Inter-Rater Judgement analysis for Item Selection in the Development of the Questionnaire to Determine Mizaij-i-Insani

is one of the basic concepts of the Unani system of medicine upon which diagnosis and line of treatment of disease are based. According to Unani medicine, each person has uniquely Mizāj recognized by physiological, psychological, and therapeutic features. Mizāj plays an essential role in the diagnosis and treatment of disease as well. Unani scholars describe several parameters for Mizaj assessment. Some relate to the structure, and others to the functions. Due to the lack of scientific validation, no standard method or tool is available to determine Mizāj in conducting research and in medical practice. The objective of the present study is to develop a practical tool in the form of a questionnaire for the determination of individual Mizāj on the human body, so based on a thorough literature scan about Mizaj , items of the questionnaire were framed


Background and objective
Mizajis one of the basic concepts of the Unani system of medicine upon which diagnosis and line of treatment of disease are based.According to Unani medicine, each person has uniquely Mizāj recognized by physiological, psychological, and therapeutic features.Mizāj plays an essential role in the diagnosis and treatment of disease as well.Unani scholars describe several parameters for Mizaj assessment.Some relate to the structure, and others to the functions.Due to the lack of scientific validation, no standard method or tool is available to determineMizāj in conducting research and in medical practice.The objective of the present study is to develop a practical tool in the form of a questionnaire for the determination of individual Mizāj on the human body, so based on a thorough literature scan about Mizaj, items of the questionnaire were framed, and the inter-rater judgment analysis was carried out to validate the items.
the proper use of diets and drugs.Therefore, we first should know the Ṭaba 'ī Mizāj of an individual.
Unani scholars describe several parameters for assessing the Mizāj of a human being through various Signs ('Alāmāt).Some parameters are related to the body's structure, and others to the functions.The assessment methods are subjective and depend upon the judgment of an individual who assesses them.Due to these issues, there is no adequate tool for determiningMizāj to be used in research and medical practice.A questionnaire by Mujahidi et al for assessing the human Mizāj is purely based on the signs ('AlāmātAmzajā) mentioned in Al Qanoon fit Tibb only 4 .Still, this study questionnaire is based on symptoms (AlāmātAmzajā) said in Al Qanoon fit Tibband included other characters as mentioned by various Unani physicians in Kamil us Sana, ZakheeraKhwarazm shahi, Kitab al Kulliyat, Firdaus ul Hikmat, KulliyatNafeesi, Kitab al Mansoori, Kitab al Mukhtarat fit TibbandKitab fil Mizaj, etc.Moreover, cross-cultural factors also show variations, which necessitate framing separate Questionnaires for the assessment of Mizāj-i-Insāni.
It is a well-known fact that Mizāj is a subjective entity; to make it practical, the most appropriate and easiest way is to formulate a questionnaire.This study attempted to develop a tool to assess Mizāj of humans from the observations mentioned in Unani literature.The most important feature of this questionnaire is its easy comprehension and feasibility, making it readily answerable without hesitancy.Several questionnaire items regarding BMI, respiratory rate, pulse rate, etc., along with other items like sleep, appetite, and daily habits, have been included in the questionnaire.Careful observations framed these questionnaire items from the literature of Unani Medicine, and ten experts reviewed it for inter-rater judgment analysis.

Methodology
The present study is based on the "preparation of tool for the determination of Mizāj-i-Insāni".The methodology framework used for the present study is based on the following steps: Literature regarding Mizāj available in Unani medicine: Content for the item selection was surveyed from Unani classical literature.The collection of material was mainly from primary sources, and classical books; secondary sources were different periodicals, journals, theses, etc. Tertiary sources were authentic digital materials, e.g., online journals, trusted websites, etc., available in other libraries and places.These places were visited to collect relevant materials from time to time.

Item Analysis through inter-ratter judgment:
Items in the questionnaire were selected based on literature mentioned in classical books.After framing the questionnaire with the help of the literature in Unani medicine, the content and face validity of the selected items were assessed by inter-ratter judgment.Ten experts with professional knowledge of Unani medicine were selected.Their indices' descriptions were explained to equalize the expert's conceptions of content validity indices (relevancy, clarity, and appropriateness of the questionnaire).They were asked to rate each item for clarity, relevance, and the appropriateness of the questionnaire from 01 to 04 (1 = unacceptable, 2 = somewhat acceptable, 3 = good, 4 = highly OK).The experts scored the individual items.Since 'AlāmātAmzajais a summative assessment, the items that fit in the 'items rate criteria ̓ were selected for each 'Alāmat.The content validity indices were calculated.To determine the inter-ratter judgment for each item's relevancy, clarity, and appropriateness, the number of experts who chose "quite appropriate" or "appropriate" for each item was divided by the total number of experts.
Ethical approval: This study was approved by ethics committee of NIUM Bangalore.

