Customers’ satisfaction is imperative for success. Clinical laboratories continuously strive to attain very high levels of customer satisfaction to serve their clients and maintain accreditation. The concept of customer satisfaction has not yet been asserted in most clinical laboratories in Cameroon.Our objectives were to assess the satisfaction of clinicians with the laboratory services at the Bamenda Regional Hospital Laboratory, identify important challenges, corrective actions implemented and changes in satisfaction.This retrospective study reviewed secondary data from clinician satisfaction survey records from March 2017 and November 2017. Challenges and implemented corrective actions were identified for assessed statements of dissatisfaction (dissatisfaction rates ≥ 20%) on the March 2017 survey. Satisfaction rates in March 2017 and November 2017 were compared.High levels of dissatisfaction were observed for general satisfaction, waiting time, communication, duty consciousness, specimen collection and approach on the March 2017 survey. The main challenges identified were: lack of respect for the expected length of the waiting time, poor attitude, inadequate information, staff shortage and inadequate supervision. Statistically significant reductions in rates of dissatisfaction were observed for general satisfaction, waiting time, communication, response to emergencies, issuing of results, specimen collection, approach and duty consciousness.Waiting time is a major cause of clinician dissatisfaction with laboratory services. The identification of clinicians’ challenges and the effective implementation of corrective actions contribute to improvements in clinician satisfaction. This is done through the effective implementation of the International Organization for Standardization (ISO) 15189 and ISO 17025 Standards.6 Feedback from laboratory customers is a compulsory quality indicator in the preparation of the balanced scorecard for monitoring the effectiveness of the quality management system.6 One of the tools used to assess feedback is the clinician satisfaction survey.For every business to succeed, customer satisfaction is imperative. The satisfaction of customers at health institutions such as clinical laboratories, which includes clients (patients) and clinicians , is evaluated by using customer satisfaction surveys to continuously improve services.8 and Africa.9 Findings from these studies reveal that most clinicians were satisfied with the cleanliness of the environment, quality of the results, presentation of the results, sample collection and handling of samples, whereas others were dissatisfied with the waiting times and attitude of the staff.11 Most of these studies did not identify the corrective actions implemented or document changes in satisfaction. Although clinician satisfaction surveys are conducted for clinical laboratories in Cameroon that are enrolled in the Stepwise Improvement Process Towards Accreditation,14 there is little published literature on the topic.Many previous studies have assessed clinicians’ satisfaction with clinical laboratories in Europe, America15 that routinely makes use of customer satisfaction surveys as a tool to assess customer feedback. Surveys are done twice a year and corrective actions implemented in order to continuously improve on the quality of service delivery. Our objectives were to assess clinicians’ satisfaction with the laboratory service, identify challenges, corrective actions implemented and document changes in satisfaction.The Regional Hospital Bamenda is a public hospital that uses feedback from customer satisfaction surveys from patients to identify departments in the hospital that they are dissatisfied with. Feedback from the surveys are presented to the clinicians and heads of the departments during the weekly hospital coordination meetings. However, corrective actions are not evaluated, and the questionnaires used are not standard. Besides, apart from the laboratory services, the concept of a ‘clinician survey’ has not yet been established by other departments of the hospital. The Bamenda Regional Hospital Laboratory is a business centre in the Regional Hospital Bamenda. It is a newly accredited clinical laboratoryEthical approval to carry out this study was obtained from the Institutional Review Board (IRB) of the Bamenda Regional Hospital (IRB reference number: 18/APP/RDPH/RHB/IRB). Consent to participate in the survey was obtained verbally (by agreeing to fill out the questionnaire).15The study was conducted at Bamenda Regional Hospital Laboratory (BRHL), which is a department at the Regional Hospital Bamenda. The Regional Hospital Bamenda is a level II referral hospital in the North-West Region of Cameroon with a capacity of 400 beds and a bed occupancy rate of about 90%. The BRHL was chosen for this study for the following reasons: it is the largest public laboratory in the North-West Region with high quality and specialised services. It has a central laboratory made up of six departments and three satellite laboratories within the hospital premises. It has the capacity to run 118 different tests and a staff of 35. It serves about 170 patients (inpatients and outpatients) and about 90 clinicians . It performs customer satisfaction surveys to continuously improve the services and the presence of records. Besides, the Haematology, Biochemistry and Serology services are newly accredited for competence and compliance with the ISO 15819:2012 Standard by the South African National Accreditation System.This retrospective study reviewed secondary data collected from clinician satisfaction surveys that were carried out at the BRHL in March 2017 and November 2017. Information from the survey questionnaires and corrective action records were the primary data from which secondary data for the study were collected.16 and were administered to clinicians selected at random at the BRHL by the head of the customer service in March 2017 and again in November 2017 to the same group of participants. Both surveys were completed within a week during the hospital coordination meetings and the responses collected at the end of the meeting or at the offices of those who were not present in the meetings and those who were not on duty. The content of the questionnaires was explained to the participants who personally responded to the questions. The respondents were free to provide a phone number  and signature  so they could be contacted in case clarification was needed.The BRHL has an advanced quality management system and conducts customer satisfaction surveys twice a year as a quality indicator for its balanced scorecard. The designed questionnaires were reviewed by the laboratory management and medical adviser17 The statements covered the following areas: accuracy (correctness of laboratory results), reliability (trustworthiness of laboratory results), waiting time (time between sample collection and dispatch of results), communication (management of information by the laboratory), response to emergencies (attention to emergency tests), staff-client relationship (the bond between laboratory staff and clinicians), cleanliness (neatness of the laboratory and staff), duty consciousness (awareness of laboratory staff to perform their duty promptly), specimen collection (effectiveness of phlebotomists), issuing of results (effectiveness of delivery of results), approach (the way laboratory staff attended to patients and clinicians) and general satisfaction . Open-ended questions included: What did the clinician like most about the laboratory? What did the clinician dislike about the laboratory, recommendations for improvements and suggestions of the tests that could be included on the laboratory test menu?Each questionnaire was made up of rating statements and open-ended questions. The statements were assessed using a 5-point Likert ranking as follows: poor (1), fair (2), good (3), very good (4), excellent (5).At the end of the surveys, reports were presented to laboratory staff during the staff meetings and to clinicians in the laboratory-clinic interface  meeting. Action plans with corrective actions were implemented for the non-conformities  identified. Evidence of the closed gaps were maintained in action plan reports, communication logs, complaint logs and meeting notes.Data from clinicians who were part of the surveys were included in the study. This included clinicians who were present at the hospital coordination meetings and clinicians who were on duty during the weeks that the surveys were conducted. Participation was based on a random selection with verbal consent (by agreeing to respond to the questionnaire).Data from clinicians who were not part of the surveys were excluded from the study. This included clinicians who were not present at the hospital coordination meetings and clinicians who were not on duty during the weeks the surveys were conducted.Data were collected by three reviewers trained to collect secondary data for the study using a structured data collection format. All available questionnaires from the two surveys were used. The data were classified by level of satisfaction as follows: responses of excellent and very good were classified as ‘satisfied’, good was classified as ‘neutral’, and fair and poor were classified as ‘dissatisfied’. Data for statements assessing: accuracy, reliability, waiting time, communication, response to emergencies, staff-client relationship, cleanliness, duty consciousness, specimen collection, issuing of results, approach and general satisfaction were decoded and entered into a Microsoft Excel 2010 spreadsheet . Action plans (the plan of activities in the laboratory), communication logs (records of communication with clinicians), complaint logs (records of complaints from clinicians) and meeting notes (minutes from laboratory staff meetings and laboratory-clinic interface meetings) were reviewed to capture the corrective actions implemented. Key informants  were contacted in case a clarification or further explanation or information was needed.p-value of 0.05 or less was considered to be statistically significant.8Percentage frequency distributions were calculated to rate the levels of satisfaction  for each of the assessed statements. Dissatisfaction with an assessed statement was defined as a percentage score of 20% or more of dissatisfied responses. Chi-square and Fisher exact tests were used to compare the rates of satisfaction of the two surveys. A 18 Responses that were related to assessed statements with a dissatisfied score were identified as challenges. Clarification on the challenges and the corrective actions implemented were identified through a review of clinician survey reports, meeting notes, communication logs, complaint log action plans and interrogation with key informants .Assessed statements with 20% or higher dissatisfaction score on March 2017 were selected for review. Qualitative content analysis was conducted for the open-ended question responses by using calculated frequencies from two reviewers.Out of 85 questionnaires administered to the clinicians in March 2017 and 89 administered in November 2017 during the clinician satisfaction surveys, 83 and 88 clinicians responded (response rates: 97.6% for March 2017 and 98.9% for November 2017) . Followip = 0.014), general satisfaction , communication , issuing of results , specimen collection , approach , and duty consciousness . Although not statistically significant, there was a general decrease in dissatisfied scores between the two surveys for responses to emergencies, reliability and the staff-patient relationship. In addition, accuracy and cleanliness had reduced dissatisfied scores on the November 2017 survey, although they were not considered for evaluation, since they did not register dissatisfied rates below 20% on the March 2017 survey.In November 2017, no assessed statements had a dissatisfied score. Between March 2017 and November 2017, statistically significant reductions in dissatisfied scores were registered for: waiting time  as challenges. For corrective actions, the laboratory staff and clinicians were educated and trained on the specimen collection procedures and the need for proper specimen collection.Communication: For communication, clinicians identified the following challenges: an inadequate explanation of procedures or difficulties and unavailability of laboratory information (phone numbers of some of the laboratory