Clinical Review

The authors report no financial relationships relevant to this article.

Many senior obstetricians—you may be among them—have vivid recall of performing their first vaginal delivery as an intern or junior resident, guided by a seasoned obstetric nurse or senior resident. “See one, do one, teach one,” an unwritten motto at large teaching hospitals, aptly characterized the learning environment for many older physicians.

Regrettably, obstetric residents and fellows today face a very different situation. Restrictions on residents’ working hours, financial pressures that make attending faculty less available for supervision, and wariness prompted by malpractice litigation—all these have made such teaching cases less available. So, how can physicians-in-training acquire the skills they will need in practice? And how can experienced clinicians breathe life back into skills that they use infrequently but are nonetheless critical?

We believe the answer can be found in the educational technique of simulation, which we describe in this article.

Simulation provides opportunities for physicians to practice, gain experience, and refresh. The technique offers a credible way to augment the educational curriculum and, even in the absence of unequivocal proof, to improve patient safety and reduce the likelihood of adverse outcomes.¹ For that reason, some malpractice insurers are making simulation training part of their safety and risk reduction initiatives.

To begin our discussion, a brief history of simulation appears below.

What simulations reveal about OBs’ skills

Maslovitz and colleagues, in a study that used simulated events, investigated errors among residents and nurse-midwives that occurred while teams managed four critical obstetric events¹ :

• eclamptic seizure
  
• postpartum hemorrhage
  
• shoulder dystocia
  
• breech extraction.
  

The most common management errors found were:

• delays in transporting a bleeding patient to the operating room (82% of the time)
  
• unfamiliarity with administering prostaglandin to reverse uterine atony (82%)
  
• poor cardiopulmonary resuscitation technique (80%)
  
• inadequate documentation of shoulder dystocia (80%)
  
• delayed administration of blood products to reverse consumptive coagulopathy (66%)
  
• inappropriate avoidance of episiotomy in shoulder dystocia and breech extraction (32%).
  

 

Managing eclampsia

Thompson’s study of eclampsia simulation drills² identified three major problems in handling this emergency:

• difficulty summoning senior staff
  
• multiple protocols for managing eclampsia, without a clear first-line anticonvulsant
  
• significant time lost gathering items required to manage seizures.
  

Based on what was observed in simulations, Thompson recommended 1) creating so-called eclampsia boxes that contain all necessary equipment and 2) establishing a liaison with the pharmacy to ensure consistency in supplies of magnesium sulfate.

Shoulder dystocia

The 5th Report on Confidential Enquiries into Maternal Deaths in the United Kingdom found that, in 66% of neonatal deaths following shoulder dystocia, “different management could have reasonably been expected to have altered the outcome.”³

Using a standardized shoulder dystocia simulation, Deering and colleagues reported significantly higher scores for residents who were trained in the scenario, including in the timeliness of their intervention, performance of maneuvers, and overall performance.⁴

Crofts, Draycott, and various colleagues developed a training mannequin for hospital staff that included a force-monitoring system comprised of a strain gauge mounted on both clavicles. After training, they found a reduction in 1) head-to-body delivery duration and 2) maximum applied delivery force after training, although these reductions did not reach statistical significance.^5,6

Where do you begin?

Starting a simulation program can be challenging: Significant financial hurdles may exist, and teamwork and communication issues can be major barriers to yielding improvements in practice. What’s the first step?

Find backing. Garner support for your project ( TABLE 1 ). It’s imperative to involve administrative leadership early.⁷ One champion cannot sustain a program of this magnitude.

Assemble a multidisciplinary team. Include obstetricians, gynecologists, anesthesiologists, neonatologists, and other members of the perinatal or surgical team. All will be needed to create complex interdisciplinary drills or simulations.

Build consensus. Determine the scope, goals, and objectives of the project. Define measurable outcomes.

Outline a budget. Make a realistic assessment of the resources available to fund the curriculum you design.

TABLE 1

Opening questions about a simulation training program

How do you get started?
Garner support Build consensus Define outcomes Create a budget
What are the key components?
Skills inventory Necessary competencies Stated objectives Adult learning principles Performance measures Debriefing Feedback

Know how adults learn

A simulation designed to raise the skill level of professionals—be they residents, nurses, or attending physicians—must recognize the special characteristics of adult learners. Unlike school children, adult learners are self-directed; they bring real-life experience to the table, are motivated primarily by a need to know, have individual learning styles, and deserve to be treated with respect.

A simulation curriculum should incorporate so-called crew resource management skills—a style of open cockpit communication of proven worth in improving airline safety.⁸ Those crew skills should promote best practices in closed-loop communication (such as the readback/hearback system⁹ ), information sharing, assertiveness, adaptability, and leadership skills—all elements of successful simulation. Means of coordinating, allocating, and monitoring team resources should be built into the curriculum ( TABLE 1 ).

Find the time

A practical rule to follow when designing a simulation goes by the acronym ARRON—As Reasonably Realistic as Objectively Needed.¹⁰

The team leader should match the task to:

• time allotted
  
• baseline level of medical knowledge of the trainee (resident, nurse-midwife, experienced attending)
  
• budget.
  

A major hurdle, especially in a community hospital, is to schedule sessions at a time when as many providers as possible can attend. Taking time off for training is particularly difficult for office-based providers; a workable schedule must take their needs into consideration—possibly with evening or weekend sessions.

Multiple nursing shifts may necessitate repeating a simulation several times. Consider having a so-called stand-down declared, in which all nonemergency cases are delayed (if hospital administration is amenable). Alternatively, the hospital may allot time for a simulation exercise during a slot for a weekly educational lecture or monthly department meeting.

What equipment is needed?

A community hospital can develop a simulation program that is focused on its educational and safety needs. For example, a broad range of birth simulators is available ( TABLE 2 ). The features and capabilities of each model vary with cost (we do not recommend any particular simulator). The ideal childbirth simulator has yet to be defined, but existing modalities can be adapted to meet specific needs of a target audience. A standard obstetric birthing pelvis equipped with an inflatable uterus for simulating uterine atony, for example, can be modified and made to bleed from the model’s cervical os to simulate postpartum hemorrhage.¹¹ Commercial models (mannequins) are not always necessary for OB simulation; task trainers (devices that allow repeated practice of individual skills) and standardized patients (persons trained to portray patient scenarios) can also be used.

