Social Prescribing (SP) is an intervention to link users of the primary healthcare services to non-clinical organizations based on the community to tackle social determinants of health. Despite the potential benefits of SP, the effectiveness of this complex intervention remains uncertain. This paper presents the study protocol of the evaluation of the first SP project in Portugal.A mixed-methods study will be conducted to evaluate the SP project. For the quantitative component, a longitudinal, prospective study with a pre-post design will be performed. Data on patients referred to SP will be collected in four different points in time throughout the intervention, using questionnaires on patients’ health status and sociodemographic characteristics, and scales on patients’ well-being, quality of life and activation. The secondary data will be collected using patients’ medical records and SP’s forms about the referral and social responses elaborated within the intervention. Semi-structured interviews with patients and focus groups with stakeholders will be conducted to assess experiences of participation and improvement suggestions on SP.Comprehensive and complementary evidence will provide insights and learning for the implementation of future SP interventions. This can contribute to inform policy and practice, and to increase investment in social prescribing interventions. The health of individuals is broadly acknowledged to be influenced by a combination of multilevel interrelated determinants – genetic, psychological, lifestyles, ecosystems, as well as social, economic, cultural and structural  . These mIt has been evidenced that situations of loss of employment, poor social and economic resources, social isolation, interpersonal problems, or illness of a relative can trigger the manifestation of physical symptoms, stress, depression, anxiety . Moreove342Social Prescribing (SP) has a potential role in effectively tackling social determinants of health and in preventing exacerbation of pre-existing diseases, with the purpose of improving users’ health and well-being 7. SP is 81011The process of SP starts with the identification of a patients with social, emotional or practical needs by a health professional. These patients include people with one or more chronical medical conditions, who have complex social needs which affect their health and well-being, who are lonely or isolated, or who need support related to mental health . The heaBased on the identified needs and the co-designed plan, the patient may be referred to a diverse set of social responses from the community resources, such as physical activities, dance groups, arts and crafts, professional training, education activities, food bank support, day-care centre, volunteering, among others. These responses can be provided by different institutions, including local authorities, social services, community and voluntary organizations .SP has been broadly implemented in the English National Health Service (NHS) as an intervention of the NHS Long-Term Plan since 2019 14. One o17The available research does not provide consistent evidence on the impact of SP. Several studies do not present significative differences in anxiety, depression and well-being levels between control groups and groups of patients enrolled in SP 19. FurthEvidence on the provision of integrated care and networking in SP interventions is scarce, although some policy reports suggest that SP may reinforce the proximity between the social and healthcare sectors by having the participation of local organizations in SP as key-partners in the implementation of personalized, local and preventive activity plans for the patients . Other p6In terms of the health system, although contradictory results are often found, some studies indicate that SP can have an impact in the reduction of the number of appointments with a General Practitioner (GP) and in decreased prescription of antidepressant, hypnotic, and anxiolytic medicines for patients enrolled in this type of intervention 21. OtherSP evaluation studies are still incipient and present controversial results. When it comes to the evaluation of SP, a variety of studies has been performed, comprising randomized controlled trials, case-control studies, case studies, qualitative studies, among others, that used various data collection instruments applied with different periodicities, and measured different outcomes 1922232425.222324102026Baixa and Almirante Family Health Units – located in central Lisbon and provide healthcare to approximately 27500 patients with a high variability of sociodemographic characteristics. All users registered in these Primary Healthcare Units can be referenced to SP, except patients with severe and uncontrolled mental health issue.The first SP project in Portugal was launched in two Primary Healthcare Units – The intervention starts when a healthcare professional , during an appointment with a patient, identifies social needs, namely related to social isolation, migrant integration, mental health, physical activity, employment and training, or housing issues. After that, the healthcare professional makes an internal referral through an SP online platform to the link worker, which in the Portuguese context is the unit’s social worker. In this platform the healthcare professional fills in the reasons for referral, presence of chronic diseases and brief history of the patient. Afterwards, the patient is encouraged to schedule a SP appointment with the social worker to continue the support of SP.In the SP appointment, the social worker performs a needs assessment and helps patients to identify the issues that impact on their health and well-being. Then, the social worker develops a tailored intervention plan in collaboration with the patient, based on the person’s priorities, interests, values and motivations . This plIn the next stage of the SP pathway, the social worker refers the patient to the key community partners. Communication between the social worker and community partners is made by e-mail containing information about the patient’s needs and the social partner’s availability of response, and through online forms to monitor the activities in which the patient is participating and the frequency of adherence.Throughout SP intervention, the social worker communicates with the patient through face-to-face SP appointments or phone calls to follow the compliance and satisfaction with the activity plan, and communicates with the healthcare professional to give feedback on the patient´s case. The number of appointments with the link worker depends on each user’s needs, but as documented elsewhere, the SP intervention takes around 4–6 appointments per patient 28, althoOverall, the SP intervention changed the conventional role of the social worker in Health Units in Portugal. Health professionals usually referred patients to the social work service when the issues were mainly associated with administrative issues in access to social and health benefits, such as support to buy medicines, functional dependency or end of life support. SP intervention allowed to expand the role of the social worker within primary care to include: advice and support on lifestyle changes , community engagement, employment and training, mental health promotion, personalised emotional and social support, as well as connect people to community groups and statutory services.The aim of this protocol is to evaluate the SP intervention implemented in Primary Healthcare Units of Lisbon, with a focus on patients’, health-social sector collaboration, and health system’ levels.The specific objectives are to: I) Explore the extent to which the SP intervention leads to enhance patients’ quality of life, well-being, and activation; II) Explore experiences of patients during their participation on SP activities, including positive and negative aspects, and suggestions for improvement; III) Understand the implementation of SP from the perspectives of health professionals, social workers, and community partners; IV) Describe the networking experience of the key actors involved in SP.Figure 1.This evaluation protocol will use a mixed-methods approach consisting of four studies, each one addressing a specific objective, as illustrated in Figure 2).In order to explore the extent to which the SP intervention leads to enhance patients’ quality of life, well-being and activation, a pilot study will be conducted, with an exploratory, longitudinal and prospective design, comprising four assessment moments: baseline, follow-up 1 (third month), follow-up 2 (sixth month) and follow-up 3 (twelfth month) , who are housebound, and who present uncontrolled use of drugs and/or alcohol are excluded from participation in the study. A recruitment target is estimated at 300 patients, with the chances of non-acceptance of participation and losses to follow-up (attrition rate) being estimated at >20%, based on previous studies 192028.1920All patients referred to SP in the first 12 months will be included in the baseline and the data collection will be conducted during 24 months. Both the patients who undertake SP activities and those who end their participation during data collection period will be included in the follow-ups.Table 1 summarizes the instruments and measures used for data collection throughout the assessment moments.Before the first SP appointment, the patient will be invited to participate in the study (baseline) and will be asked to provide a written informed consent. A questionnaire will be applied to collect data on: I) Sociodemographic characteristics ; II) Health status ; III) Mental well-being ; IV) Patient activation (through 13-item patient activation measure – PAM13); and V) Quality of life (using the EuroQol 5 dimensions instrument – EQ-5D-3L). Prior authorization for the use of each of the scales in Portuguese and English versions was obtained.The questionnaire was tested in a purposive sample of patients not enrolled in the study. As a result, the guidelines for filling the questionnaire were simplified in order to ensure clarity of the information.In addition to the questionnaire, secondary data will be collected from patients’ medical records. This data will consist of indicators related to the use of healthcare services  and health status .In the follow-ups, data will be collected using the same instruments of baseline. The questionnaire will be applied in the health unit before the SP appointments. In order to ensure the inclusion of people with low literacy and educational levels or that experience difficulties with self-administration, the questionnaire will be administered by a researcher through an interview (either in Portuguese or in English). In situations where the patient has interest in participating in the study but is unable to communicate in Portuguese or English, or has learning disabilities and other types of disabilities, a person that accompanies the patient can help in collecting the information, with the consent of the patient and when applicable. A unique alphanumeric code will be used to identify each participant in all evaluation instruments throughout the longitudinal assessment moments.Additional information about the SP intervention will comprise data on the type of health professional that made the referral and motive for signposting  and information about the SP activities provided, accepted and programmed, and patient’s adherence to the activities (through the online forms filled in by the community partners).The primary outcome measures comprise the levels of quality of life, well-being and the patients’ activation. The sociodemographic