Prevalence,pattern,magnitude and associated factors of trauma in the Emergency Department at Health Institutes in Ethiopia: A systematic review

Abstract

BACKGROUND:

Trauma is one of the important public health problems that causes significant economic and social crisis with more than 10% of all disease cases are associated with it. We aimed to identify and describe the prevalence, patterns, magnitude and associated factors of trauma in the Emergency Department at Health Institute in Ethiopia.

METHODS:

In this systematic review, we searched for peer-reviewed and grey literature publications reporting the prevalence, pattern, magnitude and associated factors of trauma between 2000 and 2019. The documents which recruited are directly related to trauma and emergency department. In this regard, we searched databases of PubMed, Elsevier, Science directed, MEDLINE, and Google scholar by using Google as searching engine. Furthermore, publication with secondary data and not in English was excluded.

FINDINGS:

A total of 9,768 injured participants were included in the studies, of which 71.2% (6950) were males. Among the injured participants, 53.4% of cases were living in Addis Ababa followed by Gondar and Jimma with 20.3% and 11.3% cases, respectively. Severe road traffic accident, occupational injury, and surgical patients were among the major risk factors of trauma. The mortality rate of the trauma case fatality was reached about 4%. The majority of the studies (37.5%) analyzed the pattern and magnitude of trauma among patients seen at emergency outpatient department of health institutes in Ethiopia. The largest percentage of studies (62.5%) relied on systematic random sampling. Thirty eight percent of the reviewed studies were utilized retrospective approaches to address the research questions. An completed the registry forms and/or Kampla Trauma Score (KTS), which accounted for 37.5% of articles on prevalence, pattern, magnitude and associated factors of trauma in the emergency was the most commonly used strategy. The majority (75%) of the reviewed studies were used both descriptive statistics and bivarate and multivariate logistic regression for data analysis. The majority 6950 (71%) of the participants who have been included in those reviewed articles were male and 2818 (29%) were female by gender. Meanwhile, the majority 5 (62.5%) of reviewed studies had included $<$ 1000 injured persons.

CONCLUSION:

The degree and types of injuries in different hospitals in Ethiopia was considerably high and its casualty is also under predictable. Therefore, a variety of actions including policy decision should be implemented in order to minimize the incidence of trauma at department of emergency care center in the country.

Keywords

Prevalence pattern magnitude trauma emergency department health institutes Ethiopia

1. Introduction

Globally, trauma is one of the vital problems and it may cause substantial economic and social crisis. More than 10% of all kinds of diseases as such communicable and non communicable diseases have been reported to be integrated with trauma and its risk factors. The evidence showed that death due to injuries had been reached five million people since 2000 [1]. Last decades, trauma had been reported as important cause of increasing both child morbidity and mortality rate but also loss of life in developing countries as well as developed nation [2].

According to World Health Organization recent report (2014) found that those five million deaths and which caused harm to millions more were due to various factors related to injuries. The report was indicated that traffic collisions, war, self-inflicted violence, assaults, falls, burn, drowning, poisonings and others were recorded as major causes of injuries among the communities [3]. Therefore, injuries are best example which caused by day to day activities at home and work place.

Now a day, traffic accident injuries are a major public health problems and it causes death and disability at childhood and adulthood stages. Hence, TAIs is still critical case with increases in many world countries [4]. For example, some trauma care centers as such OHSU (Oregon Health and Sciences University) has been reported that about 3003 patients were attended to the health institutes and they had treated appropriately in 2016. The findings also indicated that near to three fourth (65%) transported from scene of injury to hospital but only one-fourth (35%) were from different hospitals in the country [5].

In Africa, accidents which related to pedestrians, motor bicycles and others like people riding more than two wheels are most common cause of death due to trauma. Evidence showed that more than (52%) of those listed users has been constituted on killed the people who are living in these African countries [6, 7]. Recently the road traffic accidents are rising with economic growth and motorization in African countries [8, 9, 10]. As result few research findings shown that still pediatricians have been killed more than one third of people in African region. The severity of pedestrian recorded in both Liberia and Mozambique is very high. The modes of injuries have big difference among the countries. For instance pedestrians killed at road were 55.6 in Mozambique and 66.3 of death at road in Liberia were through walking on foot around the road [6]. For example, currently pedestrians were mostly presented in road traffic city in Kenya [11], but it was highly accelerated in the capital city of Ethiopia, Addis Ababa and Kampala in Uganda [12, 13].