 

Most hospitals do not have an extensive simulation center. Several state-of-the-art facilities exist in the United States, including:

• The Uniformed Services University of the Health Sciences, Bethesda, Md.
  
• the Center for Medical Simulation, Cambridge, Mass.
  
• the International Academy for Clinical Simulation and Research, Miami, Fla.
  

The Society for Simulation in Healthcare maintains a list (at www.ssih.org/public) of institutions that host a simulation center.

TABLE 2

What are the commercially available childbirth simulators?
Models are listed in ascending order by price

Manufacturer	Model	Price	Features
Childbirth Graphics	• Vinyl Pelvic Model set	$ 188.50	Accommodates cloth fetal model’s head
	• Abdominal Palpation Model	486.70	Fetal head with palpable anterior and posterior fontanels; fetal body flexes for demonstration of all presentations; movable gel packs to simulate amniotic fluid
Gaumard Scientific	• Advanced Childbirth Simulator	500.00	Removable diaphragm end plate for manual positioning of fetus
Simulaids	• Obstetrical mannequin	547.00	Includes disposable umbilical cords and powder to make simulated blood
	• Forceps/vacuum delivery OB mannequin	651.00	Used in Advanced Life Support in Obstetrics training programs; soft vinyl pelvis replicates the resistance encountered in an operative vaginal delivery
Nasco	• Life/form birthing station simulator	720.00	Shows relationship between fetal head and ischial spines
Gaumard Scientific	• Obstetric Susie	995.00	Adaptive birth canal to demonstrate shoulder dystocia; ability to practice manipulation of breech
3B Scientific	• Standard Childbirth Simulator	1,336.00	Covered belly cavity; removable vulva and fetus at 40 weeks gestation
Gaumard Scientific	• NOELLE S552 Birthing Torso	1,750.00	Automatic birthing system that rotates baby as it moves through birth canal
Gaumard Scientidfic	• NOELLE S551 Birthing Simulator	2,795.00	Inflatable airway with chest rise, IV arm for meds/fluids, vulval inserts for suturing practice
Limbs & Things	• PROMPT Birthing Simulator: Standard	3,600.00	Movable legs (semirecumbent, lithotomy position, McRoberts maneuver, all fours)
	• PROMPT Birthing Simulator: Force Monitoring	6,100.00	Electronic strain gauge allows for measurement of force applied to baby as it is delivered
Gaumard Scientific	• NOELLE S555 Birthing Simulator	11,995.00	PEDI Blue full-term newborn included; nine prepackaged scenarios
	• NOELLE S560 Birthing Simulator	15,995.00	Testing stations include ALS, NRP, and obstetrics; virtual instruments used to monitor the mother include heart rate, blood pressure, pulse oxygenation, and electrocardiogram
	• NOELLE S565 Birthing Simulator	19,995.00	Computer interactive; instructor controls delivery as well as fetal monitor
Koken	• Full-body pregnancy simulator	28,518.00	Model made of lifelike materials for realistic practice
Gaumard Scientific	• NOELLE S575 Birthing Simulator	34,995.00	Wireless, tetherless, and fully responsive; built-in scenarios for crash C-section, postpartum hemorrhage, shoulder dystocia, placenta previa, and operative vaginal delivery

What topics should be covered by simulation?

A simulation curriculum may begin with low-frequency, high-acuity events, such as shoulder dystocia, postpartum hemorrhage, breech delivery,¹² and maternal cardiorespiratory arrest ( TABLE 3 ).

Some birth simulators included prepackaged clinical scenarios ( TABLE 2 ). We recommend that you conduct prescenario and postscenario didactic teaching seminars on the specific topic of the simulation. These seminars should touch on the major aspects of care and specifically address risk components.

TABLE 3

What are possible scenarios in an OB simulation curriculum?

Amniotic fluid embolism Breech delivery Eclampsia Episiotomy/procto-episiotomy repair Maternal cardiac arrest Operative vaginal delivery Postpartum hemorrhage Shoulder dystocia Trauma in pregnancy Umbilical cord prolapse Vaginal birth after C-section/uterine rupture

Debriefing is key

Real learning occurs during postscenario debriefing, during which participants explain, analyze, and synthesize information on their actions and emotional state during the simulation (or a real event). The objective? To improve performance in similar situations.¹³

In a debriefing, teammates gather to discuss:

• their assumptions, actions, and feelings
  
• matters of teamwork and communication
  
• availability of needed equipment or other resources.
  

After-action reviews. Debriefing has its origins in 1) so-called after-action reviews that are part of military protocol—that is, preflight and postflight discussions aimed at diminishing airplane crashes—and 2) studies of organizational behavior and psychology. Gaba is credited for leading the first “critical medical event management” debriefing in the late 1980s.¹⁴ Debriefing can be self- or team-directed or led by a skilled facilitator; the team can address routine or critical events.

Good judgment. Ideally, a trained instructor or facilitator leads a debriefing session, encouraging group feedback and reflection on clinical practice and team behavior. Debriefing with good judgment is an approach that values the expert opinion of the instructor and the unique perspective of each participant. It allows the instructor to match teaching objectives with trainee concerns by understanding the assumptions and beliefs that drive participants’ actions.¹³

Debriefing can identify deficiencies in practice and documentation, and can promote best practices for teamwork among physicians, nurses, and support staff. ¹⁵ Objective and subjective performance can be assessed by reviewing videotaped simulations [Editor’s note: Watch a video of a C-section simulation in the OBG Management Video Library (www.obgmanagement.com)], participant or third-party performance evaluations, and pre- and postsession testing.

Vulnerabilities. Simulation can expose interpersonal and intrapersonal vulnerabilities. To hear criticism from colleagues about behavior and technical performance can be difficult, whether participants are inexperienced students or professional colleagues who work together in a high-stress perinatal environment.

 

In a debriefing with good judgment, the leader ensures an atmosphere of safety, in which teammates can speak up freely and must be mutually respectful and accountable to each other. Suggestions that arise from a debriefing session should be viewed as an opportunity for improvement, not a time to assign blame or impose penalties.

