Due to its conflict-ridden recent history, it has been difficult to launch major archaeological projects and advanced field research in Afghanistan during the last forty years. Lately, the proliferation of remote sensing methods, especially the increasing availability of satellite imagery, has allowed generating a much-needed impetus for documentation and monitoring of the heritage in Afghanistan. In this study, we present novel site data obtained through an examination of publicly available satellite imagery in the southwestern region of Kandahar. The sites presented here consist of a multitude of cultural heritage such as settlement mounds, architectural remains, religious monuments, fortresses, and traditional water management systems. We also discuss the advantages, as well as the drawbacks of remote sensing surveys for archaeological research in Afghanistan, and share our data to be employed in further research and cultural heritage management in the region. Afghanistan has been in a constant state of war during the last four decades. After the beginning of the Civil War in 1978, the conflict in Afghanistan has evolved in many directions, becoming ever increasingly complex. While the actors and alliances involved in the war continually changed and transformed throughout the course of these forty years, each shift in the power dynamics has added to the complexity and endurance of war. The plight of war that befell civilian populations, though, remains unchanged. Besides human suffering, an unprecedented attack on Afghanistan’s cultural heritage has unfolded in broad daylight, sometimes even on live TV. While high-profile attacks, such as the notorious case of the Bamiyan Buddha –6.Climate change is the other major factor that contributes to the overall deterioration of the human condition in Afghanistan, and especially in the sensitive dryland regions around the Registan Desert and southern Afghanistan. Intensely arid conditions, which began in 1998, have led to the displacement of around 100.000 nomads who used to live and stock breed in the Registan Desert . The ongth Millennium BC in the northwestern Pontic Region  is the most conspicuous one due to its large surface area and its steep flanks. Its irregular shape, as well as the remains of a citadel on its western eminence, provide distinctive elements that help distinguish Spirwan from the surrounding landscape of cultivated fields and small farmsteads. The other investigated mounds in the region, such as Deh Morasi Ghundai , Said Qala Tepe , and Mundigak , are much smaller in comparison with Spirwan, and therefore their topographic features are less pronounced. These sites also lack some of the distinctive visual elements present in Spirwan’s case, and therefore they blend in much better with their surroundings. Nevertheless, when viewed in the 1/2000 scale, a distinctive change in soil colour is discernible in all three cases. Although their topographic qualities are far subtler, it is still possible to distinguish these smaller mounds by their surface colour and texture.The region under study consists mostly of rocky hills and flat plains among the valleys. While mounded sites are fairly easy to spot on flatlands with relatively sparse topographic features, the valleys and plains around Kandahar contain many high ridges and rock outcrops. In some cases, the surface texture of the feature can be helpful to distinguish mounds from rock outcrops, as the surface of the mound seems often more homogeneous and duller due to the fine sediments it consists of. The presence of visible architectural elements such as traces of wall foundations on the surface is also a good indicator. The surface of the mounds that are situated within sown fields are most often left uncultivated in the Kandahar region and therefore such cases are much easier to distinguish in comparison with the mounded sites in drier and sparsely vegetated areas.kurgans, stupas, or eroded remains of single structures. In this sense, 90 cases can be interpreted as potential settlement mounds since their surface area exceeds 0.35 ha , Indo-Parthian, Timurid and Post-Timurid periods  , Deh Morkurgan cemeteries . The square or rectangular footprints in some cases suggest that they might be remains of shrines, stupas, or other architectural remains that are completely eroded . These are, however, limited cases and most of the mounds under 0.35 ha are completely devoid of such characteristic details.The remaining sites, where the mound formation is visible but under 0.35 ha, are also concentrated in the alluvial zone. Only ten of these sites are located north of the Arghandab River. The real difficulty with these mounds is to define exactly what kind of remains they represent. The larger ones may represent small village type settlements, hamlets or forts which are known from the Margiana and other regions of Central Asia –83  were at times overbuilt subsequently by Islamic ritual structures like shrines and mosques –88. IndeThe stupas in the Kandahar region are situated on various types of terrain without a selective pattern; examples have been recorded on hillsides, river banks or flatlands. Except for one case where four stupas cluster together , they are distributed as singular features across the landscape. It should also be noted that a part of the smaller mounds discussed above, those without conspicuous features such as rings, could also represent the remains of stupas, although this must remain uncertain given the lacking characteristic details. For this reason, the actual number of stupas in the region can be significantly higher than the ones we were able to identify during this study.Defensive structures such as mudbrick fortresses and fortifications are quite common features of the historical landscape in Afghanistan. Five such features have been previously identified in the region through conventional surveys: the fortifications of the old city of Kandahar  , LalkhānThe largest and probably the best-preserved settlement site encountered during the survey was K311 . A walleQanats (or Karez in Pashto) are sloping underground channels with a series of vertical access shafts that provide freshwater for irrigation and stock breeding as well as drinking water [Qanats rely on gravity to deliver water from higher elevations such as hillsides or mountain slopes, down to the settlements and cultivated areas that are located on lower elevations [qanats a completely carbon-neutral and sustainable water management strategy [qanats have been documented through satellite imagery in southern and central Afghanistan, including also the northern part of the Registan Desert [ng water . The oring water , 91. Theng water . Qanats evations . The lacstrategy . Around strategy , and recn Desert , 96.Qanats are the most abundant type of feature that we have come across during this study. All together 582 examples of these traditional water management structures were spotted. Except for their tendency to be located in the areas where the terrain allows the cultivation of crops, qanats do not reveal any other obvious spatial patterns in their distribution , they are all under 4 km . Mound type sites are also severely affected by illicit excavations, as nearly half of them are noticeably marked with clusters of looting pits (67 out of 138 cases). Other than the looting pits, primary causes of damage in archaeological sites seem to be the soil erosion and agricultural production. Terracing around the archaeological sites to increase the size of cultivated fields, as well as modern construction activities also result in considerable damage in many cases.Satellite imagery can be used to assess and monitor the damage at archaeological sites which result from illicit excavations and looting. Looting pits form distinctive features in the landscape due to their characteristic shape, shallow depth, and the mounds of debris accumulating around them. In some cases, looting pits form large clusters, and thus, make their identification from space easier –105. TheAlthough it is not within the scope of this paper, a comparison of the site data presented here with legacy satellite imagery (such as CORONA) may help expose the patterns and processes associated with the destruction of cultural heritage in Afghanistan. Archives consisting of satellite imagery collected over a long-time span (decades in the case of CORONA) provide information on the status of heritage before the expansion of industrialized agriculture and the growth of urban areas in many parts of the world . Both falapis lazuli, copper, and tin which were in high demand in Mesopotamia during the Chalcolithic period and the Bronze Age [Beyond their value as part of the region’s rich cultural heritage, the mounds in the Kandahar region may help resolve some of the outstanding questions in archaeological research. Previous studies and fieldwork provided evidence that the region was involved in the networks that were responsible for the procurement and distribution of resources such as onze Age –60, 95. th Millennium BC, possibly even earlier. Surface surveys at the sites presented in this paper are necessary to establish their dating and to put the site distribution data in a diachronic perspective. The on-going communication with colleagues from the Institute of Archaeology of Afghanistan has already contributed to this study by increasing our ability to locate and define certain elements, especially the architectural remains and stupas. Continued cooperation in these areas will certainly help us address these points.Unlike the areas north of the Amu Darya River where towns of urban proportions, such as Dzarkutan in Uzbekistan or Gonur Depe further west in the Karakum Desert of Turkmenistan, appear already during the Early Bronze Age , there iWith this study, we were able to record a large and diverse group of sites that are of archaeological interest in a region that was previously lacking sufficient data even for a basic understanding of the archaeological and heritage potential. The results are significant since they clearly demonstrate how great a gap there is between what we currently know about the past of Afghanistan and what we may actually find out by targeted, intensive research. The new data presented here may benefit future survey projects in the region by providing a road map for potential points of interest. The results also demonstrate that the cultural heritage situation in Afghanistan is at a tipping point. Many sites in the region are threatened by a multiplicity of factors such as looting, urban development, soil erosion, and agricultural practices. Nonetheless, the location data that we provide in the open-access appendix may assist the local authorities and specialists in Afghanistan in their efforts to monitor and preserve these sites . The ongS1 Appendix(PDF)Click here for additional data file.


