Aim: With the resolution from April 28, 2014, the Bavarian state government in Germany decided to found a new medical school at Augsburg University, thereby requiring the development of a competency-based medical curriculum.Methods: Two interdisciplinary groups developed a spiral curriculum (following Harden) employing the model of Thumser-Dauth & Öchsner. The curriculum focuses on specifically defined competencies: medical expertise, independent scientific reasoning, argumentation and scholarship, as well as communication skills.Results: The spiral curriculum was developed as a hybrid curriculum. Its modular structure incorporates the mandatory subjects required by the German regulations for medical licensure (Approbationsordnung) into organ- and system-centered blocks which are integrated both horizontally and vertically. Basic preclinical sciences are covered in the blocks “Movement,” “Balance” and “Contact.” The clinical sciences are organized according to six pillars  which students revisit three times each over the course of the program. A longitudinal clinical course incorporates interdisciplinary education. A particular focus is on scientific education encompassing a longitudinal course in the sciences (including interdisciplinary classes with other university departments), block practicums, and two scientific projects.Conclusion: It is not only the degree of integration und intensity of the Augsburg University undergraduate medical degree program, but also its targeted advancement of academic, social and communication skills that have not yet been realized to such an extent elsewhere in Germany. On July 8, 2016, the German Council of Science and Humanities unanimously gave this concept a positive evaluation. Future research will examine and evaluate the Augsburg medical curriculum and the impact of the new medical school on the hospital and university in Augsburg. There is consensus among several professional organizations that there are not enough spaces to study medicine at German universities. The current shortage of young doctors in hospitals and private practices will become more acute over the next 10 years, especially as many physicians retire , 3]. Th. Th3]. TThe Bavarian state’s intention to promote undergraduate medical education at state schools by founding a sixth medical school at Augsburg University is undoubtedly a response to a clear need.Augsburg University was founded in 1970 as an interdisciplinary university. Approximately 20,000 students are presently enrolled at the university’s seven schools. With 1,700 beds, Augsburg’s hospital is one of the largest in Bavaria and the only tertiary care hospital in the region of Swabia that is home to a population of approximately two million. The hospital, which opened its doors in 1982, was conceived from the start as a future university teaching hospital. However, the first attempt in the 1980s to establish a center for medical teaching and research at Augsburg University was unsuccessful . With thWith the founding of a medical school in Augsburg, the capacity to admit medical students in Bavaria will be increased by around 14%; in the final stage of expansion this will mean 252 additional spaces per year. In addition, the newly created medical school enables implementation of an innovative curriculum following the recommendations of the German Council of Science and Humanities regarding the development of medical study in Germany with the long-term objective of qualitatively improving medical care in the Augsburg region by innovatively educating a new generation of physicians  and P.B. [TUM]), professors from neighboring medical schools serving as experts on research in medical education, generated the basic structure of the degree program which was then further refined as described in the following section.According to Schaper et al (2014), when designing new degree programs it is important to involve the stakeholders from the start in any development processes regarding the academic program and to actively include them in any changes. For this reason, it is good practice not only to appropriately structure the development process in terms of design, but also to set this up as an organizational development process with the associated communicative and participatory elements . For thiThe intention was to design a curriculum not only to ensure practical clinical education and learning, but also to strongly encourage and foster the academic development and personal growth of the students. It was assumed that special teaching and learning formats would be necessary to achieve this, ones that can be realized only to a limited extent in a conventional degree program. This was the basis for the decision to develop a model degree program.A second working group was founded within the initial working group appointed by the Bavarian Ministry (StMBW) as an operative expert group to design the Augsburg curriculum . The intention was to form a mixed group in which experts with different backgrounds and expertise  and from different levels of the hierarchy could come together.Participation was voluntary and open to all medical employees at the Augsburg Hospital. A chief physician familiar with the structural and organizational aspects of the hospital served as committee chairman. In addition, eight hospital physicians  actively participated in the working group. Furthermore, it was possible to recruit the Augsburg University’s vice-president for academic affairs, continuing education and equal opportunity as an expert on the university’s structure and organization. Also participating in the curriculum design were three other professors  from neighboring medical schools who served as experts on research in medical education and a university employee specialized in medical education. Within this second working group focused on hospital teaching, the goals and timetables for the planning processes were determined, work packages were assigned, and decisions about the development process were made.By combining the two working groups focused on Augsburg University and the Augsburg Hospital, it was ensured that, although the pertinent university structures did not yet exist, all process-relevant institutions were included in developing the curriculum: representatives of the StMBW, Augsburg University, external experts, and physicians practicing at the Augsburg Hospital (most with prior experience in higher education). The working group housed at the hospital generated the basic content for development and made regular reports to the working group at the university which, in turn, after holding discussions formally passed the related resolutions. Other institutions were included when necessary.Describing competencies is associated with several problems including the ambiguity of the very word itself . The terCompetency is defined as the ability to act appropriately, responsibly and successfully in specific settings marked by a high degree of complexity, novelty or uncertainty that demand high quality solutions.Abilities to act in this manner draw on bundles of complex knowledge, skills, motivational focus, values and attitudes in relation to these specific settings.In addition, Schaper  describeCompetency-based medical education has been defined by Frank et al. as:“Competency-based education (CBE) is an approach to preparing physicians for practice that is fundamentally oriented to graduate outcome abilities and organized around competencies derived from an analysis of societal and patient needs. It deemphasizes time-based training and promises greater accountability, flexibility, and learner-centredness” [redness” .Based on this definition and taking the extenuating logistical situation into consideration, the basic elements of the teaching and learning formats were developed in accordance with Harden’s SPICES model . While dDetailed development of the curriculum will take place over the next years as part of establishing a medical school at Augsburg University. As this is accomplished, the curricular content, learning objectives, teaching and learning formats, as well as assessment formats, will be coordinated with each other and routinely evaluated in terms of constructive alignment .Verification that objectives are being met at the student and program levels can, of course, only be undertaken after the program has been up and running for awhile, meaning after the first student cohorts have graduated. A first draft of a quality assurance concept has been generated for this purpose. This aspect will be developed in parallel to the curriculum.The aim of the degree program is to enable the practice of medicine in the clinical setting and in academic research. The following competency areas were identified building off of the understanding of competency stated in section 2.4:Medical expertise Independent scientific reasoning, argumentation and scholarshipSocial and communication skillsAs a result, the new degree program will have a primary focus on imparting both the ability to act responsibly in a solution-oriented manner in complex medical situations and the ability to engage in academic scholarship and apply scientific concepts to complex topics . Social Based on the competency areas described here, a rough concept was initially laid out for the Augsburg curriculum , Balance  and Contact . Delineations between the three core topical blocks are maintained. Clinical relevance will be consistently underscored by weekly patient consultations and by the accompanying presence of the clinical and theoretical clinical subjects. Practical skills, specifically leading symptom anamnesis, examination, diagnostic investigations, and the principles of pathophysiology, are integrated into these areas. Content dealing with anatomy is learned using living persons and models as preparation for the dissection course at the end of the second year of study. As a result, students will already have a wide knowledge of anatomy once they begin the dissection course; repetition of this knowledge using a cadaver is meant to enhance, consolidate, and integrate this anatomical knowledge (e.g. topographic anatomy). Moreover, at the end of the second year the closely linked blocks Perspectives  and Living and Dying  enable students to acquire an integrative perspective on the material learned thus far.The first year of study begins with an introductory block on the principles of cell biology, physics, chemistry and biology. The aim is to homogenize students’ knowledge, which is not expected to be uniform at this stage. The guiding principle of the degree program, the al model , is alsoThe third through fifth years of study are predominantly organized into thematic and system-centered blocks. At the beginning of both the third and fourth years there is a block on Diagnostics and Therapy introducing diagnostic investigations and lab-based diagnostics, general pathology, and pharmacotherapy. This serves as preparation for the subsequent six clinical blocks. The required subjects defined by the medical licensure regulations (Approbationsordnung) are represented in six blocks in the Augsburg curriculum: Conservative Medicine, Surgical Medicine, Men’s-Women’s-Children’s Medicine, The Senses, The Nervous system and the Mind, and General Medicine. These blocks are, in turn, made up of sub-blocks taught in the third, fourth and fifth years of study so that students attend three separate blocks over three years on each one of the six topics above , communication and cooperation, as well as intra- and interprofessional collaboration.The longitudinal course in science begins in the first years of study and covers the basic principles of scientific work. This includes reading and critically evaluating scientific literature, knowledge of medical research methodologies and their scientific and sociological contexts. Central to the methodology of the first two academic years is the planning and realization of a small-group, scientific research project. In the more advanced years, knowledge of research basics is expanded to