewing ( MI dietitians , n=18 ) or not ( control dietitians , n=19 ) . MAIN OUTCOME MEASURES Counseling style of dietitians ; total self-reported saturated fat , fruit , and vegetable intake , measured body mass index ( BMI ) , waist circumference , and glycated hemoglobin ( Hemoglobin A(1c ) , HbA(1c ) ) of patients . ANALYSIS Analyses of variance and multiple linear regression analyses . Alpha = .05 RESULTS MI dietitians were significantly more empathetic , more often showed reflection during consultations , and were more likely than control dietitians to let their patients talk for the majority of the consultation . Patients of MI dietitians had significantly lower saturated fat intake levels at posttest compared to patients of control dietitians . No effects on HbA(1c ) , BMI , and waist circumference were found . CONCLUSIONS AND IMPLICATION S Basic training in MI changed the dietitians ' counseling style and result ed in lower saturated fat intakes in their patients OBJECTIVE The aim of this r and omized pilot study was to examine whether the addition of motivational interviewing strategies to a behavioral obesity intervention enhances adherence and glucose control in older obese women with NIDDM . RESEARCH DESIGN AND METHODS Twenty-two older obese women ( 41 % black ) with NIDDM were r and omly assigned to 1 ) a st and ard 16-week group behavioral weight-control program that provided instruction in diet , exercise , and behavioral modification or 2 ) the same group behavioral program with three individualized motivational interviewing sessions added . RESULTS The motivational group attended significantly more group meetings ( 13.3 vs. 8.9 ) , completed significantly more food diaries ( 15.2 vs. 10.1 ) , and recorded blood glucose significantly more often ( 46.0 vs. 32.2 days ) than the st and ard group . Further , participants in the motivational group had significantly better glucose control post-treatment ( 9.8 vs. 10.8 % ) . Although both groups demonstrated significant weight loss , no differences were apparent between groups . CONCLUSIONS These results suggest that augmenting a st and ard behavioral treatment program for obese women with NIDDM with a motivational interviewing component may significantly enhance adherence to program recommendations and glycemic control . Preliminary data warrant further investigation with larger sample s and a longer follow-up Cardiac pain arising from chronic stable angina ( CSA ) is a cardinal symptom of coronary artery disease and has a major negative impact on health-related quality of life ( HRQL ) , including pain , poor general health status , and inability to self-manage . Current secondary prevention approaches lack adequate scope to address CSA as a multidimensional ischemic and persistent pain problem . This trial evaluated the impact of a low-cost six-week angina psychoeducation program , entitled The Chronic Angina Self-Management Program ( CASMP ) , on HRQL , self-efficacy , and re source fulness to self-manage anginal pain . One hundred thirty participants were r and omized to the CASMP or three-month wait-list usual care ; 117 completed the study . Measures were taken at baseline and three months . General HRQL was measured using the Medical Outcomes Study 36-Item Short Form and the disease-specific Seattle Angina Question naire ( SAQ ) . Self-efficacy and re source fulness were measured using the Self-Efficacy Scale and the Self-Control Schedule , respectively . The mean age of participants was 68 years , 80 % were male . Analysis of variance of change scores yielded significant improvements in treatment group physical functioning [ F=11.75(1,114 ) , P<0.001 ] and general health [ F=10.94(1,114 ) , P=0.001 ] aspects of generic HRQL . Angina frequency [ F=5.57(1,115 ) , P=0.02 ] , angina stability [ F=7.37(1,115 ) , P=0.001 ] , and self-efficacy to manage disease [ F=8.45(1,115 ) , P=0.004 ] were also significantly improved at three months . The CASMP did not impact re source fulness . These data indicate that the CASMP was effective for improving physical functioning , general health , anginal pain symptoms , and self-efficacy to manage pain at three months and provide a basis for long-term evaluation of the program OBJECTIVES 1 . Quantitative description of the adherence to the principles of Motivational Interviewing ( MI ) in smoking counseling sessions , 2 . Examination of the relation between clients ' characteristics and the adherence to the principles of MI , and between adherence to the principles of MI and future smoking status . METHODS A sample of n=163 sessions conducted during a r and omized controlled trial in testing the effectiveness of a population -based smoking intervention in women postpartum was investigated . Demographic and behavior-related variables were included in a logistic regression to predict adherence to MI .  Adherence was measured using the  Motivational Interviewing Treatment Integrity ( MITI ) scale . RESULTS Of the sessions , 49.4 % showed good adherence to MI . The OR of receiving a good MI session was 3.1 for non-smokers in comparison to daily smokers . No other demographic or behavioral variable gained statistical significance . The relation between adherence and intervention outcome after 6 months was statistically significant ( chi(2)=6.459 , p<0.05 ) . CONCLUSIONS This intervention study shows a satisfactory degree of adherence to and the effectiveness of MI . MI-adherence seems more likely in sessions concerned with smoking relapse prevention compared to smoking cessation sessions OBJECTIVE To test the effects of a high intensity home-based progressive strength training program on the clinical signs and symptoms of osteoarthritis ( OA ) of the knee . METHODS Forty-six community dwelling patients , aged 55 years or older with knee pain and radiographic evidence of knee OA , were r and omized to a 4 month home based progressive strength training program or a nutrition education program ( attention control ) .  Thirty-eight patients completed the trial with an adherence of 84 % to the intervention and 65 % to the attention control . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index pain and physical function subscales . Secondary outcomes included clinical knee examination , muscle strength , physical performance measures , and question naires to measure quality of life variables . RESULTS Patients in the strength training group who completed the trial had a 71 % improvement in knee extension strength in the leg reported as most painful versus a 3 % improvement in the control group ( p < 0.01 ) . In a modified intent to treat analysis , self-reported pain improved by 36 % and physical function by 38 % in the strength training group versus 11 and 21 % , respectively , in the control group ( p = 0.01 for between group comparison ) . In addition , those patients in the strength training group who completed the trial had a 43 % mean reduction in pain ( p = 0.01 vs controls ) , a 44 % mean improvement in self-reported physical function ( p < 0.01 vs controls ) , and improvements in physical performance , quality of life , and self-efficacy when compared to the control group . CONCLUSION High intensity , home based strength training can produce substantial improvements in strength , pain , physical function and quality of life in patients with knee OA CONTEXT Improving