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Comparison of 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

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Indian Journal of Otolaryngology and Head & Neck Surgery Aims and scope Submit manuscript

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.

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References

  1. Graf J, Loda T, Zipfel S et al (2020) Communication skills of medical students: survey of self- and external perception in a longitudinally based trend study. BMC Med Educ 20:149

    Article  PubMed  PubMed Central  Google Scholar 

  2. Deveugele M, Derese A, De Maesschalck S, Willems S, Van Driel M, De Maeseneer J (2005) Teaching communication skills to medical students, a challenge in the curriculum? Patient Educ Couns 58(3):265–270

    Article  PubMed  Google Scholar 

  3. Baribeau DA, Mukovozov I, Sabljic T et al (2012) Using an objective structured video exam to identify differential understanding of aspects of communication skills. Med Teach 34:4

    Article  Google Scholar 

  4. Keeney S, Hasson F, McKenna HP (2010) The Delphi technique in nursing and health research. https://doi.org/10.1002/9781444392029

  5. Kampmann M (2006) Communication errors are the most common cause of treatment failures. MMW Fortschr Med 148(3):32–35

    Article  CAS  PubMed  Google Scholar 

  6. Krug SE (2008) The art of communication: strategies to improve efficiency, quality of care and patient safety in the emergency department. Pediatr Radiol 38(Suppl 4):S655–S659

    Article  PubMed  Google Scholar 

  7. Kripalani S, LeFevre F, Phillips CO, Williams MV, Basaviah P, Baker DW (2007) Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA 297(8):831–841

    Article  CAS  PubMed  Google Scholar 

  8. Makoul G (2001) Essential elements of communication in medical encounters: the Kalamazoo consensus statement. Acad Med 76(4):390–3

    Article  CAS  PubMed  Google Scholar 

  9. Rider EA, Hinrichs MM, Lown BA (2006) A model for communication skills assessment across the undergraduate curriculum. Med Teach 28(5):e127-34

    Article  PubMed  Google Scholar 

  10. Lahmann C, Dinkel A (2014) Doctor-patient-communication. Conversational skills of doctors—a highly skilled area [Arzt-Patienten-Kommunikation. MMW Fortschr Med 156(88):84–87

    PubMed  Google Scholar 

  11. von Fragstein M, Silverman J, Cushing A, Quilligan S, Salisbury H, Wiskin C (2008) UK consensus statement on the content of communication curricula in undergraduate medical education. Med Educ 12:1100–1107

    Article  Google Scholar 

  12. Joekes K, Noble LM, Kubacki AM, Potts HW, Lloyd M (2011) Does the inclusion of ′professional development′ teaching improve medical students′ communication skills? BMC Med Educ 11:41

    Article  PubMed  PubMed Central  Google Scholar 

  13. Choudary A, Gupta V (2015) Teaching communications skills to medical students: Introducing the fine art of medicine practice. Int J App Basic Med Res 5:41–4

    Article  Google Scholar 

  14. Aspegren K (1999) BEME guide no 2: teaching and learning communication skills in medicine—a review with quality grading of articles. Med Teach 21(6):563–570

    Article  CAS  PubMed  Google Scholar 

  15. King JS, Moulton BW (2006) Rethinking informed consent: the case for shared medical decision-making. Am J Law Med 32(4):429–501

    Article  PubMed  Google Scholar 

  16. Grady C (2015) Enduring and emerging challenges of informed consent. N Engl J Med 372(9):855–862

    Article  CAS  PubMed  Google Scholar 

  17. Cainzos MA, Gonzalez-Vinagre S (2014) Informed consent in surgery. World J Surg 38(7):1587–1593

    Article  PubMed  Google Scholar 

  18. Moskop JC (1999) Informed consent in the emergency department. Emerg Med Clin N Am 17(2):327–340

    Article  CAS  Google Scholar 

  19. Lin YK, Chen CW, Lee WC et al (2017) Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique. BMC Med Ethics 18(1):67

    Article  PubMed  PubMed Central  Google Scholar 

  20. Beauchamp TL, Childress JF (2001) Principles of biomedical ethics, 5th edn. Oxford University Press, Oxford, p 454

    Google Scholar 

  21. The PLoS Medicine Editors (2009) Making the “right” health care decisions: why values matter. PLoS Med 6(8): e1000136. doi:https://doi.org/10.1371/journal.pmed.1000136.

  22. Ochieng J, Ibingira C, Buwembo W et al (2014) Informed consent practices for surgical care at university teaching hospitals: a case in a low resource setting. BMC Med Ethics 15:40

    Article  PubMed  PubMed Central  Google Scholar 

  23. Smith ME, Lakhani R, Bhat N (2013) Consenting for risk in common ENT operations: an evidence-based approach. Eur Arch Otorhinolaryngol 270(9):2551–2557

    Article  CAS  PubMed  Google Scholar 

  24. Goodyear PW, Anderson AR, Kelly G (2008) How informed is consent in a modern ENT department. Eur Arch Otorhinolaryngol 265(8):957–961

    Article  CAS  PubMed  Google Scholar 

  25. de Costa J, Shircore M, de Costa A (2021) Junior doctor experiences and challenges in obtaining surgical informed consent: a qualitative systematic review and meta-ethnography. J Surg Res 267:143–150

    Article  PubMed  Google Scholar 

  26. McCullough LBCF, McCullough LB, Chervenak FA (2007) Informed consent. Clin Perinatol 34(2):275–285

    Article  PubMed  Google Scholar 

  27. Moskop JC, Marco CA, Larkin GL et al (2005) From Hippocrates to HIPAA: privacy and confidentiality in emergency medicine–part I: conceptual, moral, and legal foundations. Ann Emerg Med 45(1):53–59

    Article  PubMed  Google Scholar 

  28. Covindan VK (2008) Enhancing communication skills using an OSCE and peer review. Med Educ 42:535–536

    Article  Google Scholar 

  29. Jenkins V, Fallowfield L, Saul J (2001) Information needs of patients with cancer: results from a large study in UK cancer centres. Br J Cancer 84:48–51

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  30. Street RL (2003) Communication in medical encounters: an ecological perspective. In: Thompson TL, Dorsey AM, Miller KI, Parrott R (eds) Handbook of health communication. Lawrence Erlbaum Associates Publishers, pp. 63–89

    Google Scholar 

Download references

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.

Funding

There has been no funding for the study.

Author information

Authors and Affiliations

  1. Department of ENT, Government Medical College, Kozhikode, Kerala, India

    Sapna Sreedharan Nambiar

Authors
  1. Sapna Sreedharan Nambiar
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Corresponding author

Correspondence to Sapna Sreedharan Nambiar.

Ethics 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.

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Appendices

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

     

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Nambiar, S.S. Comparison of 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. Indian J Otolaryngol Head Neck Surg 75, 1557–1567 (2023). https://doi.org/10.1007/s12070-023-03546-2

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