Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review

ABSTRACT

BACKGROUND:

The diagnostic criteria for carpal tunnel syndrome (CTS) lack uniformity. Moreover, because CTS is a syndrome, there is no consensus as to which signs, symptoms, clinical and complementary tests are more reproducible and accurate for use in clinical research. This heterogeneity is reflected in clinical practice. Thus, establishing effective and comparable care protocols is difficult.

OBJECTIVE:

To identify the diagnostic criteria and outcome measures used in randomized clinical trials (RCTs) on CTS.

DESING AND SETTING:

Systematic review of randomized clinical trials carried out at the Federal University of São Paulo, São Paulo, Brazil.

METHODS:

We searched the Cochrane Library, PubMed, and Embase databases for RCTs with surgical intervention for CTS published between 2006 and 2019. Two investigators independently extracted relevant data on diagnosis and outcomes used in these studies.

RESULTS:

We identified 582 studies and 35 were systematically reviewed. The symptoms, paresthesia in the median nerve territory, nocturnal paresthesia, and special tests were the most widely used clinical diagnostic criteria. The most frequently assessed outcomes were symptoms of paresthesia in the median nerve territory and nocturnal paresthesia.

CONCLUSION:

The diagnostic criteria and outcome measures used in RCTs about CTS are heterogeneous, rendering comparison of studies difficult. Most studies use unstructured clinical criteria associated with ENMG for diagnosis. The Boston Questionnaire is the most frequently used main instrument to measure outcomes.

REGISTRATION:

PROSPERO (CRD42020150965- https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965).

KEYWORDS (MeSH terms):
Diagnosis; Carpal tunnel syndrome; Randomized clinical trials [publication type]; Systematic Review [publication type]

AUTHORS’ KEYWORDS:
Diagnostic; Outcome; Carpal tunnel; Surgery

INTRODUCTION

Carpal tunnel syndrome (CTS) is the most prevalent peripheral neuropathy in the world.¹,² Although some patients are treated conservatively, most require surgical treatment, which generates spending more than US$ 2 billion/year.²

The socioeconomic impact of the disease drove numerous randomized clinical trials (RCTs) to determine the best treatment for CTS. To identify effective interventions, accurate and relevant outcomes for the patient are needed.³–⁶ There is extensive literature about objective outcomes (e.g., loss of strength) and variables derived from nerve conduction studies. However, how these outcomes translate into tangible benefits to the patients remains unclear.³–⁶

In CTS, the lack of uniform criteria poses a challenge in diagnosis. Thus, Graham proposed well-defined criteria, based on a robust methodology.⁷ Moreover, because CTS is a syndrome, experts do not agree on which signs, symptoms, clinical and complementary tests are more reproducible and accurate in clinical research.⁸

This heterogeneity is reflected in clinical practice and has led to difficulty in establishing effective and comparable care protocols.⁹,¹⁰ Thus, studies must use precise diagnostic methods and clarify the main post-surgical outcomes to be evaluated in patients with CTS.

Systematic reviews promote synthesis, provide a comprehensive view, and recommend the best available evidence on a topic. Diagnostic and rational management criteria are of interest.⁸,¹⁰ Importantly, evaluation outcomes should reflect the impact of treatments on body structure and function, including activity limitations and participation restrictions, through a broad evaluation model.¹¹–¹³ The Classification of Functioning and Disability and Health (ICF), approved in 2001 by the World Health Organization, proposed a comprehensive assessment from both individual and social perspectives.¹⁴,¹⁵ The model aimed to recognize the abnormalities in the body structure, identify the consequences on function, and describe the repercussions and adaptations to such changes in the individual's social dynamics.¹⁴ A previous systematic review on the subject was published in 2006.⁸ Given the importance of the topic, we sought to give an update.

OBJECTIVE

The objective of this systematic review is to compare the diagnostic criteria and outcome measures based on ICF used in CTS over the past 15 years.

METHODS

This systematic review was approved by the Research Ethics Committee (no. 2248181019) and developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The protocol was published a priori in the PROSPERO database (CRD42020150965 - https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965).

