Abstract
Communication skill is a core competency and the training must begin in the undergraduate period itself. The Phase III MBBS students during their ENT posting are required to obtain informed consent for procedures and surgeries in ENT which forms the basis for efficient communication skills in house-surgency (internship) and residency. Informed consent taking is an important aspect and in the clinical postings, the teaching of communication skills along with history taking and physical examination can go a long way in making a strong foundation to good doctor patient relationships. This study aimed to compare the structured consent process using modified Delphi technique with the standard process in obtaining informed consent for procedures in ENT by PHASE III MBBS students. The need to sensitise the MBBS students on appropriate consent taking procedures with familiarisation of the essential elements of the Kalamazoo consensus statement were raised, accepted and final OSCE assessment attributes decided by the modified Delphi technique. The Modified Delphi technique is a unique means to obtain opinions of experts across the field in various spheres so as to identify lacunae if any in the existing teaching with means to reach a valid and reliable consensus. Our study included Phase III MBBS students posted to the Department of ENT, Govt Medical College Kozhikode during Jan–Feb 2022 wherein one batch of 30 students were taught with 2 classes on informed consent taking by the structured process obtained after Modified Delphi technique and included as; “MD” group and another batch of 30 students from the entire batch taught by the standard process was included as; “T” group respectively. After completion of the clinical postings an assessment was carried out with OSCE stations in Mar 2022; wherein 10 students were evaluated for each of the 6 common ENT procedures, 5 students from “T” group and 5 students from “MD” group respectively. Median total score of MD group was 6.5 (3.25–8) and median score of T group was 4.5 (2.25–6.75). The difference in mean ranks of these scores was statistically significant, p < 0.0001. The feedback assessment using the questionnaire with Likert scale had all 30(100%) students recommend this method of structured consent taking for enhancement of communications skills. However 20% of the students were not satisfied with the teaching learning method expressing the need for more time allocation and demonstrations. Informed consent taking requires the appropriate training in the undergraduate period itself as seen by the improved OSCE scores on assessment after teaching by the structured consent taking process as well as from the feedback of the students.
Keywords: Communication skills, Informed consent taking, ENT procedures, Modified Delphi technique
Introduction
Communication skill (CS) development is an important aspect of medical training that is crucial for doctor-patient interactions. Strong communication skills are important for prospective physicians and should be taught as early as possible in medical training as it is a key component of the curriculum of medical schools [1]. CS is regarded as one of the fundamental factors for delivering high quality health care. Good communication skills in physicians can be understood as a multidimensional phenomenon, which is characterised by an emphasis on patients’ expectations, concerns and emotions and their need for information. Relationship building, negotiating and facilitating patients’ co-operation are also core elements of communication skills [2].
The practice of informed consent has historical roots in various disciplines and plays a critical role in medicine as we are in the era of patient as a consumer and doctor as a service provider. Knowledge of communication skills increases through an experiential approach to learning [3]. The students’ ability to identify communication skills varies depending on the skill sub-type. Studies have found students to be better at identifying information or organization based tasks such as sharing information and closing the discussion. They were weaker at recognizing patient-centred tasks such as building the relationship and reaching agreement with the patient [3]. Training for novices should focus on the development of patient-centred communication skills and on how to recognize and improve ineffective communication. The MBBS students in phase III during ENT postings are taught to obtain consent for various procedures using the standard process by role plays and small group discussions. It is imperative on the part of the treating doctor to ensure that the patient fully understands all of the information that has been explained and provides answers to all questions asked by the patient in a manner that the patient considers satisfactory and in understandable terms. In medical schools the formal training in consent taking is mainly during residency by observation. The role of effective communication can be compared to the toppings on the pudding which can make significant impact on the patients and their relatives who are looking forward for due support and concern during the period of illness. The patients invariably can be made to feel better when they are kept informed of the happenings with the involvement in decision making which is their fundamental right. The Delphi technique is an approach used to gain consensus among a panel of experts. It has much to offer in terms of gaining consensus from a wide range of individuals on specific topics [4].The incorporation of learning proper counselling of patients and developing the right skills in improving communication and interpersonal relationships will go a long way, if began early during the MBBS graduation itself. The Phase III MBBS students do attend the clinical postings in ENT where it would be