managers and test menu) to some clinicians. For corrective actions, adequate information on the laboratory services was provided and the hospital intercommunication system was maintained.Response to emergencies: Clinicians identified the following challenges related to response to emergencies: lack of respect for the procedures and waiting time for emergency requests. For corrective actions, laboratory staff were cautioned about having a poor attitude towards work, clinicians were oriented on the procedure for handling emergency requests, emergency requests were tracked to monitor waiting times and laboratory staff were cautioned about the need for adequate communication.16 was registered for both surveys, which was attributed to the fact that most of the questionnaires were issued to the respondents (clinicians) during hospital coordination meetings, where almost all of the respondents were present and the responses were collected at the end of the meeting. For both surveys, some of the questionnaires administered to clinicians at their offices were not returned. Respondents knew the surveys were routine and that they were an avenue for them to give their feedback, express their challenges and make proposals for the improvement of the laboratory services.8The purpose of this study was to assess clinicians’ satisfaction, identify what challenges clinicians faced when accessing laboratory services, identify corrective actions implemented in response to those challenges and document changes in satisfaction. A good response rateThe dissatisfaction rate in relation to waiting time in the March 2017 survey was the highest. Although the laboratory had an advanced quality management system in place for the management of patients, the system was not respected by the laboratory staff. In addition, the absence of the hospital intercommunication system affected the flow of information from the laboratory to the wards and clinicians. Due to the implementation of some of the corrective actions, there was a significant reduction in the dissatisfaction rate concerning waiting time on the November 2017 survey. The clinicians  created greater awareness of the activities and relationships between clinicians and the laboratory. They understood why the waiting time of some tests were longer than others and could, in turn, inform their patients. Furthermore, the maintenance of the hospital intercommunication system strengthened communication between the laboratory and clinicians.8 They attributed this to inadequate information about the waiting time of emergency requests, lack of respect for procedures for emergency requests and high prices for emergency tests.8 For corrective action, the laboratory informed the clinicians about the waiting time and advised them to order emergency tests for emergency cases.8 Steindel and Howanitz in a survey of clinicians in the United States also reported low satisfaction rates for waiting time.7 They observed that the waiting time for laboratory services was too long and the clinicians did not consider the laboratory sensitive enough to handle their emergency requests.7 Allen and Harris19 and Boyde et al.,20 in the United Kingdom also reported dissatisfactory rates for waiting time by clinicians. Teklemariam et al. reported a satisfactory score for the waiting time for notification of critical values and timely results for HIV testing, but this was for a single test,9 whereas the report from our study was for the entire laboratory. Zarbo et al. and Zarbo, in another study in the United States, reported low satisfaction scores by clinicians that were related to timeliness of reporting,11, 21 and although corrective actions were implemented in the study in Finland, there was no significant change in the dissatisfaction rate.Similar dissatisfaction rates have also been identified in many other studies. Oja et al., reported a dissatisfactory score for waiting time by clinicians in a study in Finland.8Duty consciousness received a high dissatisfaction rate score on the March 2017 survey. The corrective actions and the introduction of the laboratory attendance register by the laboratory management significantly reduced the dissatisfaction rate. This improved supervision of staff by the laboratory management, because details of staff attendance and movements, including when they went on break, were monitored promptly and daily. Oja et al. in Finland, observed a low dissatisfaction rate for the attitude that was not appropriate for comparison during their statistical analysis.11The approach by the laboratory staff also had a high dissatisfaction rate score in March 2017, this was attributed to a poor attitude on the part of some laboratory staff, possibly due to burnout from high workload. The corrective actions implemented significantly reduced the dissatisfaction rate in November 2017. The re-training and re-orientation of laboratory staff and the hiring of more workers also reduced burnout. Other studies did not assess the approach.8 and Zarbo21 reported a dissatisfaction rate for notification of abnormal results.Clinicians were also dissatisfied with the issuing of results on the March 2017 survey. The laboratory staff were cautioned on attitude, and the corrective actions implemented significantly reduced the dissatisfaction rate. Oja et al., in Finland, reported a non-significant rate of dissatisfaction for missing results8Specimen collection registered a high dissatisfaction rate on the March 2017 survey. According to key informants, this was attributed to inadequate training and orientation and failure to respect laboratory policies and procedures. Many laboratory staff and clinicians were newly hired and were not trained on specimen collection. The corrective actions implemented significantly reduced the dissatisfaction rate. The clinicians became aware that they have to assist in specimen collection in emergency cases, including difficult cases, during routine working hours (7:30 to 15:30 pm). Oja et al., in Finland, reported a significant reduction in dissatisfaction rate for phlebotomist rounds, after the rounds were rescheduled in cooperation with the in-patient unit and other clinical units adjusted their work pattern to integrate better with the laboratory service.8, in Finland reported a low dissatisfaction rate in their study that was not appropriate for comparison during statistical analysis.Communication registered a high rate of dissatisfaction among the assessed statements in the March 2017 survey. According to key informants, this was attributed to the fact that some of the wards were recently renovated and information posted on the walls had been removed. Some of the clinicians were newly hired or recruited and had not received an adequate orientation on the laboratory procedures and policies. Although the main communication tools of the laboratory were in place, the laboratory did not adequately use them and verbal communication was still a problem. The laboratory did not register some of the verbal complaints presented by the clinicians for follow-up, and the complaints were persistent. Information from key informants identified poor verbal communication of laboratory staff as the main cause of most of the challenges, which included long waiting time, many specimen rejections and poor follow-up of pending results. Normally, after specimen collection in the wards, the phlebotomist was supposed to inform the patient of the exact hour of the day to collect results, but some phlebotomists informed them of the duration . This caused some of the patients to speculate the exact hour of the day to collect their results and resulted in numerous complains about waiting time even when the time had not been exceeded. Besides, the laboratory results of patients admitted to the wards were dispatched directly to the clinicians, but some patients and caregivers presented to the laboratory separately to collect results that had already been issued to the wards. This was due to the failure to provide adequate information to the patient or caregiver during specimen collection by the laboratory. The corrective actions implemented significantly reduced the dissatisfaction rate of communication in the November 2017 survey. Clinicians could better orient their patients on the functioning of the laboratory. Oja et al.,Response to emergencies registered a high dissatisfaction rate in the March 2017 survey. Key informants attributed this to the poor attitude of the staff and lack of adequate information on laboratory services provided to clinicians. The corrective actions implemented significantly reduced the dissatisfaction rate. Oja et al., in Finland, observed a non-significant reduction in dissatisfaction rate for scheduling of phlebotomists during emergency hours.11General satisfaction was the general impression of the clinicians about the laboratory services. General satisfaction registered a high rate of dissatisfaction among the assessed statements on the March 2017 survey. This was due to the accumulation of challenges from all the other assessed statements. The corrective actions implemented following the identification of all the challenges accounted for the significant reduction in the dissatisfaction rate in the November 2017 survey. Several other studies did not consider the general satisfaction with laboratory services.A significant increase in customer (clinicians) satisfaction level of the BRHL can be achieved through cooperation among hospital management, laboratory management, clinicians and other hospital staff. It is recommended that: the government should improve laboratory infrastructure to boost patient flow, employ more staff to replace those who transfer or retire and provide more automated machines to increase efficiency and reduce waiting times. The hospital management should: provide an interface system to link laboratory equipment to the laboratory information system to reduce clerical errors, maintain the internal communication system in the hospital, provide a web-based communication system that links the laboratory service to patients and clinicians, notify them when their results are ready, remind them of their appointments with the laboratory and allow logging of issues with laboratory services, provide equipment such as a television set, video or audio player to entertain customers, especially when they are waiting to be served, hire more staff to handle the workload, sign engagements with hired workers to guarantee their job security and motivation, and retain existing staff to maintain continuity, train other hospital staff on the importance of customer satisfaction, support the laboratory in the effective implementation of corrective actions, and plant close-circuit television cameras in the departments of the laboratory and hospitals to ease supervision and monitoring of staff activities and customers.Clinicians should respect the policies and procedures of the laboratory and hospital. They should follow their appointments and report any incidents to the laboratory management, educate and counsel their patients before sending them to the laboratory, communicate well with their patients and the laboratory management in case of any incident, and receive and direct patients properly to avoid cross-aggregation with other services. The laboratory management and staff should positively change their attitude, respect all laboratory policies and procedures, intensify supervision, regularly train new and old staff, effectively implement corrective and preventive actions in real-time, intensify meetings (laboratory-clinic interface) with the users of the laboratory, educate the public on the use of laboratory services by making more frequent public talks over the radio and television, and revise the questionnaire to include more open-ended questions.Since this is a retrospective study, we could not control the consistency of the data collected. Our study was based on the data collected, so we were limited to the assessed statements or questions. The fact that some participants provided their phone numbers might not be a bias since they knew that they could be called up as key informants and this was optional.According to our study, waiting time was a major cause of clinician dissatisfaction with laboratory services. To maintain reduced dissatisfaction rates in clinical laboratories, it is important to continuously identify challenges and effectively implement corrective actions.


