Writing assessment relies closely on scoring the excellence of a subject’s thoughts. This creates a faceted measurement structure regarding rubrics, tasks, and raters. Nevertheless, most studies did not consider the differences among raters systematically. This study examines the raters’ differences in association with the reliability and validity of writing rubrics using the Many-Facet Rasch measurement model (MFRM) to model these differences. A set of standards for evaluating the quality of rating based on writing assessment was examined. Rating quality was tested within four writing domains from an analytic rubric using a scale of one to three. The writing domains explored were vocabulary, grammar, language, use, and organization; whereas the data were obtained from 15 Arabic essays gathered from religious secondary school students under the supervision of the Malaysia Ministry of Education. Five raters in the field of practice were selected to evaluate all the essays. As a result, (a) raters range considerably on the lenient-severity dimension, so rater variations ought to be modeled; (b) the combination of findings between raters avoids the doubt of scores, thereby reducing the measurement error which could lower the criterion validity with the external variable; and (c) MFRM adjustments effectively increased the correlations of the scores obtained from partial and full data. Predominant findings revealed that rating quality varies across analytic rubric domains. This also depicts that MFRM is an effective way to model rater differences and evaluate the validity and reliability of writing rubrics. Writing skills are complex processes and require the coordination of various high metacognitive skills. In order to produce written ideas, a writer must be able to organize and generate ideas, develop plans for ideas, review the writing, and monitor self-esteem in writing . WritingWriting skills are productive and expressive, and both are important as information conveyers. Writing skills are productive because writing is a productive activity of written work in the form of the expression of one’s thoughts. Whereas expressive implies appropriate (able to) give (expression) images, intentions, ideas, and feelings . WritingThe production of a piece of writing is the highest level in writing skills, which is the skill of producing an essay have harmony of words and meaning. The basic skills in writing are constantly developing and becoming more complex, especially when it comes to high-level writing skills that involve more complex knowledge about oral language skills, including knowledge of vocabulary and word retrieval as well as grammar and syntax. High-level writing also requires proficiency in the use of executive functions such as planning and working memory involved in the generation and transformation of ideas into words .Refers to the context of writing skills in learning Arabic; it is a language skill that is emphasized a lot. This is in line with the content of textbooks that are more inclined to a written assessment format than listening, speaking, and reading . StudentConducting a study to assess the mastery of writing skills is a necessity. The aspect of vocabulary knowledge is one of the aspects of language that need to be paid attention to in writing skills in addition to aspects of grammar, organization of ideas, and language style. In fact, vocabulary is also an aspect of the language that needs to be mastered, as stated in the Arabic curriculum document. There are several issues regarding the assessment of Arabic language writing. The first issue is that Arabic language teachers usually only focus on teaching grammar to the point of marginalizing the importance of vocabulary mastery . While fIn line with this requirement, this research aims to examine written assessment in Arabic using an expository essay, which provides valid, accurate, and fair ratings that are compatible with students’ word acquisition in Form Four for religious schools in Malaysia. There are four aspects of language that are emphasized in the assessment of writing skills based on the rubric of the Malaysian Certificate of Education (SPM) Arabic Trial Exam in the State of Selangor, namely, (1) vocabulary, (2) grammar, (3) language style, and (4) aspects of text organization before formulated into the overall test score for students’ writing skills.The designed writing assessments are a reflection of language learning purposes. The essay produced by a student is an indicator of the student’s ability to master a foreign language communicatively . In lineExamining the facts in-depth, In line with Holistic scoring is difficult for second-language learners as distinct elements of writing skills evolve differently for various writers. A study conducted by Earlier studies have shown that raters have a significant effect on written assessment results. Researchers recognize the mediating importance of rater judgment in student writing . In otheThe present study emphasizes that raters have several variables to address when rating and participating in tasks that require an assessment from various information sources. However, in contrast to the studies conducted in the Arabic language, written assessment receives less attention and emphasis on empirical validation and reliability. Therefore, it is essential to monitor rater quality in terms of their usage of rating scales and contribution to test the validity and reliability. The current study focuses on the examinees (essays), raters, writing domain (rubric), and rating scale for 15 Arabic essays. Thus, the analytical method was selected in order to control the consistency of raters’ ratings based on the designated scoring criteria.This research aims to examine written assessment in Arabic using an expository essay, which provides valid, accurate, and fair ratings. Concurrently, this study provides information on the characteristics of effective writing. We used a scoring rubric from previous examinations that inform raters about high-quality writing throughout the scoring process. These rubrics also minimize discrepancies between raters given the distinct instrument interpretations. The following sections present the sample, rating processes, and data analysis procedures that demonstrate the validity, reliability, and fairness of the data scores. Specifically, the following research questions are to be answered in this study:a.To what extent do the interpretation and use of writing domains in the rubric demonstrate validity?b.To what extent do the interpretation and use of writing domains in the rubric demonstrate reliability?c.To what extent do interpretation and use of writing domain in the rubric demonstrate fairness?This study uses an analytic scoring rubric adopted from previous state examinations for the Malaysian Certificate of Education Trial Examination for Arabic. The main reasons of doing this research topic is because it has highly needs to examine written assessment in Arabic which will provides valid, accurate, and fair ratings. Previously, not much was discussed regarding empirical evidence about the accuracy of assessors in giving accurate assessments related to Arabic writing. Formerly, evaluation was limited to the use of analysis such as Cohen Kappa, which is more limited to raters. The main instrument/examinee in this study are 15 essay selections based on the writing performances of the respondents. The essay was produced by Form Four students from a religious secondary school, which is under the supervision of the Ministry of Education. However, the topic of the proposed essay is one of the themes in the Arabic language syllabus, which is written in the textbooks. Therefore, it is not a peculiar matter for respondents to write an essay according to the selected title. The essay selection was based on a researcher’s brief assessment of the essay quality ranging from good to moderate and weak. The essay was collected and printed in one booklet. Rubric scoring guides and rating scales were provided for each essay. The layout print was used to enable the raters to review the essays.Five proposal titles were chosen for expository essays to gain experts’ agreement. First, the procedure for determining the content validity of the writing task involves five experts in the selection of appropriate essay titles and scoring rubric items. At this phase, the content validity index (CVI) was applied to determine the expert agreement scores. The CVI covers the validity of the item (I-CVI) and that of the entire instrument (S-CVI) . Each exThe value of I-CVI was used to determine the reliability between the experts in line with the average level of suitability of each item based on the assessment of all appointed experts. The accepted I-CVI value is 1.00 based on the value of the five expert’s agreement. Meanwhile, the S-CVI value of the essay is 0.91. Students were informed that the essay was to assess students’ knowledge of vocabulary and their ability to construct context-related sentences. Students were asked to write no fewer than 40 words based on their creativity within 30 min. The five raters were then given the five essays to evaluate. Five raters gave each essay a score, and the amount of connectivity needed for a Rasch analysis was found. The five raters were asked to rate the essays using the Malaysian Certificate of Education Trial Examination for the Arabic rating scale . The rubric is analytical, which comprises domains of writing known as vocabulary, grammar, language use, and Organization as agreed by experts. Every domain contains three scales: excellent (score 3), moderate (score 2), and weak (score 1). The reasons for choosing the analytical rubric are because it can explicitly segregate an assignment into its constitutive skills and provides the assessor