feasible to sensitise them on the importance of informed consent taking. Therefore a structured consent process using the modified Delphi technique can help consolidate and strengthen the existing process thereby enhancing the communication skills. In order to be a ‘good doctor’, physicians require not only clinical and scientific knowledge, but also excellent communication skills to ensure a good doctor-patient-relationship [5–7]. The competences necessary for the application of the Kalmazoo criteria can be taught in medical curricula and can be examined in OSCE exams (objective structured clinical examination) [8]Overall good communication skills requires all four dimensions to be addressed; empathy, content structure, verbal expressions and non verbal expressions. As highly developed communication skills are crucial for doctor-patient interactions, it is recommended to incorporate them in teaching from the very beginning at medical school [9, 10]. If knowledge of medicine, surgical skill, and clinical acumen is the craft of medical practice, the communications skills are the fine arts [11]. Professionalism, which is an integral part of good medical practice, also demands effective communication skills along with knowledge, skill, competence and ethics. There are certain misconceptions about teaching communications to medical students, like communication skills are not considered teachable, or the skills acquired during training period tends to decline over time [12]. In fact inculcating habits of good communications skill during formative years will help the medical students and future practitioners [13]. The most effective point in time to learn these at medical school is probably during the clinical posting. After a short training, doctors can be effective as teachers [14]. The development of a structured consent process for obtaining consent from patients for various procedures in Otorhinolarygology can help in improving the communication skills acquired by the medical student in Phase III during their clinical posting itself. The aim of the study is to enhance the communication skills of an Indian medical graduate ensuring a strong foundation to enable them excel in clinical practice.
Objectives of the Study
To compare the structured consent process using modified Delphi technique with the standard process in obtaining informed consent for procedures in ENT by the final year MBBS students.
To assess the feedback from the students on the effectiveness of the method in improving communication skills.
Materials and Methods
The study is a prospective study that was conducted at the Department of ENT, Government Medical College Kozhikode on the Phase III MBBS students during their clinical posting in the department after obtaining approval from the Institutional Research Committee (Ref No. IRC/2021/Protocol/316 dated 23/10/2021) and Institutional Ethics Committee (Ref No. GMCKKD/ RP 2022/IEC/02 dated 10/01/2022) respectively.
The Delphi technique is commonly used in health care research and seeks opinions from a group of experts to assess the level of agreement and resolve disagreement on an important issue [4].In our study the modified Delphi technique was used to build consensus [15]on a set of items generated through literature review.
The consensus building in this study was conducted in three phases:
-
(i)
Identification of modifications required in the teaching learning method to improve and enhance the process of consent taking for procedures in ENT with development of a structured process and assessment protocol.
-
(ii)
The modified Delphi study was conducted to build the consensus (Dec 2021 to Jan 2022)
-
(iii)
A consensus was arrived with preparation of structured consent process which was to be taught along with appropriate OSCE assessment form for evaluation.
Phase I Informed consent taking in ENT is taught to the Phase III MBBS students while they are in the OPD, during demonstration of minor procedures and also in OT during observation of major surgeries. It definitely requires thorough knowledge of the procedure or surgery with understanding of the likely complications, follow up and ability to answer the common queries of the patients. The standard process has consent taking included in theory classes with practical demonstrations during observation of each procedure or surgery with assumption of knowledge of attributes of communication skill. However there is a need of teaching the elements of communication skill assessment with modification of the existing teaching learning method. Therefore the Kalamazoo consensus statement and essential element communication checklist was used as the basis to develop the structured consent taking process for 6 common procedures in ENT with an OSCE assessment form to help evaluate the students.
The 6 procedures in ENT selected for the study included commonly performed procedures done in wards, minor procedure room or operation theatre where informed consent taking is important and also required to be carried out by the house surgeons under supervision of the resident or Medical faculty on duty:
-
(i)
Wax removal
-
(ii)
Diagnostic Nasal endoscopy (DNE)
-
(iii)
Diagnostic Nasal endoscopy (DNE) in pediatric patients
-
(iv)
Flexible Nasopharyngolaryngoscopy (Consent being similar to any endoscopic procedure commonly done in ENT for diagnostic purposes)
-
(v)
Rigid endoscopy with Foreign body removal throat
-
(vi)
Incision and drainage in a patient with quinsy
After the procedures were selected and OSCE assessment form was devised, an expert panel was selected. The experts selected included professionals in the field of ENT working in a clinical or academic setting with experience over 15 years ensuring representation from the government and private sectors as well as from teaching institutions and corporate hospitals respectively.
