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Published on in Vol 11, No 9 (2022): September

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/21878, first published .
Design and Rationale of the National Observational Multicentric Tunisian Registry of Hypertension: Protocol for Evaluating Hypertensive Patient Care in Clinical Practice

Design and Rationale of the National Observational Multicentric Tunisian Registry of Hypertension: Protocol for Evaluating Hypertensive Patient Care in Clinical Practice

Design and Rationale of the National Observational Multicentric Tunisian Registry of Hypertension: Protocol for Evaluating Hypertensive Patient Care in Clinical Practice

Authors of this article:

Leila Abid1 Author Orcid Image ;   Rania Hammami1, 2 Author Orcid Image ;   Salem Abdesselem1 Author Orcid Image ;   Selim Boudiche3 Author Orcid Image ;   Ben Slima Hédi4 Author Orcid Image ;   Khaled Sayahi5 Author Orcid Image ;   Amine Bahloul2 Author Orcid Image ;   Ikram Chamtouri6 Author Orcid Image ;   Salma Charfeddine2 Author Orcid Image ;   Lamia Rais7 Author Orcid Image ;   Meriem Drissa8 Author Orcid Image ;   Badreddine Ben Kaab7 Author Orcid Image ;   Hassen Ibn hadj amor9 Author Orcid Image ;   Lilia Ben Fatma7 Author Orcid Image ;   Riadh Garbaa1 Author Orcid Image ;   Sabrine Boukhris8 Author Orcid Image ;   Allouche Emna10 Author Orcid Image ;   Manel Ben Halima3 Author Orcid Image ;   Nesrine Amdouni6 Author Orcid Image ;   Shayma Ghorbel11 Author Orcid Image ;   Sabrine Soudani8 Author Orcid Image ;   Imen Khaled12 Author Orcid Image ;   Syrine Triki2 Author Orcid Image ;   Feten Bouazizi12 Author Orcid Image ;   Imen Jemai13 Author Orcid Image ;   Ouday Abdeljalil6 Author Orcid Image ;   Yemna Ammar12 Author Orcid Image ;   Amani Farah6 Author Orcid Image ;   Adnen Neji14 Author Orcid Image ;   Zeineb Oumaya10 Author Orcid Image ;   Sana Seghaier15 Author Orcid Image ;   Samir Mokrani16 Author Orcid Image ;   Hamza Thawaba1 Author Orcid Image ;   Hela Sarray2 Author Orcid Image ;   Khalil Ouaghlani10 Author Orcid Image ;   Houssem Thabet17 Author Orcid Image ;   Zeineb Mnif18 Author Orcid Image ;   Boujelben Masmoudi Fatma1 Author Orcid Image ;   Mohamed Sghaier1 Author Orcid Image ;   Roueida Khalifa6 Author Orcid Image ;   Sami Fourati1 Author Orcid Image ;   Yassmine Kammoun2 Author Orcid Image ;   Syrine Abid1 Author Orcid Image ;   Chiheb Hamza1 Author Orcid Image ;   Syrine Ben Jeddou8 Author Orcid Image ;   Lassaad Sabbah19 Author Orcid Image ;   Rim Lakhdhar1 Author Orcid Image ;   Najla Dammak20 Author Orcid Image ;   Tarak Sellami1 Author Orcid Image ;   Basma Herbegue1 Author Orcid Image ;   Alia Koubaa21 Author Orcid Image ;   Faten Triki2 Author Orcid Image ;   Tarek Ellouze2 Author Orcid Image ;   Aicha Hmoudi22 Author