After the session is over

The steps you take after debriefing are the most important of all ( TABLE 4 ). To have a real impact, a simulation program must include mechanisms for assessing and documenting measurable outcomes, staff satisfaction, and improvements in patient safety. Ongoing feedback to, and from, the staff—by way of newsletters, announcements, grand rounds, and social gatherings—is crucial. Last, assessment and feedback must be used to inform regular updates of the simulation program.

TABLE 4

What ongoing program elements are needed?

Documented assessment Ongoing feedback Periodic program updates

What simulation does best

According to a “root cause” analysis by the Joint Commission on Accreditation of Healthcare Organizations, most (72%) cases of perinatal death and permanent disability can be traced to problems with organizational culture and communication among caregivers.¹⁶ These are precisely the kind of issues that simulation training is best suited to confront: Simulation allows participants to identify system-based issues and staff responses that are inadequate for managing critical clinical events.

The impact of simulation training programs can be assessed by monitoring trends in key maternal and neonatal outcomes.¹⁷ A downward trend in adverse events (e.g., low Apgar score for term newborns, maternal or neonatal birth-related injury), for example, would underscore the value of simulation in improving patient safety and quality of care.

Liability insurance. Professional liability carriers are beginning to incorporate simulation training into patient safety and risk-reduction initiatives. Harvard University’s medical malpractice insurer, Controlled Risk Insurance Company/Risk Management Foundation, established a voluntary incentive program in 2003 that provides a 10% premium credit to providers of OB services who complete risk-reduction activities that include simulation-based and didactic team training. A downward trend in obstetrical claims in association with this incentive program was recently noted.¹⁸

Resident and continuing medical education. The Council on Resident Education in Obstetrics and Gynecology featured simulation at its annual meeting in 2007 as a credible way to augment the curriculum for resident education.¹⁹ Simulation is also being used to train OBs who need to learn new skills and procedures, refresh infrequently needed skills (cesarean-hysterectomy, laparoscopy), or reenter the workplace after an extended absence.²⁰

What does the future hold?

Simulation provides a safe environment, in which mistakes are tolerated without harming patients and appropriate responses can be learned and practiced.²¹ Benefits of the technique are acknowledged in England, where annual skill drills, using simulation, are recommended by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists.

In the United States, the use of OB simulation in residency and postresidency training programs is growing. This change is likely to trigger the introduction of simulation into board certification and credentialing procedures.

Work is needed to validate and standardize simulation-based scenarios. Studies will need to show that simulation improves clinicians’ and teams’ performance not only on simulators but in practice. Despite these hurdles, it is reasonable to conclude that respect for patients and a desire to learn without doing harm will expand and diversify the role of simulation in OB training and practice.

The authors report no financial relationships relevant to this article.

Many senior obstetricians—you may be among them—have vivid recall of performing their first vaginal delivery as an intern or junior resident, guided by a seasoned obstetric nurse or senior resident. “See one, do one, teach one,” an unwritten motto at large teaching hospitals, aptly characterized the learning environment for many older physicians.

Regrettably, obstetric residents and fellows today face a very different situation. Restrictions on residents’ working hours, financial pressures that make attending faculty less available for supervision, and wariness prompted by malpractice litigation—all these have made such teaching cases less available. So, how can physicians-in-training acquire the skills they will need in practice? And how can experienced clinicians breathe life back into skills that they use infrequently but are nonetheless critical?

We believe the answer can be found in the educational technique of simulation, which we describe in this article.

Simulation provides opportunities for physicians to practice, gain experience, and refresh. The technique offers a credible way to augment the educational curriculum and, even in the absence of unequivocal proof, to improve patient safety and reduce the likelihood of adverse outcomes.¹ For that reason, some malpractice insurers are making simulation training part of their safety and risk reduction initiatives.

To begin our discussion, a brief history of simulation appears below.

What simulations reveal about OBs’ skills

Maslovitz and colleagues, in a study that used simulated events, investigated errors among residents and nurse-midwives that occurred while teams managed four critical obstetric events¹ :

• eclamptic seizure
  
• postpartum hemorrhage
  
• shoulder dystocia
  
• breech extraction.
  

The most common management errors found were:

• delays in transporting a bleeding patient to the operating room (82% of the time)
  
• unfamiliarity with administering prostaglandin to reverse uterine atony (82%)
  
• poor cardiopulmonary resuscitation technique (80%)
  
• inadequate documentation of shoulder dystocia (80%)
  
• delayed administration of blood products to reverse consumptive coagulopathy (66%)
  
• inappropriate avoidance of episiotomy in shoulder dystocia and breech extraction (32%).
  

 

Managing eclampsia

Thompson’s study of eclampsia simulation drills² identified three major problems in handling this emergency:

• difficulty summoning senior staff
  
• multiple protocols for managing eclampsia, without a clear first-line anticonvulsant
  
• significant time lost gathering items required to manage seizures.
  

Based on what was observed in simulations, Thompson recommended 1) creating so-called eclampsia boxes that contain all necessary equipment and 2) establishing a liaison with the pharmacy to ensure consistency in supplies of magnesium sulfate.

Shoulder dystocia

The 5th Report on Confidential Enquiries into Maternal Deaths in the United Kingdom found that, in 66% of neonatal deaths following shoulder dystocia, “different management could have reasonably been expected to have altered the outcome.”³

Using a standardized shoulder dystocia simulation, Deering and colleagues reported significantly higher scores for residents who were trained in the scenario, including in the timeliness of their intervention, performance of maneuvers, and overall performance.⁴

Crofts, Draycott, and various colleagues developed a training mannequin for hospital staff that included a force-monitoring system comprised of a strain gauge mounted on both clavicles. After training, they found a reduction in 1) head-to-body delivery duration and 2) maximum applied delivery force after training, although these reductions did not reach statistical significance.^5,6

Where do you begin?

Starting a simulation program can be challenging: Significant financial hurdles may exist, and teamwork and communication issues can be major barriers to yielding improvements in practice. What’s the first step?

Find backing. Garner support for your project ( TABLE 1 ). It’s imperative to involve administrative leadership early.⁷ One champion cannot sustain a program of this magnitude.

