Clinical Practice Review Issue 6 SEPT/OCT 2007

the royal women’s hospital quality and safety unit newsletter

Total laparoscopic hysterectomy at the Women’s New techniques and technologies

Conclusions from the experience

dealing with old clinical problems are

at the Women’s

exciting but must still be assessed according to their benefits for patients

comparable to previous published data

At the weekly gynaecology clinical meeting (20/9/07) Dr Philip Thomas

• Operating times are also comparable to previous work

presented an audit of total laparoscopic hysterectomy (TLH) at the Women’s and placed this

• TLH can be performed at similar cost to TAH

experience in perspective with the current literature.

• The major cost in TLH is theatre time

Total laparoscopic hysterectomy offers a number of possible advantages to

• Improvements in theatre time

women including shorter hospital stay,

(and therefore cost) can be

more rapid return to work, the ability

expected from increasing

to treat coincident pathology and

familiarity with the procedure

minimising abdominal scarring. There

and improved equipment

is no push for all hysterectomies to be laparoscopic; vaginal hysterectomy plays an important role where possible as it has the shortest operating time and consistently low morbidity1. The role of TLH is in avoiding abdominal hysterectomy where vaginal hysterectomy is contra-indicated, its more morbid incision and slower recovery and return to work. The TLH audit performed by four clinicians all currently at the Women’s (Drs Thomas, Ang, Daly and Sgroi)

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Editorial

1

Book review

2

Current clinical news

3

Quality and safety news

Pharmacy news

EDITORIAL We report this month on total laparoscopic hysterectomy (TLH) a new surgical procedure at the Women’s. This procedure has been now well researched for over a decade with Chapron et.al. reporting a 3 year experience with 222 patients in 1996. Once an operation has been shown to have potential benefits its introduction should be orderly by those trained in the procedure with availability of the appropriate resources followed by clinical audit and review. The report

Other issues raised by the introduction

by Anthony Woodward of Phil Thomas’

of TLH to repertoire at the Women’s

audit is well worth reading. Ongoing

are:

review is necessary and finding the

• Utilisation of theatre time – the longer TLH operating time

appropriate place for the procedure in our practice will continue to evolve.

limits the other work that can

By contrast Mary Draper’s review

be performed on any given

of J Kroopman’s book ‘How Doctors

operating list

Think’ looks not at the technical aspects

• Maintenance of training

of our practice but at the thinking bits.

at all levels (resident

What attracted a lot of doctors to O + G

to consultant) in all methods

is that it has both these dimensions as

of hysterectomy

distinct from medicine or surgery! So both articles might be of interest

spanned the period Nov 2005 to

Anthony Woodward

January 2007 and was presented at

to readers of the CPRN. Finally we’ve

Fellow Quality and Safety

included a Current Clinical News

the recent Australian Gynaecological

section. Do let us know if this is

Endoscopy Society conference.

something you’d like us to continue.

25 TLH procedures performed

References

by three principal operators were

(1) Johnson N, Barlow D, Lethaby A,

included in the assessment. The work examined morbidity (including blood

4 5-6

• Complication rates are

and the health system as a whole. Anthony Woodward

Total Laparoscopic Hysterectomy

Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign

Leslie Reti Editor

gynaecological disease. Cochrane Database

Surgery: Is total laparoscopic hysterectomy

of Systematic Reviews 2006, Issue 2. Art.

a safe surgical procedure? Chapron CL et.al.

operative time, length of inpatient stay

No.: CD003677. DOI: 10.1002/14651858.

1996 Human Reproduction, Vol. 11, No. 11,

and a detailed cost assessment.