reflect more specialized knowledge regarding statistics, qualitative methods, etc. In terms of electives, courses are offered in conjunction with the other academic departments at Augsburg University.The two longitudinal courses are complemented by related block practicums. The clinical block practicums may be served at hospitals, private practices or other healthcare institutions . The scientific block practicums may be served at any of the institutions of the Augsburg University and even at other research institutions; they may also function as preparation for the fifth-year academic project which is mandatory for all students. In addition, a doctoral program is offered to which students may apply.In regard to teaching formats, the Augsburg curriculum is a hybrid one. Starting in the first year of study, both problem-based learning  and interactive seminars and practicums (group work and lab practicums) will be established as forms and methods of teaching. Lectures are interactive (inverted classroom) and offered only as an accompaniment to the core curriculum.The blocks themselves will be designed according to the principle of constructive alignment  once theInstruction in each individual block will be based on the SPICES model put forth by Harden . A focusBoth summative and formative assessment formats will be used. After completing the second year of study, a summative equivalency test corresponding to the first section of the state medical exam will be administered. Furthermore, an assessment is planned after completion of the final year to demonstrate learning outcomes for the fifth and final year focused on practical studies. In addition to established assessment formats such as multiple-choice exams and Objective Structured Clinical Examinations (OSCE) , other aBy following the process described above and involving representatives from all stakeholders, it has been possible to develop a conceptual framework for a new competency-based curriculum while taking current recommendations into consideration. Moreover, the following competency areas are represented in the curriculum:Medical expertise is imparted in the modularly structured part of the curriculum with the preclinical blocks , the dissection course as well as through the six pillars of clinical medicine, supplemented by the blocks on diagnostics and therapy and the clinical block practicums.Independent scientific reasoning, argumentation and scholarship are fostered by the three pillars of the scientific curriculum—the longitudinal course in science, the scientific block practicums and the academic projects—with the possibility of subsequently entering the doctoral program.Social and communication skills are promoted by integrating these competency areas into the interdisciplinary blocks during the first two years of study , the longitudinal clinical course and the clinical block practicums.Specifically the level integration and intensity of the university teaching, in collaboration with all of the academic departments of Augsburg University, have been realized in the design of this medical curriculum to an extent not yet seen elsewhere in Germany. Central characteristics of the Augsburg curriculum – which can be implemented as a model degree program – include an emphasis on problem-based, seminar-based, small-group instruction, a delineation between subjects despite horizontal and vertical integration into the curriculum, while turning away, for the most part, from large-group lectures.Since the medical school has not yet been formally founded, this conceptual groundwork needed to have been done by the affected staff at the Augsburg Hospital, the neighboring medical schools in Munich and the Augsburg University in addition to their regular duties. This cooperative endeavor has been reported as constructive and productive by all those involved. This kind of interdisciplinary cooperation requires very strict organization, particularly among practicing physicians with professional duties in intensive care units, operating rooms and as emergency medical personnel. In general, successful working group activities relied on clear coordination and communication of tasks and pressing ahead with the process even when not all working group members were able to be present at each meeting.When planning the first phase of establishing any medical school there is no choice but to leave many questions still open. This affects not only aspects related to content  but also the logistical aspects of the new medical school. Continuation of the conceptual planning must now be preceded by appropriate human resource planning and the creation of the pertinent academic, administrative and institutional structures. Among these are a Dean of Studies, a Professorship in Medical Education, the requisite administrative staff, and the academic instructors at the individual hospitals and institutes who make up the interdisciplinary groups that will then collaboratively design each of the blocks. Furthermore, drafting specific regulations governing the medical school, the degree program and the theoretical and practical assessments is among the next tasks to be completed, as is the extensive construction on the hospital campus to build the needed space for teaching and research.Setting up a new medical school at an existing university involves an extensive change process. Taking a targeted and strategic approach with regard for diverse external factors is critical to success. Not only must the existing structures be taken into account but also the many different broader influences  . This neMost recently a new medical school was founded in 2012 at the University of Oldenburg and the European Medical School Oldenburg-Groningen (Fakultät für Medizin und Gesundheitswissenschaften). Relatively little is known about that process and the individual steps taken to establish the school or its effects on the people and places mentioned directly above. As a consequence, the change process here will be the subject of further study in addition to the founding of the Augsburg University Medical School, the refinement of the Augsburg curriculum, and the implementation of appropriate quality assurance measures to evaluate teaching and learning.The authors declare that they have no competing interests.


An unequal distribution of health personnel, leading to unfavourable differences in health status between urban and rural populations, is a serious cause for concern globally. Part of the solution to this problem lies in attracting medical doctors to rural, remote communities, which presents a real challenge. The present study therefore explored the factors that influence medical doctors’ decision to practise in rural Ghana.We conducted a cross-sectional descriptive study based on questionnaires. Participants were doctors working in health facilities in the districts and rural areas of the Northern Region, Ghana. The qualitative data analysis consisted of an iterative process of open, axial and selective coding.We administered the questionnaires to 40 doctors, 27 of whom completed and returned the form, signalling a response rate of 67.5%. The majority of the doctors were male (88.9%) and had been trained at the University for Development Studies, School of Medicine and Health Sciences (UDS-SMHS) (63%). Although they had chosen to work in the remote areas, they identified a number of factors that could prevent future doctors from accepting rural postings, such as: a lack of social amenities, financial and material resources; limited career progression opportunities; and too little emphasis on rural practice in medical school curricula. Moreover, respondents flagged specific stakeholders who, in their opinion, had a major role to play in the attraction of doctors and in convincing them to work in remote areas.The medical doctors we surveyed had gravitated to the rural areas themselves for the opportunity to acquire clinical skills and gain experience and professional independence. Nevertheless, they felt that in order to attract such cadre of health professionals to rural areas and retain them there, specific challenges needed addressing. For instance, they called for an enforceable, national policy on rural postings, demanding strong political commitment and leadership. Another recommendation flowing from the study findings is to extend the introduction of Community-Based Education and Service (COBES) or similar curriculum components to other medical schools in order to prepare students for rural practice, increasing the likelihood of them accepting rural postings.The online version of this article (10.1186/s12909-018-1234-y) contains supplementary material, which is available to authorized users. The unequal global distribution of health personnel is a serious problem confronting the health sector. This disparity of health personnel between the rural and urban populations can contribute to differences in health outcomes . People Some middle- and low-income countries have implemented several strategies to motivate health workers to accept rural postings. Thailand and Sierra Leone, for instance, have adopted coercion and financial measures to make doctors accept postings in rural areas. Likewise, the Ghanaian government has resorted to a 20–30% salary top-up and a staff vehicle hire purchase scheme for health staff in an effort to attract and retain health workers in rural areas. However, neither of these has yielded the desired results in addressing the lack of health professionals in rural areas. A review of the literature on the attraction of health staff to rural areas in middle- and low-income countries and their retention clearly points to poor working conditions such as a lack of potable water, poor sanitation, limited career progression prospects, a lack of management and community support and the absence of proper equipment and infrastructure at the health facility level , 6–9 as Recognising that the shortages and maldistribution of the health workforce pose a significant threat to the health system in Ghana , the GhaAs one of the developing countries in sub-Saharan Africa, Ghana is located on the West African coast and has a population of approximately 28 million people. We conducted this study in one of the country’s ten administrative regions, specifically the Northern Region, which has Tamale as its capital city and a population of over 2 million inhabitants. Most of the communities in the region are deprived. The region counts 345 health facilities and is divided into 26 districts, each having at least one district hospital, a number of health centres, Community-based Health Planning and Services (CHPS) compounds and maternity homes. The Ministry of Health has assigned specific levels of care to these facilities, depending on the category of health staff managing the facility: Level M refers to maternity homes (managed by midwives); Level A to CHPS compounds ; Level B1 to health centres without a doctor; Level B2 to health centres with a doctor; Level C to District hospitals; and Level D to regional and tertiary hospitals .The School of Medicine and Health Sciences of the University for Development Studies (UDS-SMHS) is the only medical school in the region that offers community training as an integral part of the curriculum, known as Community-Based Education and Service (COBES). Through COBES, students spend 4 weeks in the same community in each of the first 3 years of the programme. In the first year, they learn to identify and explain factors -demographic, social, environmental and economic- affecting the community’s health. In the second year, they conduct a study into the health needs resulting in a community health diagnosis, whereas in the third year they undertake to resolve those needs by identifying resources available in the community. The aim of this curriculum element is to teach students to provide service to the people in the community. In later years of their medical training, students are sent to the district hospitals for a community rotation of 6 to 8 weeks.We conducted a