The Tobacco Control Scale (TCS) was designed for advocacy purposes but has also been used as a research tool. In the present study, we characterized TCS use, its limitations and strengths, and critically assessed its use as a research instrument.We conducted an extensive search of the biomedical databases PubMed and Web of Science for the keyword ‘tobacco control scale’ in all fields. The search was limited to studies published in the period March 2006 to December 2019. Out of 69 hits, 32 studies met the inclusion criteria. Two reviewers independently extracted information from each publication regarding their general characteristics, publication and research aspects, and the characteristics of the use of the TCS.We found that researchers have used the TCS as a tool to monitor tobacco control policies mainly in cross-sectional observational studies with ecological and multilevel designs directed to advocacy and the promotion of further research. Different outcomes, such as smoking prevalence and quit ratios, have been associated with tobacco control policy scores. The main reported limitations of the TCS were a low variance across countries and a failure to express enforcement and to incorporate the most recent legislation.The TCS has been commonly used to assess differences in outcomes according to tobacco control policies. However, there are still areas for improvement in its use in research regarding the lack of comparability of TCS scores across time. The lessons that have been learned should be used to adapt and expand the TCS overseas. Many efforts have been made globally to tackle the tobacco epidemic3, stimulated by the enforcement of the Framework Convention on Tobacco Control. In the European Union (EU), the Tobacco Products Directive has driven the application of stringent tobacco control policies to reduce tobacco use and its negative consequences on health. However, the implementation and enforcement of tobacco control policies still vary greatly across Europe4.Effective tobacco control policies help denormalize smoking, decrease smoking prevalence5 developed the Tobacco Control Scale (TCS) in 2006. The TCS score is determined by a questionnaire based on six cost-effective policy interventions that should be prioritized according to the World Bank. These measures include taxation, smoke-free policies, public spending in information campaigns, advertising bans, health warnings, and treatment. The score assigned to each of these components is weighted by its reported evidence-based effectiveness. Therefore, the score attributed to each country increases with the strength of tobacco control policies up to a maximum of 100 points, indicating full implementation5.Among the initiatives to monitor the implementation of tobacco control policies in Europe, Joossens and Raw5 and to inform the agenda by highlighting the policy components for which progress is lacking, as well as the countries or regions most affected by such delays6. Since 2006, the TCS has been updated every three years .At its inception, the aim of the TCS was to monitor the progress in tobacco control in Europe at a national level by comparing the performance of countries by their rankingEvaluating the impact of tobacco control policies among the population has become an important research area; thus, the TCS has been used as a research tool to measure the implementation of tobacco control policies, though it was not designed for such purposes. However, little is known about the use of the TCS by the tobacco control research community and its advantages and disadvantages as a research tool. Therefore, our aim was to characterize the use of the TCS by researchers and its main limitations and strengths as a research tool in order to critically assess its use as a research instrument.We performed an extensive literature search in the online databases PubMed and Web of Science to identify publications that have used the TCS score(s) as an independent or dependent variable from 27 March 2006, when the first TCS was published, until 1 December 2019. The search was conducted using ‘tobacco control scale’ as the keyword in all fields without any other restrictions to ensure a very sensitive search. The Ethics and Clinical Research Committee of the Hospital Universitari de Bellvitge approved this study (PR247/18).www.scholar.google.com; with search terms in English). These additional searches provided five new publications that met the inclusion criteria and the full-texts were reviewed.We identified 69 publications (32 duplicated in both databases). After removing duplicates, two researchers (AF and AB) screened the titles and abstracts, obtaining 32 studies. The inclusion criteria were quantitative research and inclusion of the TCS score(s) (as dependent or independent variable) in the analysis. We found 27 eligible publications . We compTherefore, we finally included 32 publications that used the TCS score(s) as a dependent or independent variable.® database were designed to extract and register the information from each publication. The evaluation protocol was developed by three researchers who are experts in tobacco control . The protocol describing the main objectives, information sources, search strategy and eligibility criteria, and the data collection was reviewed and approved by all researchers. All variables for which data were described in the publications’ Methods sections were listed.A detailed protocol and Microsoft AccessTwo reviewers independently extracted the data according to the protocol (AF and AB). If any discrepancies emerged, the reviewers discussed the papers until agreement was reached and, when no consensus was met, divergences were solved by discussing them with a third reviewer (CM). The evaluation process was conducted in January 2020.The extracted information included general characteristics, publication characteristics, research characteristics, and characteristics of the use of the TCS .The 32 publications were published between 2008 and 2019. More than two-thirds  were published by research groups from the Netherlands (n=8), Spain (n=9), and the United Kingdom (n=6). Almost all  were original articles published in peer-reviewed journals, 12 of which were Open Access (37.5%). In addition, almost all declared no conflicts of interest  and were financially supported  with public funds , both public and private funds , or private funds .Most of the publications (n=31) were observational studies; 16 used ecological data (50%) with the country as the unit of analysis and 16 used multilevel data (50%) with individual data from surveys as the first-level unit and TCS score by country as second-level aggregated information. Regarding the study design, 23 of the publications were crosssectional studies (78.6%). Most of the articles   included7; however, 46.9% of publications included scores from all EU Member states except Croatia because it was first included in 2013.Twelve out of 21 articles (60%) using individual TCS scores included all six policy components in the analysis. The most frequently used policy components were the individual score on bans in public places  and advertising bans . In contrast, the least used were data on public spending on information campaigns . The publications included data from between 1 and 31 countries; only one publication used scores from all of the countries included in the TCS report, including >30 EU and non-EU countriesHalf (n=16) of the publications were directed towards policymakers with the aim of urging governments to implement more stringent tobacco control policies, 6 publications aimed to foster further research on this topic (18.8%), and the conclusions of 10 papers (31.3%) addressed both aims.7, of hard-core and light smokers8, and of smoking in adolescents10; smoking prevalence and quit ratios11; consumption of rolling tobacco, e-cigarettes, and readiness to quit in adults12; and risk of lung cancer13. Other indicators were smoking in private venues14, self-reported exposure to secondhand smoke (SHS)17, and attitudes towards smoking and tobacco product restrictions21.Almost all of the studies that used the TCS reports as a primary source (n=22) , were ob22, the effects of sales restriction laws on adolescents23, and the factors associated with exposure to tobacco and e-cigarette advertising24. One study assessed the association between smoking prevalence and public sector corruption and other national characteristics25. The main characteristics and results of each article are given in Other publications were focused on exploring the association between the price of tobacco products and infant mortality27 and socio-economic inequalities outcomes in adolescents28 or adults over time31, or to examine political factors that drive tobacco control policy development32. According to the type of data, these publications were half ecological and half multilevel studies.As shown in 33 and providing an overview and comparing the tobacco control progress in Eastern Mediterranean countries34. The main characteristics and results of each study are shown in Two publications computed scores for nonEuropean countries to monitor their tobacco control policy implementation by using the same rationale and methodology. These publications were aimed at measuring the progress after implementation of the WHO-FCTC in Armenia35, except for the smoke-free policies4. Another limitation is that the countries’ rankings have only slightly changed over the years (i.e. the UK has remained in the top position from 2007 to 2016)4. This low variance across countries may reduce the robustness of the results of the studies10. Moreover, some studies reported that the information described by the TCS score(s) does not incorporate the most recent national legislation on tobacco control due to its cross-sectional design13, potentially underestimating the impact of such policies when using the TCS11.Only 11 (34.4%) of all publications included comments on the limitations of using the TCS score as a tool to assess tobacco control policies. The main limitations reported by the studies were that they failed to express the degree to which legislative policies are enforced34 because of potential error in the measurement of their estimates, and inadequate accuracy and comparability of the data33.Finally, among the studies not using data from the original TCS reports, the main limitations were that some policy areas could not be quantified accurately and that some of the policy components assessed by the TCS could not be includedOur results reveal that the TCS has been used mostly in observational, cross-sectional studies with either ecological  or multilevel data . The TCS score has been mainly used as an independent variable to explain the potential variation in outcomes , and mostly employed in European countries, as these countries were the target of the TCS when it was created.This is the first attempt to assess all of the available publications that have used the TCS as a means to measure tobacco control policy implementation since it was developed in 2006. In addition, this is the first study to map out the characteristics of the use of the TCS in scientific research, to understand how this tool has been applied despite its original design as a means to advocate for comprehensive tobacco control policies. Therefore, our findings suggest that the TCS has commonly been used as an indicator