Search strategy

We conducted a search of works published in English, from 2006 to 2019, at the Cochrane Library, Medline (via PubMed), and Embase (via Ovid). The search was performed independently by RLS and AFZ. We use the terms: carpal tunnel syndrome and randomized controlled trial along with the Boolean term AND for free search of Cochrane Library and Embase. For Medline, we searched the MeSH term carpal tunnel syndrome and randomized controlled trial; we then used the PubMed Search Builder tool to combine terms.

Criteria for selection of studies and procedures

After the initial screening based on the title and abstract, the full-text articles were independently reviewed by RLS and AFZ. These were included if they met the eligibility criteria enumerated below. Disagreements were resolved by a third author, VYM.

The inclusion criteria were: 1. Type of study: randomized clinical trials with follow-up longer than three months; 2. Patients: adults (>18 years) with initial diagnosis of CTS.

Exclusion criteria

1. Studies not published in English.

2. Studies that did not involve at least one surgical intervention

Data extraction

We extracted the following data: 1. Study design (country and year of publication); 2. Experimental and control interventions; 3. Sample size; 4. Follow-up time; 5. Blinding; 6. Diagnostic criteria; 7. Pre- and post-operative outcome measures.

Methodological quality assessment

We use the Cochrane Collaboration Risk-of-Bias tool,⁵¹ which evaluates: 1. random sequence generation (selection bias); 2. Allocation Concealment (selection bias); 3. Blinding of participants and staff (performance bias); 4. Blinding of assessments and outcome (detection bias); 5. Incomplete outcomes (friction bias); 6. Selective outcome reporting (reporting bias) and 7. Other sources of bias (other biases).

Assessment of outcomes based on the International Classification of Functioning, Disability and Health (ICF)

This classification facilitates understanding of health determinants and health-related effects through a standardized and comprehensive terminology.¹⁵ Correlating the pathophysiology of CTS with its clinical manifestations (i.e., signs and symptoms) assists in identifying specific structures and functions of the body altered by the disease (first domain of ICF). Additionally, patients may also have disabilities or limitations in performing activities of daily life (second domain of ICF), which impact situations of social life and satisfaction (third domain of ICF).⁸,¹⁴

Data analysis

The data collected were presented in tables. Each study was labelled according to its author. The data was managed in Excel 2020 (Microsoft Corporation, Redmond, Washington, United States).

RESULTS

From the 582 studies screened, 35 were included in the systematic review (Figure 1).¹⁶–⁵⁰ Table 1 provides a meta-summary of the characteristics of the studies included.¹⁶–⁵⁰

