Digital health research encompasses methods from human-computer interaction and health research.This paper aims to describe how these methods were combined to develop HeLP-Diabetes: Starting Out, a web-based structured education program for people newly diagnosed with type 2 diabetes.in the wild testing in the National Health Service with people newly diagnosed with type 2 diabetes, and further revisions. We adopted an iterative user-centered approach and followed steps from the human-computer interaction design life cycle and the Medical Research Council guidelines on developing and evaluating complex interventions.The development process consisted of three phases: initial design for effectiveness, optimization for usability, and in the wild testing provided data on uptake of and barriers to use. The study suggested low uptake and completion of the program, but those who used it seemed to benefit from it. The qualitative findings suggested that barriers to use included an expectation that the program would take too long. This informed refinements to the program.The initial design process resulted in an 8-session program containing information and behavior change techniques targeting weight loss, being more active, and taking medication. The usability testing was highlighted at an early stage, where changes needed to be made to the language and layout of the program. The The use of interdisciplinary methods resulted in an iterative development process and refinements to the program that were based on user needs and data on uptake. The final intervention was more suitable for a definitive evaluation than the initial version. The description of our approach informs other digital health researchers on how to make interventions more sensitive to user needs. The research methods used in HCI, such as health research, are largely empirical . However, health research tends to use a sequential approach, based on the methods used in pharmacological drug development, culminating in a randomized controlled trial to determine its effectiveness . In HCI the user -4. Accepthe user . A decisThe Medical Research Council (MRC) has published guidelines for health researchers researching complex interventions to help them adopt appropriate methods. The 2006 MRC framework suggested a nonlinear approach to the development and evaluation of complex interventions, with four key stages: (1) development, (2) feasibility and piloting, (3) evaluation, and (4) implementation [These 4 stages involve using evidence and theory to develop complex interventions, then testing them with a series of pilot studies aimed at key design uncertainties, before moving on to an exploratory and then a definitive evaluation . MRC besIterative development and evaluation are also features of the HCI development life cycles. A life cycle is the sequence of activities that occurs from the initial concept, through to the eventual phasing out and replacement . The proThe challenges of interdisciplinary work across HCI and health have been highlighted by Pagliari  and BlanThis paper focuses on this development phase, with the aim of highlighting the importance of careful user-centered design and early-stage usability testing before further evaluation. We have reported how we tackled this, by describing the 3 phases of development and describing the methods from HCI and the methods from health that we incorporated at each phase. The aim of reporting our methods is to guide other researchers in developing similar interventions. Historically, complex interventions, such as diabetes self-management programs, have not been well described ,13. BettOur approach was also informed by guidelines on evaluating DHIs , which din the wild testing stages.There are other examples where the process of combining interdisciplinary methods have been documented -19. The Guidelines for evaluating DHIs recommend starting by defining the problem to be addressed, namely the health need that the DHI is intended to address and the population who could benefit from the DHI. For HeLP-Diabetes: Starting Out (HDSO), the health need that is being addressed is the provision of a structured education for people with type 2 diabetes mellitus (T2DM). T2DM is an international priority, affecting approximately 425 million people worldwide. T2DM places a considerable burden on patients in terms of premature morbidity and mortality and on health services, in terms of cost. Both these burdens can be reduced by structured self-management education, which can improve patient knowledge, self-care behaviors, metabolic control, psychological outcomes, and health care costs -23. In tIt is an NHS policy that all patients diagnosed with T2DM are offered structured education . GeneralHowever, QOF payment and QISMET accreditation require a structured program  aimed at newly diagnosed patients. HeLP-Diabetes was not structured , and it was not aimed at newly diagnosed patients but at patients at all stages of their diabetes journey. Therefore, we decided to develop a web-based structured course that could gain QISMET accreditation and meet the QOF requirements. The established courses that the GPs could refer patients to and gain QOF remuneration were all group-based and face-to-face; thus, a web-based structured course would provide an alternative that could potentially bypass some of the barriers to uptake described earlier. The interdisciplinary development process required the skills of a multidisciplinary team of patients, GPs, diabetes nurse specialists, and health and HCI researchers. KP and JR formed part of the HeLP-Diabetes team, and KP and SP formed part of the HDSO team. EM led both teams.in the wild testing and further revisions.This paper aims to describe how we combined the methods described in the MRC and HCI guidelines, using the development of the HDSO program as a worked example. The three stages of development we undertook were as follows: (1) phase 1—initial design, (2) phase 2—optimizing for usability, and (3) phase 3—For each stage of development, we have described the methods from HCI, the methods from health, and how we combined the two. The evaluation of the final intervention for feasibility, acceptability, and impact is described elsewhere .The first steps of the HCI design process involve understanding the user context and requirements. This took place during the development of the HeLP-Diabetes website, before the development of the HDSO-structured program.wants) and features needed to help improve health outcomes (needs). The HeLP-Diabetes team conducted focus groups with patients and health professionals  to collect this information.Understanding the contexts in which people live, work, and learn allows designers to develop products that fit easily into users’ everyday lives. Products that are easy to use are more likely to be acceptable to patients and more widely taken up. Extensive work in establishing the requirements of patients with T2DM went into the development of HeLP-Diabetes, the precursor to HDSO, and has been reported by Dack et al . User rethinking aloud while undertaking prespecified tasks , a technique common and unique to HCI [The content identified as necessary in the focus groups was integrated by the design team and then reviewed by a participatory design group consisting of patients with T2DM. The content went through several iterations and was put through usability testing. Usability testing is commonly used in software engineering and HCI research. It has been described as “representative users attempting representative tasks in representative environments, on early prototypes or working versions of computer interfaces” . Usabilie to HCI . UsabiliSystematic reviews of web-based diabetes self-management interventions -42 have The aim of the structured program was not only to impart knowledge but also to empower and encourage people newly diagnosed with T2DM to improve their self-efficacy (self-confidence in self-management) and emotional well-being by learning about living a healthy lifestyle, making the most of the NHS and staying motivated. There were many theories and theoretical models which related to the aims of the program. These included the Corbin and Strauss model for the work of living with a long-term condition  and behaMedical management: adopting healthy behaviors , working with health professionals , and taking medicines. Emotional management: addressing the negative emotions associated with being diagnosed with a long-term condition.patient role and managing the impact of one’s diagnosis on relationships with friends, family, and colleagues.Role management: coming to terms with the disruption to one’s sense of self, including adjusting to the Behavior change theories were used because they can help predict how and when behavior change occurs . BehavioGuidelines on evaluating DHIs  recommenIn the long term, the proximal outcomes of knowledge, motivation, self-efficacy, and emotional distress combine to enable behavior change and better glycemic control. We opted not to measure long-term outcomes but focus on the short-term outcomes, including registration, use, and change in these 3 proximal outcomes.Findings from the work on user requirements (HCI) and evidence, theory, and causal modeling of the intervention  were combined to select appropriate BCTs and develop the content, format, and structure of the program.The usability testing of the HDSO program was conducted using questionnaires emailed to 5 patient volunteers. The questionnaires were written by the GPs and diabetes specialist nurses in the HDSO team and included the following four items: (1) the title of the session , (2) the information contained in the session , (3) the visual design of the session , and (4) any other specific suggestions.in the wild testing with patients in the NHS.Usability testing formed part of the early phase work recommended by the MRC and was undertaken to test the initial design with target users, before the exploratory Combining the phased approach advocated by the MRC and making changes to the program based on the results of 1 round of usability testing meant that the early development of the program was iterative. This was a key strength of this research. We did not immediately proceed to evaluation after the initial design of the program but undertook cycles of testing, refinement, retesting, and further refinement until we were more confident that the intervention fulfilled user needs and did not need major changes. This was recommended by both the MRC guidelines used by health researchers and the HCI lifecycle models used by HCI researchers. The refinements made to the design of the program were based on the results of the usability testing (and therefore based on user needs and experience).in the wild testing.The purpose of the next stage of testing and refinement was to evaluate the design of the program against user requirements. This was undertaken using in the wild is a term used for research conducted in natural settings. It is increasingly used in HCI to understand how people react to and integrate technologies in their everyday lives over a period [in the wild studies nearly always provide unexpected findings regarding what humans do when confronted with a digital intervention; these can be the most informative findings [Research a period ,49. In sin the wild testing was to understand more about how patients were using the HDSO program in their everyday lives, including their experiences and views of the problems they encountered in using the program. Therefore, mixed methods were used in this study. Quantitative data were collected on the number of patients registering for and completing the program, patient characteristics, and changes in questionnaire scores. The questionnaires administered were the Problem Areas in Diabetes measuring diabetes-related distress [The aim of the distress , and thedistress . Questiolocus of expertise differs. In health and social science research, researchers typically start with their own expertise rather than the user’s expertise, and the design interventions that (it is hoped that) users will engage with [user-centered approaches to address the challenge of low uptake and adherence, with a focus on understanding and accommodating the perspectives of the people who will use the intervention [Qualitative methods are used in both health and HCI research, but there are some important differences in the approaches used. For example, the age with . In HCI rvention . In healin the wild testing of the HDSO program. The setting for the in the wild testing was GP practices. This was the natural setting for this study as referrals to structured education for T2DM patients occurs in primary care. Practices in 2 London boroughs that had taken part in a