Vaccination is the most effective tool to combat the COVID-19 pandemic. However, it is ineffective without appropriate public acceptance. In Poland, 53% of the country’s population is vaccinated, which puts us in the last position among the EU countries. Therefore, this study aims to assess the main concerns regarding vaccination in the unvaccinated population of Poland. The study was based on an original questionnaire that was distributed online. There were three phases of the study: Phase 1—before the preventive vaccination plan, Phase 2—2 months after implementation of the programme, Phase 3—after 4 months when the immunisation rate in Poland was 42%. A total of 4459 individuals participated in the study. As many as 1943 participants were excluded from the analysis due to lack of consent (30 subjects) or COVID-19 vaccination (1913 subjects). Out of the remaining 2516 unvaccinated individuals, 463 were participants in the first phase of the study, 1137 in the second phase of the study, and 916 in the third phase. As the preventive vaccination plan in Poland continued, concerns about vaccine adverse events, safety and efficacy were raised. The only lower concern was that about the vaccine transportation rules. Moreover, as the vaccination programme continued, there was an increase in the percentage of individuals declaring their full reluctance towards vaccination against COVID-19. Conclusions: The Internet is the main source of knowledge about the COVID-19 vaccination, so it should be focused on during vaccination campaigns. The public is primarily concerned about adverse events of vaccines and the lack of appropriate tests of the products used. Therefore, it is advisable to popularise the current state of knowledge and promote reliable information concerning the COVID-19 vaccination. Currently, the SARS-CoV-2 vaccination is the most effective way to prevent hospitalisations and deaths from COVID-19, a disease that has contributed to the deaths of nearly five million people out of more than 240 million detected infections . Those iThe previous reports show that the main sources of knowledge concerning the COVID-19 vaccination include health professionals, the Internet and family members . While rAn adequate percentage of vaccinated people in a community can help produce herd immunity and reduce transmission of the virus in the community, and thus slow down the pandemic . The exaAnother adverse event of under-vaccination is the continued circulation of the virus in the population of susceptible individuals, which causes further mutations of the virus. Some of these mutations may involve elements of the virus against which the vaccine-stimulated immune response is directed. Such an immune escape mechanism may reduce the previous vaccine efficacy and, in extreme cases, result in a lack of post-vaccination immunity ,22.Therefore, COVID-19 vaccination is currently a key pandemic control strategy, so it is extremely relevant to continuously monitor public sentiment and rapid local responses to improve it. Therefore, this study aims to assess the concerns that make people reluctant to get vaccinated against COVID-19 and their change over time. This study also aims to both determine demographic characteristics of vaccine refusers and the sources of knowledge they use, as well as identify potential changes throughout the epidemic. The distinguishing aspect of our study is the fact that the reports so far both from Poland and many countries around the world focus on one period. As we know, social moods may change over time, and our knowledge about vaccination also changes, which significantly affects the level of social acceptance. Therefore, to maintain the implementation of the vaccination program, it is necessary to constantly monitor the social mood and react appropriately based on scientific reports. The following research hypotheses were established: (1) As population vaccination continues, reluctance to COVID-19 vaccination in Poland is still at a high level and is even increasing. (2) Individuals who are not willing to get vaccinated are primarily concerned about vaccine-adverse events and lack of vaccine efficacy. (3) Opponents of vaccination derive their knowledge from unverified sources, mainly online ones. (4) Younger people with lower levels of education and those living in rural areas are less willing to get vaccinated.The methodology of the study was based on an original questionnaire created for this project. The distribution of the questionnaire was via Facebook within groups concerning both COVID-19 vaccination, prophylactic vaccination and in general fora, with a total of nearly 30 groups being published. Questionnaire was powered by free Google Forms tool. The target group included individuals living in Poland, aged 18 and more. There was no sample size calculation and participants were collected randomly, but were always voluntary. Participation in the survey was fully voluntary and anonymous and respondents had the opportunity to withdraw from the study at any stage without giving any reason. The survey was visible and available to each member of the group in which the information was distributed. It was a cross-sectional study consisting of three successive stages. The first phase of the study was conducted over the period from 14 to 26 December 2020, before the implementation of the vaccination programme in Poland. The second phase of the study was conducted 2 months after the population vaccination was initiated in Poland when it was possible to vaccinate health professionals, individuals aged 70+ and younger with chronic, immunocompromising comorbidities ,24,25,26Before participation in the study, each respondent was informed about the nature of the study, its objectives, and after becoming familiar with the information, the participant gave their informed consent to participate in the study.The study was approved by the Bioethics Committee of the Wroclaw Medical University and it was conducted in accordance with the Declaration of Helsinki.The original questionnaire consisted of both single-choice and multiple-choice questions. The initial section included an assessment of the sociodemographic status of the respondents, including age, sex, place of residence, level of education, marital status and being a health professional. Immunisation history (no vaccinations/mandatory vaccinations/mandatory and recommended vaccinations) and individual experience of COVID-19 infection were also assessed. The major concerns associated with receiving the COVID-19 vaccine were also assessed, including the concern about lack of vaccine efficacy, lack of appropriate tests of the products, the concern about transport/storage of products, the concern about vaccine adverse events and future complications. Concerning public sentiment, subsequent concerns were sequentially added to the survey at various phases of the study. Moreover, in the second phase of the study, the questionnaire was extended to include main sources of knowledge about COVID-19 vaccination, including TV, Internet, doctor, health professional (other than doctor), friends and information leaflets. A question was also added to address public attitudes towards mandatory COVID-19 vaccinations. The question assessing willingness to get vaccinated against COVID-19 was phrased “Do you plan to get vaccinated against COVID-19?” and possible answers were “I am already vaccinated/Yes, as soon as possible/Yes, in a few months (up to a year)/Yes, in a year or more/I cannot make a decision/No, but I might consider it in the future/No, never”. The analysis in this study included the questionnaires of those participants who declared that they were not vaccinated against COVID-19.The statistical analysis was performed using Statistica 13.0 software, StatSoft . Variables were of a qualitative and quantitative nature. Initially, basic descriptive statistics methods were used. The Pearson’s chi-squared test was used for determining the relationships between qualitative variables. The Cramér’s V coefficient or phi coefficient were additionally assessed. The analysis of covariance (ANCOVA) was performed to exclude the influence of potential confounding factors such as age, sex, place of residence, level of education, marital status and past COVID-19 infection.p = 0.05 was assumed in all tests that evaluated the statistical significance of the differences between mean values.The significance level of This section may be divided by subheadings. It should provide a concise and precise description of the experimental results, their interpretation, as well as the experimental conclusions that can be drawn.A total of 4459 individuals participated in the study. For the purposes of this study, 1943 participants were excluded from the analysis due to lack of consent (30 subjects) or COVID-19 vaccination (1913 subjects). Out of the remaining 2516 unvaccinated individuals, 463 were participants in the first phase of the study, 1137 in the second phase of the study, and 916 in the third phase. Young people, women, and residents of large cities predominated each phase of the study. The proportion of respondents who got infected with COVID-19 increased from phase to phase. When asked about their willingness to vaccinate, respondents most frequently indicated extreme answers: 32.35% of them are willing to get vaccinated as soon as possible, while 31.08% never want to get vaccinated. As the study continued, the proportion of those who opposed to the COVID-19 vaccination increased, most likely because those willing to vaccinate had already vaccinated and thus they were excluded from the study.A detailed profile of the study participants by study phase is shown in The participants indicated varied concerns about COVID-19 vaccination. Initially, the large number of people who were willing to receive the vaccine as soon as possible indicated concerns about vaccine adverse events, lack of appropriate tests, demanding transport of the vaccine or appropriate vaccine efficacy; however, fewer respondents reported such feelings as time went on. The situation is different for those who were not willing to get vaccinated—the longer the vaccines were available, the more often they reported concerns about them. Moreover, according to them, COVID-19 vaccination is linked to a conspiracy and is a medical experiment, and the virus itself is not dangerous—such concerns were hardly ever raised by those willing to get vaccinated. Considering all study groups over