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Knowledge, attitude, practice, and beliefs about drug proving in students of Homoeopathy

Background and Aim: Students in homoeopathic colleges are often encouraged to participate in drug proving programs. There is no valid and reliable instrument for identifying their concerns. Therefore, an instrument has been designed and tested to identify knowledge, attitude, practice, and beliefs (KAPB) of homoeopathic students. This can be used for motivating students to participate in drug proving programs. Design and Methods: First, the questionnaire items were identified by a telephonic interview with investigators of drug proving program. The questionnaire was pilot tested on interns of a homoeopathic college to identify its internal consistency, test-retest reliability, and face and construct validity. A survey using this instrument followed by training of homoeopathic medical students was conducted, and the change in KAPB was also assessed. Results: A questionnaire of 28 questions testing knowledge, beliefs, attitudes and practices was developed with Cronbach's α =0.71 for the entire scale. Students were of the opinion that with participation in proving studies, homoeopathic Materia Medica will develop, which will be their contribution to Homoeopathy. Students will be personally benefitted by having an experiential knowledge rather than theoretical knowledge of philosophy. Although the majority is aware that proving does not cause long-term damage to health, nor does it cause irreversible pathological change, a major concern is the development of severe or unmanageable symptoms. Students can be motivated to participate in proving programs by re-enforcing that it will be a unique experience, assuring them about that no acute unmanageable symptoms are likely to develop.


INTRODUCTION
Homoeopathic drug proving program (or Homoeopathic Pathogenetic Trial) is essential and fundamental for the development of materia medica of new drugs and validating the existing information. Most proving trials are done in homoeopathic teaching or research centers with students or sympathizers of Homoeopathy as volunteers [1] under the supervision of research scientists/faculties. In India, in undergraduate curriculum prescribed by the Central Council of Homoeopathy the students are taught about drug proving under the subjects Organon of Medicine and Principles of Homoeopathy, Pharmacy, and Materia Medica. [2] Central Council for Research in Homoeopathy (CCRH) conducts drug proving on standardized protocols. [3][4][5] Till date, Council has conducted proving of 98 drugs. [6] Proving studies are mostly conducted in collaboration with homoeopathic colleges where scientists from the Council and teachers from the colleges, encourage students to participate.
Although homoeopathic physicians and students are considered to be the best provers, [7] there are ethical concerns in involving students into any research program, [8] which includes obtaining their written informed consent voluntarily to participate as provers. Over the years, it has been identified that students do not come up proactively to participate in drug proving. Motivational sessions and training programs are required to encourage students. However, for these programs to be effective, it is essential that they bridge the knowledge gap, remove myths, and address specific concerns and apprehensions of students. For this, knowledge, attitudes, practices, and beliefs (KAPB) of students about drug proving is desirable.
One study has been conducted in the past to identify the KAPB of students and interns in homoeopathic college about the drug proving programs. [9] No standardized questionnaire used in the study. Therefore, firstly an instrument was developed, tested, and validated. Thereafter, it was used in to identify KAPB and detect a change in KAPB of students following a training session.

STUDY 1: QUESTIONNAIRE DEVELOPMENT
Study 1 was conducted to develop a KAPB questionnaire.

Procedure
A telephonic interview was undertaken with seven proving masters. They were asked three questions: • What questions do students commonly ask when they are approached for enrolment? • What are the common reasons provers often cite for not being interested? • What do the investigators tell the students to encourage them for enrolment?
The responses of the proving masters were listed. The responses were assessed to develop individual items of the questionnaire, under the four domains. These items formed one part of the questionnaire. Questions to compile demographic data and experience with proving were added.

Result
In response to the 3 questions, 44 responses were generated. Out of these, 15 responses to the questions asked by students and common reasons of not being interested were on personal health concerns such as, "if any long lasting or serious symptoms develop during proving." The provers also ask about the "drug that would be given to them during proving." Since studies are doubleblind studies, the investigators themselves are not aware of the drug substance, which would be given to the provers. Students also frequently ask about "procedure of the study and incentives that they would be given to participate in proving and time that they will have to devote to drug proving in terms of duration and frequency of visits to the proving masters." Reasons for dropouts identified were fear of undergoing investigations, concerns by family members, and personal illness. Proving masters usually inform students that the symptoms will be mild in nature, and antidotes or appropriate treatment will be given if need be, when motivating them for proving.
Based on the responses received, 30-item KAPB questionnaire consisting of 10 on knowledge, 10 about beliefs, 5 each on attitudes, and practices was developed. Response option of definitely true, probably true, probably false, definitely false, and do not know was kept. Both positive and negative questions were included to maintain a balance and reduce unidirectional responses.