characteristics, health status, use of healthcare services and characteristics of the intervention are considered the secondary outcome measures. A statistical analysis will be conducted to analyse the association between primary and secondary outcomes. Furthermore, comparative measures between the baseline and follow-up 1, 2 and 3 will be computed, using generalized estimating equations (GEE) . All anaWith the purpose of exploring experiences of patients during their participation on SP activities, a qualitative study will be conducted through semi-structured interviews to patients included in study 1.Participants will be recruited during the follow-up 1 or in SP appointments. In cases where the patients completed the intervention plan or had given up the intervention or follow-up, they will be recruited with the cooperation of the social worker in contacting and inviting them for the study. Selecting patients with different socioeconomic characteristics  and level of attendance to the intervention will help to obtain a diverse sample and distinct perspectives on this intervention.Both the patients that are still in SP and those who had concluded their participation (i.e. who completed the SP intervention plan or who gave up the intervention) will be included. Those with significant hearing impairments, or with insufficient Portuguese/English speaking skills (when unaccompanied by a translator) will be excluded from participation.The participants will be contacted via phone call or email and invited to participate in a face-to-face interview. Interviews will take place in primary healthcare facilities or other location according to participants’ preference and availability.A semi-structured guide will be used to conduct the interview with patients and will include questions about characteristics of the SP intervention, experiences on the SP activities performed, perceived changes in lifestyle, perspectives about positive and negative aspects of SP, opinions on the interactions with healthcare professionals and community partners, patient’s satisfaction with the SP intervention and suggestions for improvement. All interviews will be audio recorded.Participants will be recruited until no new themes emerge from the data collected (data saturation) . We estiAudio records of the interviews will be transcribed verbatim. Participants will revise the transcripts of their interviews for validation, to ensure its accuracy. Then, the transcripts will be anonymized for storage and scientific publication purposes. The transcripts of the interviews will be analysed through content analysis technique, as described by Bardin .Aiming to further understand the implementation of SP a qualitative study will be conducted through focus groups with health professionals , social workers, and community partners involved in SP. The focus group technique, through group interaction, allows to broaden the understanding of the subject under study, its complexity and dynamic character, providing rich, valuable information and collective perspectives, and has been increasingly used in SP evaluation studies .In order to get the perspective of the stakeholders who have a role in the PS process, and based on the number of professionals involved in the SP intervention in Lisbon, five focus groups will be conducted: two focus groups with health professionals , one focus group with social workers, and two focus groups with community partners. Each focus group will include 6–8 participants, resulting in an approximate total of 30 participants. Focus groups will be conducted by a moderator and a co-moderator of the research team.A semi-structured guide will be used, covering common topics for all groups regarding perspectives on the process of implementing SP, barriers and facilitators, suggestions for improvement and experiences of collaboration and networking. In addition, each group will discuss about topics specifically related to their role in the SP intervention. The focus group sessions will be audio recorded.Audio records of the focus groups will be transcribed verbatim. Participants will revise the transcripts of their focus group discussion for validation, to ensure the accuracy of the transcription. The transcripts will be anonymized for storage and scientific publication purposes. Content analysis will be performed to analyse the data, as described by Bardin .This study aims to explore the perceptions of the key actors involved in SP about their interactions and experience of collaboration within the intervention. This study draws on data collected in study 2 (interviews with patients) and study 3 .This study will focus on the collaboration between key actors, namely the interactions and exchange of information, the development of new responses, the challenges, lessons learned and perceived added value of acting in an intersectoral network.The procedures for data treatment and analysis of the interviews and the focus group discussions are described in Study 2 and 3, respectively.Ethical approval for this evaluation study was obtained from the Ethics Committee of the Regional Health Administration of Lisbon and Tagus Valley (nº 5 2020/CES/2020).In all studies, potential participants will be informed about the study’s objectives, data collection procedures, benefits and potential risks of participation. Participants will be assured that their participation in the study is voluntary and anonymous, and that the collected data is confidential. Participants will also be assured that refusing to participate or withdrawing consent at any moment will not entail any consequences, nor interfere with their participation in SP activities. After each participant agrees to participate, he/she will be asked to read and sign the informed consent. In study 1, this will take place prior to the first SP appointment, and in the studies 2 and 3 before the interviews and focus groups, respectively.In study 1, the unique alphanumeric code will ensure that participation in the study is anonymous, and only the healthcare units’ professional will have the information needed to link the codes with patients’ personal information (name and contacts). The secondary data will be extracted, anonymized, processed and stored by the healthcare units’ professional, and then made available to the research team.In studies 2, 3 and 4, an authorization to audio records the interviews and focus groups will be requested to each participant. The interviews and focus groups will be conducted in a private room to ensure the comfort of the participants and avoid interruptions.Electronic data  will be stored as protected files with exclusive access of the research team. Paper-based data (questionnaires and consent forms) will be stored in locked cabinets in secure offices, only accessible by the research team. The identifiable information, such as participants’ names, will not be included in the transcriptions.This evaluation protocol covers the three major dimensions where SP has potential impact: the patients, the collaboration between the health and social sectors, and the health system. This will be accomplished through triangulation of methods and information sources  based on all key actors’ perspectives. Using such a broad evaluation scope will enable to obtain a diverse data corpus, allowing to explore in more depth the complexity of SP and its effects . In factIn the patient’s dimension, the use of standardized, validated and repeated measures throughout time will provide a quantitative overview of SP’s contribution to individuals’ quality of life, well-being and activation. The WEMWBS, EQ-5D and PAM13 scales are the most frequent measuring tools used in SP evaluation studies 20. Hence112017Moreover, the qualitative study will enable us to obtain in-depth insights on the patients’ experiences of participation in SP activities. Previous research on impact evaluation show that a qualitative approach can reveal strong positive narratives about the impact of SP in patients’ lives (such as improvements in feelings of well-being), even if the quantitative outcomes do not reflect these improvements  20.The SP’s impact on the collaboration between the health and social sectors will also be evaluated. Specifically, SP interventions and social responses provided to patients, and accepted and performed by them will be assessed using information from the quantitative, longitudinal study. The focus groups will provide information on articulation and communication between both sectors. Additionally, it will provide an insight into the health professionals’, social workers’ and community partners’ perspectives, which has only been obtained in few studies and remains an important gap in the literature regarding SP evaluation 20.More broadly, the collection of information about the use of healthcare services will enable an evaluation of the influence of SP at the health system level. The relevance of assessing SP’s effects on this dimension has been previously highlighted 24. SP reBesides the SP’s impact, this evaluation study also intends to provide useful knowledge on its process of implementation. The follow-up of all patients referred to SP, including those who conclude or withdraw their participation from SP activities before the follow-up evaluations represents an important innovation of this study. This will shed light on barriers to adherence to SP’s activities, while also allowing a comparison of outcomes between adherent and non-adherent patients.Another differential of this evaluation study is that information on activities provided by community partners, accepted by patients and performed within SP will be collected and monitored for each participant. This will allow to collect detailed information about each patient’s pathway within SP, which has been described as a limitation in several studies 17. It isMoreover, this evaluation study also covers the experience of collaboration and perceived added value of intersectoral networks composed of different key actors. These topics have not been broadly addressed in published studies, and this exchange of information between the different levels of service provision – social and health sectors – can be valuable for the success of the SP intervention 363738.3637An expected limitation of this study is the challenges in generalizing the obtained results, since this is an evaluation of an SP intervention implemented in a local and specific context. The lack of a control group is a limitation of the Study 1 and therefore the results of this study will need to be interpreted with caution. It will be beneficial to conduct controlled studies in the future. Another limitation, previously described by other authors, is the possible loss of participants in the follow-up assessments 20, mainl28This study protocol is designed to conduct a robust assessment of the SP intervention by addressing the limitations pointed out in other studies and by comprising the perceptions of the different stakeholders involved in the intervention. Although many studies have assessed the impact of this intervention in the last years, the heterogeneity of study designs and the discrepancy of results make it essential to conduct a tailored and comprehensive evaluation of the intervention.The results of this study will provide knowledge on the potential impact of the SP intervention for patients, for the collaboration between the health and social sector, and for the health system in the Portuguese context. These results can also contribute to inform practice and policy in national and international contexts, and to provide insights and learning for the implementation of future SP interventions.