the quality of mental health care requires moving clinical interventions from controlled research setting s into real-world practice setting s. Although such advances have been made for depression , little work has been performed for anxiety disorders . OBJECTIVE To determine whether a flexible treatment-delivery model for multiple primary care anxiety disorders ( panic , generalized anxiety , social anxiety , and posttraumatic stress disorders ) would be better than usual care ( UC ) . DESIGN , SETTING , AND PATIENTS A r and omized controlled effectiveness trial of Coordinated Anxiety Learning and Management ( CALM ) compared with UC in 17 primary care clinics in 4 US cities . Between June 2006 and April 2008 , 1004 patients with anxiety disorders ( with or without major depression ) , aged 18 to 75 years , English- or Spanish-speaking , were enrolled and subsequently received treatment for 3 to 12 months . Blinded follow-up assessment s at 6 , 12 , and 18 months after baseline were completed in October 2009 . INTERVENTION CALM allowed choice of cognitive behavioral therapy ( CBT ) , medication , or both ; included real-time Web-based outcomes monitoring to optimize treatment decisions ; and a computer-assisted program to optimize delivery of CBT by nonexpert care managers who also assisted primary care clinicians in promoting adherence and optimizing medications . MAIN OUTCOME MEASURES Twelve-item Brief Symptom Inventory ( BSI-12 ) anxiety and somatic symptoms score . Secondary outcomes included proportion of responders ( > or = 50 % reduction from pretreatment BSI-12 score ) and remitters ( total BSI-12 score < 6 ) . RESULTS A significantly greater improvement for  CALM vs UC  in global anxiety symptoms was found ( BSI-12 group mean differences of -2.49 [ 95 % confidence interval { CI } , -3.59 to -1.40 ] , -2.63 [ 95 % CI , -3.73 to -1.54 ] , and -1.63 [ 95 % CI , -2.73 to -0.53 ] at 6 , 12 , and 18 months , respectively ) . At 12 months , response and remission rates ( CALM vs UC ) were 63.66 % ( 95 % CI , 58.95%-68.37 % ) vs 44.68 % ( 95 % CI , 39.76%-49.59 % ) , and 51.49 % ( 95 % CI , 46.60%-56.38 % ) vs 33.28 % ( 95 % CI , 28.62%-37.93 % ) , with a number needed to treat of 5.27 ( 95 % CI , 4.18 - 7.13 ) for response and 5.50 ( 95 % CI , 4.32 - 7.55 ) for remission . CONCLUSION For patients with anxiety disorders treated in primary care clinics , CALM compared with UC result ed in greater improvement in anxiety symptoms , depression symptoms , functional disability , and quality of care during 18 months of follow-up . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00347269 AIM To determine whether glycemic control is improved when motivational interviewing ( MI ) , a patient-centered behavior change strategy , is used with diabetes self management education ( DSME ) as compared to DSME alone . METHODS poorly controlled type 2 diabetes ( T2DM ) patients ( n=234 ) were r and omized into 4 groups : MI+DSME or DSME alone , with or without use of a computerized summary of patient self management barriers . We compared HbA1c changes between groups at 6 months and investigated mediators of HbA1c change . RESULTS study patients attended the majority of the four intervention visits ( mean 3.4 ) , but drop-out rate was high at follow-up research visits ( 35 % ) . Multiple regression showed that groups receiving MI had a mean change in HbA1c that was significantly lower ( less improved ) than those not receiving MI ( t=2.10 ; p=0.037 ) . Mediators of HbA1c change for the total group were diabetes self-care behaviors and diabetes distress ; no between-group differences were found . CONCLUSIONS DSME improved blood glucose control , underlining its benefit for T2DM management . However , MI+DSME was less effective than DSME alone . Overall , weak support was found for the clinical utility of MI in the management of T2DM delivered by diabetes educators Background . Counseling sedentary primary care patients can increase physical activity , but whether this approach will increase exercise and fitness in elderly adults with chronic diseases remains to be determined . Methods . After receiving individualized nurse counseling to begin a program of walking for health , 60- to 80-year-old primary care patients were r and omized to one of three levels of telephone contacts over 10 months : ( i ) 20 nurse-initiated calls , ( ii ) 10 nurse-initiated calls plus 10 motivational calls programmed through an automated phone calling system , or ( iii ) no program-initiated phone contacts .  Self-reported ( diary ) walking adherence was the primary outcome ; other activity , social support , health quality of life , and measured walking performance , mobility , and body mass index and girths were also assessed during the initiation ( months 1 - 6 ) and maintenance ( months 7 - 10 ) phases of the trial . Results . Average adherence for the 181 participants to the goal of walking at least 20 minutes on 3 or more days per week was 44 % for initiation and 42 % for maintenance . Participants receiving the combination of nurse-initiated personal and automated phone calls  walked significantly more frequently than those with no phone contacts . Fitness improved in all three groups ; changes were generally correlated with self-reported walking . Having a companion was associated with more frequent walking . Perceived quality of physical and mental health did not change . Conclusions . Simple and relatively inexpensive nurse contacts can motivate elderly primary care patients to walk for exercise , and this activity is associated with measurable health benefits Background Many older adults are both highly sedentary ( that is , spend considerable amounts of time sitting ) and physically inactive ( that is , do little physical activity ) . This protocol describes an exploratory trial of a theory-based behaviour change intervention in the form of a booklet outlining simple activities ( ‘ tips ’ ) design ed both to reduce sedentary behaviour and to increase physical activity in older adults . The intervention is based on the ‘ habit formation ’ model , which proposes that consistent repetition leads to behaviour becoming automatic , sustaining activity gains over time . Methods The intervention is being developed iteratively , in line with Medical Research Council complex intervention guidelines . Selection of activity tips was informed by semi-structured interviews and focus groups with older adults , and input from a multidisciplinary expert panel . An ongoing preliminary field test of acceptability among 25 older adults will inform further refinement . An exploratory r and omized controlled trial will be conducted within a primary care setting , comparing the tips booklet with a control fact sheet . Retired , inactive and sedentary adults ( n = 120 ) aged 60 to 74 years , with no physical impairments precluding light physical activity , will be recruited from general practice s in north London , UK . The primary outcomes are recruitment and attrition rates . Secondary outcomes are changes in behaviour , habit , health and wellbeing over 12 weeks . Discussion Data will be used to inform study procedures for a future , larger-scale definitive r and omized controlled trial . Trial registration Current Controlled Trials IS RCT N47901994 Background Evaluation of an  implementation process  and