Process evaluations provide contextual insight into the way in which interventions are delivered. This information is essential when designing strategies to implement programs into wider clinical practice. We performed a process evaluation of the HiBalance effectiveness trial investigating the effects of a 10-week of highly challenging and progressive balance training for mild-moderate Parkinson’s disease (PD). Study aims were to investigate i) the quality and quantity of intervention delivery and ii) barriers and facilitators for implementation.Process outcomes included; Fidelity; Dose (delivered and received) Recruitment and Reach. Investigation of barriers and facilitators was guided by the Consolidated Framework for Implementation Research. Program delivery was assessed across four neurological rehabilitation sites during a two-year period. Data collection was mixed-methods in nature and quantitative and qualitative data were merged during the analysis phase.Thirteen program trainers delivered the intervention to 12 separate groups during 119 training sessions. Trainer fidelity to program core components was very high in 104 (87%) of the sessions. Participant responsiveness to the core components was generally high, although adherence to the home exercise program was low (50%). No significant context-specific differences were observed across sites in terms of fidelity, dose delivered/ received or participant characteristics, despite varying recruitment methods. Facilitators to program delivery were; PD-specificity, high training frequency and professional autonomy. Perceived barriers included; cognitive impairment, absent reactional balance among participants, as well a heterogeneous group in relation to balance capacity.These findings provide corroborating evidence for outcome evaluation results and valuable information for the further adaptation and implementation of this program. Important lessons can also be learned for researchers and clinicians planning to implement challenging exercise training programs for people with mild-moderate PD.NCT02727478, registered 30 march, 2016 − Retrospectively registered.ClinicalTrials.gov, The online version contains supplementary material available at 10.1186/s12877-021-02031-1. Once the efficacy and effectiveness of a healthcare intervention has been established the next step is to implement findings in order to reach typical patients . A proceWe have previously established the efficacy and effectiveness of the HiBalance program , 10 − a This study is the process evaluation of the clinical effectiveness trial, which was performed concurrently as part of a type 1 hybrid effectiveness-implementation design , as prevThis study was guided by Medical Research Council (MRC) guidelines, which provide a framework for conducting process evaluations . MeasureOverload of balance challenge: that the balance exercises should be performed at an intensity level which challenged participants at the limits of their capacity, in order to facilitate physiological adaptation [Specificity: physical adaptation is specific to the type of training undertaken. Specificity was incorporated by separately targeting four balance sub-components impaired in Parkinson’s disease, two per session on alternate weeks. iii) Progression: placement of a gradual increase in stress on the body to force adaptation to changing stimuli. Systematic progression of the complexity of group exercises was outlined in a 10-week framework (previously published) [Sensory integration, targeted due to difficulties for PwPD to integrate peripheral sensory stimuli necessary when predicting a motor response. Withdrawal of visual feedback while walking on varied surfaces was an example of a progressed exercise in this balance sub-component. Anticipatory postural adjustments were targeted in order to train the postural muscle activation responses which occur prior to a voluntary movement in order to counteract balance destabilization. Sit to stand exercises and movements in standing while throwing and catching a ball, were examples of exercises in this sub-component. Stability limits were challenged during for example, reaching exercises where participants were required to move their center of mass, without adjusting their base of support in standing. Motor agility was targeted through exercises involving reciprocal and whole-body coordination during different walking conditions. Participants also trained quick shifts in speed, amplitude and direction of the movements during gait. Additionally, we hypothesized that gradual exposure to cognitive and motor dual-task conditions would improve dual-task performance, and that addition of a home exercise program (HEP) − which focused on lower limb and core-strengthening exercises − would improve participant’s capacity to partake in the hour long clinical training sessions and increase their physical activity level. Participants were encouraged to perform the HEP a minimum of once per week, which incorporated six functional strength training exercises and 30 min (achievable through 10 min bouts) of pulse-increasing exercise such as walking or cycling on an exercise bike. Nonetheless, the HEP was considered an adaptive intervention component, as modification of the HEP was not anticipated to significantly alter intervention effects.The primary hypothesis of the HiBalance program was that highly challenging, specific and progressive balance training would improve balance and gait in PD. Program core components were grounded on established principles of exercise; i) aptation . TrainerFidelity involves the extent to which core components, or essential elements, of the program were delivered as intended by program developers [quality of delivery of program core components and ii) Participant responsiveness – the extent to which the target audience engages with or is satisfied with the intervention [Participant responsiveness to the core components –overload of balance challenge, progression and specificity − was investigated using a self-administered questionnaire. This structured questionnaire was developed in order to capture participant experiences of specific aspects of the program and has been published in the study protocol [Dose delivered is the frequency of intervention provided by program trainers. Dose received is the frequency of intervention received by PwPD, this included the twice-weekly clinical training sessions and the once-weekly HEP. This data was collected using standardized protocol forms and patient questionnaire respectively. Recruitment refers to the procedure used to engage rehabilitation clinics and PwPD. In the present study, each clinic was encouraged to recruit independently and to register logs concerning the process. Descriptive characteristics of participating clinics, as well as figures for patient turnover at each primary/out-patient care department, were gathered through email contact with clinic administrative controllers. In implementation research Reach relates to the extent to which the target audience comes into contact with the intervention. In the present study however, it was not our intention to reach all PwPD in the Stockholm region. Reach was therefore operationalized as the variation in participant characteristics across training sites.velopers . Analysirvention . Trainerprotocol . Dose deFocus group interviews were used to explore trainer perceptions of the program and potential barriers and facilitators to program implementation, as well as capture their suggestions for eventual adaptation. The interview guide, previously published in the study protocol , was devQuality of delivery of the core components was analyzed through a comparative analysis of each training report card with the HiBalance 10-week structural framework. Firstly, a research assistant with program experience analyzed each outlined exercise regarding the balance sub-components targeted and categorized whether the exercise targeted the correct balance subdomain as i) yes, ii) no and iii) partially. These categorizations were then independently checked at a second stage by the author BL, documented and summarized using Microsoft Excel. Participant responsiveness data from the questionnaire were coded in Excel and analyzed using descriptive statistics. Dose delivered and received data were extracted from protocol and planning forms and entered into Excel spreadsheets before being summarized statistically. In relation to reach, patient characteristics at baseline were summarized and between-clinic variation in patient groups was analyzed using analysis of variance (ANOVA) test for normally distributed data and Pearson’s Chi-squared test was used for non-parametric analysis of variance. All statistical analysis was performed using Stata Statistical Software: Release 15, College Station, TX. Statacorp LLC.Intervention Characteristics, Outer setting and Characteristics of Individuals. Meaning units were grouped together using an organizational matrix in Microsoft Excel, where similar codes were grouped