HeLP-Diabetes implementation study and practices in 2 London boroughs that were interested in commissioning the HDSO program participated in the study. The program was offered to these practices for free as an alternative to established face-to-face diabetes structured education courses that were already commissioned.Methods from HCI and health were combined to conduct the The study was submitted to the Health Research Authority (HRA) for NHS Research Ethics Committee (REC) for review. Secondary analysis of information collected as part of normal care was excluded from the REC review by the HRA as long as the patients were not identifiable . TherefoA total of 15 practices agreed to offer the HDSO program to patients for the study. The program was offered to patients as an NHS service; therefore, there were no formal inclusion and exclusion criteria. Practices were informed that the target population of the intervention was adults (aged ≥18 years) with T2DM diagnosed in the last 9 months and asked to offer the program to everyone in this population. Practices were asked to identify eligible patients by running a search of the electronic medical records. Practices were sent registration packs to mail out to eligible patients. A total of 322 packs were mailed out. The registration pack contained information about the HDSO program , how to register, and a reply slip. Patients interested in using the program returned a reply slip to the HDSO administrator with their contact details. Patients were then telephoned by the HDSO administrator who collected baseline demographic data  and created a username and password for the program. The HDSO administrator also confirmed whether they were happy to take part in research interviews and securely sent SP the ID numbers of all the patients who agreed. The username and password for the HDSO program were then emailed to the patient, along with information on who to contact if there were any problems.We used qualitative telephone interviews with patients to explore their experience of using the program. We took an HCI approach of rapid data collection and used the data to inform optimization before further evaluation.One of the members of the HDSO team (SP) contacted patients who registered for the HDSO program but did not start or complete it. We were unable to contact patients who did not register for the program, as they did not provide us with their details or consent to be contacted. The patients who did not start or complete the program were contacted, because we were particularly interested in the problems encountered with the program. The telephone calls were semistructured and lasted approximately 10 minutes. Questions included “What would help you to use the program more regularly?”The interviews were carried out by telephone by SP, and written notes were taken rather than audio-recording and transcribing because the data needed to be collected and analyzed quickly to inform the program optimization. Note-taking is a recognized form of recording , and altEthical approval was obtained from the HRA (reference number: 159488). Data on registrations, completed sessions, and questionnaire scores were excluded from the HRA REC review, because of a clause that states that secondary analysis of information collected as part of normal care is excluded from REC review by the HRA, as long as the patients are not identifiable .Results from the focus groups showed that patients needed help in managing the complexities of living with diabetes, such as managing the impact that irregular working hours had on diet and blood sugar, impact on relationships and social life, and support in dealing with the profound negative emotions caused by the diagnosis, which included anger, guilt, shame, and despair. The tools to help them manage these tasks included high quality, detailed information, personal stories from other people with similar experiences, and quizzes to test knowledge and provide feedback. Health professionals had similar perceptions of patient needs. Both patients and health professionals wanted HeLP-Diabetes to be interactive and visual , to be easy to use, and have a positive tone .These results were combined with the results of the usability testing to create HeLP-Diabetes, a website containing 560 pages of information divided into 8 sections, which patients at any stage of their illness journey, could dip in and out of.We used selected content from the HeLP-Diabetes website  to construct the HDSO-structured program, which was needed to meet the QISMET and QOF requirements described in the introduction.The causal modeling process helped us postulate that information and BCTs targeting healthy eating, weight loss, activity levels, smoking, alcohol consumption, and medication intake, would help users achieve the intended outcomes. Modules targeting these behaviors were therefore selected from the HeLP-Diabetes website to be integrated into the HDSO. The modules contained BCTs, including goal-setting, action-planning, self-monitoring, and feedback on performance . These BIn addition to the BCTs from HeLP-Diabetes, self-assessment questionnaires and feedback were added as new components to the HDSO-structured course. The questionnaires assessed self-efficacy (self-confidence) in self-management, diabetes-related distress, and diabetes knowledge. These were positioned in the course in weeks 1 and 8 (before and after the program), thereby allowing users to reflect on the change in their scores.Personalized emails were also added as new components to the HDSO-structured course. These were added to encourage motivation and engagement. A systematic review by Alkhaldi et al  on the eA curriculum was needed to structure the content and components of the program and to achieve accreditation as a structured course. By identifying relevant theory (as suggested by the MRC guidelines), we decided that the program would follow a spiral curriculum based on the Harden and Stamper spiral curriculum model . This moThe qualitative work that was conducted to establish user requirements for HeLP-Diabetes showed that users wanted information to be presented using text, images, and videos. These formats were therefore used to present information in the HDSO program and included videos of others living with diabetes. The text was written for people with a reading age of 12 to correspond with 80% of the population in the United Kingdom .The result was an 8-session program containing information presented as text, images, and videos, and BCTs including goal-setting, action-planning, self-monitoring, and feedback on performance. Each session was designed to take approximately 40 to 50 minutes to complete and for people to complete 1 session per week. A screenshot of the HDSO program showing a video giving an introduction to T2DM is shown in Responses to the questionnaires described earlier were reviewed by the team. The relevant changes were made where there was agreement among responses from the patient volunteers. Where there was disagreement in responses from the patient volunteers, the suggested changes were discussed among the team members, and a consensus decision was made as to whether to make the changes. Changes were made to the language and layout of each session of the program, including making text and titles clearer and easier to understand for users.Examples of questionnaire responses and changes made to the program, as a result, are given in We made changes to the design and content of the program based on the questionnaire responses. This ensured that the development of the program was grounded in user needs. The changes included clearer subtitling, advice about physical activity made more concise, a more appropriate number of videos of people’s stories included, and links to support and advice organizations added.During the study, 24 people registered for the HDSO program. Quantitative data were collected on program use, questionnaire scores, and characteristics. Of the 24 people registered, 3 (13%) people completed the program, 13 (54%) people started the program but did not complete it, and 8 (33%) people did not start the program. The data suggested low uptake and completion, but those who used it seemed to benefit from it (mean self-efficacy in self-management scores and diabetes knowledge scores increased).The telephone interview responses were analyzed using a thematic analysis approach, and a list of barriers to completing the program emerged from the data. These are listed in These themes were used to inform the refinement and optimization of the program as discussed in the next section. The ideas were followed up in subsequent interviews conducted as part of the evaluation of the final intervention and reported elsewhere .The themes identified from the interviews suggested that there were patient and program factors which influenced program use. Patient factors such as ambivalence were difficult to address. However, we were able to shorten the program and provide users with quicker access to the program with web-based registration.Following a discussion among the HDSO team, the following changes were agreed upon:managing my diabetes when I’m ill, working with diabetes, and driving with diabetes were taken out of the main course and moved to the fifth bonus session. The final 4-session intervention is described elsewhere [getting started, self-management, improving my health and well-being, and taking control of my diabetes.Reducing the number of sessions in the program: evidence from systematic reviews of engagement with digital behavior change interventions  and reselsewhere  and contReducing the number of questionnaires: we decided to reduce the number of questionnaires from 3 to 2 by removing the AdKnowl questionnaire. The AdKnowl (knowledge) questionnaire  was remoWeb-based self-registration: it was decided to change to web-based registration to save time and to make it easier for patients to access the program quickly. The self-registration page included a demographic questionnaire, which allowed for the collection of baseline data. Telephone support from the HDSO team was still available for those who had difficulty registering on the web or using the program.We decided to offer the program to everyone with T2DM and not just people who were newly diagnosed. The HDSO program was developed in line with the national clinical guidelines for GPs advising them to offer patients with T2DM structured education at and around the time of diagnosis . Howeverin the wild testing allowed us to identify low completion rates, which were not picked up in the usability testing because it was conducted with highly motivated patient volunteers. The methods from health and the MRC framework for complex interventions emphasized the impact of the intervention. This helped us to understand the potential effectiveness of the intervention. The iterative development process that we went through with the intervention, in contrast to traditional piloting and feasibility studies conducted in health research [We have described the stages of the development of a web-based structured education program for people newly diagnosed with T2DM, HDSO. Methods from HCI and health research were used in combination at every stage. Methods from HCI put more emphasis on understanding user requirements and determining uptake. The research , resulteresearch . Randomiresearch .The existing reporting of complex behavior change interventions is limited, and this prevents successful replication of successful interventions . ReviewsThe strength of this research is the use of methods from both health and HCI. We combined the theory of living with long-term conditions and a user-centered design to understand and meet user requirements. This meant that users of different age groups, education levels, and ethnic backgrounds could use the intervention, as demonstrated by the analysis of the usage data from subsequent studies . A weaknAnother weakness of our approach was patient involvement. More extensive patient involvement could have been used in the design of the interview guide for the telephone interviews in the user experience study and data analysis. The patient volunteers could also have been asked to make their own suggestions for refinements to the first iteration of the program, instead of relying solely on the data.This paper describes how interdisciplinary methods can be used to develop a web-based structured education program for people newly diagnosed with T2DM. Methods were combined from human-computer research and health research. The reporting of the development processes for DHIs needs to continue, especially when interdisciplinary methods are used, for researchers to be able to learn from each other and create user-centered interventions.