Orcid Image ;   Ikhlas Ben Ameur1 Author Orcid Image ;   Mohamed Mongi Boukhchina23 Author Orcid Image ;   Neila Abid19 Author Orcid Image ;   Wejdene Ouechtati10 Author Orcid Image ;   Nizar Nasrallah24 Author Orcid Image ;   Yousra Houidi25 Author Orcid Image ;   Fathia Mghaieth Zghal3 Author Orcid Image ;   Ghodhbane Elhem22 Author Orcid Image ;   Mounira Chayeb25 Author Orcid Image ;   Chenik Sarra26 Author Orcid Image ;   Samira Kaabachi8 Author Orcid Image ;   Nizar Saadaoui1 Author Orcid Image ;   Ines Ben Ameur1 Author Orcid Image ;   Moufida Affes19 Author Orcid Image ;   Sana Ouali3 Author Orcid Image ;   Mouna Chaker2 Author Orcid Image ;   Hela Naana1 Author Orcid Image ;   Dghim Meriem26 Author Orcid Image ;   Mourad Jarrar1 Author Orcid Image ;   Jihen Mnif1 Author Orcid Image ;   Ahmed Turki2 Author Orcid Image ;   Ihsen Zairi27 Author Orcid Image ;   Jamel Langar1 Author Orcid Image ;   Safa Dardouri17 Author Orcid Image ;   Imen Hachaichi28 Author Orcid Image ;   Rafik Chettaoui1 Author Orcid Image ;   Wajih Smat1 Author Orcid Image ;   Amel Chakroun29 Author Orcid Image ;   Khadija Mzoughi27 Author Orcid Image ;   Rachid Mechmeche1 Author Orcid Image ;   Afef Ben Halima30 Author Orcid Image ;   Sahar Ben Kahla Koubaa31 Author Orcid Image ;   Slim Chtourou1 Author Orcid Image ;   Maalej Mohamed abdelkader1 Author Orcid Image ;   Mohsen Ayari32 Author Orcid Image ;   Moufid Hadrich1 Author Orcid Image ;   Tlili Rami33 Author Orcid Image ;   Fares Azaiez33 Author Orcid Image ;   Imen Bouhlel17 Author Orcid Image ;   Samir Sahnoun19 Author Orcid Image ;   Habib Jerbi34 Author Orcid Image ;   Ben Mrad Imtinene27 Author Orcid Image ;   Leila Riahi26 Author Orcid Image ;   Mohamed Sahnoun1 Author Orcid Image ;   Abdelhamid Ben Jemaa2 Author Orcid Image ;   Amal Ben Salem10 Author Orcid Image ;   Bassem Rekik10 Author Orcid Image ;   Maroua Ben Doudou27 Author Orcid Image ;   Mohamed Rachid Boujnah1 Author Orcid Image ;   Anissa Joulak1 Author Orcid Image ;   Abid Omar2 Author Orcid Image ;   Rabie Razgallah35 Author Orcid Image ;   Milouchi Sami11 Author Orcid Image ;   Elyes Neffati36 Author Orcid Image ;   Habib Gamra37 Author Orcid Image ;   Soraya Ben Youssef38 Author Orcid Image ;   Wissem Sdiri39 Author Orcid Image ;   Nejeh Ben Halima40 Author Orcid Image ;   Youssef Ben Ameur33 Author Orcid Image ;   Salem Kachboura30 Author Orcid Image ;   Sondes Kraiem27 Author Orcid Image ;   Wafa Fehri26 Author Orcid Image ;   Lilia Zakhama38 Author Orcid Image ;   leila Bezdah10 Author Orcid Image ;   Mourali Mohamed Sami3 Author Orcid Image ;   Habiba Drissa8 Author Orcid Image ;   Mohamed Faouzi Maatouk6 Author Orcid Image ;   Samir Kammoun2 Author Orcid Image ;   Faouzi Addad1, 30 Author Orcid Image
Article Authors Cited by Tweetations (2) Metrics