cross-sectional descriptive study among doctors working in health facilities in the Northern Region between September 2016 and March 2017. To collect data, we used a 23-item questionnaire consisting of both open- and closed-ended questions about participants’ demographic characteristics, medical school, motivation, challenges, perceptions and preferences related to work in a rural area ’. HF10MD.The final suggestion put forward by participants was that key players would do well to collaborate on matters of rural practice. For instance, medical schools should work together in partnership with the community in order to render its COBES programme effective. Such collaboration could result in the community offering transportation and supervisory assistance to students. It would also create a favourable learning environment for students, which, in turn, could increase the likelihood of them returning to the rural areas in the future: ‘We need more district hospitals to be accredited for training to enhance compulsory posting of interns to the district hospitals’. HF1MD.Participants also suggested that schools, hospitals and national authorities should join forces in order to increase the number of accredited hospitals in the region. By sending specialists to some of the district hospitals, the Ministry of Health could help raise quality standards in these institutions, making them eligible for accreditation. As a result, students would have more opportunities to undertake an accredited specialty training after graduation. A positive experience could make young doctors want to stay and work there after their training has ended, thereby helping address the undersupply of doctors in such areas: A number of factors influence medical doctors’ decision to practise in rural remote communities. The medical doctors who took part in this study had accepted rural postings for the opportunity it afforded them to take an active role in patient care, gain experience and hone their clinical skills, and also to ultimately gain professional independence. Apart from these reasons, they were drawn by a desire to serve the needy in a completely new environment. These results echo and confirm previous international research findings suggesting that acquiring experience, clinical skills and professional independence are common reasons for doctors to choose rural practice , 17–19. Lack of career progression opportunities and professional isolation were key complaints voiced by the doctors in this study. Despite their willingness to work in rural areas, their enthusiasm had become overshadowed by a belief that entry into postgraduate studies would have been easier had they stayed in the cities. In their experience, the relevant authorities tended to forget about doctors stationed in the rural area when deciding on allocation of positions for postgraduate medical training. Hence, lack of career progression opportunities became a critical disincentive for these doctors to serve in rural areas. Study delays, lack of continuing professional development and a feeling of being ‘abandoned’ by the ministry were sources of concern to the doctors working in the rural areas. These have been long-standing problems in Ghana and successive governments have been struggling to address some of these challenges , 20. To An additional key finding in this study is the important and paramount role of medical education. Most of the doctors we surveyed were graduates of the UDS-SMHS which includes rural exposure as an integral part of the curriculum through its PBL/COBES component. To increase the attraction and retention of medical doctors in remote practice in sub-Saharan Africa and middle- and low-income countries, medical students should be exposed to the rural communities early in training. Respondents suggested that medical schools should thus incorporate rural outreach/practice in the curricula to make students spend time in the rural communities before they graduate, in order to prepare them for rural practice and increase the likelihood of them accepting rural postings. The respondents envisaged a clear role for medical education in attracting doctors to such areas and retaining them by means of early rural exposure. To accomplish this, medical schools must incorporate appropriate teaching methods in the curricula, such as COBES, rural rotations and outreaches. Similar suggestions on the role of medical education in the attraction of doctors to the rural communities and their retention have been made by prior studies on Community-Based Education and Service (COBES) . AnotherUDS-SMHS graduated doctors previously showed their willingness to work in the rural communities . This isAnother prominent finding in this study was the need to improve basic essential equipment, accredit various district health facilities and post specialists to these facilities for internship training and rural rotations. It is therefore very important for the Ghana Ministry of Health (MoH) to provide the necessary human and material resources for the health facilities to improve the delivery of healthcare in the rural communities. Again, the Ministry of Health, should consider creating incentives packages to attract and retain health professionals in the country and deprived communities in particular. This could be another powerful strategy to retain doctors in the rural areas after their internship. Most of the respondents further believed that the government has a duty to develop human resource policies and plans and should have the political will to implement and monitor them. Curriculum designers can learn from the findings of this and similar studies that instituting Community-Based Education and Service as part of health training institutions’ curricula to provide rural exposure serves the purpose of motivating students and thereby creates a favourable attitude towards rural practice and positively influences graduates’ willingness to work in the rural areas.This study has some limitations. The study was conducted in only one region of Ghana where UDS-SMHS is located and the limited number of responses to the survey, thus making it difficult to generalise the findings. However, the findings are interesting and concur with similar studies conducted in both developed and developing countries especially on the role of medical education in the training of doctors. The location of UDS-SMHS in the region where the research was conducted could also have influenced the large proportion of UDS-SMHS trained doctors who participated in the study. The regions in which health professions institutions are located generally have more of the professionals practising in those regions. We would welcome replications of the present research in other regions of the country. Another limitation of this study is the use of open-ended questions that provided limited space for participants to write their comments. This did not allow participants to fully express their opinions and perspectives. However, the findings provide valuable information that is useful for future research and also adds to our understanding of the factors that motivate doctors to accept rural practice.Another limitation is that doctors’ work schedules did not allow for interviews to be conducted as they frequently indicated that their workload was high and they could not free time for the provision of verbal data. Although, the authors have the impression saturation was reached, it cannot be excluded that additional themes would have surfaced in a larger sample. This is a limitation of the study.Ghanaian medical doctors are willing to work in the rural areas to acquire clinical skills, experience and professional independence. The key role of medical education in the attraction and retention of doctors to the rural communities was clearly acknowledged. Medical schools should incorporate rural outreach/practice, such as COBES, in the curricula to immerse students in rural practice, increasing the likelihood of them accepting rural postings after graduation.In addition, the Ministries of Education and Health, in collaboration with the communities could improve the inadequacy of medical doctors in the rural communities by developing a national policy on rural posting. This Policy could be directed towards improvement of district health facilities as centres for internship training and rural rotation for medical doctors.Additional file 1:Questionnaire. (DOCX 18 kb).


This study addressed the development of and the relationship between foundational metalinguistic skills and word reading skills in Arabic. It compared Arabic-speaking children’s phonological awareness (PA), morphological awareness, and voweled and unvoweled word reading skills in spoken and standard language varieties separately in children across five grade levels from childhood to adolescence. Second, it investigated whether skills developed in the spoken variety of Arabic predict reading in the standard variety. Results indicate that although individual differences between students in PA are eliminated toward the end of elementary school in both spoken and standard language varieties, gaps in morphological awareness and in reading skills persisted through junior and high school years. The results also show that the gap in reading accuracy and fluency between Spoken Arabic (SpA) and Standard Arabic (StA) was evident in both voweled and unvoweled words. Finally, regression analyses showed that morphological awareness in SpA contributed to reading fluency in StA, i.e., children’s early morphological awareness in SpA explained variance in children’s gains in reading fluency in StA. These findings have important theoretical and practical contributions for Arabic reading theory in general and they extend the previous work regarding the cross-linguistic relevance of foundational metalinguistic skills in the first acquired language to reading in a second language, as in societal bilingualism contexts, or a second language variety, as in diglossic contexts. Arabic is a typical case of diglossia , which iThis linguistic distance traverses all linguistic domains and is remarkable in the phonology and in the lexicon. For instance, a recent study recorded 5-year-olds as they were interacting with each other on a regular kindergarten day. A corpus of about 4,500 different word types were collected and analyzed for their lexical–phonological distance from their equivalent form in StA. The analysis showed that only about 21% of the words in the spoken lexicon of children consisted of identical words, that is, words that maintain an identical lexico-phonological structure in StA, whereas the remaining words were divided almost evenly between cognate words  and completely different unique forms in SpA and StA .This linguistic distance between SpA and StA was also found to affect children’s phonological processing skills, such as phonological awareness (PA), phonological processing, naming , childreBesides linguistic distance between SpA and StA, reading acquisition in Arabic implicates another important feature. This is the use of diacritics in the Arabic orthography to encode phonological information necessary for reading accuracy. Orthography is defined as a set of principles that define the basic units of the writing system . HoweverThis two-layered system of optional diacritics results in two orthographies: a voweled orthography largely transparent: regular and consistent  and an uThe question of role that diacritical vowelization has in reading in Arabic has been studied extensively. This research shows that diacritics facilitate reading accuracy and comprehension in both poor and skilled readers , 2001. MThe co-occurrence of diglossia and vowelization in Arabic, as in many Arabic-script-based orthographies in Africa , provideThe role of linguistic distance and diacritic vowelization on Arabic reading has been the focus of many research studies . Rather Phonological awareness (PA) refers to one’s awareness of, and access to, the sound structure of oral language . The rolAlthough phonological recoding