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Volume - 01 September 2015-Monthly Issue Issue - 01
OF MEDICAL SCIENCES Bridging The Gap‌..!!!
- Informed Consent....Are Your Patients Properly Informed? - Shortfall of Health Care Service Provider Free Circulation
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~ Editorial ~
EDITORIAL BOARD Editor - In - Chief Dr. Jayesh Warade
We are happy to present you the first issue of "THE WATCHMEN". This magazine is dedicated to social responsibility of medical fraternity, the obligation on the part of society toward medical fraternity, development of science, limitations of the science, issues regarding medical practice and all other aspects of this profession to create awareness among medical professionals as well as society. All of you are requested to extend your support, provide feedback and suggestions for the success of this venture
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For Business, Make your clinic, nursing home, hospital, diagnostic centres and testing laboratory
Opportunities to "consent" a patient
go global. We invite short classified full
abound on the wards. The aim of this
1 article is to provide you with the tools
appropriate information to a competent
required for the "basic minimum" as well
patient so that the patient may make a
as providing a more comprehensive
voluntary choice to accept or refuse
picture of the informed consent process.
treatment.
You
particular
originates from the legal and ethical right
circumstances (e.g. the patient's needs or
the patient has to direct what happens to
the procedure) will determine whether a
her body and from the ethical duty of the
basic or comprehensive informed consent
physician to involve the patient in her
process is necessary.
health care.
will
find
that
the
(Appelbaum,
2007)
It
What are the elements of full informed consent? The most important goal of informed consent is that the patient has an What is informed consent?
opportunity to be an informed participant
Informed consent is the process by which
in her health care decisions. It is generally
the treating health care provider discloses
accepted that informed consent includes a
1 discussion of the following elements: The
nature
of
reasoning the
process
with
the
patient.
Comprehension on the part of the patient
decision/procedure
is equally as important as the information
Reasonable alternatives to the
provided. Consequently, the discussion
proposed intervention
should be carried on in layperson's terms
The relevant risks, benefits,
and
uncertainties related to each alternative Assessment
of
patient understanding The acceptance of the intervention by the patient In order for the patient's consent to be valid, she must
be
competent
considered to
make
the
decision at hand and her consent must be voluntary. It is easy for coercive situations
and the patient's understanding should be assessed along the way.
to arise in medicine. Patients often feel powerless and vulnerable. To encourage voluntariness, the physician can make clear to the patient that she is participating in a decision-making process, not merely signing a form. With this understanding, the informed consent process should be seen as an invitation for the patient to participate in health care decisions. The physician is also generally obligated to provide a recommendation and share his
Basic or simple consent entails letting the patient know what you would like to do; giving
basic
information
about
the
procedure; and ensuring that the patient assents or consents to the intervention. Assent refers to a patient’s willing acceptance of a treatment, intervention, or clinical care. Basic consent is appropriate, for example, when drawing blood in a
1 patient who has given blood before.
How much information is considered
Sometimes consent to the procedure is
"adequate"?
implied (e.g. the patient came in to have
How do you know when you have
blood drawn), but an explanation of the
provided enough information about a
elements
proposed intervention? Most of the
of
the
procedure
remain
necessary.
literature and law in this area suggest one Decisions that merit this sort of basic informed consent process require a low-
of three approaches: ďƒ˜
Reasonable
physician
level of patient involvement because there
standard: what would a typical
is a high-level of community consensus
physician
that the treatment being offered is the only
intervention?
or best option and/or there is low risk
allows
involved in the treatment If a patient does
determine what information is
not consent under the paradigm of basic
appropriate
consent, then a fuller informed consent
However, this standard is often
discussion is warranted.
inadequate, since most research
say the
about This
standard
physician to
this to
disclose.
1
ďƒ˜
ďƒ˜
shows that the typical physician
voice in health care decisions.
tells the patient very little. This
What
standard
informed consent?
is
also
generally
sorts
of
interventions
require
considered inconsistent with the
All health care interventions require some
goals of informed consent, as
kind of consent by the patient, following a
the focus is on the physician
discussion of the procedure with a health
rather than on what the patient
care provider. Patients fill out a general
needs to know.
consent form when they are admitted or
Reasonable patient standard:
receive treatment from a health care
what would the average patient
institution. Most health care institutions
need to know in order to be an
have policies that state which health
informed
the
interventions require a signed consent
decision? This standard focuses
form. For example, surgery, anesthesia,
on considering what a typical
and other invasive procedures are usually
patient would need to know in
in this category. These signed forms are
order to understand the decision
the culmination of a dialogue required to
at hand.
foster the patient's informed participation
participant
Subjective
in
standard:
what
in the clinical decision.
would this particular patient
For a wide range of decisions, explicit
need to know and understand in
written consent is neither required nor
order to make an informed
needed, but some meaningful discussion is
decision? This standard is the
always needed. For instance, a man
most challenging to incorporate
contemplating having a prostate-specific
into practice, since it requires
antigen screen for prostate cancer should
tailoring information to each
know the relevant arguments for and
patient.
against this screening test, discussed in lay
The best approach to the question of how much information is enough is one that meets both your professional obligation to provide the best care and respects the patient as a person, with the right to a
terms.