    Protocol

    1Tunisian Society of Cardiology and Cardiovascular Surgery, Tunis, Tunisia

    2Cardiology Department, Hedi Chaker-Sfax University Hospital, Faculty of Medecine of Sfax, University of Sfax, Sfax, Tunisia

    3Cardiology Department, La Rabta 1 (Pr Mourali) University Hospital, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    4Cardiology Department, Hospital of Menzel Bourguiba, Bizerte, Tunisia

    5Cardiology Department, ElKef Hospital, Elkef, Tunisia

    6Cardiology Department B, Fattouma Bourguiba University Hospital, Faculty of Medecine of Monastir, University of Monastir, Monastir, Tunisia

    7Nephrology Department, La Rabta University Hospital, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    8Cardiology Department, La Rabta 2 (Pr Drissa) University Hospital, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    9Cardiology Department, Tahar Sfar Hospital, Mahdia, Tunisia

    10Cardiology Department, Charles Nicole University Hospital, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    11Cardiology Department, Habib Bourguiba Hospital, Medenine, Tunisia

    12Basic Health Centers, Medenine, Tunisia

    13Habib Bourguiba Hospital, Medenine, Tunisia

    14Hospital of Tozeur, Tozeur, Tunisia

    15Private clinic, Tunis, Tunisia

    16Hospital of Mateur, Bizerte, Tunisia

    17Cardiology Department, Farhat Hached Hospital, Faculty of Medecine of Sousse, University of Sousse, Sousse, Tunisia

    18National Social Security Fund, Sfax, Tunisia

    19Private clinic, Sfax, Tunisia

    20Nephrology Department, Hedi Chaker-Sfax University Hospital, Faculty of Medecine of Sfax, University of Sfax, Sfax, Tunisia

    21Basic Health Centers, Ben Arous, Tunisia

    22Basic Health Centers, Tataouine, Tunisia

    23Private clinic, Gabes, Tunisia

    24Private clinic, Ariana, Tunisia

    25Basic Health Centers, Tunis, Tunisia

    26Cardiology Department, The Main Military Instruction Hospital of Tunis, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    27Cardiology Department, Habib Thameur Hospital, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    28Basic Health Centers, Gabes, Tunisia

    29Hospital of Habib Bougatfa, Bizerte, Tunisia

    30Cardiology Department, Abderrahmen Mami-Ariana Hospital, Faculty of Medecine of Tunis, University of Tunis, Ariana, Tunisia

    31Cardiology Department, Mahres Hospital, Faculty of Medecine of Sfax, University of Sfax, Sfax, Tunisia

    32Private clinic, Nabeul, Tunisia

    33Cardiology Department, Mongi Slim Hospital, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    34Private clinic, Sousse, Tunisia

    35Dacima, Tunis, Tunisia

    36Cardiology Department, University Hospital Sahloul, Faculty of Medecine of Sousse, Sousse, Tunisia

    37Cardiology Department A, Fattouma Bourguiba University Hospital, Faculty of Medecine of Monastir, University of Monastir, Monastir, Tunisia

    38Cardiology Department, Internal Security Forces Hospital, Faculty of Medecine of Tunis, University of Tunis, Tunis, Tunisia

    39Cardiology Department, Bougatfa Hospital, Bizerte, Tunisia

    40Cardiology Department, Ibn El Jazzar Hospital, Kairouan, Tunisia

    Corresponding Author:

    Leila Abid, MD

    Tunisian Society of Cardiology and Cardiovascular Surgery

    Rue du Lac Huron, Résidence Les Pergolas

    Apt. 201 Les Berges du Lac

    Tunis, 1053

    Tunisia

    Phone: 216 71965432

    Email: leilaabidt@yahoo.fr


    Background: This study was designed to evaluate the care of hypertensive patients in daily clinical practice in public and private centers in all Tunisian regions.

    Objective: This study will provide us an overview of hypertension (HTN) management in Tunisia and the degree of adherence of practitioners to international recommendations.

    Methods: This is a national observational cross-sectional multicenter study that will include patients older than 18 years with HTN for a duration of 4 weeks, managed in the public sector from primary and secondary care centers as well as patients managed in the private sector. Every participating patient signed a consent form. The study will exclude patients undergoing dialysis. The parameters that will be evaluated are demographic and anthropometric data, lifestyle habits, blood pressure levels, lipid profiles, treatment, and adherence to treatment. The data are collected via the web interface in the Dacima Clinical Suite.

    Results: The study began on April 15, 2019 and ended on May 15, 2019. During this period, we included 25,890 patients with HTN. Data collection involved 321 investigators from 24 Tunisian districts. The investigators were doctors working in the private and public sectors.

    Conclusions: Observational studies are extremely useful in improving the management of HTN in developing countries.

    Trial Registration: ClinicalTrials.gov NCT04013503; https://clinicaltrials.gov/ct2/show/NCT04013503

    International Registered Report Identifier (IRRID): DERR1-10.2196/21878

    JMIR Res Protoc 2022;11(9):e21878

    doi:10.2196/21878

    Keywords

    National Tunisian Registry; hypertension 


    Hypertension (HTN) is widespread in many developing and developed countries [1]. According to a 2010 report by the Institute of Medicine, HTN is a neglected disease, often ignored by the general public and underestimated by the medical world [2].

    However, more than a quarter of the world's adult population is already hypertensive, and this number is expected to increase to 1.56 billion by 2025 [3,4]. Unfortunately, HTN causes more than 7 million premature deaths a year and contributes to 4.5% of the global disease burden [5,6]. HTN is also a risk factor for cardiovascular diseases responsible for 30% of all deaths worldwide, which can be controlled [7,8].