Assemble a multidisciplinary team. Include obstetricians, gynecologists, anesthesiologists, neonatologists, and other members of the perinatal or surgical team. All will be needed to create complex interdisciplinary drills or simulations.

Build consensus. Determine the scope, goals, and objectives of the project. Define measurable outcomes.

Outline a budget. Make a realistic assessment of the resources available to fund the curriculum you design.

TABLE 1

Opening questions about a simulation training program

How do you get started?
Garner support Build consensus Define outcomes Create a budget
What are the key components?
Skills inventory Necessary competencies Stated objectives Adult learning principles Performance measures Debriefing Feedback

Know how adults learn

A simulation designed to raise the skill level of professionals—be they residents, nurses, or attending physicians—must recognize the special characteristics of adult learners. Unlike school children, adult learners are self-directed; they bring real-life experience to the table, are motivated primarily by a need to know, have individual learning styles, and deserve to be treated with respect.

A simulation curriculum should incorporate so-called crew resource management skills—a style of open cockpit communication of proven worth in improving airline safety.⁸ Those crew skills should promote best practices in closed-loop communication (such as the readback/hearback system⁹ ), information sharing, assertiveness, adaptability, and leadership skills—all elements of successful simulation. Means of coordinating, allocating, and monitoring team resources should be built into the curriculum ( TABLE 1 ).

Find the time

A practical rule to follow when designing a simulation goes by the acronym ARRON—As Reasonably Realistic as Objectively Needed.¹⁰

The team leader should match the task to:

• time allotted
  
• baseline level of medical knowledge of the trainee (resident, nurse-midwife, experienced attending)
  
• budget.
  

A major hurdle, especially in a community hospital, is to schedule sessions at a time when as many providers as possible can attend. Taking time off for training is particularly difficult for office-based providers; a workable schedule must take their needs into consideration—possibly with evening or weekend sessions.

Multiple nursing shifts may necessitate repeating a simulation several times. Consider having a so-called stand-down declared, in which all nonemergency cases are delayed (if hospital administration is amenable). Alternatively, the hospital may allot time for a simulation exercise during a slot for a weekly educational lecture or monthly department meeting.

What equipment is needed?

A community hospital can develop a simulation program that is focused on its educational and safety needs. For example, a broad range of birth simulators is available ( TABLE 2 ). The features and capabilities of each model vary with cost (we do not recommend any particular simulator). The ideal childbirth simulator has yet to be defined, but existing modalities can be adapted to meet specific needs of a target audience. A standard obstetric birthing pelvis equipped with an inflatable uterus for simulating uterine atony, for example, can be modified and made to bleed from the model’s cervical os to simulate postpartum hemorrhage.¹¹ Commercial models (mannequins) are not always necessary for OB simulation; task trainers (devices that allow repeated practice of individual skills) and standardized patients (persons trained to portray patient scenarios) can also be used.

 

Most hospitals do not have an extensive simulation center. Several state-of-the-art facilities exist in the United States, including:

• The Uniformed Services University of the Health Sciences, Bethesda, Md.
  
• the Center for Medical Simulation, Cambridge, Mass.
  
• the International Academy for Clinical Simulation and Research, Miami, Fla.
  

The Society for Simulation in Healthcare maintains a list (at www.ssih.org/public) of institutions that host a simulation center.

TABLE 2

What are the commercially available childbirth simulators?
Models are listed in ascending order by price

Manufacturer	Model	Price	Features
Childbirth Graphics	• Vinyl Pelvic Model set	$ 188.50	Accommodates cloth fetal model’s head
	• Abdominal Palpation Model	486.70	Fetal head with palpable anterior and posterior fontanels; fetal body flexes for demonstration of all presentations; movable gel packs to simulate amniotic fluid
Gaumard Scientific	• Advanced Childbirth Simulator	500.00	Removable diaphragm end plate for manual positioning of fetus
Simulaids	• Obstetrical mannequin	547.00	Includes disposable umbilical cords and powder to make simulated blood
	• Forceps/vacuum delivery OB mannequin	651.00	Used in Advanced Life Support in Obstetrics training programs; soft vinyl pelvis replicates the resistance encountered in an operative vaginal delivery
Nasco	• Life/form birthing station simulator	720.00	Shows relationship between fetal head and ischial spines
Gaumard Scientific	• Obstetric Susie	995.00	Adaptive birth canal to demonstrate shoulder dystocia; ability to practice manipulation of breech
3B Scientific	• Standard Childbirth Simulator	1,336.00	Covered belly cavity; removable vulva and fetus at 40 weeks gestation
Gaumard Scientific	• NOELLE S552 Birthing Torso	1,750.00	Automatic birthing system that rotates baby as it moves through birth canal
Gaumard Scientidfic	• NOELLE S551 Birthing Simulator	2,795.00	Inflatable airway with chest rise, IV arm for meds/fluids, vulval inserts for suturing practice
Limbs & Things	• PROMPT Birthing Simulator: Standard	3,600.00	Movable legs (semirecumbent, lithotomy position, McRoberts maneuver, all fours)
	• PROMPT Birthing Simulator: Force Monitoring	6,100.00	Electronic strain gauge allows for measurement of force applied to baby as it is delivered
Gaumard Scientific	• NOELLE S555 Birthing Simulator	11,995.00	PEDI Blue full-term newborn included; nine prepackaged scenarios
	• NOELLE S560 Birthing Simulator	15,995.00	Testing stations include ALS, NRP, and obstetrics; virtual instruments used to monitor the mother include heart rate, blood pressure, pulse oxygenation, and electrocardiogram
	• NOELLE S565 Birthing Simulator	19,995.00	Computer interactive; instructor controls delivery as well as fetal monitor
Koken	• Full-body pregnancy simulator	28,518.00	Model made of lifelike materials for realistic practice
Gaumard Scientific	• NOELLE S575 Birthing Simulator	34,995.00	Wireless, tetherless, and fully responsive; built-in scenarios for crash C-section, postpartum hemorrhage, shoulder dystocia, placenta previa, and operative vaginal delivery

What topics should be covered by simulation?

A simulation curriculum may begin with low-frequency, high-acuity events, such as shoulder dystocia, postpartum hemorrhage, breech delivery,¹² and maternal cardiorespiratory arrest ( TABLE 3 ).