The World Health Organization was estimated that 90 of interpersonal violence exposure and its burdens will be occurred in low and middle income countries [14]. Few research findings shown that interpersonal violence direct related with injury has rated 48.0(%) in Ethiopia. This indicated that one of the most common mechanisms of all kinds of injuries is presented at different health care facilities in the countries including Ethiopia [15, 16].

Emergency Department of health care institutes in Ethiopia is very crowded with emergency and critical ill patients, very low utilization of the services, shortage of skilled professionals and staff members including equipments and supplies. In other words, formal prehospital care and at hospital emergency case management as such trauma center, poisonings, burn and other related care centers at emergency development is a recent issue in the country [17]. Recent finings shown that the challenges of increasing patient loads and waiting time are considerable. In other words, the burden of emergency and critical illness and kinds of injury related deaths has previously not documented well. However, now days, the emergency department are considered for clients who are injured with intentional and unintentional accident but also critically ill patients at hospital and all emergency health care service setting [18].

Even through the competent provision of emergency medical and trauma care has been contributed, in order to minimized the death rate, in developed and developing countries [19], still mortality due to traumatic injuries and medical illness among patients at emergency department are uncharacterized in Ethiopia [18]. We aimed to consolidate existing data on the prevalence patterns magnitudes and associated factors of trauma in the emergency department. Findings are of greatest relevant for Ethiopia Sub-Saharan Africa and world notion because now there is high incidence of injuries. Therefore it helps to initiate the policy makers in order to designing and implementing appropriate trauma prevention strategies.

2. Methods

We conducted a systematic review of the research literature in the field of prevalence, pattern, and magnitude and associated factors of trauma in the emergency department at health Institutes. Incidentally, we investigated the PubMed, Elsevier, Google, BMJ, PMC, MEDLINE, and Psych info search engines. This method was used to determine the accuracy of the results through comparing them in the related articles from various sources. This review is based on peer-reviewed journal articles on “prevalence trauma”, “Pattern of Trauma”, “magnitude of trauma”, and “associated factors of Trauma in emergency department at health institutes”, that were published between 2000 and 2017. This time span was chosen because up-to-date information is important to justify and address the objective of the review articles.

After assessing all titles and contents of the articles, the relevance of the articles to address the objectives of this study were considered and evaluated. The terms used for searching related articles were “Prevalence”, “Pattern”, “Magnitude”, “Associated factors of Trauma”, and “Emergency department”. Also “Emergency Department” and “Ethiopia” were used together to search the articles from different websites. In the first step, a total of 25 articles were found. The titles, summary or abstract, and the whole body of each article were then checked for their relevance and suitability to be included in the analyses. Finally, a total of 8 articles were found to be eligible. First, we used the Effective Public Health Practice Project Quality Assessment Tool (EPHPP) (EPHPP, 2009) to assess the quality of quantitative research in this review. This instrument had ordinal scoring for the following components: selection bias, study design, confounders, blinding, data collection methods, withdrawals and dropouts. Each component was rated strong, moderate, or weak, and these ratings were also combined into a global quality rating (strong, moderate or weak). Two reviewers assessed the quality, and discrepancies were resolved by discussion.

3. Inclusion and exclusion criteria

The authors read the titles and decided to include articles in the review regarding the following criteria: The study included one or more instruments to gather information on prevalence, patterns, magnitudes, and associated factors of trauma in the emergency room in health Institutes in Ethiopia. Inclusion of only emergency department which have given trauma care and were working outpatient at health Institutes in Ethiopia. Articles published between 2000 and 2017, and those published in English were eligible for the analysis.

Studies that did not meet these criteria were excluded. This systematic review is focused on the assessment of the prevalence, magnitude and pattern of trauma, the outcome and burden of the injury, and associate factors of trauma in the emergency department of different health institutes in Ethiopia. Furthermore, the review identified the main characteristics of outcomes and burden of injury, injury management and utilization of personal protection.

However, all abstracts were excluded from this review article. For instance, articles about case related with inpatient, non-emergency cases, other than Ethiopia, were excluded from this review.