1 that any questions about his/her medical care will be answered, the physician may seek consent from a family member in lieu of the patient. When is it appropriate to question a patient's ability to participate in decision Is it ever acceptable to not have a full
making?
informed consent?
In most cases, it is clear whether or not
Exceptions to full informed consent are:
patients have capacity to make their own
If the patient does not have decision-
decisions. Occasionally, it is not so clear.
making capacity, such as a person with
Patients are under an unusual amount of
dementia, in which case a proxy, or
stress during illness and can experience
surrogate decision-maker, must be found.
anxiety, fear, and depression. The stress
A
lack
of
decision-making
associated
with
illness
should
not
capacity with inadequate time to
necessarily
find an appropriate proxy without
participating in one's own care. However,
harming the patient, such as a life-
precautions should be taken to ensure the
threatening emergency where the
patient does have the capacity to make
patient is not conscious.
good decisions. There are several different
When the patient has waived consent. When
preclude
one
from
standards of decision-making capacity. Generally you should assess the patient's
a
competent
patient
ability to:
designates a trusted loved-one to
Understand his or her situation,
make treatment decisions for him
Understand the risks associated
or her. In some cultures, family members make treatment decisions on behalf of their loved-ones.
with the decision at hand, and Communicate a decision based on that understanding.
Provided the patient consents to
When this is unclear, a psychiatric
this arrangement and is assured
consultation can be helpful. Of course,
1 just because a patient refuses a treatment
What should occur if the patient cannot
does not in itself mean the patient is
give informed consent?
incompetent. Competent patients have the
If the patient is determined to be
right to refuse treatment, even those
incapacitated/incompetent to make health
treatments
life-saving.
care decisions, a surrogate decision maker
Treatment refusal may, however, be an
must speak for her. There is a specific
indication that it is necessary to pause to
hierarchy of appropriate decision makers
discuss further the patient's beliefs and
as defined. If no appropriate surrogate
understanding about the decision, as well
decision maker is available, the physicians
as your own.
are expected to act in the best interest of
that
may
be
the patient until a surrogate is found or What about the patient whose decision
appointed. In rare circumstances, when no
making capacity varies from day to day?
surrogate can be identified, a guardian ad
A patient’s decision-making capacity is
litem may have to be appointed by the
variable
or
court. Confer with social work and risk
underlying disease processes ebb and
management if you have trouble finding a
flow. You should do what you can to catch
legal surrogate for the patient.
as
their
medications
a patient in a lucid state - even lightening up on the medications if necessary and
How does informed consent apply to
safe - in order to include her in the
children?
decision
Delirious
Children do not have the decision-making
patients have waxing and waning abilities
capacity to provide informed consent.
to understand information. However, if a
Since consent, by definition, is given for
careful
and
an intervention for oneself, parents cannot
documented at each contact, and during
provide informed consent on behalf of
lucid periods the patient consistently and
their children. Instead they can provide
persistently makes the same decision over
informed permission for treatment. For
time,
adequate
older children and adolescents, assent
decisional capacity for the question at
should always be sought in addition to the
hand.
authorization
making
process.
assessment
this
may
is
done
constitute
of
legal
surrogates.
Adolescents and mature minors are legally
1 and
ethically
authorized
to
provide
different from the values of the physician.
informed consent if they are emancipated, they may provide consent for matters regarding sexual and reproductive health, mental health, and substance abuse. The
primary
responsibility
of
the
physician is the well-being of the child. Therefore, if the parental decision places the child at risk of harm then further action may be indicated. When there are differences in opinion between the parents and physicians that cannot be resolved ethics consultation may be pursued, and legal avenues may be pursued when all other means have failed. Children should be included in decision-making at a developmentally appropriate level and assent should be sought when possible. Is there such a thing as presumed/implied consent? The patient's consent should only be "presumed," rather than obtained, in emergency situations when the patient is unconscious or incompetent and no surrogate decision maker is available, and the emergency interventions will prevent death or disability. In general, the patient's presence in the hospital ward, ICU or clinic does not represent implied consent to all treatment and procedures. The patient's wishes and values may be quite
While the principle of respect for person
1 obligates you to do your best to include the patient in the health care decisions that affect her life and body, the principle of beneficence may require you to act on the patient's behalf when her life is at stake.