at the level of grapheme-to-phoneme decoding is essential for the development of successful reading, alphabetic orthographies represent two layers of language: phonemes and morphemes. Therefore, awareness of morphemes should contribute to reading development in an alphabetic orthography besides awareness of phonemes . MoreoveMorphological awareness is defined as the ability to reflect on and manipulate the constituent morphemes of words, the smallest meaningful word units . ResearcIn the Arabic writing system, the two basic morphemic units in words: the root and the word-pattern are not linearly concatenated, as is the case in English or French. Yet, they are regularly represented in the letter structure of the word as explained above. The root is a strong semantic entity and is a constituent of the stem of almost all content words in Arabic. All this implies the salience of the root in processing Semitic Arabic. In fact, the root and the word-pattern appear to be central to the way that words are organized in the Arabic lexicon . It alsoGiven the morphological richness of Arabic  and the The goal of the present study is to examine the development of PA and morphological awareness in SpA and StA separately. It further explores word reading in SpA among Arabic-speaking children compared with their StA word reading with the objective of probing quantitative differences between these abilities in the two language varieties and their relation to StA reading ability. The question of whether the children’s SpA metalinguistic awareness and word reading show different developmental trajectories, and whether they show different patterns of relationships with reading in StA, has never been studied. Moreover, earlier research never addressed this question in the reading of voweled versus unvoweled words separately. These questions are critical given the fact that children are taught to read in StA whereas the language they master and naturally use is SpA, a language that differs from SpA in all linguistic domains including in the phonological and in the morphological structure. This developmental examination is also warranted given the phonological transparency of voweled Arabic, yet the morphological transparency of unvoweled Arabic. This might impact the relevance of phonological versus morphological awareness to reading in different grades an in voweled versus unvoweled Arabic.To date, only one study has investigated the effect of diglossia on the development of reading skills in voweled and unvoweled SpA and StA among typically developing readers  and anotM = 7;7, SD = 3.00 months), 20 fourth graders , 20 sixth graders , 20 eighth graders , and 20 tenth graders . There were 10 female and 10 male students in each grade level. All participants were native speakers of a local dialect of Palestinian Arabic spoken in the north of Israel and were sampled from two public schools in the north school district with an officially ranked middle socioeconomic background. No participant had reported neurological, language, or psycho-educational difficulties. Data collection took place during the winter–spring of 2016. Official authorization by the chief scientist of the Ministry of Education, as well as by Bar-Ilan University ethics committee was obtained. Written parental consent was obtained for all children participating in the study.A total of 100 students participated in the study: 20 second graders  and phoneme deletion . One score was assigned for completing each item correctly and a zero score for any kind of error. No partial scores were assigned. The PA score is a total score obtained on both the phoneme segmentation and the deletion tasks per each language variety separately. It is important to note that the correlation between the two tasks was high, and therefore we used a composite score.Two sets of PA tasks were developed: one in SpA and another in StA. SpA tasks used phonological structures (phonemes and syllabic structures) that are used in both StA and the SpA vernacular used by the children, whereas StA tasks targeted phonological structures that are used only in StA. Phonological structures (mainly phonemes) that are used only in SpA were not targeted because these may not have a conventional orthographic representation, namely, a grapheme that represents them in the written language. Two tasks per language variety (SpA and StA) were developed: full phoneme segmentation equally targeting initial, final, and medial phonemes (N items = 40) and another in StA  SpA tasks targeted morphological units that are used in both StA and the SpA vernacular used by the children , whereas StA tasks targeted morphemes that are used only in StA . The morphological tasks employed the Word Analogy format adapted from  He brought – We brought; He achieved, We ________, and for testing derivational morphology, the following item was used:  Wrote-writer; Ran-…… .Two sets of morphological awareness tasks were developed: one in SpA (N = 110 items per task). For the real word reading tasks, we selected SpA words with identical word forms in StA and SpA  and StA words that exist in StA but not in SpA. The latter word type comprised cognate words, which have similar forms in StA and SpA , and unique words, which are used in StA but not in SpA (StA /Ʒara:/- SpA /rakad/ “ran”). Words were matched on phonemic length (three to 12 phonemes), syllabic length (one to five syllables), orthographic length (three to ten letters), morphological structure (one to four morphemes), and on word familiarity/frequency as determined by 10 Arabic language experts based on a five-point scale. StA words across tasks were also matched on the type of the StA linguistic structure they encoded . Words within tasks progressed in linguistic complexity and frequency. Separate lists of words were presented in the voweled (phonemic diacritics only) and unvoweled orthography. None of the unvoweled words were homographic or could be read in more than one way based on the specific diacritics that were missing. SpA and StA pseudowords were derived from the voweled words by changing one or two letters in the word while ensuring that the pseudowords abided by SpA and StA phonotactic rules, respectively . Pseudowords across tasks were matched on phonemic length, orthographic length, and syllabic complexity.Twelve different word-level reading tasks were constructed that measured accuracy and fluency of reading SpA and StA voweled and unvoweled real and pseudowords . To measure fluency, participants were instructed to read the list of words as accurately and as quickly as possible, and testing was discontinued after 1 min. Reading fluency was calculated as the number of words read accurately in the first 45 s of testing. Data collection took place in May, 2 months before the end of the school year. Analysis participants’ performance on the reading accuracy tasks showed satisfactory Cronbach’s alpha reliability levels exceeding 0.7.In order to examine performances on the phonological and morphological awareness tests, two 5×2 repeated measures analyses of variance (ANOVA) were conducted, with grade  as the between-subject variable, and language variety (SpA and StA) as the within-subject variable: one analysis for the PA and one for the morphological awareness.Table 1).The main effect of language variety was found to be significant, indicating greater performance on the SpA than on the StA test. The main effect of group was also significant, indicating that the students in the higher grades performed better than those in the lower grades .The two-way interaction of grade × language variety was significant on the PA test. Bonferroni analysis indicated that the second and fourth grades performed better on the SpA compared to the StA. No significant differences between the performances on the SpA tests and the StA tests were found in the sixth, eighth, and tenth grades (Table 1).The main effect of language variety was found to be significant, indicating greater performance on the SpA than on the StA test. The main effect of group was also significant, indicating that the students in the higher grades performed better than those in the lower grades .The two-way interaction of grade × language variety was significant on the morphological awareness test. Bonferroni analysis indicated that the second, the fourth, and the sixth grades performed better on the SpA compared to the StA. No significant differences between the performances on the SpA tests and the StA tests were found in the eighth and tenth grades  were conducted, with grade  as the between-subject variable, and language variety (SpA and StA) as the within-subject variable: two analyses for the performances on the accuracy tests and two analyses for the performances on the fluency tests. For the reading accuracy tests, we also conducted two 5×2 repeated measures analyses of variance (ANOVA) for the item level, with grade as the within-participants variable and language variety as the between-participants variables.Table 2).The main effects of language variety were found to be significant, indicating greater performance on the SpA than on the StA on the two reading accuracy tests. The main effects of group were also significant, indicating that the students in the higher grades performed better than those in the lower grades .The two-way interactions of grade × language variety were significant on both voweled and unvoweled reading accuracy tests. Bonferroni analyses on both tests indicated that the second, the fourth, and the sixth grades performed better on the SpA compared to the StA. No significant differences between the performances on the SpA tests and the StA tests were found in the eighth and tenth grades  = 1074.62, p < 0.001, F = 1174.48, p < 0.001, F = 1028.92, p < 0.001, F = 524.97, p < 0.001, F = 80.72, p < 0.001, F = 29.16, p < 0.001, The main effects of language variety were found to be significant on both voweled and unvoweled reading accuracy tests [Table 2).The main effects of language variety were found to be significant, indicating greater performance on the SpA than on the StA on the two reading fluency tests. The main effects of group were also significant, indicating that the students in the higher grades performed better than those in the lower grades .The two-way interactions of grade × language variety were significant on both voweled and unvoweled reading fluency tests. Bonferroni analyses indicated that on both the voweled and the unvoweled StA and SpA fluency tests, all the five grades performed better on the SpA compared to the StA (Table 3).Pearson correlations were conducted in order to examine the correlations between the performances on the reading accuracy and fluency in the StA tests and the performances on the SpA phonological and morphological awareness tests .In order to examine the contribution of the grade and the performances on the SpA phonological and morphological awareness tests to the prediction of the performances on the reading accuracy and fluency in the StA tests, we conducted four hierarchical regression analyses, two analyses for the prediction of the performance on the voweled and unvoweled reading accuracy tests and two analyses for the prediction of the performance on the voweled and unvoweled reading fluency tests. In the first step, the background characteristic – grade was entered. In the second step, the performance on the PA test were entered, and in the third step, the performance on the morphological awareness test were entered. We entered the performance on the morphological awareness test in the third step in order to examine whether the performances would contribute significantly to the explained variances of the performances on the accuracy and fluency in the StA tests, beyond the background characteristic and the performance on the PA test (Table 4 indicates that the performances on the SpA PA tests added significantly 11.3 and 9.8% beyond the participants’ grade to the prediction of the performance on the voweled and unvoweled StA accuracy tests (ps < 0.001) and 3.6 and 