with guidelines for what each performance level looks like for each skill.The selected scoring rubric is from a previous state examination for the Malaysian Certificate of Education Trial Examination for Arabic. This examination was implemented in one of the states in Malaysia in 2015. The use of a scoring rubric is based on assumptions that the scoring format is similar to the summative test, which is commonly used for school-based assessment. Although the scoring rubric has been used widely, its validity and reliability have to be tested according to the scope of this study. In contrast, the respondents of this study are also exposed to such essays in the classroom.The essay selection is the result of the respondents’ writing performances. They were 15 essays of Form Four students from a religious secondary school, which is under the supervision of the Ministry of Education. However, the topic of the proposed essay is one of the themes in the Arabic language syllabus, which is written in the textbooks. Therefore, it is not a peculiar matter for respondents to write an essay according to the selected title. The essay selection was based on a researcher’s brief assessment of the essay quality ranging from good to moderate and weak. The essay was collected and printed in one booklet. Rubric scoring guides and rating scales were provided for each essay. The layout print was used to enable the raters to review the essays.Meanwhile, the selection of raters was based on their experience in Arabic language education. Two teachers are expert teachers in Arabic who have been teaching for more than 10 years in secondary schools. In contrast, two more raters are experienced teachers who have been teaching Arabic for over 20 years in a religious secondary school that is under the supervision of the Ministry of Education. Another teacher is a novice teacher who has 5 years of teaching experience in Arabic in a secondary school. They were chosen because of the research to evaluate the rubrics used as well as validate them using the Malaysian Certificate of Education Trial Examination for Arabic rating scale. This study employed the Many-Facet Rasch measurement model (MFRM) model to explain how the rater interpreted the scores of the writing tasks. For this research context, the Rasch model is extended by MFRM to situations in which more than two facets interact to produce an observation in Arabic writing. It enables the development of a frame of reference in which quantitative comparisons are no longer dependent on which examinee was rated by which judge on which item. In order to support the research in the Arabic language, this analysis seeks to evaluate the rubrics used as well as validate them. Raters mediate the scores of the essays. In other words, self-rating does not represent the writing quality of the test directly as the rater’s judgment plays a crucial role . Hence, A previous study used MFRM to investigate the variations in rater’s severity and consistency before and after practice and found that rater training contributed to increasing the accuracy of the scorer’s intra-rater reliability  . Lim 20.The findings could portray in-depth that the MFRM can monitor rater’s performances and considers the potential effects of facets on the resulting scores. Facets such as raters, rating scales, and examinations are arranged within the standard interval scale with rater scores . Two assThe raw data were keyed-in using Microsoft Excel and analyzed using the MFRM by the FACETS 3.71.4. A program named FACETS 3.71.4 was used to analyze the data in MFRM. This study represents the relationship between facets assessment and the probability in which specific results will be observed within more than one-faceted circumstances. In addition, this research is an expansion of the Rasch measurement theory , in whicThis variation in the MFRM enables a classification scale framework to differ by item in this situation. The MFRM can demonstrate discrepancies among raters in the use of scoring classifications . The Mann represents individual ability, δi represents the level of scales difficulty, Fk represents the level of threshold difficulty, and Cj represents the level of rater’s efficiency.where βThe reliability of the essay is 0.88, while the separation index is 3.88, thus indicating good reliability . WhereasRaters displayed reasonable agreement based on the value of the inter-rater reliability of 52.9%, which was not different from the 55.0% despite the moderate reliability. These findings may elaborate that the raters had the same opinion in scaling the essay rating and vice versa . OverallThis calibration was analyzed using a rubric-based rating scale, where scale 3 = distinction, scale 2 = medium, and scale 1 = weak. In general, the variation in each rubric scale is in the appropriate range of 1.4–5.00 , 2004, aOn average, the examinee (essays) locations were close to logit scales at the rater scale and rubric base rating scale . This measure suggests acceptable targeting between the three facets. The first column indicates the estimated location of the logit scale of the test-takers (essay), raters, and item . Higher numbers denote higher judged writing performance, more severe raters, and more difficult rating scale categories. The second column depicts the locations for essays. The examination of the essay locations reveals a wide range of locations between −3.40 and 1.76 logits for the lowest (mean rating = 1.18) and highest judged writing performances (mean rating = 2.45), respectively. The third column shows the locations for the item or writing domain for the rubric. The examination of these estimations reveals a range of item difficulties, between −0.41 logits for the item that was judged as easiest  and 0.39 logits for the item that was judged as the most difficult . The fourth column depicts the locations of the individual raters. The location estimates reflect differences in rater severity, ranging from −0.78 logits for the most-lenient rater  to 0.01 logits for the most severe rater . The final fifth column in the variable map illustrates the categories of the calibration of the rating scale ranging from scale 1 to 3.The accuracy of the location estimation was assessed using SEs and separation statistics. The five raters who assessed the essay can be classified into three categories: stringent, moderate, and lenient. This measure can be seen in the fourth column (column Rater) in the range of −1 to +1. Rater E is considered the most lenient in scoring, while raters A and D are modest in scoring. Meanwhile, raters B and C are stringent raters in this essay scoring, and both of them taught Arabic in a lower form. Rater E is a novice teacher who only has 4 years of experience in teaching Arabic at a lower form in a secondary school. Rater B is an Arabic teacher who has taught Arabic for 15 years for lower form, and also rater C who taught Arabic for 22 years at a religious secondary school.Rater E is a novice teacher who has taught the Arabic language for 4 years in a lower form at secondary schools. Meanwhile, raters A and B have been teaching Arabic at secondary schools for more than 10 years for upper and lower forms. In addition, rater C taught Arabic in the lower form, while rater D taught the upper form for more than 20 years at religious secondary schools. The diversity of the rater’s backgrounds reflects their performance in assessing the essay. The Arabic teachers who taught upper forms are considered a better scoring performance than those who taught lower forms. The performance displayed by raters A and D is likely to result from their experience in teaching senior high-school students. Notably, the type of school does not influence the rater’s performance. Conclusively, the variable map see  depicts Additional proof is required in various contexts to determine the psychometric features of the rubrics in writing. Specifically, a future study could investigate whether the new rubrics may be added to determine the efficacy and efficiency of each rubric rating in terms of reliability, validity, and fairness. The raters in this study demonstrated different seriousness levels when using the rubrics to evaluate the students’ outcomes. Statistically, the Rasch model alleviates rater severity in the calculation of test-takers’ results . HoweverThe findings from this study demonstrate strong validity, reliability, and fairness of scores. Overall, the Many-Facet Rasch measurement model (MFRM), which is rarely used in Arabic studies, reflected that the rubric for rating scores has good reliability and validity and can be used in actual studies. All raters can effectively differentiate the functions of each rubric and rating scale. The use of rubrics in scoring can detect the strengths and weaknesses of students in writing skills . The feedback from scoring could assist teachers in developing ideas regarding teaching strategies based on students’ weaknesses. The choice of the analytical method is more accurate than the holistic method in order to assess the writing performance. Moreover, an analytical method could be provided through the information on the mastery stage of each writing domain.The original contributions presented in this study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.The studies involving human participants were reviewed and approved by Ministry of Education Malaysia, Putrajaya. The ethics committee waived the requirement of written informed consent for participation.HB was involved in data collection. ZM wrote the first draft of the manuscript. All authors were responsible for the conception, design of the study, performed statistical analysis, contributed to the interpretation of findings, made critical revisions, and have read and agreed to the published version of the manuscript.