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Recently released government data on the rural health infrastructure and personnel confirms that Samarin Bai's problem of not finding doctors nearby is not a rare example from some inaccessible forest. At the country level, there is a staggering shortfall of 81% of specialist doctors, 12% of percent general physicians, 21% nurses and 5% of auxiliary nurse cum midwives. Among technical support staff, shortfalls range from 29% percent for pharmacists to 45% percent for laboratory technicians and 63% percent for radiographers. But what is more shocking is that since a decade ago, many of these shortfalls have increased except for nurses and ANM. A bizarre aspect of this data put out annually by the ministry of health is that in many categories of health personnel, some states have surplus appointments while others have shortfalls. For example, at the country level, 25,308 doctors are required going by the Indian Public Health Standards (IPHS), which says that one doctor is needed for every primary health centre (PHC). But actually, there are 34,750 doctors sanctioned. 25 states have surplus doctors in position
1 compared to required, the total surplus working out to 5,115. On the other hand, the remaining states have a combined shortfall of 3,002 doctors. The
surpluses
shown
in
healthcare
personnel in many states are not real they arise because goal posts are shifted by lowering requirements. In reality the shortages are all round. This would apply to ANMs too which are 'surplus' in 25 states/UTs amounting to a whopping 42,548 for India. This is because the earlier standard of two ANMs per subcentre has been diluted to one. Despite this several states don't even have that sole ANM
in
many
sub-centres.
In fact, the norm of having a sub-centre for every 5000 persons (or 3000 persons in tribal and hilly areas) is crumbling fast. Currently, the national average is over 5400, with some states like UP having an above
7000
average.
Similarly,
the
national average of population per PHC is nearly 33,000 against the norm of 30,000 and the average for community health centres (CHC) is running at 1.5 lakh compared to the prescribed norm of one lakh per CHC
1 women, and especially black women, may help health care professionals identify these patients before they experience a serious [heart disease] event, like a heart attack The test tracks the activity of a specific biological
signal
of
vascular
inflammation, called Lp-PLA2. Vascular inflammation is strongly associated with the buildup of artery-clogging plaques in blood vessels, the FDA explained. As plaque accumulates, arteries narrow and the chances of a serious cardiovascular event increase. "Patients with test results that show LpPLA2 activity greater than the level of 225 nanomoles per minute per milliliter are at increased risk for a [heart disease] event"
Recently FDA Approved Drug
Lp-PLA2 Test to Gauge Heart Attack Risk
Repatha (evolocumab) ; Amgen; For the treatment of high cholesterol, Approved August 2015
The test is designed for people with no history of heart disease, and it appears to be especially useful for women A cardiac test that helps better predict future coronary heart disease risk in
Addyi
(flibanserin);
Sprout
Pharmaceuticals; For the treatment of premenopausal women with generalized hypoactive
sexual
desire
disorder,
1 Approved August 2015 Varubi
(rolapitant);
prevention
of
Tesaro;
delayed
For
nausea
the and
vomiting associated with chemotherapay, Approved September 2015 Synjardy (empagliflozin and metformin hydrochloride) ; Boehringer Ingelheim; For the treatment of type II diabetes, Approved August 2015
With Best Complement From...
1 Indian Patients undergoing transplants. The regimes
immunosuppressive used
by
various
centres. Short term and long term results of the allograft. Complications
during
management in short term and long term. Patient
survival
after
transplants. The HLA profile of Indian Patients. Number
of
Living
and
cadaver transplants. Relationship in case of related transplants. Profile of Donors The data will be stored in a secure server and can be accessed by any The purpose of National Transplant
registered
Registry is to collect transplant related
information submitted will be treated as
data from various centres in the country
highly confidential. So the members will
and to be able to collate the data from
be able to see the data of their hospital.
time to time to derive the following
Only collated data will be available for
information
viewing. The site is to be developed in
The number of transplants done in the country. Essential demographic data of
member
of
ISOT.
The
phases and in the first phase data related to kidney and liver transplants will be captured. If you are doing transplants in
1 India (kidney, heart, liver, pancreas, lungs), you may register on the website with your essential information and a username and password will be sent to you within 24 to 48 hours. The Registry would help in doing a national audit to understand short and long term outcomes in the complicated field of transplants.