Background: Practice-based evidence can inform and support clinical decision making. Case-report series about the implementation of programs in real-world clinical settings may contribute to verifying the effectiveness of interventions for treating PPA in specific contexts, as well as illustrating challenges that need to be overcome. Objective: To describe and provide practice-based evidence on the effectiveness of four cognitive rehabilitation programs designed for individuals with PPA and directed to speech and language impairments, which were implemented in a specialized outpatient clinic. Methods: Multiple single-case study. Eighteen individuals with different subtypes of PPA were each assigned to one out of four training programs based on comprehensive speech and language assessments. The treatments targeted naming deficits, sentence production, speech apraxia, and phonological deficits. Pre- and post-treatment assessments were undertaken to compare trained and untrained items. Gains were generalized to a different task in the first two types of intervention (naming and sentence production). A follow-up assessment was conducted 1–8 months after treatment among 7 participants. Results: All individuals presented better performance in the trained items at the post-test for each rehabilitation program accomplished, demonstrating that learning of the trained strategies was achieved during the active phase of treatment. For 13 individuals, statistical significance was reached; while for five, the results were maintained. Results about untrained items, generalization to other tasks, and follow-up assessments are presented. Conclusions: The positive results found in our sample bring some practice-based evidence for the benefits of speech and language treatment strategies for clinical management of individuals with PPA. Primary progressive aphasia (PPA) is characterized by gradual deterioration of language with relative preservation of other cognitive functions and functional independence, except for situations in which language is critical ,2.The international consensus for diagnosing PPA  defined Symptom onset may occur before the age of 65, with a devastating effect on functionality. In the absence of effective pharmacological treatments ,6, enablNon-pharmacological interventions in PPA can be classified into those directed to the deficits  and functional interventions . Positive results were reported in most studies but, to be recommended, treatments require further investigation regarding their effectiveness . Most evLexical retrieval and/or semantic deficits are common features of PPA syndromes and may predominate over other language or cognitive impairments for long periods. Subsequently, communication becomes markedly affected by word production and comprehension deficits, difficulties in sentence production (agrammatism or paragrammatism) and/or in syntactic comprehension. Speech may also be affected by apraxia of speech and dysarthria .Lexical retrieval treatment is the most widely applied approach ,10, indeSubjects with PPA are able to relearn target vocabulary during the active phase of treatment and to maintain gains for varying periods after the intervention ,15,16,17Beales et al.  showed tMeyer et al.  used theVolkmer et al.  explaineThese interventions are offered to nonfluent subjects and are aimed at syntax training with different approaches, as shown below. Schneider et al.  examinedAndrade-Calderón et al.  analyzedA constraint-induced treatment approach implemented with two nfvPPA subjects resulted in improved production of grammatical structures, with maintenance of gains observed at two months post-treatment .Studies on nfvPPA subjects were also directed to speech apraxia  and havePhonological deterioration starting from a phonological short-term memory deficit characterizes lvPPA. While most individuals with lvPPA mention lexical retrieval problems as their main deficit, some of them are concerned with spelling and short-term memory deficits.With the premise that the phonological loop is a working memory component, spelling and repetition activities are positive resources used in phonological interventions. Two studies on spelling showed positive results, with learning of phoneme-to-grapheme and phoneme-to-word correspondences ,34. In aThe objective of the present study was to explore intervention techniques for specific language and speech deficits in PPA in a specialized outpatient clinic. Four intervention programs were implemented based on strategies that had shown positive effects in previous studies  and agreement to complete the treatment cycle, be evaluated and undergo post-evaluation. The exclusion criteria involved severe hearing and/or visual deficits, and severe motor or language deficits that would impact the implementation of the programs.The subjects were seen at the Behavioral and Cognitive Neurology Outpatient Clinic. The first stage consisted of a medical evaluation , followed by evaluation by a speech therapist and a neuropsychologist. An overall cognitive assessment and a neuropsychological evaluation were used to assist in making the clinical diagnosis and to identify the degree of preservation of non-linguistic cognitive abilities. With these assessments and neuroimaging examinations, the study team assessed the clinical diagnoses and invited participants.(1).Mini-mental state examination (MMSE) ,37;(2).Dementia rating scale (DRS) ,39,40.Overall cognitive assessment and neuropsychological evaluation:(1).Auditory comprehension tests: word and sentence comprehension tests from the Montreal-Toulouse battery (MTL) ,42 and/o(2).Visual confrontation naming tests: Boston naming test (BDAE) and/or CSMRB;(3).Repetition—words, non-words, and phrases of MTL or BDAE;(4).Reading words and non-words—HFSP reading aloud test ;(5).Writing words and non-words—HFSP writing to dictation test ,55,56;(6).Reading comprehension: subtests from MTL and BDAE;(7).-Semantic category  ,58;-Phonemic fluency (FAS) ;Verbal fluency tasks:(8).Recognition and naming of famous faces ;(9).Oral discourse—description of the cookie theft picture ,61 and c(10).Word definition—CSMRB;(11).Camels and cactus test of semantic association ,64;(12).Speech praxis protocol ; oral agLanguage assessment:The cognitive and language evaluation for PPA diagnosis and characterization varied among the cases and included some of the tests listed below.Reading, writing, object knowledge and motor speech were assessed qualitatively. For reading and writing assessments, we used the list of words and pseudowords that was developed as part of the HFSP research project. This list was devised in order to study acquired dyslexia and dysgraphia across different written systems and contains words and pseudowords. We analyzed error types in two ways: (a) regularizations  were read or written by applying grapheme-to-phoneme or phoneme-grapheme conversion rules, supported by the auditory representation of the stimuli instead of orthographic memory); (b) phonological or graphemic paralexias and paragraphias .A different selection of tests for language assessment was applied to each subject. The results from these tests supported classification of the type of aphasia according to the semantic or syntactic losses that were identified, for example. Through this, the most evident difficulties could be identified in order to decide which type of program each individual should be referred to. Some of the tools used for language assessment were not validated for use in Portuguese but were translated, adapted, and applied to a group of cognitively healthy controls. The studies conducted on the versions of the language tests used in the current study are referenced above.This was a multiple single-case study consisting of four stages: (1) complete language assessment and pre-test (trained/untrained items); (2) speech and language intervention (four different types); (3) post-test (trained and untrained items) and, for the naming and sentence production interventions, subjects were also assessed in another task in order to address generalization; (4) follow up, which was conducted 1–8 months after completion of the program.After the language assessment, each participant was allocated to a cognitive intervention program directed towards a specific language-speech impairment. This program was individualized and was chosen considering: (1) speech and language deficits (the most severe or apparent impairment); and (2) complaints and communication needs, in order to achieve functional adaptation. The functional deficits were identified during the clinical interview with the patients and their families. The best approach was then defined as a consensus with at least two speech therapists.For the intervention phase, three speech and language therapists adapted four semi-structured programs that was designed for PPA deficits. Rehabilitation materials were personalized, and intervention programs were adjusted to the severity of deficits. The subjects were invited to participate in a 24-session program, but this length of program was not always possible, and the number of sessions was adjusted  to account for any particular mobility issues .The post-test stage consisted of reevaluation on the trained and untrained items (one week after the last rehabilitation session) to assess the effects of the treatment. In addition, for the interventions that focused on naming and on sentence production, generalization was also assessed in a different language task.The degree of maintenance of the gains (follow up) was assessed in a subgroup of the subjects, at the time when they returned for a clinical consultation. The participants were retested on trained and untrained items. Due to time constraints, in two cases only the trained items were tested.The clinical evaluations and intervention programs were performed by licensed speech and language therapists at the Behavioral and Cognitive Neurology Outpatient Clinic of Hospital das Clínicas, Federal University of Minas Gerais, in Belo Horizonte, Brazil.The participants were offered 24 sessions of 50 min each, implemented over four months (twice a week). The programs were adjusted according to each individual’s or family’s time constraints in this context of a real clinical setting. In some cases, the subjects were just temporarily visiting the region, to look for a diagnosis in a specialized clinic, and treatment had to be implemented within a period of only two weeks. In other cases, the families committed to