Therapist-guided internet-based cognitive behaviour therapy (ICBT) has been proposed as a potential means to increase individuals' access to quality mental health care and effective treatment. Guided ICBT aims to increase a patient's knowledge and competence to better cope with their disorder. Despite the growing evidence supporting the effects of guided ICBT, there is remarkably little research on the different factors that are important for patients to achieve effects from using such digital treatment interventions. Thus, the aim of this study was to conduct a user evaluation of a therapist-guided ICBT program using the updated DeLone and McLean (D&M) model for measuring information systems (IS) success or effectiveness. This model includes the following six dimensions: system quality, information quality, service quality, intention to use and use, user satisfaction, and net benefits (impacts or effect).Assisted Self-Help’ (Assistert Selvhjelp) participated in phone-based individual interviews. Data were analysed using directed content analysis. Results showed that the participants were quite satisfied with the program's system quality and information quality. However, participants suggested improvements, including in-program instruction, improved visibility of system status, more flexibility regarding automated measurement surveys, and the inclusion of more videos with patient stories. Further, the results indicated a need for improvement in the service quality of guided ICBT introduction, instruction, follow-up, guidance, and support from therapists. The results showed that user friendliness and high educational content might not be sufficient for a therapist-guided ICBT program to be perceived as effective. It might also be necessary for therapists to provide follow-up, guidance, and support that are more in line with individual patient needs. Thus, the results suggest that guided ICBT requires active participation from all involved in the process, including the therapist.Ten users of a Norwegian therapist-guided ICBT program for treating anxiety disorders named ‘ •The Norwegian Assistert Selvhjelp ICBT for treating anxiety disorders was assessed.•User evaluations were conducted with 10 patients based on the DeLone and McLean Model of IS Success.•Overall, patients were satisfied with the internet-based cognitive behaviour therapy program.•Improvements in follow-up, guidance, and support from therapists were requested.•Guidelines should ensure the implementation of various important success dimensions. CBT is The goal of the World Health Organisation's Special Initiative for Mental Health (2019–2023) is to ensure universal health coverage of mental health conditions . One of The effect of therapist-guided ICBT has been investigated in many randomized controlled trials , as atteAssisted Self-Help’) for treating anxiety disorders using the updated D&M model for measuring IS success or effectiveness  will singularly or jointly affect subsequent “use” and “user satisfaction”. Intention to use, use, user satisfaction, and net benefits measure effectiveness success. For example, attitudes (intention to use) links with behaviour (use). Positive experiences with “use” will lead to greater “user satisfaction” and further to increased “intention to use”. Certain “net benefits” will occur as a result of “use” and “user satisfaction”. Experience of positive or negative benefits will lead to increased or decreased intention to use and user satisfaction . The dimAccording to 2.2Assisted Self-Help’ (Assistert Selvhjelp) for treating anxiety, is a low-threshold mental health service for treating mild-to-moderate anxiety disorders among people over 16 years of age. ‘Assisted Self-Help’ is distributed as a public healthcare service, mainly by the mental health services in municipalities, which focus on short-term early interventions. People may be referred through their general practitioner (GP), rapid municipal mental health services, or student organisations. Therapists who offer this program have backgrounds mainly in health or social work and are typically nurses, psychologists, or social workers. Most of these therapists have additional training in cognitive behaviour therapy.The therapist-guided ICBT program ‘Assisted Self-Help’ program involves exercises, tasks, and information based on how a psychologist would design an anxiety therapy process. This program follows a fixed structure with the following six modules: 1) “What is Anxiety?”, 2) “The Physiology of Anxiety,” 3) “Basic Techniques,” 4) “What Kind of Anxiety Do You Suffer From?”, 5) “Practice Makes Perfect,” and 6) “Setback or Relapse?”. After the first three modules that generally apply to all anxiety disorders, patients enter the fourth module, in which one of the four following types of anxiety is chosen based on the patient's primary issue: social situations , anxiety attacks (panic anxiety), specific anxiety (phobic anxiety), or anxiety in various situations without a particular cause . The patients received guidance from the therapist on this part. The rest of the program is adapted to the user's type of anxiety. No personal data that can directly identify the user are stored. The program is provided on personal computers, tablets, and smartphones. The whole program could be finished within 6 weeks. The ‘The participants in our study had mostly been referred by their GP or through rapid municipal mental health services. After the therapist deemed a user suitable for this form of treatment , the user received access to the program with a unique and anonymized code. Regular structured follow-ups were conducted by therapists via individual in-person or online meetings (lasting up to 45 min), and/or by telephone consult (lasting 10–20 min). Patients were offered weekly consultations.Little empirical research has been conducted involving the ‘Assisted Self-Help’ therapist-guided ICBT program. The program has been included in a study that evaluated the usability of five Scandinavian therapist-guided ICBT programs conducted by 2.3Assisted Self-Help’ program for treating anxiety disorders were conducted. Here, evaluation is defined as “the act of measuring and exploring properties of a health information system, the result of which informs a decision to be made concerning that system in a specific context”  mild-to-moderate anxiety disorder, 2) normal cognitive function, and 3) ability to work independently. It was preferable to the study design that participants be over 18 years old, there be a spectrum of ages and genders, and participants have completed the whole or at least half of the ‘Assisted Self-Help’ program for treating anxiety disorders were recruited for this study, and they were contacted by the main author to schedule time for the interview via phone. The main author and the participants had not been in contact before this.According to 2.5Assisted Self-Help’ program guided by a theoretical framework for measuring IS success or effectiveness (1)First, both authors read all textual data and highlighted parts of the text that, on first impression, appeared to be related to the six dimensions dictated by the D&M framework. These dimensions were viewed as predetermined main categories for the analysis.2)Second, the first author used NVIVO 12 software  for data3)Third, the two authors met to discuss the fit between the textual data and its highlighted parts with the coding of main- and sub-categories. The two authors did not identify any highlighted text that had not been coded into the six main categories. However, some of the identified subcategories did not fit the suggested measures by D&M  and wereA professional service transcribed all the interviews. The main author who conducted the interviews read through the transcribed data and compared them with the audio data. According to tiveness , the ana2.6Assisted Self-Help’, and not to measure the effects on the user's anxiety symptoms, more detailed data regarding the patient's mental health condition were not collected. Therefore, approval from the Regional Committees for Medical and Health Research Ethics was not required (Number: 117187).This study was approved by the Norwegian Center for Research Data (Number: 214266) and followed general ethical guidelines . Since tAll participants received written and oral information about the project, and oral consent was acquired and recorded before the interview started. Each participant's name was assigned a unique number in the event of requirement of further information. Confidentiality was maintained by storing names and participant numbers separately and by storing all personal information in a secure location.3Assisted Self-Help’ program varied from one to six months, with two months being the most common completion time.The characteristics of the 10 participants are displayed in Assisted Self-Help’ collection of resources, such as for stress, worry, and depression. Two participants used other types of online resources, such as apps and YouTube videos. The participants that had prior experience with similar online resources had used other programs within the broader ‘3.13.1.1Only one participant thought it was cumbersome to log in due to difficulty remembering the code. That participant expressed, “It should have been possible to create a personal code when logging in for the first time” (Participant 5). Further, nine out of ten participants thought learning to use the program was easy. One expressed, “…it was quite self-explanatory” (Participant 10). However, two participants proposed that the program should have included information or an instructional video on how to use it. One participant missed information about whether to complete the modules in order or whether it was possible to complete the modules, depending on personal needs. Only two participants had experienced technical issues. One had been disconnected from the program, but was unsure whether that was due to the program itself or the participant's internet access. The other participant experienced problems accessing a YouTube video in one of the modules.Due to information security issues, the participants could not fill out the forms within the program. The forms either had to be downloaded or printed. As a result, one of the participants chose not to use these forms. However, the other participants downloaded and printed them out or just used the forms to take notes elsewhere. One commented that the forms were greatly beneficial because they provided an overview of the mental health situation.A participant's progress in the program is indicated by colour codes for complete and incomplete modules. One participant (who used an iPhone) thought it was hard to navigate the overview of the progress made in the program. Another participant stated that if an entire module was not completed in one sitting, one had to start over again the next time instead of being able to resume the progress of the prior attempt. Further, one participant expressed that it was difficult to know approximately how long each module took to finish and how many tasks remained before finishing a module. The user interface displayed participant progress in percentage but did not show how many tasks were left.3.1.2Two participants expressed that they did not like the protocol of being forced to fill in a questionnaire containing four to five questions regarding their psychological condition and social relations before each module. One participant experiencing stress stated, “I do not always feel like answering these questions” (Participant 6). The same participant suggested that the questions be asked at the end of each module. The other participant thought being forced to answer these questions before each module was inconvenient, especially after being asked similar questions in several modules in a row. In contrast, another participant commented that it was nice to be able to follow one's own progress by looking at a diagram.One participant thought the program became complicated to use when there were forms that had to be filled out about situations where the participants felt insecure: “It's probably what you have to do to get rid of your problems, but it did not quite suit me” (Participant 5).Most participants appreciated that they could go back and forth in the program by using arrows. However, one participant expressed that the flexibility of being able to automatically move to the next module could be a drawback, as she read too much too fast. Another participant suggested including a function that asked if you wanted to move on to the next module.3.1.3Most participants expressed that they enjoyed the user interface design, which employed