Background: International migration processes are some of the most important events of our time. Migrating implies a broad range of factors that affect integration, and which may be linked to radicalization. Host countries use different methods for the integration of migrants. The aim of this systematic review is to analyze intervention programs that aim at promoting social integration and preventing the radicalization of migrants, with the objective of studying actions carried out in the US, Canada, and Europe to this effect.Method: Worldwide known bibliographic databases  were used to search studies published before January 2019 and which analyzed integration or radicalization prevention programs with migrants.Results: A total of 601 studies were screened, from which 18 met the inclusion criteria. The analysis of programs addressed to migrant women points to a decrease in loneliness and depression and an increase of migrants' perception of social support and self-esteem. Programs carried out in schools and families improve children's knowledge of their culture and that of others, increase their feelings of inclusion, and reduce their aggressiveness, stress, and anxiety. Language programs promote communication and employment search, as well as improve migrants' quality of life. One of the most effective activities included in these programs is to connect recently arrived migrants with local population and/or long-term residents. The latter act as mentors and teachers, helping recently arrived migrants understand resources and to be more integrated in the new country, as well as reducing discrimination from the local population.Conclusions: The review concluded the importance of intervention programs for integration, migrants' quality of life, prevention of extreme behaviors, and intercultural cohabitation. Future programs must be more detailed regarding participants' information and carry out more comprehensive assessments. The phenomenon of migration is universal. According to Blackwell , humans The conceptualization of social integration processes for migrants is a complex matter and there is a lack of consensus. The variety of approaches from which integration has been analyzed is explained by the interest shown by several disciplines, such as Sociology, Anthropology, Social Psychology, and Demography, among others . FurtherMigration implies a wide variety of factors that affect the integration of individuals from different origins and situations. Migration does not generally take place under favorable circumstances; on the contrary, most migrants face huge challenges upon their arrival in host countries: securing a place to live, overcoming language barriers, finding employment, and adapting to new systems and expectations. They also face physical, legal, structural, and social barriers that affect their arrival and subsequent integration . SeparatFailed integration of migrants can lead to serious consequences for host countries. According to Holguín , a balanThe increasing number of migrants in Europe, US, and Canada makes it necessary to develop intervention programs aimed at integrating migrants and stopping radicalization processes. Based on this statement, we ask ourselves the following:Which intervention programs are being carried out to favor integration and prevent the radicalization of migrants?The objective of the present study is to update and analyze intervention programs aimed at migrants' social integration in order to know the actions that are currently being carried out in this field. More specifically, we want to analyze the radicalization prevention programs in place. For this purpose, a systematic review of empirical studies that contributed to the development of programs for integration and/or prevention of radicalization of migrants was suggested. The review was performed following the PRISMA recommendations for information search and report processes .Systematic review of programs published in scientific papers put in place to promote migrants' integration and prevent radicalization.In order to achieve the objective of the research, a systematic search of scientific papers was carried out in two stages. Seven databases were consulted in total. Initially, searches in worldwide known databases were carried out . ProQuest metasearch engine was used in the first stage to group the first five databases. The first search was conducted on December 11, 2018, and the second one was conducted on January 11, 2019, for confirmatory and updating purposes. According to the information extracted, the search was broadened to the remaining two databases, carried out between February 4 and 8, 2019. Terms used for each database and the number of papers that met the initial filtering are shown in The initial screening process consisted in locating title, abstract, and participant information with the aim of verifying whether the following inclusion criteria were met: (a) study of an integration or radicalization prevention program, (b) study that includes social intervention, (c) migrant participants, (d) papers published in magazines, and (e) written in English or Spanish. When in doubt, if a paper met or not some of the criteria, they were included to be screened in the stage of full-text analysis. A total of 601 papers were screened. Of those papers liable to be included, 11 were found duplicated in some databases. Those papers that did not meet inclusion criteria were removed from the remaining 590. Most papers did not meet criterion b, meaning that they did not include social intervention with the collective .Fifty-two papers met the inclusion criteria to be included in the full-text analysis . Thirty-three papers were discarded, most of them due to not including interventions but research through questionnaires to know the factors that affect migrants or about integration policies. One paper was discarded due to being written in French. The remaining 18 papers met the criteria and passed to the review stage. Papers were read by one researcher and codified according to categories described in The following categories were considered for the analysis of results: Location of the program, duration, funding, participants, objectives, characteristics of the intervention, assessment method, and results see . Such caThe following assessments were concluded after analyzing each category named above.Results show that there are six integration programs in the US [see list of references ], nine in Europe , and three in Canada . All programs focus on the integration of migrants.In most programs, participants come from Latin America , followed by Arab countries  and European countries such as Greece and Russia . Some programs do not specify the origin of migrants .A large proportion of programs are addressed to migrant women . This is probably because there has been an increase in the number of migrant women, according to the General Assembly of the United Nations , who repOther programs are addressed to recently arrived migrants , since the process of integrating in the new country is usually a challenge due to integration barriers . There aFinally, programs addressed to children's and adolescents' integration in the school environment must be noted . These programs are very relevant because studies show that migrant students who have low academic performance relate to negative self-esteem, stress, insecurity, etc. –31.In the US, most programs are long term. There are two with a duration of 3 years , one with a duration of 2 years (3), and another one with a duration of 1 year (5). Conversely, Europe carries out short-term programs . Except for one intervention that has a duration of 6 years (9), the remaining ones have a duration of <1 year. In Canada, the lengthiest program has a duration of 6 months (16).The programs analyzed focus on issues that, as pointed out by Suárez-Orozco and Carhill , are fouOne of the studies analyzed focuses on acculturative stress and “migratory morbidity” (3). This study focuses on the integration of migrants in the health system in order to ensure healthcare is accessible and linguistically adapted to them. Some authors confirm that migrating can modify health, not because of the experience on its own, but due to the conditions under which it takes place . AccordiOne of the programs analyzed that focuses on the tensions related to family dynamics aims at improving the skills of Muslim parents (15). It is important to highlight that this program suggests tackling parents' emotional and cognitive issues by teaching them positive skills to educate their children. This has a positive impact on children and makes them grow in a calmer and happier environment. It is remarkable that it took 1 year to adapt this intervention in order to make it compatible with Islamic teachings and make discussion subjects in line with Mohammed's actions. In general, it has been proved that improving parents' skills to face their children's education has a positive impact for the family's functioning . In thisIn the field of the challenges for the creation of identities, we found programs that aim at integrating migrants based on language skills . Linguistic differences prevent many migrants from participating in the host society and integrating in the new community. Studies show that for recently arrived migrants, knowing the language and the culture of the host country helps them overcome the barrier of communication as well as makes it easier for them to find employment . AuthorsThe programs that carry out educational adaptations and results aim at improving migrants' social skills, empathy, acceptance, ability to express feelings, and students' empowerment . Studies show that adolescents with high levels of global self-concept show behaviors of self-control and leadership and low levels of shyness, isolation and anxiety, as well as good levels of social adjustment and improved chances of making friends and classmates . Other pWe analyzed one integration program whose participants were all Arab migrants (17), aged between 20 and 30. There is another program (8) addressed to refugees coming from Africa, in which 68% of participants are aged between 21 and 40. In both interventions, participants would be included in the range of highest vulnerability for radicalization, who according to , are youThere are several programs that pair migrants with long-term residents in the city . In other programs , participants talk about personal experiences and subjects of interest for the group . Other activities also carried out in some programs are dynamical and artistic , as well as cooking workshops (5). In one of the programs, sport activities are carried out in a mosque (16), with the aim of providing migrants with clinical and psychosocial benefits. New technologies are used in several interventions; one of the programs with students teaches about other cultures and ethnic groups through virtual activities (13). There are two programs with adult migrants that also make use of new technologies. One of them is carried out in a library (4), were there is a program called “The American Place” (TAP), designed to help migrants with public services, legal advice, classes, and employment references. The other intervention uses a smartphone application to train migrants in the pronunciation of the language (8).Several programs use mixed methodologies to assess interventions , in conjunction with quantitative and qualitative instruments. When these instruments are used in parallel, validity, transferability, and reliability increase . The mosPrograms that carried out quantitative assessments used different questionnaires. Two