a three-month period, while in yet other cases we were able to extend the intervention and see the subjects for 12 months. Because of the heterogeneity of the duration of the treatments provided, as well as the decision to use a tailor-made approach in designing the therapy, we applied a multiple single-case study design in order to report on the effectiveness of the therapies.Regardless of the type of intervention, the participants were encouraged to practice at home, and we offered training to the caregivers to support this practice (they were trained to assist when the subjects required help), but not all individuals and caregivers were able to follow this procedure. The stimuli sent to their homes were the same as those trained in the sessions. Practice at home was encouraged throughout the treatment; however, it was not formally monitored.This treatment was based on Senaha et al.  and was After selecting the training set, another set of items was prepared by two or three speech and language therapists for each subject (control set). These included items of the same grammatical category, of similar familiarity and picture complexity as in the training set. The subjects’ performance regarding the trained and untrained items was assessed twice in all cases (one week before and after the intervention). Some participants had a third evaluation (follow-up). The trained items were individualized, but the untrained items were selected from a set of stimuli that the speech and language therapists used for their interventions, which were matched as much as possible to the trained set, according to psycholinguistic parameters . The subjects’ comprehension and preservation of some semantic knowledge of the stimuli in the sets was assessed indirectly through qualitative analysis on the responses to naming in the pre-test and the consensual decisions of the speech and language therapists, based on clinical judgment. Retention of basic semantic knowledge of the items in the lists was demonstrated through the ability to provide at least a basic description or show with gestures how to use the item or the context in which it is usually found.The effectiveness of the intervention was evaluated by comparing the numbers of correct responses before and after the treatment from the trained and untrained (control) items. The generalization was evaluated by comparing the individuals’ performances in another task , before and after the treatment.This intervention was based on Bock and Levelt’s model of sentence production. In our study, the two participants assigned to this treatment received an intervention targeting the positional level. We aimed at verb inflections for production of accurate simple sentences with the structure “subject-verb-object”. We targeted the verb due to its central role in the sentence.Twenty regular, familiar and high-frequency verbs were selected for the set of training and control stimuli, based on daily routines . We used a set of 40 written sentences with a gap to be filled by a verb in the present or in the past tense . Each verb was practiced in both tenses with a model provided by the therapist (repetition). The therapist provided the model aloud (adverb + subject + inflected verb) and the subject was asked to read the sentence and reproduce the verb form in the correct position and inflection (where there was a blank). Then, the therapist asked the subject to produce the full sentence again without reading support. A second drill consisted in providing a written prompt (adverb + subject + verb in the infinitive form) and ask the subject to produce the full sentence. Errors were discouraged; if necessary, the subject could use the written material . This procedure was repeated until the subject was able to produce the complete sentence accurately from the adverb, subject and verb prompt . Models and cues were gradually removed until the subjects were able to produce and speak the sentence aloud accurately.Another 40 sentences with 20 different regular, familiar, and high frequency verbs were used as control set.The effectiveness of the intervention was evaluated by comparing sentence production before and after the treatment, comparing gains in trained and untrained items. Discourse production from the cookie theft picture was used to look at the transference of the training to discourse.-The subject was required to read aloud a selected text. When he/she produced a word incorrectly (with one or more speech sound errors), he/she was asked to stop reading and practice that word (target).-The subject produced the word syllable-by-syllable many times until he/she reached the correct articulation (appropriate prosody and speed of speech). If the target was a multisyllabic word, it was underlined in the text and lines were drawn dividing the word into constituent syllables. Single-syllable words were repeated until correctly produced in isolation.Based on Henry et al. , we implAfter success in producing the word in isolation, the subjects were asked to read the sentence again in order to achieve correct word production in sentence context. If the word was again produced erroneously, the subjects were asked to repeat the previous steps, until the entire sentence was produced correctly.Two different texts were applied for training (one for each participant), considering that their educational levels were different. The simplest had 120 multisyllabic words and the most complex had 319. The untrained texts had 95 and 179 multisyllabic words, respectively.For homework, the subjects were encouraged to train on the text used in the session.The effectiveness of the intervention was evaluated by comparing accuracy in the production of trained and untrained multisyllabic words (pre- and post-intervention). The pre-test intervention measurements considered the number of errors that the subjects made in the first reading of the text. We compared their performance in the trained text with their performance in an untrained text.Spelling of words requires temporary storage of the sequence of letters in working memory (graphemic buffer) while the individual letters are being written or spelled out aloud. Moreover, spelling of familiar words in dictation involves recognition of the spoken word  and access to the correct spelling of the word  . TherefoPhonological deterioration, starting from a phonological short-term memory deficit, characterizes lvPPA. Whereas most individuals with this syndrome mention lexical retrieval problems as their main deficit, some are more concerned with spelling deterioration and short-term memory deficit. Given that there were few studies on lvPPA and, to our knowledge, none reported any treatment addressing phonological deficits and spelling, we developed a protocol based on the study of Louis et al. , while aThe training consisted of activities at the syllable and phonemic levels, along with oral and written spelling. Twenty regular words were selected for the training/control stimuli set. In every session, the subjects practiced the spelling of each word through dictation. If there was an error in the spelling, the therapist guided the subject to read his/her production aloud, so that the subject could try to identify the error and write and/or spell the word aloud again. If the word was misspelled again, visual support was provided (written word) and the subject was asked to copy the word. Other activities were also practiced in the sessions: forming words from a group of syllables or phonemes (synthesis), identifying the number of syllables and phonemes in words , identifying rhymes and alliterations and manipulating syllables and phonemes to form new words.Another set of 36 regular words were used as controls.The effectiveness of the intervention was evaluated by comparing accuracy in spelling pre- and post-intervention. We compared the performance in trained and untrained words.The treatment effects were analyzed for each subject using the Wilcoxon signed rank test to determine whether there were any differences in the numbers of correct responses from the trained and untrained stimuli sets from before and to after treatment. We used JAMOVI version 1.6,  for the Thirty-two subjects were referred to the study within the three-year recruitment period. Six subjects with severe language deficits were excluded and eight subjects did not complete the intervention program. In relation to these non-adherent cases, five were svPPA, two nfvPPA, and one mxPPA. The reasons for dropping out from the treatment program included: frustration; anxiety and discouragement due to their own difficulties; illness in the family; unwillingness to do activities at home; distance between the home and the outpatient unit; and feeling that the treatment was not solving the problem.Eighteen individuals with different PPA variants participated in the study. Out of the 18 individuals with PPA who were included in the study, 3 met the criteria for nfvPPA , 5 for lvPPA , 5 for svPPA  and 5 for mxPPA .Ten participants received an intervention focused on naming ; two received therapy for sentence production (C15 and C16); two for speech production (C17 and C18) and four for phonological awareness and verbal working memory  .As shown in Four participants presented significantly improved performance regarding untrained stimuli: C1 and C5 (svPPA); C8 (lvPPA); and C9 (mxPPA) . C1 and Generalization to a different task was observed only in C1 and C5 (both svPPA), with marginal significance in C1. Five subjects kept the same level of performance and three declined, but not significantly.Follow up was conducted in four cases . Two participants maintained the treatment results and two worsened significantly with regard to trained items. For the untrained items, all subjects maintained the results .As shown in In contrast, subject C16 received remediation treatment and improved significantly in trained and untrained items with large and medium effects, respectively. However, the strategy was not transferred to discourse, such that there was a significant decline in relation to the cookie theft picture.A follow-up assessment was undertaken in relation to one participant (C15), one month after the end of the intervention, with maintenance of treatment results, both for trained and for untrained items .As shown in The four subjects who took part in this training did not present any significant improvement in spelling after the intervention, either for trained or untrained items. However, correct responses to trained