a combination of images, videos, animations, and quizzes. Some of the comments included: “nice pictures”, “text is tidy and has proper size”, “simple and minimalist”, and “clever with video clips in between”. One participant elaborated especially on the importance of videos in the program: “I thought the opportunity to watch videos between text and questions was great” (Participant 1). However, two participants commented that they thought the animations used were too juvenile. Similarly, one participant commented that the animations were not particularly educational. However, almost all participants expressed that they appreciated the videos. Only one participant reported, “I think it is better to read text than watching the videos, because I easily lose concentration when I watch videos” (Participant 8). By contrast, another participant reported greater benefits from videos and audio files than from large amounts of text. Two participants suggested including more videos in which people with anxiety disorders share their experiences, as this may help participants self-identify.3.23.2.1Examples of comments provided about the program's information quality include: “The information was well explained”, “appropriate amount of information”, and “easy to read and understand”. However, one participant of foreign origin struggled to understand some of the content, especially the exposure techniques and exercises. The participant in question received explanations from the therapist when needed.Regarding the structure of the information, most participants agreed that it was logical. One participant commented that it was beneficial that there were different modules containing unique tasks that helped participants focus on one thing at a time. Two participants also commented that they appreciated how the program started simply and became more advanced over time. It was also noted that it was helpful that each module ended with a quiz to test whether the participant understood the information. If participants realised that they had not understood, they could return to the reading for clarity.3.2.2Participants commented that the program had an “appropriate amount of information”. Regarding the relevance and usefulness of the program's content, one participant felt that the program had not been very informative, as the participant already had substantial knowledge. However, the participant in question acknowledged that the program provided useful information for those who did not have as much knowledge of the field. Another participant who had prior knowledge thought it was helpful to have this knowledge refreshed. One other participant commented that it was beneficial that the program provided repetition of certain content, especially for users who had minimal prior knowledge.As mentioned in Assisted Self-Help’ resource .Some participants commented that it was difficult to choose only one of the anxiety categories because they felt that either a single category did not represent everything they recognized in themselves or that multiple categories were applicable. Some commented that they used other online resources and apps in addition. Participants also noted that it was helpful to have access to other programs in the broader ‘3.33.3.1Assisted Self-Help’ was recommended to three of the participants by a GP, other healthcare workers or friends. As one participant was unsuccessful in searching for information about the program on their municipality's website, this participant recommended that information about such a resource be made available and more open to the public. It was suggested that such access could decrease the stigma associated with mental health disorders and make it easier for people to seek help with their disorder.The ‘Assisted Self-Help’ guided ICBT program was mostly introduced to participants by the therapists as a resource they could use at home to apply the skills and strategies learnt in the program to better cope with their own personal situation. One participant expressed, “I didn't quite understand what the therapist was talking about, but I got the urge to try it” (Participant 2). One participant also commented that the therapist had been very limited with information in the introduction of the program: “She just asked me if I would try it, and ultimately just sent me a code” (Participant 4). Another participant was only offered the opportunity to use the program because they had tried all other available treatment options in the municipality.The ‘Assisted Self-Help’ resource as an alternative to regular treatment while the participant was on a waiting list for regular treatment. The participants were offered the use of the program until a regular appointment with the therapist was available.One participant was introduced to the ‘3.3.2Nine participants commented that they had to find out for themselves how the program worked and were sent only a code for entering the program. Only one out of the 10 participants had received a demonstration of the program from their therapist. One participant expressed, “I feel it would have been much easier if I my therapist and I had done it together the first time, that I had been shown a little how it works” (Participant 3). Another participant lamented not receiving information about the full content of the program. For example, this participant was unaware that exposure tasks were included in the program. The participant said, “If the therapist had given me more information about the program and had been more motivating, I would have benefited more from the program” (Participant 4). The kind of instruction the participants received from their therapists regarding how to use the program or how much material to complete within a given period varied greatly. Only half of the participants thought they had been given clear instructions on how much to complete between appointments. One participant proposed that the therapist should be allowed to access the full program to be able to check user progress. Two participants thought that the lack of information and instructions might have been due to the therapist not receiving any special training in using the program or not having spent the time becoming familiar with the content.3.3.3Four participants had appointments with the therapist once a week, two had appointments every other week, and three had irregular appointments. One participant did not have appointments in the beginning but eventually secured appointments after being assigned a therapist. It was then agreed that the participants would meet with the therapist once a week. No participants expressed that they needed more frequent meetings than what was agreed upon. Two of the participants expressed that the most important was how time was spent during the appointments with your therapist.Six of the participants had only telephone contact with their therapists. Two initially had telephone contact but were offered digital video meetings after expressing the need for in-person meetings with their therapist. Physical meetings could not be conducted due to the COVID-19 pandemic. As a result, two of the participants who initially had physical meetings with their therapists had to switch to telephone contact. One expressed, “I feel it would have been much better if I could have come to the therapist's office once a week instead of just calling” (Participant 5).Three participants were not satisfied with the guidance or support they received from their therapists while using the program. One of the participants commented that while there was nothing wrong with the program itself, the follow-up, guidance, and support were insufficient. This participant recommended more assistance with carrying out the exposure therapy, as this was perceived to be the most important segment of the program: “You have been given tools, but do not always know how to use them” (Participant 3).Further, one of the participants was unclear on what extent of the program was the therapist's responsibility versus the participant's. All three participants mentioned issues including a lack of specific assignments from one appointment to the other, minimal or no follow-up conversation after each module, and failure to set up an exposure plan together with the therapist.Among the participants who were satisfied with the support and guidance from their therapist, three expressed that they found the briefing with their therapist particularly useful, as they could review and discuss what they had completed in the program and receive explanations on a segment that was difficult to understand. One of the participants reported improved understanding through the combination of using the program and having these subsequent conversations with the therapist. One participant did not require much follow-up due to significant progress alone. That participant did, however, remark that it was reassuring to be able to schedule an occasional check-in with the therapist and be reminded to work on the program further. Some participants commented that it was useful to be assigned specific tasks and to be actively encouraged by their therapist. One remarked: “She got strict with me and said I had to use ten minutes each day to work on the program, then I just had to grab myself by the neck and do it” (Participant 10).3.43.4.1Three of the participants expressed that they were not particularly motivated by the introduction provided by their therapists. One of the reasons mentioned for the lack of motivation was that the therapist did not have enough knowledge about the program. Those who felt that follow-up from the therapist had been sufficient remarked that the therapist had managed to motivate them and positively impact their success. All 10 participants expressed that the follow-up and guidance (or lack thereof) provided by their therapists affected their efforts as well as their perceptions of the program's usefulness.Assisted Self-Help’ resource.Nine out of 10 participants stated that they would continue to use the program even after they had completed it. One participant expressed a wish to complete the entire program one more time, while another only wanted to review certain sections and use the techniques learned. Participants viewed access to the program for a whole year and access to the other programs in the online resource as positive. Several participants expressed that they wanted to use the other programs within the ‘3.4.2The participants' use of the program varied in both the number of hours spent per week and the minutes spent in each sitting. Six of the participants could not estimate how many times per week they used the program, as it varied greatly. Four of the participants stated that they used the program approximately one or two times per week. The estimated time spent using the program in a single sitting varied from 10 min to 3 h. One of the participants commented, “I have actually used it whenever I have felt for it myself” (Participant 1).Six of the participants used the program in accordance with an agreement with their therapists. Two participants had used it over a longer period of time than agreed upon due to a lack of time or opportunity to sit down undisturbed. Among the two remaining participants, a lack of follow-up and reduced motivation were given as reasons for their level of use; these participants were among those who were not satisfied with their follow-ups.Participants were asked if they had any preferences for how the program should be used to achieve the best results from this kind of treatment. One participant stated that one had to be undisturbed when using the program, as it was quite energy intensive. Another participant commented that the most important thing was getting started with the program. It was recommended as part of a regular routine but not excessively during one sitting . One participant suggested, “it is important to spend some time to reflect on what you have read, before moving on to the next segment of the program” (Participant 6). The same participant suggested that it was a good idea to log in once a week and complete tasks. Another participant stated that it was not sufficient to read only the content of the program, as self-effort and exercises were crucial for the program to be perceived as useful. It was also recommended that participants take notes as they read and completed segments of the program.3.53.5.1Eight of the 10 participants expressed positive reactions to this type of treatment. Two participants who were initially sceptical became substantially motivated after using the program for the first time. One of them expressed, “I did not have much confidence in doing this