***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Pragmatic trials of implementation interventions focus on evaluating whether an intervention changes professional behaviour under real-world conditions rather than investigating the mechanism through which change occurs . Theory-based process evaluations conducted alongside pragmatic r and omised trials address this by assessing whether the intervention changes theoretical constructs proposed to mediate change . The Ontario Printed Educational Material s ( PEM ) cluster trial was design ed to increase family physicians ’ guideline -recommended prescription of thiazide diuretics . The trial found no intervention effect . Using the theory of planned behaviour ( TPB ) , we hypothesised that changes in thiazide prescribing would be reflected in changes in intention , consistent with changes in attitude and subjective norm , with no change to their perceived behavioural control ( PBC ) , and tested this alongside the RCT . Methods We developed and sent TPB postal question naires to a r and om sub- sample of family physicians in each trial arm 2 months before and 6 months after dissemination of the PEMs . We used analysis of covariance to test for group differences using a 2 × 3 factorial design . We content-analysed an open-ended question about perceived barriers to thiazide prescription . Using control group data , we tested whether baseline measures of TPB constructs predicted self-reported thiazide prescribing at follow-up . Results Four hundred twenty-six physicians completed pre- and post-intervention question naires . Baseline scores on measures of TPB constructs were high : intention mean = 5.9 out of 7 ( SD = 1.4 ) , attitude mean = 5.8 ( SD = 1.1 ) , subjective norm mean = 5.8 ( SD = 1.1 ) and PBC mean = 6.2 ( SD = 1.0 ) . The arms did not significantly differ post-intervention on any of the theory-based constructs , suggesting a possible ceiling effect . Content analysis of perceived barriers suggested post-intentional barriers to prescribing thiazides most often focused on specific patient clinical characteristics and potential side effects . Baseline intention ( β = 0.63 , p < 0.01 ) but not PBC ( β = 0.04 , p = 0.78 ) predicted 42.6 % of the variance in self-reported behaviour at follow-up in the control group . Conclusions Congruent with the Ontario Printed Educational Messages trial results and aligned with the TPB , we saw no impact of the intervention on any TPB constructs . The theoretical basis of this evaluation suggests possible explanations for the failure of the PEM intervention to change professional behaviour , which can directly inform the design and content of future theory-based PEM interventions to change professional behaviour . Trial registration IS RCT N , Canada IS RCT Background : Many patients with or at risk for chronic kidney disease ( CKD ) in the primary care setting are not receiving recommended care . Objective : The objective of this study is to determine whether a multifaceted , low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting . Design : A pragmatic cluster-r and omized trial , with an embedded qualitative process evaluation , will be conducted . Setting : The study population comes from the Electronic Medical Record Administrative data Linked Data base ® , which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario , Canada . The 34 primary care clinics will be r and omized to the intervention or control group . Intervention : The intervention group will receive re sources from the “ CKD toolkit ” to help improve care including practice audit and feedback , printed educational material s for physicians and patients , electronic decision support and reminders , and implementation support . Measurements : Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records . Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records . The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin . Secondary outcomes include process of care measures such as screening tests , CKD recognition , monitoring tests , angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions , blood pressure targets met , and nephrologist referral . Hierarchical analytic modeling will be performed to account for clustering . Semistructured interviews will be conducted with a r and om purpose ful sample of physicians in the intervention group to underst and why the intervention achieved the observed effects . Conclusions : If our intervention improves care , then the CKD toolkit can be adapted and scaled for use in other primary care clinics which use electronic medical records . Trial Registration : Clinical Trials.gov Identifier : Introduction As an increasing number of people are living with more than 1 long-term condition , identifying effective interventions for the management of multimorbidity in primary care has become a matter of urgency . Interventions are challenging to evaluate due to intervention complexity and the need for adaptability to different context s. A process evaluation can provide extra information necessary for interpreting trial results and making decisions about whether the intervention is likely to be successful in a wider context . The 3D ( dimensions of health , drugs and depression ) study will recruit 32 UK general practice s to a cluster r and omised controlled trial to evaluate effectiveness of a patient-centred intervention . Practice s will be r and omised to intervention or usual care . Methods and analysis The aim of the process evaluation is to underst and how and why the intervention was effective or ineffective and the effect of context . As part of the intervention , quantitative data will be collected to provide implementation feedback to all intervention practice s and will contribute to evaluation of implementation fidelity , alongside case study data . Data will be collected at the beginning and end of the trial to characterise each practice and how it provides care to patients with multimorbidity . Mixed methods will be used to collect qualitative data from 4 case study practice s , purposively sample d from among intervention practice s. Qualitative data will be analysed using techniques of constant comparison to develop codes integrated within a flexible framework of themes . Quantitative and qualitative data will be integrated to describe case study sites and develop possible explanations for implementation variation . Analysis will take place prior to knowing trial outcomes . Ethics and dissemination Study approved by South West ( Frenchay ) National Health Service ( NHS ) Research Ethics Committee ( 14/SW/0011 ) . Findings will be disseminated via a final report , peer- review ed publications and practical guidance to healthcare professionals , commissioners and policymakers . Trial registration number IS RCT N06180958 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 Objectives A patient safety intervention was tested in a 33-ward r and omised controlled trial . No statistically significant difference between intervention and control wards was found . We conducted a process evaluation of the trial and our aim in this paper is to underst and staff engagement across the 17 intervention