The study sample included Phase III MBBS students posted to the Department of ENT, Govt Medical College Kozhikode during Jan–Feb 2022 wherein one batch of 30 students taught by the standard process were included as; “T” group and another batch of 30 students were taught with 2 classes on informed consent taking by the structured process obtained after Modified Delphi technique and included as; “MD” group respectively. The students were explained about the study, those interested and willing were allowed to participate after obtaining an informed written consent as in Annexure 1.
After completion of the clinical postings an assessment was carried out with OSCE stations in Mar 2022.The OSCE assessment was carried out on any one procedure wherein 10 students were evaluated for each procedure, 5 students from “T” group and 5 students from “MD” group respectively ensuring that all 30 students of both groups were evaluated. The evaluation by OSCE was carried out for all the 6 procedures taught with random assignment of students from both the groups respectively.
Phase 2 Invitation e-mails were distributed to the identified experts for inclusion as panelists. Invited experts who consented to participate were then sent the study protocol with request for suggestions/ modifications required in the consent taking process for the identified common procedures in ENT. The panelists were required to evaluate the set of items in the OSCE sheet with respect to the feasibility, validity, efficacy and reliability. The suggested modifications were made and the alterations included removing, replacing and rephrasing some of the text with elaborations to make statements clearer and specific.
Phase 3- The final structured consent process with the appropriate OSCE assessment form was finalised for the various procedures and surgeries in ENT. The final OSCE assessment form had 9 attributes to be assessed with 22 sub attributes which was an attempt to include all the essential elements in informed consent taking. The finalised OSCE assessment form is as attached in Annexure 2. The students of both the “T” and “MD” group were evaluated using OSCE scores. The feedback from the “MD” group was obtained to assess the student satisfaction and appreciation of the new structured consent process. The students graded their opinions using the 5 point Likert scale. The feedback form used is as attached in Annexure 3.
Statistical Analysis
Statistical analysis was done using SPSS 16.0. Feedback assessment data was expressed as frequency and percentage and scores of OSCE assessment was expressed as median and range. Normality of the data was tested using Kolmogorov-Smirnov test. The comparison between the two groups was done using Mann-Whitney U test. All tests were two sided and a p value < 0.05 was considered statistically significant.
Results
The modified Delphi method aimed to highlight lacunae if any in the present training of Phase III MBBS students in obtaining informed consent for procedures in ENT with likely suggestions or modifications to help develop a structured process for the same.
Phase 1 Identification of the procedures in ENT and expert participants to be included in the study.
The common ENT procedures done were included in the study with relevance to those seen in emergencies, where the role of house surgeons is important. Since the MBBS students during their house surgency are required to be present in the casualties, wards and minor procedure rooms; procedures routinely done here in ENT were included. A total of 6 procedures including; procedures done in minor procedure rooms like wax removal, diagnostic nasal endoscopy (DNE) in adults and pediatric patients, procedures done in wards like incision and drainage of quinsy, most common ENT emergency presenting in the casualty foreign body throat and hence rigid endoscopy with removal of foreign body and flexible nasopharyngolaryngoscopy too were included in our study.
Eight experts were identified based on our predefined inclusion criteria for “expert” panelists including 2 from Government Medical Colleges in Kerala, 2 from private medical colleges in Kerala, 1 from Government Medical College in India, 3 from the private sector. Of the experts 75% felt the need to improve the informed consent discussions as it is indeed a core entrustable professional activity that all medical students must be well versed with upon entering residency. The consent taking process for surgeries though felt more important since the study included MBBS students the included procedures were acceptable as it would lay a strong foundation which could be extrapolated for other procedures and surgeries if well understood.
Phase 2 Modified Delphi study to build the consensus.
An invitation to participate in the study was sent to all 8 experts with the study protocol. The confidentiality was maintained and time allotted to receive replies. Though all readily consented to participate in the study replies with suggestions and modifications were received from 75% of the experts. The structured consent process was prepared incorporating all the modifications and sent again to all of them. The remaining experts were contacted for their valuable suggestions, they were satisfied with the structured consent process and OSCE sheet with no modifications proposed. The concerns that arose included; assessment of these students would actually be during their residency when they interact with the patients and that the OSCE assessment sheet was cumbersome for evaluation.
Phase 3 Final preparation of the structured consent process and appropriate OSCE assessment form for evaluation.