    Many clinical trials have shown that stringent blood pressure (BP) control can significantly reduce cardiovascular risk [9,10] and certain sequelae such as stroke, myocardial infarction, sudden cardiac arrest, peripheral vascular disease, and renal insufficiency [11-13].

    HTN in Tunisia is a public health issue considering its current frequency [14-16]. As no relevant updated data exist, this work presents a new relational database to obtain an overview of the management of hypertensive patients in Tunisia and enable adequate protection planning. Therefore, a multicenter observatory focusing on the demographic, anthropometric, and therapeutic features of HTN in Tunisia is mandatory. The collected data will allow us to assimilate our practices and know the degree of adherence by practitioners to international recommendations for this pathology treatment.

    The aim of the National Tunisian Registry of Hypertension (NATURE-HTN) is to describe the epidemiological profile of HTN in Tunisia, determine the cardiovascular risk level of Tunisian hypertensive patients, and obtain an idea about the percentage of patients treated for therapeutic purposes.


    Several secondary end points are defined, such as evaluating the therapeutic adequacy with respect to that specified in the international recommendations of the European Society of Hypertension-European Society of Cardiology (ESH-ESC) 2018 for managing HTN and evaluating the degree of therapeutic inertia.

    Study Design and Patient Enrollment

    A national observatory, longitudinal, and multicentric register study was carried out over a month, without clinical follow-up and investigations. We included patients managed in the private and public sectors as well as from primary and secondary care centers.

    During office visits, we included patients above 18 years with known or newly diagnosed elevated BP after signing a consent form. Except for severe HT (eg, grade 3 and especially high-risk patients), the new HT diagnosis was confirmed according to the ESC and ESH guidelines as either out-of-office BP measurements above the recommended thresholds or repeated office BP measurements above 140 mmHg for the systolic blood pressure (SBP) and 90 mmHg for the diastolic blood pressure (DBP) during more than 1 visit [11].

    Exclusion Criteria

    We excluded patients undergoing hemodialysis, pregnant women, individuals classified as white-coat HT patients, and patients who refused to sign the consent form from the study.

    During the office visit, the physician had to complete the case report form of the registry after patient interrogation and examination. Information on sociodemographic characteristics including age, gender, education level, health insurance, smoking, diabetes, pulmonary diseases, hypothyroidism, moderate renal failure history defined by an MDRD (Modification of Diet in Renal Disease) creatinine clearance <60 mL/min, coronary disease, and history of stroke were collected.

    The interview included questions related to drug compliance and salt intake as well as sport practice. Physical activity was considered regular when it was performed at least 30 minutes 3 times a week. During physical examination, we measured the weight and height to assess the BMI (BMI= weight/[height]2). Obesity is operationally defined as a BMI exceeding 30 kg/m2 and is subclassified into moderate (BMI=30-34.9), morbid (BMI=35-39.9), and severe (BMI≥40). BP measurements were conducted using a standardized auscultatory or oscillometric sphygmomanometer after at least 15 min of rest. We recorded 2 separate measurements at least 3 minutes apart and considered the mean of the 2 measurements. In patients with asymmetric BP between the 2 arms, we considered the higher pressure.

    We confirmed whether the patients had a sinus rhythm or atrial fibrillation through electrocardiograms and searched for left ventricle hypertrophy (LVH) based on the definition recommended by the ESC/ESH guidelines (Sokolow-Lyon index>35 mm or R in a VL≥11 mm) [11]. We searched for LVH in echocardiographic findings as well (if the patients underwent echocardiography during the last year).

    We also recorded the biological tests performed during the last 6 months before the office visit, especially creatinine, glycaemia, cholesterol, kaliemia, and microalbuminuria (if performed during the last year).

    To assess and control BP, we evaluated only patients diagnosed with HTN for more than 6 months. The primary end point in our study was the rate of HTN control. Uncontrolled HTN was defined according to the ESC/ESH guidelines as an average SBP above 140 mmHg and an average DBP above 90 mmHg [11].

    Ethics Consideration

    The study protocol, the consent form prepared by the steering committee, and the creation of the registry were approved by the ethic committee of the Hospital of the Internal Security Forces. Patients must give their consent before being included in the registry.The steering committee will check for any violation of the protocol by the investigators (inclusion of patients who are not eligible according to selection criteria) and will make a decision on the exclusion of the concerned patient(s).