STUDY 2: PILOT TESTING OF QUESTIONNAIRE
The questionnaire was pilot tested to identify its internal consistency, test-retest reliability, and face and construct validity.

Method Participants
Homoeopathic bachelor degree students in their internship year (interns) of Nehru Homoeopathic Medical College and Hospital, Delhi.

Reliability study
Forty-four (44) interns consented to participate after they were explained about the purpose of the study. Written informed consent was taken from all participants. The participants were asked to fill in the questionnaire completely to the best of their ability. At the end of the test, participants were requested not to discuss the questionnaire and their responses with others, until the re-test part has been completed. This was done to ensure that in re-test, individual responses of the participants are obtained and not of the group. Re-test was conducted after a gap of three days. Thirtysix interns (36) reported for re-test. Written informed consent was taken from all participants again, and the same questionnaire was applied.

Validation study
Interns who had participated in the re-test were invited for focus group discussion. Two independent focus group discussions were conducted simultaneously by the research team, in separate halls by (AK, SS and DT, GM). It was discussed if the questionnaire covers all aspects of concerns that the students/interns can have about drug proving. Opinions of the interns about the questionnaire, problem areas in terms of difficulty faced in understanding of questions, clarity of questions, familiarity or unfamiliarity with questions, problems while filing the questionnaire and any feedback related to questions, scale adopted for evaluation, and queries related to the questionnaire were assessed.

Statistical Analysis
The data were tabulated electronically in  Table 1]. Internal consistency was calculated using Cronbach's coefficient alpha (α) for the four domains (KAPB) and total score. Intra-class coefficients for each item and total score were estimated to assess test-retest reliability.

Demographic data
Of the 44 interns who participated in the test study, there were 36 (81.8%) females and 8 (18.2%) males.
Only 23 students had participated in the drug proving program, 21 had no experience. Twenty-five (25) interns confirmed that they had interacted with provers about the drug proving, whereas 19 had not interacted with any provers. There were multiple responses to the source of information; 31 said that they learnt from their teachers only, where remaining learnt from varied sources that include teachers, peers and earlier provers [ Table 1].

Reliability
The Cronbach's α for the five parameters of the KAPB and the total is given in Table 2. According to the rule of thumb [10] Cronbach's α (α = 0.71, p = 0.001) was acceptable for the questionnaire.
Test-re-test reliability calculated for individual items was statistically significant for 24 questions [ Table 3].
Of the 44 interns, only 36 (81.8%) completed re-test. As such the data pertains to only 36 participants. Only peers 4 (9.1)

Coverage of concerns about drug proving
Concerns were raised about the intensity and duration of symptoms appearing during drug proving. They were also not sure if proving process permits the use of any medicines in case of emergency. The question items were covering most of these aspects. The opinion of students varied if drug proving improves immunity. Since there are no available studies on the effect of proving on immune parameters, the question "if proving raises immunity" was deleted.
In response to the question, if drug proving improves knowledge of Materia Medica, some students were of the opinion that although students can become more aware of symptoms that they develop, there is no actual improvement in knowledge of materia medica until they come to know of the drug that they have proved and symptoms that have appeared for that particular agent in proving study.

Difficulty faced in understanding of the questions
The difference between ethics and morals is not clear. As such it is difficult to answer the question if drug proving is ethical or not and if students have a moral obligation to participate in drug proving. The students were not familiar with the term ethics and ethical committees. As such the question was deleted.
The question drug proving process is a long process is not a specific question and both the terms "process" and "long" add to the ambiguity. It is not clear if long means 6 months or 1 year and for whom. If the entire process of deciding on the drug to be proved, to identification and enrolment of provers, giving the drug to provers to the compilation of data and publishing it is concerned, then it is a long process. If only drug intake by provers is concerned, then it is not a long process. The question that proving is a long process was modified and the frame of reference to prover was added, i.e. for a prover, proving is a long process.

Familiarity or unfamiliarity with the questions
The interns though familiar with the term phase I trial were not clear about purpose and process of a phase I trial. Although most of them were of the opinion that the process of drug proving is different from phase I trials, they were not clear about the difference between the two.

Change in questionnaire
Two questions were deleted. Slight modification in language was made for 2 questions. The Cronbach's alpha for the questionnaire after deleting 2 questions was also 0.71 and was found to be acceptable.

Scale adopted for evaluation
The scale used "definitely" and "probably," caused confusion to the interns. The response options could be specific as "yes" or "no" and or can be quantifiable. With probable being a response option, it adds to the confusion that the interns already have about the issues. The scale used was therefore modified.