items numerically increased among all the subjects, whereas the number of correct responses to untrained items decreased for three of them and increased for C14.Follow-up of trained items was possible for C11 and C13. Both participants demonstrated maintenance of the treatment results .This study investigated the implementation and effectiveness of four different interventions for PPA. We used a client-centered approach in which treatments were offered considering the subjects’ main difficulties and concerns, and with individualized relevant stimuli for training. To our knowledge, this is one of the largest case series reporting language intervention results in PPA, and it has strong ecological validity in that it reports on work conducted in a public specialized outpatient clinic. We adjusted the programs to several individual variables involving patients and their caregivers, which is expected to happen in real clinical contexts. Motivation and engagement with treatment were also considered. Thus, some subjects received a more prophylactic form of treatment, whereas others received treatments with more items that involved “relearning” or “reacquiring”.We acknowledge that the high variability of treatments compromises the generalization and replicability of our results. In addition, as the list of trained and untrained stimuli were not strictly matched according to psycholinguistic parameters or to pre-treatment performance, there are important limitations on interpreting the results from generalization. Therefore, our conclusions and discussions should be considered at the level of “practice-based evidence” , in whicPractice-based evidence can also be demonstrated through case studies of individuals with PPA with gains after intervention . MoreoveIn our study, all ten subjects  who underwent this type of intervention improved significantly in relation to the treated items and four also significantly improved in relation to untreated items. Other studies have had similar results and have demonstrated that individuals with PPA are able to relearn target vocabulary during the active phase of treatment ,15,16,17Four participants underwent a follow-up evaluation, on average six months after the end of the intervention. Two maintained the treatment results and two worsened significantly in relation to trained items. In the untrained items, all subjects maintained their results. Our findings differ partly from those of the systematic review of Cadório et al. , which iSimilarly to the present study, Croot  also stuNfPPA usually presents with mixed symptoms of motor and cognitive-linguistic deficits. Studies on treatments for this variable are less common than on treatments for svPPA. The results show that approaches that focus on the deficit  are beneficial to individuals with PPA.Our two participants who underwent this type of intervention (both nfPPA) improved in relation to both treated and untreated items, thus corroborating previous studies ,31,35,73Only one subject presented generalization for other language activities (cookie theft picture description), with better sentence construction in relation to the pre-test. Schneider et al.  and LouiOne participant underwent a follow-up evaluation one month after the end of the intervention, with maintenance of the results. Among the follow-up studies, only Hameister et al.  reportedFew studies have implemented interventions to improve fluency in nfPPA.Structured oral reading proved to be an efficient and effective means of addressing multisyllabic word production in speech apraxia associated with nfPPA. In the study by Henry et al. , one parAmong the four subjects (two lvPPA and two mxPPA) treated with this type of intervention, none presented any significant improvement in spelling after the intervention, in relation either to trained or to untrained items. However, all four of them showed numerical increases in the correct responses relating to trained items, whereas three showed decreases relating to untrained items and only subject C14 showed an increase in this regard.It is noteworthy that maintenance signs of the same level of function in progressive disorders should be seen as a success. Moreover, in these cases it is important to slow down the progression and maintain the communication abilities of subjects .Regarding follow up, two participants were reassessed, with maintenance of treatment results, but without statistical significance. This was comparable with the results of Beeson et al.  and HenrWe have reported on treatment results for a case series of individuals with PPA. We now discuss some challenges and limitations of our study and other factors of relevance to interventions directed towards speech and language deficits in PPA.There are few studies on PPA treatment in low and middle-income countries. Like in other studies on this topic, our sample was not large  and the participants’ characteristics varied considerably even within the same variant of PPA. However, given the relatively low prevalence of PPA, treatment studies on this population usually involve a small number of participants .Another related matter is adherence to treatment. In our sample, eight subjects dropped out of the study before the post-test: five svPPA, two nfvPPA, and one mxPPA. The average number of sessions that they attended was 17.5. Their reasons for dropping out from the treatment comprised frustration, anxiety, and discouragement with their own difficulties, illness in the family, unwillingness to do activities at home, distance between the consultation office and their home and a perception that their speech and language difficulties were not being “solved”.Jokel et al.  stated tInformation about participant adherence to treatment requirements is rarely reported in research studies. Taylor-Rubin et al.  studied Taylor-Rubin et al.  discusseThe initial severity of deficits and the length of time since the onset of symptoms affects the response to treatment, although it is difficult to establish how this occurs. It is coherent to think that the longer the disease duration is, the greater the linguistic impairment will be and hence the greater the treatment limitations. There is considerable inconsistency in reporting the time that has elapsed post-onset and severity levels in the literature on treatments, since the onset of symptoms is not easily defined. Another effort towards treating individuals with PPA consists of interpreting the response to treatment in the context of disease progression, given that a situation of little or no change in the language skills treated may represent a positive outcome, in comparison with the expected decline ,74.A significant number of potential participants could not be included in our study because they were severely impaired. One good alternative for these individuals and their families would be orientation and interaction groups, for the exchanging of experiences and counseling, as proposed by Jokel et al.  and by MThat is also the reason for some of the very short-term cycles of interventions reported in this study. We believe that interventions need to be patient-centered and tailored. Ideally, cognitive rehabilitation programs should be long-term, in line with the progression of the disease and the changing needs of the subjects. However, many individuals do not have access to cognitive intervention clinics or cannot afford treatments. In contrast, some public services need to deal with high demand from patients and cannot provide long-term follow up. For these contexts, brief cycles of intervention and follow up can be an alternative.We believe that one important contribution of this paper was that it allowed us to share our clinical experience in implementing interventions among PPA subjects. We reported the results from programs and strategies that could be implemented by speech and language therapists as part of a more comprehensive rehabilitation program. Short cycles can be implemented in contexts where patients lack access to full care and to interventions that can be implemented by caregivers. Conversely, in more complete care settings, therapists may combine different strategies according to the needs of the individual.Other options for interventions with promising preliminary results are being studied. These include neuromodulation, computer-based approaches, the use of social media and electronic devices, and home-based interventions ,79,80,81Behavioral interventions in PPA showed improvement of the targeted language function. However, not all of them showed generalizable and long-lasting effects. Tippett et al.  pointed Generalization of treatment gains for untrained tasks may be related to the nature of the intervention and to the use of episodic/autobiographical information . The maiSome participants reported having a subjective perception of improvement in functionality regarding communication at the end of treatment. However, as we did not have any means of objective assessment for analyzing this information, we did not include this observation as part of our results. In future studies, we intend to objectively quantify this information.Another limitation related to the lack of control over practice at home. Differences between participants may have contributed to different treatment results. The absence of supervision of the control stimuli in the patients’ daily life should also be considered as a limitation of the work, since this could potentially interfere with the results.We recognize that the absence of a control group is a limitation, but we point out that it is a small sample and heterogeneous as to the types of deficits, which makes it difficult to compare patients with and without rehabilitation.Lastly, we can highlight that this study addressed some important matters: 1. Our study reported on a range of interventions targeted to the individuals’ communication needs; 2. Different treatments were selected for different individuals, determined by the participants’ language symptoms, and not by their PPA variant; 3. Our study had stronger ecological validity because it was implemented in a clinical context and because the number of subjects who did not adhere to therapy and the reasons for this were also reported.Although PPA is a progressive disorder, both the immediate effects of treatment and, in some cases, the maintenance results, were positive. The results from our study show the effectiveness of specific behavioral interventions even at “low dose” (short-term intervention cycles).