The purpose of this study was to explore whether team-based learning (TBL) was more effective than traditional didactic lectures (TDLs) in improving medical students' problem-solving and study skills in the clinical course of ophthalmology. In addition, we were also concerned about Chinese students' satisfaction with TBL.Our study program involved 275 students of the 5-year clinical medicine program from Central South China University, of which 140 were enrolled in a modified TBL course. A questionnaire that included closed-ended and open-ended items was distributed to students immediately following the completion of the TBL session, and 108 valid questionnaires were collected. Descriptive statistics were used to analyze quantitative data. The effects of the TBL module on students' performance were measured between the groups using a one-way between-group analysis of variance (ANOVA) test by the individual readiness assurance test (IRAT), the group readiness assurance test (GRAT), and final examination scores (FESs), compared with a class without the TBL session.p = 0.3434). The performance in a pre-class quiz was significantly better in the GRAT compared to the IRAT. In comparison to the TDL session, the modified TBL was preferred and acceptable by most medical students.With our modified TBL strategy, 140 students achieved a mean test score of 72.65 on test questions that assessed their knowledge of ophthalmology compared to 135 students who achieved a mean score of 70.8 using the TDL method (By applying the modified TBL to ophthalmology, students improved their performance, self-study, and teamwork, and their class engagement and satisfaction were enhanced. However, TBL should be further optimized and developed to enhance educational outcomes. Team-based learning (TBL) was first popularized at the University of Oklahoma in the 1970's due to increasing class sizes and concerns about its effectiveness . It is aHowever, the most popular education method in China is the traditional didactic lecture (TDL) . These sTo improve the medical teaching method in large classes, we decided to apply TBL an ophthalmology clerkship and evaluate its efficiency and student's learning abilities. According to a previous study, we launched the modified TBL with the help of advanced technology of Superstar app and lecture, which intends to attract the students' attention and interest. The lecture in the TBL covers clinical development or biological advances in each unit. At the end of our pedagogical method, we assessed TBL satisfaction and efficiency using a questionnaire. In addition, we investigated whether any other improvement of TBL would benefit our students, based on the feedback from students. In conclusion, these findings can provide insights into an understanding of the ways of effective teaching and some TBL problems in medical education, which may also be referable to other countries, especially those countries with similar pedagogical structures as China.Our study population comprised third year medical students  from the Central South China University. In the third year, the students moved to the hospital, where they were rolled into various medical subspecialties including ophthalmology, and underwent clinical clerkship during our TBL course. Approximately 80 faculty members from the ophthalmology department were part of the TBL teacher. In total, 140 students participated in the TBL session. The Human Research Ethics Committee of Central South University approved this study. All methods were carried out in accordance with relevant guidelines and regulations.The score of the individual readiness assurance test (IRAT) and the group readiness assurance test (GRAT), including the score of a comprehensive clinical application at the end of the class, and the final examination scores (FESs) were selected to provide learning outcomes in our assessment. Furthermore, our results also include satisfaction questionnaires and the evaluation of teaching goals.The duration of the TBL session was 150 min with two breaks. The session was held outside the students' regular weekly schedule to preview the MOOC video and book. The students were randomly divided into 10 teams per class and evenly distributed by gender, with each team consisting of ~14 members. Two or three teachers were randomly allocated to these groups to participate in the discussion section in the GRAT and the comprehensive clinical application task.All students were allocated required compulsory readings for pre-class reading and pre-recorded lectures to review.At the beginning of the class, all students were required to complete an online quiz with the Superstar app. The quiz consisted of 10 multiple-choice questions, with a single best answer or multi-choice for each question. Questions were aligned with pre-class reading and pre-recorded lectures. Students were provided with a 15-min window to complete the quiz and were provided with their total score upon completion.The same IRAT quiz was repeated by the other students in their teams. The test was conducted online, and students submitted one answer per team, with the intention of promoting a discussion to establish a team consensus.Then, the correct answers were released and explained, giving immediate feedback on the team's responses in ~30 min. The teacher offered clarification, particularly when individuals or teams had problems.Our teachers gave an interesting lecture with the intention of exploiting the horizon of medical students in learning ophthalmology and the content of the lecture which includes the progress of scientific research, the operation of each disease, and advanced medical technologies. This lecture lasted for about 1 h. We added this section with the intention of increasing students' interest in ophthalmology.The students worked in their teams on problem-solving activities, using the knowledge consolidated through the prior steps. In the immediate feedback session, there was an opportunity for students to initiate a discussion and challenge the answers. The overall plan is shown in Each TBL class comprises a professional team of facilitators and three ophthalmologists. These facilitators received prior training in TBL facilitation by either attending a face-to-face training semester. In our modification, we provided additional professional research lectures and specialty clinical lectures in the international language, which include elements such as how to prompt clinical reasoning through questions.We collected data using multiple questionnaires regarding TBL experiences and study outcomes. The questionnaire was distributed to the student immediately following the completion of the TBL session. These questionnaires included closed items .The interviewers used a guide that contains seven standardized, open-ended interview questions about general impressions of the dissemination of TBL in the school, the degree of use of TBL in specific courses, scholarship on TBL, and the future. A series of prompts were included to ensure that each question was explored in similar detail between interviewers. A copy of the interview guide is provided in We used the descriptive statistics method to analyze our questionnaire data. Thematic analysis was used to build an understanding of the students' experience of the TBL session. A portion of the data was read by the first author and analyzed to identify initial themes. Following the negotiation of meaning with the second author, a coding framework was developed and applied to the full data set.2 test; differences in the mean of the IRAT and GRAT scores were tested using a two-sample t-test if the assumptions of normality and homogeneity were satisfied; otherwise, the nonparametric Mann–Whitney U-test was applied. A one-way analysis of variance (ANOVA) were used to compare the IRAT, GRAT and final exam scores among students stratified according to BOLs. All analyses were performed using SPSS software version 22.0 .Differences in proportions between the TBL and PL groups were tested using the χThe Institutional Review Board (IRB) of Xiangya Hospital, Central South University approved this study. Participation was voluntary, consent forms were signed, and anonymity was guaranteed. All methods were carried out in accordance with relevant guidelines and regulations.A total of 140 students participated in our TBL method . Of thesp = 0.3434). However, the number of failed students is much higher in TDL than in TBL (31 vs. 17) and the number of students passed is more in TBL than in TDL (36 vs. 25). Fair, good, and excellent students are similar in number in both TBL and TDL .The proportion of correct answers was significantly higher in the GRAT than in the IRAT  and withThe data showed that TBL training could at least match our previous traditional method, and some other capabilities, such as collaboration and expression, demonstrated strength in this educational method.At the end of the module, students were asked to rate their experience with TBL. We first evaluated the teaching objectives of the TBL model, and the result is shown in We next investigated the effects on learning ability and study interest, with a focus on oral expression, independent thinking, and time management, with 20.37, 18.52, and 25.93% disagreeing, respectively ; there sThe aim of TBL was to increase the collaboration ability; thus, we wondered whether teamwork was somewhat enhanced, and we also collected data on their clinical competence after our TBL class. We clarify our issues in the following parts, such as the participation of each person and the existence and acceptance of different opinions. The data are shown in At last, we focused on the evaluation of students' satisfaction with TBL, where students thought that TBL helped them to master their present knowledge, provided them with more opportunities to express themselves, and had a positive impact on their learning attitudes. In Over the past 30 years, educators on college campuses have increasingly employed a group teaching method called TBL . It was Before our class, we used MOCC and guidebooks to publish tasks. The TBL method was unacceptable at first due to heavy tasks, and they did not have enough time to preview the entire curriculum; after several TBL training sessions, students tended to accept it and were more willing to spend time on the preview.During our class, we used the Superstar app for a test during our TBL class, and it can show the learning results immediately so that students' wrong knowledge points are displayed in the form of a pie chart , which iIt is accepted that, with group learning methods such as TBL, groups should outperform individuals , 18. TheHowever, we also found that the section of group discussion was not fierce, and students were afraid to communicate with each other even if they had an idea, which might be due to the spoon-fed education pattern, and TDL is the most universal education model in China since primary school. They were afraid of expressing themselves, so they were more inclined to listen than deliver their opinions.In our survey, we collected feedback at the beginning of our TBL, and most of the students do not accept this model. Approximately 57.8% of them are more willing to return to TDL. They complain about little time to preview due to the heavy task of their study work. In the program of medical