Figure 1
Flow diagram of eligible studies.¹⁶–⁵⁰

Table 1
Summary of the included randomized controlled trials

First Author	Country	Diagnostic Criteria		Experimental studies	Intervention Control	Sample Size		Follow-up (months)	Blinding
		Clinics	Complementary examinations			Patients	Hands
Rab16	Austria	Paresthesia + special tests	ENMG (Non-Padua criteria)	Endoscopic	Classic open CTD release	10	20	12
Siegmeth17	United Kingdom	Paresthesia + special tests	–	CTD open modified release	Classic open CTD release	42	84	6	x
Zyluk18	Poland	Unspecified	ENMG (Non-Padua criteria)	CTD open modified release	CTD open modified release	65	73	12	x
Forward19	United Kingdom	Graham Criteria (CTS-6)	ENMG (Non-Padua criteria)	Classic open CTD release	CTD open modified release	112	112	3	x
Atroshi20	Sweden	Diagram Katz	ENMG (Non-Padua criteria)	Endoscopic	Classic open CTD release	128	128	12	x
Huemer21	Austria	Unspecified	ENMG (Non-Padua criteria)	Classic open CTD + release Small bandage	Classic open CTD release + Bulky bandage	50	50	3
Pomerance22	United States	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release + Physiotherapy	Classic open CTD release	150	150	6	x
Atroshi23	Sweden	Katz Diagram	ENMG (Non-Padua criteria)	Endoscopic	Classic open CTD release	126	126	60
Gordon24	Canada	Unspecified	ENMG (Non-Padua criteria)	Physiotherapy	Classic open CTD release	21	21	12
Faraj25	Iraq	Paresthesia + special tests	ENMG (Non-Padua criteria)	CTD open modified release	Classic open CTD release	40	40	3
Nabhan26	Germany	Unspecified	ENMG (Non-Padua criteria)	Classic open CTD release + local anaesthesia	Classic open CTD release + regional anesthesia	43	43	6	x
Eriji27	Japan	Paresthesia + special tests	ENMG (Non-Padua criteria)	Endoscopic	Open Surgery	79	101	3	x
Uçar28	Turkey	Unspecified	ENMG (Non-Padua criteria)	CTD open modified release	CTD open modified release	90	90	30
Larsen29	Denmark	Unspecified	ENMG (Non-Padua criteria)	CTD open modified release	Endoscopic	90	90	6	x
Tarallo30	Italy	Paresthesia + special tests	ENMG (Non-Padua criteria)	CTD open modified release	Classic open CTD release	120	120	12
Ullah31	Pakistan	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release	Pharmacological	40	40	13	x
Andreu32	Spain	Katz Diagram	ENMG (Non-Padua criteria)	Classic open CTD release	Pharmacological	95	95	12
Vanni33	Italy	Paresthesia + special tests	ENMG (Non-Padua criteria)	CTD open modified release	Classic open CTD release	220	220	12	x
Peñas34	Spain	Paresthesia + special tests	ENMG (Non-Padua criteria)	Physiotherapy	Classic open CTD release	111	111	12	x
SadatsuneI35	Brazil	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release + Pharmacological	Classic open CTD release + Pharmacological	37	37	6	x
Rojo-Manaute36	Arab Emirates	Unspecified	ENMG (Non-Padua criteria)	CTD open modified release	CTD open modified release	82	82	12	x
Acar37	Turkey	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release	CTD open modified release	113	159	24	x
Gumustas38	France	Unspecified	ENMG (Non-Padua criteria)	Endoscopic	Classic open CTD release	50	50	–	x
Cho39	South Korea	Paresthesia + special tests	ENMG (Non-Padua criteria)	CTD open modified release	CTD open modified release	79	79	24	x
Herold40	United Kingdom	Paresthesia + special tests	–	Physiotherapy	Classic open CTD release	93	93	3	x
Peñas41	Spain	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release	Physiotherapy	120	120	12	x
Logli42	United States	Unspecified	ENMG (Non-Padua criteria)	Physiotherapy	Classic open CTD release	249	249	12	x
Peñas43	Spain	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release	Physiotherapy	100	100	12	x
Peñas44	Spain	Paresthesia + special tests	ENMG (Non-Padua criteria)	Physiotherapy	Classic open CTD release	95	95	12	x
Boriani45	Italy	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release + Pharmacological	Classic open CTD release + Pharmacological	64	64	3	x
Kleermaeker46	Germany	Paresthesia + special tests	ENMG (Non-Padua criteria)	Classic open CTD release	Physiotherapy and Pharmacology	43	43	6	x
Kanchanathepsak47	Thailand	Unspecified	–	CTD open modified release	Classic open CTD release	33	36	3	x
Oh48	South Korea	Unspecified	Ultrasonography	Endoscopic	CTD open modified release	67	67	6
Rimdeika49	Germany	Unspecified	ENMG (Non-Padua criteria)	CTD open modified release	Classic open CTD release	104	104	4
Zhang50	China	Paresthesia + special tests	ENMG (Non-Padua criteria)	CTD open modified release	Pharmacological	46	46	3	x
TOTAL n = 35						3,007	3,138
Average ± SD						82 ± 51	90 ± 51	12 ± 11

• CDT = carpal transverse ligament; ENMG = electroneuromyography; SD = standard deviation.