to form categories. These categories were then further interpreted, with respect to whether they represented barriers or facilitators to program implementation, in peer-debriefing sessions involving authors BL and CJ.Interview transcripts were analyzed using the qualitative analysis approach − Directed content analysis . The disBetween March 2016 and Feb 2018, a total of thirteen program trainers  at one clinic were missing. Overall trainer fidelity to the core components of the group-training sessions was very high. In 104 out of 119 (87%), of the group training sessions, trainers designed exercises, which adhered to the 10-week HiBalance framework that outlines the specific balance sub-domains and dual-task components to be targeted, during which weeks. In the five sessions (4%) where fidelity was poor-fair, balance subdomains were trained, but exercises were not exactly in line with the 10-week HiBalance scheme. These five sessions all occurred at one clinic. We also analyzed the nature of the exercise focus in Block C (weeks 7–10), where trainers were free to choose among the four balance components to target. In three of the four clinics, there was a tendency for trainers to continue to follow the training protocol scheme from Block B by focusing on two specific balance components per week ─ Overload of balance challenge component of the program – by responding that their balance was challenged to ‘partially’ or to ‘a high’ degree  of participants responded positively to the Overall, 85% (SD: 11) of training sessions were attended by participants. The range for attendance as per the predetermined 20 sessions was 50–100%. A further sub-analysis showed that 12 participants attended between 50 to 75% (10 to 15 sessions), whereas 41 participants attended between 80 and 100% . The ANOVA test indicates no differences with respect to attendance rates across the four training clinics Table .Table 3n = 47 (77%) indicated that the individual exercises in the HEP were adapted to their ability at training outset. A further 77% of participants indicated that they were motivated to continue with the HEP once the training ended.In terms of the HEP, approx. 50% of participants reported completing it, and a majority , years with the disease (P = 0.695), balance control (P = 0.648), gait speed (P = 0.688) or physical activity level (P = 0.132). The pattern was similar for the variance of non-parametric data; Functional mobility  and Executive function . Different recruitment processes did not therefore result in different samples of PwPD in relation to descriptive or disease-related characteristics. We consider that our target group of those with mild-moderate PD came into contact with the intervention at all training sites.Parametric analysis of variance of the baseline characteristics of PwPD at the various clinics showed no significant differences between participants recruited in relation to; age (P = 0.90). Similarly, no difference was observed in the proportions of those who improved their gait speed (beyond the SEM of 0.06 m/s) across the four training sites (P = 0.47).No statistical difference was found in the proportion of those who improved their balance (beyond SEM of 2 points) across the different sites , with more falls occurring in block B where dual task exercises were introduced. It was most common for falls to have occurred while training anticipatory postural adjustment exercises involving ball play (40% of cases) as well as during motor agility exercises. Men were overrepresented (80% of cases) among adverse events occurring during the training sessions. Six people in the training group reported non-injurious falls or stumbles during the HEP.Inner setting – Evidence strength and quality; Compatibility and Implementation climate – had positive or negative influences on trainer perceptions of program delivery.Seven out of ten of the CFIR sub-constructs explored in the interviews were represented in the data as influencing trainer perceptions of the program. Facilitators and barriers to program implementation could be categorized under the CFIR domains Intervention Characteristics, Outer Setting and Characteristics of Individuals. An overview of the analysis process involving coding, CFIR sub-constructs, category formation and grouping as barriers or facilitators to program delivery can be seen in Additional file disease-specific nature of the program and it sole focus on balance was considered to fill an existing gap in terms of patients’ needs – disease and symptom-specific group training. Trainers expressed how existing forms of training tended to be more general in nature, and targeted a wider spectrum of neurological diagnoses, while also combining balance with cardiovascular or muscle strength training elements. Additionally, the specific and progressive focus on balance facilitated delivering a higher level of challenge, thus enabling those at mild levels of impairment to benefit from group training.That it  is specifically targeted towards balance training, a lot of other training focuses on strength and mobility where maybe balance has been a smaller part … the specific focus on balance means that you can zone in on one area and really train it hard.Trainer at Clinic 1.The treatment frequency of twice a week over 10 weeks exceeded the more standard once weekly programs already in practice at their clinics. Program frequency was considered a facilitating factor for successful implementation as it enabled therapists to attain a more in-depth knowledge of each patient’s balance capacity, while also allowing patients to gain a better understanding of their capacity. Trainers also perceived it easier to expose all patients to a sufficiently high level of balance challenge or intensity – and therefore maintain program fidelity – when participants had mild as opposed to moderate levels of balance impairment.Then it’s really positive to get to meet them (patients) so many times, because you really do get to know them, and because they also get the chance to get to know themselves, sometimes by doing extreme types of exercises.Trainer at clinic 2.Trainers described how a professional autonomy within the schematic structure, whereby exercises were not pre-set but needed to be constructed and progressed. They perceived this feature as something that encouraged creativity and ingenuity. The program structure was discussed as advantageous in two ways, firstly in providing a reassurance that all important elements would be targeted, and secondly, as the program does not consist of set exercises this allowed trainers the opportunity for professional autonomy. That exercises shifted in focus during alternate weeks was experienced as a facilitatory factor to effective delivery as it required trainers to ‘constantly re-think their approach’ to planning the training sessions.Because it  is designed and so carefully thought through, it feels as if you can’t miss any important parts of balance … it’s easy otherwise if you can improvise completely freely that you can forget a certain part because you chose those exercises you like the best, it’s a reassuring feeling.Trainer at clinic 1.Trainers described the program as allowing for increased self-efficacy gave them greater certainty when stressing the importance of focusing on exercise quality as opposed to intensity during the initial two weeks. Trainers also described having gained perspective on the rate of progression of exercise challenge over time.The difference was that we felt a little more, more confident about how we could handle everything. We knew how it would end, if you know what I mean, we know in which direction we were going. We didn’t know that the first time, but the build- up … we were much more sure about where we were heading. We felt like ─ now we are going to really drum this in, now we are going to stick to this ─.because we knew that soon it would get much more difficult.Trainer at clinic 4.Having completed one entire 10-week program gave trainers greater confidence in their ability to deliver the programs core components. This cognitive impairment as a barrier for patients to benefit from the group sessions. They also discussed the limitations of standard physiotherapy assessment, which does not incorporate an objective assessment of cognition, when trying to establish a person’s suitability to group training. Trainers were mindful of the risk that people who performed poorly during cognitive dual-tasks could feel exposed or vulnerable in front of other group members. To offset this potential vulnerability, trainers proposed pairing patients of equal dual-task capacity.I remember how when we did the cognitive exercises the first time, we realized how we really had to group two (patients) at a time who were around the same level, because otherwise there could be one person that really shined at the task, and one person that didn’t, you know … you didn’t want anyone to feel like they stood out in any way.Trainer from clinic 2.Trainers perceived heterogeneous patient