of the programs carried out in schools  used the Strength and Weaknesses Questionnaire , completMost programs performed an assessment prior to the intervention and another one just after the end of it. However, some programs also used control group designs . Besides pre- and post-assessments, some programs perform a follow-up after 6 months (16), after 1 month and 3 months (10), and after 1 and 2 years (14).It must be noted that the results obtained in the different programs reviewed are positive, even reaching the desired objectives and with participants expressing agreement and satisfaction with interventions.Programs addressed to migrant women show very positive results and improved women's quality of life and integration. Generally, there is a decrease in loneliness and depression ; an increase in relation networks, perception of social support, and self-esteem; and higher levels of migrants' self-confidence (11). There is also an increase in mothers' confidence in rising their children and their self-sense of ability (6). Women with post-traumatic stress who participated in the intervention showed significantly reduced symptoms, compared to the women from the control group (2), as well as experiencing a clear improvement in their symptomatology and great satisfaction with the treatment they received (10).Programs carried out in the school and family context showed results that favor the integration of migrant children and adolescents. These programs enabled children to improve their knowledge about themselves, their culture, and that of others, as well as democratic and social justice values (13). In the intervention program for social and emotional learning with adolescents (7), students learned how to work together with their classmates and feel integrated; they felt more motivated and concentrated in all activities; they expressed their thoughts and feelings more openly, they reduced their aggressiveness, and they felt happier and with better moods. Other results from interventions with migrant adolescents show that after the intervention, they were able to reduce their stress and anxiety levels, learn coping strategies, and reduce emotional imbalances, the pain of the experience, and that of feeling different (9). The program of school therapy for migrant adolescents and refugees (18) did not report any improvements in participants' self-esteem or emotional and behavioral symptoms. However, children from the experimental group showed a significant improvement in the learning of the language and their mathematical performance compared to the control group. The program with migrant fathers in the educative context (1) also had beneficial results for participating families, as it allowed fathers to broaden their knowledge and awareness about the problems in the family and ways of helping children; communication and positive interactions between parents and children improved, as well as motivation and security feelings in children. Furthermore, trauma and skill learning in children also improved.Programs aimed at the integration of migrants that include a relation with a long-term resident  achieved a significant reduction of participants' loneliness and increased their social support and social integration perceived, as well as an increase in the search of emotional and instrumental support. To connect recently arrived migrants with long-term residents makes their transition easier and allows recently arrived migrants to build long-term relations with migrant residents.Language training programs  showed positive results and enabled communication and employment search. The program aimed at improving healthcare for migrants (3) showed statistically significant results related to better quality of life. Results showed that almost 94% of participants expressed general satisfaction with the services received and access to such services; 96% expressed satisfaction with the quality and appropriateness of services received, as well as satisfaction with their participation in the program. The program aimed at improving Muslim fathers' skills was also very positively valued by participants (15).Interventions with migrants are full of limitations; each project faced barriers or difficult situations when applied. Some programs shared the obstacle of a lack of time from the part of migrants. Some participants express having difficulties to attend programs because of their working conditions or because of being too busy with family life . The legal status of migrants is also another aspect that must be taken into consideration, because in some occasions, for fear of deportation, some migrants hesitate to provide information or participate in such programs (2). There is another limitation caused by migrants' high levels of mobility, which makes their follow-up and long-term assessment difficult (18). Finally, some communities like Muslims, based on faith, reject participating in random studies, which greatly limits their participation (16).It has been proved that there are more programs in Europe to integrate migrant population. However, longer-term programs are carried out in the US. It is possible that the US understands the need to create long-term and efficient integration programs for migrants, since it is the major receiver of migrants worldwide and the main origin of international migration flows between 2000 and 2010 .It is important to bear in mind that migrants face great barriers for their integration, so the four domains noted by Suárez-Orozco and Carhill  must be There are few programs in which native population participates. It must be taken into consideration that programs exclusively addressed to migrants, rather than helping them, contribute to segregation and exclusion, as well as increasing migrants' perception of vulnerability. It would be necessary to design programs where native population and migrants participate equally and where the whole community could participate, cohabitate, and know one another.There should be more programs in which both children and parents participate. It is key for families to have a good connection between parents and adolescents, since the family is still one of the main contexts in which social and educative values are transmitted . It has Only one program aims at integrating migrants in the field of healthcare. Some authors note that privatizing public services disconnected these services from social obligation, thus making it more difficult for individuals and institutions to have a language that can include the principles of racial justices as a common good . AccordiSchool is the main contact place between migrant students and native students, which makes it the ideal place for programs that aim at promoting integration and inclusion. Students who are well-integrated in the education system of the host country, both academically and socially, are more likely to reach their potential . AccordiIn all programs analyzed, there is a general lack of use of new technologies to support migrants' integration. Pantoja and Villanueva  note thaRegarding the adaptation of programs, Falicov  identifiMost programs use mixed methodologies, since quantitative information does not allow for casual connections to be made . The mosWith the present work, a lack of studies that carry out programs aimed at working with the migrant collective has been observed, and only some of them perform comprehensive assessments to know whether interventions are successful and reach the desired objectives . AgainstIt has been observed that there is a lack of resources, or that the existing ones are very limited, when it comes to carrying out the programs; only seven of them were subsidized by the State where they were being carried out. This evinces that the economic support given to these programs is still insufficient, even though integration is an issue that deeply affects intercultural cohabitation. It would be necessary, therefore, to improve social policies to reduce and/or avoid the social consequences brought about by migrating processes that have political, demographic, socio-economic, and cultural impacts.It must be highlighted that there is a lack of intervention with Muslim migrants of second and third generation, even though second generations of the Muslim diaspora have been particularly vulnerable to processes of jihadist radicalization . InterveIt has been observed that some of the most effective activities are those that group recently arrived migrants with native population and/or long-term residents. The latter act as mentors and translators, resource guides, and teachers, helping recently arrived migrants understand and know the resources available, feel more secure and less isolated in the new country, and thus helping to reduce prejudices and discrimination from the part of native population. Furthermore, results show the importance of language training for migrants, which should be a priority for host countries. To work on intercultural education is also important, since not only is it a “complement” to the standard education plan, but also, according to the United Nations Education, Science and Culture Organization , the devIt is important to highlight the positive results of those programs focused on migrant women. Today, there is talk of a “feminization of migration,” even though female migration is not a new phenomenon . We consResults from the present research allow us to identify key elements when it comes to carrying out programs for the integration of migrants. Our results suggest that future studies of programs should be more detailed and specify data such as origin, number of participants, age of participants, and activities carried out. Besides, programs should also perform more exhaustive assessments as well as develop in a more extensive and detailed manner citizen participation and community work in social cohesion interventions. Programs aimed at the integration of migrants contribute to decrease feelings of lack of roots and identity and, subsequently, as pointed out by Heelsum and Vermeulen , the seaThere were several limitations during the present research. One of them was the lack of programs that focus on the integration of migrants, despite being an issue of concern for countries. It must be noted that some studies analyzed do not specify the origin of migrants or their age, and most interventions do not detail activities carried out. Another limitation of the study is that some programs do not have systematic assessments in place and, sometimes, do not mention who carries out the said assessment. If the team responsible for carrying out the intervention is the same as the one carrying out the assessment, results can become contaminated. This means that the conclusions of the present study are limited when it comes to how the programs analyzed work, due to the limited information available from such programs.Through this study, we have confirmed the great importance of integration programs in countries with increasing flows of migration, since the benefits include an improvement in migrants' quality of life. Likewise, these programs also benefit host countries, since integrating migrants prevents extreme and radical actions and favors intercultural cohabitation.The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author/s.NDP-B, IH-M, and LG-J contributed to conception and design of the work, substantial contributions to revising the work critically, and wrote the manuscript. AG-C and MM-F wrote the manuscript. All authors involved approved the final version of the manuscript to be published.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.