myself” (Participant 6). However, three out of ten participants expressed more faith in face-to-face consultations.One of the participants who was dissatisfied with the introduction to the program that was received was initially positive about trying the program, but lost interest upon feeling that the program's approach was not suitable for their own treatment needs. The participant felt that the therapist pushed the program upon them to avoid face-to-face consultations. This participant stated feeling deprived of much-needed in-person treatment.Nine of the 10 participants were generally satisfied with the program. One participant expressed, “I think it is a very nice and straightforward program that contains a lot of useful information. So, I am very impressed” (Participant 2). This participant was originally unmotivated but became very engaged during the first experience, sitting for an hour and a half. Another participant expressed hope that this program would remain available and that as many people as possible would get the opportunity to use it. The same participant expressed, “I have had my anxiety disorder for many years without knowing what it actually is. If I only had known what I know now” (Participant 9).3.5.2Commonly reported advantages among participants were low price, ability to engage peacefully, ability to read and answer questions, less effort required than travelling to a consultation, and ability to control the pace of engagement.Assisted Self-Help’ stress treatment program was more helpful than the anxiety program. Other reported disadvantages of the anxiety program were the loss of face-to-face consultations and a lack of therapist control and direction over participant engagement with the program.One dissatisfied participant thought the program was demanding, specifically with respect to the forms that had to be completed. This participant thought that the ‘3.63.6.1Eight of the 10 participants responded that the program contributed to increased insight into their anxiety disorder. Five participants commented that it was especially useful to receive explanations about the disorder's impact on their minds and bodies. One commented, “Whenever I had anxiety symptoms, I was very scared. But when I started reading, I started to understand a little bit. Yes, anxiety is normal, anxiety is not dangerous” (Participant 7). Another participant responded that the program contributed to better self-insight by instructing how to familiarize oneself with one's own mental health situation in a systematic way . For example, the participant said, “Now I am more aware of self-securing strategies to avoid getting anxiety symptoms, such as getting enough sleep before going to work” (Participant 8).3.6.2All 10 participants expressed that the follow-up and guidance (or lack thereof) provided by their therapists affected their perceptions of the program's usefulness. Seven of the 10 participants thought that using the program had contributed to an increased ability to cope with their anxiety disorder. One commented, “I feel things have gone much better in the last few weeks after I started with it, absolutely” (Participant 2). All seven participants used the exposure therapy techniques they had learned through the program. Two of them felt that their ability to manage and cope with their symptoms had increased, although they were not 100% improved. One of the two noted less restlessness than before, while the other noted no longer having panic attacks. Both participants reported that the increase in knowledge afforded more control over and more confidence about their anxiety disorder. One of the participants commented that a change in mindset contributed to increased mastery. Nevertheless, another participant commented that it is important to continue working to maintain that control: “When I started with this … after 4–5 weeks, the anxiety disappeared for the first time in my life, and I thought now I'm fine. But then the panic attack came back again after 3 weeks, so it is important to keep it up” (Participant 9).Among the three participants who did not think that the program contributed to increased mastery, one noted having prior knowledge and perhaps had not completed enough of the program to experience an effect. Another did not feel suited to the program, stating that exposure treatment was superior to reading. The remaining participants thought that if additional guidance  had been received, it could have contributed to a better coping experience.4Assisted Self-Help’) for treating anxiety disorders using the updated D&M model for measuring IS success or effectiveness . The intention of such guidelines is to define how to make web content more accessible to people with visual, auditory, physical, speech, cognitive, language, learning, and neurological disabilities. The lack of agreement of study results indicates that it may be useful to conduct a usability evaluation of the ‘Assisted Self-Help’ program and its different platforms with end users in a usability laboratory. Design, layout, structure, usability, and interactivity have been considered by ICBT users as essential elements for maintaining engagement throughout the course  and its links with actual system use (behaviour) have been difficult to measure . ConsequAssisted Self-Help’ program and the completion time varied among the participants. In contrast to findings by Evidence has shown a positive correlation between time spent on internet-delivered treatment programs and clinical effects . The timAssisted Self-Help’ resource. This may be related to their satisfaction with the program but can also be explained by the fact that the ‘Assisted Self-Help’ program only lasts about 6 weeks. For comparison, similar resources in Europe last between 10 and 20 weeks  from the therapist were important factors impacting adherence and satisfaction. This is in line with prior research . HoweverIn line with results from the critical metareview of 4.6The most common relationships that have been examined in the application of the D&M model are between system quality and information quality and net benefits . However4.7Despite growing evidence supporting guided ICBT's effects and individual predicting factors of treatment response , more reThe present study has certain limitations. For example, the sample size was limited. Fortunately, the data collected from the 10 participants reached a point where no new information was discovered—a state called data saturation . As seveIn this study, the therapist, rather than the organisation, was viewed as the service provider. An optimal view would have involved gathering more information about how guided ICBT was implemented in the particular departments of the organisation where the therapists work and what resources, information, and training the therapists received on how to use guided ICBT. For example, Trustworthiness values in the qualitative analyses, such as credibility, dependability, and transferability , were pr5Assisted Self-Help’.In line with the D&M model, the results in this study indicate that a therapist-guided ICBT program's user-friendliness and high-quality educational content are not alone sufficient for a guided ICBT program to be perceived as useful. It is necessary that proper instruction, follow-up, guidance, and support from therapists be in line with patients' individual needs. Further, a strong working alliance must be created during the first appointment and maintained throughout the treatment process. These results provide useful information for a forthcoming randomized controlled study that will evaluate the effect of the therapist-guided ICBT program ‘A cornerstone of health promotion is empowering individuals to ensure their own mental health and well-being. This requires active participation from all involved in the process, including the therapist. We propose that guidelines should be established for developing and implementing therapist-guided ICBT programs to ensure that important dimensions are considered, which is necessary for patients to perceive this type of treatment as useful.This research project was commissioned by Assistert Selvhjelp AS and conducted by the authors on behalf of the Centre for e-Health at the University of Agder. Assistert Selvhjelp AS had no role in the study design, collection, analysis or interpretation of data, writing the manuscript, or publication of this manuscript. There has been no financial relationship with Assistert Selvhjelp AS. The project was funded by the main author's own departmental funds at the Department of Health and Nursing Science, University of Agder.


To describe in detail an innovative program based on telemedicine for semi-automated prioritization of referrals from Primary Care (PC) to Rheumatology, for reproducibility purposes, and to present the results of the implementation study.The context and situation were carefully analyzed, paying attention to all processes in place, referral numbers, waiting times, and number of complementary tests prior to discharge from Rheumatology. The composition of the team, aims, users, scope, and implementation phases were defined. Eight process indicators were established and measured before and 32 months after the program implementation.The program, which includes IT circuits, algorithms based on response to specific guideline-based checklists, e-consultation, and appointments based on priority, was fully implemented in our health area after a pilot study in two PC centers. After implementation, 6185 rheumatology referrals showed an e-consultation response delay of 8.95 days, and to first face-to-face visit (after e-consultation) of 12.6 (previous delay before program implementation was 83.1 days). Resolution by e-consultation reached 20% (1195 patients did not need seeing the rheumatologist to have the problem solved), and 1369 patients (32%) were discharged after the first visit. The overall resolution rate was 44.0% (2564 discharges/5830 e-consultations). From a random sample of 100 visits, only 10% of patients needed additional complementary tests to make a diagnosis and decision by Rheumatology (20.9% decrease from previous period).A careful analysis of the situation and processes, with implementation of simple IT circuits, allows for the improvement of the efficiency and resolution of problems in Rheumatology.The online version contains supplementary material available at 10.1186/s12913-021-07455-4. Early and proper diagnosis is essential in inflammatory rheumatic diseases.Given the shortage of rheumatologists, this may require innovative healthcare models.A model based on IT circuits, checklists, e-consultation, and appointments based on priority, helped improve process indicators significantly.Rheumatic and musculoskeletal diseases (RMDs) are highly prevalent; up to 28.9% of the population would consult their doctor for one such condition in any given year . RMDs poDespite their frequency, RMDs are often not properly addressed, unless seen by rheumatologists . HoweverThe 'traditional' model of referral from Primary Care (PC) to specialized care works on a first-come, first-served basis . ReferraIn the Vigo Health Area (North West of Spain), we have implemented one such innovative pathway to improve the referral process of patients with RMDs by applying information technology (IT) tools and telemedicine to improve communication between the PCPs and the Rheumatology team. The main aims of this telehealth program are the prioritization of referrals in a sensible way, the optimization of time to Rheumatology consultation, and the improvement of clinical problem resolution. In this article, we describe the program in detail and present the results of the implementation study so that it can be replicated and adapted elsewhere.The core elements to support the implementation of an innovative health program are the context or environment, the analysis of the situation, the implementation team, the definition of aims, users and scope, program phases, and evaluation , 16.The geographical location of the program is the Vigo Health Area in North West Spain, in which the central referral hospital is the University Hospital of Vigo. In 2012, the area population was 427,504 , of whom 74,131 were under 15 years of age, 282,655 were in the15 to 64-year range, and 70,719 were 65 years old or older. Life expectancy of this population was 83.7 years . GaliciaPrior to the implementation of the program in 2013, the healthcare organization model of the Vigo Health Area was based on specific services provided by different specialists who had hardly any previous communication or coordination with PC. The reasons for referral to Rheumatology