The outcome measures reported in the RCTs were classified according to the domains of the ICF: A) Body functions and structures (Table 2);¹⁶–⁵⁰ B) Activity limitations (Table 3)¹⁶–⁵⁰ and C) Social life/Satisfaction (Table 3).¹⁶–⁵⁰

Table 2
Outcomes in randomized clinical trials - body functions and structures

First Author	Symptoms	Motor Functions			Sensitive Functions			Body Structures
	Paresthesia in the territory of the median and nocturnal nerve	Manual Grasping Force	Tweezers	Pick-up Test	2 Point Discrimination	Monofilament	Vibration	Nerve Conduction (sensitive and motor)	Wound Complications	Local Sensitivity Disorders	Causalgia
	Standard questionnaire used
Rab16	Boston Questionnaire	x	x		x	x		x
Siegmeth17	PEM score	x								x
Zyluk18	Boston Questionnaire	x	x		x	x
Forward19	PEM score	x	x
Atroshi20	Boston Questionnaire	x	x		x	x				x
Huemer21	–	x		x	x			x		x
Pomerance22	Dash score	x	x
Atroshi23	–
Gordon24	Boston Questionnaire						x	x
Faraj25	–								x
Nabhan26	MHQ
Eriji27	–	x	x		x	x		x		x
Uçar28	Boston Questionnaire
Larsen29	–	x
Tarallo30	Boston Questionnaire	x	x		x				x	x
Ullah31	–
Andreu32	–								x
Vanni33	Boston Questionnaire
Peñas34	–							x
SadatsuneI35	–										x
Rojo-Manaute36	Quickdash score	x								x
Acar37	–							x		x
Gumustas38	Boston Questionnaire							x
Cho39	Boston Questionnaire									x
Herold40	MHQ			x	x	x	x			x
Peñas41	Boston Questionnaire
Logli42	Dash score	x							x
Peñas43	Boston Questionnaire
Peñas44	Boston Questionnaire		x
Boriani45	Boston Questionnaire				x			x
Kleermaeker46	Boston Questionnaire
Kanchanathepsak47	Boston Questionnaire	x	x		x	x		x	x
Oh48	Boston Questionnaire + Dash score
Rimdeika49	Dash score	x	x		x	x
Zhang50	Boston Questionnaire							x

• PEM score = Patient Evaluation Measure; Dash = Disabilities of the Arm, Shoulder and Hand; MHQ = Michigan Hand Outcomes Questionnaire.

Table 3
Outcomes in randomized clinical trials - activity and social life limitations/satisfaction

First author	Activities (limitations)			Social life/Satisfaction
	Dexterity	Use of hands in AVD's	Functional Status Scale - Boston Questionnaire	Time away from work	Satisfaction	Aesthetics
Rab16			Applied
Siegmeth17		x	Not applied			x
Zyluk18			Applied
Forward19			Not applied
Atroshi20		x	Applied	x
Huemer21			Not applied
Pomerance22			Not applied	x
Atroshi23			Not applied		x
Gordon24	x		Applied
Faraj25			Not applied		x
Nabhan26		x	Not applied	x	x	x
Eriji27		x	Not applied
Uçar28			Applied
Larsen29			Not applied
Tarallo30			Applied		x	x
Ullah31			Not applied
Andreu32		x	Not applied
Vanni33			Applied			x
Peñas34			Not applied
SadatsuneI35			Not applied
Rojo-Manaute36			Not applied	x
Acar37			Not applied
Gumustas38		x	Applied
Cho39			Applied		x
Herold40	x	x	Not applied
Peñas41		x	Applied		x
Logli42			Not applied
Peñas43			Applied
Peñas44			Applied
Boriani45			Applied
Kleermaeker46			Applied
Kanchanathepsak47			Applied
Oh48			Applied
Rimdeika49		x	Not applied
Zhang50			Applied

Characteristics of studies and evaluated outcomes

We analyzed studies that evaluated the effectiveness of different surgical and conservative techniques; some studies used more than one intervention. In the experimental group, classical open carpal ligament (CLL) release (12; 34%), modified open CLL release (12; 34%) and endoscopic CT release (6; 17%) were used. In addition, conservative interventions such as physiotherapy (5; 14%) and the use of drugs (3; 8%) were also tested. As control, classical open CT release (20; 57%), modified open CT release (7; 20%), endoscopic CT release (1; 3%), open surgery (1; 3%), physiotherapy (3; 8%) and drugs (6; 17%) were used. A total of 3,007 patients and 3138 hands were studied (some patients received treatments for both hands). The follow-up time ranged from 3 to 60 months. The average follow-up was 12 months; five reported follow-up longer than 13 months. From the total, 25 studies (71%) showed adequate blinding.