groups in terms of balance capacity were considered a barrier to maintaining fidelity to program core components. If one person’s capacity differed largely from others, due to either low or high levels of balance impairment, this was considered a hinder to achieving a sufficiently high level of challenge for all members of the group.If someone stands out too much, because they are either too good or too bad, well then it gets very difficult to challenge them, if they have poor balance then you need to point mark them and then you lose a certain flow.Trainer at clinic 4.For similar reasons, impaired balance reactions. Trainers suggested that, in the interest of patient safety when performing highly challenging exercises, people with a total absence of balance reactions should be not be included in this program.In accordance with this, trainers perceived that homogeneity in relation to balance capacity facilitated a better group dynamic among participants. An additional barrier that emerged during interview analysis regarded patients with initial level of exercise challenge was a recurring theme, as were difficulties determining an adequate weekly rate of exercise progression. This was especially the case when choosing cognitive dual-task exercises where it was difficult to choose an exercise that challenged patients at an individual and even more so at group level.I thought that it has been hard to understand which level to start at, that was really tricky. Like just how easy or difficult it was supposed to be in the beginning, because you knew that you were supposed to step up the challenge gradually.Trainer from clinic 3.Trainers’ difficulties in choosing a suitable initial two weeks of the program were perceived as somewhat repetitive and trainers felt a need to advance the exercises more than the program structure indicated. They were conscious to avoid patients feeling bored or unmotivated with the program in the early stages. This perceived difficulty was grounded in difficulties maintaining specificity when choosing exercises that targeted one particular balance sub-component during Block A. It was perceived as easier to construct complex exercises targeting several domains than to streamline tasks to target one specific balance component at a time. Trainers commonly perceived that maintaining fidelity to exercise specificity during Blocks A and B a greater challenge, than when all components could be targeted simultaneously in the final block of the program.We felt as if the first couple of weeks were too easy and that we felt to steered in the different areas, sometimes we would have liked to progress the exercises at a faster rate … and then it’s also the case that the patients want to push forward as well, they want to constantly increase the difficulty level, perhaps they thought it was too easy in the beginning.Trainer from clinic 2.The Adding lack of protective fall reflexes  as an exclusion criterion to the program.Reducing the initial two-week block to one week in order to start challenging participants earlier on in the program.Adding basic balance exercises to the HEP and planning a third session during week one to allow for instruction and individual adaptation of the HEP.Setting individual goals with patients during inclusion to the groups in order to mirror clinical practice.Running parallel training groups for patients at mild and moderate levels of impairment, could benefit maintain fidelity to the highly challenging aspect of the program.Using exercise ‘stations’ when the gym space is small, so that patients of similar balance capacity can be paired. That way high levels of challenge can be achieved, and safety ensured by supervising at a particular station rather than one particular person.Findings from this process evaluation show that the HiBalance intervention was delivered with very high fidelity to the programs core components. Trainers planned and delivered exercises in line with the structure intended by the research group, in all except for 4% of the sessions. Evidence for fidelity in program delivery is further supported by participant responsiveness to the programs core components, whereby a strong majority of them reported it to be challenging, progressive and specific in nature. Additionally, we find no evidence, in terms of dose delivered, dose received, or site-specific training response, to suggest that program delivery was more or less effective at any particular site, despite a variation in the nature of the clinics and trainers or varied recruitment strategies.Qualitative findings revealed that trainers perceived lower cognitive reserve as a main threat to challenging patients at a high level during the sessions, in particular during dual-task exercises. There is extensive support for the fact that PwPD have difficulties performing dual-task exercises , possiblTrainers expressed uncertainties determining the appropriate initial level of balance challenge. Difficulty in quantifying the level of balance challenge is previously acknowledged among specialist clinicians . AdditioInterestingly, all trainers in the current study reported challenges of maintaining specificity when designing exercises targeting isolated balance sub-components. That planning ‘simpler’ exercises was perceived as more challenging than designing complex exercises encompassing several balance components is somewhat surprising, considering that physiotherapists are accustomed to working autonomously and adapting programs to patients’ capacity . This fiProcess evaluation findings highlight the need to further refine and develop the content and delivery of the HEP. Although a majority of participants reported being positive to carrying out home training, overall adherence was low (50%). The HEP consisted of a fixed set of exercises, with suggestions for how each exercise could be progressed during the 10-week period. Although trainers were encouraged to individually adapt the HEP to the varied functional capacity of participants at program outset, trainers reported having insufficient time to individualize or progress the HEP during the intervention period. It is possible that sub-optimal individualization, progression, and active follow-up of the HEP, lead half of participants to perceive the exercises as underchallenging or irrelevant. These factors, in combination with PD-related symptoms such as initiative-taking difficulties and apathy, may explain low adherence levels to the program, and possibly also why the HEP did not result in increased levels of habitual physical activity as reported in the outcome evaluation of this trial  and PwPDPwPD in the current study reported that exercises targeting sensory integration were most challenging. In the outcome evaluation no improvement in this specific domain was observed due to a strong ceiling effect . InterprRecruitment difficulties experienced in the initial trial stages − that starting clinics did not succeed in recruiting 12 PwPD to enable randomization − reflects the difficulties of participating in a clinical trial, as opposed to difficulties recruiting 6 PwPD to HiBalance training as a part of standard care. Nonetheless, our findings show that clinics with no previous experience of holding PD-specific training would need to advertise upcoming groups by communication with patient organizations or establishing a collaboration with Neurologists in their area. Concerning our operationalized definition of Reach, with respect to the wide variation in the nature of participating clinics, the broad recruitment strategies used, as well as the variation in participant characteristics reported in the outcome evaluation , we consThe major strengths of this study lie in the application of existing theoretical frameworks – MRC guidelines and CFIR – that enabled a more systematic approach to data collection and analysis and also increases the replicability and generalizability of study findings , 39. AddThe HiBalance intervention was delivered with high fidelity, in terms of trainer adherence and participant responsiveness to the program core components. Dose delivered and received of the group training sessions was high and people with PD reached represented our target population across all sites. Trainer perceptions of barriers to program delivery, such as, difficulty maintaining specificity to exercises and setting the initial levels challenge could be overcome by further development of program materials and on-site training. Barriers such as cognitive impairment, heterogeneous groups and impaired balance reactions could be addressed by refining guidelines for group inclusion as well as increasing trainer proficiency in dual-task training approaches.Additional file 1 Table S1. Program resource materials provided to trainers for intervention delivery.Additional file 2 Table S2. Description of participating clinics where training occurred.Additional file 3 Table S3. Overview of the qualitative analysis process of the investigation of the barriers and facilitators to program delivery.