varied enormously, from the need of a bone densitometry to be requested by the specialist to a suspicion of complicated lupus. Before the implementation of the program, no specific referral protocols were applied. The previous communication model between primary and specialized care and in between specialists, was a printed or electronic referral form that placed the patient on the waiting list without the specialists having had access to their clinical record beforehand. The full process, integrated in the electronic health record system in Galicia (IANUS), is depicted in Fig. Over a 9-month period (September 2012 to May 2013), before the implementation of the program, the number of referrals from PC to Rheumatology was 3115, an average of 388.2 patients/month. In the same period, the average waiting time for that first visit was 83.1 days, with a minimum value of 0 and a maximum value of 469 days. The percentage of patients who were discharged from Rheumatology after the first visit was 30%.The implementation team members were designated by the medical director and Rheumatology. The team was made up of rheumatologists and PCPs, along with computer and innovation experts  to improve the screening of patients with RMDs to establish cases who may need priority care, and 2) to make communication between Rheumatology and PCPs more fluent.The system was conceived to be used by PCPs and rheumatologists from the health area. All referrals - which were paper-based in the past - were turned into electronic referrals on the rheumatologists’ patient agendas. The transition from paper-based to electronic was carried out progressively and regular checks were performed before this was further advanced.The target population of the program was that of the Vigo Health Area  with suspected RMDs. Extrapolating from nationwide epidemiological estimates, this would be a total population of over 94,000 , 19 . HoThe program is based on clear processes incorporated in the IT systems, well defined prioritization criteria and times, indicators, and reports.Each aspect of the program - circuits, referral criteria, diagnostic tests to be carried out before the assessment by the rheumatologist, critical indicators, and the evaluation (July to September 2013) - was designed by consensus following a thorough analysis of the situation, areas to be improved and potential solutions.In order to achieve seamless communication between healthcare levels, regular meetings were held at each of the PC centers with representatives of PC, Rheumatology and medical directors, to present the program and to introduce any changes or improvements suggested by PC.In the next 3 months, the healthcare integration circuit between PC and Rheumatology was designed on and implemented with IT tools. A 3-month pilot program was carried out in two PC centers, covering a population of 80,586 people (October to December 2013).The pilot program allowed for the finetuning of the IT circuit. During this phase, all PCPs in the area were given proper training. This included the standardization of procedures, the establishment of dynamic agendas, and guidelines on how to proceed in the e-consultation with specialists.In January 2014, the program was implemented in the entire health area and all PCPs were informed that no other referral systems would be accepted other than those cases demanding urgent attention. These should be referred directly to the emergency department.Once the program had been implemented in all the health centers of the area, data were analyzed including all referrals from PC to Rheumatology from October 2014 to June 2017.The objectives and indicators established to measure and control the implementation of the program are presented in Table This study did not require Ethics Committee approval.Figure In summary, any suspected RMD is recorded by the PCP onto the IT system (IANUS) and, following the pre-agreed criteria, priority of referral is established and the specific tests requested Fig. .Fig. 3ReThe e-consultation request submitted by the PCP with a priority tag specifying the waiting time for an e-consultation (less or over 5 days) is received by Rheumatology. In the e-consultation, a rheumatologist analyzes the information provided together with the diagnostic tests and either advises the PCP on the way to proceed by means of an e-report, or sets a face-to-face appointment for the patient . Then, an assistant contacts patients to provide details about the date of appointment and possible further tests to be done before the face-to-face consultation. Some patients, i.e., those referred to bone densitometry are managed directly through the IT system via a specific circuit including a fracture risk score calculation inserted in the intranet. These patients are not seen face-to-face in Rheumatology unless the results of the densitometry are unfavorable, and osteoporosis is severe or secondary, in which case, an appointment is set by an assistant.All PCPs of the area (100%) channeled referrals to Rheumatology through the proposed program (Electronic History and Electronic Request Manager).In the 32 month-period of evaluation, a total of 6185 referrals (e-consultations) were sent from PC to Rheumatology. Table The delay in response was 8.95 days, which means a reduction in the delay of the first consultation of 74.1 days (89.2%) with respect to the period analyzed prior to implementation in 2012. The delay until the first face-to-face visit was 12.6 days .The average percentage of e-consultations resolution reached 20.5% , while the average number of patients who did not need a second consultation after a first face-to-face visit was 32.3% (1369 patients). The overall resolution capacity between the two consultations was 44.0% .In relation to the requests for diagnostic tests , the number of first visits to Rheumatology for which tests had not been carried out was analyzed in two randomly selected months, one prior to the implementation of the e-consultation process (April 2013) and the other after its implementation (April 2016). They totaled 608 in 2013 and 481 in 2016 (20.8 % reduction). After implementation, almost 90% of the patients had complementary tests performed from PC before their face-to-face specialist assessment. As a result, the request for complementary tests by the Rheumatology service before and after the implementation of the program decreased by 20.9% .Before the program, patients referred from PC to Rheumatology had to wait for a long time before their first face-to-face visit. In the case of minor clinical problems, these could have been solved immediately, without requiring a visit to the hospital. After the implementation of this e-consultation program, waiting times were significantly reduced, while assuring prioritization of inflammatory diseases, and improving communication between health care levels. Furthermore, the overall optimization of the waiting list had a positive effect on referrals from other specialties as well as reductions in waiting times due to wider availability of consultation slots.In general, most studies of health services in Rheumatology show a significant consultation delay of patients with inflammatory diseases –26. EvenThe situation in our area prior to the implementation of the integrated e-consultation program, was no outsider to such inefficient context. This could be defined by the following characteristics: 1) all referrals to Rheumatology were made for face-to-face visits; 2) absence of a prioritization scheme ; and 3) many first visits to Rheumatology required additional consultation. Many of the patients referred to Rheumatology could have easily avoided the visit, many others requiring specialist attention had to wait too long for a visit.The success of the implementation of the program was based on two fundamental aspects: the involvement and consensus of all stakeholders and the establishment of the electronic referral as the only way to access Rheumatology. All the information on the e-forms, including referral criteria and tests to be performed, as well as the circuits to be followed, had been agreed upon by the rheumatologists and PCPs in the area. The program was presented at each PC center by a representative of both the board of directors and Rheumatology. Also, the involvement of the IT Department since the beginning of the project made its implementation in the intranet accessible to all . PatientA significant proportion of the attention to chronic diseases , would not require patients’ attendance by medical specialties and could be managed by PC if there was a channel of agile and immediate communication between this and the specialists. Even before the COVID-19 pandemic, it was obvious that many situations could be managed by Rheumatology without a face-to-face visit . This haThis type of consultation has a positive impact on both levels of care since mutual interaction, trust and learning between PCPs and rheumatologists are greatly enhanced.It is necessary to prioritize patients’ attention based on adequate and reliable clinical information provided by the PCP to offer individualized care according to the particular situation and demand of each patient. This prioritization can be established by rheumatologists in a triage stage, through protocols previously agreed upon with the PCPs , 35, 36.Such a strategy should always be implemented in close coordination with the PCPs, this being the reason why they have been involved in every stage of the process.One of the most outstanding aspects of our study is the reduction in waiting times for a first face-to-face visit. Before the implementation of our strategy, the average waiting time was 83.1 days, with virtually all patients within 2-3 months. Only very occasional cases had waiting times longer than one year . Once our project was launched, the average waiting time for a first face-to-face visit was reduced by approximately 85%. A key aspect of any waiting time management strategy is the coordination between administration and triage of referrals. Much work has been done to define the best referral system. Single-entry models have been used successfully in some service industries, where users 'gather' at a single-entry point to access the first service available. These could represent a useful approach to reducing waiting times for health services when, for example, waiting times between consultants are variable, as patients who wait longer can be scheduled for the next available slot , 38. AltOther aspects of the evaluation of implementation are still missing. Although our perception was that both provider and patient satisfaction were really high, we have not assessed the experience of patients and providers with this process, or safety outcomes. Unfortunately, as we had no prior indicators for these aspects before the program implementation, a comparison was not possible. On the other hand, we did not have excessive problems from the PCPs when implementing our project, likely due to the previous explanation of its characteristics and the degree of consensus reached. The greatest reluctance came from the rheumatologists, in relation to the change in working procedures. This initial resistance was overcome when they began to perceive the advantages that the strategy entailed both for the patient and for the services involved in it.From a cost-effectiveness point of view, and after the 12-month part-time period allocated by a rheumatologist to its development and implementation, the program has not involved any additional financial costs to the Public Health System. Even when we did not perform a formal economic evaluation, using the technical resources already existing in the system, not requiring the hiring of personnel and avoiding the displacement of the patient, is inescapably associated with saving money.Despite its encouraging results, our work may have some limitations. The fact that it has focused only on the Vigo Health Area may limit the extrapolation of the results. In turn, our program could be considered for implementation by other health areas. Another possible limitation is the certain degree of digitalization required, which in some places can be a problem.In summary, innovative circuits and e-consultation tools widely agreed upon by users achieved a more efficient referral from PC to Rheumatology in the Vigo Health Area. Patients requiring priority consultation are now assessed in the shortest time possible. All other patients wait only a little longer in favor of the first. In addition, the communication between PCPs and rheumatologists was strengthened and facilitated, providing the former with greater resolution capacity.Additional file 1.