students in China, students enter the medical undergraduate program after high school, which increases our students' need to learn more basic knowledge in their MD program and virtually increases the learning task of medical students.Moreover, in our study, we found that TBL is superior to lecture-based learning only when students have reached a comparable understanding of ophthalmological theories; otherwise, it will be difficult for students to answer quizzes and engage in effective discussion. The data show that about 47% of them have problems with the online quizzes at the beginning of class, but at the end of several TBL classes, only 4.63% of the student agree with the difficulty of IRAT . We thouPrevious studies  found thOur students are more willing to be neutral when there is a neutral choice in each quiz but are likely to partially agree if the options do not have neutral. This suggests that most of our students are neither sure about the effect of TBL on themselves nor about their future planning. However, we overlooked one significant detail that we provide answers to after the IRAT, and this may decrease their explorative learning and has also affected the group dynamics, which is essential to keep them focused. They indeed do not know what is most suitable for them. The reason for this phenomenon may be attributed to a long time of spoon-feeding education, and students are reluctant to express their radical ideas. We need to improve our discussion step since the highest proportion of disagreement on team discussion facility is understanding knowledge. At this point, TBL will be a kind of quality cultivation, learning from excellent team members.In conclusion, we used questionnaires to gain insights into the use of TBL in medical education. Despite an increase in the use of TBL, it is not popularized in Chinese undergraduate education. We are on the way to creating a Chinese-adapted TBL model. These changes were associated with several factors at the faculty, student, course, and administrative/curricular levels. Schools that desire to implement TBL would do well to consider these characteristics when developing their implementation plans.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by the Central South University of Human Research Ethics Committee. The patients/participants provided their written informed consent to participate in this study.WW and DW designed the questionnaire. LP drew some figures. EZ distributed the questionnaire. WW analyzed the data and wrote this manuscript. XX, SX, XZ, and DW revised this manuscript. All authors contributed to the article and approved the submitted version.This work was supported by Hunan Province ordinary higher education reform research general education project (HNJG-2021-0311) to DW, CSU education reform research general education project (2021jy138) to DW, the key project of Postgraduate Education and Teaching Reform of CSU (2020JGA008) to DW, the key project of Academic Degree and Postgraduate Education Reform in Hunan Province (2020JGZD011) to DW. The key project of Hunan Provincial Education Department entitled Exploration and practice of classified training of clinical medical doctoral students (2020JGZX002) to XX.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


Background: Therapeutic drug monitoring (TDM) is one of the useful clinical tools that aim to improve and ensure the best therapeutic effects while avoiding drug-related toxicity. We aimed to evaluate the knowledge and attitude toward TDM practices among healthcare practitioners in the Najran region, Saudi Arabia.Methodology: A cross-sectional study was conducted between May 2021 and October 2021 for assessing the awareness and attitude of licensed doctors and pharmacists working in Saudi Arabia regarding TDM practices. A 31-item questionnaire was distributed to the healthcare professionals via an electronic link. Descriptive and inferential statistics were used to report the data.Results: A total of 392 participants submitted questionnaires. More than half of the professionals (55.9%) had an overall awareness of the TDM, while only 3.1% did not. Only 16% and 23% of those who were surveyed indicated that TDM is used at the beginning of medication administration and when shifting from one drug to another, respectively. The majority of the professionals responded that TDM is revealed with laboratory changes in liver and kidney function (81%), and TDM is specified with suspected therapeutic failure (93%). Only half of the respondents claimed that they had ever requested or suggested a TDM in their practice. More than 90% of the respondents claimed that they were aware of the indications for vancomycin (n = 381), gentamicin (n = 375), lithium (n = 369), digoxin (n = 380), and theophylline (n = 369).Conclusion: This study found that the majority of the healthcare professionals in Najran were aware of the TDM, particularly those with more than 10 years of professional experience. In addition, TDM service is not widely available in smaller hospitals in Najran. There is a need to conduct customized training programs for junior healthcare professionals, thus increasing the levels of awareness toward TDM. Future studies in Saudi Arabia can explore the role of clinical pharmacists in the provision of TDM services by assessing the clinical and economic outcomes of pharmacist interventions in TDM. Therapeutic drug monitoring (TDM) is defined as “measuring serum concentrations of a drug at single or multiple time points in a biological matrix after a dosage with appropriate medical interpretation .” The maIn the 1970s, TDM concentrated on drug safety, and reduced the occurrence of toxicity through determination and confirmed therapeutic ranges . After tDrug monitoring facilities became one of the most important subjects in modern hospitals between clinicians, clinical pharmacists, and pharmacologists in the former two decades. The enhanced awareness about the association between drug concentration and therapeutic response among several physicians in different specialties worldwide encouraged a wide range of computerized analytical technology involved in TDM . HealthcIn Saudi Arabia, the TDM service was formerly recognized, but this service is still limited, especially in decentralized regions . The appWe conducted a cross-sectional study between May 2021 and October 2021 for assessing the awareness and attitude of licensed doctors and pharmacists (working in the Najran region of the Kingdom of Saudi Arabia) regarding TDM practices.A 31-item questionnaire  had an overall awareness of the TDM, while only 3% did not demonstrate awareness of the TDM Table . There wOnly 16% and 23% of those who were surveyed indicated that TDM was used at the beginning of medication administration and when shifting from one drug to another, respectively. On the other hand, most of the professionals responded that TDM is revealed with laboratory changes in liver and kidney function (81%), and TDM is specified with suspected therapeutic failure (93%). None of the professionals’ characteristics had been associated with their awareness of TDM’s indication during the liver and/or kidney impairment. Except for the working site , there were statistically significant differences between the other demographic variables and awareness of the shift from one medication to another and the onset of treatment (Table Only half of the respondents claimed that they had ever requested or suggested a TDM in their practice. More than 90% of the respondents claimed that they were aware of the indications for vancomycin, gentamicin, antiepileptics, lithium, digoxin, and theophylline, which are targeted by TDM assays Table .After adjustments for other factors Table , only thRespondents were also asked to mention barriers to not using TDM in their hospitals Figure . The mosThis study was performed using an anonymous electronic questionnaire to assess the level of awareness and attitude of Najran-based healthcare professionals, such as doctors and pharmacists, toward TDM practices. World Health Organization highlights that there is a lack of an appropriate setting of a system of surveillance for drug-drug interactions, irrational prescribing, and polypharmacy . These pThe majority of the healthcare professionals in our study had an overall awareness of the TDM, which is consistent with that of other studies conducted among healthcare professionals ,16,17. SRegarding the barriers that limit the application of TDM in Najran according to the opinion of healthcare professionals, study participants reported that the unavailability of the analytical test in the hospital was the most important barrier to not using TDM in the hospital, followed by the insufficiency of the proper laboratory report and proper laboratory recommendations and the absence of awareness about the proper sampling timing and guidelines. The previous study also reported the insufficiency of a proper laboratory report with guiding recommendations . For druHalf of the healthcare professionals in our study claimed that they had ever requested or suggested a TDM in their practice and were aware of the indications for vancomycin, gentamicin, antiepileptics, lithium, digoxin, and theophylline, which are targeted by TDM assays. This evidence is consistent with those of other reports ,20.In this study, the size of the hospital showed a significant association with a higher number of reported medications, indicating TDM. Healthcare professionals working in hospitals with more than a 50-bed capacity were twice more to report a higher number of medications indicating TDM than those working in hospitals with a 50-bed or less occupancy. In our study, most of the healthcare professionals work in a small hospital with less than 50 beds, which is also one of the reasons for not providing TDM services. Likewise, a previous study in Malaysia reported that hospitals with a smaller number of beds lack TDM service . AnotherThe most important strength of this study was the diversity among healthcare professionals who responded to the study questionnaire from different areas of Najran. However, there are certain limitations as well. The participants only belonged to one state. The nature of this study meant that we superficially explored this research area, and more detailed work would be of value in the future, including exploring the reasons for the unavailability of TDM service in smaller hospitals nationally and strategies to overcome barriers. Another limitation is related to the self-reported questionnaire, as outcomes may certainly be influenced by healthcare professionals’ subjective factors. However, it is anticipated that the anonymity of the study questionnaire urged honesty.This study found that majority of the healthcare professionals in Najran were well aware of the TDM, particularly those with more than 10 years of professional experience. In addition, TDM service is not widely available in smaller hospitals in Najran. There is a need to conduct customized training programs for junior healthcare professionals, thus increasing the levels of awareness toward TDM. Future studies in Saudi Arabia can explore the role of clinical pharmacists in the provision of TDM services by assessing the clinical and economic outcomes of pharmacist intervention in TDM, and their knowledge, attitude, and practices toward TDM.