The studies analyzed the following clinical diagnostic criteria for CTS: paresthesia in the territory of the median nerve, night paresthesia, and Phalen's and Tinel's tests (part of the six criteria described by Graham) (18 studies; 51%), the Katz diagram (3; 9%) and all the Graham criteria - CTS-6 (2; 6%). Other studies (12; 34%) did not specify the diagnostic method used (Table 1). Studies that used only part of the six criteria described by Graham⁷ were classified as paresthesia and special tests.

Electroneuromyography (ENMG) was a complementary examination in 31 studies (89%) and ultrasonography in only one (3%). The studies that used ENMG were then classified based on the use of the Padua criteria,⁵² used by 22 (71%). Three other studies (9%) did not use any type of complementary examination (Table 1).¹⁶–⁵⁰

Diagnostic criteria

Risk of bias - Cochrane Collaboration

Figure 2 presents the risk of study bias.¹⁶–⁵⁰ Because surgical intervention was involved, blinding was difficult; most were classified as having uncertain or high risk of bias.

Figure 2
Risk of bias of randomized clinical trials included in the study - Cochrane Collaboration Tool.

Categorization of the outcomes analyzed based on the International Classification of Functionality, Disability and Health (ICF)

The outcomes reported in the ECR were categorized according to the three domains of the ICF.

A) Body functions and structures (Table 2): Among the outcomes analyzed, symptoms (paresthesia in the territory of the median and nocturnal nerve) were the most frequently employed (26 studies; 74%).¹⁶–⁵⁰

Standardized questionnaires were used in 25 studies (71%): the Boston Questionnaire (BQ) (17; 65%), Disabilities of the Arm, Shoulder and Hand (Dash score) (4; 15%), Patient Evaluation Measure (PEM score) (2; 8%), Michigan Hand Outcomes Questionnaire (MHQ) (2; 8%), and QuickDash score (1; 4%). Only one study used more than one questionnaire.

Motor functions, included in 16 studies (46%), were operationally defined as manual grasping force (14; 88%), tweezers (10; 62%) and pick-up test (2; 12%).

Sensory function was evaluated in 11 studies (31%). The most studied variable was two-point discrimination (10; 91%), followed by the monofilament test (8; 73%) and vibration (1; 10%).

Finally, the body structures were analyzed in 18 studies (51%), through sensory and motor nerve conduction (12; 67%), local sensitivity disorders (9; 50%), wound complications (3; 17%) and causalgia (1; 6%).

B) Limitations of activity (Table 3): Twenty-four (69%) studies evaluated activity limitations. The functional status scale of the BQ was the most frequently used outcome (17; 71%). The use of hands in daily life activities was analyzed in nine (38%) and dexterity in only two studies (8%).¹⁶–⁵⁰

C) Restrictions of activities of social life/satisfaction (Table 3): Participation restrictions were analyzed in 12 studies (34%). Satisfaction was the most frequent outcome (6; 50%), followed by time off work (4; 33%) and aesthetic (4; 33%).¹⁶–⁵⁰

DISCUSSION

This systematic review mapped the diagnostic criteria and outcome measures used in CTS ECRs. Paresthesia, in conjunction with special tests (part of Graham's criteria)⁷, was the most widely used diagnostic clinical criterion, together with the complementary ENMG examination (mostly without the use of structured classification, such as that of Padua).⁵² Various outcome measures were found; these categorized according to the domains of the ICF. For body functions and structures, symptoms (paresthesia in the territory of the median and nocturnal nerve) were the most evaluated outcomes, measured predominantly by means of BQ. The functional status scale of the BQ was the outcome of the highest evaluation in assessing activity limitations. Finally, participation/satisfaction restrictions were mainly evaluated through patient satisfaction.