There are few studies on the impact of cardiac rehabilitation (CR) in the Eastern Mediterranean Region (EMR), where the burden of risk factors and context is somewhat different from Western countries where much of the evidence is derived.To evaluate patient engagement in, and outcomes associated with, participation in Qatar’s first and only CR program, from inception.This was a retrospective, observational study of patients referred to Heart Hospital’s CR program from January 2013-September, 2018. The program offered 3 sessions/week over 6–12 weeks, depending on patient risk. An initial assessment was performed, and outcomes  were re-assessed post-program in those who did not drop-out. Session attendance was recorded.2 pre and 28.2 ± 5.4 post; p < 0.001), waist circumference , low-density lipoprotein , total cholesterol , systolic blood pressure , hemoglobin A1c  and depressive symptoms . Improvements on 7 of the 8 quality of life domains were also observed .682 patients enrolled; they attended 77.6% of prescribed sessions; 554 (81.2%) completed the program and post-assessment. Improvements in functional capacity were statistically and clinically meaningful . There were significant improvements in body mass index  as well as functional capacity and health-related quality of life improvements, which likely translate to reduced morbidity and mortality. Cardiovascular diseases (CVD) in the Eastern Mediterranean Region (EMR) are the leading cause of disability, accounting for 9.2% of total disability-adjusted life years. The burden of risk factors is also very high in those with CVD in the EMR, yet there is poor control. This puts patients at increased risk of recurrent events.Cardiovascular rehabilitation (CR) is an established model of outpatient care to mitigate this burden. Network meta-analyses of randomized trials, all of them primarily from Western settings, demonstrate that CR participation results in significantly lower mortality and morbidity. However, despite the fact that CR exists in 12 of the 22 EMR countries 245. This 4In 2013, Qatar opened a first CR program; it remains the sole program in the country. The purpose of the current study was to evaluate patient: (1) engagement in the program , and (2) change in outcomes ) from pre- to post-program among those participating in this new program for the first time.This is an observational retrospective cohort study, analyzing patients’ records obtained from the CR program at the Heart Hospital in Qatar. A waiver of patient consent was received .Details about the institutional setting and CR program are shown in the Supplemental file.The study sample included all patients who enrolled in the sole Qatar CR program, from program inception (January 2013) to September 2018. Patients were ≥18 years. There were no exclusion criteria for the study.2], and self-reported tobacco use), as well as psychosocial well-being .For objective 1, adherence was defined as proportion of prescribed sessions attended. Completion was defined as undertaking the post-program assessments. Outcomes were: functional capacity , risk factors , high-density lipoprotein (HDL)], body mass index [BMI; kg/mData were analyzed using STATA v16. A paired-sample t-test was performed to assess change from pre- to post-program in the continuous outcome measures, and chi-square test for categorical measures .During the period of study, 682 patients enrolled in the program; their characteristics are shown in Supplemental Table 1. Participants attended a mean of 20.4 ±12.3 sessions (median = 22.0), or 77.6% of prescribed sessions and 554 (81.2%) patients completed the program and post-program assessment. As also shown in the Table, there was some retention bias.As shown in Table This is the first study to test the effects of CR in Qatar; as anticipated the patients who accessed CR were very engaged in the program, and realized significant improvements in outcomes; the implications of these findings are shown in the Supplemental Appendix. Although rates of adherence and completion vary and are not well-established, these rates do seem much higher than what is observed in Western settings  , but areFunctional capacity improved by 19.3%, or approximately 2 METs, which is greater than the .5–1 MET threshold to indicate a “quality” program and which is associated with mortality reductions . With reCaution is warranted when interpreting these results. First, with regard to generalizability, data come from a single centre, and therefore generalizability to other programs in the EMR is unknown; certainly, these results are consistent with the benefits observed with CR in Iran 345. Gene34https://globalcardiacrehab.com/ICRR-Governance).In conclusion, the new Qatari CR program is very engaging to patients, and results in clinically significant risk factor reduction, as well as functional capacity and psychosocial well-being improvements, which likely translate to reduced morbidity and mortality. Some areas to potentially improve program processes and quality were identified, which will likely be implemented through the program expansion and piloting of the International Cardiac Rehab Registry (ICRR; The additional file for this article can be found as follows:10.5334/gh.862.s1Online supplementary file.This includes: Supplemental Table 1; CR setting description; and Measures description.


The 2011 magnitude (M) 9.0 Tohoku-oki earthquake was followed by seismicity activation in inland areas throughout Japan. An outstanding case is the M6.2 Northern Nagano earthquake, central Japan, occurred 13-h after the megathrust event, approximately 400 km away from its epicenter. The physical processes relating the occurrence of megathrust earthquakes and subsequent activation of relatively large inland earthquakes are not well understood. Here we use waveform data of a dense local seismic network to reveal with an unprecedented resolution the complex mechanisms leading to the occurrence of the M6.2 earthquake. We show that previously undetected small earthquakes initiated along the Nagano earthquake source fault at relatively short times after the Tohoku-oki megathrust earthquake, and the local seismicity continued intermittently until the occurrence of the M6.2 event, being likely ‘modulated’ by the arrival of surface waves from large, remote aftershocks off-shore Tohoku. About 1-h before the Nagano earthquake, there was an acceleration of micro-seismicity migrating towards its hypocenter. Migration speeds indicate potential localized slow-slip, culminating with the occurrence of the large inland earthquake, with fluids playing a seismicity-activation role at a regional scale. In addition, the accompanying aftershock activity along the plate interface may cause further damage, in particular because such aftershocks could have rather large magnitudes.Huge megathrust earthquakes can cause widespread destruction either because of their violent shaking, or due to their associated natural disasters, like tsunami or induced landslides. Thus, the occurrence of the magnitude (M) 9.0 Tohoku-oki earthquake in 2011 reportedly2. Such activity has been induced either by static stress changes , dynamic stress changes , local excitation of fluids  or a combination of those . One of the most remarkable activations of seismicity5 took place in northern Nagano Prefecture, central Japan, where a M6.2 crustal earthquake occurred at shallow depth, 13 h after the megathrust event. No seismicity has been detected in the Nagano epicentral area by the Japan Meteorological Agency (JMA) in the 13 h interval; therefore, a causal link between the megathrust event and the occurrence of the relatively large inland earthquake in Nagano region has not been found out.Moreover, the 2011 Tohoku-oki earthquake caused widespread activation of seismicity throughout Japanese IslandsHere we take advantage of the data from a very dense local seismic network , around the northern Nagano region, using over 1000 events listed in the existing earthquake catalog as template events. In the current research, however, the matched-filtered event detection has been applied to waveform data of a dense local seismic network (Methods section) leading to the detection of 285 micro-earthquakes in the first area. The current earthquake dataset is characterized by a high event completeness . Since the local dynamic stresses associated with the passage of Tohoku-oki surface waves were relatively large, 300–400 kPa (0.3–0.4 MPa) (Table 5 (~ 0.02 MPa), thus making them an unlikely mechanism for the activation of seismicity in northern Nagano.One of the important questions is how and why the seismicity activation in northern Nagano has started. The earliest events of the recorded sequence Fig.  occurredlay Fig.  could bea) Table , we infe3, except for several restricted clusters where the relative seismicity increase has been linked to pore fluid pressure changes10 and migration of fluids11.Following the Tohoku-oki earthquake, northeast Japan experienced negative Coulomb static stress changes, which had as a result an overall decrease of seismic activity2/s. Generally, estimated D values for crustal fluids are on the order of 0.01–10 m2/s . However significantly larger values are also reported in the literature, for example in the case of the Umbria-Marche seismic sequence . Note that up-down migration of seismicity as shown in the two sub-clusters has been also documented during shallow earthquake swarms at Yellowstone volcano and interpreted in terms of fluid movement16. A detailed tomography study in the area7 revealed a relatively large velocity ratio of compressional and shearing waves (vp/vs) at shallow depths, which is an indicator for the presence of fluids . The seismicity within the eastern cluster . The eastern fault zone is likely located in the hanging-wall of the fault plane on which the M6.2 earthquake occurred. Each point from where diffusion starts . Since the seismicity migration is observed very close to the M6.2 earthquake, it is reasonable to relate it with possible aseismic slip along the fault. On the other hand, diffusivities of D = 25–60 m2/s are consistent with the observed migration speeds (see the discussion for the eastern cluster). Since a high vp/vs ratio is observed in southwestern part of this cluster . As a result, we have detected five and ten aftershocks that may have potentially caused additional activation in the western and eastern clusters, respectively. Then, by performing Monte Carlo simulations, we have evaluated that the local activity in the northern Nagano region has been significantly increased following five of these remote Tohoku-oki aftershocks.While we infer that dynamic stress changes due to the Tohoku-oki mainshock were likely responsible for the onset of local seismicity in northern Nagano, many large aftershocks occurred after the M9.0 Tohoku-oki megathrust event, raising the question of whether dynamic stress changes caused by large remote aftershocks modulated local seismicity. We therefore searched for Tohoku-oki aftershocks of MIn both western and eastern clusters, the first local events occurred during the passage of the surface waves from some larger aftershocks Figure . The fir22). Hence, despite the lack of observations of instantaneous triggering by the Tohoku-oki mainshock, some of its moderate or large aftershocks might have contributed to the activation of seismicity in both the eastern and western clusters. There are two triggering scenarios that may explain the onset and evolution