its  fidelity can give insight into the ' black box ' of interventions . However , a lack of st and ardized methods for study ing fidelity and implementation process have been reported , which might be one reason for the fact that few prior studies in the field of health service research have systematic ally evaluated interventions ' implementation processes . The aim of this project is to systematic ally evaluate  implementation fidelity  and possible factors influencing fidelity of complex interventions in health and social care . Methods A modified version of The Conceptual Framework for Implementation Fidelity  will be used as a conceptual model for the evaluation . The modification implies two additional moderating factors : context and recruitment . A systematic evaluation process was developed . Multiple case study method is used to investigate implementation of three complex health service interventions . Each case will be investigated in depth and longitudinally , using both quantitative and qualitative methods . Discussion This study is the first attempt to empirically test The Conceptual Framework for  Implementation Fidelity . The study can highlight mechanism and factors of importance when implementing complex interventions . Especially the role of the moderating factors on implementation fidelity can be clarified . Trial Registration Supported Employment , SE , among people with severe mental illness -- a r and omized controlled trial : NCT00960024 Background To examine the effects of a multicomponent exercise program on the cognitive function of older adults with amnestic mild cognitive impairment ( aMCI ) . Methods Design : Twelve months , r and omized controlled trial ; Setting : Community center in Japan ; Participants : Fifty older adults ( 27 men ) with aMCI ranging in age from 65 to 93 years ( mean age , 75 years ) ; Intervention : Subjects were r and omized into either a multicomponent exercise ( n = 25 ) or an education control group ( n = 25 ) . Subjects in the multicomponent exercise group exercised under the supervision of physiotherapists for 90 min/d , 2 d/wk , for a total of 80 times over 12 months . The exercises included aerobic exercises , muscle strength training , and postural balance retraining , and were conducted using multiple conditions to stimulate cognitive functions . Subjects in the control group attended three education classes regarding health during the 12-month period . Measurements were administered before , after the 6-month , and after the 12-month intervention period ; Measurements : The performance measures included the mini-mental state examination , logical memory subtest of the Wechsler memory scale-revised , digit symbol coding test , letter and categorical verbal fluency test , and the Stroop color word test . Results The mean adherence to the exercise program was 79.2 % . Improvements of cognitive function following multicomponent exercise were superior at treatment end ( group × time interactions for the mini-mental state examination ( P = 0.04 ) , logical memory of immediate recall ( P = 0.03 ) , and letter verbal fluency test ( P = 0.02 ) ) . The logical memory of delayed recall , digit symbol coding , and Stroop color word test showed main effects of time , although there were no group × time interactions . Conclusions This study indicates that exercise improves or supports , at least partly , cognitive performance in older adults with aMCI Background Missing data present a challenge to many research projects . The problem is often pronounced in studies utilizing self-report scales , and literature addressing different strategies for dealing with missing data in such circumstances is scarce . The objective of this study was to compare six different imputation techniques for dealing with missing data in the Zung Self-reported Depression scale ( SDS ) . Methods 1580 participants from a surgical outcomes study completed the SDS . The SDS is a 20 question scale that respondents complete by circling a value of 1 to 4 for each question . The sum of the responses is calculated and respondents are classified as exhibiting depressive symptoms when their total score is over 40 . Missing values were simulated by r and omly selecting questions whose values were then deleted ( a missing completely at r and om simulation ) . Additionally , a missing at r and om and missing not at r and om simulation were completed . Six imputation methods were then considered ; 1 ) multiple imputation , 2 ) single regression , 3 ) individual mean , 4 ) overall mean , 5 ) participant 's preceding response , and 6 ) r and om selection of a value from 1 to 4 . For each method , the imputed mean SDS score and st and ard deviation were compared to the population statistics . The Spearman correlation coefficient , percent misclassified and the Kappa statistic were also calculated . Results When 10 % of values are missing , all the imputation methods except r and om selection produce Kappa statistics greater than 0.80 indicating ' near perfect ' agreement . MI produces the most valid imputed values with a high Kappa statistic ( 0.89 ) , although both single regression and individual mean imputation also produced favorable results . As the percent of missing information increased to 30 % , or when unbalanced missing data were introduced , MI maintained a high Kappa statistic . The individual mean and single regression method produced Kappas in the ' substantial agreement ' range ( 0.76 and 0.74 respectively ) . Conclusion Multiple imputation is the most accurate method for dealing with missing data in most of the missind data scenarios we assessed for the SDS . Imputing the individual 's mean is also an appropriate and simple method for dealing with missing data that may be more interpretable to the majority of medical readers . Research ers should consider conducting method ological assessment s such as this one when confronted with missing data . The optimal method should balance validity , ease of interpretability for readers , and analysis expertise of the research team BACKGROUND Because preventing functional decline in older adults is a national priority and senior centers have been identified as potentially important venues for health-promotion activities , a trial of a multicomponent disability prevention program was conducted at a senior center . METHODS One hundred older adults were recruited for a 6-month r and omized clinical trial . All members of the experimental group received an exercise intervention , nutrition counseling , and a home safety assessment . Smoking and alcohol interventions were delivered to at-risk subjects . Outcome variables included the Medical Outcomes Study Short Form ( SF-36 ) health survey , the CES-Depression scale , bed days , and restricted-activity days . RESULTS A single study announcement result ed in a response sufficient to recruit 100 subjects . The exercise program was well received : 85 % of intervention subjects completed the 6-month program and adherence was excellent , with over 90 % attendance at exercise classes . After 6 months the intervention group had significantly better scores on 7 of 8 SF-36 subscales and fewer depressive symptoms than controls . CONCLUSIONS Senior centers may be excellent sites for community-based health promotion interventions : participation and adherence rates