Instrument Developed
A KAPB questionnaire was developed consisting of three parts: First part contains demographic data, participation in a drug proving program and source of receiving information about drug proving.
Part two of the questionnaire consists of 28 KAPB Questions, 9 questions on knowledge, 9 on beliefs, 5 on attitudes, and 5 on practices. The questions comprise of 5 options, with scoring system used as: 5 = strongly agree with the statement, 4 = agree, 3 = neutral, 2 = disagree, and 1= strongly disagree with the statement. To avoid bias both positive and negative statements are included. The scores of negative statements are to be reversed while calculating the total score. All items are to be scored so that high scores reflect high knowledge, positive attitudes, correct beliefs, and positive practices toward drug proving.
Third part had questions to identify motivators and de-motivators for participation in drug proving studies and yes/no response to the willingness of the students to participate in proving studies.

STUDY 3: KNOWLEDGE, ATTITUDE, PRACTICE AND BELIEFS SURVEY
A survey was conducted to identify KAPB of students about drug proving. The survey was repeated to identify a change in KAPB after a training session for students.

Method Participants
Graduation students on ANSS Homoeopathic Medical and Hospital (ANSSHMH), Kottayam.

Procedure
In a seminar on drug proving at Central Research Institute of Homoeopathy, Kottayam for the students of ANSSHMH, printed questionnaire and voluntary informed consent were distributed. The survey was conducted before the seminar. The students were given 15 minutes to fill in the questionnaire and return them to the research team. Immediately at the end of the seminar, the questionnaires were again distributed and were returned by students after 15 minutes.

Statistical method
The data were tabulated electronically using Microsoft Excel and analyzed by using the software IBM SPSS 20.0 version. The demographical details of the participants were expressed in frequency and percentage [ Table 4]. Means and standard deviations were calculated for KAPB items and for complete scale. The items left blank by respondents (missing data) were put in as zero when calculating scores, i.e., scale score represent the average for all items in the scale answered or not answered. Total scores and scores for subscales on KAPB scores were compared before and after the training intervention. Paired t-test was used to compare mean scores.
Qualitative data were analyzed to identify motivators and de-motivators of the students for participation in drug proving programs.

Results
Pre-training and post-training assessments were filled by 122 participants present at the seminar.

Demographic Data [Table 4]
Of 122 students, most (63.11%) were students of the 1 st year in the age group of 18-20 years. Percentage of female students far exceeded the male students. Only 8 students had participated in a drug proving program, as compared to 114 with no experience. However, 34 students responded that they have interacted with provers about drug proving, whereas 88 had not interacted with any provers. There were multiple responses to the source of information about the drug proving program. Teachers are the main source of information followed by peers.

Change in mean scores before and after training
There was a statistically significant increase in mean scores after the training [ Table 5]. Change in individual items was also identified [ Table 6].

