informed consent for hip fractures

Click here to load reader

Post on 20-Feb-2017

388 views

Category:

Health & Medicine

1 download

Embed Size (px)

TRANSCRIPT

PowerPoint Presentation

Informed consent for geriatric hip fractures

Dr Uday Kumar MS(Orth) DNB(Orth)Sagar HospitalsSindhi HospitalChinmaya Hospital Bangalore

6th Sept 2015 ASRAM MC ELURU

1

75 year old lady---fracture neck femurTreatment?

80 year old male ----trochanteric fractureTreatment?

What is Consent?

Consent given by the patient based on knowledge of the procedure to be performed, including its risks and benefits, as well as alternatives to the proposed treatment.What is INFORMED Consent?

-- is no longer an option.It is now a must under the current guidelines & regulationsINFORMED Consent

We do not have national guidelines

6

Informed consent is it

a Document or a Process ??

7What is IC?Wt about documentation??Informed Consent is more than just the IRB-approved document

Consent is a continuous process, not a one-time event

pre op Intra opPost op

8Based on face to face conversationContiuous as long as the study is conducted

Elderly patients

Co-morbid conditions

HypertensionDiabetesIHDCOPDOsteoporosis

Elderly patients are particularly vulnerable in theinformed consent process.

Medical conditions: Impairs cognition e.g.hearing loss, vision loss

Social Factors: physical dependency, financial impoverishment, restricted health care resources and family pressures

These factors prevents them from expressing their truly autonomous decisions with regard to their healthcare.10

11Here I have an nice example hereFor the setting of ic process of an optimum an environment for process of consentI think the most interesting her is the privacy

The Consent process:

Take the time at the initial discussion

Test subject comprehension

You sholuld consider contiinuing coprehension at everthy time you/...Discuss new information that may impact a subjects willingness to continue study participation (i.e., new known risks, benefits, alternatives, changes in study design, etc.)Remind subject of study goals and objectives this will improve subject compliance with the protocol and improve retention of subjects

12

VoluntarinessDisclosure CompetenceUnderstandingREQUIReMENTS

The Process of Consent:Choose the right environment and location

Involve multiple health care personnel surgeon, physician, anesthetist, cardiologist etc

Include all family members in the process

14Legally authorized representative

Consent Process PlanDecide where consent discussion will be held

Conduct it in a quiet area

Patient and attenders should have adequate uninterrupted time

Provide space for family members or friends to be present during the consent discussion

15The next step is to decide where the consent discussion will be held. The consent discussion should take place in a quite, private area where the subject and the person obtaining consent can have adequate uninterrupted time to discuss all aspects of the study. The room should be conveniently located to the PI so he/she can spend time with the subject answering any questions about the study. The room should be large enough to accommodate any family or friends the subject would like to have present during the consent discussion.

Consent Process PlanProvide adequate time to explain the surgery procedure to the attendersDraw a visual description of the procedure

Use patient education tools / brochures to assist in discussion

Explain the responsibilities of the attenders get them over to your side

16Informed consent involves educating the prospective participant, not merely disclosing information. Prospective participants must understand the purpose, the procedures, the potential risks and benefits of their involvement and the alternatives to participation. While a consent document gives this information and is a vital part of the process, in some patients the consent document can be intimidating and complicated. Providing adequate time to discuss the study and study procedures with the subject and to address any questions or concerns is a necessary part of the informed consent process. Try to create a word picture or use patient education tools / brochures to assist in the discussion and to foster understanding. The subject should understand not only the study and study procedures but also their responsibilities during the study.

.

Consent Process PlanProvide adequate time for patient/attenders to read and considerNo undue influence or coercionAllow them to discuss with families or friends

Provide time for questions to be answered aboutmorbidity and mortality and alternative treatments

17In order to avoid coercion or undue influence, prospective participants should be given time to think about their decision and to discuss it with family, friends or religious advisors. Time should be provided after the subject has read the consent to answer any questions. The question and answer session may or may not occur on the same day as the consent discussion. If it occurred on a different day from the consent discussion, the same considerations should be given for this discussion as for the consent discussion. The question / answer sessions should be conducted in a quiet place without interruptions and the study doctor should be available to answer questions.

The burden of ensuring that the research subject genuinely understands the study falls upon the PI. So it is critical to the consent process that the person obtaining consent not only answers questions but also ask questions. Asking questions can further the discussion, elicit questions from the prospective subject, prompt the prospective subject to think more carefully about the project, and help you decide whether the person has adequately understood the study. Useful questions will be open-ended and non-directive. Rather than asking for yes or no answers, they ask for explanations because these questions often can be answered in a variety of ways, and do not already contain the correct answer.Open ended questions are often introduced with what where, how often, when and please describe.

Summary for Consent for surgery

Benefits

ContactPurposeRisksAlternative ConfidentialityCostsVoluntary

DatePatient orLegally Acceptable RepresentativeSurgeon

Date

DateWitness

Who can sign the Consent Form?Impartial Witness

19

(Address each line of the signature page)Subject/ legally acceptable representative - Once a subject agrees to participate in a study, the consent document must be signed by the subject or legally acceptable representative. Each country has laws that address issues such as capacity of a subject to sign an Informed Consent, age of consent, childrens assent, who is a legally acceptable representative and may other issues. You can obtain information about laws affecting research consent from various locations including your Merck Monitor or IRB / IEC.

Person obtaining Consent -

Witness (ask the question: Who puts this line on their consent form?) Who can be a witness? What is the witness witnessing? This line is not really needed on the consent form and should not be put on.

Impartial witness When is an impartial witness required? An impartial witness is required if the subject cant read. Who can be an impartial witness? Anyone who is not affiliated with the study. What are they witnessing? The impartial witness must be present during the entire consent discussion and attest to the accuracy of the consent presentation, (and) the understanding of the subject and that informed consent was freely given.

Date - The date must be completed by the individuals who sign the same person can not complete all dates (i.e. study coordinator can not pre-fill the dates). All dates (and signatures) should be completed BEFORE any protocol specific activities are being performed.

terminationcostsbe providedNumber

Additional information

UnexpectedRisksConsequences of Withdrawal

Questions about your careWhat sort of hip fracture do I have?Do I have to have an operation?Please tell me what particular type of surgery I need, and why.What will the surgery involve?What are the risks and benefits of having this surgery?Are the risks minor or serious? How likely are they to happen?Are there other options that don't involve an operation?What care will I need after the operation?What may happen if I don't have the operation?When should I start to feel better, and what should I do if I don't start to feel better bythen?What will happen when I leave the hospital?How can I help prevent another fracture from happening in the future

A good consent form:Complete informationAccurate informationIn compliance with regulations and guidelinesShort simple sentences Simple understandable languageCulturally sensitive language

22

POSTOPERATIVE COGNITIVE DISORDER HAS TO BE INCLUDED WITHIN INFORMED CONSENT OF ELDERLY PATIENTS UNDERGOING TOTAL HIP REPLACEMENTOAlexa, et al 2013CONCLUSIONS: The main post-surgery cognitive decline risk factor in geriatric patients is the pre-surgery cognitive status, and based on the data obtained, we are r