may be acceptable , interventions can be design ed that are feasible in this setting , and these interventions appear to affect health status positively . The study program improved physical and psychosocial functioning and is a promising model for preventing functional decline through activities based at senior centers Objective : To examine the feasibility of a strategy training clinical trial in a small group of adults with stroke-related cognitive impairments in inpatient rehabilitation , and to explore the impact of strategy training on disability . Design : Non-r and omized two-group intervention pilot study . Setting : Two inpatient rehabilitation units within an academic health centre . Participants : Individuals with a primary diagnosis of acute stroke , who were admitted to inpatient rehabilitation and demonstrated cognitive impairments were included . Individuals with severe aphasia ; dementia ; major depressive disorder , bipolar , or psychotic disorder ; recent drug or alcohol abuse ; and anticipated length of stay less than five days were excluded . Intervention : Participants received strategy training or an attention control session in addition to usual rehabilitation care . Sessions in both groups were 30–40 minutes daily , five days per week , for the duration of inpatient rehabilitation . Main outcome measures : We assessed feasibility through participants ’ recruitment and retention ; research intervention session number and duration ; participants ’ comprehension and engagement ; intervention fidelity ; and participants ’ satisfaction . We assessed disability at study admission , inpatient rehabilitation discharge , 3 and 6 months using the Functional Independence Measure . Results : Participants in both groups ( 5 per group ) received the assigned intervention ( > 92 % planned sessions ; > 94 % fidelity ) and completed follow-up testing . Strategy training participants in this small sample demonstrated significantly less disability at six months ( M ( SE ) = 117 ( 3 ) ) than attention control participants ( M(SE ) = 96 ( 14 ) ; t8 = 7.87 , P = 0.02 ) . Conclusions : It is feasible and acceptable to administer both intervention protocol s as an adjunct to acute inpatient rehabilitation , and strategy training shows promise for reducing disability OBJECTIVE To determine the effects of structured exercise programs on  self-reported disability in older adults with knee osteoarthritis . SETTING AND DESIGN A r and omized , single-blind clinical trial lasting 18 months conducted at 2 academic medical centers . PARTICIPANTS A total of 439 community-dwelling adults , aged 60 years or older , with radiographically evident knee osteoarthritis , pain , and self-reported physical disability .  INTERVENTIONS An aerobic exercise program , a resistance exercise program , and a health education program . MAIN OUTCOME MEASURES The primary outcome was self-reported disability score ( range , 1 - 5 ) . The secondary outcomes were knee pain score ( range , 1 - 6 ) , performance measures of physical function , x-ray score , aerobic capacity , and knee muscle strength . RESULTS A total of 365 ( 83 % ) participants completed the trial . Overall compliance with the exercise prescription was 68 % in the aerobic training group and 70 % in the resistance training group . Postr and omization , participants in the aerobic exercise group had a 10 % lower adjusted mean ( + /- SE ) score on the physical disability question naire ( 1.71 + /- 0.03 vs 1.90 + /- 0.04 units ; P<.001 ) , a 12 % lower score on the knee pain question naire ( 2.1 + /- 0.05 vs 2.4 + /- 0.05 units ; P=.001 ) , and performed better ( mean [ + /- SE ] ) on the 6-minute walk test ( 1507 + /- 16 vs 1349 + /- 16 ft ; P<.001 ) , mean ( + /-SE ) time to climb and descend stairs ( 12.7 + /- 0.4 vs 13.9 + /- 0.4 seconds ; P=.05 ) , time to lift and carry 10 pounds ( 9.1 + /- 0.2 vs 10.0 + /- 0.1 seconds ; P<.001 ) , and mean ( + /-SE ) time to get in and out of a car ( 8.7 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P<.001 ) than the health education group . The resistance exercise group had an 8 % lower score on the physical disability question naire ( 1.74 + /- 0.04 vs 1.90 + /- 0.03 units ; P=.003 ) , 8 % lower pain score ( 2.2 + /- 0.06 vs 2.4 + /- 0.05 units ; P=.02 ) , greater distance on the 6-minute walk ( 1406 + /- 17 vs 1349 + /- 16 ft ; P=.02 ) , faster times on the lifting and carrying task ( 9.3 + /- 0.1 vs 10.0 + /- 0.16 seconds ; P=.001 ) , and the car task ( 9.0 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P=.003 ) than the health education group . There were no differences in x-ray scores between either exercise group and the health education group . CONCLUSIONS Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability , physical performance , and pain from participating in either an aerobic or a resistance exercise program . These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis BACKGROUND The aim of the present study was to determine whether the addition of nurse case managers ( NCMs ) trained in motivational interviewing ( MI ) to usual care would result in improved outcomes in high-risk type 2 diabetes patients . METHODS A 2-year r and omized controlled pragmatic trial r and omized 545 patients to usual care control ( n=313 ) or those who received the intervention ( n=232 ) with additional practice -embedded NCM care , including MI-guided behavior change counseling . The NCMs received intensive MI training with ongoing fidelity assessment .  RESULTS Systolic blood pressure ( SBP ) was better in the intervention than usual care group ( 131 ± 15 vs. 135 ± 18 mmHg , respectively ; P<0.05 ) . Improvements were seen in both the control and intervention groups in terms of HbA1c ( from 9.1 % to 8.0 % and from 8.8 % to 7.8 % , respectively ) , low-density lipoprotein ( LDL ; from 127 to 100 mg/dL and from 128 to 102 mg/dL , respectively ) , and diastolic blood pressure ( from 78 to 74 mmHg and from 80 to 74 mmHg , respectively ) . Depression symptom scores were better in the intervention group . The reduction in diabetes-related distress approached statistical significance . CONCLUSIONS The NCMs and MI improved SBP and complications screening . The large decrease in HbA1C and LDL in the control group may have obscured any further intervention effect . Although nurses prompted providers for medication titration , strategies to reduce provider clinical inertia may also be needed OBJECTIVE Adherence to continuous positive airway pressure ( CPAP ) therapy for obstructive sleep apnoea ( OSA ) is poor . We assessed the effectiveness of a motivational interviewing intervention ( motivational interview nurse therapy [ MINT ] ) in addition to best practice st and ard care to improve acceptance and adherence to CPAP therapy in people with a new diagnosis of OSA . METHOD One hundred six Australian adults ( 69 % male ) with a new diagnosis of OSA and a clinical recommendation for CPAP treatment were recruited from a tertiary sleep disorders center . Participants were r and omly assigned to receive either 3 sessions of a motivational interviewing intervention ( MINT ; n = 53 ; mean age = 55.4 years ) or no intervention ( control ; n = 53 ; mean age = 57.74 years ) . The primary outcome was the difference between the groups in objective CPAP adherence at 1-month , 2-month , 3-month , and 