The use of theory in process evaluations conducted alongside randomized trials of implementation interventions: A systematic review.

Interventions to implement changes into health care practice (i.e., implementation interventions) are critical to improving care but their effects are poorly understood. Two strategies to better understand intervention effects are conducting process evaluations and using theoretical approaches (i.e., theories, models, frameworks). The extent to which theoretical approaches have been used in process evaluations conducted alongside trials of implementation interventions is unclear. In this study context, we reviewed (a) the proportion of process evaluations citing theoretical approaches, (b) which theoretical approaches were cited, and (c) whether and how theories were used. Systematic review (PROSPERO: CRD42016042789). MEDLINE, PsycINFO, Embase, CINAHL, and Cochrane CENTRAL were searched up to July 31, 2017. For all studies, data extraction included names and types of theoretical approaches cited. For studies citing a theory, data extraction included study characteristics and extent of theory use (i.e., "informed by," "applied," "tested," "built/created" theory). We identified 123 process evaluations. Key findings: (a) 77 (63%) process evaluations cited a theoretical approach; (b) the most cited theory was normalization process theory; (c) 32 (26%) process evaluations used theory: 7 (22%) were informed by, 18 (56%) applied, 7 (22%) tested, and none built/created theory. 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 understanding of how implementation interventions operate.

How do hospitals respond to feedback about blood transfusion practice? A multiple case study investigation.

National clinical audits play key roles in improving care and driving system-wide change. However, effects of audit and feedback depend upon both reach (e.g. relevant staff receiving the feedback) and response (e.g. staff regulating their behaviour accordingly). This study aimed to investigate which hospital staff initially receive feedback and formulate a response, how feedback is disseminated within hospitals, and how responses are enacted (including barriers and enablers to enactment). Using a multiple case study approach, we purposively sampled four UK hospitals for variation in infrastructure and resources. We conducted semi-structured interviews with staff from transfusion-related roles and observed Hospital Transfusion Committee meetings. Interviews and analysis were based on the Theoretical Domains Framework of behaviour change. We coded interview transcripts into theoretical domains, then inductively identified themes within each domain to identify barriers and enablers. We also analysed data to identify which staff currently receive feedback and how dissemination is managed within the hospital. Members of the hospital's transfusion team initially received feedback in all cases, and were primarily responsible for disseminating and responding, facilitated through the Hospital Transfusion Committee. At each hospital, key individuals involved in prescribing transfusions reported never having received feedback from a national audit. Whether audits were discussed and actions explicitly agreed in Committee meetings varied between hospitals. Key enablers of action across all cases included clear lines of responsibility and strategies to remind staff about recommendations. Barriers included difficulties disseminating to relevant staff and needing to amend feedback to make it appropriate for local use. Appropriate responses by hospital staff to feedback about blood transfusion practice depend upon supportive infrastructures and role clarity. Hospitals could benefit from support to disseminate feedback systematically, particularly to frontline staff involved in the behaviours being audited, and practical tools to support strategic decision-making (e.g. action-planning around local response to feedback).

Knowing too much: Knowledge of energy content prevents liking change through flavour-nutrient associations.

Associations between flavours and the consequences of ingestion can lead to changes in flavour liking depending on nutrient content, an example of flavour-nutrient learning (FNL). Expectations about the consequences of ingestion can be modified by information at the point of ingestion, such as nutritional labelling. What is unknown is the extent to which these label-based expectations modify FNL. Since nutrient information can alter expectations about how filling a product would be, we hypothesised that labels predicting higher energy (HE) content would enhance satiety and so promote more rapid flavour learning. To test this, participants consumed either a lower energy (LE: 164 kcal) or HE (330 kcal) yoghurt breakfast on four separate days, either with no product label or with labels displaying either the actual energy content (Congruent label) or inaccurate energy (Incongruent label). Participants rated liking on all four days: on Days 1 and 4, they could also consume as much as they liked, but consumed a fixed amount (300 g) on Days 2 and 3. Both liking and intake increased with exposure in the HE, and decreased in the LE, condition when unlabelled in line with FNL. In contrast, no significant changes were seen in either the Congruent or Incongruent label conditions. Contrary to predictions, these data suggest that FNL occurs when there is an absence of explicit expectations of actual nutrient content, with both accurate and inaccurate information on nutrient content disrupting learning.

The evaluation of enhanced feedback interventions to reduce unnecessary blood transfusions (AFFINITIE): protocol for two linked cluster randomised factorial controlled trials.