time, there was an increase in the proportion of participants who reported concerns about vaccine adverse events and about appropriate tests and vaccine efficacy. Only vaccine transportation issues were a concern that decreased over time. Detailed data concerning reported concerns by willingness to vaccinate and study phase are shown in The second and third phases of the study included questions about illnesses reported by study participants. The detailed data are included in The respondents used various sources to gain knowledge about COVID-19 vaccines—complete information is summarised in The impact of sociodemographic factors on the decision to get vaccinated against COVID-19 is presented in detail in The aim of this study was to assess the variability of concerns over time and in the course of implementation of the national COVID-19 vaccination programme among respondents in Poland. As the population-based vaccination programme continued, an increase in the proportion of unvaccinated individuals in Poland reporting concerns about the efficacy and safety of vaccination versus vaccine adverse events was observed. The only concern that decreased over time was that of the transport of vaccines.Furthermore, it was demonstrated that a considerable proportion of the population is still unable to make a decision or is planning to postpone vaccination. Additionally, a persistent reluctance to vaccinate among nearly 1/5 of the respondents is evident. The presence of chronic diseases as well as the sources of knowledge except for the Internet and television are not significant in the formation of attitudes towards vaccination, although in other studies the reliance on knowledge from health professionals influenced the willingness to vaccinate . All theAmong those who never want to get a vaccine are mainly ‘anti-vaxxers’, that is, people who challenge the scientific value of vaccination. They undermine the role of vaccination in health care and exaggerate the risks of vaccine adverse events. Moreover, they accuse vaccination of adverse events that have not been scientifically linked to the vaccine . At the It is worth pointing out that out of those who are not vaccinated, 11% were health care workers. At each phase of the study, it was noticeable that the percentage of medical workers who do not want to be vaccinated was increasing; however, it should be noted that the data concerns only those not yet vaccinated, and the healthcare workers were vaccinated first, which means that the majority of those willing to vaccinate had already been vaccinated, and in the study group, an increasing percentage were vaccination opponents. In Poland, no official statistics on vaccination rates among medical workers are kept, while those in Europe, Hungary, Iceland and Ireland show that 100% of medical workers are vaccinated. In Denmark, Czech Republic and Malta, this percentage is also approaching 100%. At the other extreme stands Bulgaria with nearly 30% of healthcare workers vaccinated . CurrentIn addition to anti-vaxxers, another group can be distinguished among those unwilling to vaccine, persons with doubts, who have concerns about vaccination that make them unable to make a final decision. Those individuals should become the target of public education efforts, with prior identification of factors deterring them from getting the vaccination . While aAt the time of the survey, there was a recognisable trend of unvaccinated individuals’ attitudes shifting towards indecision or complete aversion towards vaccination. This is probably due to the fact that those who were willing to get vaccinated have already got their vaccines, while the unconvinced individuals have been influenced by the anti-vaccine circles. Thus, those originally determined to vaccinate began to doubt, and those initially unconvinced became completely reluctant to vaccinate, among other things by amplifying the smoldering fears they had.Of the concerns reported, some were related to the potential lack of vaccine efficacy—people who do not know what protection the vaccination offers are unwilling to undertake the risk if they believe they will not receive adequate protection . MoreoveAnother argument encountered from people opting against vaccination is the fact of being convalescent, as these people assume that they will not contract COVID-19 again. As studies demonstrate that having recovered from COVID-19 infection does not exclude recurrence of the disease . MoreoveAn additional advantage of vaccination may be the reduction of virus transmissibility, although this has not been conclusively demonstrated in studies. As mentioned earlier, this is not the primary purpose of vaccination, but by making vaccinated individuals less likely to transmit the virus to others, an outbreak can be more easily controlled, and those who cannot get a vaccine for medical reasons can be protected ,47,48.It can also be observed that patients’ concerns have changed over time as new vaccine-induced complications were reported to the public, such as thromboembolic incidents in the case of vector vaccines or myocarditis incidents in the case of mRNA vaccines . DespiteThe only concern that was reported less frequently over time was that related to vaccine transport. The mRNA-based vaccines initially required transport and storage at low temperatures: −70 °C for Comirnaty and −20 °C for Spikevax. Such requirements were related to limited knowledge of mRNA stability at higher temperatures ,54,55. OThe Internet can be a very useful source of knowledge, but because of the abundance of information it contains, it can also be a dangerous source for someone who does not know how to verify the content they consult. Recently, there has been a noticeable increase in the activity of anti-vaccine movements, mainly on the Internet . Social Most surveys tested attitudes towards vaccination only once, without reassessment after a period of time, hence the limited ability to directly compare survey results. Williams et al. found a higher proportion of people willing to be vaccinated over time, at the same time as no significant difference in reported disincentives to vaccination . In earlResults from other studies on key factors are consistent with the findings we obtained. A history of influenza vaccination (which is a recommended vaccination in Poland) is a key factor that affects those willing to vaccinate against COVID-19, while concern about vaccine adverse events or lack of confidence in vaccine efficacy remain the primary factors associated with a lower willingness to vaccinate ,63,64.From a psychological perspective, the reason for the persistence of anti-vaccine attitudes may be the confirmation effect—participants in anti-vaccine communities present anecdotal evidence of the inefficacy or harmfulness of vaccines, while ignoring other explanations for the phenomenon in question, resulting in a misreading of the incidence of vaccination with the phenomenon as the cause thereof. This cognitive error is very common and in order not to commit it, scientific methods should be employed to assess the observed effects and the possible correlation between them ,66.Another justification is the phenomenon of reactance, that is, psychological resistance. People who are forced or forbidden to do something are more inclined to perform the opposite action, because it seems more attractive, regardless of whether it will be beneficial or harmful for that person ,68. SuchThe mass media are an enormous tool in providing reliable information to the public. Owing to a wide range of recipients, the media may create and reinforce pro-health attitudes, including pro-vaccination ones, by educating, verifying the information transmitted and combating the false information already propagated ,70.Another aspect to consider is making access to places and services dependent on the state of vaccination. Usually a certificate called “green pass” helps with this. In many countries a green pass is mandatory to access public places and it probably limits the spread of the epidemic . In PolaThe authors are aware of the limitations of this study. Undoubtedly, it is the methodology of data collection in the form of a questionnaire distributed via the Internet, which is subject to group selection bias. In order to compensate for this, the authors distributed the questionnaire to groups including not only extreme supporters and opponents of vaccination but also groups of general interest. Another limitation is the impossibility of estimating the number of people who received the questionnaire and the response rate. It should also be noted that the surveyed group is not representative for the Polish population due to the predominance of women, people of young age and those living in larger cities.In conclusion, the analysis indicates a significant change in attitudes of previously unvaccinated people towards COVID-19 vaccination as the pandemic progresses, it identifies the most common concerns holding back the decision to vaccinate, and it highlights the most potentially effective tools for educating the public about vaccination. By understanding these factors, measures can be taken to increase the number of people willing to get a vaccine not only in Poland. The study’s results can be implemented by educational campaigns provided in any country. This is essential to achieve herd immunity, especially when new variants of the virus emerge—otherwise a lack of immunity will stimulate mutations creating new variants, which could sustain a death spiral locking humanity within a pandemic for many years.Over time, a growing aversion to vaccination among the respondents was noticeable. This is a clear failure of vaccination education, promotion and popularisation in the country. The population is mostly concerned about the vaccine adverse events and the lack of appropriate tests. The main source of knowledge on vaccinations is the Internet, so it is the main resource to be focused on while launching campaigns encouraging people to get vaccinated. The public is primarily concerned about the vaccine adverse events and the lack of appropriate tests of the products used, so it is advisable to popularise the current state of knowledge and promote reliable information concerning the COVID-19 vaccination. At the same time, it should be emphasized that this survey is not fully comprehensive due to the fact that the surveyed group is not representative of the general population. Further research in this area is necessary.