Some birth simulators included prepackaged clinical scenarios ( TABLE 2 ). We recommend that you conduct prescenario and postscenario didactic teaching seminars on the specific topic of the simulation. These seminars should touch on the major aspects of care and specifically address risk components.

TABLE 3

What are possible scenarios in an OB simulation curriculum?

Amniotic fluid embolism Breech delivery Eclampsia Episiotomy/procto-episiotomy repair Maternal cardiac arrest Operative vaginal delivery Postpartum hemorrhage Shoulder dystocia Trauma in pregnancy Umbilical cord prolapse Vaginal birth after C-section/uterine rupture

Debriefing is key

Real learning occurs during postscenario debriefing, during which participants explain, analyze, and synthesize information on their actions and emotional state during the simulation (or a real event). The objective? To improve performance in similar situations.¹³

In a debriefing, teammates gather to discuss:

• their assumptions, actions, and feelings
  
• matters of teamwork and communication
  
• availability of needed equipment or other resources.
  

After-action reviews. Debriefing has its origins in 1) so-called after-action reviews that are part of military protocol—that is, preflight and postflight discussions aimed at diminishing airplane crashes—and 2) studies of organizational behavior and psychology. Gaba is credited for leading the first “critical medical event management” debriefing in the late 1980s.¹⁴ Debriefing can be self- or team-directed or led by a skilled facilitator; the team can address routine or critical events.

Good judgment. Ideally, a trained instructor or facilitator leads a debriefing session, encouraging group feedback and reflection on clinical practice and team behavior. Debriefing with good judgment is an approach that values the expert opinion of the instructor and the unique perspective of each participant. It allows the instructor to match teaching objectives with trainee concerns by understanding the assumptions and beliefs that drive participants’ actions.¹³

Debriefing can identify deficiencies in practice and documentation, and can promote best practices for teamwork among physicians, nurses, and support staff. ¹⁵ Objective and subjective performance can be assessed by reviewing videotaped simulations [Editor’s note: Watch a video of a C-section simulation in the OBG Management Video Library (www.obgmanagement.com)], participant or third-party performance evaluations, and pre- and postsession testing.

Vulnerabilities. Simulation can expose interpersonal and intrapersonal vulnerabilities. To hear criticism from colleagues about behavior and technical performance can be difficult, whether participants are inexperienced students or professional colleagues who work together in a high-stress perinatal environment.

 

In a debriefing with good judgment, the leader ensures an atmosphere of safety, in which teammates can speak up freely and must be mutually respectful and accountable to each other. Suggestions that arise from a debriefing session should be viewed as an opportunity for improvement, not a time to assign blame or impose penalties.

After the session is over

The steps you take after debriefing are the most important of all ( TABLE 4 ). To have a real impact, a simulation program must include mechanisms for assessing and documenting measurable outcomes, staff satisfaction, and improvements in patient safety. Ongoing feedback to, and from, the staff—by way of newsletters, announcements, grand rounds, and social gatherings—is crucial. Last, assessment and feedback must be used to inform regular updates of the simulation program.

TABLE 4

What ongoing program elements are needed?

Documented assessment Ongoing feedback Periodic program updates

What simulation does best

According to a “root cause” analysis by the Joint Commission on Accreditation of Healthcare Organizations, most (72%) cases of perinatal death and permanent disability can be traced to problems with organizational culture and communication among caregivers.¹⁶ These are precisely the kind of issues that simulation training is best suited to confront: Simulation allows participants to identify system-based issues and staff responses that are inadequate for managing critical clinical events.

The impact of simulation training programs can be assessed by monitoring trends in key maternal and neonatal outcomes.¹⁷ A downward trend in adverse events (e.g., low Apgar score for term newborns, maternal or neonatal birth-related injury), for example, would underscore the value of simulation in improving patient safety and quality of care.

Liability insurance. Professional liability carriers are beginning to incorporate simulation training into patient safety and risk-reduction initiatives. Harvard University’s medical malpractice insurer, Controlled Risk Insurance Company/Risk Management Foundation, established a voluntary incentive program in 2003 that provides a 10% premium credit to providers of OB services who complete risk-reduction activities that include simulation-based and didactic team training. A downward trend in obstetrical claims in association with this incentive program was recently noted.¹⁸

Resident and continuing medical education. The Council on Resident Education in Obstetrics and Gynecology featured simulation at its annual meeting in 2007 as a credible way to augment the curriculum for resident education.¹⁹ Simulation is also being used to train OBs who need to learn new skills and procedures, refresh infrequently needed skills (cesarean-hysterectomy, laparoscopy), or reenter the workplace after an extended absence.²⁰

What does the future hold?

Simulation provides a safe environment, in which mistakes are tolerated without harming patients and appropriate responses can be learned and practiced.²¹ Benefits of the technique are acknowledged in England, where annual skill drills, using simulation, are recommended by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists.

In the United States, the use of OB simulation in residency and postresidency training programs is growing. This change is likely to trigger the introduction of simulation into board certification and credentialing procedures.

Work is needed to validate and standardize simulation-based scenarios. Studies will need to show that simulation improves clinicians’ and teams’ performance not only on simulators but in practice. Despite these hurdles, it is reasonable to conclude that respect for patients and a desire to learn without doing harm will expand and diversify the role of simulation in OB training and practice.

The authors report no financial relationships relevant to this article.

Many senior obstetricians—you may be among them—have vivid recall of performing their first vaginal delivery as an intern or junior resident, guided by a seasoned obstetric nurse or senior resident. “See one, do one, teach one,” an unwritten motto at large teaching hospitals, aptly characterized the learning environment for many older physicians.

Regrettably, obstetric residents and fellows today face a very different situation. Restrictions on residents’ working hours, financial pressures that make attending faculty less available for supervision, and wariness prompted by malpractice litigation—all these have made such teaching cases less available. So, how can physicians-in-training acquire the skills they will need in practice? And how can experienced clinicians breathe life back into skills that they use infrequently but are nonetheless critical?

We believe the answer can be found in the educational technique of simulation, which we describe in this article.

Simulation provides opportunities for physicians to practice, gain experience, and refresh. The technique offers a credible way to augment the educational curriculum and, even in the absence of unequivocal proof, to improve patient safety and reduce the likelihood of adverse outcomes.¹ For that reason, some malpractice insurers are making simulation training part of their safety and risk reduction initiatives.