Finally by the end of the modified Delphi study, the structured consent process was prepared wherein the Kalamazoo consensus statement on essential elements in communication and assessment tools were incorporated. The OSCE assessment form included 9 attributes with 22 sub attributes for which the students were evaluated and compared.
We have 2 groups of students; Group “T” 30 students who obtained training in the informed consent taking for procedures in ENT by the standard process and group “MD” wherein 30 students obtained training in informed consent taking for procedures in ENT by the structured consent process using modified Delphi technique. The OSCE was conducted for all the students; since there were 6 procedures 10 students were assessed for each; 5 from either groups. The scores obtained were entered in the Excel data sheet.
There were a total of 9 attributes in the OSCE assessment. Sum of scores of these 9 attributes was calculated to get the total scores obtained by each of the students. The minimum, maximum and median scores of individual attributes are given in Table 1.The Kolmogorov-Smirnov test p value was < 0.005 for total scores as well as for all individual attribute scores for both groups showing a violation of normality. Median total score of MD group was 6.5 (3.25–8) and median score of T group was 4.5 (2.25–6.75). The difference in mean ranks of these scores was statistically significant, p < 0.0001. Only one student in MD group got a lower score of 3.25 and rest all students scored > = 5.5. All the differences in mean ranks except for attribute 6 were statistically significant.
Table 1.
The minimum, maximum and median scores obtained for the attributes in the OSCE sheet by students of the two groups respectively
| Group | Min score | Max score | Median | P value | |
|---|---|---|---|---|---|
| Attribute 1 | MD | 0.25 | 1 | 0.75 | < 0.0001 |
| T | 0 | 1 | 0.5 | ||
| Attribute 2 | MD | 0 | 1 | 0.5 | 0.005 |
| T | 0 | 1 | 0 | ||
| Attribute 3 | MD | 0.25 | 1 | 0.5 | 0.001 |
| T | 0 | 0.75 | 0.5 | ||
| Attribute 4 | MD | 0.25 | 1 | 0.5 | 0.002 |
| T | 0 | 0.75 | 0.5 | ||
| Attribute 5 | MD | 2 | 3 | 2 | < 0.0001 |
| T | 1 | 2.5 | 2 | ||
| Attribute 6 | MD | 0.25 | 0.5 | 0.5 | 0.115 |
| T | 0 | 0.75 | 0.5 | ||
| Attribute 7 | MD | 0 | 1 | 0.5 | 0.001 |
| T | 0 | 0.75 | 0.25 | ||
| Attribute 8 | MD | 0.25 | 0.5 | 0.25 | 0.037 |
| T | 0 | 0.5 | 0.25 | ||
| Attribute 9 | MD | 0 | 0.5 | 0.25 | 0.017 |
| T | 0 | 0.25 | 0 | ||
| Total | MD | 3.25 | 8 | 6.5 | < 0.0001 |
| T | 2.25 | 6.75 | 4.5 | ||
The feedback was obtained from the students of “MD” group who had received the training in informed consent taking for procedures in ENT by the structured consent process using modified Delphi technique and assessed subsequently by OSCE. The 5 levels of the Likert scale were consolidated into 3 categories: “strongly agree/agree”, “strongly disagree/disagree” and “neutral” The results were encouraging as shown in Fig. 1; all 30(100%) students recommended this method of structured consent taking for enhancement of communications skills and as a guide in obtaining consent for procedures in ENT. 29(97%) students felt that this method has stimulated interest in the topic of communication skill development with considerable help in understanding the concepts of consent taking. The 29(97%) students also felt that the teaching learning method used in the study has thrown light on facts of consent taking they were totally unaware of with the belief that this training will definitely help in improvement of interpersonal relationships as well as patient doctor relationship and that this form of consent taking will help in preventing litigations against doctors for want of adequate training in obtaining consent from patients. However 24(80%) students alone were satisfied with the teaching learning method with 6(20%) students who felt this was not enough. The discussion with the batch revealed the requirement of more demonstrations or video presentations on the process of informed consent taking in the mentioned 6 procedures in ENT which could be kept as ready reference for all Phase III MBBS students.
Fig. 1.