Result and Observation:
Assessment of Mizāj of normal humans is essential to describe the dominant humour, know the behavioral traits, and predict predisposition to diseases.Ibne Sina has mentioned ten signs that are required to be assessed to know the Mizāj of humans.The assessment of the signs is subjective and has to have relied on the accessor's ability to elicit the sign and its severity.Mujahidi et al developed Mizāj questionnaire based on Ibn Sina's observations.The questionnaire so developed measures the Mizaj on individual homour dominance with two domains to be assessed simultaneously.It has validated it on the Iranian population residing in a particular limited geographic region.The present study is in the process of developing Mizaj questionnaire which encompasses a larger region and the items of the questionnaire have been chosen from the vast literature of Unani medicine encompassing information from major sources of Unani medicine.It includes fifteen Available at: http://www.banglajol.info/index.php/BJMSsource books on Unani medicine.The first phase of item validation by inter-rater judgment is under consideration using face and content validity methods.The reliability and validity of the questionnaire and norm development are being taken up and the data will be available in the near future.
Identification of Domains: Domain selection was made from the mentioned types of Mizāj-i-Insan̄i for Ḥārr, Bārid, Raṭb, and Yābis characteristics along with the combination of HārrYābis, HārrRaṭb, BāridYābis and BāridRaṭb [5,6].The items were selected from the individual features or signs mentioned in Unani literature.

Literature regarding Mizaj available in Unani
Medicine: Mizāj of a person was searched from the literature.It was seen that Unani scholars interpreted a particular Mizāj through the 'Alāmāt (Signs).There were 'Alāmāt for active Kafiyāt, Hārr and Bārid and a separate list of 'Alāmāt for passive Kafiyāt, i.e., Raṭb and YābisMizāj.Also, some authors have mentioned 'Alāmāt for both Kafiyāt together [8].The 'Alāmāt mentioned in Unani literature is summarised in table 1.
Table 1.Identification of items: Thorough literature scan enabled one to choose items and locate them in various domains.

Blinking of eyes
Fast blinking of eyes-Hot-temperament people; Slow blinking of eyes-Cold-temperament people 3 . Kulliyat-e-Qanoon.
Odour and colour of urine and stool.
Hot-temperament people have a sharp odour and dark colour of urine and stool; Cold-temperament people have Light odour and light yellow colour of urine and stool 8,9,14 .

Season and food
Hot-temperament people: like cold season and cold temperament food; Cold -temperament people: like hot season and hot temperament food 3,8 . Kulliyat-e-Qanoon,Kulliyat-e-Nafisi.

Body vessels and their texture
Hot-temperament people: vessels are thick and prominent; Coldtemperament people: Inconspicuous / not visible; Wet-temperament people: vessel texture is Soft; Dry-temperament people: vessel texture is hard 1,8,9 .

Age of Menarche
Hot-temperament female: Early onset of menarche.Cold-temperament female: Delayed onset of menarche 16 .GhinaMuna.

Skin texture
Moist-temperament people: skin texture will be soft.Dry-temperament people: skin texture will be dry 3,8,9 .

Rage and anger
Hot-temperament people: get angry quickly; Cold-temperament people: Get less angry; Wet -temperament people have: Quick onset of anger which resolves quickly; Dry -temperament people: delayed irritation that lasts for a long time 1,13 .

Characteristics Signs Reference
Voice Hot-temperament people: Loud voice; Cold-temperament people: Dull or low-pitched voice.
Wet -temperament people: Captured voice; Dry -temperament people: Fine and sharp voice 1 .

Menstrual history
Hot-temperament female: menses are regular, menstrual days are normal; Cold-temperament female: overweight, oligomenorrhea or hypomenorrhea; Wet-temperament female: Most of the time cervix is wet; Menstrual bleeding is thin in consistency, menses are regular; Drytemperament female: Most of the time cervix is dry, less amount of menstrual blood 1,17,18 .