of seismicity due to dynamic stress changes from events of-shore Tohoku.By using waveform data recorded at the NZWH Hi-net station, we estimated the maximum dynamic stresses for seven Tohoku-oki aftershocks that increased the local seismicity significantly or were followed by remarkable activity Table . These v23, fracture impermeable media25, or excite fluids during the dilatational phase of surface waves26, leading to seismicity activation. Fluid flow might have been encouraged by repeated shaking due to the passage of surface waves from the M9 event and its subsequent aftershocks. Even though the probability of initiating fluid flow per one passage of surface waves might be relatively low, multiple passages in a relatively short time may rapidly increase this probability.In the first scenario, distant seismic waves dislodge sedimentary particles blocking flow paths27 in Nagano, likely through partial damage of frictional contacts28. Changes of the rate-and-state29 variables by dynamic stress changes on a fault which is close to failure may have caused considerable aseismic slip acceleration30, which in turn triggered micro-seismicity.In the second scenario, transient seismic wavetrains from the events off-shore Tohoku renewed the frictional state of faults31. Thus, the seismicity in the western cluster might be the byproduct of aseismic slip induced by fluid flow from the area located southwest from the M6.2 fault and accelerated by additional damage of frictional contacts caused by the dynamic stress changes from the Tohoku-oki aftershocks. On the other hand, the third intense activation in the vicinity of the M6.2 hypocenter might be also interpreted as cascade triggering through stress transfer between small foreshocks located close to each other . The culmination of these aseismic processes and/or cascade triggering, within the western cluster, resulted in the triggering of the M6.2 Northern Nagano earthquake.Note that the fluid flow scenario may involve aseismic slip. Indeed, as recent research suggests, fluid intrusion into a fault with heterogeneous frictional properties may induce aseismic slip and secondary seismicityWe have clarified the seismicity patterns before the occurrence of the M6.2 Northern Nagano earthquake and proposed detailed scenarios to explain the nucleation of the large inland earthquake, as well its relationship with the Tohoku-oki megathrust event.Our results indicate that the seismicity in the vicinity of the M6.2 Nagano earthquake was likely activated dynamically by the surface waves of both the Tohoku-oki earthquake and its largest aftershocks. Although the dynamic stresses induced by each of the remote aftershocks were relatively small, their repeated shaking modulated the local seismicity activation in northern Nagano, either by facilitating fluid flow, changing the faults’ frictional parameters, or a combination of these factors. Repeated migrations of micro-seismicity in the vicinity of the mainshock hypocenter indicate localized slow-slip, with fluids playing a facilitating role. The final acceleration of seismicity (foreshock activity) that has started about one hour before the Northern Nagano earthquake migrated towards the mainshock hypocenter leading to the occurrence of the large inland earthquake.Our findings suggest that the detailed monitoring and modeling of seismicity may provide important clues for the forecasting of large inland earthquakes. The detailed investigation of different geophysical processes, like migration of micro-seismicity, swarm-like seismic activity, remote triggering, localized slow-slip and the presence of crustal fluids may lead to successful short-term forecasting of large inland earthquakes. Moreover, understanding the occurrence mechanism of large triggered earthquakes may help estimate the seismic hazard after huge megathrust events.34. Using WIN system’s picking program, we first detect some events to use as first templates for event detection by MFT. Then we obtained 43 first template events at the vicinity of 0286 and 2289 stations (see next paragraph).We picked the P- and S-wave arrivals of earthquakes on continuous seismograms recorded at the local network seismic stations as well as the NIED seismic station (NZWH) in the region Fig. a, and lo35. The waveforms of all newly identified events were visually checked to minimize the possibility of spurious detection. The events thus detected were relocated by using P- and S-wave arrivals manually picked on seismograms recorded by at least three nearby seismic stations and were then used as new templates. We also applied MFT to the continuous waveform data recorded from 4 h before the Tohoku-oki earthquake until its occurrence, and confirmed that no event was detected in the Nagano region.The located events were used as the first MFT templates in the study region Fig. a, to red36 and the 3D-velocity model in the Northern Nagano region7. We end up with a catalogue of 285 events  for the 13-h time period following the Tohoku-oki mainshock.The earthquakes detected by the above procedure were relocated using the tomoDD softwared were estimated as Gu’/vph (Jaeger and Cook37), where G is the shear modulus (30 GPa), vph is the phase velocity (considered here as 3.5 km/s for Rayleigh waves and 4.1 km/s for Love waves38), and u’ is the peak particle velocity, determined directly from seismograms.Dynamic stresses, σThe magnitudes of all the earthquakes detected in this study are body-wave magnitudes, determined from the maximum amplitudes of vertical-component seismograms recorded by the dense local seismic network and the NZWH (NIED) station; these magnitudes are in general consistent with the JMA magnitude scale. The magnitude (M6.2) of the Northern Nagano mainshock is a moment-magnitude (Mw), obtained by moment tensor analysis of the F-net (NIED) broadband seismograph network data. All the other event magnitudes are those reported in the JMA earthquake catalog.Supplementary Information


Despite comprehensive guidelines for healthy gestational weight gain (GWG) and evidence for the efficacy of dietary counseling coupled with weight monitoring on reducing excessive GWG, reporting on the effectiveness of interventions translated into routine antenatal care is limited.This study aims to implement and evaluate the Living Well during Pregnancy (LWdP) program in a large Australian antenatal care setting. Specifically, the LWdP program will be incorporated into usual care and delivered to a population of pregnant women at risk of excessive GWG through a dietitian-delivered telephone coaching service.2 and gaining weight above recommendations at <20 weeks’ gestation who are referred for dietetic care during the 12-month study period will be eligible for participation. The setting is a metropolitan hospital at which approximately 6% of the national births in Australia take place each year. Eligible participants will receive up to 10 telecoaching calls during their pregnancy. Primary outcomes will be service level indicators of reach, adoption, and implementation that will be compared with a retrospective control group, and secondary effectiveness outcomes will be participant-reported anthropometric and behavioral outcomes; all outcomes will be assessed pre- and postprogram completion. Additional secondary outcomes relate to the costs associated with program implementation and pregnancy outcomes gathered through routine clinical service data.Metrics from the RE-AIM  framework will guide the evaluation in this hybrid effectiveness-implementation study. All women aged ≥16 years without pre-exiting diabetes with a prepregnancy BMI >25 kg/mData collection of all variables was completed in December 2020, with results expected to be published by the end of 2021.This study will evaluate the implementation of an evidence-based intervention into routine health service delivery and will provide the practice-based evidence needed to inform decisions about its incorporation into routine antenatal care.DERR1-10.2196/27196 Excessive gestational weight gain (GWG) is a problem within the Australian obstetric population, occurring in 40% to 60% of pregnancies, particularly in the 50% of women already above a healthy weight prior to pregnancy . This weIn Australia, comprehensive guidelines for healthy GWG from the Institute of Medicine (IOM ) have beIn addition, poor uptake of the typical clinical (face-to-face) model of dietetic counseling is seen in both research trials ,10 and rTelephone counseling has been demonstrated as an effective and cost-effective solution for delivering positive weight management outcomes in a wide range of adult populations -19. IndiThe LWdP program will use a type 2 effectiveness-implementation hybrid design  to compa2 who are referred for dietetic weight management care during the study period will be eligible for participation. For the purpose of this evaluation, participants must be able to speak and read English sufficiently to allow program participation. Those women who do not meet these criteria will be provided with appropriate face-to-face dietetic care and not participate in this evaluation. Women will be referred into the program by their treating health care provider if they meet these criteria. Alternatively, women meeting these criteria will be able to self-refer into the program through a dedicated program website. Women who are engaged in the program who develop gestational diabetes will be provided the option to remain in the program or withdraw to the hospital’s gestational diabetes model of care.All women aged ≥16 years without pre-exiting diabetes with a prepregnancy BMI >25 kg/mStaff will be engaged in the planning phase of LWdP program implementation to identify preferred referral processes for each of the hospital’s 8 different antenatal models of care. This will inform the introduction of an outpatient dietetic referral form for the LWdP program alongside other dietetic services at the facility and the inclusion of the LWdP program referral in paperwork completed during women’s initial booking-in appointment. A program website will be developed to facilitate an online referral pathway, allowing both self-referral and referral by external antenatal health care providers located in the community of women under their care. A consumer engagement survey will be undertaken to inform the flexible program delivery hours, education needs, and topics of interest. Staff from each antenatal model of care will be provided with regular in-services, and the hospital’s media and communications team will be engaged to help build publicity for the program by featuring consumer stories in local newsletters, social media accounts, and local general practitioner communications.A waiver of participant consent was received as part of the ethics application to retrospectively access routinely collected clinical and administrative data from eligible women in the preimplementation group. For the postimplementation group, all women booked for an initial appointment in the LWdP program will be provided with an electronic link to the participant information sheet and electronic consent form with their participant workbook.At the commencement of the program, the dietitian counsellor will discuss the evaluation process and answer any questions the participant may have. Program participants who consent to the evaluation will be requested to complete the consent form online in addition to having verbal consent recorded in their health record.At the completion