CD003677.pub3.

pp. 2422-2424

loss), conversion to laparotomy,

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Do doctors ever get it wrong? Mary Draper

A woman presents to the hospital. She is assessed by an experienced doctor – the doctor gets the diagnosis wrong. Looking back in retrospect, the clinician wonders how he/she could have got it so wrong and spends several days or weeks repeating to themselves ‘if only I had….’.Has this ever happened to any doctor you know? Doctors - and other clinicians as well, do get it wrong from time to time. Medical decision making happens in a world of uncertainty and messiness, according to Jerome Groopman, an oncologist, in his book, ‘How Doctors Think’. As you might expect from someone who is also a staff writer for The New Yorker, Kroopman’s book has plenty of stories from his own experience that illustrate all the ways mistakes can happen in assessing a patient. Basically, doctors arrive at a diagnosis though pattern recognition – putting all the cues together. Often this happens quite quickly and first impressions count. Unfortunately, pattern recognition can go wrong and Groopman describes common ways that this happens. Common ways that cognitive errors occur arise from ‘anchoring’ and ‘availability’. Anchoring’ is latching early on to one of the possible diagnoses. This can led to confirmation bias which then results in selectively accepting and ignoring information – once your mind has anchoring on to one of the possibilities, you see what you expect to see and don’t see the nonconforming data. ‘Availability’ errors happen when clinicians judge the likelihood of an event by the ease with which other examples come to mind – ‘this looks like’. This leads to a bias arising from a preference for the familiar. If you hear hoof beats, these are attributed to something familiar – horses, not zebras. It’s why some missed diagnoses seem to come from left field. Another way the wrong diagnosis is arrived at can also happen through ‘framing’ – a patient arrives with a diagnosis or label about what is wrong or has a previous clinical history – the patient with previously diagnosed irritable bowel syndrome

who presents three times to an emergency department in a week with abdominal pain and the fourth time by ambulance with a ruptured ectopic pregnancy. Accepting the frame can lead to significant error. Related to this is ‘diagnosis momentum’, when a diagnosis is passed from clinician to clinician despite incomplete data. It’s not difficult to find examples where this has happened in this hospital. These sources of error are all apparent when we analyse significant clinical incidents and complaints, for example, a significantly wrong estimation of gestation, problems that develop in a ‘low risk’ labour and are not recognised, preferring a gastro type diagnosis because the patient had a recent meal and not picking up a bowel perforation complication from recent surgery, delay in recognising a deteriorating patient. People are caught in a particular mind frame and discount or don’t pick up contradictory data. In retrospect, people look back, shake their heads and wonder how on earth they missed it. Sometimes the patients themselves have been more accurate about their condition. What clinicians think about a patient can also influence diagnosis. ‘Representation errors’ happen when the clinician is guided by a prototype (this person is fit) and fails to consider possibilities that contradict this (don’t consider cardiac options). What they feel about a patient is even more potent. Attribution errors happen when negative stereotypes affect diagnosis – the disheveled looking ‘drunk’ person who turns out to be on the verge of a diabetic coma. Groopman gives an example of a woman diagnosed for over a decade with an eating disorder who has been faithfully following doctor’s orders to eat more pasta and bread to put on weight, who very late in the piece sees a gastroenterologist who finds that she has celiac disease. A wealth of research, Groopman argues, shows that patients thought to have a psychological disorder get short shift from internists, surgeons and sadly gynaecologists, with undiagnosed and late diagnosed physical ailments. Very positive feelings for a patient are no guarantee and bring their

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own thinking traps. Very positive feelings can lead to ‘affective errors’ – unconsciously preferring data that indicates a favorable diagnosis. The sickest patient, he suggests, can be least liked by doctors. The inability to help and cure and sense of failure from a group of people that like to cure and help can affect what doctors feel about the patient. Some patients will perceive this feeling in the doctor. Does technology - ultrasound, X-rays, CT scans, MRI, CTGs – get it any better? While the research shows that diagnoses are incorrect 15% of the time, the range for radiologists, allowing for false positives and negatives, is in the order of 20-30%. A key bias for radiologists arises from search satisfaction, the natural tendency to stop when a major finding is identified. Radiologists often see what they expect to see. How do doctors and other clinicians guard against these common errors in thinking? Understanding how cognitive errors can happen is a good way to prevent them and Groopman thinks that this should be part of clinical education. Acknowledging and learning from errors and mistakes is essential to avoiding future mistakes. Intellect and intuition, careful attention to detail, active listening and psychological insight, Groopman argues, make a good clinician. The book is written for a lay audience. Patients have a role to play in protecting themselves and doctors from mistakes through understanding that these types of thinking errors can happen even in the best of clinicians and should ask questions. What else could it be? Is there anything that doesn’t fit? Is it possible I have more than one problem? ‘How Doctors Think’ is a recommended read.