Introduction: Cognitive behavioral therapy (CBT) for children and adolescents has shown efficacy in treating different psychiatric disorders. It has been added to multiple clinical guidelines as the first-line treatment. However, despite more studies of its efficacy, CBT is underutilized in clinical settings due to a lack of rigorous training programs and qualified CBT therapists. The limited knowledge of parents in this intervention and their negative attitudes toward it have been considered as possible reasons.Methods: This is a cross-sectional survey-based study among 464 Saudi parents living in Riyadh city. We aimed to evaluate the preference, knowledge, and attitudes of Saudi parents toward CBT for their children. We compared the difference in the level of knowledge and attitudes toward CBT in relation to the characteristics of parents. An online questionnaire that included 39 questions was carefully reconstructed from four validated scales, approved by an expert panel, and piloted. Participants were recruited to participate through online social media.Results: Saudi parents had average knowledge about CBT; however, they had positive attitudes toward the therapy itself and its role in treating the behavioral issues of children. Male participants showed better knowledge than female participants. Participants with higher education and those with high income had more favorable attitudes toward CBT than others.Conclusion: The knowledge of parents is considered inadequate and indicated the need for more awareness and perhaps mass education. In contrast, they maintained positive attitudes and were interested in evidence-based treatment, with more preference toward non-psychopharmacological interventions. Cognitive behavioral therapy (CBT) for children and adolescents has shown efficacy in treating different psychiatric disorders. It also has been mounting evidence from different treatment guidelines to be a first-line treatment recommendation for children and youth with many mental illnesses. For instance, in depression, NICE guidelines recommend CBT as a first-line intervention for mild-to-moderate symptoms . However, we faced many challenges in recruiting and maintaining parents and patients to complete the program. Some of those challenges were pertinent to the attitudes of parents and their agreement with and knowledge about CBT. At other times, it was parents favoring psychopharmacological interventions over a long wait list for CBT. Until present, no studies have been conducted in Saudi Arabia that assessed parental knowledge or attitudes toward psychotherapy or CBT for their children and how much they prefer medication over psychotherapy. In this study, we aimed first to measure the preference of Saudi parents for medication and/or psychotherapy for their children. Then, we would like to further assess their fund of knowledge, and finally, their attitudes toward CBT, which were divided into three factors, namely, perceived usefulness, responsibility, and effectiveness, as a possible intervention to consider for their children when indicated.This cross-sectional study was part of the King Saud University Cognitive Behavioral Therapy Program for children with anxiety (KSU-CBT). The data were collected from September 2020 to October 2020. As the most recent report of the Saudi Communication and Information Technology Commission stated that more than 91% of the Saudi population uses the Internet, with more than 87% and more than 55% of the Saudi population using WhatsApp and Twitter, respectively, and due to the precautions of coronavirus disease 2019 (COVID-19) during data collection, we used an online questionnaire to collect the data. Participants were able to access the questionnaire through the link that was distributed on Twitter and WhatsApp.We created an account on Twitter, and tweets were sent directly to both individuals and organizations as a request to retweet the survey link. We also shared the questionnaire link through WhatsApp groups and encouraged people to share the link. The participants understood the objective of the study and provided informed consent. Considering our hospital location and the majority of our patients being Saudis, we restricted our sample to Saudi parents who live in Riyadh and have children between the ages of 7 and 18. Noncitizens, parents who work in the mental health field, and individuals with previous experience with CBT were all excluded, as we assume those will not reflect the actual knowledge of the general population. The age range of children was chosen based on the most common age accepted in CBT programs in Saudi Arabia.Since there is no validated Arabic scale to help answer our research questions, the survey contents were first identified from four different scales in English : We selected questions from the study by Donovan et al. , which w3. and 4. Knowledge about CBT and Aims and Values of CBT (questions 20–31): These questions were taken from the previous study by Berg et al. . We have5. Attitude toward CBT (questions 32–37): We used the Psychological Treatment Consumer Questionnaire (PTCQ) : We used the same questions that were used by Donovan et al. .After data collection and before analysis, the research team, in consultation with the team biostatistician, reorganized survey questions to five different themes to provide the survey with more consistency and control after being reconstructed from four different scales to meet our research objectives. After redistribution, we identified the following five themes: knowledge about CBT, perceived general usefulness of CBT, perceived CBT responsibility, perceived trust/effectiveness of CBT, and the overall attitude toward CBT. We then analyzed the data accordingly .Table 3.In regard to the scoring system, participants were asked to rate the answers on a 5-point Likert scale . Additionally, in assessing the preference of parents for the mental health treatments of their children, the five options provided were scored as follows: 1 = A combination of medication and psychotherapy, 2 = Do not prefer psychotherapy at all, 3 = Medication only, 4 = Psychotherapy only, and 5 = Peer support group only. Furthermore, parents were asked to indicate, with regard to decision-making when it comes to the mental health treatment of their children, whether they would decide based on the treatment recommendation of providers or would prefer treatment that research suggests is most effective for their child. Some questions were rated on a 3-point Likert scale . The options for a few questions were yes, somewhat, or no, and the answers were rated as 1, 2, and 3, respectively. For the knowledge section, each correct answer was given a score of 1, and each wrong answer was given a score of 0. Finally, for yes/no questions, they were given a score of 1 = yes and 0 = no. The minimum and maximum scores for each section are presented in n = z2p (1 − p)/d2, with a proportion of 50% of parents having good knowledge and positive attitudes, z = 1.96 (95% CI), and d = 5% (margin of error). The estimated sample size is 385 participants, and an additional 20% was added to the original sample size to anticipate nonresponse participants. Out of 582 responses in total, 464 were included, and the main reasons for exclusion were as follows: noncitizens, parents who work in the mental health field, and individuals with previous experience with CBT.The sample size was calculated by the calculator.net website and confirmed manually by the following equation: t-test and one-way ANOVA) statistical tests for the quantitative outcome variables. A p < 0.05 reports the statistical significance of the results. The informed consent was clear and indicated the purpose of the study and the right of the participant to withdraw at any time without any obligation toward the study team. Participant anonymity was assured by assigning each participant a code number for the purpose of analysis only.The data were analyzed using SPSS version 24.0 statistical software. Descriptive statistics  were used to describe the quantitative and categorical variables. The bivariate statistical analysis was carried out using appropriate  = 2.918, p < 0.08 Furthermore, the household monthly income of respondents showed a statistically significant difference, with people with a monthly income >15,000 Saudi Riyals having the highest scores.To better understand the knowledge and attitudes of parents toward CBT, differences across sociodemographic factors were analyzed. The results of the findings  suggestee scores . HoweverThe purpose of this study was to investigate the preference of Saudi parents for psychotherapy and/or medication and their basic knowledge and attitudes in considering CBT for their children. During the assessment of the preference of parents toward the modality of treatment for their children, we found that the majority of parents prefer either psychotherapy alone or a combination of psychotherapy and pharmacological interventions. These findings are consistent with the study conducted by Brown et al. , which aParents are encouraged to ask their providers for further information about psychotherapy; it is also crucial that clinicians understand how to explain and offer these interventions properly. In line with this view, half of the parents (50.2%) stated that it was a joint responsibility of themselves and their providers to provide information about treatment options. Moreover, half of the respondents (49.8%) said that the recommendation of their providers is more important in treatment selections than research findings. Those results were lower than those published in the study by Kuckertz et al.  (58%). TThe CBT, especially for children, is considered a new modality in the Saudi culture with a few number of therapists who could provide this intervention. Thus, assessing the general knowledge of parents about CBT was considered an important aspect of our study. In our results, we found that the majority of participants were able to understand the relationship between mood and behavior; however, and one-third knew the importance of active participation in the therapy. While the best outcome in CBT is achieved through combining behavioral and cognitive intervention  did not find a gender preference for CBT or any gender differences in response to CBT compared with medication (Thase et al., As this study addresses parents choosing CBT for their children, findings were not different from other reports about the influence of gender on psychotherapy preference, particularly CBT. For example, the Sequenced Treatment Alternatives to Relieve Depression Study (STARThis study aimed to measure treatment preference, level of knowledge, and attitudes of Saudi parents toward CBT for their children. Based on the analysis, parents have a more positive attitude toward CBT than hypothesized, but their knowledge was found to be more limited than their attitudes. These results might encourage more efforts to fulfill a higher level of knowledge about CBT among Saudi parents by utilizing the newly established Ministry of Health Community Empowerment Initiative. Further studies are needed to assess the knowledge and attitudes of the population toward CBT in Saudi Arabia and to consider validating a scale for that purpose.The self-reported data increased the possibility of non-response and recall bias. The questionnaire was not validated and had long questions that may have impacted the response rate and the accuracy of the reported data. The limited sample to one city in Saudi Arabia and the significant gender variation in our study might limit the generalizability of the study. The survey questions had limited consistency and high heterogeneity, so more elaborating questions are needed to increase reliability, especially for the knowledge section.The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.The studies involving human participants were reviewed and approved by Institutional Review Board at King Saud University College of Medicine. The patients/participants provided their written informed consent to participate in this study.SA, IA, AAld, and GA conceived the study and designed the research methods. NA, LA, AAld, RA, and AAlo collected the research data. AAld prepared the data analysis plan. LA, IA, GA, and RA wrote the manuscript under the guidance of SA. 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.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.