Sleep
Cold and dry temperament people: less sleep; cold and wet temperament people, More sleep; hot and wet temperament people: Moderate sleep; hot and dry temperament people: Less and Disturbed sleep 1,3,8,9,18 .

Male genital function
Hot and wet temperament people: Moderate sexual desire which is controlled, strong penile erection; Cold and wet temperament people: Less sexual desire, weak penile erection; Hot and dry temperament people: More sexual desire which is uncontrolled; Cold and dry temperament people: Very less sexual desire 1,13,18 .

Childhood illness
Hot-temperament people: If fever occurs, it is very high grade; Coldtemperament people: Sinusitis, tonsillitis, rhinitis, in the cold season; Wettemperament people: Indigestion, loose stool, rhinorrhea, edema on face and eyelid; Dry-temperament people: Dry skin, skin disorders, more in the autumn season 3,9 .

Identification of Domains and items:
Literature provides 'Alāmāt for individual Kafiyāt as well as for Kafiyāt taken together.Therefore, the questionnaire was divided into four domains.Accordingly, the Mizaj-i-Insani Questionnaire was developed with these domains.Since the literature emphasized gender-specific items apart from general items applicable to all gender.Two items were added for the female gender, and one specific for the male.The overall Questionnaire with respective domains is presented in table 2.  No changes are seen / no white line is formed.
A whitish line is included but not prominent.
A prominent white scratch is formed.

Q4
The   The number of experts in panel=10, I-CVIs-Item Content Validity index.

Content Validation of Developed Questionnaire:
Inter-ratter judgment analysis showed that the items' average I-CVI for Appropriateness, Relevancy, and Clarity were found to be0.976, 0.97, and 0.996, respectively.All things across the domain for appropriateness of judges were in perfect agreement except Q4 (0.9), Q5 (0.9), Q11 (0.9), and Q21 (0.9).However, for Q24 I-CVI value was 0.8.In the case of relevancy, Q4, Q11, and Q13 showed an I-CVI value of 0.9; in Q12 and Q21, it was 0.8.For Clarity, Q21 had a 0.9 I-CVI value.The judges perfectly rated all other items.The data for inter-ratter judgment and I-CVI values are summarised in Table No.3