BACKGROUND: Blood for transfusion is a frequently used clinical intervention, and is also a costly and limited resource with risks. Many transfusions are given to stable and non-bleeding patients despite no clear evidence of benefit from clinical studies. Audit and feedback (A&F) is widely used to improve the quality of healthcare, including appropriate use of blood. However, its effects are often inconsistent, indicating the need for coordinated research including more head-to-head trials comparing different ways of delivering feedback. A programmatic series of research projects, termed the 'Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE' (AFFINITIE) programme, aims to test different ways of developing and delivering feedback within an existing national audit structure. METHODS: The evaluation will comprise two linked 2×2 factorial, cross-sectional cluster-randomised controlled trials. Each trial will estimate the effects of two feedback interventions, 'enhanced content' and 'enhanced follow-on support', designed in earlier stages of the AFFINITIE programme, compared to current practice. The interventions will be embedded within two rounds of the UK National Comparative Audit of Blood Transfusion (NCABT) focusing on patient blood management in surgery and use of blood transfusions in patients with haematological malignancies. The unit of randomisation will be National Health Service (NHS) trust or health board. Clusters providing care relevant to the audit topics will be randomised following each baseline audit (separately for each trial), with stratification for size (volume of blood transfusions) and region (Regional Transfusion Committee). The primary outcome for each topic will be the proportion of patients receiving a transfusion coded as unnecessary. For each audit topic a linked, mixed-method fidelity assessment and cost-effectiveness analysis will be conducted in parallel to the trial. DISCUSSION: AFFINITIE involves a series of studies to explore how A&F may be refined to change practice including two cluster randomised trials linked to national audits of transfusion practice. The methodology represents a step-wise increment in study design to more fully evaluate the effects of two enhanced feedback interventions on patient- and trust-level clinical, cost, safety and process outcomes. TRIAL REGISTRATION: http://www.isrctn.com/ISRCTN15490813.

Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review.

BACKGROUND: Over 60 implementation frameworks exist. Using multiple frameworks may help researchers to address multiple study purposes, levels, and degrees of theoretical heritage and operationalizability; however, using multiple frameworks may result in unnecessary complexity and redundancy if doing so does not address study needs. The Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) are both well-operationalized, multi-level implementation determinant frameworks derived from theory. As such, the rationale for using the frameworks in combination (i.e., CFIR + TDF) is unclear. The objective of this systematic review was to elucidate the rationale for using CFIR + TDF by (1) describing studies that have used CFIR + TDF, (2) how they used CFIR + TDF, and (2) their stated rationale for using CFIR + TDF. METHODS: We undertook a systematic review to identify studies that mentioned both the CFIR and the TDF, were written in English, were peer-reviewed, and reported either a protocol or results of an empirical study in MEDLINE/PubMed, PsycInfo, Web of Science, or Google Scholar. We then abstracted data into a matrix and analyzed it qualitatively, identifying salient themes. FINDINGS: We identified five protocols and seven completed studies that used CFIR + TDF. CFIR + TDF was applied to studies in several countries, to a range of healthcare interventions, and at multiple intervention phases; used many designs, methods, and units of analysis; and assessed a variety of outcomes. Three studies indicated that using CFIR + TDF addressed multiple study purposes. Six studies indicated that using CFIR + TDF addressed multiple conceptual levels. Four studies did not explicitly state their rationale for using CFIR + TDF. CONCLUSIONS: Differences in the purposes that authors of the CFIR (e.g., comprehensive set of implementation determinants) and the TDF (e.g., intervention development) propose help to justify the use of CFIR + TDF. Given that the CFIR and the TDF are both multi-level frameworks, the rationale that using CFIR + TDF is needed to address multiple conceptual levels may reflect potentially misleading conventional wisdom. On the other hand, using CFIR + TDF may more fully define the multi-level nature of implementation. To avoid concerns about unnecessary complexity and redundancy, scholars who use CFIR + TDF and combinations of other frameworks should specify how the frameworks contribute to their study. TRIAL REGISTRATION: PROSPERO CRD42015027615.

A multidimensional approach to assessing intervention fidelity in a process evaluation of audit and feedback interventions to reduce unnecessary blood transfusions: a study protocol.