The feedback on the structured consent process using modified Delphi technique for informed consent taking obtained from the students of the’ “MD” group is as shown below:
Our study does conclude that informed consent taking is an important aspect of acquiring communication skills and appropriate training in the Phase III MBBS students during undergraduate training itself does benefit in acquiring it. Effective communication has been linked to improved patient adherence to instructions and failure to do so has been shown to be one of the leading causes of adverse events. There is an increasing evidence of the positive effects of communication skills training on both the physicians’ and patients’ overall well being. The assumption that medical students develop communication skills implicitly as they progress through their training requires a change and the consensus that communication skills are not spontaneously acquired through clinical experience alone must be understood.
Discussion
Informed consent is more than a process or document [16]. It is a vital process for communicating with patients and families and building trust. Controversy remains regarding how much information should be provided to patients during the informed consent process [17]. Although the law mandates that healthcare providers disclose information concerning the procedures, risks, benefits, and alternatives to the patients, the extent to which this information should be disclosed remains a challenging issue [18]. Reasonable personal and professional standards provide healthcare providers with reference guides to deliberate and deliver adequate information to patients. The MBBS students are taught to acquire communication skills in their profession by observing their seniors and teachers. However they must be trained adequately in taking consent for various procedures and surgeries. Researchers have proved that training in communication skills have found to be efficient in improving doctor patient relationship. The standard process of consent taking is taught to medical students using role play, small group discussions etc. addressing all points with which they are likely to be evaluated during OSCE. The evaluation of communication and interpersonal skills from the emotionally involved simulated patient perspective can be a valuable complement to communication ratings by examiners alone.The modified Delphi technique is an effective method of collecting experts’ opinions and reaching a consensus on the content for informed consent and educational materials. [19]
Informed consent in medical practice is essential and is a global standard that should be sought at all the times doctors interact with patients. [15] Its intensity would vary depending on the invasiveness and risks associated with the anticipated treatment [20].There are several factors that influence the consent taking process right from ethical practices, level of knowledge, working environment, experiences, societal values and beliefs. In spite of these factors, patients’ autonomy should be respected as doing so is actually respecting the patients’ rights as an individual to make decisions that affect their lives [21]. Surgery being an invasive practise requires a more rigorous informed consent process ensuring improved shared decision making because of the higher frequency and intensity of associated risks as compared to general medical care [22]. Performing informed consent discussions(ICDs) has also been described as a core entrustable professional activity (EPA) “that all medical students should be able to do upon entering residency, regardless of their future career specialty” by the Association of American Medical Colleges (AAMC). However, deficiencies in the training process for informed consent discussions (ICDs) span across specialties. Over a period of time the art of communication has been either taken for granted or forgotten as an entity that requires training in the early days of medical school. This is what formed the basis for this study where a change in the consent process in ENT was felt necessary not only to protect patient autonomy but meet both legal and professional body requirements just as was brought out by Smith ME et al [23] and Goodyear PW et al. [24]
This study aims to develop a structured consent process for teaching communication skills to an IMG (Indian medical graduate). It is an attempt to improve the training of MBBS students in obtaining informed consent for procedures in ENT during their clinical postings. A significant proportion of surgical informed consent is likely to be acquired by junior doctors, who lack adequate training and education in assessing capacity, in ensuring adequate disclosure related to surgical procedures and in adequately documenting consent. Medical educators and policy-makers should be aware of these issues when creating policies impacting surgical informed consent and when designing surgical education programs for medical students and junior doctors alike [25]. The modified Delphi technique called on the expertise and reflection of the panelists who are not only involved in the training of medical (MBBS) students but have also witnessed them as they enter into the society to work as qualified doctors. Their feedback and observations helped identify lacunae if any and reach a consensus in developing the structured consent process for obtaining informed consent for procedures in ENT. The prepared and finalised structured consent process in obtaining informed consent included 9 attributes which were to be assessed during the evaluation in OSCE. The foundation of medical ethics is based on the following key principles: informed consent, privacy and confidentiality. The aim of informed consent is to ensure that patients can autonomously be involved in decisions related to their health care [26]. This process involves not only the patient's autonomy, but also disclosure of complete and correct information. Doctors are to elaborate in detail about the diagnostic, therapeutic, and prognostic factors of the optimal treatment and how it will specifically benefit the patient [27]. The