of the program, participants who verbally agreed to be involved in the evaluation but did not complete the consent form will be reminded to complete this online and a replacement link will be sent if required. Verbal consent will be documented on this second occasion. If no written consent form is received by the time of data analysis but two occasions of verbal consent are documented in the participant’s health record, consent to participate in the evaluation will be considered granted.The LWdP program is aimed at supporting women at high risk of excessive weight gain during pregnancy to achieve GWG within recommendations  through Women referred to the program will be eligible for up to 10 telephone coaching calls over the course of their pregnancy that will usually span a period of 6 months  and will also receive a participant workbook . The iniIntroduction to the Living Well during Pregnancy programCoach introduction, scheduling, and discussion of the importance of healthy weight gain in pregnancySection 1: Planning for successParticipant aimsSMART  goal setting and action planProblem solvingTracking tools for eating behaviors, physical activity, weight gain, and meal planningSection 2: What to eat and how muchBenefits of healthy eating and recommendations in pregnancyImportant nutrients (including supplementation)Portion guideSelf-monitoringSection 3: Fat, fiber, and food safetyIncreasing intake of fruits, vegetables, and whole grainsReducing saturated fat intakeFood safetySection 4: Keeping activeSafe exercise during pregnancyPlanning activityPelvic floor exercisesReducing sitting timeSection 5: Healthy pregnancy weight gain and energy balanceEnergy density and food substitutionsStrategies to slow rapid weight gainHealthy snackingSection 6: Meal planning and preparationCreating healthy mealsGrocery shopping planningPlating portion guideStrategies for healthy eating away from homeSection 7: Mindful eatingBreaking the dieting cycleHunger cuesMindful eatingOvereating triggersFood and emotionsSection 8: Celebrating success and planning aheadPlanning aheadPotential obstaclesCelebrating successGetting support from othersHealthy eating during breastfeedingAccredited Practising Dietitians with experience in providing antenatal care services who have undergone additional training in motivational interviewing will be trained in the delivery of the program. A training manual detailing the program protocol including call transcripts will be provided to all dietitians delivering the program. This additional training includes program philosophy, person-centered care, work shadowing, and the delivery of each call with provision of feedback from the trainer and a checklist of training requirements prior to commencing program delivery. At the completion of each call, the dietitian coach will be required to complete a fidelity checklist to assess the degree to which the call aligned with the protocol.The program is structured to offer flexibility in the scheduling of call times outside of usual business hours, with early morning and evening times available. Additionally, a caseload continuity of care model will be offered where each participant is allocated one dietitian coach for their pregnancy. Upon booking the first coaching session, each participant will be provided with a welcome letter with information about her coach to assist with establishing rapport.The participant workbook will be used to structure the order of intervention topics for each telecoaching session . ParticiIn the telephone-delivered program, the calls are structured into three phases , with weThe retrospective group was provided with traditional, unstructured face-to-face dietetic care. Women were offered individual appointments with the dietitian in a dedicated clinic within the maternity outpatient department. An initial appointment was booked for 40 minutes, with review appointments allocated 20 minutes. There was no guarantee of the same dietitian at each review appointment, and review appointments were booked based on clinical judgment in negotiation with the woman. No specified educational content or strategies were provided.Data will be collected by study-trained dietitian research assistants. Research Electronic Data Capture (REDCap), a secure online survey and data capture tool, will be used to record details of each telephone counselling session including progress, clinical information, and fidelity to the call procedures and topics. Routinely collected maternal and infant data will be accessed from medical records.Outcomes are shown in Women who withdraw from the program after receiving at least one coaching call will be sent a text message with a link to a short electronic survey. This anonymous survey will evaluate satisfaction with the program and reasons for program withdrawal.The understanding and acceptability of the program by staff (including clinicians and administrative personnel) will be assessed via a survey 2 months prior to completion of the evaluation period. Both electronic and paper-based surveys will be available. Electronic links to the online survey will be disseminated to staff from line managers. Paper-based surveys will be available in staff lunchrooms with collection boxes available for return of the survey. Administrative staff will be asked about referral and booking processes, whereas clinicians will be asked about their referral practices, program understanding, and barriers to referral. Survey responses will be provided on a 5-point Likert scale.The fat and fiber behavior questionnaire (FFBQ) is a 20-item questionnaire used to assess dietary behaviors  that has been validated against a food frequency questionnaire in the adult Australian population and is able to detect changes in fiber and fat-related intake behaviors . It provThe Intuitive Eating Scale-2 is a 23-item tool that measures individuals’ tendency to follow their physical hunger and satiety cues when determining when, what, and how much to eat . ParticiThe Active Australia Survey consists of 8 questions designed to assess the frequency and duration of walking and performing moderate and vigorous physical activity in the past week . The totPregnancy weight data have been collected routinely at the study hospital since 2015. GWG will be calculated by subtracting self-reported prepregnancy weight from weight recorded at 36 weeks’ gestation . Self-reAn economic analysis from a health services perspective will be conducted following the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for modeling . The fixThe costs of different birth outcomes will be determined from the Royal Brisbane and Women’s Hospital’s unit costing based on the previous 12 months of administrative data covering all births occurring in this time frame. Costs will be stratified by BMI category and gestational diabetes status. As cost data of this nature generally have asymmetric distributions and heteroskedastic errors , an apprA cost-utility analysis will be undertaken with the primary analysis from the perspective of the health care system. This perspective is the most commonly used economic evaluation method in Australia for policy makers  and willint is the new intervention, usual represents usual care, and QALY stands for quality-adjusted life-year.where The model will include sensitivity analysis of key parameters, and outputs will include cost-effectiveness acceptability curves; these will display the probability of cost-effectiveness at varying thresholds of net monetary benefit.t tests will compare outcomes between retrospective and prospective groups. Analyses of secondary (program effectiveness) outcomes in the prospective group will be by mixed models, which will allow for repeated measures (baseline and follow-up) and include all participants with baseline data (including those with missing data at follow-up), with adjustment for predictors of dropouts to minimize selection bias. The relationship between intervention dose  and secondary behavioral and clinical outcomes will be examined. The optimal model will be selected using both indices of fit and model interpretability and parsimony. Outcomes will be reported as per protocol and intention-to-treat. Per protocol is defined as any participant who completed 4 or more telephone counseling sessions. Sensitivity of conclusions to missing data assumptions will be evaluated.Primary (program implementation) outcomes  will be reported descriptively and compared with the outcomes of a retrospective face-to-face comparison group. Where corresponding data are available for any secondary outcomes (such as GWG), results from the retrospective group will be compared with those of the prospective group. Chi-square and independent sample The LWdP program commenced in February 2018. The prestudy period for retrospective data inclusion was from October 2016 to October 2017 and includes data from 49 women. The poststudy period for data collection commenced when the program was initiated in February 2018 and the last included participant for data analysis was enrolled in August 2019. A total of 152 women consented to have their data included in the poststudy period. Data collection of all variables was finalized in December 2020. Data cleaning has commenced and data analysis will be completed by June 2021.Gaining too much weight in pregnancy is an issue in Australia and occurs more frequently with women who begin their pregnancy above a healthy weight ,6. AlthoThe LWdP telephone counseling program is aimed at supporting women at high risk of excessive weight gain during pregnancy to achieve GWG within the recommendations. Dietetic counseling will be used to promote healthy eating and physical activity, consistent with the Australian dietary guidelines, during 10 telephone coaching calls. This paper presents a pragmatic implementation and evaluation of the LWdP program to reduce excessive GWG using the RE-AIM evaluation framework to determine considerations for dissemination, scalability, and sustainability. This study will extend the current knowledge base that telephone counseling is cost-effective and results in desired behavior changes in many other adult populations ,28, addiA potential limitation of the study is that it will be delivered at a single (Queensland) institution. However, it is hoped that with 6% of the approximately 68,000 Queensland births taking place at this hospital each year and the hospital’s antenatal population being generally representative of the state’s demographics , the gen