BACKGROUND: In England, NHS Blood and Transplant conducts national audits of transfusion and provides feedback to hospitals to promote evidence-based practice. Audits demonstrate 20% of transfusions fall outside guidelines. The AFFINITIE programme (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) involves two linked, 2×2 factorial, cluster-randomised trials, each evaluating two theoretically-enhanced audit and feedback interventions to reduce unnecessary blood transfusions in UK hospitals. The first intervention concerns the content/format of feedback reports. The second aims to support hospital transfusion staff to plan their response to feedback and includes a web-based toolkit and telephone support. Interpretation of trials is enhanced by comprehensively assessing intervention fidelity. However, reviews demonstrate fidelity evaluations are often limited, typically only assessing whether interventions were delivered as intended. This protocol presents methods for assessing fidelity across five dimensions proposed by the Behaviour Change Consortium fidelity framework, including intervention designer-, provider- and recipient-levels. METHODS: (1) Design: Intervention content will be specified in intervention manuals in terms of component behaviour change techniques (BCTs). Treatment differentiation will be examined by comparing BCTs across intervention/standard practice, noting the proportion of unique/convergent BCTs. (2) Training: draft feedback reports and audio-recorded role-play telephone support scenarios will be content analysed to assess intervention providers' competence to deliver manual-specified BCTs. (3) Delivery: intervention materials (feedback reports, toolkit) and audio-recorded telephone support session transcripts will be content analysed to assess actual delivery of manual-specified BCTs during the intervention period. (4) Receipt and (5) enactment: questionnaires, semi-structured interviews based on the Theoretical Domains Framework, and objective web-analytics data (report downloads, toolkit usage patterns) will be analysed to assess hospital transfusion staff exposure to, understanding and enactment of the interventions, and to identify contextual barriers/enablers to implementation. Associations between observed fidelity and trial outcomes (% unnecessary transfusions) will be examined using mediation analyses. DISCUSSION: If the interventions have acceptable fidelity, then results of the AFFINITIE trials can be attributed to effectiveness, or lack of effectiveness, of the interventions. Hence, this comprehensive assessment of fidelity will be used to interpret trial findings. These methods may inform fidelity assessments in future trials. TRIAL REGISTRATION: ISRCTN 15490813 . Registered 11/03/2015.

Application of theory to enhance audit and feedback interventions to increase the uptake of evidence-based transfusion practice: an intervention development protocol.

BACKGROUND: Audits of blood transfusion demonstrate around 20% transfusions are outside national recommendations and guidelines. Audit and feedback is a widely used quality improvement intervention but effects on clinical practice are variable, suggesting potential for enhancement. Behavioural theory, theoretical frameworks of behaviour change and behaviour change techniques provide systematic processes to enhance intervention. This study is part of a larger programme of work to promote the uptake of evidence-based transfusion practice. OBJECTIVES: The objectives of this study are to design two theoretically enhanced audit and feedback interventions; one focused on content and one on delivery, and investigate the feasibility and acceptability. METHODS: Study A (Content): A coding framework based on current evidence regarding audit and feedback, and behaviour change theory and frameworks will be developed and applied as part of a structured content analysis to specify the key components of existing feedback documents. Prototype feedback documents with enhanced content and also a protocol, describing principles for enhancing feedback content, will be developed. Study B (Delivery): Individual semi-structured interviews with healthcare professionals and observations of team meetings in four hospitals will be used to specify, and identify views about, current audit and feedback practice. Interviews will be based on a topic guide developed using the Theoretical Domains Framework and the Consolidated Framework for Implementation Research. Analysis of transcripts based on these frameworks will form the evidence base for developing a protocol describing an enhanced intervention that focuses on feedback delivery. Study C (Feasibility and Acceptability): Enhanced interventions will be piloted in four hospitals. Semi-structured interviews, questionnaires and observations will be used to assess feasibility and acceptability. DISCUSSION: This intervention development work reflects the UK Medical Research Council's guidance on development of complex interventions, which emphasises the importance of a robust theoretical basis for intervention design and recommends systematic assessment of feasibility and acceptability prior to taking interventions to evaluation in a full-scale randomised study. The work-up includes specification of current practice so that, in the trials to be conducted later in this programme, there will be a clear distinction between the control (usual practice) conditions and the interventions to be evaluated.

Effects of energy density and portion size on development of acquired flavour liking and learned satiety.

The concept of learned satiety (LS) suggests that associations between the sensory quality and post-ingestive effects of foods may lead to acquired control of meal-size. Although a recent study appeared to support LS since participants learned to eat more of a flavoured cereal with lower energy density (ED) after repeated experience, suggesting that they adjusted voluntary intake to ensure adequate energy was consumed, the large serving portion used in training may have lead to over-satiation. To investigate this further, groups of 12 men were assigned to one of four conditions based on the trained serving portion (150 or 300 g) and presence or absence of cues to differentiate high and low ED versions. In the absence of sensory cues, neither mass consumed nor rated pleasantness differed between high and low ED conditions either before or after training, resulting in greater energy intake in the high ED condition. When sensory cues differentiated ED, intake increased significantly post-training in both the high ED condition trained with the small portion and low ED condition trained with the large portion, and flavour pleasantness changed similarly. Moreover hunger increased significantly after the food was tasted in both conditions where intake increased. These data provide further evidence that learning can moderate meal-size dependent on energy content, but suggest that these changes are driven by changes in flavour liking rather than LS.