1.8% to the prediction of the performance on the voweled and unvoweled StA fluency tests (respectively). The positive beta coefficient of participants’ grade and the performances on the SpA PA tests to the prediction of the performances on the voweled and the unvoweled StA accuracy and fluency tests indicated that as the grade and the performances on the SpA PA tests increase, the performances on the voweled and the unvoweled StA accuracy and fluency tests increase, respectively.ps < 0.001) and 1.9 and 1.6% to the prediction of the performance on the voweled and unvoweled StA fluency tests . The positive beta coefficient of the performances on the SpA morphological awareness tests to the prediction of the performances on the voweled and the unvoweled StA accuracy and fluency tests indicated that as the performances on the SpA morphological awareness tests increase, the performances on the voweled and the unvoweled StA accuracy and fluency tests increase, respectively.In the third step, the performances on the SpA morphological awareness tests added significantly 4.7 and 6.5% beyond the participants’ grade and the performance on the PA test to the prediction of the performance on the voweled and unvoweled StA accuracy tests  and unvoweled (opaque) words. The study also examined children from different age groups in the school system, thus providing a developmental point of view on the link between metalinguistic skills in general, and in relation to voweled and unvoweled word reading in Arabic.Specifically, the first goal of the study was to explore performance differences on phonological and morphological awareness as well as word reading tasks among Arabic-speaking children, by comparing these tasks in SpA and StA. The examination of PA, morphological awareness, and word reading accuracy and fluency tasks yielded different results. The results showed an initial discrepancy in the second and fourth grades in PA and morphological awareness in SpA and StA words, in favor of the former, that was eliminated in the sixth and eighth grades for the two tasks, respectively. The rather quick improvement in PA compared to morphological awareness might relate to learner’s gradual development in understanding the complex relations of form and meaning . This deLinguistic Affiliation Constraint (diglossia effect (The current study also showed that metalinguistic awareness in SpA was consistently higher than that in StA. These findings conform with reported evidence and they offer further evidence for the nstraint  which waa effect , which ia effect  operatioa effect .With respect to reading, this study suggests a number of differences in the development of SpA and StA word reading skills. The results reveal that both word reading accuracy and fluency in Arabic are higher for SpA words than StA words. This advantage for SpA words over StA words was found to persist across development and to surface in the reading of both voweled and unvoweled words. This finding is cardinal, indicating the long-term impact of diglossia and its interplay with orthographic depth. Given the fact that the Arabic orthography, at least in its voweled form, is highly transparent, the results underscore the importance of another factor in word reading development in Arabic. This factor might be diglossia and the linguistic distance between SpA and StA word morphology. This finding might also be explained by the lack of efficiency in basic phonological and morphological processing skills in StA that might clarify some of the possible mechanisms by which diglossia might affect word reading accuracy and fluency in Arabic.With respect to the role of vowelization in explaining differences in word reading accuracy and fluency skills between SpA and StA, the results showed that the gap in reading accuracy between SpA and StA was evident in the case of both unvoweled and voweled words. While it closes up in the eighth grade in reading accuracy of SpA voweled words, in the case of StA voweled words, the differences vanish when readers reach the tenth grade. In the fluency measures, the gap between unvoweled SpA and StA words remains in all grade levels we checked. This finding coincides with the prediction that differences between SpA and StA should be smaller when reading transparent words than opaque ones. Thus, in reading vowelized words, where successful decoding merely requires grapheme–phoneme correspondence, children reached a similar fluency level in SpA and StA. On the other hand, when reading unvoweled words, children reading StA words encountered greater difficulty in rapidly reading the words. Hence, Arabic-speaking children still seem to rely heavily on simple decoding skills while reading StA. While reading voweled words in Arabic is compatible with a heavy reliance on alphabetic mechanisms in reading and with high rates of reading accuracy , this stThe second goal of this study was to explore the connection between PA, morphological awareness in SpA, and word reading in StA. Examining these three aspects of language provided an opportunity to clarify the contribution of metalinguistic skills in SpA to StA word reading, as these aspects provide an opportunity to consider answers related to questions such as the following: what aspect is most important to be included in SpA intervention programs, or at what age is it beneficial to provide preventative instruction? Results of this study indicate that in addition to the expected role of SpA PA, SpA morphological awareness plays a cardinal role in StA word reading fluency. This finding is well aligned with the established claim that morphological awareness contributes to school-age students’ performance reading and spelling words or pseudowords , 2017. SIn addition to demonstrating a significant contribution of phonological and morphological awareness to reading in Arabic, the current results are particularly interesting given the design of the current study in which phonological and morphological skills were tested in SpA but reading was naturally conducted in StA. The evidence that SpA phonological and morphological awareness predicts StA reading supports earlier evidence of the role of metalinguistic awareness in L1 I predicting reading in L2 . MoreoveOur findings, together with those of several previous studies, seem to suggest that morphological awareness is more a language- or variety-specific construct . In otheThe present data support previous reports of the link between diglossia, linguistic skills, and reading ability . The finIt is important to note some directions for further study. First, the present study focused only on phonological and morphological awareness skills as well as reading skills among children from mid-high socio-economic background. Because this study found evidence for differences in these skills, future research should examine the phonological and morphological awareness abilities as well as reading skills among children of different socioeconomic backgrounds, to explore whether the gaps found in this study increase among children from low socio-economic background. Second, the current study is cross-sectional in nature, thus in order to clarify whether the differences in the phonological and morphological awareness as well as reading abilities of children across grades indeed indicate a different developmental pattern, future studies should employ a longitudinal design and follow the same group of children over grades. Finally, future studies could potentially extend the investigation to other diglossic contexts.All authors listed have made a substantial, direct and intellectual contribution to the work, and approved it for publication.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.


The Scottish Medicines Consortium evaluates new drugs for use in the National Health Service in Scotland. Reforms in 2014 to their evaluation process aimed to increase patient access to new drugs for end-of-life or rare conditions; the changes include additional steps in the process to gain further information from patients and clinicians, and for revised commercial agreements. This study examines the extent of any impact of the reforms on funding decisions.Data on the Scottish Medicines Consortium’s funding decisions during 24 months post-reform were extracted from published Advice, for descriptive statistics and thematic analysis. Comparison data were extracted for the 24 months pre-reform. Data on decisions for England by the National Institute for Clinical and Health Excellence for the same drugs were extracted from published Technology Appraisals.The new process was used by 90% (53/59) of cancer submissions. It is triggered if the initial advice is not to recommend, and this risk-of-rejection level is higher than in the pre-period. Thirty-eight cancer drugs obtained some level of funding through the new process, but there was no significant difference in the distribution of decision types compared to the pre-reform period. Thematic analysis of patient and clinician input showed no clear relationship between issues raised and funding decision. Differences between SMC’s and NICE’s definitions of End-of-Life did not fully explain differences in funding decisions.The Scottish Medicines Consortium’s reforms have allowed funding of up to 38 cancer drugs that might previously have been rejected. However, the contribution of specific elements of the reforms to the final decision is unclear. The process could be improved by increased transparency in how the non-quantitative inputs influence decisions. Some disparities in funding decisions between England and Scotland are likely to remain despite recent process convergence. Drugs to treat rare conditions , and drugs to treat patients in their last months of life, have been the subject of contentious funding decisions in many countries, including the United Kingdom (UK). For rare conditions, small patient populations often result in the drugs being expensive, and they may not have the necessary level of evidence when submitting to reimbursement agencies to support a funding decision with certainty. For drugs related to end-of-life care (notably in cancer), there is a belief that extensions to the last months of life are particularly valuable to patients and their families  althoughHealth Technology Appraisal is a devolved responsibility in the UK, and England and Scotland responded differently over time to the challenges of assessing these drugs. The first adjustment was by National Institute for Health and Care Excellence (NICE) in England in 2009, introducing its ‘End of Life Criteria’, which define situations in which evaluation committees can place greater weighting on health gain for drugs to treat patients with short life expectancy . The ScoDefinitions of end of life, orphan, and ultra-orphan conditions. A drug may qualify under rarity, end-of-life, or both (for example a rare cancer).Introduction of a Patient And Clinician Engagement (PACE) meeting; purpose is to clarify aspects of value perceived by patients and clinicians that are not fully captured in the QALY, implicitly supporting acceptance of medicines with a cost per QALY above the standard threshold.Option for the submitting company to propose or modify a Patient Access Scheme (PAS) at the PACE stage.An additional framework of non-scored criteria for evaluating ultra-orphan drugs.SMC introduced a further set of reforms in 2014, specifically for medicines to treat EOL and rare conditions. The changes take the form of an add-on process that is triggered only if the initial advice of SMC’s New Drug Committee (NDC) is not to recommend funding , 6 and iThe SMC definitions are different from the end-of-life criteria used by NICE, both structurally and numerically Table , and areThe 2014 SMC changes are significant in the context of UK health technology appraisal, as a novel approach to incorporating broader aspects of value into cost-effectiveness analysis. With continued calls for NICE reform from advocacy groups, and similar pressures in other countries, it is important to evaluate the Scottish