4. Results

Out of 8 reviewed studies, 3 (37.5%) analyzed the pattern and magnitude of trauma among patients seen at emergency outpatient department of health institutes in Ethiopia [21, 22, 25]. Two studies (25%) analyzed the pattern of injuries visiting emergency department in case of injury [23, 27]. The remaining studies (37.5%) analyzed the pattern of trauma among patients seen at emergency outpatient department of public hospital [20], epidemiology and outcomes of eye injury [24], and the prevalence of occupational injuries with related to the factors which affecting the occupational injuries at work place [26].

The selection of participants was made using both random and non-random sampling methods such as systematic random sampling and conveniently sampling methods. The majority of studies reported techniques of participants’ selection; the largest percentage of studies (62.5%) relied on systematic random sampling [20, 21, 22, 23, 27]. Two out of 8 studies used stratified sampling techniques [24, 26], and only 1 study (12.5%) relied on conveniently methods [25]. This study result shown that all of those reviewed articles are equally selected. All of them was from 2003 to 2016. However, two studies (25%) were conducted in 2016 [20, 26], and 2 (25%) were in 2003 [20, 22, 25]. Eight of 8 reviewed studies (37.5%) utilized retrospective approaches to address the research questions [23, 24, 25]. The remaining studies (62.5%) used retrospective review (12.5%), simplified trauma registry (12.5%) [22], prospective cross-sectional based study (12.5%) [23, 24, 25], cross sectional (12.5%) [26], and facility based cross sectional study to address the same questions (12.5%) [27].

Table 1
The prevalence, patterns, magnitude and associated factors of trauma in the Emergency Department at Health Institutes in Ethiopia

Author, Year	Aim	Study area	Study design	Study period	Sample size	Sampling technique	Inclusion criteria	Things which assessed
Amdeselassie et al., 2016 [20]	To determine the pattern of trauma among patient seen at emergency out patients department	Public Hospital in Mekelle City	Retrospective	January 1, 2013–December 31, 2013	321 patients	Systematic random sampling	All patients who came to Emergency Department during the study period	Injured related information
Woldemicheal and Berhanu, 2011 [21]	To determine the magnitudes and pattern of injury	Jimma University of Specialized Hospital	Retrospective review	April 09, 2011–January, 07, 2011	13500 patient	Systematic random sampling	All patients who came to Emergency Department during the study period	Injured related information
Taye and Munie, 2003 [22]	To obtain preliminary data on the patterns and magnitude of injuries and establishing the basis towards sueivelliance system	TikurAnbessa Hospital	Simplified trauma registry	January, 1, 1999–June, 31, 1999	3822 patients	Systematic random sampling	All patients who came to Emergency Department during the study period	Injury event specific – Severity and outcome data
Taddesse et al., 2014 [23]	To determine the pattern of injuries and variables associated among patient visiting emergency department in case of injury	Black Lion Hospital, Addis Ababa, Ethiopia	Prospective cross-sectional Hospital based study	February 1 to April, 30, 2013	321 patients	Systematic random sampling	All patients who came to Emergency Department during the study period	Potential problem areas – Unanticipated interpretation – Cultural objectives
Addisu, 2011 [24]	To evaluate the epidemiology and outcomes of ocular trauma cases presented to Grarbet Hospital in Central Ethiopia over in a one year period	Grabet Hospital Central Ethiopia, ButajiraGurage Zone of the Southern Nations Nationalities and Peoples Regional State (SNNPR)	Prospective Hospital based Survey	November, 2009–October, 2010	753	Stratified Sampling	All patients with occur injuries seen in the eye unit for the first time	Initial and final visual acuities _ Types of injury -Injury management
Osman et al., 2003 [25]	To assess the magnitude, pattern outcome and burden of injuries	North Gondar administrative zone, Northern West, Ethiopia	Prospective study	April to July, 2000	1982	Conveniently (All presented)	All trauma victims presenting to twenty health Institutes	Magnitude of injuries – pattern of injuries – Outcomes of the case – Burden of injuries
Eskezia et al., 2016 [26]	To assess the prevalence of occupational injuries and its associated factors	Four Zones of Amhara region (DebreMarkos, Finoteselam, Injibara town and Bahir-dar city administration	Cross- sectional	February to May, 2015	394 patients	Stratified simple random Sampling	At least one year work experience that is selected by sampling techniques	Working environment Behavioral – characteristics of MSWs – Job satisfaction – Substance and work
Habtu et al., 2014 [27]	To assess the magnitude and factors affecting occupational injuries among worker engaged in large scale metal manufacturing industries in Addis Ababa, Ethiopia	Large scale metal Manufacturing Industry in Addis Ababa, Ethiopia	Facility based Cross-sectional study	Feburary,1 to March, 30, 2010	829 Workers	Simple random sampling after stratification		Working environment – Record review – Employee’s behavior – How to utilize personal protective devices

Figure 1.

