Evaluation of implementation of informed consent in

obstetrics & gynecology operations in Khartoum-

Sudan 2009

Umbeli T1, Marium A A2, & Elhadi M APub.: journal of medical sciences: vol.5 N0 3 Sept 2010;

173-177

Prof. Taha Umbeli MD, FCM.Prof. Taha Umbeli MD, FCM.

Omdurman Islamic universityOmdurman Islamic university

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

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.

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.

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.

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.

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.

Challenges in OBGYN:

Patients in labor or delivery. Adolescents. Sexuality & reproduction. Genetic counseling. Patient’s wellbeing & rights for choice.

Challenges in OBGYN

Challenges affects both patients & HCP.

It is NOT impossible. It alerts physician to identify patient’s condition & its limits.

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

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.

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.

Objectives-:

To assess health care providers KAP on informed consent, with regard to contents, importance & implementations.

To assess barriers against implementation.

Methodology:

Descriptive study. All HCP, during study period. List of participants was prepared

to avoid double participation. HCP data, collected by

investigators,

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.

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.

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.

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.

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.

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.

Thank you