There were few studies of individual differences in prognostic decision-making from the psychological point of view; most of them focused on the differences between novices and experts making the prognoses. In this study, we suggested a new task that matched the criteria of a prognostic one, was computerized, and did not require expertise in any field of knowledge. Thus, the proposed method investigated how people processed information and controlled uncertainty in prognostic tasks. On a sample of 78 people aged 17–66, we used a quasi-experimental design to find the patterns of the proposed task parameters and how they correlated with personality and cognitive variables. Five well-known personality questionnaires accessing traits, known to be included in decision-making regulation, were used along with a cognitive abilities test to measure those variables. Two patterns were identified via cluster analysis. Differences in intolerance for uncertainty were demonstrated for the people from two identified clusters. Those patterns could be interpreted as uncertainty control strategies for decision-making grounding in prognostic tasks. Most of the studies of forecasting and prediction in psychology over the past decades were somehow related to cognitive biases and heuristics, leading to incorrect estimation of the probabilities of certain events. That research area originated from the works of Kahneman, Slovik, and Tversky ,2. AccorAt the same time, relatively little attention was paid to the problem of individual differences and the role of personality variables in forecasting and prognosis. Wright and Ayton showed a significant contribution of individuals’ characteristics to judgmental forecasting . The autAmong personality traits that mediate decision-making in uncertain situations, the key variables were those that reflect personal attitudes towards uncertainty. Frenkel-Brunswick was one of the first researchers to use the terms tolerance and intolerance for uncertainty . She shoAmong other personality factors that could mediate decision-making in uncertain situations were impulsiveness , intuitiIn most studies, tasks from a certain domain of interest were used as prognostic tasks. Among them were sales forecasting , sports Another common trait of the existing research was the use of the tasks in which a person had either to extrapolate time series or to assess the probability of an event according to the data available on the probabilities of possible outcomes. In our opinion, this might determine certain results. E.g., forecasting specialists were more used to or at least acquainted with this type of data presentation while non-specialists could have a very different experience with those types of information. Thus, such tasks were better suited for the study of cognitive biases and limitations of the human cognitive system in making probabilistic judgments. Yet, in real life, a deciding human  would deal with sequences of events, and not with their formal representation via time series, trends, probabilistic estimates, etc. .On this basis, one of the aims of this study was to develop and test a model of a prognostic task, which, on the one hand, would to the limit exclude the use of domain-specific experience and knowledge when making a prognosis, and on the other hand, would avoid the use of a formal data presentation and instead be more a process, a series of events for which the participant would have to make a prognosis.To define a task as prognostic, it must meet several criteria. Regush  suggesteIn the computerized task that we proposed as an experimental model of the prognostic situation, the participants were able to choose the moment when they were ready to make a prognosis independently, thereby adjusting the acceptable level of uncertainty in the situation , one chose a subjectively acceptable level of uncertainty.Awareness (a more complete orientation in the situation before decision-making) was positively associated with rationality and intolerance for uncertainty.The prognosis justifiability as the reliability of the possible outcome derived from the information available, positively correlated with the level of intelligence and negatively—with the risk-readiness and venturesome-ness.The trend, reflecting the tendency to react to momentary changes in a situation when giving a prognosis, was positively associated with impulsiveness and unproductive coping, hypervigilance, manifested as a tendency to make impulsive decisions in an uncertain situation.There were stable correlational patterns of awareness, justifiability, and trend, which indicate strategies for uncertainty control were associated with differences in personal and cognitive traits involved in decision-making regulation.Along with testing the proposed task, our study aimed to assess the regulatory role of personality traits  as well as cognitive abilities in solving prognostic tasks. We supposed that those would manifest through the preference for different levels of the prognosis value and different strategies of mastering the task. Based on that notion, several research hypotheses were formulated:The voluntary participants for the research were recruited via advertising in the students’ groups  and the “snowball” sampling afterward. As we were aiming to assess the capabilities of the new game task, the inclusion criteria were rather broad: Russian as the native language to ensure understanding instructions, age over 17 years old, and completed secondary education. Initially, 105 people were recruited. In further processing, partial protocols were excluded, and only full protocols with all tasks done and no signs of random answers were analyzed, leaving us with 78 participants. Among that sample, there were 64 women and 14 men, aged 17–66 , including 60 undergraduate students and 18 participants with a university degree.Computerized modification of Azarov’s ,27 cogniThe game used a payment matrix to encourage the participants to make their choice as early as possible: at the beginning of each series, each participant received 100$ . For each row opened, 10$ were deducted. If the participant made a wrong choice  (s)he was fined 50$. Thus, to maximize the final gain, the participant had to make a choice as early as possible, but at the same time, try not to make mistakes. In order to do that (s)he had to rely on the situation present at the time of the decision-making. The whole task consisted of 30 trials.The game scenario was the same for all participants. Before the main task, the participants were asked to go through a training session to get acquainted with the program and the rules.In the original Azarov’s task, the only measurement used (as the “cognitive decision threshold”) was the average number of moves (average number of rows opened before making the decision) in all the trials. We used three measurements instead. While solving the prognostic task, the participant could rely on two parameters of the current situation: (1) the ratio between the opened and closed rows, and (2) the difference in the number of lines in opened rows between the left and right halves of the screen. With more rows opened (higher indicator 1) and a more noticeable difference between the left and right halves of the screen (higher indicator 2), the likelihood of the correct prognosis was higher. At the same time, according to the payment matrix, the gain would be less with each additional row opened. Thus, we suggested that those indicators specify an individually acceptable measure of uncertainty at which the participant was ready to make his/her prognosis. We designated those two indicators as awareness and justifiability, respectively. We also deduced the third parameter for the participants to use in their decision-making, which we called trend . This indicator was not intended from the beginning of the research but rather found during the data gathering and evaluation process. It was noticed that the participants were often making their decisions at the very moment when a newly opened row of vertical lines gave a noticeable boost to the general difference between the number of lines on the right and on the left. Those changes were not supposed to be sustainable, yet the participants seemed to react to them as if they were. The trend indicated the way the number of lines in the two halves of the screen was increasing or decreasing compared to the previous step. The previous studies also supported the idea to include the trend as one of the possible indicators, showing how non-experts’ prognoses changed in situations of upgrade and downgrade trends previously shown in the experts’ prognoses in that field ,29.The above-mentioned parameters were gathered automatically by the program used to operate the prognostic task.Personal Decision-Making Factors Questionnaire (LFR-21) developed by Kornilova . The queNew questionnaire of tolerance/intolerance for uncertainty (NTN) developed by Kornilova . The queEysencks’ Impulsiveness Scale   in RussiRussian version of Epstein’s Faith in Intuition scale from the Rational Experiential Inventory (REI) ,34 with Melbourne decision making questionnaire (MDMQ), a Russian adaptation by Kornilova ,36. The Brief screening test (BST), the Russian modification of The Wonderlic Personnel Test. The test consisted of 50 questions. For the Russian version, participants had 15 min to