A validated evidence-based guideline was developed to reduce physical restraint use in home care. However, the implementation of guidelines in home care is challenging. Therefore, this study aims to systematically develop and evaluate a multicomponent program for the implementation of the guideline for reducing the use of physical restraints in home care.Intervention Mapping was used to develop a multicomponent program. This method contains six steps. Each step comprises several tasks towards the design, implementation and evaluation of an intervention; which is theory and evidence informed, as well as practical. To ensure that the multicomponent program would support the implementation of the guideline in home care, a feasibility study of 8 months was organized in one primary care district in Flanders, Belgium. A concurrent triangulation mixed methods design was used to evaluate the multicomponent program consisting of a knowledge test, focus groups and an online survey.n = 15), the tutorials, the physical restraint checklist and the flyer. The results of the feasibility study show the necessity to select uniform terminology and definition for physical restraints, to involve all stakeholders from the beginning of the process, to take time for the implementation process, to select competent ambassadors and to collaborate with other home care providers.The Social Cognitive Theory and the Theory of Planned Behavior are the foundations of the multicomponent program. Based on modeling, active learning, guided practice, belief selection and resistance to social pressure, eight practical applications were developed to operationalize these methods. The key components of the program are: the ambassadors for restraint-free home care , to guide implementation on a larger scale and to formally evaluate the effectiveness of the multicomponent program. Based on the theory- and evidence-based methods, the research group and expert group of stakeholder selected and designed eight practical applications to operationalize those methods; i.e. a website, social media, promo video, flyer, summary of the guideline, physical restraints checklist, tutorials and ambassadors for restraint-free home care. More information on the different components of the program can be found in Fig. n = 8) home care organizations , a senior and community center (n = 1), an organization that provides assisted living facilities (n = 1) and an adult day care center (n = 1).In step 4 of IM the multicomponent program , with a mean age of 41.5 ± 10.6 years. The majority of the participants were certified nursing assistants (n = 23), home health aides (n = 22) and registered nurses (n = 20).After 8 months of testing the multicomponent program, a knowledge test was completed by 73 home care providers of the participating organizations, of which 13 were ambassadors and 60 were non-ambassadors (Table The ambassadors scored noticeably higher on the knowledge test (mean score = 28.9 ± 1.98) (than the non-ambassadors (mean score = 22.6 ± 4.36) Fig. . The nonMulticomponent programA process evaluation was performed after 8 months of delivering the multicomponent program. Ten out of fifteen ambassadors participated in the online survey  less helpful and not appealing. Half of the ambassadors did not visit the social media pages.“The flowchart, part of the summary of the guideline, is too complex to use especially for home health aides. We have made adaptations.”2.Perceived barriers to the implementation of the guidelineThe summary of the guideline aimed to support the professional home care providers in the analysis of the care situation and the decision-making process. In the focus group interviews, the ambassadors indicated that the summary of the guideline was not useful and too complex. A minority of the ambassadors used the summary monthly.term ‘physical restraints’ is being interpreted too narrow; only the most extreme and least acceptable methods  were taken into account. Due to the fact that ‘physical restraints’ has a negative connotation and home care providers were not aware of the full meaning of this term, it resulted in limited recognition of the problem. So, the narrow interpretation of ‘physical restraints’ by the ambassadors and other home care providers formed a barrier to fully exploit the added value of the multicomponent program for the implementation of the guideline. The ambassadors found it important to think about a more suitable and uniform terminology and a clear definition for physical restraints, so that confusion could be avoided.“Locking the door or room, people don’t see this as physical restraints … Also if you prevent someone from going upstairs. Not everyone sees this as physical restraints.”Several perceived barriers to the implementation of the guideline are identified from the focus group interviews. The ambassadors experienced that, in practice, the fragmented approach in home care a challenge when trying to implement a guideline. They found it difficult to involve and collaborate with different care providers such as self-employed nurses, GPs and physiotherapists. The ambassadors indicated that a common vision, general agreements and uniform documents are important to facilitate this collaboration.“We want to do it, but if the other care providers are not part of the story, we will remain in the physical restraints circle.”The ambassadors found the legislation on physical restraint use was experienced as an important barrier to implement the guideline in home care. In Belgium, only doctors, nurses, certified nursing assistants (if they meet certain conditions such as working in a structured team and under direct supervision of a registered nurse) and informal caregivers  can apply physical restraints [“The legislation is very restrictive for home care. If you apply it strictly, we will give the home health aides the feeling that they are unneeded.”“We have been very careful and have not explained the content of the guideline explicitly to the home health aides.”The straints , 10, 11.lack of time for facilitating the implementation as an important barrier. The entire process requires effort and time. The implementation process must be well thought out and prepared, before the actual start. With an implementation period of only 8 months, all ambassadors perceived the feasibility study as too short.“It is such a short period of time to realize it. And it takes time to become more aware and to let everything settle. And for an organization you have far too little time to implement something. You solely have time to create awareness.”The ambassadors experienced a lack of involvement and support of their managers. The ambassadors found it necessary that managers set priorities and develop a common vision and implementation plan related to the use of physical restraints. Not all of the ambassadors had the organizational power to implement a guideline on physical restraint use within their organization, which formed a barrier for the implementation process.“The management is not yet on board. We need to involve them in order to implement it. We are now working on a vision or policy. That has been the bottleneck, to continue and have a complete concept. Everyone has to go along, including managers. It must be supported by the organization and the management.”Another challenge experienced by the ambassadors was the This study developed and evaluated a complex intervention to support the implementation of a guideline for reducing the use of physical restraints in home care. Modeling, active learning, guided practice, belief selection and resistance to social pressure are the evidence-based methods used to select the eight practical applications. The developed multicomponent program has three main objectives: to disseminate and make the guideline more accessible, to increase awareness and knowledge of the problem of physical restraint use and to work towards sustained implementation. This multicomponent program consists of eight practical components . The guideline for reducing the use of physical restraints in home care is not openly accessible and therefore it is not part of the developed multicomponent program , 16. It The results show that the multicomponent program is useful for implementing the guideline in home care. The ambassadors positively received, experienced and evaluated various components of the program. Components that were recognizable, compact, brief and concise, such as the physical restraints