12-month follow-ups . RESULTS Fifty ( 94 % ) participants in the MINT group and 50 ( 94 % ) participants in the control group met all inclusion and exclusion criteria and were included in the primary analysis . The number of hours of CPAP use per night in the MINT group at 3 months was 4.63 hr and was 3.16 hr in the control group ( p = .005 ) . This represents almost 50 % better adherence in the MINT group relative to the control group . Patients in the MINT group were substantially more likely to accept CPAP treatment . CONCLUSIONS MINT is a brief , manualized , effective intervention that improves CPAP acceptance and objective adherence rates compared to st and ard care alone OBJECTIVES To investigate the feasibility of implementing a Sleep Education Program ( SEP ) for improving sleep in adult family home ( AFH ) residents with dementia , and the relative efficacy of SEP compared with usual care control in a pilot r and omized controlled trial . PARTICIPANTS Thirty-seven AFH staff-caregivers and 47 residents with comorbid dementia and sleep disturbances . INTERVENTION SEP consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans . MEASUREMENTS Treatment fidelity to the  SEP  was assessed following the National Institutes of Health ( NIH ) Behavior Change Consortium model utilizing trainer observations and staff-caregiver reports . Resident sleep was assessed by wrist actigraphy at baseline , 1-month posttreatment , and 6-month follow-up . Caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected . RESULTS Each key area of treatment fidelity ( SEP delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes . Staff-caregivers learned how to identify sleep scheduling , daily activity , and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors .  SEP  decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the 6-month follow-up period compared with the control condition . CONCLUSION Results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with AFH residents with dementia Venous thromboembolism ( VTE ) is a significant cause of morbidity and mortality in hospitalized medical patients . Evidence -based guidelines exist for preventing VTE ; unfortunately , these guidelines are not always adhered to by clinicians . The aim of this study was to evaluate the acceptability , utility and clinical impact of an educational outreach visit ( EOV ) on nurses ' provision of mechanical prophylaxis to hospitalized medical patients using a prospect i ve , uncontrolled , before- and -after design . Nurses received a 1-to-1 educational session on mechanical VTE prevention by a trained nurse facilitator . The EOV intervention was design ed by a multidisciplinary group of healthcare professionals using social marketing theory . Eighty-five of the 120 eligible nurses ( 71 % ) attended the EOV . The median length of each visit was 11.5 minutes ( interquartile range [ IQR ] , 10 - 15 ) and the median time spent arranging and conducting each visit was 63 minutes ( IQR , 49 - 85 ) . Eighty-four ( 99 % ) of the 85 participants gave a verbal commitment to trial the new evidence -based mechanical VTE prevention practice s. However , there were no measurable improvements in the proportion of patients risk assessed ( -1.7 % improvement ; 95 % confidence interval [ CI ] , -7.0 to 10.3 ; P = .68 ) or provided appropriate mechanical prophylaxis ( -0.3 % improvement ; 95 % CI , -13.4 to 14 ; P = .96 ) . Research ers conclude that EOV should not be used to improve  nurses ' use of mechanical VTE prevention because it has no measurable impact on clinical practice and is re source intensive , requiring 4.5 minutes of preparation for every minute spent face to face with participants . Further research into the specific mechanism of action is required to explain the variability in clinical effect seen with this intervention BACKGROUND Mental health policy in many countries is oriented around recovery , but the evidence base for service-level recovery-promotion interventions is lacking . METHODS We did a cluster , r and omised , controlled trial in two National Health Service Trusts in Engl and .  REFOCUS is a 1-year team-level intervention targeting staff behaviour to increase focus on values , preferences , strengths , and goals of patients with psychosis , and staff-patient relationships , through coaching and partnership . Between April , 2011 , and May , 2012 , community-based adult mental health teams were r and omly allocated to provide usual treatment plus REFOCUS or usual treatment alone ( control ) . Baseline and 1-year follow-up outcomes were assessed in r and omly selected patients . The primary outcome was recovery and was assessed with the Question naire about Processes of Recovery ( QPR ) . We also calculated overall service costs . We used multiple imputation to estimate missing data , and the imputation model captured clustering at the team level . Analysis was by intention to treat . This trial is registered , number IS RCT N02507940 . FINDINGS 14 teams were included in the REFOCUS group and 13 in the control group . Outcomes were assessed in 403 patients ( 88 % of the target sample ) at baseline and in 297 at 1 year . Mean QPR total scores did not differ between the two groups ( REFOCUS group 40·6 [ SD 10·1 ] vs control 40·0 [ 10·2 ] , adjusted difference 0·68 , 95 % CI -1·7 to 3·1 , p=0·58 ) . High team participation was associated with higher staff-rated scores for recovery-promotion behaviour change ( adjusted difference -0·4 , 95 % CI -0·7 to -0·2 , p=0·001 ) and patient-rated QPR interpersonal scores ( -1·6 , -2·7 to -0·5 , p=0·005 ) at follow-up than low participation . Patients treated in the REFOCUS group incurred £ 1062 ( 95 % CI -1103 to 3017 ) lower adjusted costs than those in the control group . INTERPRETATION Although the primary endpoint was negative , supporting recovery might , from the staff perspective , improve functioning and reduce needs . Implementation of REFOCUS could increase staff recovery-promotion behaviours and improve patient-rated recovery . FUNDING National Institute for Health Research OBJECTIVE The objectives are to describe for the first time a home-based exercise intervention for frail elderly hip fracture patients and to describe the feasibility of this exercise program . DESIGN A home-based exercise program was used in a r and omized controlled trial in which the authors investigated exercise intervention versus no exercise intervention in patients after hip fracture . SETTING This program was implemented at the patients ' own home or place of residence after discharge . PARTICIPANTS Women 65 years of age or older were recruited within 15 days of hip fracture . Eligible patients were those with a nonpathologic fracture who were admitted within 72 hours of injury , had surgical repair of the hip fracture , and met medical inclusion criteria . Participants initially were r and omized to exercise groups and then assigned to exercise trainers . INTERVENTION The exercise contained strength training and aerobic components . Participants were expected to exercise 5 days per week by performing a combination of supervised and independently performed exercise sessions . Intensity and duration were increased gradually by trainers in a st and ardized way . The frequency of the supervised sessions decreased as participants became more independent . Treatment