complete as many questions as possible to assess their level of general cognitive abilities .K-means clustering was used to identify the stable patterns of prognostic task measurements. Cronbach’s Alpha coefficient was applied to evaluate the internal consistency of the strategy indicators. For group comparison and correlational analysis, non-parametric methods were chosen due to sample-sizes and non-normal data distribution. Thus, Mann–Whitney U test and Spearman’s rank correlation coefficient (rho) were used for further calculations. All calculations were made in IBM SPSS Statistics version 22. First, we wanted to see whether the performance indicators in our prognostic task (described in Only a few significant correlations were found for the prognostic task indicators see .Two main indicators of the prognostic task performance (awareness and justifiability) showed significant positive correlations with cognitive abilities. Together, those two indicators defined the uncertainty of the current in-game situation. Thus, the level of cognitive abilities was associated with the tendency to make more reliable prognosis, based on the current situation, even though the potential gain was reduced.The trend indicator only positively correlated with the tolerance for uncertainty scale (NTN). We supposed that there were stable patterns of awareness, justifiability, and trend which the participants preferred when they needed to determine the uncertainty of the game situation. To further identify those patterns, a K-means cluster analysis was carried out using the K-means method. As variables for clustering, all three game strategy indicators were used. We considered two-, three- and four-cluster solutions. The convergence with a small number of iterations (4) was achieved for a two-cluster solution see .Participants from the first cluster preferred to make more risky prognosis, making a choice when fewer rows were opened (lower awareness) and with a smaller difference in the number of vertical lines between two halves of the screen (lower justifiability), but at the same time they relied more on the situational cumulative difference change after the last row opened (higher trend), compared to the participants from the second cluster.Then we assessed the internal consistency of the awareness, justifiability, and trend indicators separately in each cluster using Cronbach’s Alpha coefficient see .As shown in Spearman’s rho coefficients were calculated to see if the values of the performance indicators correlated in both clusters, see .While awareness and justifiability showed similar strong positive correlations in both clustered groups, the relationships of those two parameters with the third parameter—trend—were different for both clusters. The negative correlation between trend and both awareness and justifiability indicated that the participants from the first cluster were making their prognoses earlier and with a smaller observable difference in the number of vertical lines between the left and right parts of the screen, at least when there was a noticeable change in that difference after the next row was opened (higher trend). In the second cluster, those correlations were both insignificant . This meant that the participants from this group did not rely on the momentary changes between the newly opened rows while evaluating the game situation to make their prognoses.p = 0.047) were found for only one scale—intolerance for uncertainty (NTN questionnaire). The mean score for the first cluster was 59.38 comparing to 55.47 in the second cluster. Thus, the participants from the first cluster were significantly more uncertainty intolerant.Mann-Whitney criterion was used to compare personality specifics and cognitive abilities in both clustered groups, as most of the variables were not normally distributed. Significant differences  . The parWhile there were no other significant correlations between awareness, justifiability, and personality traits, a positive correlation was found between the decision strategy indicator trend and intolerance for uncertainty. That is, people with high intolerance to uncertainty trait relied more on the current game situation changes while making a prognosis. That allowed us to reformulate our previous assumption about the personality regulation factors manifested in the trend strategy indicator. We had to reject hypothesis 3 about the trend’s relationship with impulsiveness and risk-readiness. However, we could suggest that intolerance for uncertainty should be included in the participant’s control over the dynamics of changes in situational uncertainty due to established strong positive correlations.It should be noted that trend (unlike awareness and justifiability) did not predict the outcome—This was not assumed by the game scenario and was not in the game code. Thus it could be seen as a false indicator making decisions more difficult for the participants. The obtained result confirms the data on the relationship between irrational gambling beliefs and intolerance for uncertainty .The results obtained in our study indicated that two of the three strategy indicators in the prognostic task (awareness and justifiability) demonstrated high internal consistency, and, therefore, can be considered as stable individual decision-making criteria for at least this particular task. We considered their levels as a comparative measure of a subjectively acceptable level of uncertainty . The established correlations of those two parameters with the cognitive abilities might indicate that the regulatory role of cognitive components of the intellectual and personal potential was manifested to a greater extent . A possiThe results allowed us to accept the 4th hypothesis. Two identifiable patterns of awareness, justifiability, and trend were found, indicating two distinct strategies for uncertainty control in the prognostic task solving. The first strategy involved a steady reliance on most parameters of the situation and their relationship . The use of this strategy in our task turned out to be connected with the tendency to make riskier forecasts. At the same time, the participants, who used this strategy showed higher levels of intolerance for uncertainty. We suggested that the desire for maximum clarity, characteristic of individuals with high rates of intolerance for uncertainty, in this situation, could be associated with the search for as many guidelines to reduce the uncertainty of the situation as possible. Yet, in this task, it was not the best strategy, according to the results. In our study, the average number of correct predictions for people using the first strategy was 17.24  versus 20.67 for those who preferred an alternative, second strategy. The second strategy was associated with a stable reliance on one indicator—awareness . People who used this strategy preferred to make a prognosis based on the ratio of available and missing information, opening more rows in the task to secure their decision.Several limitations should be mentioned. The small sample size limited the ability to summarize the results of our research. Another important limiting factor was the use of the only payment matrix. Using several different payment matrices would be necessary to generalize the results further and to see whether the strategies would be stable or dynamic if the lose-gain ratio were different. The large dispersion of the participants’ age and heterogeneity of its distribution in the sample did not allow us to assess whether the choice of strategies and correlations between the variables were related to this factor. This might be the goal for further research.The results indicated that the characteristics of a prediction-based situation (ratio of available and missing information and justifiability of a possible choice) could be considered as individually stable subjective guidelines when making decisions in prognostic tasks. At the same time, the absence of significant relationships with the measured dispositional characteristics left open the question of their contribution to the regulation of human prognostic activity and would require further research.The level of general cognitive abilities was associated with the tendency to make more informed prognoses based on more information available.Two strategies for decision-making in prognostic tasks were identified, differing in the reliance on the available information. The first strategy involved more indicators to rely on, yet it was less successful than the second strategy, characterized by sustainable reliance only on the awareness parameter. The first strategy was related to the tendency to give earlier and less informed prognoses.Intolerance for uncertainty was associated with a more detailed orientation in the task, manifesting in the tendency to take more parameters into the account, yet, without a full understanding of their real contribution to the final result, which could lead to an underestimation of the role of significant parameters, and made the prognosis more risky and less justified. These findings allowed us to look from a new perspective on the connection of intolerance for uncertainty and various irrational beliefs. Intolerance for uncertainty could manifest in the tendency to search for patterns in random events and the uncritical adoption of such patterns as the basis for decision-making.