Research for diagnostic methods (clinical and complementary) of CTS is important because of the high prevalence and potential disability resulting from the disease.¹,² The presence of classical signs and symptoms (numbness and tingling in the distribution of the median nerve with nocturnal worsening) is appropriate for the diagnosis in most patients,.⁵³ However, clinical and complementary tests are important in most cases to determine the suitability of surgical or conservative management.⁵³ Graham's criteria are widely recommended.⁷ However, systematic reviews challenge the use of two-point discrimination (one of Graham's criteria), due to its low diagnostic sensitivity for CTS.⁵⁴ Our results suggest the same, because most of the studies do not use two-point discrimination.

ENMG is widely used as a complementary quantitative method and is considered an important tool for analyzing and monitoring CTS intensity.⁵²,⁵⁴,⁵⁵ Few studies utilized ENMG to predict outcomes for CTS.⁵²,⁵⁵,⁵⁶ The ENMG Padua criteria (Electroneuromyography classification for stratification of median nerve involvement in CTS), is one of the most widely used tools.⁵² However, although ENMG was a predominant complementary examination in the included studies, most did not use the quantitative criteria of Padua fully.

In addition to effective diagnostic methods, the correct definition of primary and secondary outcomes in RCTs allows the generation of responses to the hypotheses previously defined in these studies.⁸,¹⁰ The focus of the included studies was the outcomes of body function and structure, with less attention to activity limitation and participation restriction. BQ was the most widely used, being an important outcome measure for assessing symptoms (body function and structure) and functional capacity (activity limitations). BQ has good psychometric properties in patients with CTS.⁵⁷–⁵⁹ Thus, its use should replace other non-standardized methods.⁵⁹

Similarly, previous systematic reviews were less focused on outcomes related to activity limitations and participation restriction.⁸,⁶⁰ Gummesson et al. reviewed 92 studies of upper limb dysfunction. The authors demonstrated that the outcomes of body function and structure were used in all studies, while only 41% of these also used measures of activity and participation.⁶⁰

Jerosch-Herold et al.,⁸ investigated the most valid and accurate tools to assess the clinical outcomes of the CTS. The authors also reported that most of the variables evaluated (sensory functions, pain sensations, motor functions and sleep functions), were concentrated in body functions and structures. Outcomes related to activity limitations and participation restrictions were evaluated less frequently and included the functional status scale of the BQ, timed manual dexterity test, and reported time to resume activities of daily living. The only participation restriction measures were the number of days to return to work and patient satisfaction.

Considering these findings, our review informs the selection of precise outcomes for future CTS ECRs and highlights the most utilized clinical and complementary diagnostic instruments. Future RCTs should use paresthesia in the median nerve territory, nocturnal paresthesia, and special tests (i.e., the Phalen's and Tinel's tests), and ENMG with quantitative Padua criteria as diagnostic criteria for CTS. To reflect the impact of treatment on the three domains of analysis of ICF (body functions and structures, activity limitations and participation restrictions), BQ and participation restriction measures (e.g., number of days to return to work and patient satisfaction) should be standardized as main outcomes of analysis.

This is the first systematic review aimed at identifying the diagnostic criteria and the outcome measures used in ECR on CTS. The protocol was previously published in the PROSPERO database, restricting biases in methodology and enhancing credibility.⁶ In addition, in order to improve the quality of the report of this systematic review, the PRISMA statement was used.

Our review has several limitations. We only looked for studies written in English. Because we eliminated studies with less than three months follow-up to eliminate anesthesiology papers, studies of surgical interest may have been lost. We considered only RCTs, due to the greater ability to identify of the outcome. However, longitudinal studies also report results of surgical processes, and their non-inclusion may have generated the loss of important outcome and diagnostic measures.

CONCLUSION

Almost half of the high-level methodological studies do not support diagnosis based on structured clinical criteria, such as Graham's. Most use ENMG as a complementary examination. Contrary to the literature, most studies do not prioritize patient-reported outcomes as relevant or primary outcomes. A task force is needed to standardize CTS research.

• Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil
• Sources of funding: None
• Editors responsible for the evaluation process:
  Paulo Manuel Pêgo-Fernandes, MD, PhD
  Álvaro Nagib Atallah, MD, PhD

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Publication Dates

• Publication in this collection
  17 Apr 2023
• Date of issue
  2023

History

• Received
  01 Feb 2022
• Reviewed
  01 Feb 2022
• Accepted
  07 Feb 2023