clinical postings in ENT is where the Phase III MBBS students are familiarised with case taking, clinical examinations, procedures and surgeries in ENT. During this period the exposure to acquiring good communication skills is important for a healthy doctor patient relationship. The familiarisation and training therefore must begin during the clinical postings itself and hence the essential elements as in the Kalamazoo consensus statement were taken as the basis for finalising the OSCE attributes and sub attributes in effective informed consent taking. The standard process of teaching informed consent taking is done during the theory classes, small group discussions, demonstrations etc. wherein with the procedure or surgery the additional aspects to be ensured are explained. This was done for all students of which a batch of 30 students were included as; “T” group. The developed structured consent taking process obtained by modified Delphi method, had 2 interactive small group discussions with demonstration for a batch of 30 students; “MD” group. The evaluation in our study was done using OSCE; OSCEs offer a method to assess clinical competency based on objective testing through direct observation in a formal setting. The OSCE has been proven to be a valuable tool for evaluating the required clinical skills of undergraduates in medicine [28]. The difference in mean ranks of the scores in the two groups was statistically significant, p < 0.0001 which reiterates the enhancement in obtaining informed consent for procedures in ENT by phase III MBBS students using the structured consent process. However one student in our study in the MD group got a lower score of 3.25 though rest all students scored > = 5.5. This though unfortunate is acceptable as there are various factors that affect the receptiveness and understanding of students in a class. The feedback too rightly brought out the fact that 20% of students felt the need of more or even better techniques to be used in developing the communication skills during medical undergraduate training. Invariably there are problems identified like physicians give sparse information to their patients, with most patients wanting their doctors to provide more information than they do [29, 30]. The students in our study definitely performed better with the same expressed by them in the feedback too recommending the need for teaching of informed consent taking and emphasising the significance of guidance in obtaining consent for procedures in ENT. They expressed the urge to probably have more classes or demonstrations on the same which would further enhance their communication skills.
Conclusion
Communication is a core competence and maximising effectiveness in it not only enhances your personal performance but helps improve your relationship with the patients and facilitates career progression. The earlier you sow the seeds for development of good communication skills and strong doctor-patient relationships the better results you harvest. Informed consent taking is one of the essential elements in biomedical ethics demanding proficiency in communicating with the patient. It must be seen as an ongoing process or dialogue with patients who need to be engaged in shared decision making. The phase III MBBS students during the ENT clinical postings are likely to benefit with a structured consent taking process devised using modified Delphi technique as compared to the standard process. Students too have recommended the need for learning to communicate efficiently which would help maximise personal effectiveness in various spheres like informed consent taking with the need to fully integrate communication skill teaching protocols in undergraduate curriculum. Future studies are needed to improvise and find out better teaching learning methods to support deliberate communication skill training.
Recommendation
Informed consent taking, an ongoing process in doctor patient relationship requires training to obtain proficiency right from the undergraduate days in MBBS curriculum. Communication skills just like the clinical skills must include formal educational programmes with better teaching learning methods and assessment tools to help the Indian Medical graduate (IMG) improve as they go through the various phases during training.
Acknowledgements
The author would like to acknowledge all panelists who participated in the Modified Delphi study which included Professors in ENT both from Government and private medical colleges in Kerala and India and also the Senior Consultants in ENT from Kerala in the private sector, it is their participation with valuable contributions that helped the successful completion of this study. A special mention of the help received in statistical analysis for which the author is indebted to Dr Ajitha B K, Associate Professor Statistics Govt Medical College Kozhikode. This study was possible only with the help of the 2018 batch of MBBS students of Government Medical College Kozhikode, who took keen interest and actively participated in the study. It is the constant support and encouragement of the entire Department of ENT at Government Medical College Kozhikode; the Head of the Department, all faculty members, residents, post-graduates, staff nurses, technicians and Grade IV staff that helped in timely completion and submission of this study. The author is indeed grateful to the faculty of the Nodal Centre Kottayam, MEU faculty at Government Medical College Kozhikode, IRC and IEC members of the Institution, batchmates of Advanced Course in Medical Education (ACME 11) and batch of ACME 10 for all their help and guidance throughout the study.
Annexure 1 CONSENT FORM
Part I Information sheet for participant in the research study
The current study is an educational research study with the title, “Comparison of the structured consent process using modified Delphi technique with the standard process in obtaining informed consent for procedures in ENT by a PHASE III MBBS student.” teaching & evaluating the effectiveness of the structured consent process using modified Delphi technique in developing the necessary communication skills.