To begin our discussion, a brief history of simulation appears below.

What simulations reveal about OBs’ skills

Maslovitz and colleagues, in a study that used simulated events, investigated errors among residents and nurse-midwives that occurred while teams managed four critical obstetric events¹ :

• eclamptic seizure
  
• postpartum hemorrhage
  
• shoulder dystocia
  
• breech extraction.
  

The most common management errors found were:

• delays in transporting a bleeding patient to the operating room (82% of the time)
  
• unfamiliarity with administering prostaglandin to reverse uterine atony (82%)
  
• poor cardiopulmonary resuscitation technique (80%)
  
• inadequate documentation of shoulder dystocia (80%)
  
• delayed administration of blood products to reverse consumptive coagulopathy (66%)
  
• inappropriate avoidance of episiotomy in shoulder dystocia and breech extraction (32%).
  

 

Managing eclampsia

Thompson’s study of eclampsia simulation drills² identified three major problems in handling this emergency:

• difficulty summoning senior staff
  
• multiple protocols for managing eclampsia, without a clear first-line anticonvulsant
  
• significant time lost gathering items required to manage seizures.
  

Based on what was observed in simulations, Thompson recommended 1) creating so-called eclampsia boxes that contain all necessary equipment and 2) establishing a liaison with the pharmacy to ensure consistency in supplies of magnesium sulfate.

Shoulder dystocia

The 5th Report on Confidential Enquiries into Maternal Deaths in the United Kingdom found that, in 66% of neonatal deaths following shoulder dystocia, “different management could have reasonably been expected to have altered the outcome.”³

Using a standardized shoulder dystocia simulation, Deering and colleagues reported significantly higher scores for residents who were trained in the scenario, including in the timeliness of their intervention, performance of maneuvers, and overall performance.⁴

Crofts, Draycott, and various colleagues developed a training mannequin for hospital staff that included a force-monitoring system comprised of a strain gauge mounted on both clavicles. After training, they found a reduction in 1) head-to-body delivery duration and 2) maximum applied delivery force after training, although these reductions did not reach statistical significance.^5,6

Where do you begin?

Starting a simulation program can be challenging: Significant financial hurdles may exist, and teamwork and communication issues can be major barriers to yielding improvements in practice. What’s the first step?

Find backing. Garner support for your project ( TABLE 1 ). It’s imperative to involve administrative leadership early.⁷ One champion cannot sustain a program of this magnitude.

Assemble a multidisciplinary team. Include obstetricians, gynecologists, anesthesiologists, neonatologists, and other members of the perinatal or surgical team. All will be needed to create complex interdisciplinary drills or simulations.

Build consensus. Determine the scope, goals, and objectives of the project. Define measurable outcomes.

Outline a budget. Make a realistic assessment of the resources available to fund the curriculum you design.

TABLE 1

Opening questions about a simulation training program

How do you get started?
Garner support Build consensus Define outcomes Create a budget
What are the key components?
Skills inventory Necessary competencies Stated objectives Adult learning principles Performance measures Debriefing Feedback

Know how adults learn

A simulation designed to raise the skill level of professionals—be they residents, nurses, or attending physicians—must recognize the special characteristics of adult learners. Unlike school children, adult learners are self-directed; they bring real-life experience to the table, are motivated primarily by a need to know, have individual learning styles, and deserve to be treated with respect.

A simulation curriculum should incorporate so-called crew resource management skills—a style of open cockpit communication of proven worth in improving airline safety.⁸ Those crew skills should promote best practices in closed-loop communication (such as the readback/hearback system⁹ ), information sharing, assertiveness, adaptability, and leadership skills—all elements of successful simulation. Means of coordinating, allocating, and monitoring team resources should be built into the curriculum ( TABLE 1 ).

Find the time

A practical rule to follow when designing a simulation goes by the acronym ARRON—As Reasonably Realistic as Objectively Needed.¹⁰

The team leader should match the task to:

• time allotted
  
• baseline level of medical knowledge of the trainee (resident, nurse-midwife, experienced attending)
  
• budget.
  

A major hurdle, especially in a community hospital, is to schedule sessions at a time when as many providers as possible can attend. Taking time off for training is particularly difficult for office-based providers; a workable schedule must take their needs into consideration—possibly with evening or weekend sessions.

Multiple nursing shifts may necessitate repeating a simulation several times. Consider having a so-called stand-down declared, in which all nonemergency cases are delayed (if hospital administration is amenable). Alternatively, the hospital may allot time for a simulation exercise during a slot for a weekly educational lecture or monthly department meeting.

What equipment is needed?

A community hospital can develop a simulation program that is focused on its educational and safety needs. For example, a broad range of birth simulators is available ( TABLE 2 ). The features and capabilities of each model vary with cost (we do not recommend any particular simulator). The ideal childbirth simulator has yet to be defined, but existing modalities can be adapted to meet specific needs of a target audience. A standard obstetric birthing pelvis equipped with an inflatable uterus for simulating uterine atony, for example, can be modified and made to bleed from the model’s cervical os to simulate postpartum hemorrhage.¹¹ Commercial models (mannequins) are not always necessary for OB simulation; task trainers (devices that allow repeated practice of individual skills) and standardized patients (persons trained to portray patient scenarios) can also be used.

 

Most hospitals do not have an extensive simulation center. Several state-of-the-art facilities exist in the United States, including:

• The Uniformed Services University of the Health Sciences, Bethesda, Md.
  
• the Center for Medical Simulation, Cambridge, Mass.
  
• the International Academy for Clinical Simulation and Research, Miami, Fla.
  

The Society for Simulation in Healthcare maintains a list (at www.ssih.org/public) of institutions that host a simulation center.