checklist, tutorials and flyer, were best evaluated. The ambassadors indicated that due to the combination of the different components of the program their knowledge, skills and awareness of the problem of physical restraint use in home care had increased. Especially the tutorials and the training to become an ambassador restraint-free home care, including peer coaching sessions and telephone follow-up, are considered essential for the program. The website and promo video are valuable, but are not the essential components of the program. In the focus group interviews the ambassadors did not put as much emphasis on the website and the promo video in comparison to the key components. Optional components of the multicomponent program are the social media pages and the summary of the guideline. The ambassadors thought the social media pages were less appealing and saw the summary of the guideline, more in particular the flowchart, as too complex.This study also highlights barriers to the implementation of the guideline. First, the term ‘physical restraints’ is interpreted too narrowly. For this reason, it forms a barrier to fully exploiting the added value of the multicomponent program for the implementation of the guideline. Some ambassadors indicated that professional home care providers were not aware of the broad definition of physical restraints as used in the guideline , 16. OnlThis study uses Intervention Mapping in line with the widely used and cited United Kingdom Medical Research Council (MRC) framework for developing and evaluating complex interventions. The MRC framework provides a useful general approach to systematically design and evaluate complex interventions. The key elements of the development and evaluation process are: development, feasibility and piloting, evaluation and implementation . In addin = 10) and the focus groups (n = 9). Not all of the trained ambassadors evaluated the multicomponent program. A possible reason for not evaluating the multicomponent program can be the limited duration of the feasibility study (8 months). The ambassadors were still working towards increasing awareness. Not all the ambassadors had the time to use the different components of the program. It can be assumed that we performed the evaluation too early in the process. For this reason it is important to interpret the results of the process evaluation with caution. The management is also insufficiently involved in the feasibility study. This could explain why the ambassadors did not experience support from the management of the organization. Lastly, we let the participating organizations select the suitable candidates for becoming an ambassador for restraint-free home care. The findings of this study emphasize the necessity to carefully select the ambassadors based on strict competences .Nonetheless, it is important to note the limitations of this study. The first limitation is the limited involvement of management. A change requires time, resources and sufficient support. Therefore, the involvement of this group is already crucial during the development phase and should be strengthened in future efforts. Another limitation is that patients, informal caregivers and self-employed home care providers are insufficiently represented in the development phase of the study. Various initiatives were taken to involve these groups; but this proved to be difficult. A possible explanation for their absence, is that given the sensitivity of this topic and the negative connotation of the term ‘physical restraint use’, no patients, informal caregivers or self-employed home care providers were willing to participate. There are also some limitations of the feasibility study. First, the knowledge test was cautiously constructed based on the content of the guideline and evaluated by the researchers of the research group. Yet, the knowledge test was not externally validated, and therefore the results for this knowledge test need to be interpreted with some caution. Second, only two thirds of the ambassadors participated in the online survey . In addition, it is important to determine the effects of the multicomponent program on the attitudes, self-efficacy, knowledge and skills of the professional home care providers. Furthermore, we need to gain more insight into the implementation outcomes  and the effect of the multicomponent program on the use of the guideline for physical restraint use in home care  .We can conclude that the multicomponent program shows promising results for implementing the guideline for reducing the use of restraints in home care. The multicomponent program is necessary, yet not fully sufficient to guide the full implementation of this guideline. Prior to further implementation, research is still necessary and needs to focus on larger scale implementation and evaluation of the effect of the multicomponent program. For future implementation it is important to involve all stakeholders from the beginning of the implementation process, use uniform terminology and a uniform definition for physical restraints, select competent ambassadors, assure buy-in of the management and facilitate collaboration between different home care providers.Additional file 1. Methodology literature search.Additional file 2. Topic guide focus group interview IM step 1.Additional file 3. Methodology evaluation multicomponent program .Additional file 4. Topic guide focus group interviews IM step 4.Additional file 5. Results survey evaluation multicomponent program.


In 2015, Michigan implemented a rule requiring parents to attend an education session at a local health department (LHD) prior to waiving mandatory child vaccinations. This study utilizes Normalization Process Theory (NPT) to assess program implementation, identifying potential threats to fidelity and sustainability.We conducted 32 semi-structured interviews with individuals involved in these education programs across 16 LHDs. Participating LHDs were selected from a stratified, representative sample. One interviewer conducted all interviews using a semi-structured interview guide; two authors coded and analyzed the interview transcripts according to the NPT framework .There was a lack of consensus about who the stakeholders of this new rule and its resulting program were (sense-making). Perhaps as a result, most LHDs did not solicit advice from key stakeholder groups  in their planning (engagement). While most interviewees identified providing education and information as the goal, some identified the more challenging goal of persuading vaccine hesitant parents to immunize their children. There was also some variation in perception of who held health educators accountable for meeting the goals of the waiver education program (collective action). Formal program evaluation by LHDs was rare, although some held informal staff debriefings. Additionally, sessions that went particularly well or poorly were top-of-mind (reflexive monitoring).The immunization waiver education program may be at risk of not becoming fully embedded into routine LHD practice, potentially compromising its long-term effectiveness and sustainability. Managers at the local and state level should maintain oversight to ensure that the program is delivered with fidelity. As the program relies on sustaining inconvenience to encourage parents to immunize their children, any shortcuts taken will undermine its success. Vaccine hesitancy, where individuals forgo or are reluctant to receive available vaccinations, was named as a major threat to global health by the World Health Organization in 2019 , 4. StatMichigan had among the highest kindergarten nonmedical exemption rates and least effective exemption laws of any state , 8. In 2This study utilizes Normalization Process Theory (NPT) to evaluate the implementation process and identify potential barriers to fidelity and sustainability at the LHD level. NPT was chosen because it focuses on the individual and organizational factors associated with successful long-term program performance. NPT has been widely used to examine how interventions become embedded into routine practice in organizations such as LHDs –14. If aGiven the nature of Michigan’s approach, it is paramount that LHD staff continue administering it properly. This study evaluates Michigan’s novel local-level intervention, utilizing qualitative interviews with a representative sample of LHDs implementing the program. The purpose is to identify challenges to normalizing the program, and