Acquired hedonic and sensory characteristics of odours: influence of sweet liker and propylthiouracil taster status.

Repeated pairings of novel food-related odours with sweet tastes can result in enduring changes in sweetness of the odour alone, but have less consistent effects on odour liking. Variation in ability to taste propylthiouracil (PROP) might account for this, since PROP supertasters (ST) have been reported both to experience stronger sweetness intensity and to be more likely to dislike sweetness than do PROP nontasters (NT). Alternatively, individual differences in liking for sweetness may transfer to sweet-paired odours independently of PROP sensitivity. To explore this, evaluations of sucrose, saccharin, and PROP solutions were used to classify 92 volunteers as either sweet likers or dislikers and as PROP ST, NT, or medium tasters (MT). Changes in pleasantness of odours that had been paired with the taste of saccharin increased in sweet likers but decreased in dislikers. Odour sweetness increased regardless of PROP taster or sweet liker status. PROP ST rated saccharin as more bitter than did other taster groups and also showed greater increases in acquired bitterness of the saccharin-paired odour. Overall, these data suggest that individual differences in evaluation of saccharin reliably predict subsequent changes in evaluation of saccharin-paired odours, with hedonic changes corresponding with liking for sweet tastes and sensory changes reflecting differences in sensory quality between PROP taster groups.

Acquired liking for sweet-paired odours is related to the disinhibition but not restraint factor from the Three Factor Eating Questionnaire.

Previous research suggests that women scoring high on dietary restraint may be insensitive to flavour-flavour learning, but no study has yet explored this using the olfactory conditioning paradigm. Accordingly, 56 women who were sweet likers were classified as either high or low on both the Three Factor Eating Questionnaire restraint and disinhibition scales. They evaluated two odours before and after disguised pairings of one odour with 10% sucrose and the other with 0.01% quinine. Liking for the quinine-paired odour decreased post-training, with no effects of restraint or disinhibition. In contrast, the increase in liking for the sucrose-paired odour was significantly greater in women classified as scoring high in disinhibition, but was unaffected by restraint. Sweetness of the sucrose paired odour increased, and bitterness of the quinine-paired odour decreased, similarly in all groups. These data suggest that sensitivity of restrained eaters to flavour-based learning may result from their attitude to the food used as reinforcer rather than some basic failure in the learning process, and also suggest that women scoring high on disinhibition may show heightened sensitivity to hedonic cues.

Acquired flavor acceptance and intake facilitated by monosodium glutamate in humans.

Monosodium glutamate (MSG) is known to enhance liking for the flavor of savory foods, but whether associations between flavors and effects of MSG lead to changes in subsequent liking and intake for the flavor alone is unclear. To test this, 32 volunteers evaluated and consumed a novel savory soup with no added MSG before and after four training sessions where the same soup was consumed either unchanged (Control) or with added MSG. The addition of MSG during training increased both pleasantness and savory character of the soup and resulted in a larger increase in rated pleasantness of the soup in the MSG-trained relative to control condition when the soup was re-evaluated Post-training without MSG. There was also a significant increase in voluntary soup intake Post-training after the soup had been paired with MSG but not in the Control condition, and rated hunger increased more after tasting the soup Post-training in the MSG-trained but not Control condition. These findings demonstrate that co-experience of a savory flavor and MSG can result in increased subsequent liking and intake for the flavor in the absence of MSG, and possible explanations for how MSG reinforces learning are discussed.

Differential hedonic, sensory and behavioral changes associated with flavor-nutrient and flavor-flavor learning.

Flavor-flavor and flavor-nutrient associations can modify liking for a flavor CS, while flavor-flavor associations can also modify the sensory experience of the trained flavor. Less is known about how these associations modify behavioral responses to the trained CS. To test this, 60 participants classified as sweet likers were divided into five training conditions with a novel flavor CS. In the flavor-flavor only condition, participants consumed the target CS in a sweetened, low-energy form, with energy (maltodextrin) but no sweetness added in the flavor-nutrient only condition and both energy and sweetness (sucrose) in the combined flavor-flavor, flavor-nutrient condition. Comparison groups controlled for exposure to the CS, and repeat testing. Training was conducted in a hungry state on four non-consecutive days. To test for acquired changes in evaluation and intake, the flavor CS was processed into a low-energy sorbet, which was evaluated and consumed ad libitum on test days before and after training. Liking for the flavor CS increased only in the sucrose-sweetened condition, but intake increased significantly in both high-energy conditions. In contrast, rated sweetness of the sorbet increased in both sucrose-sweetened and aspartame-sweetened conditions. These findings suggest that liking changes were maximal when flavor-flavor and flavor-nutrient associations co-occurred, but that behavioral changes were specific to flavor-nutrient associations.