wards . Design Large qualitative process evaluation of the implementation of a patient safety intervention . Setting and participants National Health Service staff based on 17 acute hospital wards located at five hospital sites in the North of Engl and . Data We concentrate on three sources here : ( 1 ) analysis of taped discussion between ward staff during action planning meetings ; ( 2 ) facilitators ’ field notes and ( 3 ) follow-up telephone interviews with staff focusing on whether action plans had been achieved . The analysis involved the use of pen portraits and adaptive theory . Findings First , there were palpable differences in the ways that the 17 ward teams engaged with the key components of the intervention . Five main engagement typologies were evident across the life course of the study : consistent , partial , increasing , decreasing and disengaged . Second , the intensity of support for the intervention at the level of the organisation does not predict the strength of engagement at the level of the individual ward team . Third , the st and ardisation of facilitative processes provided by the research team does not ensure that implementation st and ardisation of the intervention occurs by ward staff . Conclusions A dilution of the intervention occurred during the trial because wards engaged with Patient Reporting and Action for a Safe Environment ( PRASE ) in divergent ways , despite the st and ardisation of key components . Facilitative processes were not sufficiently adequate to enable intervention wards to successfully engage with PRASE components Background To reduce the spread of antibiotic resistance , there is a pressing need for worldwide implementation of effective interventions to promote more prudent prescribing of antibiotics for acute LRTI . This study is a process analysis of the GRACE/INTRO trial of a multifactorial intervention that reduced antibiotic prescribing for acute LRTI in six European countries . The aim was to underst and how the interventions were implemented and to examine effects of the interventions on general practitioners ’ ( GPs ’ ) and patients ’ attitudes . Methods GPs were cluster r and omised to one of three intervention groups or a control group . The intervention groups received web-based training in either use of the C-reactive protein ( CRP ) test , communication skills and use of a patient booklet , or training in both .  GP attitudes were measured before and after the intervention using constructs from the Theory of Planned Behaviour and a Website Satisfaction Question naire . Effects of the interventions on patients were assessed by a post-intervention question naire assessing patient enablement , satisfaction with the consultation , and beliefs about the risks and need for antibiotics . Results GPs in all countries and intervention groups had very positive perceptions of the intervention and the web-based training , and felt that taking part had helped them to reduce prescribing . All GPs perceived reducing prescribing as more important and less risky following the intervention , and GPs in the communication groups reported increased confidence to reduce prescribing . Patients in the communication groups who received the booklet reported the highest levels of enablement and satisfaction and had greater awareness that antibiotics could be unnecessary and harmful . Conclusions Our findings suggest that the interventions should be broadly acceptable to both GPs and patients , as well as feasible to roll out more widely across Europe . There are also some indications that they could help to engender changes in GP and patient attitudes that will be helpful in the longer-term , such as increased awareness of the potential disadvantages of antibiotics and increased confidence to manage LRTI without them . Given the positive effects of the booklet on patient beliefs and attitudes , it seems logical to extend the use of the patient booklet to all patients Background R and omised trials of knowledge translation strategies for professional behaviour change can provide robust estimates of effectiveness , but offer little insight into the causal mechanisms by which any change is produced . To illustrate the applicability of causal methods within r and omised trials , we undertook a theory-based process evaluation study within an implementation trial to explore whether the cognitions of primary care doctors ' predicted their test requesting behaviours and , secondly , whether the trial results were mediated by the theoretical constructs . Methods The process evaluation comprised a cross-sectional question naire survey of a r and om 50 % sample of the r and omised groups of primary care practice s in Grampian ( NHS Grampian ) , UK , who took part in a trial of the effect of enhanced feedback and brief educational reminders on test requesting behaviour . The process evaluation was based upon the Theory of Planned Behaviour and focussed on three of the test requesting behaviours that were targeted in the trial -- ferritin , follicle stimulating hormone ( FSH ) , and Helicobacter Pylori serology ( HPS ) . Results The question naire was completed by 131 primary care doctors ( 56 % ) from 42 ( 98 % ) of the sample d practice s.  Behavioural intention , attitude , and subjective norm were highly correlated for all the tests . There was no evidence that perceived behavioural control was correlated with any of the other measures . Simple linear regression analysis of the rate of test requests on minimum behavioural intentions had R2 of 11.1 % , 12.5 % , and 0.1 % for ferritin , FSH , and HPS requesting , respectively . Mediational analysis showed that the trial results for ferritin and FSH were partially mediated ( between 23 % and 78 % mediation ) through intentions . The HPS trial result was not mediated through intention . Conclusions This study demonstrated that a theory-based process evaluation can provide useful information on causal mechanisms that aid not only interpretation of the trial but also inform future evaluations and intervention development Background There is a considerable evidence base for ' collaborative care ' as a method to improve quality of care for depression , but an acknowledged gap between efficacy and implementation . This study utilises the Normalisation Process Model ( NPM ) to inform the process of implementation of collaborative care in both a future full-scale trial , and the wider health economy . Methods Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory r and omised controlled trial of a collaborative model of care for depression . Results Findings are presented as they relate to the four factors of the NPM ( interactional workability , relational integration , skill-set workability , and context ual integration ) and a number of necessary 
    Output:
    
Although nearly two thirds of process evaluations cited a theoretical approach , only a quarter were informed by , applied , or tested a theory-despite the potential complementarity of these strategies .
When theory was used , it was primarily applied .
Using theory more substantively in process evaluations may accelerate our underst and ing of how implementation interventions operate