Current study will be carried out at the Department of ENT, Govt Medical College Kozhikode which will include the Phase III students who are willing to participate in the study. Willing students will be allocated to two different groups where they will be taught the process of obtaining consent for various procedures in ENT. Each group will be taught the skill after which they will be assessed using the OSCE scores. At the end of the sessions all participants will have to fill a feedback form provided on their experience and perspective of the sessions.
Participants will be benefitted in learning the fine art of medicine the communication skill required for efficiently obtaining the consent for various procedures in ENT. The teaching and learning during this research study period will be independent of the regular academic activities carried out by the department in the subject of ENT. The participants will be at their will to continue or discontinue with the research study. At any time of the study participating student can withdraw from the study without giving any explanation. Withdrawing from the study won’t adversely affect any of the regular academic activities or assessment or evaluation of the student in the department.
All the related study data of every participating student will be kept confidential. Generated data can be used for further result discussion of study through different academic discussion platforms without revealing any identity of the participant.
Details of the Principal Investigator:
Dr Nambiar Sapna Sreedharan.
Asst Professor ENT.
Govt Medical College Kozhikode.
Mobile No. 9495816275.
Email: snambiar25@gmail.com.
Part 2- PARTICIPANT CONSENT FORM.
Name of the participant:
Age:
Gender:
Course & Phase:
KUHS Reg. No.
Annexure 2 OSCE ASSESSMENT SHEET
Consent taking for ENT PROCEDURE
| S. No. | Attribute assessed | Done well | Needs improvement | Not done | Scoring |
|---|---|---|---|---|---|
| 1 | Building overall rapport | (_ /1) | |||
| Greets and introduces | |||||
| Uses words that show care & concern | |||||
| Uses tone, pace, eye contact & posture showing concern | |||||
| Responds explicitly to concerns of the patient | |||||
| 2 | Overall ability to open discussion | (_/1) | |||
| Allows the patient to state their understanding & express concerns | |||||
| 3 | Ability to seek and elicit further information | (_ / 1) | |||
| Addresses using open ended questions | |||||
| Clarifies details as necessary | |||||
| Summarises | |||||
| 4 | Overall ability to understand patient’s perspective | (_ /1) | |||
| Asks about/ addresses patient’s concerns and how patient processes the info received | |||||
| Ellicit’s & allows space for patient belief/concerns & expectations | |||||
| 5 | Overall ability to share information | (_ /3) | |||
| Explains using words that patient can understand | |||||
| Clearly conveys the information | |||||
| Asks if patient has any questions | |||||
| 6 | Overall ability to reach an agreement | (_ /1) | |||
| Assists patient in decision making | |||||
| Confirms understanding and acceptability of immediate steps | |||||
| Identifies consent on addl resources if required | |||||
| 7 | Overall ability to communicate accurate information | (_ / 1) | |||
| Gives enough info to assist with informed decision making | |||||
| Accurately conveys seriousness of the situation | |||||
| 8 | Overall ability to demonstrate empathy | (_ /0.5) | |||
| Shows compassion & concern with appropriate demeanor | |||||
| Identifies and validates patient’s emotional responses with appropriate response | |||||
| 9 | Overall ability to provide closure | (_ / 0.5) | |||
| Summarizes, clarifies and reiterates the immediate next steps | |||||
| Acknowledges and closes the process | |||||
| Total Score (/10) |
Annexure 3
LIKERT FEEDBACK QUESTIONNAIRE
| SI No | Questions | Strongly agree | Agree | Neutral | Disagree | Strongly disagree |
|---|---|---|---|---|---|---|
| 1 | The method has stimulated interest in the topic of communication skill development | |||||
| 2 | The method has helped me understand the concepts of consent taking | |||||
| 3 | The method has thrown light on facts of consent taking I was totally unaware of | |||||
| 4 | I am satisfied with the teaching learning method | |||||
| 5 | I recommend this method for enhancement of communications skills and as a guide in obtaining consent for procedures in ENT | |||||
| 6 | This training will definitely help me improve my interpersonal relationships as well as patient doctor relationship | |||||
| 7 | This form of consent taking will help in preventing litigations against doctors for want of adequate training in obtaining consent from patients |
Funding
There has been no funding for the study.
Declarations
Conflicts of interest
None.
Ethical Approval
Institutional Ethics Committee (Ref No. GMCKKD/ RP 2022/IEC/02 dated 10/01/2022).
Informed Consent
Attached as per Annexure 1.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
References
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