Obesity contributes to the acquired flatfoot deformity which in turn impairs balance.  The purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercises on balance, foot posture, and functional mobility in obese children with a flexible flatfoot.  Forty-seven children participated in the study. Their age ranged from 7 to 11 years. Participants were randomly divided into 3 groups: experimental group I (EGI), experimental group II (EGII), and the control group (CG). The EGI received plyometric exercises and the EGII received corrective exercises, 2 sessions weekly for 10 weeks. The control group did not perform any planned physical activities. The Prokin system was used to assess balance, the timed up and go test (TUG) was used to assess functional mobility, and the navicular drop test (NDT) was used to assess foot posture.  EGI showed significant improvement in all balance parameters, foot posture, and TUG. EGII showed improvement in the ellipse area and perimeter in addition to foot posture and TUG.  Plyometric exercises and foot correction exercises had a positive effect on foot posture, balance, and functional mobility in obese children with flatfeet. Obesity appeared among children and adults as one of the critical and major community health worries within the past century . The preRiccio et al.,  mentioneThe study was conducted at the balance lab of the Faculty of Applied Medical Sciences. It was started on 15 January 2021.G∗power . The participants were selected randomly from different elementary schools in Taif, Saudi Arabia. Participants were enrolled by contacting their parents by phone using the phone numbers in the schools' database. Their age ranged from 7 to 11 years. Initially, a specialist examiner conducted a comprehensive evaluation of all participants. He was blinded about the groups' division. Inclusion criteria are as follows: all children were classified as obese . The participants were not involved in strength, balance training, or competitive sports aiming to enhance muscular strength or balance. All participants had balance impairments and a mobile flat foot. Their degree of flatfoot deformity according to NDT was ranged from 16 to 19 millimeters in all participants. The exclusion criteria were as follows: the children were excluded when they had a previous injury to the lower limb which required medical care or had other confounding conditions, such as deformity of or surgery in the lower limb or visual impairment. Additionally, they were excluded if they engaged in obesity treatment programs three months prior to the study. The written informed consent (from parents or children's guardians) was obtained before they enrolled in the study.A sample of 47 male children participated in the current study without having female participants due to the cultural issues and order of the society in Saudi Arabia. The sample size was detected by using statistical power analysis—A simple randomization technique was used. After gathering the baseline measurements, the participants were randomly assigned into three groups: experimental group I (EGI) contained 16 participants, experimental group II (EGII) contained 16 participants, and the control group (CG) contained 15. The stratification was done using sealed envelopes. The children were not aware of the group that they belonged to.Demographic data collection was as follows: a specially designed survey was used to collect demographic data for all participants such as age, weight, and height.BMI percentile is a screening tool used to classify the participant's degree of obesity in children according to the American Academy of Pediatrics recommendations. To calculate the BMI percentile, at first, obtain accurate height and weight measurements for each child. The subjects' body weight in bare feet and with minimal clothing was measured. Standing height was measured with the children standing straight without footwear. The height and weight were measured twice to minimize errors. The body mass index (BMI)was then calculated by dividing the weight (kg) by height (m) squared.The static balance was assessed by using the Prokin system . The balance assessment is based on the degree of postural sway using a tilting board. Before the actual assessment, all participants were engaged in certain practical sessions and the whole procedures were illustrated to them to be familiarized with the testing procedures and balance device.2), standard backward-forward deviation, and standard medial-lateral deviation.In the first step, the system was opened and calibrated and the demographic data was entered . The next step is selecting the type of stability test, and the participant stands comfortably on the tilting board and was asked to look towards at the screen keeping his hands beside the body while his eyes are focused on the fixed target on the screen. Each participant applied three trials with eyes opened (EO) and the mean score was recorded. The participants had a five-minute break after each trial, and we tried to avoid any distractions. There are four variables that were measured for all participants at the beginning and at the end of the study with EO: perimeter area (mm), ellipse area (mm(NDT) was used to assess the degree of flatfoot deformity. The NDT revealed excellent reliability, with ICC values reaching 0.945 and standard error of measurement < 1 mm . FirstlyFunctional mobility was assessed using the timed up and go (TUG) test to detect participants' functional mobility. It is a valid and reliable test. At first, a sign was placed 3 meters away from the chair. A seat with back support without arms was chosen from the children's environment. The seat should allow the feet to be flat on the ground and the knee and hip to bend 90 degrees. Then, the child was asked to stand up, walk at his free gait, touch the mark, and return to sit down on the chair. The time was counted as the child left the seat and stopped when the child returned to the sitting position using a stopwatch. The test was run three times and the average value was taken .The EGI received a plyometric exercise program. The EGII received the corrective exercises. The control group was not involved in any planned physical activity during the intervention period but persisted in their traditional physical activities. The designed exercises were applied two sessions per week with three days of rest in between for 10 weeks. The session started with 5 minutes warming up and ended with 5 minutes cooling down in the form of gentle stretching of the lower limb muscles. All participants were engaged in certain practical sessions at the beginning of the study to be familiarized for all intervention procedures. Additionally, the supervisor emphasized the correct application of the exercises. The selected plyometric exercises and their repetitions are illustrated in The ethical committee at the research and studies department, directorate of health affairs, Taif, Saudi Arabia , approved the current study on 11 November 2020 with approval number 452.NCT05026294). The study was double blinded, the examiners and participants were blinded about the group division. All statistical measures were performed through the Statistical Package for Social Studies (SPSS) version 26 for Windows. The MANOVA test was conducted to determine if there were any significant differences in the mean values of age, weight, height, and BMI between both groups. Additionally, repeated measures MANOVA was used to compare the within- and between-subject effects of both interventions  in addition to the significant improvement in foot posture (as indicated by navicular height) and TUG. Regarding EGII, there was a significant improvement in the previous items except for the backward-forward deviation and the mediolateral deviation which showed nonsignificant improvement. On the other hand, there were no significant changes in the CG .Concerning EGI, it showed a significant difference in all assessed parameters when it was compared to the EGII and CG except the improvement in foot posture and TUG which showed a nonsignificant difference between EGI and EGII. EGII showed significant improvement in all parameters when compared to the CG except for the backward-forward deviation which showed nonsignificant improvement in the EGII .The study is aimed at investigating the effect of plyometric exercises on foot posture, balance, and functional mobility in obese children with mobile flatfeet. We have selected the balance parameters to be investigated in obese children because appropriate balance control is necessary for routine activities of daily living and obesity has a tremendous negative effect on balance . The resConcerning preintervention balance assessment, the results of the study revealed that obese children have deficient balance skills. This comes in agreement with Deforche et al.  who mentConcerning the effect of plyometric exercises on balance, the results of the current study revealed that the balance was improved significantly in the EGI postintervention. This comes in consistency with Arazi and Asadi  who mentOn the other hand, Twist et al.  contradiConcerning the effect of plyometric exercises on foot posture, the results of the current study revealed that there was a significant improvement in the foot posture in EGI after plyometric training. We can attribute this improvement to the improvement in plantar flexor strength and mechanical properties after plyometric exercises. Kubo et al.  support On the other hand, Klaikaew and Panichaporn  contradiConcerning the effect of corrective exercises on the foot arch, the results of the study revealed that there was a significant improvement in the foot posture in EGII postintervention. Halabchi et al.  confirmeConcerning the effect of corrective exercises on balance, the results of the study revealed that there was a significant improvement in all balance measures in EGII postintervention except for the backward-forward and mediolateral deviation. The improvement in the balance measures may be attributed to an increase in the strength of the intrinsic muscles of the foot, which in turn improves the arch height and postural control as reported by Kim and Kim . MoreoveRegarding the improvement in functional mobility, the results of the current study showed that there was a significant improvement in the TUG test scores in both EGI and EGII when it was compared with CG at the endpoint. The improvement may be related to the improvement in balance skills, muscle strength, and foot posture that occurred in both experimental groups.Only male children were examined without having female participants because of cultural values in Saudi Arabia. Additionally, foot posture was assessed using the ND test only.Both plyometric exercises and foot correction exercises had a positive effect on foot posture, balance, and functional mobility in obese children with flatfeet. Both should be considered in the rehabilitation of children with obesity.