Here, we provide insight in the development of preclinicaltrials.eu (PCT) and evaluate its use during the first 3 years after its launch. Furthermore, we elaborate on ongoing developments such as the rise of comparable registries, increasing support for preregistration in the Netherlands—which led to the funding of PCT by the Dutch government—and pilots of mandatory preregistration by several funding bodies. We show the international coverage of currently registered protocols but with the overall low number of (pre)registered protocols.Open, prospective registration of a study protocol can improve research rigour in a number of ways. Through preregistration, key features of the study’s methodology are recorded and maintained as a permanent record, enabling comparison of the completed study with what was planned. By recording the study hypothesis and planned outcomes a priori, preregistration creates transparency and can reduce the risk of several common biases, such as hypothesising after results are known and outcome switching or selective outcome reporting. Second, preregistration raises awareness of measures to reduce bias, such as randomisation and blinding. Third, preregistration provides a comprehensive listing of planned studies, which can prevent unnecessary duplication and reduce publication bias. Although commonly acknowledged and applied in clinical research since 2000, preregistration of animal studies is not yet the norm. In 2018 we launched the first dedicated, open, online register for animal study protocols:  PLoS Biology.1This article expands on an existing short communication paper published in Although controversial, animal experiments are still considered essential in many fields of biomedical and toxicological research. Unfortunately, concerns are raised about their validity and robustness, especially when new therapies based on promising animal studies fail to show clinical efficacy, safety and return on investment.Our vision is to optimise the efficacy of preclinical research for improving human health. We propose that registration of a protocol before starting an experiment (preregistration) can play an essential role in improving the robustness and transparency of animal studies and lead to more reliable research. Such preregistration of preclinical studies has four main benefits:21 22Disclosing the a priori study intention, that is, hypothesis, exploratory or confirmatory character and key elements of its design, including primary and secondary outcomes and sample size calculations.Promoting the use of methods to reduce risks of bias  and creating transparency about their use.Providing a complete overview of all performed studies (including those that remain unpublished) and the possibility to share or link to related data.Creating transparency and accountability within the research community and towards society.Several other initiatives have been developed to improve animal study robustness, for example, guidelines for planning  guidelines) and reporting  guidelines). Compared with guidelines for reporting, the added value of preregistration is its timing. Requesting the ARRIVE-checklist (or any other reporting guideline) at the submission stage may improve reporting, but for that particular research project it is too late to optimise the study design.In 2014 we first published a review suggesting an online registry for preclinical trial protocols.The format of the protocol registration form was discussed with fellow researchers from the Transnational Alliance for Regenerative Therapies in Cardiovascular Syndromes (TACTICS) group, the Radboud University Medical Center, University Medical Center Utrecht, the University of Sydney and several animal welfare bodies within the Netherlands. Based on this, we optimised the level of detail of the information required for registration  and aimed to determine the minimal amount of detail required to have an impact on research rigour, thereby minimising the additional administrative burden for researchers  the privacy of researchers submitting protocols and (2) the risk of intellectual theft of research ideas or loss of intellectual property. Regarding privacy, personal details of the researcher submitting the protocol are anonymised, except for the institution where the experiments are performed. It is possible to contact the submitting researcher through an encrypted email message to facilitate contact and collaboration. To prevent abuse, detailed information of study protocols can only be accessed after creating an account and logging in. Without an account only limited data  of studies are visible. Regarding the fear of sharing preliminary ideas, PCT provides the option to register a protocol under embargo. The full details of the protocol remain hidden until revealed by the investigator or after a release date which is automatically set at 1 year after registration. We feel that even though an embargo delays our aim to create full transparency, the other benefits of preregistration outweigh this downside. Also, we propose that the option to register under embargo is necessary at this stage, until preregistration becomes the gold standard and the research community comes to view preregistration as a safeguard against intellectual theft of scientific ideas and intellectual property (since preregistration in fact ’claims’ an idea), rather than a risk.The first protocol on PCT was published in September 2017 (PCTE0000098). A position paper from TACTICS supporting PCT and discussing the importance of preregistration was published in January 2018 .21 Subseet al.31The Royal Netherlands Academy of Arts and Sciences stated in 2018 that funders and journals should make preregistration mandatory for hypothesis-testing research.Since its launch, PCT has been internationally recognised for its importance in promoting rigour in animal studies. In 2018, we received the University of Sydney–Utrecht Partnership Collaboration Award, together with Dr Kieron Rooney, to empower collaboration on preregistration. In April 2019, PCT received the Science-based Refinement Award from Johns Hopkins University Center for Alternatives to Animal Testing. In August 2019, we were awarded second place in the Cochrane-REWARD prize.www.animalstudyregistry.org).34Three years after the official launch of PCT, there are over 1563 active accounts. Users originate from institutions in industry and academia in 30+ countries all over the world. Despite international recognition and encouraging engagement of stakeholders in, for example, the Netherlands, the number of registered protocols is still low.In comparison to preclinical registration, clinical trials registration is widely accepted and embraced by journals.42Following the example set by clinical trials registries, we may speculate that preclinical registration would need incentives from journal editors or governmental agencies to encourage researchers to preregister their studies.Preregistration might not be the only approach for improving translational research, but it is generally an easily implemented solution that will contribute to addressing various problems that currently reduce the impact of translational research. Ideally, preregistration would not be limited at all , but the provided solutions act to lower the threshold for stakeholders to embrace preregistration and are therefore necessary at this phase of preregistration. We have learnt from our experiences so far and are continuously working on improving the platform. At this point, two free and public databases dedicated to preclinical registration exist, but this could increase, as has been the case for clinical trial registration platforms. A meta-search engine, like the WHO ICTRP, could be an added value for researchers. To carry our ambitions and increase the number of registered protocols, we designed a strategy for focusing on three main action points: promote, facilitate and understand. To promote preregistration among researchers, we will provide webinars and aim to develop e-learning tools. We also create promotional material and publish relevant information online, in collaborators’ newsletters or via short communications.43Moreover, an international ambassador network was started to further promote preregistration worldwide. Ambassadors commit to showing the example by preregistering themselves, promoting preregistration in their teams and institute and helping us reach out to important stakeholders in their countries.BMJ Open Science and the Journal of Neuroscience Research among others.To facilitate and ease preregistration, we are currently focusing on minimising the administrative burden for researchers.Preregistration increases transparency and contributes to more effective preclinical research. Multiple platforms to facilitate preregistration have been developed, but the number of registered protocols is still low. We show in this paper the development of and considerations behind PCT and highlight the growing interest for preregistration of animal studies and the role of multiple stakeholders in this endeavour. Several Dutch stakeholders have taken the lead in implementing preregistration. We are encouraging other stakeholders to follow these examples and thereby increase the number of registered protocols. At the same time, we keep putting preregistration on the agenda in all our discussions with relevant stakeholders. We believe it is time for the scientific community to take responsibility and move towards more effective animal research.