The prevalence of obesity is disproportionately high among African Americans in the Southern US. More information is needed about factors that influence participation in nutrition and physical activity programs to promote healthy weight.The purpose of this study is to explore the weight management perceptions of young to middle aged adult African Americans.The Church Bridge Project intervention participants were recruited for two focus groups. Qualitative data were recorded, transcribed and a thematic content analysis was conducted to identify major themes.Barriers included technology learning curve/burden and competing priorities. Facilitators included support, limited cost, convenience, and health. Participants perceived the term “weight management” program as overwhelming and defeating.The Church Bridge Project model confirmed social support and disease prevention as key factors for weight management. Further work should substantiate social support as a key factor to guide minority health efforts. Obesity and chronic disease behavior management can be especially challenging in rural areas in the Deep South. Nearly half of the rural population in the United States (U.S) resides in the South , and in Community- and church-based programs have been effective in improving health outcomes and reaching minority and underserved populations. However, greater program attendance is key for better health outcomes as shown in previous church-based intervention research , 7. AddiFocus group research was selected as the methodology for this study to gain collective information and rich understanding from a population that was reached (and either participated in the program or not) to enroll in a church-based weight management program that was not captured by our quantitative outcomes . Focus gUpon arrival, focus group participants were assigned a random number to maintain confidentiality. Research staff reviewed the study consent information and obtained consent to participate after all questions were answered. The focus groups were conducted by two trained research assistants with one serving as a moderator and the second as a note-taker. A script was provided that served as a guide for the focus groups, which included study overview and procedures related to how the focus group was to be conducted and recorded. After providing informed consent, participants were informed that a digital voice recorder would record the conversation until the end of the session. Each focus group lasted approximately 1 h. The “completer” focus group included open-ended questions related to barriers and facilitators to participation in a weight management intervention and suggestions for program improvement, whereas the “non-participant” focus group included questions related to weight management program perceptions as well as barriers and facilitators to participation and the use of technology in a weight management intervention. Focus group participants were given a $25 gift certificate to a superstore at the completion of the session.Our qualitative research process was guided by the four tenets of trustworthiness: credibility, confirmability, transferability, and dependability . After tAs data were analyzed, we also considered saturation of the data and defined saturation based on theoretical saturation or the emergence of new themes in the data . Theoretn = 6 “completers” and n = 6 “nonparticipants”) participated in two focus groups. Themes were identified based on barriers and facilitators to and suggestions for improvement of the weight management program as well as diet values and weight management program perceptions. Table A total of 12 individuals (Two themes for weight management program barriers were identified by “completers”: 1) technology learning curve, and 2) competing priorities. Participants found it difficult to locate specific food items or activities in the mobile app to log their nutrition and physical activity behaviors. However, the technological barrier was viewed as something that could be overcome with time with one person stating “… but I got into how to do it and stuff, and I learned how to do it so it wasn’t too bad …” It was agreed by all participants that the main barriers to program attendance were work, family, and church obligations and holidays. These competing priorities were noted as a barrier related to physical or mental exhaustion rather than lack of time. One participant reported, “Once you get off of work, and you are kind of mentally drained.”Program support/engagement was the major theme identified by “completers” as a motivator for participation in a weight management program. “Completers” defined program support/engagement as accountability, social support from group setting, support and engagement from interventionists, and technology support. Participants’ expressed that the program provided accountability to support program compliance. When asked if they would prefer group or individualized sessions, all preferred the group session format because of the perceived social support it provided. “Completers” also expressed appreciation for the program support and engagement received from interventionists, who were predominantly undergraduate and graduate students. Last, there was a general agreement of satisfaction with having access to recorded sessions among “completers” and it was viewed as a benefit when unable to physically attend a session. Table “Completers” were asked for suggestions to improve the weight management program. The main suggestion for improvement was related to enhancing the food and physical activity tracking functions of the application. One participant stated it was the only problem, “The only thing I had a problem was the app, that was just the app thing, that, you know, that was pretty much the only …” The age criteria for participation in the program also caused confusion and potential enrollment delays. “Completers” suggested the age criteria be clarified and thought the call for “younger adults” was not for them; one person stated, “When I read the criteria, I thought I aged out of it.” Table “Non-participants” were asked to identify thoughts and emotions associated with three different phrases that could be used to recruit participants for a weight management program. Those terms included “health and diet,” “weight management program,” and “nutrition and physical activity program.” Common thoughts regarding the terms “health and diet” included longevity and improved health. Many “non-participants” indicated the term “weight management program” evoked feelings of being overwhelmed or defeated. One participant stated, “Almost defeated before I start.” “Non-participants” agreed the term “nutrition and physical activity” was less intimidating and more positive and approachable, compared to “weight management.” One participant responded in agreement with another, “See like she said, different way of putting it. When you think about it, it’s the same thing, just putting different words... But nutrition and physical activity sounds a whole lot better than weight management.” Table Similar to “completers,” “non-participants” expressed that competing priorities would be the major barrier to participation, to include family, work, church, and volunteer obligations.When asked what would motivate them to participate in a nutrition and physical activity program, limited cost and convenience were identified. Additional motivators identified were health benefits to include pre-existing health conditions and overall health status. Pre-existing conditions were chronic diseases, including high blood pressure and diabetes. Overall health status included both mental and physical health. One participant explained: “Right now, what’s motivating me is my health. The second thing motivating me is loss of self, because I look in the mirror and I go, ‘Who is that person?’ I don’t recognize her because I’ve always been smaller my entire life. It’s just the last 5 or 10 years that I’ve slowly continued to gain weight.” “Non-participants” expressed that if they were able to participate in a program, they would hope to gain program support as accountability to achieve health goals. “Non-participants” also voiced technology could promote participation by providing support via being motivational, assisting with coaching, and providing reminders. Others expressed concerns with feeling burdened by needing to be consistent with using technology. Table This study examined perceptions about a weight management program delivered in a church-based setting that were useful for identifying factors related to the weight management intervention design and implementation. The themes gleaned from the focus groups suggested that the participants of the intervention, the “completers”, had positive perceptions about the program. However, use of technology seemed to be both a barrier and facilitator of program success. Competing priorities were discussed as barriers to weight management program participation among both “completers” and “non-participants.” Another theme involved the negative connotation associated with the “weight management program” terminology. Suggestions included framing the wording as a nutrition and physical activity program. Social support and personal health were also identified as key factors for the success of a weight management program.The results of the focus groups indicate that careful considerations are needed when incorporating technology into health intervention research. Mobile technology was viewed as a way to facilitate motivation, session attendance, and social support; however, a predominant theme among “completers” was that the food log function of the mobile application was difficult to use. A review of articles about dietary assessment using mobile phones found that six of the seven included studies reviewed had high participant satisfaction regarding use of mobile phones for dietary assessment . The resWhile mobile technology may not reduce data collection burden, the supplementation of behavior interventions with technology may assist with maintaining program intensity/contact and providing individualized participant support without increasing participant burden. A review indicated that technology-based weight loss interventions induced positive weight-related outcomes, enhanced social support and self-monitoring opportunities, and improvement in program adherence . Our preVarious types of social support  have been associated with improved diet and physical activity behaviors among minority and rural communities , 9 and iAn additional theme, disease management and prevention objectives were identified as motivating factors of weight management program participation. It was interesting to note that although “non-participants” voiced a common theme of the importance of participating in weight management programs for health and longevity, they were not sufficiently motivated to actually participate in the program when offered. The relevant themes from the focus group data and previous literature support the importance of shifting the conversation about obesity from body ideals towards health in a culturally appropriate manner . ChallenIn alignment with the four tenets of trustworthiness of qualitive inquiry , our resLast, our research is both dependable and confirmable. Dependability refers to the research process in that it is clear and reproducible. Our steps are documented and in alignment with best practice guidelines for qualitative inquiry. Confirmability requires demonstration of how conclusions were reached which is met when credibility, transferability and dependability are achieved. Our study outlines a clear qualitative process for how themes were derived with multiple checkpoints and results have clear implications for weight management in a specified population, which may have implications for and guide research in other populations.The findings from this study may help improve the development of lifestyle interventions intended for implementation among underserved, rural populations. The language used to describe weight management programs may deter participants and should consider a focus on the key factors identified by the population of interest  versus the weight loss itself. Technology may serve to alleviate certain barriers and introduce others. Careful consideration of the population to be served and understanding technology related barriers is recommended to ensure that the pros outweigh the cons of use.