    Sample Size and Data Collection

    Eligible patients according to the inclusion and exclusion criteria were selected by more than 600 investigators (working in the public and private sectors) specialized in cardiology, nephrology, endocrinology, internal medicine, and general medicine.

    The target simple size of the whole study was calculated using the following formula: N = Z2 × p0 × (1 – p0)/i2 (Z=1.96 if we consider a confidence level of 95%, and p0=24.1%; it corresponds to the control rate of HTN in the TAHINA project). More than 7000 patients were needed.

    Patients were included continuously until the end of the inclusion period. The inclusion lasted for 1 month without any follow-up, as shown in Figure 1. Given the observational nature of the NATURE-HTN study, no specific treatment or intervention is planned for HTN management. Patients should be cared for according to their usual medical habits.

    The data were collected via the web interface in the Dacima Clinical Suite (Dacima Software Inc). The electronic data capture platform complies with the following international standards: Food and Drug Administration 21 Code of Federal Regulations part 11, Health Insurance Portability and Accountability Act, and International Conference on Harmonization.

    ‎
    Figure 1. Protocol of population inclusion. HTN: hypertension.
    View this figure

    Statistical Analysis

    The Dacima Clinical Suite platform enables the collection of data through the web interface and their extraction in the SAS or SPSS format. The statistical analysis is exploratory, involving the calculation of the 95% CI.

    The data will be described for the entire population of interest. Statistical tests will be bilateral with a statistical significance threshold of 5%. ANOVA will be performed for the quantitative variables according to their normal distribution (parametric tests for the variables that follow a normal distribution and nonparametric tests in the other cases). A chi-square test will be performed for the categorical variables (or corrected for continuity if the validity conditions for the chi-square test are not met, namely if the theoretical number is less than 5).

    The data review committee is composed of the coordinators of the steering committee of the study as well independent experts in data management. The purpose of the data review committee is to manage data queries and validate the final statistical analysis plan. The committee will also be responsible for validating subsequent publications that will be conducted.

    The protocol of the NATURE-HTN registry has been approved by the Tunisian Society of Cardiology and Cardiovascular Surgery. The NATURE-HTN study has been submitted to ClinicalTrials.gov and registered under the identifier NCT04013503.

    The NATURE-HTN registry does not impose any specific intervention. Treatments of the patients follow the usual recommendations for managing HTN. Clinical events occurring during the study are not to be recorded.

    Study Sponsorship

    The NATURE-HTN registry study is sponsored by the Tunisian Society of Cardiology and Cardiovascular Surgery.


    The study began on April 15, 2019 and ended on May 15, 2019. During this period, we included 25,890 patients with HTN. Data were collected by 321 investigators from 24 Tunisian districts. The investigators were doctors working in the private and public sectors. Cardiologists included 71% (n=18,382) of the patients, and general practitioners included approximately 25% (n=6473) of the patients.


    Study Significance

    NATURE-HTN is the largest observational registry in the field of HTN management in Tunisia. The results will be compared to those of the TAHINA study. The latter was a national survey including 8007 patients aged between 35 and 70 years. The prevalence of hypertension was 30.6%, and it was higher in women (n=2682, 33.5%) than in men (n=2186, 27.3%). Only 38.8% (n=3107) of those with HTN were aware of their diagnosis, of which 84.8% (2635/3107) were receiving treatment. BP control was achieved in only 24.1% (635/2635) of the treated hypertensive patients. Women were more aware than men (1202/2682, 44.8% vs 630/2186, 28.8%), but the rates of treatment and control of HTN did not differ between the 2 genders. Higher age, being female, lower education level, and urban area emerged as important correlates of HTN awareness [15]. Certainly, there is an urgent need for comprehensive integrated population-based intervention programs to ameliorate the growing problem of HTN in Tunisians. BP control has not improved even in the developed countries. In France, according to the Flash studies, the percentage of the participants with BP is approximately 51%, and the use of monotherapy is one of the major problems registered in the French survey [17].

    Conclusions

    BP control should be continually evaluated through observational studies involving different populations to conduct intervention programs and reduce the burden of HTN in developing countries.