TABLE 2

What are the commercially available childbirth simulators?
Models are listed in ascending order by price

Manufacturer	Model	Price	Features
Childbirth Graphics	• Vinyl Pelvic Model set	$ 188.50	Accommodates cloth fetal model’s head
	• Abdominal Palpation Model	486.70	Fetal head with palpable anterior and posterior fontanels; fetal body flexes for demonstration of all presentations; movable gel packs to simulate amniotic fluid
Gaumard Scientific	• Advanced Childbirth Simulator	500.00	Removable diaphragm end plate for manual positioning of fetus
Simulaids	• Obstetrical mannequin	547.00	Includes disposable umbilical cords and powder to make simulated blood
	• Forceps/vacuum delivery OB mannequin	651.00	Used in Advanced Life Support in Obstetrics training programs; soft vinyl pelvis replicates the resistance encountered in an operative vaginal delivery
Nasco	• Life/form birthing station simulator	720.00	Shows relationship between fetal head and ischial spines
Gaumard Scientific	• Obstetric Susie	995.00	Adaptive birth canal to demonstrate shoulder dystocia; ability to practice manipulation of breech
3B Scientific	• Standard Childbirth Simulator	1,336.00	Covered belly cavity; removable vulva and fetus at 40 weeks gestation
Gaumard Scientific	• NOELLE S552 Birthing Torso	1,750.00	Automatic birthing system that rotates baby as it moves through birth canal
Gaumard Scientidfic	• NOELLE S551 Birthing Simulator	2,795.00	Inflatable airway with chest rise, IV arm for meds/fluids, vulval inserts for suturing practice
Limbs & Things	• PROMPT Birthing Simulator: Standard	3,600.00	Movable legs (semirecumbent, lithotomy position, McRoberts maneuver, all fours)
	• PROMPT Birthing Simulator: Force Monitoring	6,100.00	Electronic strain gauge allows for measurement of force applied to baby as it is delivered
Gaumard Scientific	• NOELLE S555 Birthing Simulator	11,995.00	PEDI Blue full-term newborn included; nine prepackaged scenarios
	• NOELLE S560 Birthing Simulator	15,995.00	Testing stations include ALS, NRP, and obstetrics; virtual instruments used to monitor the mother include heart rate, blood pressure, pulse oxygenation, and electrocardiogram
	• NOELLE S565 Birthing Simulator	19,995.00	Computer interactive; instructor controls delivery as well as fetal monitor
Koken	• Full-body pregnancy simulator	28,518.00	Model made of lifelike materials for realistic practice
Gaumard Scientific	• NOELLE S575 Birthing Simulator	34,995.00	Wireless, tetherless, and fully responsive; built-in scenarios for crash C-section, postpartum hemorrhage, shoulder dystocia, placenta previa, and operative vaginal delivery

What topics should be covered by simulation?

A simulation curriculum may begin with low-frequency, high-acuity events, such as shoulder dystocia, postpartum hemorrhage, breech delivery,¹² and maternal cardiorespiratory arrest ( TABLE 3 ).

Some birth simulators included prepackaged clinical scenarios ( TABLE 2 ). We recommend that you conduct prescenario and postscenario didactic teaching seminars on the specific topic of the simulation. These seminars should touch on the major aspects of care and specifically address risk components.

TABLE 3

What are possible scenarios in an OB simulation curriculum?

Amniotic fluid embolism Breech delivery Eclampsia Episiotomy/procto-episiotomy repair Maternal cardiac arrest Operative vaginal delivery Postpartum hemorrhage Shoulder dystocia Trauma in pregnancy Umbilical cord prolapse Vaginal birth after C-section/uterine rupture

Debriefing is key

Real learning occurs during postscenario debriefing, during which participants explain, analyze, and synthesize information on their actions and emotional state during the simulation (or a real event). The objective? To improve performance in similar situations.¹³

In a debriefing, teammates gather to discuss:

• their assumptions, actions, and feelings
  
• matters of teamwork and communication
  
• availability of needed equipment or other resources.
  

After-action reviews. Debriefing has its origins in 1) so-called after-action reviews that are part of military protocol—that is, preflight and postflight discussions aimed at diminishing airplane crashes—and 2) studies of organizational behavior and psychology. Gaba is credited for leading the first “critical medical event management” debriefing in the late 1980s.¹⁴ Debriefing can be self- or team-directed or led by a skilled facilitator; the team can address routine or critical events.

Good judgment. Ideally, a trained instructor or facilitator leads a debriefing session, encouraging group feedback and reflection on clinical practice and team behavior. Debriefing with good judgment is an approach that values the expert opinion of the instructor and the unique perspective of each participant. It allows the instructor to match teaching objectives with trainee concerns by understanding the assumptions and beliefs that drive participants’ actions.¹³

Debriefing can identify deficiencies in practice and documentation, and can promote best practices for teamwork among physicians, nurses, and support staff. ¹⁵ Objective and subjective performance can be assessed by reviewing videotaped simulations [Editor’s note: Watch a video of a C-section simulation in the OBG Management Video Library (www.obgmanagement.com)], participant or third-party performance evaluations, and pre- and postsession testing.

Vulnerabilities. Simulation can expose interpersonal and intrapersonal vulnerabilities. To hear criticism from colleagues about behavior and technical performance can be difficult, whether participants are inexperienced students or professional colleagues who work together in a high-stress perinatal environment.

 

In a debriefing with good judgment, the leader ensures an atmosphere of safety, in which teammates can speak up freely and must be mutually respectful and accountable to each other. Suggestions that arise from a debriefing session should be viewed as an opportunity for improvement, not a time to assign blame or impose penalties.

After the session is over

The steps you take after debriefing are the most important of all ( TABLE 4 ). To have a real impact, a simulation program must include mechanisms for assessing and documenting measurable outcomes, staff satisfaction, and improvements in patient safety. Ongoing feedback to, and from, the staff—by way of newsletters, announcements, grand rounds, and social gatherings—is crucial. Last, assessment and feedback must be used to inform regular updates of the simulation program.

TABLE 4

What ongoing program elements are needed?

Documented assessment Ongoing feedback Periodic program updates

What simulation does best

According to a “root cause” analysis by the Joint Commission on Accreditation of Healthcare Organizations, most (72%) cases of perinatal death and permanent disability can be traced to problems with organizational culture and communication among caregivers.¹⁶ These are precisely the kind of issues that simulation training is best suited to confront: Simulation allows participants to identify system-based issues and staff responses that are inadequate for managing critical clinical events.

