Evaluation of implementation of informed consent in obstetrics & gynecology operations in Khartoum- Sudan 2009

1. Evaluation of implementation of informed consent in obstetrics & gynecology operations in Khartoum- Sudan 2009 Umbeli T1, Marium A A2, & Elhadi M A Pub.: journal of medical sciences: vol.5 N0 3 Sept 2010; 173-177 Prof. Taha Umbeli MD, FCM. Omdurman Islamic university

2. WHAT IS INFORMED CONSENT? • Is a voluntary unforced decision made by a competent autonomous person to accept rather than to reject some purpose or course of action, based on appreciation & understanding of facts & implications of action, even if refusal may result in harm

3. Requirements for informed consent • It is a process NOT a form. • Active participation (dynamic process) • Free from coercion (voluntarism) • Good communication, patient & HCP. • Successful relationship, patient & HCP. • disclosure of adequate understandable information. Needs understanding. • Setting reasonable expectations. • Through documentation.

4. Informed consent review • It is first defined in 1950s • An impt. Tool for improving service. • An ethical obligation. • Poor consent, poor satisfaction. • NOT protect negligence or SOC.. • Responsibility of treating doctor. • Delegates should be well trained.

5. Taking an informed consent • Should be written. • If verbal, witnessed & documented. • Ideally should be signed by patient. • Can be signed by surrogate or a proxy • By physician for best interest of patient.

6. When a proxy is to sign? • Patient is below legal age. • Patient is mentally retarded. • unconscious or under medicat. • Refusal of treatment, does not mean an incompetent patient. • Patient has right to refuse.

7. Informed consent in OBGYN • Important due to expanded & interconnected medical options. • public health problems (shortage). • Legal litigation. • Political or financial agenda. • Needed in all surgical procedures & anesthesia.

8. Challenges in OBGYN: • Patients in labor or delivery. • Adolescents. • Sexuality & reproduction. • Genetic counseling. • Patient’s wellbeing & rights for choice.

9. Challenges in OBGYN • Challenges affects both patients & HCP. • It is NOT impossible. • It alerts physician to identify patient’s condition & its limits.

10. Procedure specific consent • Cesarean section. • Evacuation or D&C. • All major gynecological operation. • Tubal ligation. • Instrumental delivery. • Episiotomy. • Amniocentesis. • High risk pregnancy & outcome.

11. Consent documentation • Hospital consent to be used. • Spell out procedures. • Detailed description of procedure. • Who will perform procedure. • Generic risks & benefits. • Any quires. • Disposal of parts removed.

12. Informed consent in Sudan • Implied or verbal consent used for long. • Informed consent, needed in last two decades, due to ;- •  expand of services. •  public awareness for litigations. •  access to good quality care services. •  people less tolerant to medical errors • More conflicts, affects medical practice.

13. Objectives:- • To assess health care providers KAP on informed consent, with regard to contents, importance & implementations. • To assess barriers against implementation.

14. Methodology: • Descriptive study. • All HCP, during study period. • List of participants was prepared to avoid double participation. • HCP data, collected by investigators,

15. Results: • 393 HCP included. • Its importance is known to 90.3%. • Its contents is known to 66.9%. • It is taken by 75.5% of operations. • All HCP no training before graduation. • Only 41% of regst. had some training. • Trained group practicing taking IC.

16. Taken informed consent:- • It is written in 93.6%. • 55.2% signed by husband. • 35.4% signed by patients. • 19.4% signed by relatives. • NO detailed informations. • It is an agreement format.

17. Barriers for taking IC:- • 60% due to over work, time. • 27% language (96% Arabic spea) • Utilization of informed consent • provider’s experience. • Patient’s awareness.

18. Utilization of IC depends on: • Provider’s knowledge is still low. • How message is conveyed. • What patient need to understand. • Legal aspects NOT known to many HCP. • Patients believe it is for protection of HCP & NOT for decision sharing.

19. Conclusion:- • Considerable number of HCP do not know the contents & importance of informed consent. • Utilized format- SMC, brief, deficient, non-informative, rather agreement, deficient practice & adherence to regulations.

20. Recommendations :- • Communication skills should be included in curricula at university & post graduate. • Strengthen training & implementation of informed consent. • Utilized format should be reviewed, with procedure explanation. • Should be simple & understandable.

21. Thank you