Attempts to optimize monitoring of brace adherence prescribed to adolescents with idiopathic scoliosis (IS) have generally relied on sensors. Sensors, however, are intrusive and do not allow the assessment of psychological and physical consequences of brace use that might underlie poor adherence. Mobile applications have emerged as alternatives to monitor brace compliance. However, the feasibility and utility of these app-based systems to assess key psychological and physical domains associated with non-adherence remain unexplored. This feasibility study aims to test the usability, acceptability, and clinical utility of an app-based system that monitors brace use and related psychological and physical factors. Forty adolescents with IS daily respond to the app for 90 days. The patient responses may generate clinical alarms  that will be sent daily to the medical team. Primary outcomes will be app usability, acceptability, and response rates. Secondary outcomes will include brace adherence, the number of side effects reported, number and type of clinical alarms, stress, quality of life, perceived health status, and mood. If accepted by patients and clinicians, apps may allow rapid detection and response to undesired events in adolescents undergoing brace treatment. Scoliosis is defined as a torsional deformity in the shape and position of the spine, the thorax, and the trunk, which is generally diagnosed when the Cobb angle, a measure of the spinal deformity, is equal to or higher than 10° , as well as Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 and Directive 95/46/EC (GDPR) on the protection of personal data and on the free movement of such data. QualtricsIf authorized by the patient in the informed consent form, the external researcher responsible for the study (Dr. Carlos Suso Ribera) has access to their personal information  to contact them and solve app-related technical issues . These actions are recorded and reported as potential barriers for future implementation and acceptability of the new monitoring method. The study and its procedures are not associated with clinical complications or harmful effects. All participants may voluntarily suspend their participation in the study at any point. Their IS treatment and doctor–patient relationship will not be compromised by the discontinuation of the study.Data are analyzed using intention-to-treat principles. Descriptive data  are reported for all study variables. These include usability and acceptability and response rates in the app (primary outcomes), together with brace adherence, the number of side effects, the number and type of clinical alarms generated by the app, stress, quality of life, perceived health status, and mood (secondary outcomes). Statistical differences between completers and non-completers are calculated. Completers are those who respond to at least 85% of the requested daily assessments, which is the average completion rate in EMA revealed in past meta-analytic research . AdolescRegarding feasibility, app adherence is calculated by dividing the number of responses registered in the app and the number of assessments programmed in the app .In relation to the clinical utility of the app, brace adherence is calculated by dividing the number of hours of use reported by the prescription they were given, as suggested in previous research . Low braThe results derived from the statistical analyses described above will be reported in the form of tables, graphs, and flowcharts. All the analyses are performed separately by the lead researcher and an independent researcher. An interim analysis is planned at the end of the study once 50% of the total sample has been evaluated. All coauthors and the Ethics Committee of the Vall d’Hebron University Hospital have access to these analyses and are allowed to participate in the decision to terminate the trial. The database is available under reasonable request for any researcher who requests it. Personal information from the participants is not included in this data set. The results from this feasibility study will be published anonymously in international journals and conferences.IS is a prevalent health condition that usually appears during adolescence due to the development of the spine that occurs at puberty ,44. IS cThe present protocol described a feasibility study whose aim is to test the usability, acceptability, and clinical utility of an app-based system for the monitoring of adolescents with IS who use a brace. Specifically, we hope to provide new insights into the feasibility of the app , as well as into its utility in detecting non-compliance with brace (treatment adherence), brace-related side effects like pain and interference in sleep (treatment safety), and psychological distress associated with wearing the brace . Regarding feasibility, we expect to find high compliance rates with the app-based monitoring system in the end users. Non-adherence to the app will generate clinical alarms, so the professional will be able to contact the participants to encourage them to interact with the app. For this reason, we expect to find low attrition rates during the study period (90 days). Additionally, in relation to the feasibility results, we anticipate that the participants will be very satisfied with the app in terms of acceptability and usability . Based on previous similar research ,46, we aThe present study has some limitations. Regarding the inclusion criteria, only adolescents with a smartphone will participate in the study. Therefore, a small proportion of patients may not be able to participate in the study. According to recent global statistics on smartphones, between 80% and 86% of adolescents between 12 and 17 years old own a smartphone ,48. TherWhile we recognize the limitations mentioned above, if the app-based telemonitoring of adolescents with IS leads us to the hypothesized results in terms of feasibility and possible clinical utility, this study will have important clinical implications. Among the novelties of the present study is the implementation of an app-based EMA system for the multidimensional monitoring of adolescents with IS. An advantage of implementing this methodology includes the minimization of problems found in retrospective face-to-face episodic assessments . Taking recall bias, ecological assessments are known to be more accurate than retrospective ones . TherefoIn short, we hope that this new passive telemonitoring method will reduce the current burden on health care services, as doctors will contact patients only when necessary rather than routinely calling patients to assess their physical and psychological functioning. Last but not least, because alarms will occur on an individual level, treatments will become more personalized as specific responses and adaptations will be possible due to the variety of brace-related physical and psychological dimensions evaluated in the app.


Medication nonadherence is a costly problem that is common in clinical use and clinical trials alike, with significant adverse consequences. Digital pill systems have proved to be effective and safe solutions to the challenges of nonadherence, with documented success in improving adherence and health outcomes.The aim of this human factors validation study is to evaluate a novel digital pill system, the ID-Cap System from etectRx, for usability among patient users in a simulated real-world use environment.A total of 17 patients with diverse backgrounds who regularly take oral prescription medications were recruited. After training and a period of training decay, the participants were asked to complete 12 patient-use scenarios during which errors or difficulties were logged. The participants were also interviewed about their experiences with the ID-Cap System.The participants ranged in age from 27 to 74 years , and they were heterogeneous in other demographic factors as well, such as education level, handedness, and sex. In this human factors validation study, the patient users completed 97.5% (196/201) of the total use scenarios successfully; 75.1% (151/201) were completed without any failures or errors. The participants found the ID-Cap System easy to use, and they were able to accurately and proficiently record ingestion events using the device.The participants demonstrated the ability to safely and effectively use the ID-Cap System for its intended use. The ID-Cap System has great potential as a useful tool for encouraging medication adherence and can be easily implemented by patient users. Medication nonadherence is a problem that continues to plague the health care system. Data have shown that patients do not report their own adherence accurately  and thatIn addition, medications that have been shown to improve the quality of life, prevent tumor progression, and prolong survival are often not taken as prescribed by patients with cancer . A systeNonadherence is multifactorial. The common reasons for nonadherence are confusion (about complex drug regimens), a lack of commitment to the treatment plan, fear of adverse events, cost of drugs, forgetfulness, lack of symptoms, illness factors such as depression or psychosis, and miscommunication or lack of trust between the patient and the health care team -11.Clinical trials too are often impaired by suboptimal adherence and flawed in the way they track medication adherence -14. For The need for objective and reliable ways to confirm medication use has driven the development of various tracking methods, including patient self-reports, adherence-reporting mobile apps, pill counts, pharmacy prescription refill rates, electronic pill dispensers, and other solutions—but none have been optimized, and many are not reliable . DigitalThe ID-Cap System  is a digital pill system and ingestible event marker  that enables adherence measurement through an embedded ingestible sensor. The biocompatible sensor, upon coming into contact with gastrointestinal fluid, communicates a digital signal through radio frequency after ingestion and dissolution of the pharmaceutical-grade capsule shell that encapsulates it. A reader worn by the patient detects the radio frequency signal and forwards ingestion data to the patient app and clinician dashboard. Information about the ingestion event is then wirelessly transferred to a Health Insurance Portability and Accountability Act–compliant cloud-based server  for secuThe Food and Drug Administration granted 510(k) clearance to the ID-Cap System in December 2019. The regulatory review of this medical device and its related software encompassed the results of human factors validation testing among patient users, clinician users, and system administrators, including the results of the study reported herein. The components of the ID-Cap System are shown in In this paper, we describe the human factors validation study involving patient users, the intent of which is to evaluate the ID-Cap System for usability, ensuring that patient users will be able to operate the system as intended in a simulated real-world use environment. Our key questions were as follows:Are patient users able to perform critical tasks effectively and safely, using an interface representative of the final device design, in conditions representing the actual conditions of use?Can they do so without errors and without difficulties that could cause harm?This validation study excluded clinical safety and effectiveness elements, which have been assessed and documented in separate evaluations and pivotal clinical trials supporting the use of the device. The researchers hypothesized a priori that the patient users would successfully demonstrate their ability to safely and effectively use the ID-Cap System for its intended use.To conduct the human factors validation test of the ID-Cap System, we used assessment testing. This type of test provides users with realistic tasks to perform, using a working prototype of the device but without requiring any clinical use .The training and testing took place at the office facilities of Tensentric, Inc, in Boulder, Colorado. The test was conducted in either conference rooms or dedicated research rooms set up to represent a typical home-use environment. An ID-Cap System was provided, including supplemental test equipment  and product labeling.The research team had a recruitment target of up to 18 patient users to ensure that the goal of a minimum of 15 participants from the intended user population would be met; 15 test participants per user group represents the most stringent sample size guidance from regulatory bodies for human factors validation testing . The parOur goal was to obtain a sample of test participants who represent the intended patient users of the ID-Cap System. The recruited participants took medication by mouth on a regular basis, were able to understand and follow directions, and communicated clearly. If a caregiver