Healthcare associated infections are of significant burden in Australia and globally. Previous estimates in Australia have relied on single-site studies, or combinations thereof, which have suggested the burden of these infections is high in Australia. Here, we estimate the burden of five healthcare associated infections (HAIs) in Australian public hospitals using a standard international framework, and compare these estimates to those observed in Europe.We used data from an Australian point prevalence survey to estimate the burden of HAIs amongst adults in Australian public hospitals using an incidence-based approach, introduced by the ECDC Burden of Communicable Diseases in Europe.We estimate that 170,574 HAIs occur in adults admitted to public hospitals in Australia annually, resulting in 7583 deaths. Hospital acquired pneumonia is the most frequent HAI, followed by surgical site infections, and urinary tract infections. We find that blood stream infections contribute a small percentage of HAIs, but contribute the highest number of deaths (3207), more than twice that of the second largest, while pneumonia has the higher impact on years lived with disability.This study is the first time the national burden of HAIs has been estimated for Australia from point prevalence data collected using validated surveillance definitions. Per-capita, estimates are similar to that observed in Europe, but with significantly higher occurrences of bloodstream infections and healthcare-associated pneumonia, primarily amongst women. Overall, the estimated burden is high and highlights the need for continued investment in HAI prevention. Healthcare associated infections (HAIs) are associated with increased morbidity and mortality, and excess healthcare costs , 2. An aThe ECDC introduced a methodology to estimate the total number of HAI cases from a point prevalence survey . CombineClostridioides difficile infection (CDI), healthcare-associated bloodstream infection (BSI), urinary tract infection (UTI), healthcare acquired pneumonia (HAP) and surgical site infection (SSI). These estimates are also compared with previous literature-based estimates of the burden of HAIs in Australia, and with similar PPS studies conducted in Europe.A point prevalence survey (PPS) of HAIs was previously conducted across 19 public hospitals in Australia . We usedThe Australian PPS data used in this study was collected in 2018 in a sample of adult patients in 19 public, large acute care hospitals. The surveillance methodology was based on the European Centre for Disease Prevention and Control (ECDC) PPS protocol . The typA total of 2767 patients were sampled. Results from this PPS have previously been reported in detail , 14. TheAs well as the number of cases, we estimate deaths and DALYs for each condition. DALYs are a composite measure of years lived with disability (YLDs) and years life lost (YLLs), accounting for incidence, severity, and mortality of disease simultaneously. They also provide a way to compare the impact of disease across conditions, as opposed to simply ranking by incidence of prevalence.The same approach as used for the estimation of the burden of HAIs in Germany was applied to this PPS , except The process of estimation can be summarised into three steps. The first step is to use the PPS data to estimate the hospital prevalence, which is estimated aswhere mentclass2pt{minimThe final step in the estimation is the population incidence, which is calculated asThe survey used in this study was in acute public hospitals for patients over 18 years of age, which accounts for approximately 60% of separations in public hospitals for patients over 18 years of age, giving To enable comparison between the European and German burden estimates, both datasets were re-aggregated to match the wider stratification used for estimation in the Australian setting. It is noted that the data for these surveys is aggregated into five-year age bands, and so the lowest age category for these studies is 15–24 (as opposed to 18–24). However, the burden in those aged between 15 and 18 is relatively low, so is expected to have little impact on the results.As the Australian PPS used the ‘light’ survey design as specified by the ECDC, McCabe scores are not recorded. We applied the McCabe score distribution of the ECDC PPS to Australia, assuming that the McCabe score distribution in Australia would be similar to that observed in the EU. It is noted that there is little evidence of the applicability or lack thereof of these estimates to the Australian population.The estimates for the total number of cases of HAIs is contained in Table As is expected, the incidence of HAIs appears inherently age-based Fig. , with thAt a rate of 498 DALYs per 100,000 population, HAIs contribute substantially to the overall burden of disease in Australia. For comparison, it is estimated that motor vehicle injuries contribute 180 DALYs, infectious diseases 370 DALYs and respiratory diseases 1380 DALYs per year in 2015 [We have estimated the burden of five HAIs in Australian public hospitals based on point prevalence data from 2018. By computing the number of DALYs, we have provided a comparison point for other health conditions in Australia. We have also compared these estimates to similar studies in Germany and the EU.Previous estimates of the burden of HAIs in Australia were based on combinations of studies with highly varied collection protocols  or basedIn comparison to the EU and Germany, the incidence of HAIs in Australia is significantly larger per 100,000 population, particularly in females aged between 55 and 64 Table . SimilarThe uncertainty on our estimates is comparatively high, likely due to the relatively small number of patients in this PPS (2767) as opposed to the 273,753 patients in the ECDC survey and 41,539 in the Germany convenience sample.There are potential methodological explanations for the higher incidence estimate in Australia compared to German and ECDC estimates. First, the Australian point prevalence survey was performed in large acute public hospitals, whereas the European surveys were performed in a wider range of facilities. Second, the number of separations used for the EU estimates is an approximation derived from the number of patient-days, whereas we have the actual total number of separations, but have assumed the percentage of these that were in adults and in public, acute hospitals.The findings in this study are subject to the same limitations of the source PPS study, including selection bias, restriction to public hospitals and the lack of patient-level factors present in the data. That study, while unique in being the first Australian PPS since 1984, included only larger hospitals , which may have a higher prevalence of HAIs than smaller hospitals. These larger hospital categories, however, do represent 60% of public hospital separations among adults. We deliberately focussed our estimate on public hospitals rather than including the private health system given the casemix is likely to differ substantially and we have no PPS data from this sector. Although we have used a very similar methodology to other studies overseas, these limitations mean that direct comparison between studies is challenging. Further work is needed to estimate the burden of HAIs in the private sector and among children.We are also limited by the number of sample patients. Although 2767 patients is substantially more than a number of single site studies in the same setting, it is orders of magnitude less than the German and EU point prevalence surveys. The impact of this limitation is that the uncertainty in our estimates is relatively high, particularly when stratified by even broad age bands.We utilised the McCabe score distribution from the European point prevalence survey, as the Australian PPS used the “light” definition and so did not collect its own scores. There is a large number of “avoidable” hospital stays in Australia, even in the acute hospitals that were the focus of the PPS. Therefore, the use of the European McCabe scores would overestimate the severity of underlying disease, and thus underestimate the DALYs, as assumed remaining life expectancies would be lower.HAIs are a significant public health issue in Australia when compared with other health conditions. Our findings are consistent with HAI estimates in European settings. Of note, is the large contributions that pneumonia and BSI have on overall burden and in particular deaths and DALYs. This study shows the need for continued investment in the prevention of HAIs in Australia, and importantly for robust, national coordinated surveillance of these conditions.