fidelity visits ensured that the intervention was being delivered as intended across trainers and across participants . MAIN OUTCOME MEASUREMENT This work describes the feasibility and challenges of administering an intensive home-based exercise program in this population of older adults . RESULTS Of those patients r and omized to exercise , 82 % were followed by a trainer and almost all advanced to higher levels in both aerobic and strength programs . Overall , participants received an average of 44 ( 78.5 % ) of the prescribed visits by the trainer . CONCLUSIONS This study showed that it was possible to engage a frail older population of post-hip fracture patients in a program of aerobic and strength training exercise with a high rate of participation The prevalence and impact of adult asthma are substantial , and poor self-management practice s , especially failures to adhere to treatment regimens , appear to be a significant problem . Desirable characteristics of an intervention program to improve self-management were identified through needs assessment and review of existing patient education re sources . A comprehensive program was developed that integrated a workbook with one-to-one counseling and adherence-enhancing strategies . A longitudinal 1-year study compared patients receiving this self-management program with " usual care " patients receiving st and ard asthma pamphlets . Patients were r and omly assigned to conditions . Baseline score and asthma severity were statistically controlled . Self-management patients had substantially better adherence than usual care patients , as well as improved functional status , at follow-up . Hospital and emergency department visits decreased in both groups but did not differ between groups OBJECTIVES We tested the effectiveness of a community-based , literacy-sensitive , and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income , Spanish-speaking Latinos at increased diabetes risk . METHODS Three hundred twelve participants from Lawrence , Massachusetts , were r and omly assigned to lifestyle intervention care ( IC ) or usual care ( UC ) between 2004 and 2007 . The intervention was implemented by trained Spanish-speaking individuals from the community . Each participant was followed for 1 year . RESULTS The participants ' mean age was 52 years ; 59 % had less than a high school education . The 1-year retention rate was 94 % . Compared with the UC group , the IC group had a modest but significant weight reduction ( -2.5 vs 0.63 lb ; P = .04 ) and a clinical ly meaningful reduction in hemoglobin A1c ( -0.10 % vs -0.04 % ; P = .009 ) . Likewise , insulin resistance improved significantly in the IC compared with the UC group . The IC group also had greater reductions in percentage of calories from total and saturated fat . CONCLUSIONS We developed an inexpensive , culturally sensitive diabetes prevention program that result ed in weight loss , improved HbA1c , and improved insulin resistance in a high-risk Latino population AIM Our objective was to evaluate the effect of training in a patient-centred intervention for GPs and practice nurses on outcomes for patients with Type II diabetes .  METHODS We carried out a r and omized controlled trial within general practice s as the basis for r and omization and a before- and -after design for measures of patient outcome . A parallel process study examined the use of the method by professionals . The study was carried out in 29 general practice s in South Glamorgan who had participated for at least 2 years in a local scheme of audit and CME in relation to Type II diabetes care . The subjects were 252 Type II diabetic patients recruited by 15 experimental and 14 control practice s. The main outcome measures were changes in glycosylated haemoglobin , patient satisfaction with care and treatment , functional health status and professional ability to apply the intervention . RESULTS Professionals adopted the innovative method with enthusiasm , but after 2 years only 19 % continued to apply the method systematic ally . The trial was , therefore , unable to demonstrate significant biochemical or functional improvements . This highlights the need to underst and the factors associated with professional uptake and subsequent ability to sustain changes in behaviour . CONCLUSIONS The efficacy of this behavioural intervention remains unproved , despite its acceptability to professional staff . Detailed and prolonged development and testing of behavioural interventions is an essential first step before embarking on r and omized controlled trials which involve complex behavioural changes in professionals or patients Common mental disorders ( CMDs ) are a major cause of sickness absence . Twenty to 30 % of the workers who return to work after sickness absence due to CMDs experience recurrent sickness absence . We developed the Stimulating Healthy participation And Relapse Prevention (SHARP)-at work intervention , a problem solving intervention delivered by occupational physicians ( OPs ) , to prevent recurrent sickness absence in this worker population in The Netherl and s. A process evaluation was conducted alongside a cluster-r and omised controlled trial to ( 1 ) evaluate whether the SHARP-at work intervention was implemented according to the protocol and differed from treatment in the control group , and ( 2 ) to investigate the relationship between the key elements of the intervention and the effect outcome ( i.e. recurrent sickness absence ) . We collected process data for both the intervention and control group on recruitment , reach , dose delivered , dose received , fidelity , context and satisfaction . Data on recurrent sickness absence was collected through the registry system of the collaborating occupational health service . The study was performed in the Netherl and s , and between 2010 and 2012 , 154 OPs and 158 participants participated . Compared to the control group , participants in the intervention group more frequently had two or more consultations with the OP  ( odds ratio [ OR ] = 3.2 , 95 % confidence interval [ CI ] = 1.2 - 8.8 ) and completed more assignments ( OR = 33.8 , 95 % CI = 10.4 - 109.5 ) as recommended in the intervention protocol . OPs and participants were satisfied with the intervention and rated it as applicable . Several individual intervention components were linked to the effect outcome . The process evaluation showed that the SHARP-at work intervention was conducted according to the protocol for the majority of the participants and well-received by OPs and participants . Furthermore , the intervention differed from treatment in the control group . Overall , the results provide support for implementing the intervention in practice BACKGROUND We report process data on the feasibility of delivering a clinical preventive nutrition intervention that was effective in increasing participants ' consumption of fruits and vegetables . We also examine relationships between process variables and study outcomes . METHODS We r and omly assigned six practice sites in a managed care organization to a dietary intervention or control condition . We invited adults 18 years of age or older scheduled for routine health visits within the subsequent 2 months to participate . Of the 566 patients we contacted from the intervention sites , 230 ( 41 % ) enrolled . From the control sites , we contacted 617 , and 274 ( 44 % ) enrolled . Intervention participants received a tailored letter providing feedback on their consumption of target foods together with recommendations for improvement , stage-matched nutrition education booklets , a diet-health endorsement from their primary care providers ( PCPs ) , and two motivational counseling telephone calls . Of enrollees , 195 ( 85 % ) in the intervention group and 252 ( 92 % ) in the control group returned the final survey 3 months later . RESULTS Seventy-one percent of both participants and PCPs reported that the PCPs had discussed the relationship between diet and health at their visit . Fifty-seven percent of participants and 62 % of PCPs reported that they discussed the complete diet-health endorsement , which included : ( 1 ) acknowledgment of the relationship between diet and health and ( 2 ) tailored study recommendations . The inclusion of both parts of the diet-health endorsement , but not the length of time spent , appeared to correlate with healthful outcomes . CONCLUSIONS These process data suggest that the brief PCP diet-health endorsement contributed to the intervention effect on fruits and vegetables BACKGROUND Improving inhaled corticosteroid ( ICS ) adherence should improve asthma outcomes . OBJECTIVE In a r and omized controlled trial we tested whether an individualized problem-solving ( PS ) intervention improves ICS adherence and asthma outcomes . METHODS Adults with moderate or severe asthma from clinics serving urban neighborhoods were r and omized to PS ( ie , defining specific barriers to adherence , proposing/weighing solutions , trying the best , assessing , and revising ) or st and ard asthma education ( AE ) for 3 months and then observed for 3 months . Adherence was monitored electronically . Outcomes included the following : asthma control , FEV(1 ) , asthma-related quality of life , emergency department ( ED ) visits , and hospitalizations . In an intention-to-treat- analysis longitudinal models using r and om effects and regression were used . RESULTS Three hundred thirty-three adults were r and omized : 49 ± 14 years of age , 72 % female , 68 % African American , 7 % Latino , mean FEV(1 ) of 66 % ± 19 % , and 103 ( 31 % ) with hospitalizations and 172 ( 52 % ) with ED visits for asthma in the prior year . There was no difference between groups in overall change in any outcome ( P > .20 ) . Mean adherence ( 61 % ± 27 % ) decreased significantly ( P = .0004 ) over time by 14 % and 10 % in the AE and PS groups , respectively . Asthma control improved overall by 15 % ( P = .002 ) . In both groups FEV(1 ) and quality of life improved by 6 % ( P = .01 ) and 18 % ( P < .0001 ) , respectively . However , the improvement in FEV(1 ) only occurred during monitoring but not subsequently after r and omization . Rates of ED visits and hospitalizations did not significantly decrease over the study period . CONCLUSION PS was not better than AE in improving adherence or asthma outcomes . However , monitoring ICS use with provision of medications and attention , which was imposed on both groups , was associated with improvement in FEV(1 ) and asthma control This study evaluated the effectiveness of the Smoking Cessation and Reduction in Pregnancy Treatment ( SCRIPT ) Program selected by the West Virginia — Right From The Start Project for state-wide dissemination . A process evaluation documented the fidelity of SCRIPT delivery by Design ated Care Coordinators ( DCC ) , licensed nurses and social workers who provide home-based case management to Medicaid-eligible clients in all 55 counties . We implemented a quasi-experimental , non-r and omized , matched Comparison ( C ) Group design . The SCRIPT Experimental E Group ( N = 259 ) were all clients in 2009–2010 that wanted to quit , provided a screening carbon monoxide ( CO ) , and received a SCRIPT home visit .  The ( C ) Group was derived from all clients in 2006–2007 who had the same CO assessment s as E Group clients and reported receiving cessation counseling . We stratified the baseline CO of E Group clients into 10 strata , and r and omly selected the same number of ( C ) Group clients ( N = 259 ) from each matched strata to evaluate the effectiveness of the SCRIPT Program . There were no significant baseline differences in the E and ( C ) Group . A Process Evaluation documented a significant increase in the fidelity of DCC delivery of SCRIPT Program procedures : from 63 % in 2006 to 74 % in 2010 . Significant increases were documented in the E Group cessation rate ( + 9.3 % ) and significant reduction rate ( + 4.5 % ) , a ≥50 % reduction from a baseline CO . Perinatal health case management staff can deliver the SCRIPT Program , and Medicaid-supported clients can change smoking behavior , even very late in pregnancy . When multiple biases were analyzed , we concluded the SCRIPT Dissemination Project was the most plausible reason for the significant changes in behavior CONTEXT It is not known whether patient outcomes are enhanced by effective pharmacist-patient interactions . OBJECTIVE To assess the effectiveness of a pharmaceutical care program for patients with asthma or chronic obstructive pulmonary disease ( COPD ) . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial conducted at 36 community drugstores in Indianapolis , Ind. We enrolled 1113 participants with active COPD or asthma from July 1998 to December 1999 . Outcomes were assessed in 947 ( 85.1 % ) participants at 6 months and 898 ( 80.7 % ) at 12 months . INTERVENTIONS The pharmaceutical care program ( n = 447 ) provided pharmacists with recent patient-specific clinical data ( peak expiratory flow rates [ PEFRs ] , emergency department [ ED ] visits , hospitalizations , and medication compliance ) , training , customized patient educational material s , and re sources to facilitate program implementation . The PEFR monitoring control group ( n = 363 ) received a peak flow meter , instructions about its use , and monthly calls to elicit PEFRs . However ,  PEFR data were not provided to the pharmacist . Patients in the usual care group  ( n = 303 ) received neither peak flow meters nor instructions in their use ; during monthly telephone interviews , PEFR rates were not elicited . Pharmacists in both control groups had a training session but received no components of the pharmaceutical care intervention . MAIN OUTCOME MEASURES Peak expiratory flow rates , breathing-related ED or hospital visits , health-related quality of life ( HRQOL ) , medication compliance , and patient satisfaction . RESULTS At 12 months , patients receiving pharmaceutical care had significantly higher peak flow rates than the usual care group ( P = .02 ) but not than PEFR monitoring controls ( P = .28 ) . There were no significant between-group differences in medication compliance or HRQOL .  