assisted the participant in taking medication or in day-to-day activities, the caregiver also participated in the test. Participants with conditions that affected their ability to make health decisions or follow their physician’s instructions and those who did not use a smartphone were excluded.This was an all-comers study that was, by design, both inclusive and diverse. Diversity within the sample size was promoted within the recruitment screener by quantified maximums or minimums on specific populations as well as instructions to recruit a variety of participants, including a mix of handedness, sexes, races, educational levels, and disease states. The demographics that were recorded after scheduling included visual acuity, age, handedness, sex, medical conditions, how the participant currently ensures that they are taking their medication, color blindness, visual impairments, and any visual corrections.The participants received a 40-minute training session for the ID-Cap System to orient them to the basic features, functions, and nomenclature of the ingestible sensor, wearable reader, and patient app. They were shown a series of 5 short training videos containing key information and demonstrating the correct use of the device. They were then asked to demonstrate the steps for completing a successful ingestion using the reader and patient app before using the system independently during the test session. The training was equivalent to what is expected to be delivered to actual users, and the content, format, and method of delivery of training were comparable to the training that actual users would receive. The training materials and device instructions for use were designed to support a self-guided supplemental training program for the patient user.The training videos covered the following topics:Overview of the ID-Cap SystemSetup of charger and reader for the first timewithout use of the patient appRoutine use of the system with use of the patient appRoutine use of the system App navigation and functionalityTraining was conducted at least one hour before the patient’s test session to simulate a typical level of training decay. After completing the training, the participants were sent away from the test environment for at least one hour with no materials. Only after the waiting period of an hour were the participants able to begin executing the test scenarios. This 1-hour gap, which was added to be more indicative of real-world gaps that exist between training and first-time use, represents the recommended time frame when evaluating potential use-related risks related to training decay .After the training session and training decay period, the participants initiated a guided 60-minute test session. Time variation was expected in completion of the test session based on factors such as operator skill, training retention, and experience with similar devices and smartphone apps. Actual task times were documented through the video recording of each session and referenced as needed.During the recorded test session, the participants were observed as they completed the use tasks and monitored by at least one facilitator and either a second facilitator or an observer seated in the same room as the participants. Printed instructions for use were provided to the participants and placed where they would be freely available for reference. However, the facilitator did not direct the participants to use them; this enabled insight into how patients might (or might not) refer to them during actual use.During the test session, the participants were asked to complete 12 patient-use scenarios using the ID-Cap System, which included device use tasks and knowledge assessment tasks. They verbally read the use-scenario description that was provided on a printed note card and started the task. The participants were instructed by the facilitator to use the system as independently and naturally as possible to reflect actual use behavior. They were not informed how to complete the task or when to expect error conditions nor were they given any other information that would bias their realistic interaction with the system.The research team observed the participants as they attempted to carry out the task scenarios and recorded any difficulties or participant comments, which were revisited with the participant during a postscenario interview. A data logger observed and logged participant behavior, user comments, and system activity. The participant was asked to simulate the ingestion of the ID-Capsule and the medication that it was intended to track during the testing. No actual ingestion events occurred during the test session.After each use scenario, the research facilitators conducted a postscenario interview with each participant to analyze any use-related problems. The participants were prompted to provide subjective and candid assessments of any use issues experienced during the test, their probable causes, and impact.After all task scenarios were attempted, the participants completed a postsession debriefing interview with the facilitator, where neutrally worded, open-ended questions were posed to them regarding their experience. The participants were asked to provide feedback regarding the use, safety, and usability of the ID-Cap System, as well as the clarity and effectiveness of user resources containing instructions for its use.This test protocol was designed to validate the critical use tasks associated with the ID-Cap System for patient users. The tasks were selected and prioritized using a risk-based analysis to cover critical tasks, safety-related tasks, frequent tasks, tasks that must be performed correctly for the device to work as intended, and key device labeling .The tasks that tested safety mitigations were given the highest priority; for example, tasks that have the potential to alter decisions about ID-Capsule ingestion or ingestions of medications that are taken coincident with, or co-ingested with, the ID-Capsule were determined to be the most important to evaluate. Next on the priority scale were tasks that enable proper operation of the system, followed by tasks that occur infrequently or are provided as a convenience to the user.The cross-functional research team members performed a risk-based review of the human factors validation test results, including the participants’ subjective assessments of any use errors, close calls, or operational difficulties that occurred during the test. Final pass or fail determination was made based on the risk-based review of the test results and if further design modifications were required to mitigate use-related errors.The final report summarized the test results, which included evaluation of the actual versus expected task outcomes, subjective assessments, any specific use-related problems, and recommendations for resolution.A total of 17 participants met the recruitment criteria and were enrolled in the validation test, fulfilling the minimum target of 15 participants from the intended user population of patient users. The participants ranged in age from 27 to 74 years , and they were heterogeneous in other demographic factors as well, such as education level, handedness, and sex . Of the In this validation study, the participants successfully completed 97.5% (196/201) of the total patient use scenarios with the ID-Cap System. Of the 12 use scenarios, 9 (75%) were successfully completed without any failures or use errors among the 17 test participants.The task scenarios included first-time use tasks and repeat-use tasks, as well as tasks that were only completed on a single occasion, as appropriate, to represent actual use of the system. Of note, we found that when use errors did occur, they occurred only in the first instance and were not repeated. The use errors, close calls, and patterns of use difficulties identified in the testing are reported in The results of the human factors validation test were reviewed by a cross-functional team that conducted a risk-based review of each use-related finding. No new use-related risks were identified in the validation test. It was determined that no modifications of the device or software were required to improve safety or usability for the intended patient users, uses, and use environments of the ID-Cap System when operated as indicated and in a manner consistent with its labeling.The participants grasped the potential value of the system in helping them track and report medication adherence and could see the benefits to people who take medications regularly (including themselves). Many commented on the simplicity and ease of use of the system and liked the training and user resources that were provided, especially the training videos and quick start guides.as is , 16 (100%) stated that they felt that they could use the system effectively and safely to record and track ingestion events and 16 (100%) reported that they believed that the system is safe to use as is .Relevant quotes from patient users“I think it’s a really great idea for people who have issues with remembering medications and for MDs tracking how they’re doing with taking those medications.” [P03]“Pretty slick! Pretty minimalist, which is good for the target audience. Very easy. One button [on reader] is good. Easy to use, easy to set up. Not a lot to do. Seems very user friendly.” [P09]“It’s a tool. For people that have to take a lot of meds, it is a good tool. I can see the value if it communicates to a provider.” [P15]“It’s simple to use. If everything’s working correctly, it meets its intended purpose. The videos and instructions are very good. I had no problems trying to figure it out and follow the process.” [P05]“Having test driven it, I have confidence in it. That equates [to] safe use.” [P05]The patient’s voice has become an important one in health care. Patients are increasingly involved in decisions about their health and medical treatment, and they have become sophisticated health care technology users who understand the value of digital platforms and are eager to use them.Certainly, the value of the ID-Cap System and other remotely deployed digital health solutions depends on the willingness of patients to engage with them and the ability of patient users to effectively, safely, and conveniently incorporate them into everyday life with minimal training and oversight. The US Food and Drug Administration requires human factors validation testing of digital pill systems and many other medical devices to ensure safety and effectiveness for a device’s users, uses, and intended use environments .The results of this human factors validation study show that a representative group of patient users successfully completed the critical and safety-related use tasks necessary for optimal use of the system independently, after receiving training that was followed by a period of training decay. Although the participants were representative of a diverse group of potential patient users who regularly take oral prescription medications, the sample size in this study was limited. The participants ranged in age from 27 to 74 years , and they were heterogeneous in other demographic factors as well, such as education level , handedness , and sex . This study was neither designed nor powered to evaluate differences in usability based on demographic factors, medical history, or medication use. It is important to note that nearly every screened participant, regardless of age or education level, agreed to participate in this study after receiving information about the digital pill system and successfully completed the use tasks, showing that patient users of all types adapted well to a novel digital pill system. Use errors, when they did occur, occurred only in the first instance for tasks that are repeated with use, indicating that the participants learned to use the ID-Cap System rapidly—a positive prognosticator for real-world use. Most patients expressed satisfaction with the ID-Cap System and responded favorably to questions about the ease of use and the perceived value of the system.Prior iterations of digital pill systems used a patch-based reader that adhered to the patient’s skin. Clinical evaluations of the patch-based form factor indicated significant limitations from the patient user’s perspective with respect to tolerability and usability ,21. The The limitations of our study include the fact that this was a simulated use of the ID-Cap System and did not include the actual taking of medication for adherence tracking. The participants reported taking prescription medications by mouth on a regular basis. However, they were not asked to use the digital pill system in this study to actually track and record their own medication use in the same way that patient users would use it in the real world.In most clinical applications, patient users would use the system chronically over extended periods of