Percentage distribution of participate who had injured during study period by gender.

These results show the different instruments used to measure the prevalence, pattern, magnitude and associated factors of trauma in the emergency department at health institutes in Ethiopia. An completed the registry forms and/or Kampla Trauma Score (KTS), which accounted for (37.5%) of articles on prevalence, pattern, magnitude and associated factors of trauma in the emergency was the most commonly used strategy [22, 24, 25], followed by structured checklist developed by adapting the World Health Organization instruments [20, 21]. The remaining 3 studies (37.5%) of the reviewed studies were used injury surveillance guideline documents (12.5%) [23], Semi structured interviewer administrative questionnaire (12.5%) [26], and both pretested structured questionnaire, observational checklist and in-depth interview (12.5%) [27].

The reviewed studies also showed that descriptive statistics and binary-logistic regression had used for data analysis, which accounted for 75% of studies [20, 21, 23, 24, 26, 27], and was assessed severity by new scoring system (Kampla Trauma Score) [22]. However, one study (12.5%) was used only descriptive methods [26]. Five studies (62.5%) were used $P<$ 0.05 for significance of the study [20, 21, 23, 24, 27]. Followed by 2 studies (25%) were not used any $p$ -value in order to measure the significance of the factors not study [22, 26]. However, only one study (12.5%) were used $P=$ 0.05 ( $p\leqslant$ 0.05) [26].

Three of the studies explored the severity of the road traffic accident and associated with trauma. For instance, in the study by Woldemicheal and Berhanu (2011) the majority (49.7%) of severe injuries were caused due to road traffic accident [21]. According to Taye and Munie, the overall mortality rate of trauma was reached 1.47%. Meanwhile, the case fatality rate was 4%, which accounts 20% of all deaths [22]. The study findings showed that the injury of assault was occurred in rural areas (61%) less likely to be than the urban dwellers ( $P=$ 0.002) [23]. In some of the reviewed studies, the author had suggested that the rate of visual acuity was abnormal, which is accounted $\leqslant$ 6/60 [24]. There was a significant burden of trauma cases at different health institutions. As a result, reviewed studies indicated that (46%) of surgical patients were affected by Trauma [25]. The results showed a positively correlation between none formally educated, lower income and related injuries and sleeping disturbance reported with severe occupational injuries of solid waste collectors. Meanwhile, one study finding indicated that the magnitudes of occupational injury was 489/1000 exposed workers/year [26, 27].

Table 2

Prevalence, pattern, magnitudes and associated factors of trauma in emergency department instruments, purpose of instruments, and their results used in Health Institutes in Ethiopia