To develop and test a new posterior stabilization system by augmenting the posterior hook-rod system with screws and rods.A biomechanical analysis was performed using the finite element method. The anatomical structures were modeled based on computed tomography data. Instrumentation  was modeled based on the data obtained by 3D scanning. The discretized model was verified by converging solutions and validated against data from a previously published experiment. A Th12-L1 spinal segment was modeled and modified by removing the body of the L1 vertebra (corpectomy) and the entire L1 vertebra (spondylectomy). The model was additionally modified by incorporating stabilization systems: i) posterior stabilization (transpedicular screws and rods); ii) combined posterior stabilization with sublaminar hooks; and iii) combined anterior (titanium cage) and posterior (sublaminar hooks) stabilization. The rotation angles in each group, and the strains on each part of the three stabilization constructs, were analyzed separately.The combined anterior and posterior stabilization system was the stiffest, except in the case of lateral bending, where combined posterior stabilization was superior. Stress analysis showed that the posterior stabilization system was significantly unloaded when augmented with a hook-rod system. A significant strain concentration was calculated in the cranially placed hooks.Stiffness analysis showed comparable stiffness between the tested and proposed stabilization construct. Stress analysis showed luxation tendency of the cranially placed hooks, which would most likely lead to system failure. Several factors are to be considered when deciding on the type of treatment of spine fractures: biomechanical stability, deformity, and neurological injury -3. The pBiomechanical stability is achieved by using stabilization systems; based on the application site they can be anterior, lateral, and posterior. Stabilization systems enable anatomical restitution, fusion, and fast recovery . AnchoriWe aimed to test the hypothesis that the combined posterior stabilization system incorporating transpedicular screws, sublaminar hooks, and rods had comparable performance with regard to displacement and stability to the combined anterior and posterior stabilization in a virtual model of L1 corpectomy and spondylectomy.A biomechanical analysis of three stabilization systems was performed on a L1 corpectomy and spondylectomy model by using the finite element method. The analysis was performed with the finite element software ABAQUS, version 6.13-1 .The L1 corpectomy model  was usedBiomechanical properties of three stabilization systems were analyzed and compared on corpectomy and spondylectomy models: i) posterior stabilization system – transpedicular screws placed into the ThXII and LII vertebrae, connected by a longitudinal rod and a transverse link ; ii) comNode displacement was defined as a primary outcome. Displacement was calculated at four nodes at each loading cycle and each stabilization model. It was expressed in radians by calculating relative rotational displacements of specific points in the body of the Th12 vertebra during separate loadings. Next, stress distribution was analyzed during loadings on individual elements of the stabilization systems. The models were loaded by moments along three axes, leading to flexion, extension, and right-sided axial rotation . The benThe biological tissues were modeled based on data obtained by means of computerized tomography (CT) of a young multiple-traumatized patient with no injuries to the spine. Vertebrae were modeled as two separate units – vertebral body and posterior unit. Vertebral bodies were modeled as a composite of cortical and spongious bone, and posterior elements as an individual unit. Intervertebral discs were modeled so as to fit the intervertebral void produced by means of CT – the discs contain three separate elements . Inner tissue dimension were obtained from the literature  . All theBefore model validation, verification process of the model was assessed by determining the solution convergence for optimal finite elements density. Optimal node density was determined to be 282 885 hexahedral finite elements. Finally, the model was validated by comparing the calculated rotation angle at predefined specific points in the modeled functional spine unit Th12-L1 with experimental data from the 1972 Markolf experiment  and torsion (201 MPa). A similar pattern was observed for the left cranial hook . These findings might indicate weak spots of the system at which system element failure is most likely to occur.The analysis of peak stress in the screws of individual stabilization systems showed a concentration of stress at the bone entry site, which corresponds to the first thread. The result was identical for all analyzed cases and is in accordance with classical mechanics postulates.Stress analysis of the three stabilization systems showed several major results. First, reconstructing the anterior column by inserting a titanium cylinder significantly unloaded the screws of the posterior segmental stabilization system. Second, by strengthening the posterior stabilization with rods and hooks, cranial screws were significantly unloaded during flexion and extension. At the same time, stress on caudal screws remained similar to the stress on caudal screws of the combined anterior and posterior stabilization system. In addition, augmenting the posterior system with hooks and rods brought about a significant asymmetrical unloading of the screws, more prominently the caudal screws. Third, stress on the screws of stabilization systems occurred at first threads, a finding consistent with classical mechanics postulates. Fourth, stress was concentrated on the upper hooks with asymmetry in calculated strains and the maximum value at the upper left hook during lateral bending and torsion. Fifth, stress on longitudinal rods was reduced by augmenting the stabilization systems with hooks and rods, thereby making the stress values comparable to the values for the combined anterior and posterior stabilization. Sixth, stress on bones correlated with the calculated stress in the screws and hooks of stabilization systems. Finally, the transverse rod added to system stiffness mostly during lateral bending and torsion. Unloading of the transverse rod was comparable between combined posterior and combined anterior and posterior stabilization.Finite element method is based on physical discretization of a continuum. The continuum is discretized by a finite number of elements interconnected in points along the contours, called nodes of finite elements. Relations between the nodes are described by a function to determine the properties of the examined continuum – in this case, a biomechanical problem. The results of the analysis are therefore affected by: i) errors in the discretization of the continuum; ii) number and types of elements; iii) choice of function describing the properties of materials; iv) inadequately set extreme conditions and loadings; v) errors in describing the mathematical formulae; and vi) study design. The model was verified and validated to reduce the error margin.in silico experiment re-creation and comparison of experimental relations of the bending moment and resulting displacement angle of characteristic points. Difference in the displacement angle was 5.39% for flexion, 43.98% for extension, 8.4% for lateral bending, and 82.8% for torsion. These results show that the created model is only partially accurate in representing the experimental movements in the thoracolumbar spine. The discrepancies can be explained by several factors, eg, a difference in modeling material properties and a difference in patient age  between the cadaveric model and the in silico model. These differences were considered while interpreting the results.Building the model of the thoracolumbar spine included model verification and validation. Verification was used to determine the optimal density of the final elements. Validation was performed as an 2 and the cortical bone has an elasticity modulus of 12 000 N/mm2, which means that the load is transferred through the material with a higher elasticity modulus.The range of motion analysis  showed negligible differences between different types of stabilization systems for both spondylectomy and corpectomy, which excludes the impact of mechanical properties of models of the thoracolumbar spine on stabilization system models. This result is expected and easily explained by the fact that titanium has an elasticity modulus of 114 000 N/mmThe results of the analysis are affected by two other approximations. The first is the definition of the contact point between end plates of the Th11 and L2 vertebrae and the titanium cylinder, and the contact point between hooks and laminae. The contact point between the end plates and the titanium cylinder was defined as being solid, which enabled simulating properties of the anterior stabilization system – it consists of a titanium cylinder and a plate applied on the sides of the vertebral bodies and held in place by bicortical screws. We believe that the approximation is close to the real solution; however, this was not tested. Further on, the contact of the hooks and the laminae was also defined as being solid, which is not the case. The contact has a certain degree of freedom, which contributes to lesser loads on the hooks.Previous sections raise the questions of the study's internal and external validity, ie, the applicability of the results to everyday clinical practice. The results are of use when comparing the efficiency of the tested stabilization systems in a given setting, since the sources of errors are comparable between different systems. Absolute accuracy is accuracy in relation to the real situation.Internal (relative) validity of the results is significant, since the models were compared between themselves, and they all have the same degree of error in individual computer models. In this way, conditions of a separate system were met, and the results are relative values, which can be accurately compared between them. The calculated results of the stabilization models, when compared to the thoracolumbar spine model, are descriptive in their nature, ie, they are relative and hardly absolute, which results in a limited external validity of the study.As mentioned before, there are methods to assess the accuracy of the calculations, which is important for general applicability of the results of the numerical analysis. As well, it is important to compare the results with expected, ie, assumed events. For example, we assumed that the system of posterior stabilization would show the lowest stiffness and the highest loads on screws, that the system of combined anterior and posterior stabilization will be the stiffest system, and that loads on screws will be lowest – all these assumptions are in accordance with the results. The observed concentration of stress on the first thread of the screw is in accordance with the postulates of classical mechanics. Further, it is a known rule that the stabilization system should incorporate an additional level cranial to the fracture, as opposed to the caudal levels, which results in a significantly better stabilization systems stability . The resAs opposed to numerical analysis, laboratory experiments, in particular biomechanical experiments on the cadaveric spine, will yield accurate results for node displacement angles. Stress analysis results will surely have lower reliability due to technical possibilities and limitations arising from laboratory settings. Forces that would lead to stabilization systems failure would be easily measurable and analyzable. Results of such analyses have higher external validity and absolute accuracy; however the number of test samples would need to be substantial to account for different anatomical, physiological, and clinical variables. In real life, the surgeon applying stabilization systems considers variables that could lead to system failure and tailors the optimal stabilization system according to personal experience. Therefore, the single most important factor determining the optimal usage of stabilization systems is the surgeon's experience, arising from personal clinical practice, published experience, and experimental data.in silico and in vitro) are not to be considered absolute values; rather they serve to clarify relations between forces in complex systems. Technological advances have enabled direct measurements of stress on individual elements of stabilization systems. This approach permits accurate results that give precise insight into relations between forces and could probably be used for early intervention in the cases of impending system failure (Results of biomechanical analyses ( failure ,21,22.In conclusion, stiffness analysis showed comparable stiffness between the tested and proposed stabilization system. Stress analysis showed luxation tendency of the cranially placed hooks, which would most likely lead to stabilization systems failure.