Spinal cord injury (SCI) is a catastrophic injury associated with functional loss and life-threatening complications. Many people with SCI in the Gaza Strip of Palestine are discharged from inpatient rehabilitation to the community while still lacking many daily life skills. This randomized controlled trial (RCT) seeks to test the impact of the Spinal Cord Injury Activities of Daily Living Education Manual (SADL-eM)—an evidence-based occupational therapy patient educational intervention—on rehabilitation outcomes.The proposed trial aims to evaluate the SADL-eM intervention compared with standard treatment among people with SCI.This is a parallel RCT with two study arms: intervention and control. A total of 90 patients treated in inpatient rehabilitation settings will be randomly allocated to two study groups. Both groups will receive standard care. The intervention group will also use the SADL-eM with their treating occupational therapist during rehabilitation. The SADL-eM is a comprehensive activities of daily living (ADL) educational tool that was codeveloped with people with SCI and stakeholders across Gaza. The self-report version of the Spinal Cord Independence Measure will be used on admission  and after 6 weeks as the primary outcome measure. Secondary outcomes include the third version of the Spinal Cord Independence Measure, the Private Religiousness Practices Scale, the Organizational Religiousness Short-Form, additional ADL domains covered by the education manual, and adherence to the intervention. The effect of the intervention will be determined using repeated-measures analysis of variance.This study will be conducted from April 2021 through December 2022, with results expected to be available in January 2023.If the SADL-eM is demonstrated as clinically effective, this will have significant implications for occupational therapy interventions in low- and middle-income countries.ClinicalTrials.gov NCT04735887; https://clinicaltrials.gov/ct2/show/NCT04735887 Spinal cord injury (SCI) describes the damage to the spinal cord resulting from trauma , disease , or degeneration . An SCI can result in paralysis of the extremities and trunk below the level of lesion that determines residual motor and sensory dysfunction . All peoPeople with SCI have many information needs after injury. Patient education is one affordable and accessible strategy that may enhance the effectiveness of rehabilitation for people with SCI in LMIC. Health professionals, such as occupational therapists, are a preferred source of information for health education seekers about SCI ,4. EducaEffective SCI education should be accessible and motivating in terms of information and how it is presented . EducatiDespite widespread guidance on education for patients with SCI, little research has been conducted on the effectiveness of education focused on ADLs for people with SCI ,9. A recThe first intervention included in that systematic review was the clinical practice guidelines for Preservation of Upper Limb Function Following Spinal Cord Injury, an ADL educational program focused on wheelchair ambulation and transfers. It involved two separate and specific forms: one for the therapist and one for the patient. The patient form was designed to be accessible, appropriate for novice adults without a previous medical background, and organized into modules. The therapist form was more complex regarding the level of information and was suitable for health professionals with a medical educational background . To meetIn the second intervention, the Peer Mentoring Programme, people with SCI acted as mentors and educators to people with newly acquired injuries. The peer mentors saw their mentees in person or communicated with them by phone during daily life scenarios within the first week of admission to active inpatient rehabilitation. The mentors then monitored the health status of their mentees using the Medical Complications Tracking Form; provided education relevant to ADL, prevention of complications, and incontinence issues; and initiated referrals to health care professionals if needed .The third intervention, the Needs Assessment and Goal Planning Programme (NAGPP), is a comprehensive rehabilitation tool for everyday clinical use that was used as an ADL educational program. The Needs Assessment Checklist (NAC) is a part of the NAGPP and is used to evaluate and compare rehabilitation needs and outcomes. Therefore, the NAC reflects the patient’s perception of his or her needs, choices, and priorities. The NAC was administered twice by a key worker who had the responsibility of coordinating the Rehabilitation and Goal Planning Programme: the first after beginning the active rehabilitation program and the second on admission to the predischarge rehabilitation ward. The key worker had the responsibility of coordinating the goal planning system with other members of the multidisciplinary team, and the patient was responsible for establishing and identifying needs, clarifying goals, and specifying targets .More recently, Ziba and colleagues  evaluatePalestine is characterized as one of the LMIC . In 2016Similar to people with SCI in other LMIC, people with SCI in Gaza are frequently discharged prematurely from inpatient rehabilitation to the community, while lacking essential self-care skills, such as toileting and safe transfers . This plBarriers to effective rehabilitation for people with SCI in Gaza include timely admission to a suitable rehabilitation setting, inadequate stays in inpatient rehabilitation, insufficient learning of daily life skills during inpatient rehabilitation, and lack of access to proper assistive technology. Moreover, many patients are added to the waiting list before admission. These barriers drive the need to develop evidence-based interventions during inpatient care that will improve rehabilitation outcomes, such as performance of ADLs .There is little information about preferred educational formats on the part of people with SCI due to limited research targeting this topic. Some authors regard the internet as the best option, due to low cost and wide reach . This isIn 2018 we began a project to develop and evaluate the effectiveness of patient education for rehabilitation services in Gaza. We used participatory action research methods to develop an ADL education manual—the SADL-eM—that could promote occupational therapy education for people with SCI in the Gaza Strip, Palestine . The aimThe research question for this study is as follows: Does the implementation of the SADL-eM delivered to patients with SCI in an inpatient rehabilitation setting in the Gaza Strip improve independence in ADL and participation over 6 weeks?The primary objectives for this study are as follows:To compare the effect of the education manual, relative to usual care, on self-reported changes in ADL from admission to 6 weeks postadmission, using the self-report version of the Spinal Cord Independence Measure (SCIM-SR) patient-rated measure.To compare the effect of the education manual, relative to usual care, on observed changes in ADL from admission to 6 weeks postadmission, using the third version of the Spinal Cord Independence Measure (SCIM-III) clinician-rated measure.To compare the effect of the education manual, relative to usual care, on religious practice, using the Private Religiousness Practices Scale and Organizational Religiousness Short-Form.To compare the effect of the education manual, relative to usual care, on the domains of ADL covered by the education manual, including driving and community mobility, personal device care, health management and maintenance, ablution, and Islamic prayer, using questions developed for this research.The secondary objectives for this study are as follows:To determine the significance of biographical variables , the American Spinal Injury Association Impairment Scale score, and dysfunction on changes in ADL performance.To measure adherence to the intervention using the therapist-report questionnaire regarding SADL-eM adherence, which will be developed for this purpose.The null hypothesis for this study is as follows: there is no ADL outcome difference between the SADL-eM and the standard care delivered to inpatients with SCI in a rehabilitation setting.The alternative hypothesis for this study is as follows: the implementation of the SADL-eM delivered to inpatients with SCI in a rehabilitation setting has a significant impact on their ADL.Participants in the study will be inpatients with SCI from the Gaza Strip, of both genders, with any cause or type of SCI, and aged 18 to 65 years. They will be recruited from the group of admitted inpatients in one of the three rehabilitation settings in the Gaza Strip, Palestine: Hamad Rehabilitation Hospital, El-Wafa Rehabilitation Hospital, and Al-Amal Rehabilitation Hospital. Readmitted patients will be included in the study if they are eligible. Over the first 3 days of admission of each person with SCI in any of the three rehabilitation facilities, a clinical research supervisor will recruit study participants based on the study eligibility criteria. Inclusion and exclusion criteria are listed in Inclusion criteriaConfirmed spinal cord injury (SCI) diagnosis by computed tomography or magnetic resonance imaging reportThe American Spinal Injury Association Impairment Scale (ASIA): categories A, B, and CAged between 18 and 65 years oldStable medical conditionTime elapsed after SCI is not more than 6 monthsMinimum time of stay in inpatient rehabilitation unit is 6 weeksActive involvement in rehabilitation programSufficient comprehension  of the Arabic languageExclusion criteriaUnconfirmed diagnosisPatients who have communication or cognitive disorders, such as global aphasia and memory deficitPatients with a disturbed level of awareness, such as being in a coma or experiencing lethargyTime elapsed since SCI is more than 6 monthsASIA: categories D and EUnstable medical conditionPatients who have other causes of disability in