of the state of tobacco control policies in Europe.36.Almost all of the studies assessed tobacco control policies through the total TCS score, and most have used the policy components scores from the primary published reports. The policy components most commonly studied were public smoking bans and tobacco product advertising bans, possibly because they are two of the measures that have been most frequently regulated in Europe since the WHO-FCTC came into force in 20055 designed the scale to compare tobacco control policies across countries at a particular time point. Thus, the reference values for scores are sustained across each report. However, these scores are not comparable across years because these standards have changed over time 38; on the other hand, the scale methodology and scoring system changed between 2007 and 201039. Consequently, longitudinal studies to ensure temporal comparability between and within countries require adjusting scores to the highest standards by an escalation process and re-calculating scores from the 2005 and 2007 reports using the newest scoring system and methodology.Another important issue to address is the crosssectional and temporal comparability of the TCS because most of the studies make comparisons across countries and/or over time. Notably, Joossens and Raw32. Few non-European countries have adapted the scale as a proxy to monitor the status of tobacco control policies in non-European countries34. Unfortunately, most of these studies did not clearly explain how they adapted the TCS to estimate new score(s) for each policy component. Therefore, new studies should provide a full description of their adaptation process and the potential limitations and strengths not only to ensure its replication, but also to further develop strategies to adapt the TCS to other contexts overseas.Importantly, most of the studies with a longitudinal design conducted in Europe have adapted the scale rationale and methods to estimate the level of implementation of tobacco control policies to ensure the temporal comparability and include data about years for which the TCS had not been published41. MPOWER’s composite score has some clear advantages over the TCS total score because it is available for all countries, not only European countries, and is comparable over time. However, this proxy also has some disadvantages for research purposes. First, it assigns the same weight to each of the six individual MPOWER scores without taking into consideration that some MPOWER measures have been proven to be more effective than other measures (i.e. taxation). Second, MPOWER’s composite score has a narrower score range than the TCS score , which limits variation across countries and may make it difficult to address variability between countries. Finally, unlike the MPOWER composite score, the TCS score is not affected by the government’s political agenda, as the TCS is built on information from objective databases (i.e. Eurostat) and the Civil Society.These results highlight that the TCS, regardless of its limitations, has been applied as an objective indicator to measure the strength of the implementation of tobacco control policies at the country level. Other studies have used a total score obtained from summing the scores (from 1 to 5) assigned to each MPOWER policy dimension in the WHO’s Reports on the Global Tobacco Epidemic5 already reported some of its major limitations, including difficulties in assessing enforcement versus implementation and its critical dependence on tobacco control experts’ judgement when scoring5. Therefore, such underreporting of limitations makes it difficult to fully describe the limitations that researchers encounter, which is indispensable to moving forward in the field. Among the articles reporting limitations, most of them highlighted the fact that the TCS score(s) did not measure the enforcement of policies except smokefree policies. In this sense, no previous studies have examined the disparity between the implementation and enforcement of tobacco control policies; however, the TCS being predictive of so many outcomes suggests that the implementation of these policies is a good proxy of enforcement. In addition, some studies have questioned the ability of the TCS to incorporate new policies, such as smoke-free outdoor policies, indicating that the authors of the TCS should discuss how to incorporate these new tobacco control policies and which weight they should have in the scale.More than 65% of the reviewed publications did not report any limitation of the TCS as a proxy for measuring tobacco control policies. Nonetheless, Joossens and Raw13 with 54 citations and another paper23 with 103 citations (in Web of Science) up to December 2019.Moreover, our study shows that the TCS has been commonly used in Europe over the last decade, but three research groups from Spain, the Netherlands, and the UK account for more than half of the publications using the TCS for research purposes. This suggests that these groups have led and consolidated the use of this monitoring tool in the tobacco control research field. This is supported by the fact that the publications conducted by these three research groups have received a higher number of citations, including a paper5.More than half of all publications directed their conclusions towards advocacy for improving tobacco control policies. Therefore, most authors find the TCS useful for linking data to policy action, even though the TCS has been commonly used for research purposes. Therefore, the TCS has not lost its intended original purpose for advocacy, as it was developed to detect areas of improvement within each country and to establish comparisons among countries through a ranking, in order to motivate governments to strengthen their weakest polices5.Our results indicate that, despite its potential limitations and lack of a formal validity assessment, the TCS is a good proxy of the strength of tobacco control policies implementation, or at least the best approximation developed so far. However, the TCS has been used at face-value. No attempts have been made to formally validate the scale. Construct validity of the TCS is a complex issue given the composite structure of the TCS itself, though some dimensions are based on objective data (i.e. price and SHS exposure) from population-based surveys and reports of the European Commission; others are based on the answers of one or two informants to an ad hoc questionnaire 42. We searched the available literature in PubMed, the main biomedical database, as well as Web of Science and Google Scholar, and checked all references to identify other articles not published in academic journals. However, the possibility that unpublished manuscripts or other documents addressing the topic of interest may have been missed cannot be ruled out, but it was an a priori decision made by the experienced research team that was composed of tobacco control and policy experts, including the author of the TCS. Under these circumstances, selection (publication) bias seems unlikely to have affected the study.Publication bias is a potential source of error when the units of the investigation are published papersOther potential limitations of our study are linked to the fact that a high number of the publications analyzed here did not include any comment about the limitations and strengths of using TCS scores as a variable to monitor tobacco control policy implementation in research. This missed reporting has hindered the identification of the main limitations and strengths of this tool for different types of study designs, outcomes, or statistical analysis; therefore, our study may have some missing information.However, our study is the first to assess all published articles using the TCS as an indicator of tobacco control policy implementation and to characterize its use in tobacco control research, giving a full and comprehensive overview of how and for which purposes the TCS has been employed in previous studies. This study also presents information on how to best use the TCS as described by the authors in the Limitations sections of the publications. Thus, our study presents the lessons learned from previous research, creating an opportunity for researchers to plan to use the TCS to improve the quality of future studies.This study shows that the TCS has been commonly used in observational, mostly ecological, studies to assess variations in a concrete outcome according to the policies instituted in Europe as a proxy of tobacco control implementation. In addition, the TCS has been employed to detect changes in individual and population outcomes  and establish conclusions about how policies have an effect in specific populations.Our recommendations to researchers and policymakers planning to use the TCS in their future research are as follows. First, the TCS scoring methodology needs to be fully understood, as comparability is not ensured among countries across years. Second, researchers should consider a certain time gap between measuring the TCS score and the outcomes, as the TCS may not include the most recently adopted policies and policies need time to have an effect. Third, knowing the limitations of the TCS in measuring implementation (vs enforcement) of tobacco control policies is important. Fourth, researchers need to take into account the low variance of some tobacco control policies across countries, which may also reduce the robustness of the estimates.A logical next step for future applications of the TCS in research would be to study the impact of tobacco control policy enforcement in terms of several indicators, such as prevalence, SHS, and tobacco sales, and to assess the impact of these policies at the population level. To achieve this goal, more extensive cross-country population-based surveys are needed to include new enforcement measures in future editions of the TCS .Finally, to gain a broader perspective of tobacco control as a public health need and build a stronger tool for tobacco research, we suggest adapting and extending the TCS to other countries of the WHO European Region, and to the reality of other regions of the globe, such as Latin America or Asia, incorporating local and cultural characteristics of these regions while preserving the comparability among countries worldwide.The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported.AF, MF, CM, and EF were supported by the Ministry of Research and Universities from the Government of Catalonia [2017SGR319]. EF was also supported by the Instituto de Salud Carlos III, Government of Spain, co-funded by the European Regional Development Fund (FEDER) [INT16/00211 and INT17/00103]. CM was also supported by the Instituto de Salud Carlos III, Government of Spain, co-funded by the European Regional Development Fund (FEDER) [INT17/00116] and Ministry of Health from the Government of Catalonia [PERIS No. 9015586920/2017]. We thank CERCA Programme/Generalitat de Catalunya for institutional support.Study design: AF, AB, CM, and EF. Collected data and prepared database for analysis: AF and AB. Contributed to strategy of analysis: AF, AB, CM, and EF. Analyzed data: AF. Interpreted data results: AF, AB, CM, LJ, MF, AP, and EF. Drafted manuscript: AF. Critically revised manuscript: All authors. Approved final manuscript version: All authors. Guarantors: EF and CM.Not commissioned; externally peer reviewed.