Asthma patients receiving pharmaceutical care had significantly more breathing-related ED or hospital visits than the usual care group ( odds ratio , 2.16 ; 95 % confidence interval , 1.76 - 2.63 ; P<.001 ) . Patients receiving pharmaceutical care were more satisfied with their pharmacist than the usual care group ( P = .03 ) and the PEFR monitoring group ( P = .001 ) and were more satisfied with their health care than the usual care group at 6 months only ( P = .01 ) . Despite ample opportunities to implement the program , pharmacists accessed patient-specific data only about half of the time and documented actions about half of the time that records were accessed . CONCLUSIONS This pharmaceutical care program increased patients ' PEFRs compared with usual care but provided little benefit compared with peak flow monitoring alone . Pharmaceutical care increased patient satisfaction but also increased the amount of breathing-related medical care sought R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the  benefits of specialist stroke units .  Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community OBJECTIVE The aim of this study was to test whether gender moderates intervention effects in the Coordinated Anxiety Learning and Management ( CALM ) intervention , a 12-month , r and omized controlled trial of a collaborative care intervention for anxiety disorders ( panic disorder , generalized anxiety disorder , posttraumatic stress disorder , and social anxiety disorder ) in 17 primary care clinics in California , Washington , and Arkansas . METHODS Participants ( N=1,004 ) completed measures of symptoms ( Brief Symptom Inventory [ BSI ] ) and functioning ( mental and physical health components of the 12-Item Short Form [ MCS and PCS ] and Healthy Days , Restricted Activity Days Scale ) at baseline , six , 12 , and 18 months . Data on dose , engagement , and beliefs about psychotherapy were collected for patients in the collaborative care group . RESULTS Gender moderated the relationship between treatment and its outcome on the BSI , MCS , and Healthy Days measures but not on the PCS . Women who received collaborative care showed clinical improvements on the BSI , MHC , and Healthy Days that were significantly different from outcomes for women in usual care . There were no differences for men in collaborative care compared with usual care on any measures . In the intervention group , women compared with men attended more sessions of psychotherapy  , completed more  modules of therapy  , expressed more commitment , and viewed psychotherapy as more helpful . CONCLUSIONS These findings contribute to the broader literature on treatment heterogeneity , in particular the influence of gender , and may inform personalized care for people seeking anxiety treatment in primary care setting Objectives . Physicians acknowledge the need to advise their patients about dietary habits , but they may not have the training or tools to do this efficiently . In the context of a r and omized trial , we investigated the feasibility of enlisting physicians to implement a dietary intervention in the primary care setting . Methods . Physicians from 14 primary care practice s were assigned via r and omization to introduce a self-help booklet to promote dietary change at routine appointments . Delivery of the booklet was recorded by these intervention physicians at the clinic appointment ; intervention participants were asked 3 months later in a telephone interview about whether they received and used the booklet . Results . According to physician documentation , 95 % of intervention participants who kept an appointment ( n = 935 ) received the booklet ; among participants completing a 3-month interview ( n = 890 ) , 96 % reported the same . However , only about 50 % of participants reported receiving the booklet from their physician ; the remainder received the booklet from other clinic staff . Overall , 93 % reported reading at least part of the booklet . Use of the booklet varied little whether it was delivered by a physician or staff person , but it was more likely to be read as time spent discussing the booklet increased . Conclusions . Physician cooperation and evidence of intervention effectiveness support the use of primary care for the delivery of interventions to change diet ; training the entire health team and repeating dietary advice at subsequent visits may improve the success of such interventions Objective To evaluate the effectiveness and costs of a multifaceted flexible educational programme aim ed at reducing antibiotic dispensing at the practice level in primary care . Design R and omised controlled trial with general practice s as the unit of r and omisation and analysis . Clinicians and research ers were blinded to group allocation until after r and omisation . Setting 68 general practice s with about 480 000 patients in Wales , United Kingdom . Participants 34 practice s were r and omised to receive the educational programme and 34 practice s to be controls . 139 clinicians from the intervention practice s and 124 from control practice s had agreed to participate before r and omisation . Practice level data covering all the clinicians in the 68 practice s were analysed . Interventions Intervention practice s followed the Stemming the Tide of Antibiotic Resistance ( STAR ) educational programme , which included a practice based seminar reflecting on the practice s ’ own dispensing and resistance data , online educational elements , and practising consulting skills in routine care . Control practice s provided usual care . Main outcome measures Total numbers of oral antibiotic items dispensed for all causes per 1000 practice patients in the year after the intervention , adjusted for the previous year ’s dispensing . Secondary outcomes included reconsultations , admissions to hospital for selected causes , and costs . Results The rate of oral antibiotic dispensing ( items per 1000 registered patients ) decreased by 14.1 in the intervention group but increased by 12.1 in the control group , a net difference of 26.1 . After adjustment for baseline dispensing rate , this amounted to a 4.2 % ( 95 % confidence interval 0.6 % to 7.7 % ) reduction in total oral antibiotic dispensing for the year in the intervention group relative to the control group ( P=0.02 ) . Reductions were found for all classes of antibiotics other than penicillinase-resistant penicillins but were largest and significant individually for phenoxymethylpenicillins ( penicillin V ) ( 7.3 % , 0.4 % to 13.7 % ) and macrolides ( 7.7 % , 1.1 % to 13.8 % ) . There were no significant differences between intervention and control practice s in the number of admissions to hospital or in reconsultations for a respiratory tract infection within seven days of an index consultation . The mean cost of the programme was £ 2923 ( € 3491 , $ 4572 ) per practice ( SD £ 1187 ) . There was a 5.5 % reduction in the cost of dispensed antibiotics in the intervention group compared with the control group ( −0.4 % to 11.4 % ) , equivalent to a reduction of about £ 830 a year for an average intervention practice . Conclusion The STAR educational programme led to reductions in all cause oral antibiotic dispensing over the subsequent year with no significant change in admissions to hospital , reconsultations , or costs . Trial registration IS RCT No 63355948
PURPOSE Underst and ing the effectiveness of complex , face-to-face health behaviour change interventions requires high- quality measures to assess fidelity of delivery and engagement .
This systematic review aim ed to ( 1 ) identify the types of measures used to monitor fidelity of delivery of , and engagement with , complex , face-to-face health behaviour change interventions and ( 2 ) describe the reporting of psychometric and implementation qualities .