the potential inconvenience it represents to vaccine hesitant parents, into everyday practice. The alternative would be to have the inconvenience aspect erode over time in the face of public pressure—pressure that is present in some localities as well as at the state level . The conThis qualitative study utilized interviews from individuals within 16 of Michigan’s 45 LHDs to identify LHD-level implementation barriers to fidelity and sustainability of the state’s immunization waiver education program. Please refer to Fig. Overall, 32 individuals were interviewed from 16 LHDs. Preliminary contact was made with interviewees by email. None of the interviewees were known to the interviewer (DL) prior to this contact, and the other two authors  had no contact with the interviewees. One author conducted semi-structured interviews with between 1 and 4 representatives from each LHD, where interviews averaged 31 min in duration. The two pilot interviews were conducted in person; the remaining interviews were conducted via phone. No non-participants were present during the in-person interviews, and the interviewer was unaware of the presence of any non-participants during the phone interviews. There was a high response rate by LHDs invited to participate  and no participants dropped out. The study protocol was reviewed, approved, and determined to be exempt by the University of Michigan Institutional Review Board. Informed consent was obtained from each interviewee prior to participation. During the recruitment and consent process, the identity and affiliation of the interviewer, as well as the topics of interest, were provided to the participants. Interviewees were first screened for involvement with the program. All interviews were conducted between June 2016 and January 2017. Interviews were recorded and transcribed; detailed notes were taken when interviewees declined to be recorded. Please see Table Sense-making: When implementing a new initiative, those responsible for service delivery should have a clear understanding of their role, which includes an identification of the stakeholders that are affected by, and will benefit from, the initiative.Engagement: Involving stakeholders in the planning of new initiatives assists with embedding by building relationships and fostering ongoing commitment. In particular, their involvement can signal community buy-in to the initiative.Collective action: Those implementing a new initiative aim to achieve a collective goal determined, in this case, at the state level. However, personally-held goals can either support or undermine the initiative’s original intent. Relatedly, interventions can influence perceptions of responsibility and accountability, which can affect how the tasks are operationalized.Reflexive monitoring: Once implementation is underway, staff develop perceptions of the new initiative’s usefulness and effectiveness. This perception may be based on formal and/or informal evaluation efforts.The coding scheme was developed through a directed content analysis , which iThese components are not mutually exclusive. For example, a collective understanding of common goals also provides insights about how those involved in implementation make sense of the program and its benefits. For an illustration of how interview guide questions mapped onto components, please see Table Two authors with qualitative research experience, one a PhD-trained health services post-doctoral fellow (DL) and another a PhD candidate (CW), engaged in line-by-line coding of each transcript. We employed Dedoose software to assist with the organization and coding of themes. We assessed reliability by randomly selecting transcripts from four of the 16 LHDs for a line-by-line coding review. We calculated Cronbach’s alphas for each code across all LHDs: all exceeded a 0.80 threshold. Coding disagreements were discussed and resolved.To illustrate key themes, we present example quotes in the results section. Additional supporting quotes appear in Additional File Across the LHDs interviewed, there was a lack of consensus about who the stakeholders of this new rule and resulting program were. The following were identified as the stakeholders: the community (9 LHDs), parents and/or families (9 LHDs), public health or the health department (6 LHDs), schools (6 LHDs), and local medical providers (4 LHDs). As noted, all were mentioned by less than two-thirds of LHDs interviewed. Additionally, some interviewees had difficulty identifying the rule’s stakeholders. According to an immunization staff member: “It’s difficult to actually identify stakeholders [ …] [Waiver-seeking families] are not partners necessarily. Families seeking the waivers are partners in the process, but they don’t share the same goals. So when you think about traditional stakeholders, not everyone involved in the process shares the same goal” [SE4].Most LHDs interviewed did not solicit advice from key stakeholder groups in their planning. Less than a quarter indicated that they involved schools, health care practitioners, or members of the community when planning the mandated immunization education sessions. Rather, LHDs were more proactive in informing these groups after the fact. In rare instances (3 LHDs), interviewees discussed involving one or more stakeholder groups in their planning through their involvement in an immunization coalition or child health-focused group. To illustrate, one of the exceptions was a director at a northern health department, which mentioned their LHD’s involvement in a regional group that predated the new waiver education rule: “It’s representatives from health departments, hospitals, private and public schools, pediatricians, and some other key partners in our community that participate. So there was some discussion [of planning the sessions] amongst that group as well” [N1].While some goals were consistent across LHDs, others deviated in important ways. All LHDs interviewed indicated that providing education and information to the parent is the goal of the rule set forth by the state. An immunization coordinator at a south central LHD stated “Our number one goal is not to change their minds and get them to immunize. Of course, we love that when it does happen, but our main goal is strictly education of the parents of all the requirements and the benefits of vaccinating and the risk of not vaccinating” [SC2]. However, interviewees at 6 LHDs also identified more challenging, and perhaps unattainable, goals that fall outside the original intent of the rule: to persuade waiver-seeking parents to vaccinate their children or to improve local immunization rates. A health officer from an eastern health department said: “The best goal would be to try to answer questions that would allow the parent to feel comfortable getting the vaccine” [E4]. There is some acknowledgement that persuasion is difficult, as exemplified by an immunization supervision staff member from a southeastern health department: “we have our lofty goal of we would love to have them see the light and go and get their immunizations” [SE6].Related to goals, LHDs differed with regard to their perceptions of who held them accountable for meeting waiver education program goals. The most frequently identified accountability-holders were the state, or specifically the Michigan Department of Health and Human Services, and the LHDs themselves, mentioned by 11 LHDs. Client and public accountability were less-frequently identified, mentioned by 6 and 2 LHDs, respectively. A medical director from a northern health department described accountability as follows: “the school system, and the parents, and the whole public hold the health department to standards of appropriate and professional behavior, in this area and everything else we do” [N1]. And, a manager from a central health department said: “Definitely the Michigan Department of Health and Human Services and my individual local health department because this is a duty that we are charged with, and then the community as a whole” [C4].LHDs seldom engaged in formal evaluations of waiver education program implementation, while informal feedback was much more common. Four LHDs said that waiver-seeking parents may have participated in agency-wide surveys across all their programs. Two LHDs said that they initially conducted a client survey for the waiver program, but they no longer do so. In contrast, 8 LHDs described holding informal staff debriefings specific to the waiver education