Mary Draper Director Clinical Governance J. Kroopman How Doctors Think, Scribe, 2007 – available Readings

Current clinical news 37 weekers not as safe as thought Babies born at 37 weeks gestation are three times more likely to die in their first year than those born at 40 weeks, show government data for England and Wales in 2005 that link infant mortality to gestational age. However, infant mortality in this gestation range was still low, at 4.1 deaths per 1000 live births among babies born at 37 weeks and 1.3 per 1000 among those born at 40 weeks, says the report, published by the Office for National Statistics in Health Statistics Quarterly (2007;35:13-27). The data covered all 645,887 live births in England and Wales in 2005. Overall mortality in the first year of life was five deaths per 1000 live births. Babies born before 37 weeks made up 7.6% of live births but two thirds of the deaths in the first year of life.

White Coats and Neckties Banned in British Hospitals

ACOG advises against 'vaginal rejuvenation' procedure

Britain's Department of Health has issued a dress code for hospital staff that bans white jackets and neckties.

Vaginal cosmetic surgeries such as 'vaginal rejuvenation' or 'designer vaginoplasty' have not been proven safe or effective, warns the American College of Obstetricians and Gynecologists in Obstetrics and Gynecology.

The rules, released online, are intended to prevent the spread of infections via clothing. They allow only short-sleeved shirts and discourage wristwatches and all jewelry except plain wedding rings. The Department of Health says neckties "perform no beneficial function in patient care and have been shown to be colonized by pathogens." However, the department also notes, "there is no conclusive evidence that uniforms (or other work clothes) pose a significant hazard in terms of spreading infection." Link: http://www.dh.gov.uk/en/ Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_078433

See: BMJ 2007;335:420 (1 September), doi:10.1136/bmj.39317.644907.DB

The surgeries – purported to enhance sexual gratification and genital appearance altered by childbirth and aging – are growing in popularity, according to the Wall Street Journal. Some of these cosmetic procedures are variations of surgeries for recognized medical conditions, including pelvic prolapse, vaginal relaxation with symptoms, female circumcision, and treatment for labial hypertrophy or asymmetrical labial growth. However, patients undergoing the cosmetic versions should be aware of possible complications: infection, altered sensation, pain, adhesions, and scarring. Abbey B. Berenson, a member of ACOG's Committee on Gynecologic Practice, says, "An honest discussion about the wide variation in the appearance of normal genitalia could reassure women who are insecure about the look of their own genitalia." Link: http://www.acog.org/from_home/ publications/press_releases/nr09-01-07-1. cfm

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Quality and safety news The Quality and

quantifying harm from these

A recent case was reviewed

Safety Committee

events. The records for review

by the Quality and Safety

were selected randomly.

Committee. A patient was

is the hospital clinical Anthony Woodward

governance arm that reports to the Board of Directors via the Board Quality and

Penny Sheehan

Safety Committee.

After the six month trial period members of the Q&S committee felt that they would prefer a return to the more traditional “incident-based” method of maternity record review. Following discussion

At its last meeting

with Dr Peter Wein, Director

the hospital Committee

of Birth suites, the following

felt that significant

sentinel events have been

presenting for elective surgery with a moderate risk of haemorrhage but had not previously disclosed her reluctance to accept blood products/ transfusion. Thankfully this situation was resolved without harm and with satisfaction for both the patient and treating clinicians.

chosen for review: obstetric

This case review has

developments should

HDU admissions, blood

highlighted a deficiency in the

be reported to the

transfusions following delivery

pre-anaesthetic questionnaire.

(packed cells only), ruptured

We currently ask patients “Are

clinical staff

uterus, failed forceps or

you a Jehovah’s Witness?” but

in this newsletter.

vacuum extraction, Erb’s palsy

should really ask directly about

Two such initiatives

and peripartum hysterectomy.

acceptance of blood products.

are described below.