Author, Year	Instrument	Analysis	$P$ -value	Result	Conclusion	Reason	Recommendation
Amdeselassie et al., 2016 [20]	Trauma registry systems (tools)	Descriptive analysis	NA	The common causes of injuries were interpersonal violence, accidental falls and road traffic accident that accounts 31%, 19.2%, and 4.1%, respectively	There has been a high burden of trauma	Lack of awareness	It needs great attention for interventions to control the problem
Woldemicheal and Berhanu, 2011 [21]	Structured checklist developed by adapting the WHO instrument	Descriptive statistics Binary logistic regression	$P<$ 0.05	Road traffic accident alone accounted for almost half (49.7%) of severe injuries	The magnitude of injury in the hospital was considerably high	Due to age and gender	Designing and implementing appropriate prevention strategies
Taye and Munie [22]	Interns completed the registry forms Kampla Trauma Score (KTS)	Assess severity by new scoring systems	NA	The overall mortality rate was 1.47% The case fatality rate was highest (4%) accounting for 20% of all deaths	The magnitudes of fatal injuries is underestimated The pattern of injury may only reflect the situation in the big cities	Due to increasing cars in cities – Lack of awareness	Further situational studies Urgent intervention
Taddesse et al., 2014 [23]	Injury surveillance guideline documents	Descriptive statistics Binary logistic regression	$P<$ 0.005	Injury of assault is 61% less likely to be occurred in rural areas than the urban dwellers ( $P=$ 0.002)	Higher incidence of intentional injuries Higher prevalence of injury among males, farmers, civil servants and students.	Lack of awareness among community and decision makers	Appropriate intervention Educate the community
Addisu, 2011 [24]	Structured questionnaire (US trauma Registry questionnaire)	Descriptive statistics	$P<$ 0.005	The rate of visual acuity $<$ or equal to 6/60	Ocular injury is still a common and avoidable causes of blindness	Lack socioeconomic status Educational level Cultural perspectives/experience	Primary prevention and control measures
Osman et al., 2003 [25]	Structured questionnaires (Registry questionnaire)	Descriptive statistics	NA	Trauma constituted about 46% of surgical patients, which shows a significant burden to the institutions.	The average hospital stay for the admitted patterns was twelve and half days	Educational and Economic low status	Community based study
Eskezia et al., 2016 [26]	Semi structured administrated questionnaires	Binary logistic regression	$P=$ 0.005	There was significantly and positively associated between illiteracy, lower income and related injuries those who reported sleeping disturbance with severe occupational injuries of solid waste collectors	The magnitude of occupational injuries among municipal solid waste collector is lower	Due to municipal solid waste collectors	Detect early signs of work related complaints Monitor work ability
Habtu et al., 2014 [27]	Pretested structured questionnaire Observational checklist In-depth interview	Descriptive statistics Bivaraite and Multivariate logistic Regression	$P<$ 0.005	The magnitudes of occupational injury was 489/1000 exposed workers/year	The burden of occupational injury in metal manufacturing industry is really significant Public Health problem	Due to large scale metal manufacturing industries is indispensable for proper health intervention program	Provide health and safety services

The majority 6950 (71%) of the participants who had included in those reviewed articles were male and 2818 (29%) were female by gender (Fig. 1).

The majority 5216 (53.4%) of the injured participants who are recruited in those reviewed articles were living in Addis Ababa city followed by 1982 (20.3%) and 1102 (11.3%) were living in Gondar and Jimma respectively [20, 21, 22, 23, 24, 25, 26, 27] (Fig. 2).

Figure 2.

Percentage distribution of an injured patient by city distribution of patients injured in percentage by city.

The result shown that the majority 5 (62.5%) of reviewed studies had included $<$ 1000 injured person [20, 23, 24, 26, 27], followed by 2 studies (25%) from 1001–2000 injured people. Only 1 study (12.5%) was included $\geqslant$ 3001 injured person [21, 22] (Fig. 3).

Figure 3.

The percentage distribution of injured persons at Emergency Department in reviewed articles.

5. Discussion

This study findings revealed that three fourth (71%) of the participants who had included in those reviewed articles were male by gender. In contrast, a study was conducted in Turkey by Kahramansoy and colleagues [1] reported that the majority (87%) of participants who had participated on analysis of trauma patients in a rural hospital in Turkey were male [1]. It indicated that slightly lower in this study. The reason may be due to less data, sample size and knowledge awareness. Similar with a study conducted by Getachew and colleagues [28] suggested that most (69%) of the participants on the burden of road traffic injuries in an emergency department in Addis Ababa, Ethiopia were males [28].

In some of the reviewed studies, the authors had suggested that the rate of visual acuity was abnormal (factor/cause or resulted), which is accounted $\leqslant$ 6/60 [24]. A significant numbers of patients with ocular problem had retinal detachment, and nearly two third of the patients presented late [29]. This study result shown that more than half (53.4%) of the injured participants who are recruited in those reviewed articles were living in Addis Ababa city. Most of the cases which related with trauma have fracture. Similar study conducted by Simon and colleagues, suggested that the most types of injuries were which were sustained in Northern Tanzania was fracture [30].

This study result shown that the majority (62.5%) of reviewed studies had included $<$ 1000 injured person. Furthermore, it is manageable easy even if insufficient resources allocated at each health setting in the country. It is similar with a study conducted by Chichon–Mefire and Colleagues [31] showed that there was a significant improvement in completeness of all death due to trauma in South West Cameroon. And it improved over rime compared with previous administrative records [31].