DISCUSSION
Conventional medicine has focused on the biological variations between people in recent decades.Still, emerging scientific fields like epigenomics, genetics, nutrigenomics, and pharmacogenetics are attempting to categorize people according to these differences as the new and exciting field of personalized medicine 19,20 .Similarly, therapeutic interventions like prescription drugs, dietary recommendations, and lifestyle modification in Unani medicine cannot be designed without identifying Mizāj indices.Though, Unani medicine conceptualizes the concept phenomenologically.
One of the fundamental requirements in every system of medicine, including Unani medicine, is the design and validation of standard scales to achieve empirical measures.The most crucial prerequisites for strategic development in this area are having access to a decision support system, physical diagnosis, equipment application, and a questionnaire-based format that a professional or self-administered person can do 21 .
This study aims to develop a questionnaire to determine the Mizāj indices of human beings and test the questionnaire for content validity.A diagnostic consensus among experts is one of the first stages toward achieving this objective 22 .The instrument design process involves identifying the content domain, selecting samples from the content (item creation), and building the instrument[ 23 .
The first step is to identify the construct's content domain, which the instrument is designed to measure.The subject matter associated with the metrics is referred to as the content domain [ 4 .A review of the relevant literature, interviews with respondents, and focus groups can all be used to find it.The intended construct's boundaries, size, and constituent parts can be seen by precisely explaining its traits and qualities.Qualitative research techniques can also ascertain the relevant construct's variables and concepts [25].On account of this.First, we surveyed Unani classical texts to select the domains; then, the items from Unani classical literature in respect of 'Alamāt-i-Amzajawere envisaged.Ultimately questionnaire format was designed in a closed-ended format, with an appropriate number of options for each question.In this questionnaire format, the total number of domains is four, and the number of items is twenty-five.Four questions are related to Mizājof the heart and its functions like Nabḍ, Tanaffus, and human behaviours: bravery, coward, anger, and calmness.These are essential items because every Unani physician considers that Mizāj of heart affects Mizāj-i-insani 1,8,26 .
Four questions are related to Mizāj of the brain, like how someone reacts to any action, blinking of eyes, sleep, and decision making.Four questions are associated withMizāj of the liver: vessel texture, digestion quality, secretion of matter, and the formation of waste products.Three questions about physique are asked, one about the proportion of muscle and fat mass and the other about body shapes such as the broad chest, narrow chest, palm, and finger.Three questions are related to the urogenital system irrespective of male or female.For example, in the case of the feminine gender, the age of menarche and menstrual history are considered, whereas, in the masculine gender, sexual desire is felt.Two questions about the seasons are asked; one is compatible with the season other is antagonism with the season.One question is related to lungs, such as the nature of producing voice.Three questions are related to the disposition n of skin texture one is about touch characteristics, and the remaining two are related to the secretion of the skin.
In 2008, Shahabi et al. examined healthy persons of hot and cold nature/Mizājregarding their altered neuroendocrine and immune systems.They claimed they used a prescribed questionnaire for evaluating the temperament and nature of the determination of the subjects.But they failed to cite any references or scientific methods for their claim.Shahab et al 27 .andmujahidin et al. group criticized the given classification of human beings into nine groups by Shahabi et al 28 .
Herewith, Mujahidi et al state that classification deals with the pathological condition of the body.Indeed, it is not justified because such a classification is valid and exists in Unani classical texts and their arguments as described by many Unani scholars in their writings.Because in these groups, a certain Khilṭ dominates either in singular or compound Mizājof people, but the preponderance of Khilṭ is within the range, and these kinds of person are standard 1 .However, in respect of some indicators of diagnosis where Mujahidi is correct, for instance, a number of the elements used in the questionnaire above, including gastrointestinal issues, skin rashes, epistaxis, etc., are pathological symptoms that show up in sickness and an unbalanced Mizāj 28 .claimed in 2011 that they divided their chosen volunteers into various groups based on their temperaments.However, they omitted to reveal their measurements or method of selection.Other trials that are available but had similar ways of errors.
It has become a crucial step in creating the instrument due to the significance of content validity in its psychometrics and connection to reliability 29 .The content validity index is the approach for content validity that is most frequently mentioned in instrument development studies 30 .Panel members are asked to rate instrument items on a 4-point ordinal scale (1 [not relevant], 2 [somewhat relevant], 3 [quite relevant], and 4 [highly relevant]) based on their clarity and relevance to the study's underlying construct as defined by theoretic definitions of both the constructs itself and its dimensions 31,32,33 .The I-CVI calculations for the relevancy of each item are as follows.In this category, from all four domains, 20 items had an I-CVI of 1.00, 3 items had a score of 0.9, and 2 items had a score of 0.8.All these items were considered relevant.The I-CVI calculations were for the appropriateness of each item.In this category, from all four domains, 20 items had an I-CVIs of 1.00,4 items had a score of 0.9.1item had a score of 0.8.Most of the items were considered relevant.The I-CVI calculations were considered for the clarity of each item.In all four domains, 24 items had I-CVIs of 1.00, and 1 item had a score of 0.9.Most of the items were considered as clear.
Based on the content validity analysis, the result obtained from I-CVI and S-FVI/Ave, it was observed that the content validity parameters were above 0.90, indicating an excellent inter-ratter judgment.Thus, the content validity of the questionnaire for assessing the Mizāj questionnaire format was appropriate to determine further the validity, reliability, and norm development of the questionnaire.There were some limitations or drawbacks that could be considered for future studies.Still, a quick, valid, and user-friendly self-report scale is proposed for Mizāj identification indices.It is suggested that the questionnaire may be developed further regarding reliability, validity, and norm Standardization.

CONCLUSION
The tool in the development process showed fair I-CVI and S-FVI/Ave values that suggest that the items are appropriate.The Questionnaire may be developed further regarding reliability, validity, and norm Standardization.

Domain 1
had eleven items, indicating the Hot-Cold Axis.Domain II consisted of five items, indicating the Moist -Dry Axis.Domain III had five items, and all the items indicated the Hot, Cold, Moist and Dry Axis, and Domain IV consisted of four items, and all items indicated the Hot and moist, Hot and dry, Cold and wet, cold and Dry Axis.The questionnaire is in a closedended format, with an appropriate number of options for each item.In all, there were twenty-five items in the questionnaire.Respondents need to tick the option that describes them the best.

Table 2 : Item Construction of Questionnaire as a tool to assess the Mizāj-i-Insani.
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