Considering various researches were carried out to implement Lean techniques in healthcare centers, this study has tried to investigate how lean principles could be prioritized in the Emergency Department (ED) by comparing physicians and nurses viewpoints.In the first stage, relevant Lean techniques and several criteria to evaluate the ED performance were selected by reviewing the literature. Then, weight factors for each criterion were calculated using the Entropy method, and Lean techniques were compared and ranked via a questionnaire by which the physicians' and nurses' opinions were obtained separately. In the last stage, the final ranking of Lean techniques was done using VIKOR and SAW methods as two powerful means of Multi-Criteria Decision-Making (MCDM).Theory of Constraints (TOC) was selected as the most appropriate principle from the physicians' viewpoints by both decision-making methods. However, according to the nurses' opinions, Jiduka was the best approach by the VIKOR method, while with the SAW method, 5S was chosen as the most practical Lean technique.This study has illustrated that although all Lean techniques are useable for ED, these techniques' prioritization has a key role in choosing the more suitable Lean approach. Moreover, it provides a chance for the emergency wards to keep down different costs and improve staff and patient satisfaction and the quality of treatment simultaneously. Nowadays, with increasing the level of public welfare and increasing technological advancements, society and people have higher healthcare quality expectations. Conscious customers instigate change and improvement in all industries in different areas . In eachThere are many popular methods in to improve the performance of ED around the world, such as demand management, critical path, stream mapping, queuing systems, triages emergency severity index, Lean and Six Sigma management methods, bedside registration, statistical forecasting, conceptual and mathematical modelling, discrete event simulation and balanced scorecard .However, Lean manufacturing can be considered as a more attractive approach in ED in order to ameliorate the quality of care . Lean thet al. to enhance the quality of services. Using probability sampling methods was not possible due to lack of enough information about the overall population and dispersion of nurses and physician in all ED in Tehran. Furthermore, access to physicians and nurses was limited; hence, the snowball sampling method was used, and new subjects were recruited by existing study subjects. Subjects were asked if they could introduce other physicians or nurses matching wanted conditions and to provide means of connecting with them. Experts' judgment and assessment were referred to in order to ensure the content and face validity of the research tool. The reliability of the questionnaire was assessed using Cronbach's alpha, the value of which was obtained 0.82% using Minitab 16 software. Therefore, the questionnaire is reliable since the value of Cronbach's alpha is higher than 0.70. In order to determine a reliable prioritization for Lean approaches, two strong methods (VIKOR and SAW) have been chosen, which are used in different MCDM problems ,19. For SAW method: The detailed calculations of SAW are as follows  and N-=Min (Nij), and if the criterion is of negative nature, e.g., cost, then, N+= Min (Nij) and N-= Max (Nij).The best and worst cases in normalized alternative scores are called NStep 4: Calculating the utility and regret There are two basic concepts in the VIKOR method: utility (S) and regret(R). S is the distance of alternative i from the best case, and R is the maximum regret of alternatives from the best case.Step 5: Calculating the VIKOR indexesThe next step is to calculate VIKOR indexes for each criterion using the following formulas. The alternatives are ranked based on the VIKOR index.The constant v is the relative preference toward the utility or regret and is set to 0.5 for this paper.Step 6: VIKOR decision conditionsIf alternatives A1 and A2 have the first and second rank in alternatives, respectively, the following formula has to be true:Alternative A1 has to be the best choice in either S or RTwo final decision conditions in the VIKOR method:If none of these two conditions is met, both alternatives are ranked as the same rank.After an extensive ED literature survey, eight criteria were obtained to evaluate emergency performance. The criteria include the level of patient's satisfaction, percentage of patients admitted in the ED within six hours, percentage of patients discharged from the ED within 12 hours, percentage of failed CPR, percentage of patients leaving the emergency room, percentage of patients treated in ED, average triage time in each triage level, and the average duration of staying in ED. As mentioned in the previous section, there was a need to lower standards; hence, six criteria that were more important than other indicators were obtained using views of five academic and medical experts.The six criteria are as follows: Patient's level of satisfaction, percentage of patients admitted in the emergency department within 6 hours, average triage time in each triage level, the volume of patients treated in ED, percentage of failed, and percentage of patients leaving the emergency room.x which are used in , Seiton (streamlining), Seiso (cleaning), Seiketsu (standardize), and Shitsuke (sustain) .Value stream mapping (VSM): It is a tool used to distinguish non-value adding processes from the value-adding processes. This method analyzes the entire processing time and specifies value-lacking times .Jiduka: It refers to the time when the process is stopped due to a problem. This method requires staff to have maximum authority  to solveTheory of Constraints (TOC): It is a process that focuses on critical points in a process and tries to solve the constraints that stand in the way of achieving a goal .Kaizen: It means continuous improvement. This method refers to eliminating wastes on an ongoing basis .In the next step, the target clinical people were asked to complete questionnaires prepared based on comparisons of Lean approaches with respect to each criterion, as well as prioritizing indicators against each other. Finally, a total of 42 and 61 complete responses were obtained from physicians and nurses, respectively, because some of the questionnaires, which were completed imperfectly and inaccurately, were excluded. The summarized demographic information of the final sample is shown in In the following step, the mean of the weights given by ED physicians and nurses to each criterion is introduced in the entropy method, and the weight for each criterion is calculated and shown in In the next step, based on the weights calculated by the entropy method and using the normalized decision matrix, the final weight of each alternative was calculated using the SAW method. Considering different situations of work for nurses and physicians, the prioritization for these groups was done separately. The results of these calculations are shown in In the following step, after deriving the weights of criteria, the VIKOR method's calculations are implemented. Like former prioritization, physicians and nurses are separated in the decision-making process to find more transparent evaluation for improving ED. The utility (S) and regret (R) values, as well as the VIKOR value for each alternative, are shown in As shown in The reason for choosing TOC in physicians' viewpoints is that physicians think the problems and constraints imposed on treatment processes are the main reason behind the low productivity. Therefore, addressing and resolving excessive regulations and wasteful constraints can be a good way of moving toward a leaner center. On the other hand, regarding choosing Jiduka from nurses' viewpoints, nurses feel that if they are given more authority and attention, they will play a significant role in improving the ED. Moreover, maybe the difference in weighting ED indicators is the cause of this discrepancy. After C5, which is about failed CPR in ED, physicians have more attention to patients' satisfaction (C4) while nurses focus on treating more patients in ED (C3). Considering the negative effects of pausing a process to solve an error or problem on patients' satisfaction, probably physicians preferred to choose a technique without a direct effect on treatment procedure. Hence, TOC can be accounted for as a more suitable technique in their opinion because it usually considers long-term plans to eliminate constraints in ED. Considering the increasing attention to public healthcare and the need for increasing the quality of treatment services, moving toward creating new and efficient systems in emergency wards is inevitable. New systems in the emergency wards should keep down different costs and improve staffs' and patients' satisfaction and the quality of treatment simultaneously. The lean approaches, while facilitating the achievement of stated objectives, can ameliorate the value of the treatment received by patients. In this regard, there are numerous hospitals throughout the world taking advantage of lean principles in their emergency department. Because of the sensitivity of the ED as well as the high patient traffic in this ward, it is really difficult to make an optimal decision about selecting the right lean approach, due to resource constraints, to improve the performance of this ward. Therefore, the prioritization of these techniques is necessary and unavoidable. It is worth mentioning that, generally, the best classification of Lean principles does not exist. Hence, considering the similarity of structures and procedures in emergency wards, the Lean approaches have been prioritized just for ED in this research.It should be mentioned that it is impossible to use Lean thinking techniques in the ED without cooperation between managers and emergency personnel. Therefore, promoting Lean thinking culture among staff and the management and their collaboration are essential to execute these approaches.Even though many studies have been conducted on the implementation of Lean techniques in the emergency department, there are considerable opportunities for the next researches in this area. For example, one of the appropriate areas for future research is to investigate the relationship between criteria and techniques through ANP  or other novel MCDM techniques. It is also recommended to present appropriate models and roadmaps in order to implement different Lean principles in the ED. Also, prioritization of Lean techniques in other wards of the health centers can be another appropriate topic for future research.