The collapse of a country’s economy can have significant impacts on the health and healthcare infrastructure of the country. This paper compares the collapse of three national economies from widely separated regions: Venezuela, Zimbabwe, and the countries of the former Soviet Union. Despite significant differences in the environments and cultures of these countries, there are some common variables and outcomes shared by most of the countries including effects on healthcare workforce, disproportionate effects on marginalized populations, and resurgence of certain infectious diseases. It is a truism to state that an economic collapse at the national, regional, or international level can directly affect the public’s health. However, the effects in different countries are rarely uniform and often the opposite of what observers might expect. As an example of an unexpected outcome, mortality rates in the United States declined during the Great Depression . ObserveThere are numerous examples of such consequences, many of them associated with conflict and its effects on the local and national economies. An example of the deleterious effects on the public health workforce is provided by the twenty-year insurgency from 1986 to 2006 in parts of Uganda. During that time, the majority of healthcare workers in affected parts of Uganda fled the country. Those who remained were often traumatized to the point of having great difficulty in performing their jobs . Similar® and Academic Search Complete, an EBSCO host product housed in the Missouri State University Library system. In each system, the following words or word groups were used to search for appropriate literature: “economic collapse” and “public health”. These words were used in combination with the names of the three countries of interest: Zimbabwe, Venezuela, and the Soviet Union (or USSR). These countries were chosen because they exemplified very large economic crises but were each on separate continents and were very different in culture and ethnicity. Selected publications were limited to those from the last ten years from the date of the search, though a couple of older publications were used to provide some historical background on the Soviet system. This narrative review of the literature used two primary sources for access to the literature regarding the effects of economic collapse on public health: PubMed CentralThe economic collapse of the Soviet Union (USSR) probably started in the late 1980s, but the breakup of the USSR government in 1991 worsened the situation for the emerging countries left after the dissolution . In RussSoviet Russia utilized the Semashko healthcare system that was socialist in structure, with a centralized and hierarchical structure that provided health care to all citizens. It was particularly successful in addressing infectious disease, but by the 1980s the quality of care was considered low, with shortages of medical equipment, drugs, and supplies for diagnostics. Training of medical personnel was considered mediocre and pay was poor. Soviet physicians earned only 70% of the income of an average non-farm worker in that country [A detailed analysis of one rural area in Russia provides some idea of the impact both the economic collapse and the political dissolution caused in such communities. Chukotka is a region of the Russian Federation in the north-eastern side of the country; about half of it lies within the Arctic Circle . During In short, Chukotka suffered an economic collapse after the breakup of the Soviet Union that resulted in large demographic changes and resultant degradation of the public health situation. Due to improvements in governance , the ecoResults across the various former republics varied, but in Central Asia, the transition for the centralized Soviet system to smaller national systems was very difficult. The Central Asian Post Soviet (CAPS) countries experienced a reduction in gross domestic product of between 33% and 60% [Prior to the collapse, the Soviet healthcare system had been known for inefficiency and neglect; however, it was able to achieve a steady decline in the rates of tuberculosis. There were specialist tuberculosis hospitals and dispensaries across the USSR that were effective at diagnosing and treating the disease. After the demise of the USSR, some countries were able to make a transition to health insurance and general practice with increased out-of-pocket payment . HoweverIn general, the reconstruction of national health systems during the economic collapse concurrent with the demise of the Soviet Union provided unique challenges to the emerging governments. These challenges varied by country, but those countries that maintained sufficient disease surveillance and monitoring programs were more likely to be able to mitigate the public health effects of the economic collapse. Of course, this observation could be explained by the possibility that those countries that were better situated to maintain surveillance were wealthier and so better able to weather the economic situation. Nevertheless, some of the emerging nations ignored the importance of drug-resistant tuberculosis and other emerging diseases, and this resulted in a significant public health crisis in much of the former Soviet Union, most notably in the prison systems.After independence in 1980, Zimbabwe’s economy eventually went into a long decline, but a precipitous economic collapse occurred between 2000 and 2009. By 2008, the country suffered hyperinflation of up to 500 billion percent which destroyed the local currency [Several government policies contributed to the severity of the economic collapse including land re-distribution practices, unstable currency policy, and government price controls . AccordiThe economic collapse led to a variety of changes and adaptations by the populace to provide income; the sex trade was one industry that was greatly affected. At least some of these changes led to greater risk to women involved in the trade, and it probably led to a greater number of women involved as well. Female sex workers had always been disproportionately affected by the HIV/AIDS epidemic and this continued during the crisis years in Zimbabwe. What did change was an increase in “transactional sex” as opposed to “commercial sex” . The difAs with other countries undergoing economic collapse, Zimbabwe experienced a resurgence in TB. Since the onset of the HIV/AIDS pandemic, it has become very difficult to separate these two phenomena, especially in times of crisis, but TB incidence increased by 35% in 2008 when compared to a baseline from 2003–2007 . In ZimbThe economic collapse also affected the availability of healthcare as a result of deleterious changes to the healthcare workforce . An asseIn November of 2019, Reporter C.K. Carugo wrote the article “My Socialist Hell: Living in Post-Electricity Venezuela” and stated that 20-years of the “Bolivarian Revolution” had resulted in long-term underinvestment in the electrical power infrastructure in Venezuela, leading to blackouts for the entire country . Lack ofThese two news reports are not peer-reviewed nor confirmed by government sources and at least one was posted on a highly partisan site. However, the PRO-MED website, an internet-based reporting system disseminating information about outbreaks of emerging infectious diseases, also reported a national epidemic of malaria as well as outbreaks of diphtheria, trypanosomiasis, pertussis, nosocomial chickenpox, cholera, and rabies. Reports of such diseases are not unexpected given that Venezuela is a tropical country, but there is little doubt that the current economic situation in that country has contributed to a public health disaster. That disaster has been called a “humanitarian crisis of post-war dimensions” .Political perspectives influence descriptions of what caused the economic collapse. The populist policies of Hugo Chavez and his successor, Nicolas Maduro, have been blamed by many for the economic situation. The economic collapse had become obvious by 2014 and has continued into the present. Specific causes may include an over-reliance on petroleum during a world-wide reduction in oil prices, and reckless public financing followed by irresponsible printing of money that led to massive public debt, overvalued currency, and inflation. However, some variables existed before the populist revolution led by Hugo. Corruption has been an issue in Venezuela for many years. Lack of access to healthcare, education, and housing was also important. As the situation worsened, external investors and donors withdrew their money and the collapse occurred throughout the nation . An impoReduviidae). It is a disease that thrives in tropical environments where the mammalian reservoirs live. Those reservoirs include rodents, opossums, bats, and other mammals. In Venezuela, Chagas disease has emerged in an urban form in the Caracas valley, which includes the nation’s capital, Caracas [American trypanosomiasis (or Chagas disease) is a parasitic disease spread from zoonotic reservoirs to humans by the cone-nosed bugs  and social protection  . These aMost of the countries described here have progressed through a degree of recovery. For many of the countries of the former Soviet Union, this required a transition from a centralized economy with a centralized healthcare system to a variety of systems, some involving insurance schemes and others national health systems or both. Observers suggest that such transitions require an investment in health systems even while realizing the reduced availability of capital. They also recommend welfare-to-work programs and a renewed focus on education. The economic crises and the responses that each of these countries went through are not necessarily unique to those counties, so the common themes discussed here may have applications to other countries experiencing economic crises.