DISCUSSION
This is a first study conducted on a standardized questionnaire to identify KAPB of students about drug proving. The reliability of the questionnaire was confirmed using measures of internal consistency and test-retest and validity was examined. The questionnaire was identified to have an acceptable level of face and construct validity based on the focus group opinion generated by the interns. The scale was able to identify knowledge, attitudes, beliefs, and practices of students and change in KAPB scores before and after training.  A major concern of the students for participation in a program is the development of symptoms [ Table 7]. The test-retest reliability for the questions "Symptoms produced during drug proving are transient" and "A prover may develop severe unmanageable symptoms" was not significant. The KAPB survey identified that students have a fear of developing severe symptoms or unmanageable symptoms. After the training, a significant increase in the score was seen in response to the question that symptoms produced during drug proving are transient. However, the response to the question that drug proving causes old symptoms to appear reduced. No change was seen in response to the questions that prover can develop severe unmanageable symptoms, proving causes interference in concentration and natural life cycles get disturbed during proving. In the survey, 31 students were worried about adverse changes in the health that drug proving can possibly cause. Only eight students had mentioned that the overall health will improve after participation in drug proving [ Table 7]. However, overall scores indicate that students are aware that proving does not cause long-term damage to health of a person, nor does it cause irreversible pathological change.
It was identified that students have a good theoretical knowledge, but lack practical aspects. The knowledge and the beliefs that the students develop about drug proving are primarily influenced by teachers. Very few students have had actual interactions with prior provers and therefore, actual experience does not translate into knowledge that students gather. This is reflected in low scores of students in response to questions such as "A prover is bound to report to the proving master on a fixed schedule," "Provers must divulge the most personal details and life situations during proving," "A prover can withdraw voluntarily from the drug proving at any time." Some of these improved after the seminar. Although, for research studies, prover needs to report to the proving master as per schedule, enough leverage is available within the protocol, to ensure that the routine of the prover is not disturbed. The provers can withdraw voluntarily from proving at any time. The prover needs to be detailed about the procedures followed in the study. Interactions with those persons who have participated in proving studies before can also possibly reduce these misconceptions.
Students who are potential provers are also not aware of management of symptoms. The scores to the question that prover is not permitted to take treatment during drug proving even in an emergency did not have any change after the training. The provers need to be assured about the management of side effects if any and of use of medicines in case of emergency as is identified in the proving studies.
Low scores were seen in response to the question that provers have a moral obligation to participate in drug proving. Even though homoeopathic physicians are the best provers, participation in research studies should necessarily be voluntary and should not be under any moral obligation. The training programs must specifically address this issue. It is strongly suggested issues related to morals and ethics must be discussed with the students, prior to initiation of proving trials.
In the survey, 29 students were of the opinion that the homoeopathic Materia Medica will develop, and participation in drug proving will be their contribution to Homoeopathy [ Table 7]. With participation in proving students will be personally benefitted by having a better knowledge of medicines or by having an experiential knowledge rather than theoretical knowledge associated with homoeopathic philosophy. Proving studies bring in finer symptoms of materia medica, which the students can appreciate better if they have experienced some symptoms themselves. The scores were high in response to the question that drug proving improves knowledge of students about Homoeopathy.
This 28-item tool assesses KAPB of students of Homoeopathy regarding drug proving. The survey instrument can be used independently to identify the student perspective about drug proving. It can also be used in addition to a drug proving enrolment motivation program to assess change in the student perspectives after the motivation programs. Reprint of the questionnaire developed can be requested from the authors.

Limitations
It is presumed that the students have a basic understanding of the philosophy of Homoeopathy and principles of drug proving. As such the questionnaire can only be used for homoeopathic students and practitioners. It cannot be used for the general public while inviting them into drug proving programs.
Since the internal consistency of subscale items is <0.70, it is suggested that the scale is used in totality and individual subscales are not used until the scale is further developed and the internal consistency of subscale items increases.
The scale used in the study is in the process of development. This is the first survey study conducted using this questionnaire. More studies of similar nature are required to develop the scale fully.

CONCLUSION
Students can be motivated to participate in proving studies by re-enforcing that drug proving will bring in experiential knowledge, rather than theoretical Desarrollo de un cuestionario sobre los conocimientos, la actitud, la práctica y la idea que tienen los estudiantes de homeopatía en cuanto a las drqgas patogenesias RESUMEN Fundamento y objetivos: Con frecuencia, se solicita que los estudiantes en las facultades homeopáticas participen en programas de patogenesias de remedios homeopáticos. No se dispone de instrumentos válidos y fiables para identificar su postura al respecto. Por ello, se ha diseñado y examinado un instrumento para identificar el conocimiento, la actitud, la práctica y la idea (CAPI) de los estudiantes homeopáticos. Dicho instrumento se puede utilizar para motivar a los estudiantes a participar en los programas de patogenesias. Diseño y métodos: En primer lugar, los investigadores del programa de patogenesias realizaron entrevistas telefónicas para identificar los ítems que se incluyen en el cuestionario. Dicho cuestionario piloto se planteó a los internos de una facultad de homeopatía para identificar la homogeneidad interna, la fiabilidad de "test-retest" y la validez de aspecto y concepto. A continuación, se efectuó un ensayo utilizando este instrumento seguido de la formación de los estudiantes de medicina homeopática, evaluando además el cambio en su CAPI. Resultados: Se desarrolló un cuestionario de 28 preguntas para examinar el conocimiento, la idea, la actitud y la práctica, mediante la α de Cronbach = 0,71 para toda la escala. Los estudiantes eran de la opinión de que, gracias a su participación en los estudios de patogenesias, se ampliaría la materia médica, lo que significaría su contribución a la homeopatía. Los propios estudiantes se beneficiarían por adquirir un conocimiento experimental más que uno teórico conocimiento de la filosofía. Pese a que la mayoría de ellos era consciente de que la patogenesia no puede causar efectos nocivos a largo plazo en la salud, ni provocar cambios patológicos irreversibles, una de sus preocupaciones principales era el desarrollo de síntomas graves o inmanejable. Es posible motivar a los estudiantes a participar en las patogenesias haciendo hincapié en que se trata de una experiencia única, y garantizándoles de que no es probable que se desarrollen síntomas agudos inmanejable.