    Data Availability

    The data is the property of the Tunisian Society of Cardiology and cannot be distributed anywhere. The primary use of these data will be to describe the epidemiological profile of hypertension in Tunisia, determine the cardiovascular risk level of Tunisian hypertensive patients, and obtain an idea about the percentage of patients treated for therapeutic purposes. The planned secondary uses are to inform all physicians who may be involved in the management of Tunisian hypertensive patients (general practitioners, cardiologists, nephrologists, endocrinologists…) and to prepare a guide (in collaboration with the Ministry of Public Health), based on the outcomes of the registry, so that they can improve the level of hypertension control.

    Conflicts of Interest

    None declared.

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    ‎
    BP: blood pressure
    DBP: diastolic blood pressure
    ESC: European Society of Cardiology
    ESH: European Society of Hypertension
    HTN: hypertension
    LVH: left ventricle hypertrophy
    NATURE-HTN: National Tunisian Registry of Hypertension
    SBP: systolic blood pressure

    Edited by G Eysenbach; submitted 28.06.20; peer-reviewed by S Nouira, HH Wang, N Agarwal; comments to author 17.11.20; revised version received 27.12.20; accepted 30.07.21; published 02.09.22

    Copyright

    ©Leila Abid, Rania Hammami, Salem Abdesselem, Selim Boudiche, Ben Slima Hédi, Khaled Sayahi, Amine Bahloul, Ikram Chamtouri, Salma Charfeddine, Lamia Rais, Meriem Drissa, Badreddine Ben Kaab, Hassen Ibn hadj amor, Lilia Ben Fatma, Riadh Garbaa, Sabrine Boukhris, Allouche Emna, Manel Ben Halima, Nesrine Amdouni, Shayma Ghorbel, Sabrine Soudani, Imen Khaled, Syrine Triki, Feten Bouazizi, Imen Jemai, Ouday Abdeljalil, Yemna Ammar, Amani Farah, Adnen Neji, Zeineb Oumaya, Sana Seghaier, Samir Mokrani, Hamza Thawaba, Hela Sarray, Khalil Ouaghlani, Houssem Thabet, Zeineb Mnif, Boujelben Masmoudi Fatma, Mohamed Sghaier, Roueida Khalifa, Sami Fourati, Yassmine Kammoun, Syrine Abid, Chiheb Hamza, Syrine Ben Jeddou, Lassaad Sabbah, Rim Lakhdhar, Najla Dammak, Tarak Sellami, Basma Herbegue, Alia Koubaa, Faten Triki, Tarek Ellouze, Aicha Hmoudi, Ikhlas Ben Ameur, Mohamed Mongi Boukhchina, Neila Abid, Wejdene Ouechtati, Nizar Nasrallah, Yousra Houidi, Fathia Mghaieth Zghal, Ghodhbane Elhem, Mounira Chayeb, Chenik Sarra, Samira Kaabachi, Nizar Saadaoui, Ines Ben Ameur, Moufida Affes, Sana Ouali, Mouna Chaker, Hela Naana, Dghim Meriem, Mourad Jarrar, Jihen Mnif, Ahmed Turki, Ihsen Zairi, Jamel Langar, Safa Dardouri, Imen Hachaichi, Rafik Chettaoui, Wajih Smat, Amel Chakroun, Khadija Mzoughi, Rachid Mechmeche, Afef Ben Halima, Sahar Ben Kahla Koubaa, Slim Chtourou, Maalej Mohamed abdelkader, Mohsen Ayari, Moufid Hadrich, Tlili Rami, Fares Azaiez, Imen Bouhlel, Samir Sahnoun, Habib Jerbi, Ben Mrad Imtinene, Leila Riahi, Mohamed Sahnoun, Abdelhamid Ben Jemaa, Amal Ben Salem, Bassem Rekik, Maroua Ben Doudou, Mohamed Rachid Boujnah, Anissa Joulak, Abid Omar, Rabie Razgallah, Milouchi Sami, Elyes Neffati, Habib Gamra, Soraya Ben Youssef, Wissem Sdiri, Nejeh Ben Halima, Youssef Ben Ameur, Salem Kachboura, Sondes Kraiem, Wafa Fehri, Lilia Zakhama, leila Bezdah, Mourali Mohamed Sami, Habiba Drissa, Mohamed Faouzi Maatouk, Samir Kammoun, Faouzi Addad. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 02.09.2022.

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