approach as a possible model for assessing value beyond the QALY, or as a pointer to key factors to include. Further, the changes could have important effects on patient access to new drugs in Scotland, with implications for spending priorities within NHS Scotland and for cross-border parity of patient access between the nations of the UK. Cancer is of particular interest, as a category that is expected to benefit from the end-of-life element, and where there are existing disparities in access arrangements, due to the existence of the Cancer Drugs Fund (CDF) in England and the pre-existence of NICE’s EOL criteria. Hence this paper evaluates the impact of the changes on funding decisions in the first 2 years of their operation, focusing on cancer, with the aim of contributing to ongoing debate on evolution of health technology assessment processes in the UK and elsewhere.SMC advice on submissions based on the new processes was published from October 2014 , so adviAdvice Summaries and Detailed Advice (pdf) documents were accessed from the SMC website, and data extracted and tabulated in Excel for descriptive statistics and thematic analysis. Data included submission type, EOL and rarity status, decision, incremental cost effectiveness ratios (ICERs), restrictions, use of PACE and PAS, and the PACE summaries. Descriptive statistics of the extracted data were analysed in Excel.Because a simple before/after analysis does not isolate the effect of the changes, we took advantage of the structure of the reform, as an additional process triggered only for submissions that received a preliminary NDC position of a) Not Recommended, or b) Restricted more narrowly than requested by the manufacturer . We therThematic analysis of the PACE meeting summaries was carried out by an inductive process: that is, by constructing themes suggested by review of the text rather than an imposed framework. Themes were developed by determining the core idea of each phrase, and linking similar ideas together to form themes. A given phrase was only linked to one theme. Related themes were grouped together for ease of presentation and understanding. The analysis was carried out by two researchers. One researcher developed an initial thematic framework from a sample of PACE summaries; a second researcher analysed the majority of the summaries, making adjustments to the framework as needed and in discussion with the first researcher, who completed the analysis. Thematic analysis was carried out using MaxQDA software (v12).Data on NICE appraisals for the same drugs were accessed on the NICE website, and data extracted from the published Technology Appraisal Guidance documents . Data included approval status, whether EOL criteria were met, and reason for not meeting EOL criteria. For comparison of access between countries, restricted or optimised approvals were considered as ‘access’ along with full recommendation, and the most recent decision on a given drug-indication  was included to provide a point-in-time snapshot of drug availability.Coverage by the Cancer Drugs Fund in England was determined from the CDF list of September 2015, and the relevant CDF Decision Summaries, accessed from the NHS England website.Figure p > 0.05).Considering all submissions since the reforms compared to the period immediately before, the number of cancer submissions was higher post-reforms Fig. . Althougp < 0.001). In the final decisions, however, only 15 of them were actually Not Recommended; if all 53 would have been Not Recommended under the original process, this represents 38 drugs that gained market access (Accepted or Restricted status) due to following the new process. Similarly, of the 17 non-cancer submissions assumed to be at risk of rejection, 9 gained some access.In cancer, 53 of the 59 submissions (90%) were considered under the new process Fig. , which wThere were 18 cancer resubmissions (ie drugs previously Not Recommended by SMC) post-reform, an increase on the six in the pre-period. Fifteen of the resubmissions used the new process, which as above we assume to indicate a preliminary Not Recommended decision, and 10 were subsequently funded (Accepted or Restrict status), as were all three that did not trigger the new process. Review of the Detailed Advice documents for the resubmitted drugs found that the resubmissions contain multiple changes compared to the original; the resubmissions typically refer to the same clinical data as the original submission, but might propose alternative cost effectiveness models, re-analyse for specific subgroups, or include confidential commercial arrangements. Hence it is not obvious whether each decision to fund a previously Not Recommended drug is due to the new process, or to other changes that improve the proposition such that the drug can now be approved.p > 0.05).A thematic analysis of the PACE meeting summaries in the SMC Advice is presented in Table Among the high-frequency themes, although some are explicitly reflected in a typical cost effectiveness analysis , others are not, but may be considered during committee deliberations: for example, convenience for patients, impact on families, and hope. Some are partially or indirectly considered: for example, poor prognosis with an immediately shortened life expectancy would be covered by end-of-life considerations, but the severity of the condition per se is not formally weighted; similarly ‘independence’ is reflected to the extent it is symptom-dependent, and via the ‘usual activities’ and ‘self-care’ dimensions of EQ-5D, but not valued in its own right.Eleven PACE meeting summaries commented on the need for the drug to be funded in its full licenced indication. These may be candidates where NDC was minded to impose a tighter restriction than requested by the manufacturer, although that information is not explicitly available.To examine the impact of the differences between SMC and NICE criteria, we compared the post-reform evaluations by SMC with appraisals of the same drugs by NICE, considering separately the impact on the designation  and the decision (whether the drug was recommended for funding). Note this analysis is based on a cohort of completed cancer appraisals from Scotland, so conclusions cannot be drawn regarding access or appraisal timings overall between the two countries.n = 53), 25 had been considered for EOL designation by both agencies , the designation agreed between SMC and NICE despite the differences in the definitions. Of the active SMC cancer drug appraisals from the study period  because a decision to fund was reached without the need to trigger EOL consideration. Further reasons for absence of an EOL designation by NICE (ie designation by SMC only), are listed in Table Comparison of NICE and SMC decisions on this cohort of 53 cancer drugs identified 25 cases of differential recommendations between SMC and NICE in September 2016 Fig. , with 3 For a complete description of the differences in access between the countries from the patient’s perspective, we need to consider the totality of access arrangements, which includes the CDF in England. Because the CDF funds some drugs that are not available in Scotland, overall we identify 14 examples of differential access, with 8 drugs funded in Scotland only and 6 England only Fig. .This analysis of funding decisions indicates that the SMC changes appear to have resulted in increased access to drugs for end of life and rare conditions, with up to 38 cancer drugs gaining access that they might not have had pre-reforms. The new, additional process was used most commonly for cancer drugs, and the proportion of cancer drugs triggering this process (due to a preliminary Not Recommended decision) is higher than would be predicted by the Not Recommended rate in the pre-period. The relative contribution of the PACE meeting, additional PAS opportunity, and increased ICER flexibility is unclear from this work. Differences between Scotland and England in classification of drugs as EOL lead to cross-border differences in EOL status, but do not fully explain differences in access; other factors include the agencies’ timeframe for appraisals, and which drugs are within their remit.Our findings are consistent with early comments , 9 and aThe higher than expected proportion of the cancer submissions triggering the new process could be because this was an inherently challenging cohort of drugs, or because the reformed process – particularly the ICER flexibility – attracted submissions at higher ICERs than in the past. Alternatively, it may be that NDC’s readiness to use the new process is higher than the historical rate of Not Recommended decisions; for example, by being cautious in giving an Accept recommendation, which denies the opportunity for a new or revised PAS and a PACE meeting, thus losing an opportunity to gather additional information and potentially creating difficulties if SMC subsequently makes a Not Recommended decision. Irrespective of the reason, SMC appears to be handling more PACE meetings than might have been anticipated from previous decisions, and this may have implications for resources within SMC.The nature of the impact of the PACE meetings on funding decisions remains unclear. Similarities between the PACE summaries may be created in part by the structured nature of the meeting and summary template, and the need to provide a concise summary for the appraisal committee, although a study published by Cancer52 found that PACE participants thought the summaries were an accurate reflection of the discussion . The proOur analysis identifies disparities in funding decisions between Scotland and England reflecting both process and decision differences between SMC and NICE. From a patient perspective, this disparity was reduced in reality by the existence of the CDF in England, which funded several of the drugs rejected or pending by NICE. The future funding of these CDF drugs is still being determined. The CDF reforms remedied some of the process differences between NICE and SMC, notably: a) removal of the rarity requirement in NICE’s end-of-life criteria, bringing the definitions into closer alignment; b) expectation that NICE will publish a decision more quickly than previously, normally within 90 days of the marketing authorisation for cancer drugs; and c) requirement that all new cancer drugs will be referred to NICE, which was previously not the case. However, as we saw in this cohort of drugs, even where both agencies have completed an evaluation under EOL conditions they can still come to different decisions, so some differences in access are likely to remain, reflecting other process differences, differences in clinical practice, implicit preferences, and varying commercial arrangements with the pharmaceutical industry.A limitation of our study is our assumption that all the submissions that triggered the new process, would have been rejected had the reforms not been in place. Some of them might in fact have been granted some level of access following further deliberation and negotiation. Importantly, NDC do not use the ‘modifiers’ available to SMC to allow additional flexibility in specified circumstances; application of these modifiers may have supported a Recommended decision by SMC even without the reforms, despite an initial Not Recommended position from NDC. Comments from stakeholders on the NDC decision, or new analysis suggested by the NDC review, could also lead to SMC reversing an initial Not Recommended NDC position. In either case, our analysis would overestimate the number of additional approvals permitted by the reforms. Further, as outlined in the Methods section, the new process can also be triggered if the NDC are minded to impose a tighter restriction on use than proposed in the submission; however, if we take account of the 11 cases identified in the PACE analysis - assuming they were at risk of involuntary restriction rather than rejection - our observations on distribution of decisions still hold.A second limitation is our use of information available in the public domain, which