This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targeted Client Communication (TCC) via short message service (SMS) to clients. The aim is to assess the effectiveness of the automated communication strategies from the eRegistry on improving attendance and quality of care for pregnant women.This four-arm cluster randomized controlled trial will be conducted in the West Bank and the Gaza Strip, Palestine, and includes 138 clusters  enrolling from 45 to 3000 pregnancies per year. The intervention tools are the QID and the TCC via SMS, automated from the eRegistry built on the District Health Information Software 2 (DHIS2) Tracker. The primary outcomes are appropriate screening and management of anemia, hypertension, and diabetes during pregnancy and timely attendance to antenatal care. Primary analysis, at the individual level taking the design effect of the clustering into account, will be done as intention-to-treat.This trial, embedded in the implementation of the eRegistry in Palestine, will inform the use of digital health interventions as a health systems strengthening approach.ISRCTN10520687. Registered on 18 October 2018ISRCTN Registry,  Scale up of effective, high-quality interventions is essential in order to reach the Sustainable Development Goals and achieve Universal Health Coverage in maternal and child healthcare , 2. AnteCountries can improve healthcare systems by exploiting the potential of digital technology. Digital health information systems with individual-level data and mobile technologies are expanding globally and provide an opportunity to support, involve, and influence healthcare providers and their clients’ behavior –7. HowevAudit and feedback, widely used quality improvement interventions, allow healthcare providers to assess and adjust their performance and, as a result, improve the quality of the care they deliver , 10. AudDigital Targeted Client Communication (TCC) can utilize data, such as demographic characteristics and health status, to tailor communications to an individual’s specific needs if good-quality individual-level data are available , 19. ShoThe total population in Palestine is 4.17 million, 2.58 million (62%) in the West Bank and 1.59 million (38%) in the Gaza Strip . There aMCH is an important area in the Palestinian healthcare system, and gestational anemia, hypertensive disorders of pregnancy, gestational diabetes mellitus, and fetal growth restriction are identified as priority conditions for prevention . ApproxiThe routine governmental documentation tool for ANC and PPC in Palestine is the eRegistry built on the District Health Information Software 2 (DHIS2) Tracker . The eReThe eRegistry in Palestine provides clinical decision support based on national guidelines, including referral recommendations. It creates longitudinal pregnancy records and removes the need for secondary data reporting or manual aggregation for reporting. The eRegistry’s comprehensive information gathered in a continuous fashion allows TCC via SMS to clients and QID for healthcare providers, but the effectiveness is unknown.Quality Improvement Dashboard (QID) on improving appropriate screening and management for anemia, hypertension, and diabetes during pregnancy by the healthcare providerTargeted Client Communication (TCC) on improving timely attendance to ANC by the womanQiD and TCC interventions combined on the measures described aboveThe primary objectives of the eRegCom cluster randomized controlled trial (CRCT) are, compared to the basic eRegistry functionalities in public MCH PHCs in Palestine, to estimate the effectiveness of the eRegistry’s:We will also estimate the effectiveness across equity measures and, in a sub-sample, assess the effect of the TCC intervention on pregnant women’s worries and perceptions of ANC, including the quality of care and information received from the health system Fig. .Fig. 1.This CRCT is a superiority trial with four parallel arms . The unit of randomization is an individual PHC, with the exception of two clusters. These two clusters include two PHCs each, where the pair of PHCs is served by the same healthcare provider.The most common organizational structure in the public maternal and child healthcare system in Palestine includes two healthcare providers per clinic, mainly midwives, nurses, and/or community health workers, in addition to a doctor serving several clinics. Each user in the governmental eRegistry has a unique username and password, which enable access to records and specific system features according to their assigned role. The woman’s personal ID number is used to create an electronic ANC record for her pregnancy. The sociodemographic, obstetric, and medical information including clinical tests, laboratory, and ultrasound measurement results are entered into the eRegistry at point-of-care. The data trigger different digital health interventions such as the guideline-based clinical decision support and automated public health reports. Women identified with certain risk factors are referred for additional management, and their records are available in the so-called high-risk clinics after referral .All public PHCs offering ANC and PPC services using the eRegistry were eligible for the study. PHCs that enrolled less than 45 or more than 3000 new pregnancies in 2016 were excluded. No exclusion criteria were made based on individual healthcare provider’s or pregnant women’s characteristics  were eligible for randomization. They enrolled a mean of 344 and a median of 131 new pregnant women in 2016  cycles . HealthcThe QID includes four tabs for each focus area, namely anemia, hypertension, diabetes, and attendance. Healthcare providers are given a new focus area every week through a message in the eRegistry that congratulates a good performing PHC or presents an evidence-based statement on the week’s focus area. Each tab contains performance indicators calculated from data entered at point-of-care. The indicators are presented as an average over the last 3 months, in both tables and graphs, and benchmarked with clinics within the district. The clinic’s performance level—defined as an index of the absolute and relative values of an overall screening and an overall management indicator—drives the appropriate action items for each focus area. Two screening and two management action items that include recommendations for improvement are presented in colors  with monthly updates  and the utilization of care (comparison 2) to assess the effective coverage. For example for anemia, it is the proportion of all timely routine ANC visits where anemia should have been screened for and/or managed, where the woman attended and anemia was appropriately screened for and/or managed.We will assess the effects of the interventions on the primary outcomes across equity measures used in routine statistics in Palestine. The data points include average monthly household incomes , mother’s years of education , age at marriage , and age at first pregnancy .We will assess the proportion of women receiving appropriate screening and appropriate management separately at each visit for anemia, hypertension, and diabetes. We will also measure the retention rate from ANC to PPC and timely screening and management of fetal growth. The data entry in the eRegistry is continuous and the randomization permanent, which enable the analysis of overall health outcomes in a continuous and longitudinal manner for each individual woman. We might assess other outcomes if the intervention(s) shows an effect.Care providers in PHCs randomized to the TCC intervention have had the opportunity to register pregnant women to the text message service since June 2019. Care providers in PHC randomized to the QID intervention received access to the QID December 2019. We expect to reach the target sample size after approximately 6 months Fig. .Fig. 4SSample size calculations for the primary outcomes were performed in STATA “clustersampsi” . We estimated the minimum detectable difference for comparison of each intervention arm with the control arm without assuming the effect of multiple comparison (using a single control to each intervention arm). The control prevalence for the primary outcome, using data from the eRegQual CRCT, ranged from 30 to 85% for comparison I (QID vs control) and from 34 to 53% for comparison II (TCC vs control) (unpublished results). The 138 eligible clusters have an average of 172 new pregnancies per 6 months (ranging from 23 to 1500) and a 1.69 coefficient of variation of cluster size (2016 data). We assumed a priori intra-cluster correlation coefficient (ICC) of 0.05 and set the statistical significance level to 5%. We are 80% powered to detect an estimated relative 50% increase for the outcomes with the smallest control prevalence .PHCs that fulfilled the recruitment criteria were randomized to one of the four arms. Healthcare providers working in PHCs randomized to one or both of the interventions received training as described the “” sectionNo financial or non-financial incentives are or will be provided to the woman, public health officers, or healthcare providers at the PHCs included in the trial.Statisticians at the Center for Intervention Science in Maternal and Child Health (CISMAC), University of Bergen, Norway, performed the randomization independently without any influence from the research team.PHCs were allocated to the TCC intervention, QID intervention, TCC and QID intervention, or control group with an equally 1:1:1:1 randomization ratio. The randomization was stratified by the point in time the eRegistry was implemented, and constrained on laboratory availability, ultrasound availability, and the size of the PHC.In total, 10,000 randomization allocations were generated. The 10% best and balanced allocations with the least differences between the arms for the given covariates were identified, and one of these allocations were randomly selected for the trial .Healthcare providers and women attending care at PHCs included in the trial are blinded to the outcome measures. Women are expected to be blinded to the allocation of the QID intervention, but not to the TCC intervention due to the nature of the intervention. Healthcare providers are not blinded to the allocation of any intervention.Data will be extracted from the eRegistry and transformed to anonymous datasets by blinded data analysts at PNIPH. Allocation codes will be generated for each primary outcome separately . Our independent trial monitors (CISMAC) will keep the codes, which will be provided as allocation groups  for each set of outcomes after the completion of analyses.Healthcare providers will routinely and continuously enter data in the eRegistry during patient care, and all outcomes are informed by secondary data. Anonymous data will be extracted from the eRegistry in accordance with the standard operating procedure (SOP) of the Palestinian maternal and child health eRegistry for routine registry operations and use of data for research purposes.The data in the eRegistry will be managed in accordance with the governance structure approved by the Palestinian MoH. Only pre-defined anonymous data needed for the outcomes will be extracted from the eRegistry by PNIPH staff for this trial. The pre-defined anonymous original dataset will be provided to the trial sponsors and to our independent trial monitors (CISMAC), for independent monitoring and safeguarding.p < 0.05. Appropriate bivariate and multivariate regression analyses will be performed. The regression analyses will take the design effect of the clustering into account and enable adjustment for any relevant variables not accounted for during randomization. We will do complete