time. This validation test was limited to only a few simulated ingestion events and did not evaluate use over time. Certainly, there may be specific patient populations, medical conditions, or treatment-related effects that would affect the usability of the ID-Cap System. This study evaluated the general operation of the device across a diverse group of patient users with different health conditions and varied medication history. Use-related risks should be assessed when the device is applied to specific clinical situations and patient populations to ensure continued safe and effective use from a human factors perspective. Digital pill systems may be incorrectly used or misused by patients in clinical trials or in clinical practice; however, these aspects of use and failure modes were not specifically explored in this study. Risk analyses have been conducted by the device manufacturer to examine and mitigate risks to patients and device performance associated with device use and misuse.The availability of a call center or additional supporting resources during the use of the device may assist patients, as would engagement with their health care provider. These resources were not evaluated in this test protocol. Patient support programs and data-driven interventions offered by the care team members, research personnel, or device manufacturer may be beneficial for the use of the ID-Cap System in clinical practice and clinical research. Continued efforts to educate clinicians and patients alike regarding the value of the information provided by the system and proper use of the system will further enhance its adoption. In addition, integration of the ID-Cap System into existing care models, electronic health records, and clinical data management systems is being explored.There is great potential for digital pill systems such as the ID-Cap System to contribute to the efficiency and ultimate success of clinical trial programs. For example, digital pills may be used to assess the likelihood of adherent behavior among prospective trial participants. Once a trial has started, digital pills can identify patient nonadherence and changes in patterns of use early, enabling rapid intervention and course correction. Dose-finding studies for self-administered oral medications are another ideal application for digital pills because their results and outcomes are dependent on (1) human behavior as it relates to medication taking and (2) the quality of adherence measurement to optimize drug exposure and dosing decisions. The robustness of the adherence data collected with digital pills provides an added level of reassurance that the efficacy and safety results of pivotal drug development trials eventually reported are accurate. The inconsistency of medication adherence reporting within clinical trials has led to the creation of guidelines for researchers and trial sponsors on the inclusion and implementation of adherence measures in study protocols -14,22.The extent of medication adherence, both in clinical use and in clinical trials, is a controllable factor important for therapeutic success and drug development. The pursuit of a solution to the widespread problem of medication nonadherence has led to digital pill systems, which have shown strong performance and a high rate of accuracy. Currently, >15 years of experience and safety data support the use of digital pills with >140,000 ingestions recorded in >1000 patients who have used these devices safely and effectively . In this


The clinical learning environment and clinical rotation experience of students are integral to nursing curriculum and are a crucial component of nursing education which helps transform theoretical knowledge to clinical practical skills.  This study was aimed at assessing the role of the clinical learning environment on undergraduate nursing and midwifery students' satisfaction with their clinical rotation experience. p ≤ 0.05.  The study employed a quantitative cross-sectional survey design. Data was collected from a sample of 240 undergraduate nursing and midwifery students of the University for Development Studies, Tamale, Ghana, using a structured questionnaire. Ethical approval was obtained from the University of Cape Coast Ethics Review Board. Descriptive analysis was displayed as frequencies and percentages. Inferentially, Fisher's exact test, linear regression, and Spearman's correlation tests were used to test for and quantify associations between independent and dependent variables at χ2  = 80.665, p < 0.001), pedagogical atmosphere in the clinical area , the leadership style of the ward manager , the premises of nursing in the ward environment , and the students' satisfaction with their clinical rotation experience.  The level of students' satisfaction with both clinical rotation experience and the clinical learning environment was high . A statistically significant association of the students' satisfaction with their clinical rotation experience was found. There was a statistically significant relationship between the clinical learning environment ( These findings provide nurse educators and clinicians with meaningful understanding about areas to prioritise when planning clinical learning opportunities in such a way that skills learning and practice of nursing skills are successful and satisfactory for undergraduate student nurses and midwives. Clinical rotation experience is crucial in nursing and midwifery education as it helps student nurses and midwives to transform theoretical knowledge into clinical practice. Clinical rotation that exposes students to a supportive clinical learning environment (CLE) influences nursing and midwifery students' satisfaction, knowledge, skills, attitudes, and interest in their training –4.Clinical rotation experience is a planned experience for a specific nursing educational course, and experiences gained by the students in hospitals, clinics, and health care centers and in the community , 6. ClinClinical rotation experience is achieved in a clinical learning environment, which consists of all the clinical environs of the nursing and midwifery students such as the clinical settings, the staff nurses and midwives, the patients, the nurse preceptors, and the equipment. Exploration of such environments provides insight into the educational functioning of the students in clinical areas and allows nursing tutors to provide opportunities for students learning in the clinical setting , 9. ClinThe pedagogical atmosphere of the clinical environment can be positive or negative. A positive pedagogical environment is characterized by nonhierarchical structure, teamwork, good spirits, and interpersonal communications . The posThe leadership style of the ward manager remains a crucial element of experiential learning in the clinical setting . A good The premises of nursing, where nursing care and learning occur, consist of the culture and values of nursing in the ward, information flow related to patient's care, documentation of nursing care plans, recording of nursing procedures, and sufficient meaningful learning situations on the ward . CulturaThe most effective premises of nursing environment for clinical learning is one that is supportive, free from fear, and encourages openness and respect for the student as an individual . Good prDespite the importance of clinical learning environment  in contributing to trainees satisfaction with clinical rotation, it can be a major source of anxiety and stress among nursing students worldwide , 20, 21.As a result of the multifaceted nature of the clinical learning environment, students have difficulty identifying potential learning opportunities, and consequently, some student feel overwhelmed , 22, 23.In some clinical environments, nursing and midwifery students are mostly treated unfairly and, in extreme cases, discriminated against. For example, Jamshidi et al.  concludeWhile several research works have been published on undergraduate nursing and midwifery students' satisfaction with their experiential or clinical learning and the clinical learning environment in the developed countries such as Australia, Finland, Canada, and other places like Iran , 27–31, In Ghana, nursing and midwifery education has been reported to be experiencing many challenges since time immemorial such as poor working relations between clinical environment and health training institutions, poor clinical environment, inadequate preceptor preparation, and inadequate students' supervision among others during clinical placements in health facilities , 33. ThiDespite the acknowledged importance of clinical learning environment and clinical rotation on the acquisition of clinical nursing skills during training of nursing and midwifery students, research on student satisfaction with their clinical rotation and the clinical learning environment has not been adequately addressed in most countries in the developing world like Ghana.This article, therefore, sought to provide answers to the degree to which nursing and midwifery students at the University for Development Students, Tamale, Ghana, are satisfied with their clinical rotation experience, as well as the clinical learning environment's role in their satisfaction with their clinical rotation experience.To achieve the aim of the study, the following null and alternate hypotheses were formulated:0: there is no statistically significant association between the clinical learning environment and students' level of satisfaction with their clinical rotation experience.H1: there is a statistically significant association between the clinical learning environment and students' level of satisfaction with their clinical rotation experience.HThe cross-sectional survey with a quantitative approach was used for this study. Both independent and dependent variables were measured at the same time as recommended by Bhattacherjee .The study was conducted at the School of Nursing and Midwifery of the University for Development Studies, Tamale, Ghana. The University for Development Studies was established in 1992 as a multicampus institution as the fifth public University to be established in Ghana. The Tamale campus houses the School of Nursing and Midwifery, School of Medicine, and other allied health sciences. This setting was chosen because it is a tertiary institution, and the students were observed to have some challenges in the clinical environment during their clinical rotation practices in the clinical area.n=N/(1+N(e)2) , where “n” is the sample size, “N” is the population size (715), and “e” is the margin of error or level of precision (0.05).The target population for the study were 715 undergraduate nursing and midwifery students in the third and fourth years of the School of Nursing and Midwifery of the University for Development Studies, Tamale, Ghana. These students have had exposure to different clinical settings and experiences and could provide valuable information by responding to the research questions. The sample size used for the study was 240, arrived at using Yamane  formula A proportional stratified random sampling technique was used to determine the number of students from each year group based on their total numbers. This approach was necessary to ensure equitable distribution of respondents with general nursing and midwifery background in the sample. The participants were divided into two categories, general nurses and midwives. Then a number of student nurses in each category was chosen based on the proportion of nursing and midwifery students from that category in the total population. Thus, general nurses who constituted 70% of the total student population were 157 students, whiles midwifery students were 67 representing 30% of the total student population.Both postdiploma and generic students, who were regular students and had satisfactorily completed a minimum of two clinical rotation experiences, were included in the study. Students excluded were those in first and second year, as well as those on the distant learning program. This was because these students might not have had enough clinical experience to provide valuable information needed in the study. Further, students who were on field placement in communities at the time of data collection were excluded from the study because they were not available for selection.A structured questionnaire was used to collect data from the respondents. The instrument comprised three sections capturing information about the participants' demographic characteristics, their level of satisfaction with clinical rotation experience, and the clinical learning environment. Section A was designed to elicit information on demographic information of participants such as the age, gender, marital status, religion, ethnicity, financial support, category of nursing students, and the level of entry to the programme.Section B measured student's