These results show the different instruments used to measure the prevalence, pattern, magnitude and associated factors of trauma in the emergency department at health Institutes in Ethiopia. An in terms completed the registry forms and/or Kampla Trauma Score (KTS), which accounted for (37.5%) of articles on prevalence, pattern, magnitude and associated factors of trauma in the emergency was the most commonly used strategy.

These findings shown that the majority (49.7%) of severe injuries caused due to road traffic accident [21].

This result was Opposed by a study conducted in Buganda Medical centre in Northwest Tanzania by Simon et al. [30] suggested that the majority of the road traffic accident (39.3%) has been occurred. Furthermore, motor bicycle (71.2%) was former responsible [30]. It indicated that high in this study. The reason may be due to increasing number of cars in cities, un-implementation of traffic law and un-qualification with driving license. Moreover, these study findings shown that the case fatality of trauma in those reviewed studies had showed that mortality rate was reached 1.47%. Meanwhile, the 20% of all deaths due to trauma recorded; therefore, the case fatality rate was 4% [22]. It is supported by Anderl and colleagues [6] found that the mortality rate of head injury in Ethiopia was 21.2%. It indicated that there is common problem in the same country. Hence, three of the studies explored the severity of the road traffic accident and associated with trauma. For instance, in the study by [21].

One third of the reviewed studies (37.5%) analyzed the pattern and magnitude of trauma among patients seen at emergency outpatient department of health institutes in Ethiopia. As a result, the injury of assault was occurred in rural areas (61%) less likely to be than the urban dwellers ( $P=$ 0.002) [23]. In contrast, study conducted in Malawii by Kirser and colleague [14] suggested that assaults are one of the most (26.8%) of all injuries. Our review $=$ It indicated that higher in this study finding. It may be due to lack of knowledge. Moreover, this result contrasted with a study conducted in Turkey by Kahramansoy and colleagues [1] suggested that assault cases caused an excessive trauma patient density in the Emergency department, as 98.7% were discharged from the Emergency department [1].

This study result shown that descriptive statistics and binary logistic regression analysis had used for analyze data’s, which accounted for 75% of studies. More than half (62.5%) relied on systematic random sampling. However, 37.5% of the reviewed studies were utilized retrospective approaches to address the research questions. It indicated that lower rate which addresses the research question. Still it needs further observation on different retrospective and prospective researches.

The results showed a positively correlation between the non-formally educated, lower income and related injuries and sleeping disturbance reported with severe occupational injuries of solid waste collectors. Meanwhile, one study finding indicated that the magnitudes of occupational injury was 489/1000 exposed workers/year. There was a significant burden of trauma cases at different health institutions. As a result, reviewed studies indicated that 46% of surgical patients were affected by Trauma [25]. Similarly, a study was conducted in Nairobi, Kenya by Ogendi and Colleagues (2013) found that more than fifty percent of the pedestrian injuries were affected with the limb [11]. Simon and Colleagues, suggested that only 7.3% patients has been received pre-hospital care at Northern Tanzania [30]. Moreover, a study which conducted at Buganda Medical centre in Northwest Tanzania by Simon et al. [30] agreed that head/neck and musculoskeletal body parts are frequently injured which accounted 32.7% and 28% respectively [30, 31, 32].

6. Conclusion

The study findings have shown that the extent of injury in different hospitals was considerably high and its fatality is also underestimated. It might be only reflected those condition in the big cities. Furthermore, the severity and the burden of occupational injury in metal manufacturing industry were really significant for the world health community [27]. Hence, it may cause a public health problem. Finally, future researches must use rigorous methodology to elicit the real impacts of trauma among communities in Ethiopia. Suggestions for future research are also mentioned. Perhaps the implications discussed in this review are not only confined to medical students, but also can be utilized by researchers of other disciplines as a guideline to design, plan and conduct similar researches in their own settings. Use of similar health measurements for comparison of outcomes in the future researches is recommended.

Footnotes

Conflict of interest

The authors declare that they have no competing interests.

Authors’ contributions

Development of the original idea and protocol, data abstraction and analyses, writing the manuscript: Addis Adera Gebru, Ali Mohammad Mosadeghrad, Ali Akbari Sari, Tadesse Bekele Tafesse and Woldegebriel Gebreegziabher Kahsay; and Development of the protocol, overall guide, data abstraction, preparing the manuscript: All Authors.

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