case analyses and consider appropriate imputations for missing data. We will present cluster-wise effects of the intervention to explore whether a disproportionately large part of the effect can be ascribed to extreme effects in a few large clusters. The interaction effect of the two interventions will be performed as a secondary analysis. We will conduct per-protocol analyses in cases of protocol violations, including withdrawal of the eRegistry, and data from these clusters will be excluded from the time of violation when appropriate. Data will be analyzed using the latest version of STATA .Intention-to-treat analysis will be performed for the primary outcomes to compare each independent intervention arms  with the control, using individual-level data taking the design effect of the clustering into account. Descriptive statistics will be reported, and appropriate tests will be used to compare variables between the groups. Statistical significance will be set at Data management and monitoring will be done in accordance with the SOP of the Palestinian maternal and child health eRegistry for routine registry operations. We have not designated a Data and Safety Monitoring Committee, due to the lack of potential significant harm, nor an Endpoint Adjudication Committee, since we will not use any subjective clinical data for outcome measures.This CRCT only utilizes the moment of opportunity of an ongoing implementation to study new digital interventions in a health systems approach. No potential for clinically significant harm has been identified during the development and implementation of this trial. Potential discomfort from worries may occur among women attending ANC in clusters receiving the TCC intervention, and this will be examined in a sub-sample Fig. .Data confidentiality will be handled in accordance with the Palestinian MoH’s legal framework for maternal and child health electronic registries. This CRCT will only utilize anonymous data to enable the assessment of the effectiveness of the interventions. We will publish only aggregate data, and no data on individual clients, care providers, or identifiable clusters will be published.The data in the eRegistry belong to the Palestinian MoH, and the researchers will not have access to the entire registry or identifiable data of any kind. We will not publish the full data set as our legal rights to the data is limited to this analysis, and the richness of data would allow for several other analyses for which there is no ethics approval or approval from the Palestinian MoH. We will, however, publish syntaxes needed to recreate the data set from the eRegistry.This protocol follows the Standard Protocol Items: Recommendations for Intervention trials (SPIRIT) guidelines. A formal revision of the protocol will be done if the change can affect the study’s nature. The sponsors and our independent trial monitors (CISMAC) will have to agree on the revision, which will require renewed approvals from both the ethic committee in Norway and in Palestine, and the Palestinian health authorities. We will inform all users and stakeholders and publish the results of the CRCT in peer-reviewed open-access journals according to the Consolidating Standards of Reporting Trials (CONSORT) guidelines and the mHealth Evidence Reporting and Assessment (mERA) checklist. Results will also be presented at scientific meetings and congresses and to the Palestinian MoH directly. With permission from the MoH, we will inform all participating PHC and their staff directly. We will acknowledge any change in the study outcomes, study design, sample sizes, or significant administrative aspects that will impact the study’s nature when disseminating the findings. Authorship will be in line with the recommendations of the International Committee of Medical Journal Editors. Summaries of the results and other relevant information will be published on the eRegistries website.We have designed a multi-arm CRCT with two digital health interventions, namely the QID for healthcare providers and TCC sent via SMS to pregnant women. The eRegistry employs the collection and use of systematic, uniform, and longitudinally entered routine clinical data, in algorithms that instantly drive these digital health interventions . The QIDRoutine data from the eRegistry in Palestine demonstrates that both quality of care and utilization of care have significant room for improvement, and both need to be addressed to achieve a high effective coverage. To ensure healthy lives and promote well-being for all at all ages , data and digital health are highlighted as accelerators . Our intWe used the Principles for Digital Development  and a huOur experience from the pilot data collection and a recent time-motion study  is that One or two healthcare providers per PHC is the most common organizational structure in Palestine, but some healthcare providers may work or be relievers in more than one clinic. Healthcare providers working in both TCC intervention and control PHCs will receive the TCC training, but they can only register women to receive text messages from the TCC intervention PHC. Healthcare providers working in both QID intervention and control PHCs will not receive the QID training, and therefore not the full intervention. This is to avoid contamination, as the action needed to improve care can be done from any PHC without the QID tool itself. Even though very few PHCs in the trial are operated by the same healthcare provider, this may potentially lead to an underestimation of the effectiveness.Other limitations of this trial include the cadres of healthcare professions we target, which is only nurses, midwives, and community health workers. We exclude doctors, due to the risk of contamination as they work in several PHCs. However, we acknowledge that doctors play a significant role in the care for pregnant women. Our outcomes are dependent on the completeness of documentation by the healthcare provider, as our data source, the eRegistry, is the routine governmental documentation tool with few required data points. In order for the clusters to have comparable opportunities to succeed or fail, when it comes to management, we only include the first step in the management algorithm for our primary outcomes. For example, women with mild and moderate anemia, a new hemoglobin result after 4 weeks, will be counted as a success, without taking into account the response to that result. However, we will assess the total management chain in the secondary analysis.We work closely with the Palestinian MoH to mitigate the risk of changes to the PHCs’ activities and staff during the trial. A key aspect of the work with eRegistries is to facilitate the uptake of the evidence-based findings in other countries and promote our digital interventions as “Global Public Goods” . The eReThe CRCT began recruiting on 1 December 2019, and we expect to reach the target sample size after 6 months, approximately 1 June 2020. Protocol version 2—April 2020.Additional file 1. List of participating clinics and allocationAdditional file 2. Oral informed consent and interview guide


The process of aging commonly features a gradual deterioration in cognitive performance and, in particular, the decline of memory. Despite the increased longevity of the world’s population, the prevalence of neurodegenerative conditions, such as dementia, continues to be a major burden on public health, and consequently, the latest research has been focused on memory and aging. Currently, the failure of episodic and Prospective memory (PM) is one of the main complaints in the elderly, considered among the early symptoms of dementia. It is therefore increasingly important to define more clearly the boundaries between normal and pathological aging. Recently, researchers have begun to build and apply Virtual Environments (VE) to the explicit purpose of better understanding the performance of episodic and PM in complex and realistic contexts, with the perspective of further developing effective training procedures that depend on reliable cognitive assessment methods. Virtual technology offers higher levels of realism than “pen and paper” testing and at the same time more experimental control than naturalistic settings. In this mini-review article, we examine the outcomes of recently available studies on virtual reality technology applications developed for the assessment and improvement of episodic and/or PM. To consider the latest technology, we selected 29 articles that have been published in the last 10 years. These documents show that VR-based technologies can provide a valid basis for screening and treatment and, through increased sensory stimulation and enriched environments reproducing the scenarios of everyday life, could represent effective stimulating experiences even in pathological aging. Memory has been for centuries an intriguing field of brain research since it is a biologically essential function to the survival of almost all species , Mild Cognitive Impairment (MCI), Parkinson’s Disease (PD), as well as other dementias  that evaluates memory consolidation by interacting with an enriched everyday environment, which guarantees both laboratory analytical control and precise assessments of how memory and other cognitive processes operate. The main goal of VR is to allow the patient to undertake specific tasks through artificial sensory stimulation and the illusion of being in an interactive environment perceived as a real place  systems on desktop computers to fully immersive systems. This distinction is based on how much the user can perceive the outside world during the virtual simulation LaValle, . The fulIn this review article, we aimed to explore the most recent evidence about the ability to evaluate EM and PM, as well as to stimulate improvements in both normal and pathological aging, through representative and significant examples of applications in VR.Initially, a systematic online bibliography search was carried out through the following profile databases: Web of Knowledge, ScienceDirect, PubMed, and Google Scholar, on the date of June 2019. We used the following core search terms and their combinations: VR or virtual environment, prospective memory or PM, EM or EM; and the following as additional search terms with “Xor” combinations: assessment, cognitive training, aging, pathological aging, cognitive impairment. Also, to get a broader and more complete view of the topic we have included studies on young adult subjects. Second, a selection of relevant articles was limited to the period 2009–2019 to obtain information mainly about outcomes referring to the latest technology.The references selected were included in the review in case the following criteria were met as shown in Within Virtual Environments (VE), participants can be immersed in scenarios that represent different everyday situations such as virtual apartments  in both young and old groups were obtained only in the conditions of choosing the route and low navigation control. This suggests that EM performance benefits from multimodal coding, through the enrichment of motor interaction and that it has been improved by active navigation when it is not too expensive in terms of attention efforts. According to some authors  and neuroimaging (fNIRS/EEG) that can be considered valuable and indispensable tools to increase the benefits of VR. This perspective could provide a more targeted approach to neuro-training and will be the core of future research on the field.AR and GG conducted the search and selection of bibliography. VR designed and directed the project. AR, GG, PS, and VR wrote the manuscript. 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.