program. Some, like an immunization program coordinator from a southeastern health department, indicated that they have incorporated discussions of the sessions into their meetings: “We provide feedback to one another about what we’re seeing or what we’re anticipating. If we’re taking appointments and we anticipate somebody maybe more difficult or have specific questions, we’ll offer that information to the staff that may be conducting that appointment. If I see overall themes happening, we talk about that in our meetings” [SE5]. A manager from a central health department explained that their debriefings weren’t regularly scheduled: “generally debriefing is only when there is a situation that we haven’t encountered before, like a parent has a reason that we haven’t really thought of before that we don’t feel like we have enough education on. We come together to make sure that we’re better able to handle that situation in the future” [C4]. Occasionally, LHDs mentioned that, while they do not collect formal feedback, they do receive unsolicited feedback from parents attending the education program.Interviewees also revealed the parent feedback they received when discussing their experiences delivering the program. Interviewees at 9 of the LHDs indicated negative experiences, as exemplified by a public health nurse from an Upper Peninsula health department: “It’s not a super pleasant experience for me. I just try to meet the parent where they’re at, and offer information that they haven’t really been interested in taking. The people that I’ve seen are very firm in how they feel about it. Just a few parents are verbal and totally object to the sessions” [UP6]. On the other hand, interviewees at 7 of the LHDs relayed positive experiences, such as those described by an immunization staff member from a southeastern health department: “I had one person that came in that were going to get 2 of the 4 vaccines that they needed [ …] then afterwards they got everything. And there was one that came in afterwards and got their child up-to-date and sent our nurse a thank-you card with a box of chocolates” [SE4]. As illustrated by these quotes, sessions that went particularly well or poorly were top-of-mind for interviewees.Our evaluation identified several threats to the program’s long-term fidelity and sustainability. First, it was rare that LHDs engaged with stakeholders in the community when planning the waiver sessions. Relatedly, there was no clear consensus across the LHDs as to who the stakeholders were in the process. Third, while most identified feasible intervention goals, some indicated that they were aiming at more ambitious, unattainable goals. Fourth, formal evaluation was almost nonexistent, leaving open the opportunity for interviewees to assess the value of the intervention based on anecdotal experiences rather than aggregate results.This article uses NPT and its components—sense-making, engagement, collective action, and reflexive monitoring—to understand the reasons behind the implementation challenges and examine whether embedding is at risk as a result . Below, sense-making, implementers develop an understanding of the program to be delivered, which includes their perceptions of the program’s benefits and stakeholders [Through eholders . While ceholders . Similareholders . In contEngagement addresses the relationship work needed to marshal resources for the program, including stakeholder involvement [olvement . Stakehoolvement . Similarolvement .Consequently, lack of engagement has consequences for program sustainability. For example, a study of a self-management support program for patients with chronic illnesses found that the intervention was not seen as relevant by either the practitioners or the patients, meaning that neither were willing to invest time and effort in the program . The autCollective action includes whether the program aligns with the goals and activities of the implementing organization [nization . The vasnization . Howevernization . Additionization . Yet, thnization . UnderstReflexive monitoring includes implementers’ perceptions of the intervention’s impact, which are informed by participant and/or staff feedback and appraisals of the effects of the intervention [rvention . With lirvention . Howeverrvention , 34.The key mechanism of the immunization waiver education program, inconvenience, is a relatively new concept in the public administration literature and holds promise for disease prevention and health promotion. Yet, key examples of from the public administration literature focus on the negative consequences of inconvenience, termed an “administrative burden,” in that it can be used to deter qualified individuals from obtaining government assistance . HoweverAs vaccine hesitancy remains a global health concern, countries must consider various approaches to improving vaccination rates. Western democracies prioritize the balance of individual liberties with the protection of the public. Applying inconvenience as a strategy to manage vaccine hesitancy utilizes inconvenience as an incentive that successfully acknowledges individual liberties—while not imposing overly onerous administrative burdens—and encourages individuals to prioritize public health as is necessary for effective vaccine policy implementation. Overall, in the case of vaccine hesitancy, inconvenience is an effective approach that strikes the right balance of respecting individuals’ needs while reducing harm to public health. Future research should address the long-term viability of this inconvenience approach as a method of addressing vaccine hesitancy.One limitation of this research is that only one interviewee represented the views of 7 of the 16 LHDs. Given the range of responses to certain items, it does not appear that there is an indication of adverse selection. And, in those LHDs where there were multiple interviewees, responses to questions generally aligned across the interviewees. Additionally, our results relied on themes across health departments rather than what is specific to one particular LHD. Finally, this is a cross-sectional analysis of a longitudinal process, meaning that limitations in terms of causality and the inability to capture changes over time apply.Using NPT, this evaluation identifies challenges to the implementation of the immunization waiver program that have the potential to undermine fidelity and long-term policy successes. Interviews indicated a limited sense of who the key stakeholders are, which can lead to an inaccurate understanding of (and lack of commitment to) the program. Perhaps as a result, there was a lack of key stakeholder involvement in session planning. This is a lost opportunity to engage allies in favor of vaccination. Although most LHDs indicate that their goals are to provide education, others aim for goals that are more difficult to achieve. While formal evaluation is rare, and may be inappropriate in this case, waiver staff do debrief. However, the experiences shared may emphasize extreme cases, such as those parents who decide to vaccinate or who became angry, which in turn can affect staff perceptions of program value. These program aspects challenge the ability of LHDs to normalize it into regular departmental and immunization clinic operations. At the same time, interviewees are aware that they are accountable to entities such as their LHD and the state. It is imperative that these organizations continue to monitor and guide how LHDs are implementing the program, with the end result being that it remains no less inconvenient to receive the immunizations than it is to opt out.Additional file 1. Full Interview Guide. Full IRB-approved interview guide developed for this studyAdditional file 2.  Additional Supporting Quotes by NPT Component. Examples of the quotes from the study participants illustrating core domains of the Normalization Process Theory