includes summaries by SMC staff and excludes commercially confidential information, leading to risk of bias due to missing and secondary information - although our analysis does reflect the summary information available to SMC committee at the point of decision. The summarised nature of the public documents in particular limits our ability to determine which elements of post-reform resubmissions – the new process, or other improvements to the case for funding – led to the reversal of the previous decision. Further, we have not considered whether the additional spending represents value for money for NHS Scotland, which would require a comparison of the health gain achieved with expenditure; estimating the actual costs is particularly challenging given the confidentiality of any commercial arrangements. If acceptance of these drugs for funding is at higher ICERs than would be accepted for other drugs, opportunity costs are imposed elsewhere in the health system. It is not clear from the empirical literature that such prioritisation of medicines for end of life and rare conditions is in line with the preferences of the Scottish public .Strengthening the PACE analysis by using verbatim transcripts of the meetings rather than summaries, and supplementing with qualitative work exploring the experiences of key players in the process, could provide additional insight into the impact of PACE on decisions. In addition, the reforms occurred in parallel with SMC moving to holding appraisal committee meetings in public, and increase of the New Medicines Fund to £90million to help cover the cost of these medicines. In combination, these changes may have had additional effects beyond numbers of approvals, such as affecting buy-in to decisions, or encouraging pricing flexibility, and the contribution of these diverse elements deserves additional exploration. Further work is also needed to determine whether the choices made under the new SMC process provided value for money, ideally by examining actual outcomes from use of the drugs in practice. The CDF in England has been criticised for failing to provide such an evaluation of its expenditure , and datWe identified up to 38 cancer drugs that were funded post-reform that might previously have been rejected, but the contribution of each element of the reforms to the funding decision remains unclear. Differences in decisions between England and Scotland are not fully explained by differences in definitions of EOL/rare conditions, and disparities in access are likely to remain despite recent changes in England. Future improvements to the process could include enhanced transparency in use of the PACE input, and evaluation of patient outcomes from funding access to these drugs.


Recruitment is central to any research project, and recruitment itself should be well documented and researched. We describe our recruitment efforts for a community-based research project—entitled the Learning Families Project—conducted in Hong Kong.In collaboration with community stakeholders, residents from a public housing estate were recruited to participate in family programs aimed at enhancing family well-being. Various recruitment strategies were employed including the distribution of 19,200 leaflets, 688 posters, a banner, a kick-off ceremony, 10 promotion activities, 1,000 direct calls, word of mouth, 51 mobile counters, and 10 door-to-door visits. Drawing on field notes, research logs, short questionnaires, and focus group conducted with our community partners and residents, we describe and discuss our recruitment strategies, challenges, and lessons learned.Over a 9-month period, 980 participants were recruited and participated in our study, exceeding our recruitment goal (860 participants). Several observations were made including active recruitment strategies  being more effective than passive strategies ; the importance of raising project awareness to facilitate recruitment; and the challenges encountered .The lessons learned include the importance of engaging Chinese communities, utilizing a positive outreach approach, and setting realistic expectations. Although similar recruitment strategies have been reported the West, a number of cultural differences should be taken into account when working with Chinese population. Further research is needed to examine the effectiveness of tailoring recruitment strategies to various populations. The aim of this article is to report our recruitment experience on a community-based research project, designed to address the concerning rates of family problems in a deprived district in Hong Kong, China. The literature on recruitment for family programs conducted in clinical and non-clinical settings documents substantial challenges , 2. GeneYancey et al.  reportedWhile strategies and approaches on how to recruit are accumulating, reported experience outside of Western countries is rare , 9. TherThe Learning Families Project was part of the project entitled “FAMILY: a Jockey Club Initiative for a Harmonious Society” with the mandate to promote family health, happiness, and harmony in Hong Kong families. Kwun Tong district is a relatively traditional and less privileged community in Hong Kong, with a population of 622,152 . ApproxiOne public housing estate was selected as the targeted intervention estate after discussion among HKU staff, CFSC project staff, and various local leaders. The estate consisted of 7 housing blocks with approximately 5,000 households. Families who were Hong Kong residents, able to communicate in Cantonese, and residing in the targeted estate were invited to participate. A feasible and realistic sample size of 860 participants was set upon discussion and agreement with our community partners, steering committee, and funder. Our sample was a convenience sample based on community leaders’ understanding of the community. Ethics approval was obtained from the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster.The objectives of the project are as follows: (1) to promote family well-being of community residents through a series of community-based family programs; (2) to utilize community resources by building capacity among public housing estate resident leaders; and (3) to establish the platform for enhancing social networks and neighborhood support through a series of intervention strategies organized collaboratively by resident leaders, community partners, and academic staff.The project was conducted in five phases including (1) a needs assessment to determine the emerging issues and concerns in the targeted public housing estate as a basis for capacity-building and intervention planning; (2) capacity-building train-the-trainer programs to engage and equip resident leaders with various skills to design and implement community-based family programs; (3) a series of promotion activities including a kick-off ceremony to raise residents’ awareness of the project; (4) family programs aimed at improving family well-being of residents; and (5) a recognition ceremony to recognize the efforts of community members and for dissemination of findings. The focus of this article is on the planning and development of our recruitment efforts to recruit community residents into the community-based family programs. The outcomes and effectiveness of the project are presented elsewhere .Our work was guided by a belief in the importance of engaging and creating partnership with representatives of the population to be studied. Community engagement can create a sense of ownership in the local community . It can The steering committee believed that resident leaders of the targeted public housing estate would be integral to various phases of the project. The strategy was to engage resident leaders’ in planning and designing family programs and recruiting and delivering family programs to community residents, with support from CFSC staff. As resident leaders were residents of the estate, they were well situated to provide insights about issues and needs of their community. Resident leaders were also more likely to increase community involvement as they provided a readily available platform with strong networks and ties with residents.A qualitative needs assessment was first conducted with 16 resident leaders. This step was particularly important as it laid the groundwork for community participation and set the stage for collaboration between the research team and resident leaders. By providing the resident leaders an opportunity to voice their opinions, we could foster a personal commitment and their sense of ownership to the project. Further to the needs assessment, we held informal meetings with resident leaders to introduce the project and invited them to collaborate. To ensure buy-in of the project, project staff stressed the significance of research endeavors and potential family and community improvements. Capacity-building train-the-trainer programs were further organized by academic staff and social workers  from CFSC to equip resident leaders with relevant knowledge and skills for translating the project aims into effective family programs.A recruitment plan was developed during February and March 2011. We worked closely with our community partners to develop, and to modify as needed, the recruitment methods used. Potential barriers  and strategies to facilitate recruitment  were also identified. Subsequent to initial meetings, phone calls, and small group meetings took place, as necessary. Input from the CFSC project staff and resident leaders helped determine which community members/organizations to contact for recruitment and the best methods for reaching these individuals/organizations. Members of the steering committee also helped researchers to better understand local politics, which often shaped who to contact and how. Resident leaders stressed the need for CFSC and academic staff to become familiar faces in the community as we communicated the benefits of research for the community. Field visits were conducted by the academic and CFSC staff along with resident leaders to understand the dynamics and cues relating to appropriate and sensitive communication and establishing visibility in the community.Recruitment materials  were developed collaboratively. Specific attention was paid to designing recruitment materials relevant and acceptable to the residents. Simple Chinese language was used to describe the project as part of a larger city-wide effort that was well established, offering family programs that were free of charge, and the benefits of participating.Fieldwork recruitment of residents took place from March to December 2011. A diverse array of recruitment strategies were used concurrently and are described below. Resident leaders, CFSC project staff, and academic staff were actively involved in the recruitment process.Approximately 19,200 leaflets were distributed into mailboxes of the entire estate, recreational centers, and local and community organizations, and at community events at various time during recruitment. In addition, 688 posters were displayed in various community organizations, housing blocks, community events, and Housing Authority office. One banner was also displayed in a conspicuous area in the estate. Community organizations and individuals were encouraged to forward or display information to others who might be interested.via posters, word of mouth, and a banner set up within the estate. All of the members of the steering committee attended along with representative from the funding source, Housing Authority, District Council, Social Welfare Department, and a Hong Kong Television celebrity. Stage performances and game booths were hosted by CFSC project staff, resident leaders, and volunteers . Logo-adorned items that carried the project name and leaflets with information about the family programs were distributed.To raise awareness of the project, a kick-off ceremony was launched in March 2011 at a common area  within the estate. The aims of the kick-off ceremony are to (1) promote a sense of project ownership among community