The first review following the change in methodology

For many years we’ve reviewed a sample of records of discharged patients every month analyzing opportunities for improvement. Different flags have been used. For the past six months we trialed the

This question is currently being reviewed.

highlighted issues of poor

A broader issue is raised

documentation in the notes,

about optimising the patient’s

especially for events occurring

condition prior to surgery with

in birth suites or theatre and

respect to potential blood loss.

issues around prolonged

Ideally we minimise the use

second stage particularly at the

of all blood products. We as

time of the obstetric handover.

clinicians must continue to redefine the balance

Institute for Healthcare

A second initiative was

Improvement Global Trigger

regarding the pre-anaesthetic

Tool for Measuring Adverse

questionnaire. The Women’s

Events for the maternity part

elective surgery assessment

of this review. This system used

(MR90959) is a risk assessment

a number of standard “triggers”

tool for use prior to surgery.

in combination with manual

It tries to recognise and

record review to identify

address risk prior to the

Penny Sheehan

adverse events and it also

surgical encounter in an effort

and Anthony Woodward

incorporated a method of

to make the episode safer for the individual patient.

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between preoperative optimisation, issues resulting from delay in definitive surgery and the community’s finite resources.

Pharmacy news Cold sore management Yuan loke

in pregnancy and during breastfeeding Core sores (also known as herpes labialis) are generally caused by the herpes simplex virus type 1 (HSV-1). Most people are infected with herpes virus for the first time as infants or young children. Once infected the HSV-1 lives inside the body in the nerves. Following some trigger events, the virus is reactivated and travels through the nerve endings toward the lips to cause cold sores.1

Pregnancy and breastfeeding

Pharmacological management

Pregnancy may compromise the immune system, leaving women more vulnerable to the virus attack. Pregnant women can prevent cold sore outbreaks by boosting their immune system.

Cold sores are common, self-limiting and highly contagious. Transmission is through transfer of the virus via saliva to mucous membranes. Each episode usually resolves in 7-10 days. Outbreaks may begin with a prodromal phase of up to 24 hours before any visible signs appear, during which the area on or around the lips begins to tingle, burn or itch.2 Irritating fluid-filled blisters develop on the lips and skin around the mouth and breakdown secreting fluid before crusting over and healing.

• Avoid kissing and sharing items or utensils that may have been in contact with another affected person’s mucous membranes

Aciclovir cream has been available for the treatment of cold sores for over a decade. There is little evidence showing the effectiveness of topical aciclovir as a treatment for cold sores. Two randomised controlled trials of topical aciclovir 5% cream applied five times a day for four days showed that topical aciclovir compared with placebo shortened the duration of an outbreak by 0.5 days and 0.6 days respectively.4, 5

Unfortunately, once the first episode of a cold sore occurs, you are more likely to have repeated attacks.

Non-pharmacological management

• Wash hands frequently and always use sunscreen if out in the sun. • Ice compression on the affected areas should be recommended as first line • Apply lip moisturizers (e.g. vaseline lip therapy) to the lips as required to protect and lower the risk of recurrence • A study demonstrates that honey applied topically can accelerate the healing process of cold sores lesion and markedly improves the signs and symptoms of recurrent episodes3

Many over-the-counter products (table 1) may provide some symptomatic relief. These are available in pharmacies and supermarkets. Yuan Loke Clinical Pharmacist References 1. Core Sore Fact Sheet- A basic review. The Dental Assistant, 2003. 2. Nathan, A., Coping with cold sores. Pharmacy Update, 2007: p. 25-27. 3. Al-Waili, N.S., Topical honey application vs. acyclovir for the treatment of recurrent herpes simplex lesions. Med Sci Monit, 2004. 10(8): p. MT94-98. 4. Chon, Clinical inquiries. What are the best treatments for herpes labialis? The Journal of family practice, 2007. 56(7): p. 576-8. 5. Spruance, S.L., et al., Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials. Antimicrobial Agents and Chemotherapy, 2002. 46(7): p. 2238-2243. 6. MICROMEDEX Healthcare series 1974-2006, Thompson MICROMEDEX. 7. MIMS Online

Table 1 List of over-the-counter products for cold sores Generic name

Brand name

Pregnancy

Lactation

Aciclovir cream

Acihexal cream, Acivir, Blistex antiviral cold sore cream, chemists’ own cold sore cream, Lovir, Zovirax cold sore cream

Topical aciclovir appears to be absorbed minimally through normal skin and so it is unlikely to pose a substantial teratogenic risk. Use during pregnancy only if it is the drug of choice.