Understanding marketing strategies and price competition among manufacturers is essential to manage health care expenditures, particularly those related to blockbuster drugs.To assess marketing and pricing strategies of blockbuster drugs in South Korea.Baseline information on manufacturers who were granted marketing approval for choline alfoscerate in various forms was retrieved. Accumulation of manufacturers in the market was also identified, and manufacturers were categorized into first movers and latecomers based on their marketing time. Then, an event history analysis and a regression analysis were applied to estimate the duration of marketing and their price competition.Currently, 109, 83, and 26 manufacturers produce choline alfoscerate in capsule, tablet, or syrup form, respectively, indicating that many manufacturers have marketed generics and the majority of the generics are categorized as latecomers. The size of the manufacturer was a significant factor in marketing new medicines, while the variable was not related to the marketing of modified drugs. Furthermore, price competition in the market was rare and only a few major firms initiated price competition.The Korean market appears to be an example of perfect competition when we focus on the number of manufacturers. However, the market is near-monopolistic when examining the price of generic drugs. While product competition between different forms of drugs is effective in lowering price, product competition within the same form of a drug does not exist in the market. Competition in the health sector is an important and contentious issue , and phaContaining health expenditure has been a policy priority in high-income countries  as well This study is interested in the lack of price competition among generics, which is another type of market failure for pharmaceuticals. It is well documented that incentives to lower maximum allowance prices of generics do not exist in the South Korean market . FurtherIn this context, this study has two aims. First, we trace the manufacturers of generics who have entered the market, sort the manufacturers into first movers and latecomers, analyze their accumulation in the market, calculate the duration between the date of marketing approval for the first drug and the remaining generics, and then perform an event history analysis to determine a statistical estimation of duration. Second, we retrieve price information with respect to the identified drug and apply a regression model to assess price competition among manufacturers.To this end, we selected choline alfoscerate as the subject of this study. Choline alfoscerate is a semisynthetic derivative of phosphatidylcholine, a drug that has been determined to improve cognitive deficit and facilitate learning and memory for patients with Alzheimer’s disease . In SoutWe are interested in the market competition of manufacturers who were granted marketing approval for choline alfoscerate in various forms by the Ministry of Food and Drug Safety (MFDS) in South Korea from 2005 to 2019. Choline alfoscerate is currently available on the market in three forms, capsule, tablet, and syrup. Thus, all three forms of choline alfoscerate are included in this study.1. We selected drugs containing choline alfoscerate 400 mg as the generic name of the drug and then collected information regarding their unit price and manufacturers.Similar to the FDA, the MFDS constructs a publicly available dataset that provides information regarding approved drugs, including the generic and proprietary name of the drug, the date of marketing approval, and the manufacturers of the drug2 (HIRA). Using this source allowed us to observe price changes of certain drugs. Information regarding manufacturers was obtained from two sources. First, to collect information on manufacturers and understand the financial resources of the companies that conduct external audits, we used KISVALUE, an analytical dataset. Using these data, we categorized the manufacturers into major-, medium-, and small-sized manufacturers. Second, we retrieved documents from the Ministry of Health and Welfare website to identify manufacturers designated as innovative manufacturers3. In this study, we used the variable “innovative manufacturer” as a proxy for the capabilities of manufacturers in the areas of research and development . Statistical significance is denoted by The same information regarding the tablet and syrup forms of choline alfoscerate is calculated. Specifically, we found the 25% of the manufacturers were categorized as first movers of choline alfoscerate in tablet form and that approximately 44, 16, and 18% of manufacturers among the major-, medium-, and small-sized manufacturers, respectively, were categorized as first movers of choline alfoscerate in tablet form. Similarly, 41 and 21% of manufacturers among innovative manufacturers and non-innovative manufacturers, respectively, were categorized as first movers of the drugs. Drugs in syrup form could not be categorized into first movers and latecomers due to their more recent marketing, which occurred on 29 March 2019.This study presents several interesting findings. First, we reaffirmed that many manufacturers have marketed generics in the South Korean market and that the majority of the generics are categorized as latecomers. For example, while 218 choline alfoscerate drugs are currently available on the market, 88% of the choline alfoscerate drugs in capsule form are categorized as latecomers. Second, manufacturers exhibit different behaviors when marketing the various forms of the drug. For example, choline alfoscerate in capsule form is a new drug in the market, whereas the drug in tablet form is a modified drug that improves the method of storage and the method of taking the drug. Furthermore, we captured different results in the marketing of new and modified drugs in our event history analysis. For example, we found that the size of the manufacturer was a significant factor in marketing new medicines, while this variable was not related to the marketing of modified drugs. Finally, by analyzing price competition among manufacturers in the South Korean market, we confirmed that price competition in the market was rare and that only a few major firms initiated weak price competition.The classic economic theory of perfect competition assumes a market in which products are fully homogeneous, consumers are price takers, and no entry or exit barriers exist for the many manufacturers . FurtherWe observed contrasting trends in the South Korean market, a market that appears to be an example of perfect competition when we focus on the number of manufacturers. However, the market is more monopolistic or near-monopolistic when examining the price of generic drugs. The price of the majority of generic drugs adheres to the maximum allowance price. While some may argue that the maximum allowance price is a marginal cost in a perfect competitive market, the price of drugs in South Korea, particularly the price for generic drugs, is higher than the price in other high-income countries . TherefoThis gives rise to the question, “What is the role of latecomers in the South Korean market?” Product competition based on quality differentiation provides some clues to understanding the market. In a market with product competition, manufacturers attempt to differentiate their products and become more competitive based on their quality rather than on their price . In otheIn this study, we confirmed the existence of product competition in the South Korean market, and as such, the various manufacturers who produce choline alfoscerate differentiate their products. For example, choline alfoscerate was first available on the market in 2005 in capsule form. However, because drugs in capsule form are vulnerable to humidity and high temperatures, they are press packaged, which is less convenient for distribution and storage than bottle packaging . FurtherA regression model revealed a consistent result regarding product competition and its effects on price. While choline alfoscerate in syrup form, which is a newly modified drug, was significantly more expensive than the drug in capsule form, the drug in tablet form was not significantly more expensive than the drug in capsule form. The difference between the drug in syrup form and the drug in tablet form could be explained by the characteristics of the drug itself. The drug in tablet form, which was marketed in 2013, is no longer considered a newly modified drug on the market.However, product competition does not fully explain the South Korean market. More specifically, while product competition between different forms of drugs is effective in lowering drug price, product competition within the same form of a drug does not exist in the market. As previously explained, price competition within the same form is rare in the South Korean market, and unless policies are established to introduce competition in response to these issues, we may continue to see cases of a number of high-priced generic drugs in the market.Policies to expand generic penetration could be enacted to address the issue . We demoSecond, entry barriers or exit strategies would be created to manage the number of generic drugs. Currently, coorganized bioequivalence tests (coorganized tests) among generic manufacturers and original equipment manufacturers (OEMs) have been authorized in the marketing of generic drugs since November 2011 . Thus, eThird, to consolidate the market power or intervene in market with a number of manufactures, merging with other manufacturers is a recommendation worthy of consideration . For insThis study has some limitations. First, we selected choline alfoscerate to understand market dynamics in South Korea, indicating that findings from this study may not be generalizable to other drugs. However, similar trends were observed in other studies . Second,Many manufacturers have marketed generics in the South Korean market and that the majority of the generics are categorized as latecomers. Thus, the cumulative number of generics on the South Korean market is extraordinary when compared to other high-income countries, where fewer than 20 generic drugs are paired with the original. The Korean market appears to be an example of perfect competition when we focus on the number of manufacturers. However, the market is near-monopolistic when examining the price of generic drugs. The price of the majority of generic drugs adheres to the maximum allowance price. While product competition between different forms of drugs is effective in lowering price, product competition within the same form of drugs does not exist in the market. Policies to expand generic penetration, to establish entry barriers, and to consolidate the market power could be enacted to address the issue.https://nedrug.mfds.go. kr/pbp/CCBGA01/getItem?infoName=%ED%97%88%EA%B0 %80&totalPages=4&limit=10&searchYn=true&page=1&&open DataInfoSeq=7, https://biz.hira.or.kr/popup.ndo?formname=qya_bizcom%3A%3AInfoBank.xfdl&framename=InfoBank.Publicly available datasets were analyzed in this study. These data can be found here: JP and K-BS developed the concept of the manuscript and undertook the analysis. All the authors were involved with developing and refining the manuscript and approved the final draft before submission.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.