Mens Sana in Corpore Sano study. In order to enhance the sample's representativeness, the original dataset (n = 321) was oversampled in accordance with the proportion of key sociodemographic characteristics of the reference population using the ADASYN method (resampled n = 531). The results indicate that a large majority of Italian immigrants perceived that they were as or even more physically active in Norway than they would have been if they continued living in Italy, while 20% of the Italians perceived instead a negative impact. No significant differences were found in the PA levels of the Italians in comparison with the Norwegian population, though some differences were found in relation to specific modes of PA. After controlling for multiple sociodemographic characteristics, men, those with lower educational levels and, to a certain extent, older adults tended to perceive a more negative impact and be less physically active than their respective counterparts. Compared with those living in the most urbanized regions, a larger proportion of those living in less urbanized regions perceived a negative impact, though no differences were observed in terms of PA levels. The findings are discussed in light of acculturation, gender, and social gradient. The knowledge generated by this study sheds light on an important health-related behavior among Italians in Norway, which can inform initiatives that aim at promoting PA in this specific group as well as other similar contexts of intra-EEA migration.As mobility within the European Economic Area (EEA) is on the rise, it is important to understand migrants' health-related behaviors  within this context. This study investigated i) the extent to which Italian immigrants in Norway perceive that moving had a negative or positive impact on their PA; ii) possible differences between the PA of the Italian immigrants compared with the Norwegian population; and iii) possible associations of the Italian immigrants' PA with key sociodemographic characteristics . The data were retrieved from the  Physical activity (PA) is one of the lifestyle factors that most influence whether people live a long and healthy life. Recent meta-analyses based on studies using self-reported  or accelHealth-enhancing PA includes any bodily movement that leads to an increase in energy expenditure . This deIn spite of the consistent evidence on the health benefits of PA, as well as the clear and simple guidelines for PA behavior, insufficient PA remains one of the leading risk factors for poor health and mortality worldwide . In a heCompared to other western countries, Norwegians are estimated to be relatively active. Figures from the Global Health Observatory  indicateEvidence exists also on PA differences between the Norwegian general population and individuals with immigration background. Immigrants are defined as persons born abroad by foreign-born parents . AccordiFree movement of people within the European Union and the European Economic Area . Italians' immigration to Norway has been steadily increasing since the establishment of the EEA Agreement in 1994, and it has 3-fold since the economic crisis of 2008 , can shed new light into factors influencing health behaviors among immigrant population in general. Thus, the purpose of this study was to investigate the extent to which Italian immigrants in Norway perceive that moving to Norway had a negative or positive impact on their PA habits, as well as investigate whether (and how) the PA profile of the Italians differ from the general Norwegian population. Furthermore, the study aimed to investigate whether (and how) the PA profile of the Italians varied in relation to key sociodemographic characteristics.The following research questions (RQ) were designed to guide the study:RQ1. To what extent do Italian immigrants in Norway perceive that moving to Norway had a negative or positive impact on their PA habits?RQ2. Does the PA profile  of Italian immigrants in Norway differ compared with the general Norwegian population?RQ3. How does the PA profile of Italian immigrants in Norway vary in relation to gender, age, region of residence, and educational level?The data for this study were retrieved from the Mens Sana in Corpore Sano study , an invehttp://scikit-learn.org/imbalanced-learn). ADASYN automatically estimates the needed number of synthetic cases according to a density distribution defined by the expected proportions of given variable in the reference population of Italians in Norway. In particular, considering a vector case xi, a new vector case xnew will be generated considering its k 3 nearest-neighbors (xzi) as follow:A comparison of basic sociodemographic characteristics  of the sample with figures provided by national registers, such as AIRE and Statistics Norway , revealen = 531; where λ is a random number between . For this study, the oversampling process was performed on 2-factors, i.e., age and educational level. The resampled dataset reflects an acceptable distribution of key sociodemographic variables with relatively limited inclusion of synthetic cases  was developed in order to allow comparisons with existing surveys in the Norwegian population. More specifically, the items were taken from or closely inspired to items used in the following surveys:Levekårundesøkelsen om helse (Survey on living conditions), a routinely conducted survey on health, health-related behaviors, and social relations in the general Norwegian population  and Exercise in the gym . The Age by Region of residence interaction was significant for Perceived impact of moving , Time spent sitting , and Active transport . A significant Age by Educational level interaction was found for the MVPA mode “Other” . Region of residence by Educational level interaction was significant for Perceived impact of moving , Green exercise , and Occupational MVPA . A significant interaction among Gender, Age, and Region was found for Exercise in the gym  and Occupational MVPA . The interaction among Gender, Age, and Educational level was significant for MVPA amount . Finally, a significant interaction among Gender, Regin of residence, and Educational level was found for Organized sports .The multifactorial ANOVA identified also a number of significant interactions among the sociodemographic characteristics for several PA variables, herewith presented. A significant Gender by Educational level interaction was found for MVPA amount , in NorThe relation of PA with educational level  was in line with patterns previously observed in both, the Norwegian  and the To the best of the authors' knowledge, this is one of the few studies focusing on intra-EEA immigration groups, and the first study specifically investigating PA patterns among Italian immigrants. The findings of this study provide new knowledge about an under-researched immigration group, but also shed light on factors influencing health behaviors among immigrant populations in general. By using instruments developed in line with Norwegian recurrent surveys, we could make direct comparisons between the PA habits of Italian immigrants and the Norwegian population. Another strength of this study is the inclusion of a measurement of sedentary behavior . A recent systematic mapping review found, indeed, that only few studies have investigated factors associated with this variable among immigrant populations within the European context . FurtherThe resampling process permits to balance the dataset of a subset of responders in accordance with key variables observed in the original population . ADASYN allows doing this by creating artificial cases reflecting the pattern of the authentic cases detected in the dataset. The data created are, thus, expected to accurately simulate the actual respondents' answers. The main limitations of such oversampling approach is that it could overestimate patterns observed in small subgroups, inducing a low ability of this class generalization. Fortunately, the dataset used in this study does not appear to have suffered from this problem.Another limitation of the study related to the instrument used to assess the Italians general PA levels. In particular, the measure of MVPA amount conflates light-to-moderate intensity and vigorous intensity PA. This may lead to an under-estimation of the prevalence of individuals meeting the recommended PA levels by excluding those who achieve sufficient PA levels through vigorous-intensity PA . The MVPA variable used in the present study is, however, a commonly used indicator of PA levels in population studies, including the Norwegian Survey on living conditions, which served as a comparison in this study. It should be also noticed that, differently than previous recommendations , the mosAs the purpose of this study was largely descriptive, with a focus on comparing the PA patterns of Italian immigrants with the Norwegian general population, the analytical approach was rather simple. This is likely to have limited the understanding of the phenomenon in its complexity. Moreover, only a selected number of sociodemographic variables were presented. This was a deliberate choice, partly motivated by the relatively small sample size, as well as the intention to provide outcomes easily comparable with existing evidence . ItA possible important limitation, however, is the fact that the present study did not include the duration of residence  as a variable in the analyses. Duration of residence may be indicative of acculturation, and it has been previously found to be a factor that may influence PA behavior in immigrant populations in Europe . HoweverThe findings of the present study indicate that a large majority of Italian immigrants in Norway perceived they were as or even more physically active in Norway than they would have been if they continued living in Italy. However, the prevalence of perceiving a negative impact was greater in specific sub-groups . No significant differences between the Italian immigrants and the general Norwegian population were found for key indicators of PA levels, though some differences were observed in relation to specific activities. Associations of PA with different sociodemographic characteristics were observed, especially in relation to gender, educational level and, to a certain extent, age. In contrast with patterns observed in the Italian general population (as well as patterns observed in other immigration groups), women were generally found to be more physically active than men. These findings shed light on the PA habits of Italian immigrants living in Norway, a relatively small but rapidly growing immigration group and can be used to inform initiatives to promote PA in this or similar immigrations groups. In spite of some limitations, this study indicates the potential of expanding the research on health and PA to under-researched immigrants groups, in particular within the EEA context. As mobility within the EEA is on the rise, it is important to understand how individuals interact with the opportunities and the culture of the country of resettlement, as well as how social gradients influence PA patters in the context of migration.The datasets generated for this study is not publicly available at the moment. All relevant aggregated data are provided in the paper. The data used in the current study may be made available after agreement with the authors.Ethical review and approval was not required for the study on human participants in accordance with the local legislation and institutional requirements. The patients/participants provided their written informed consent to participate in this study.GC drafted the overall manuscript and led the team of authors. AR performed the resampling and statistical analyses and drafter the relative parts in the Methods. LT was the overall project coordinator for the Mens Sana in Corpore Sano project and contributed substantially to the design of the study as well as the revision of the intellectual content. All authors contributed to the article and approved the submitted version.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.