partners and (2) increase the visibility of the project and the research team to the community residents. Residents were notified of the event A total of 10 promotion activities were organized by CFSC staff and resident leaders from April to July 2011 to raise awareness, disseminate information about upcoming family programs, and recruit residents to participate in our family programs. The promotion activities included a range of fun family activities . Activities were held in the basketball court of the estate for ease of access. Each activity lasted for 1.5–3 hours and were flexible in delivery allowing residents to come and go. The aims of the promotion activities are to promote and increase the visibility of the project, to form relationships with residents, to become familiar faces in the estate area, and to create a fun and positive environment. Residents were invited to provide their contact details to receive information about our upcoming family programs.Utilizing social networks of CFSC staff, active outreach was conducted by direct contact of potential participants. Approximately 1,000 telephone calls were made to potential participants. Word of mouth was also utilized by CFSC staff, resident leaders, and volunteers to recruit residents and local community organizations to spread the recruitment message. Residents who participated were also encouraged to share and inform others who might be interested, serving as agents to expand recruitment.Fifty-one mobile counters were set up within the estate at various times during recruitment to recruit and raise residents’ awareness of the project. To increase residents’ interest, a free health checkup was set up and managed by nursing students from the University of Hong Kong. Leaflets were distributed, and staff made face-to-face contact with passerby residents to introduce the project and recruit residents. These mobile counters similar to the other promotion activities gave community residents insight into the aims of the project and personal contact with the project staff. Daytime and evening, weekday, and weekend slots were necessary to access diverse type of the estate residents.To reach the hard-to-reach residents, door-to-door visits were conducted. A total of 10 visits reaching approximately 1,000 households were made at various time. For each visit, a total of four staff members including CFSC project staff, resident leaders, and volunteers approached the residents by knocking on the door of each apartment unit during weeknights and weekends. The team introduced the project aims and invited residents to participate in the family programs. Logo-adorned items  that carried the study name were distributed as incentives to increase interest.via each strategy , it was difficult to quantify successful enrollment for each strategy or to make direct comparison of different strategies. However, we are able to share our experiences, observations, and challenges based on field notes, research logs, observations, short questionnaires by community residents, and focus groups conducted with our community partners and residents, which are detailed below.Over a 9-month period, we successfully recruited 980 participants to participate in our family programs, meeting our recruitment goal (860 participants). As we did not obtain data on the numbers of participant recruited Based on project staff’ and resident leaders’ feedbacks, active recruitment strategies  were more effective than passive strategies. The use of posters, leaflets, and banner were likely to have reached a diverse population; however, it was difficult to discern how many residents actually received the message. More specifically, how many residents viewed the poster or leaflets could not be determined. This passive form of recruitment that requires prospective participants to contact project staff were described as being “distant” by frontline workers. This was further confirmed in the residents’ focus groups with many reported seeing the posters and leaflets but paid little or no attention to such materials. Nonetheless, the use of posters and leaflets was likely to have contributed to raising awareness and heightening the profile of the project, thereby adding a sense of legitimacy when residents were later approached through other more active recruitment methods. This finding is particularly important as studies conducted in the West have reported that mass media  can reach a large group of potential participants and worked particularly well for the general population, especially white participants , 15. HowIn contrast, active strategies  were perceived by project staff to be more effective. As stated by a CFSC staff member, door-to-door visit was particularly useful for reaching those who were less active in the community and more difficult to reach. Although some households seemed “cold” and distant at first, learning that the project was a collaboration with resident leaders and local organizations helped break the ice and frontline workers were able to increase residents’ interest in the family programs. These strategies relied heavily on the personal relationships and networks our community partners had with the targeted residents. Frontline workers reported that by explaining directly how participants’ participation would impact those in their estate and how their involvement would benefit them, encouraged residents to participate. However, it was also noted that these strategies were time consuming and labor intensive.As part of our recruitment process, raising community awareness was an important strategy . Frontline workers were able to form new and build upon existing relationships and bring about a fun and positive atmosphere of the project into the estate. Based on observations by CFSC staff and academic staff, it was estimated that approximately 1,000 local residents attended or joined parts of the kick-off ceremony. The event was covered by six major mass media outlets. Although a kick-off ceremony may be an uncommon practice in projects in the West, it is a common Hong Kong practice and an important event for our Chinese community partners. The ceremony was supported by the government  with officiating guests endorsing the project and encouraging residents’ participation. It was also an event that allowed community partners to support each other and be recognized for their efforts. Based on the Chinese saying that “A good start is half way to success,” the kick-off ceremony symbolized the beginning of a meaningful and successful project. This was also noted by resident leaders in which they perceived the ceremony as successful, attracting many residents, and was therefore an important strategy to raise community awareness and increase community participation.For the promotion activities, a total of 670 residents participated with 302 residents providing contact information and expressing interest in our family programs. Of the 670 residents, 424 completed a short questionnaire to identify the reasons for participating in the promotion activities. One of the main reasons was that the promotion activities were free. We also found that learning hands-on activities received more positive feedback than seminars or talks. These findings were later used to fine-tune our family programs. Although labor intensive, these promotion activities were well received by both residents and project staff. Resident leaders noted that these activities provided an opportunity for residents to form new relationships with others and be more involved in the community. These newly formed social relationships was confirmed by residents as a motive to participate in subsequent family programs.Our project discovered that timing was an important factor influencing the success of recruitment. For specific strategies, project staff observed that certain time of the day was better suited for recruitment  reaching out to a larger number of potential participants. Similarly, certain months  of the year also appeared to yield higher response than other months. We speculate that this was due to the celebration of Mother’s Day, which reminded residents about the importance of family, and thus, residents were more willing to agree to participate. On the other hand, recruitment in months that were associated with school exams had less response from residents. This was likely because parents were heavily involved in children’s school work and were too busy to participate.Similar to other studies , one of via questionnaires) either independently or alongside academic staff. However, the capacity-building training program was not sufficient to equip resident leaders with research skills. As a result, we had a substantial number of missing or incomplete forms and data on recruitment . Questions were also constantly raised by resident leaders and volunteers in terms of why fidelity or evaluation forms had to be completed. As reflected in the resident leaders’ focus group, comments were made in which at times they felt as if they were the research subjects rather than key partners of the project. Some resident leaders and volunteers became impatient at spending time on documenting process rather than on task activities. Given recruitment was not a primary evaluation outcome at the time, we did not aim at complete data collection for recruitment strategies, instead (1) we focused on the data collection on the effectiveness of the family programs and the overall impact of the project; (2) we wanted to reduce the workload of frontline workers; and (3) we did not want the issue to become a source of tension between academic staff and community partners.Resident leaders and volunteers who had no previous experience with coordinating and managing recruitment, data collection, and issues around scientific validity posed a significant challenge on the project. For example, CFSC project staff, resident leaders, and volunteers were trained  to participate in data collection  were purposely not used, given the demographic characteristics of the targeted population  and the uncommon use of social media for recruitment at the time.It was also difficult to quantify successful enrollment for each strategy separately as they were not independent . Indeed, direct comparison with other reports in the literature is difficult as there is no standard metric for assessing enrollment success and benchmarking with other programs. We attempted to collect detailed data on recruitment but were limited by the willingness and resources of community partners to complete and/or provide the data/information. We did not want to overburden our community partners as recruitment was the only initial step and a continuing process in the early months. They were required to plan and deliver family programs soon after recruitment began.It is clear that different recruitment strategies vary substantially in cost in terms of money and manpower per participant recruited. We are not able to provide the cost-effectiveness of recruitment strategies nor an investment yield ratio. Many of our strategies were resource consuming; however, some of these events  are likely to have a more sustained impact on community residents , which sets the stage for future recruitment in the community. We believe that these strategies were useful and successful in recruiting community residents. We also acknowledge that the practical constraints of financial and human resources often limit the extent of applying various recruitment strategies.Recruitment is central to any research project, and recruitment itself should be well documented and researched . For ourEthics approval was obtained from the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster.The first author JC led the development of this manuscript. AW, KN, TL, and SC contributed to the design, implementation, and data collection of the project. TL and SS made continual input as the draft progressed and approved the final draft for submission. All authors read and approved the final manuscript.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.