No apparent neonatal risk. Topical application poses no risk to infant as minimal absorption is expected.

Betadine preparations

Use should be limited (single application only or small area for a short period). Although no adverse effects are anticipated caution is recommended due to possible effects of absorption of iodine on thyroid development and function.

Use with caution iodine might affect thyroid development and function of the infant.

Lysine; Zinc oxide tablet

Vitaline cold sore tablet

Adverse pregnancy effects of lysine supplementation have not been described and are not anticipated based on studies in pregnant rodents. Evidence of effectiveness is still pending.

Lack of human studies.

Benzalkonium chloride, Idoxuridine; Lignocaine

Virasolve

There are no human studies. Idoxuridine increases malformation in experimental animals. Consider alternative therapy.

Lack of human studies.

Povidoneiodine cream

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Human Papilloma Virus (HPV) vaccines Pregnancy

HPV vaccines have been marketed in Australia earlier this year for prevention of cervical cancer.

Laura Leung

HPV vaccines are category B2 in pregnancy. Due to the lack of safety

Cervarix® vaccine effect on breast fed infants of vaccinated mothers has not been evaluated in clinical studies. It is not known whether HPV vaccine

There are 2 HPV vaccines registered

evidence in animals and humans, HPV

for use in Australia, they are both

vaccines should not be given during

non-infectious and do not have

pregnancy and initiation of the vaccine

cancer-causing potential:

series should be delayed until after

Laura Leung

completion of pregnancy. However,

Clinical Pharmacist

Gardasil®

antigens or HPV antibodies are excreted in human milk.

inadvertent exposure to HPV vaccines during pregnancy is not an indication

• Quadrivalent vaccine containing virus-like particles of HPV types 6,

for termination. There is no evidence

References:

11, 16 and 18, and is administered

of increased adverse fetal outcomes

Product Information 2007

as a 3-dose schedule at 0, 2, 6

observed in pregnant rats or amongst

months indicated in females aged

HPV vaccine trials participants who

9 to 26 years for the prevention of

unintentionally became pregnant.

cervical, vulvar and vaginal cancer, and in males aged 9 to 15 years for the prevention of infection caused by HPV types 6, 11, 16 and 18

Cervarix® • Bivalent vaccine containing viruslike particles of HPV types 16 and 18, and is administered as a 3-dose schedule at 0, 1 and 6 months indicated in females from 10 to 45 years of age for the

after initiation of the HPV vaccine

HPV vaccine information statement 2007 – Centers of Disease Control and Prevention (CDC) Australian Immunisation Handbook 9th edition (Draft)

series, further doses should be deferred until after delivery.

Breastfeeding HPV vaccines may be given whilst lactating. In nursing mothers given the Gardasil® vaccine or placebo during clinical trials, the rates of adverse reactions in the mother and in the breast-fed infant, as well as vaccine immunogenicity were comparable in the 2 groups.

D07-154 design@thewomens

prevention of cervical cancer

If a woman is found to be pregnant

Micromedex 1974-2007

Please let the associate editors have your views on the contents of this newsletter, or any other matters involving clinical practice which may be of interest to our readers.

Mary Draper, telephone (03) 9344 2722 or email [email protected] Mary Draper, telephone (03) 9344 2722 or email [email protected] Susan Braybrook, telephone (03) 9344 2606 or email [email protected] Susan Braybrook, telephone (03) 9344 2606 or email [email protected] The Quality and Safety Unit homepage www.rwh.org.au/quality­_rwh Anthony Woodward, [email protected] Jayshree Ramkrishna, [email protected] Robin Montgomery, [email protected] 6