addition to SCI, such as stroke or amputationAged less than 18 years old or more than 65 years oldTime of stay in inpatient rehabilitation unit is less than 6 weeksInactive involvement in rehabilitation programPatients with a progressive disease or a psychiatric condition that would interfere with active participation in the rehabilitation programPatients with cardiovascular contraindicationsPersons who become ambulatory during the inpatient periodPersons with complete tetraplegia caused by an SCI at the C4 level or abovePersons on mechanical ventilationEach eligible participant who agrees to participate in the study will sign a written consent form before being included any of the study procedures or interventions. This consent form will be kept in a locked filing cabinet that will only be accessible by the research team.We aim to recruit 90 participants to demonstrate a small effect caused by the intervention, with a postintervention mean difference of 15% between the intervention and control groups. The mean scores of the SCIM-III and the SCIM-SR at enrollment are expected to be 30% for both groups; at postintervention, these are expected to be 65% for the intervention group and 50% for the control group. A sample size of 90 participants, with 45 in each group, is sufficient for 80% power, a 5% margin of error, a CI of 95%, and an SD of 20%.This study uses an assessor-blinded data collection method. The study process conceals the intervention group identity from outcome assessors after participants’ treatment assignment through randomization to minimize possible bias on the part of the outcome assessors, which could influence the reliability of study results. Moreover, therapists involved in the study and participants in the intervention group will be informed to refrain from sharing any part of the manual or included information with other patients or staff.The study sample of 90 SCI individuals will be randomized into two groups using a simple randomization approach, where an allocation list will be generated using the Random Number Generator online program. The two groups are as follows: conventional therapy group (n=45) and intervention  plus conventional therapy group (n=45). Eligible participants will be assigned to one study group according to the generated list.Hamad Rehabilitation Hospital, El-Wafa Rehabilitation Hospital, and Al-Amal Rehabilitation Hospital are three inpatient rehabilitation settings that are part of the private health sector in the Gaza Strip of Palestine and provide comprehensive rehabilitation services. Their rehabilitation teams include physical rehabilitation doctors, rehabilitation nurses, physiotherapists, occupational therapists, speech therapists, clinical dietitians, psychologists, social workers, orthoptists, and community-based rehabilitation workers.Feasibility studies are preliminary studies with small samples that investigate whether the main study can be conducted under the given conditions. RCTs usually use the feasibility study design to improve the trial’s feasibility and avoid crucial barriers . A totalBoth study groups will receive usual care. In addition, each participant in the intervention group will receive a copy of the SADL-eM. The SADL-eM was developed by the authors following a systematic review and user-led development project. A team of 54 subject matter experts collaborated in a participatory action research project to develop the manual. To our knowledge, the SADL-eM is the first comprehensive SCI ADL educational tool available in Arabic .The SADL-eM includes three elements essential to the intervention: knowledge, skills, and advice. The manual is made up of six detailed sections, including an introduction and the following five chapters: (1) Rehabilitation Team, (2) ADL, (3) Assistive Devices, (4) Home Environment Adaptation, and (5) Knowledge Guide. The SADL-eM uses text and illustrative pictures that were carefully selected for contextual relevance. The manual is simple and easy to use, and is suitable for people with a nonmedical background. However, good Arabic-language comprehension and the ability to read and write is mandatory for users. The purpose of the SADL-eM is to serve as a treatment tool during inpatient rehabilitation .A clinical research supervisor will provide each participant in the intervention group with a hard copy of the SADL-eM and will explain the purpose of the manual and how to use it. The manual will be reviewed by the treating occupational therapist who received training on the use of the SADL-eM  and by the person with SCI during their treatment sessions. During occupational therapy sessions, the therapist will refer to the relevant chapter of the manual and answer the participant’s queries regarding the content of the manual. The therapist will also indicate to the participants which parts of the manual are not relevant to them, based on their gender, driving status, or level of SCI.According to the minimum standards of SADL-eM use for SCI education, the therapist will include the manual in as many SADL-eM educational sessions as required, but not less than three 15-minute sessions per week. The minimum level of clinical experience required of each treating occupational therapist will be 2 years. Good Arabic-language comprehension and the ability to read and write is mandatory for both therapists and patients. Commitment and adherence to the SADL-eM minimum standards are prerequisites and will be assured during the consenting of participants.The participants will keep the manual to review after sessions and after discharge from the inpatient rehabilitation setting. The research assistant who performs data collection, the clinical research supervisor, and the occupational therapy team will be invited for an informational session prior to data collection in each of the participating settings. The informational session will focus on the study purpose, recruitment, eligibility criteria, use of the SADL-eM, roles, bias reduction, and blinding. The use of data collection tools will take place in a separate session with the research assistant. The principal researcher will answer all questions from the research team during informational sessions and during the research study.For the purpose of this study, the SADL-eM will be provided during face-to-face individual occupational therapy sessions without any constraints regarding the treatment area. The face-to-face delivery of the SADL-eM does not require any infrastructure or special equipment.The number of sessions, time allocated, and frequency of sessions will be determined by each therapist and participant to ensure that the treatment is person centered, given that the minimum standards of the SADL-eM implementation are met. Determinants may include a participant’s capabilities, potential, and progress during treatment as well as the scope of the service, such as time allocated for each patient, therapist-to-patient ratio, and frequency of inpatient sessions. The therapist and the participant will continue to use the manual during treatment sessions until they decide there is no need for further use of the manual or the participant is discharged. The treating occupational therapists will retain records of any change or modification of the SADL-eM administration. The researchers will conduct a pilot study in a similar sample of 15 people with SCI to improve the use of the intervention and data collection tools.Nonadherence to medical treatment in clinical trials of medical efficacy may obscure the data that are collected and disrupt the findings that are obtained . The steParticipants’ recruitment and admission to the study will continue until the desired sample size is reached. The allocation sequence will be concealed from patients, therapists, and assessors. The data regarding exposure to the educational intervention will be collected by a separate research assistant  by phone and will be concealed from the assessors. Each occupational therapy department will assign four therapists to follow up the trial cases: two for the intervention group and two for the control group. All the staff in the occupational therapy department, the participants, and the assessors will be asked to refrain from discussing the trial and intervention material between them. The importance of concealing any information until the end of the study will be explained. Study participants will not be allowed to switch between occupational therapists or study arms. They will be asked not to participate in other educational interventions, peer or external, related to their rehabilitation or seek treatment outside their trial. The head of the occupational therapy department within each rehabilitation setting will supervise participants and the assigned occupational therapists in both study arms to reduce contamination bias, such as sharing intervention content with the control group, sharing similar time and space of occupational therapy sessions, and exchange of therapists.Contamination bias due to already-existing background or receipt of additional educational interventions will be measured within each arm of the study using the chi-square test to compare the progress means. However, no case will be eliminated from statistical analysis due to contamination bias.The study will adopt approaches to prevent the loss of participants to follow-up by making questionnaires as easy to complete as possible, providing incentives in the form of a free copy of the education manual for the control group after completing the study, and explaining the importance of the study .The researchers will use the same outcome measures throughout the study and within both study arms. Biographical data will be collected by a research assistant once on admission of the participant and after they have provided consent to participate. ADL data collection from each participant in the study will take place in a face-to-face interview at two time points: once on admission before being provided with the