satisfaction with clinical rotation experience, using a 22-item scale adapted from the Clinical Learning Environment Inventory by Chan . SectionData collection was conducted among third- and fourth-year nursing students who met the inclusion criteria at the University for Development Studies, Tamale. The questionnaire along with the cover letters to introduce the study purpose and the rights of the participants were distributed to the participants by the researchers and two data collection volunteers with data collection experience. The information sheet contained clarification of ethical issues concerning confidentiality and anonymity and provided contact information for participants to reach out to for clarifications. Participants were contacted during break periods. Participants who agreed to participate in the study signed the informed consent form and were asked to complete the questionnaire within one week, on their own. The researcher and the volunteer data collectors retrieved the completed questionnaires from the students after a week in April, 2018.Of the 240 participants samples and given questionnaires to complete, 224 completed the survey, giving a questionnaire return rate of 93.3%. Upon retrieving the completed questionnaires, it was kept in separately labelled envelopes, based on the programmes of study of the respondents .The questionnaires were then cleaned, coded, and entered into SPSS for Windows Version 23 for statistical analysis. On completing the entries, the questionnaires were placed into their labelled envelopes and locked in a cabinet, only accessible to the researchers. The SPSS data was passworded and a backed-up copy of it was kept on an external drive, which was also password protected for data security reasons.Analysis of the data was carried out in SPSS for Windows Version 23. For purposes of analysis and easy communication of findings, an average score of the results from the Likert scale items  measuring satisfaction with clinical rotation experience and the clinical learning environment in the questionnaire was calculated. The level of respondents' satisfaction with their clinical rotation experience and the clinical learning environment was determined by taking an average of their total satisfaction score to determine whether they scored very low (1 to 27), low (28 to 54), high (55 to 81), or very high (82 to 11). The results were then displayed in tables as frequencies and percentages.p-value of less than or equal to 0.05 was deemed statistically significant.Inferentially, Chi-square and Fisher's exact tests were used to determine the association between selected demographic variables  and respondents' satisfaction with the clinical rotation experience and clinical learning environment. Where statistically significant associations existed, variables were entered into a logistic regression model to determine the strength of association between satisfaction with clinical rotation experience and the respective demographic predictors at the 95% confidence interval. A Further, a Spearman's correlation test was conducted to predict the association between students' satisfaction with clinical rotation experience and dimensions of the clinical learning environment such as pedagogical atmosphere of the ward environment, leadership style of ward managers, and premises of nursing in the ward.This study was conducted at the in Tamale, Ghana, at the School of Nursing and Midwifery of the University for Development Studies. Ethical approval was obtained from the Institutional Review Board of University of Cape Coast (Reference number: 0990–4279), and permission for data collection was obtained from the School of Nursing and Midwifery, University for Development Studies. Access to the participants was gained through the heads of departments of nursing and midwifery.Prior to the commencement of questionnaire distribution to sampled participants, all participants were informed about the objectives and purpose of the study. An informed consent was given to each respondent to read, seek clarifications, and consent. Issues of anonymity and confidentiality of information provided and participants were ensured as they were not required to provide their names. Information about the voluntary nature of the study and their right to withdraw at any stage without any consequence were also explained. No adverse event or effect was expected or anticipated from participating in this study.With a completed questionnaire return rate of 93.3% of the 240 respondents sampled, a sample size of 224 was finally realized and used for all statistical analyses under this section.Statistics about the students' level of satisfaction with their clinical rotation experience is presented in A Fisher's exact test was performed to determine the association between some selected demographic variables of respondents and their level of satisfaction with clinical rotation experience showing no statistically significant association as illustrated in Close to two-thirds (63.5%) of the respondents were in the category of those who said they had high levels of satisfaction with the clinical learning environment. Only a few (0.4%) of the respondents indicated that they had very low satisfaction with clinical learning environment. The details of these have been illustrated in χ2  = 80.665, p < 0.001). As a result, we fail to accept the null hypothesis, which stated that “there is no statistically significant association between clinical learning environment and students' level of satisfaction with their clinical rotation experience” and accept the alternate hypothesis, which stated that “there is a statistically significant association between clinical learning environment and students' level of satisfaction with their clinical rotation experience”. The result of this test is presented in A Fisher's exact test showed that there was a statistically significant association between the clinical learning environment and respondents' satisfaction with their clinical rotation experience  = 0.379, p < 0.001), and leadership style of ward manager also had a moderate positive correlation (rs (224) = 0.340, p < 0.001), while the premises of nursing in the ward environment had a strong positive correlation (rs (224) = 0.501, p < 0.001) with respondents' satisfaction with their clinical rotation experience.Further analysis was conducted to quantify the relationship between the dimensions of clinical learning environment and respondents' satisfaction with clinical rotation experience using Spearman's correlation test see . All thrThe findings from this study showed that nursing students generally have high levels of satisfaction with their clinical rotation experience. Many of them fell in the category of high satisfaction group, whereas a small number was in the category of very low satisfaction. This finding is similar to that of Chuan and Barnett , who fouAl-Sebaee et al.  explaineThis study also found that when students were asked to indicate if the clinical rotation was a waste of their time, most indicated that it was not a waste of time. However, a small number indicated it was actually a waste of time. This finding is in line with findings by Perli and Brugnolli , who fouFindings about nursing and midwifery students' satisfaction with the clinical learning environment show that close to two-thirds of the students were highly satisfied with the clinical learning environment. This finding is comparable to findings by Papastavrou et al.  in a stuThe findings of this current study, which shows a high level of satisfaction by nursing students with their clinical learning area, are similar to findings by Nepal et al.  in a NepThe high levels of satisfaction with the clinical learning environment by nursing students in this current study could be attributed to a number of reasons. This could be due to the presence of preceptors at Tamale Teaching Hospital, which is the main clinical learning environment for nursing and midwifery students of the University for Development Studies, more so, the clinical staff being well trained and ready to assist students, and the recognition of students as part of the health care team and being treated with utmost respect and appreciation. Another ground on which the students could demonstrate these high levels of satisfaction with the clinical learning environment has to do with effective levels of clinical nursing skills teacher guidance, constant feedback on student's clinical performance, and regular clinical conferences with clinicians and nurse teachers. Similarly, the degree of satisfaction also appeared to be influenced by the unique organizational atmosphere of the ward and hospital environment at Tamale Teaching Hospital, with well-structured clinical environment to support students' learning.On the contrary, the findings of this study are at variance with an Iranian study by Hakim , who estAnother finding from this study is that the clinical learning environment is found to have great influence on undergraduate nursing and midwifery students' satisfaction with their clinical rotation experience. Many studies have demonstrated the importance of the clinical learning environment in students' satisfaction with their clinical rotation. Perli and Brugnolli  as well The findings from this current study generally show that students satisfaction with their clinical rotation experience was significantly related to all of the three dimensions of the clinical learning environment such as pedagogical atmosphere of the ward, leadership style of ward manager, and the premises of nursing in the ward environment. Our findings are similar to that of Papastavrou et al.  who founOne notable finding in this current study was that the premises of nursing in the ward environment had more influence on the nursing and midwifery students' satisfaction with their clinical rotation experience than pedagogical atmosphere and leadership style of managers. According to Skaalvik et al. , premiseHowever, this current finding differs from some findings of Papastavrou et al.  where thBased on the finding of this study, it can be concluded that the level of satisfaction of undergraduate nursing and midwifery students of the University for Development Studies, Tamale, Ghana, with their clinical learning environment was high. This could be due to the well-structured clinical learning environment, where the students obtain their clinical experience.The clinical learning environment greatly influences nursing and midwifery students' satisfaction with their clinical rotation experience. The students indicated a high level of satisfaction with their clinical learning environment. This could be attributed to good institutional working relationship between University for Development Studies and Tamale Teaching Hospital, which is the major site where nursing and midwifery students obtain their clinical training.In light of these findings from this study, it is clear that there are other factors influencing general satisfaction of undergraduate nursing and midwifery students' satisfaction with their clinical rotation experience. Such factors, according to the findings of this study, include supervisory relationship between supervisor and student, clinical learning environment, pedagogical atmosphere of the ward, leadership style of ward manager, and premises of nursing in the ward. Therefore, if the quality of these factors is maintained and improved upon, it could lead to a very high level of satisfaction with the clinical rotation of undergraduate nursing and midwifery students and hence improving nursing and midwifery clinical education in Ghana.The findings of the study disprove the researchers initial thinking that student nurses and midwives have low levels of satisfaction with their clinical rotation experience and the clinical learning environment.In summary, while all components of the clinical learning environment are important in determining students' satisfactions with their clinical rotation, nurses and midwives at the clinical sites should pay more attention to the premises of nursing in the ward. This has to do with the culture and values of nursing in the ward, information flow related to patients care, documentation of nursing care plans, recording of nursing procedures, and sufficient meaningful learning situations on the ward as recommended by Skaalvik et al. . This isThe limitations of this study are that findings from this study could be peculiar to the study setting and may not be generalizable to other universities or jurisdictions. Moreover, due to the small number of the participants involved in the study, the study may have limited applicability. The study is also limited to third- and fourth-year nursing and midwifery students at one university. Therefore, the findings may not be generalized to all nursing and midwifery students in Ghana.