Candida albicans to denture base acrylic resin. The present study aimed to test the in vitro effect of traditional and novel fabrication methods on Candida albicans adhesion to denture base samples. Denture based acrylic discs were fabricated using: (i) computerized milling, (ii) 3D printing, (iii) heat curing, and (iv) cold curing. Discs were tested for surface roughness (Ra), hydrophobicity (contact angle), mucin adsorption (Bradford assay), and Candida albicans adhesion. 3D printing significantly increased microbial cell adhesion as compared with heat curing, and computerized milling significantly decreased it. These results were associated with mucin adsorption levels rather than surface roughness. Results suggest that 3D printing may increase the risk for developing denture stomatitis, whereas computerized milling may decrease it as compared with traditional heat curing denture base fabrication.Denture stomatitis is a common manifestation of oral candidiasis affecting some 65% of denture wearers. This condition is initiated by the adherence of  Candida infection, and the continual wearing of dentures appear to be the predominant associated etiological factors for denture stomatitis [The prevalence of denture stomatitis among denture wearers ranges from 15% to over 70%. The etiology of denture stomatitis is multifactorial and has a number of associative factors rather than a single cause. Poor denture hygiene, pathogenic Candida albicans onto the denture’s acrylic base and may give rise to painful inflammation of the oral mucosa adjacent to the contaminated dentures [Candida infection results from the adhesion and proliferation of microorganisms such as dentures ,2.Acryl-based complete or partial dentures are commonly used in the treatment of edentulous patients, especially among the elderly . TraditiCAD/CAM dentures offer several potential benefits to both the clinician and the patient. The fabrication process was found to be the most accurate, less porous, and fast manufacturing time .Candida albicans that have been implicated in precancerous lesions [Candida-infected leukoplakia indeed relates to a higher rate of malignancy [Candida infections may play a role in the development of oral epithelial dysplasia and neoplasia, and there is an association between oral epithelial dysplasia and harboring Candida species in the oral cavity [Candida infections are indeed able to cause oral cancer.Dentures’ acrylic base most commonly comprises of poly-methylmethacrylate (PMMA), a porous material that is prone to microbial biofilm accumulation . Microbi lesions  and oral lesions . Candidalignancy . Candidal cavity . HoweverCandida albicans adhesion and surface properties.Various physical properties, including surface roughness, hydrophobicity, and chemical composition, have been associated with microbial adhesion to denture surfaces ,13. The Six denture base acrylic discs (12 mm in diameter and 2 mm thickness) were prepared using four fabricating techniques as follows: (i) milling , (ii) 3D printing  (iii) hot curing , and (iv) cold curing .CAD/CAM PMMA-based specimens, designed using a computer program and then manufactured by milling . For conventional PMMA (cold and hot cure), acrylic resin discs were prepared according to the manufacturer’s instructions. The specimens were fabricated from an acrylic resin denture base material using a conventional flasking and pressure-pack technique.Finishing and polishing were carried out by a single operator on one side of the discs. Finishing was performed by an electric motor handpiece using a silicon carbide bar  and applied for 15 s. Polishing was performed using a hard brush and pumice paste, followed by a soft brush and universal polishing paste . Following polishing, the discs were rinsed with water and tested for surface properties and microbial adhesion, as described below.Samples were mounted on aluminum stubs and sputter-coated with gold. 3D images were constructed using scanning electron microscopy  in 1000× magnification. Surface roughness (Ra) was measured using image analysis software .A contact angle test was performed to evaluate the hydrophobic properties of the tested discs. The contact angle was measured using a goniometer  by placing a drop of deionized water (10 μL) on the leveled disc, measuring the contact angle on both sides of the drop and recording the mean result.w/v). A drop (40 μL) of filtered mucin  was placed on each of the tested discs for 3 min at room temperature [Pig gastric mucin  was dissolved in PBS  [6 microbial cells per mL) in BHI broth and incubated for 4 h at 37 °C. Following incubation, the discs were washed three times with saline to remove any non-adhered microbial cells. Samples were fixated in glutaraldehyde (2.5%), dehydrated in a series of ethanol solutions (30–100%), and desiccated. Following desiccation, samples were gold-sputtered and adhered microbial cells were quantified using scanning electron microscopy  by analyzing the digital images using a morphometric software .Discs were mucin coated as stated above and placed at the bottom of a 24 wells plate. Wells were added with 1 mL of l Ester)  suspensip ≤ 0.05 was considered statistically significant. Experiments were conducted in six replicates. To compare the effect of the different fabrication techniques on surface properties and microbial adhesion ANOVA was applied with post-hoc pairwise comparisons according to Dunnet and Scheffe. Pearson correlation coefficient was used to calculate the level of association between microbial adhesion and the various surface parameters. Tests applied were two-tailed, and p < 0.03).Results of the acrylic discs surface roughness (Ra) in the various test groups are presented in p < 0.001).Results of the acrylic discs’ surface hydrophobicity in the various test groups are presented in p < 0.001).Results of the mucin adsorption to the various test groups are presented in p < 0.001). Microbial adherence to cold cure acrylic discs were also significantly higher as compared with the heat cure discs (p < 0.001).Results of the microbial adhesion to the various test groups are presented in Levels of association between the adhered microbial cell counts and the various surface parameters are presented in Candida albicans to denture base acrylic resin samples using two traditional production methods (heat and cold cure) and two novel methods (3D printing and computerized milling). Results showed that manufacturing denture base acrylic resin discs using 3D printing significantly increased Candida albican’s adhesion as compared with the traditional method of heat curing, whereas computerized milling significantly decreased the microbial adhesion (In the present study, we tested the effect of the fabrication method on the adhesion of adhesion . These rCandida albicans to surfaces [Previous studies showed that mucin is an important mediator in the adhesion of surfaces ,8. Mucinsurfaces . They arsurfaces . In the surfaces ,19,20. TDenture stomatitis is a condition that is hard to treat. Candida biofilm formed on uncoated acrylic resin exhibits resistance to removal . TherefoC. albicans [Candida adhesion when compared to conventional polymerized PMMA [Several research studies have suggested that the materials’ surface roughness is an important factor affecting the adhesion of albicans . Studiesalbicans . Murat ezed PMMA .Candida albicans related problems whereas computerized milling may decrease those risks. Further research should investigate the effect of the percentage of denture materials polymerization on bacterial adherence.Within the limitations of this in vitro study, its results suggest that 3D printing of denture base may enhance microbial adhesion compared with traditional heat curing fabrication, thus increasing the risk of developing denture stomatitis and other


We propose Graded Hoare Logic (GHL), a parameterisable framework for augmenting program logics with a preordered monoidal analysis. We develop a semantic framework for modelling GHL such that grading, logical assertions (pre- and post-conditions) and the underlying effectful semantics of an imperative language can be integrated together. Central to our framework is the notion of a graded category which we extend here, introducing graded Freyd categories which provide a semantics that can interpret many examples of augmented program logics from the literature. We leverage coherent fibrations to model the base assertion language, and thus the overall setting is also fibrational.Deductive verification techniques based on program logics  are a powerful approach for program reasoning. Recently, there has been a trend of increasing the expressive power of such logics by augmenting their rules with additional information to reason about program side-effects. For example, general program logics have been augmented with cost analyses, logics for probabilistic computations have been augmented with estimate measures, and logics for differential privacy with indistinguishability bounds. In this work, we unify these various approaches via the paradigm of