education manual and again 6 weeks later. This data will be collected using the following: (1) the patient-administered SCIM-SR and (2) the research assistant–administered SCIM-III, Private Religiousness Practices Scale, Organizational Religiousness Short-Form, and domains of ADL covered by the education manual, including driving and community mobility, personal device care, health management and maintenance, ablution, and Islamic prayer. The data will be used to answer the research question and test the study hypothesis.The validity of the experimental study can be threatened by history, selection, and maturation . The valObjective data collected in clinical settings using valid and reliable tools are essential for evaluating the impact of an intervention . The valThe SCIM-SR evaluates the ability of a person with SCI to perform specified activities independently, with assistance or with assistive devices, from the perspective of the people with SCI. Research supports the criterion validity of SCIM-SR . The tooThe biographical data collection tool captures demographic and socioeconomic data, including age, gender, marital status, level of education, employment, monthly income, accommodation, diagnosis, and cause and type of SCI.The SCIM-III evaluates the ability of a person with SCI to perform specified activities independently, with assistance or with assistive devices, from the perspective of the health care provider. It requires 30 to 45 minutes to complete the assessment by observation and about 20 minutes by interview . The SCIThe Private Religiousness Practices Scale measures the frequency of an individual’s involvement in religious behaviors: prayer, religious attendance , reading the Bible or Quran, and watching religious programs on television . The tooThe Organizational Religiousness Short-Form measures the involvement of the individual with a formal public religious institution, such as a church or mosque . The tooThe SADL-eM adherence therapist-report questionnaire is based on the Morisky Medication Adherence Scale. This tool measures any change to the supplied SADL-eM in terms of the content of the intervention, topics, described techniques, mode, format, and degree of individualization of the intervention . The tooEthical approval was obtained from the Stellenbosch University Human Research Ethics Committee (HREC project ID: 1635) and the Helsinki Committee for Ethical Approval (PHRC/HC/689/20). This trial was registered at ClinicalTrials.gov (NCT04735887). At recruitment, participants will be provided with comprehensive information to explain the trial and their participation. Patients’ questions will be answered by the researcher honestly and as fully as possible. Participants’ consent to be included in the study will be recorded in writing. All the data and the signed consent forms will be securely stored during and after study completion in a locked cabinet on hospital premises, up to 5 years after publication. Participants will be free to withdraw at any time. Participant anonymity and confidentiality of information collected for the research will be assured in the consent form and sustained throughout the study. The study is unlikely to result in any harm, risk, or discomfort to participants. The participants in the control group will receive a copy of the SADL-eM at the end of the study.The treating occupational therapists and research assistant will follow the required COVID-19 precautions published by the World Health Organization and applied by each facility . This inCaptured data will be coded and reviewed by the authors for clarity and completion. A spreadsheet will be prepared by and then loaded into SPSS software  for analysis. To ensure study reliability, the first author will perform data entry, the research assistant will check the data entry using the original forms, and the clinical research supervisor will check the data for missing data and entry errors. During analysis, missing data will be replaced by the means, for continuous or discrete variables, or modes, for ordinal or nominal variables.To describe participants’ characteristics , descriptive statistics, such as frequency, percentage, and mean and SD, will be used for normally distributed data. Median and IQR will be used for continuous variables that are not normally distributed. The Shapiro-Wilk test will be used to test data distribution normality .P>.05), we will assume that the data meet the assumption of sphericity, similar to the homogeneity of variance for between-group ANOVA. Violation of the sphericity assumption will require correction using either the Greenhouse-Geiger correction (ε<.75) or the Huynh-Feldt correction (ε>.75). The effect size will be calculated using Cohen d [We will then use the repeated-measures ANOVA and linear mixed models to compare the mean scores of the primary outcome tool  and the secondary outcome tools  to test the research hypothesis. Linear mixed models have an advantage in dealing with missing values and provide fixed and random effects . Repeate Cohen d . Corallo Cohen d  providedThis is an RCT that will be conducted in clinical settings  where contamination bias is evident. Therefore, we followed the intention-to-treat (ITT) principle to assess outcomes based on the treatment group and not based on the intervention. By using the ITT principle, we aim to avoid potential bias due to exclusion of ineligible cases and prevent attrition bias when evaluating the intervention .The authors will request approval for important protocol modifications, such as changes to eligibility criteria, outcomes, and analyses, from the HREC of Stellenbosch University under the regulations of the Declaration of Helsinki. Deviations from this protocol will be reported when publishing or presenting the trial outcomes.This is an approved RCT that was registered in 2020. Data collection for the internal pilot study started in April 2021. Between April 2021 and March 2022, 32 cases were eligible and included in the study. The majority were males , and the rest were females . Each of the intervention and control groups included 16 cases. Trial data collection is expected to continue until December 2022. Results are expected to be available in January 2023.The anticipated main finding of this study is that the use of a codeveloped, contextualized ADL education manual during inpatient occupational therapy rehabilitation will improve performance of ADL for people with SCI living in Gaza, Palestine, in comparison to usual care. The study findings will provide us with important information about the performance of ADL among people with SCI, based on widely used data collection tools , as well as participation in other important aspects of religious life  and community life . The findings will also illustrate adherence on the part of people with SCI and health professionals to the educational intervention.Providing occupational therapy patient education that meets the needs of people with SCI aims to improve their ADL performance and optimize their rehabilitation outcomes . The SADInpatient SCI education is designed to promote participation . A systeA specific educational mobile app was evaluated among men with SCI and showed positive results in the marital sex life of men with SCI . MortensSelf-care and peer education are basic interventions in health and participation education. A self-care educational program was found to be significant in inpatient rehabilitation and improved the quality of life of people with SCI . Peer edThe use of a randomized controlled study design is a strength of this study. High-quality and well-controlled clinical trials are essential to developing effective interventions for people with SCI ,11. An aIf the SADL-eM is demonstrated to be clinically effective, it will have significant implications for occupational therapy research and practice in LMIC, where limited resources are allocated for SCI rehabilitation, community-based rehabilitation, and assistive devices. Furthermore, people with SCI experience many forms of occupational injustice in LMIC . Future We were unable to identify any study in LMIC that provides information about ADL performance among people with SCI measured by the SCIM-SR and SCIM-III. However, there are a number of potential limitations to the proposed study. This RCT employs strict inclusion criteria to improve the reliability of findings. Meanwhile, the incidence of SCI in the Gaza Strip is relatively low. Therefore, data collection is expected to continue for 12 to 14 months (April 2021-December 2022), during which different types of bias may be introduced. For example, sampling bias may occur due to a possible high rate of withdrawals and dropouts from the study. Familiarity of health professionals and people with SCI with the intervention is likely to create contamination bias. While the risk of maturity bias may occur due to age and long length of stay in the inpatient rehabilitation settings, exposure bias may occur due to different lengths of stay in the inpatient rehabilitation settings .The intervention used in this RCT concurs with physical distancing that is currently required in clinical settings due to COVID-19. Considering this, it is safe and compatible with infection control guidelines ,43.The findings of the proposed study will highlight the importance of a culturally relevant educational intervention in people with SCI in LMIC and will, therefore, pave the road for more constructive and creative solutions to the lack of resources in these countries. This will encourage the shift in rehabilitation services toward more just and inclusive approaches. Future dissemination and implementation efforts will be critical to ensure that this cost-effective and easily accessible intervention is used to promote participation. The SADL-eM will be made freely available on the Stellenbosch University website in Arabic, with a summary in English. The study results will be further disseminated through conference presentations.