The impact of simulation training programs can be assessed by monitoring trends in key maternal and neonatal outcomes.¹⁷ A downward trend in adverse events (e.g., low Apgar score for term newborns, maternal or neonatal birth-related injury), for example, would underscore the value of simulation in improving patient safety and quality of care.

Liability insurance. Professional liability carriers are beginning to incorporate simulation training into patient safety and risk-reduction initiatives. Harvard University’s medical malpractice insurer, Controlled Risk Insurance Company/Risk Management Foundation, established a voluntary incentive program in 2003 that provides a 10% premium credit to providers of OB services who complete risk-reduction activities that include simulation-based and didactic team training. A downward trend in obstetrical claims in association with this incentive program was recently noted.¹⁸

Resident and continuing medical education. The Council on Resident Education in Obstetrics and Gynecology featured simulation at its annual meeting in 2007 as a credible way to augment the curriculum for resident education.¹⁹ Simulation is also being used to train OBs who need to learn new skills and procedures, refresh infrequently needed skills (cesarean-hysterectomy, laparoscopy), or reenter the workplace after an extended absence.²⁰

What does the future hold?

Simulation provides a safe environment, in which mistakes are tolerated without harming patients and appropriate responses can be learned and practiced.²¹ Benefits of the technique are acknowledged in England, where annual skill drills, using simulation, are recommended by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists.

In the United States, the use of OB simulation in residency and postresidency training programs is growing. This change is likely to trigger the introduction of simulation into board certification and credentialing procedures.

Work is needed to validate and standardize simulation-based scenarios. Studies will need to show that simulation improves clinicians’ and teams’ performance not only on simulators but in practice. Despite these hurdles, it is reasonable to conclude that respect for patients and a desire to learn without doing harm will expand and diversify the role of simulation in OB training and practice.

The authors report no financial relationships relevant to this article.

We’ve heard that troubling statistic: Approximately 50% of pregnancies in the United States are unintended. But did you know that one half of those unintended pregnancies occur in women who were using some form of birth control at the time of conception?¹ Such pregnancies are due to discontinuation of the method, incorrect use, or method failure.² The focus of this article is contraceptive counseling, with special attention to:

• which methods of combination hormonal contraception women prefer
• the controversy surrounding the contraceptive patch in regard to thromboembolic disease
• long-acting reversible contraception (LARC), such as the intrauterine device (IUD) and the contraceptive implant, with an emphasis on how LARC is of benefit to both the patient and society.

The ultimate goal of good contraceptive counseling? To help women choose the easiest and most effective method with the fewest side effects.

In head-to-head comparison, women preferred the ring to the patch

Creinin MD, Meyn LA, Borgatta L, et al. Multicenter comparison of the contraceptive ring and patch. Obstet Gynecol. 2008;111:267–277.

The ethinyl estradiol/etonogestril vaginal ring (NuvaRing) and the ethinyl estradiol/norelgestromin patch (OrthoEvra)—both approved by the Food and Drug Administration (FDA) in 2001—are the only nonoral forms of combined hormonal contraception on the market. These methods are said to increase patient compliance and, potentially, efficacy, because they are nondaily forms of contraception.

Until recently, these methods had been compared only with the combination oral contraceptive (OC), but a recent trial compared them directly to each other. At the conclusion of the study, 71% of ring users and 26.5% of patch users planned to continue using the assigned method (P<.001).

This information should aid clinicians in counseling women about which combination hormonal method to choose.

Participants started out using the OC

The multicenter, randomized, controlled clinical trial comparing the patch and ring included 479 women who were using, and happy with, the combination OC. After rating their satisfaction with the OC, women were randomized to the patch or ring and given 3 months’ worth of product. Follow-up involved only two telephone calls and one visit at the end of the third cycle, because this degree of monitoring was thought to mimic clinical practice.

The percentages of women who completed three cycles of their assigned product were 94.6% and 88.2% in the ring and patch groups, respectively (P=.03). The most common reasons for early discontinuation in the ring group were discomfort and adverse effects. In the patch group, the most common reasons were adverse effects, skin irritation, and adherence problems.

Even after adjusting for age, education, and whether an OC was actively being used at the time the study began, patch users were twice as likely to discontinue the patch at the end of three cycles and seven times more likely to state that they did not want to continue the patch.

Adverse effects were greater than with the pill

Women switching from pill to patch were significantly more likely to report breast pain, nausea, skin rash, longer menstrual bleeding, and menstrual pain than women who switched from the pill to the ring (P<.001).

Women who switched from the pill to the ring were more likely to experience vaginal discharge (P=.003) and a larger amount of vaginal discharge than patch users (P<.001).

These findings are similar to those of previous studies that compared the patch with the pill, noting that breast discomfort, application-site reaction, and dysmenorrhea were more common in patch than pill users.³ Earlier studies also found the ring to be associated with complaints of vaginal discharge.^4,5

Findings may not be generalizable

The most important finding from this direct comparison is the difference in patient satisfaction between groups. Visual analog scales showed that women using the ring were happier with the ring than with the pill, whereas women using the patch were happier with the pill than with the patch (P<.001). Questionnaires revealed that women were more satisfied with the ring than they were with the patch, and were more likely to recommend the ring than the patch to a friend (P<.001).

Based on continuation rates, patient satisfaction, and adverse-effect profiles, women in this study clearly preferred the ring to the pill, and the pill to the patch. When using this information to counsel patients, however, it is important to recall that this population was specific. The women had been using an OC, with which they were happy. This study cannot necessarily be generalized to women who are just initiating combination hormonal contraception, but it can be helpful in counseling a patient who may want to switch from an OC to a method that involves nondaily dosing.

 

Does the contraceptive patch raise the risk of thromboembolism?

Jick SS, Kaye JA, Russman S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006;73:223–228.

Jick S, Kaye JA, Li L, Jick H. Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2007;76:4–7.

Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive users. Obstet Gynecol. 2007;109(2 Pt 1):339–346.

Both the media and regulatory agencies have raised concerns about whether the contraceptive patch heightens the risk of thromboembolism and is less effective in women above a certain body weight.

The controversy surrounding thromboembolic disease stems from a pharmacokinetics study by van den Heuvel and colleagues that compared serum ethinyl estradiol levels in users of the patch, vaginal ring, and a combination OC containing 30 μg of ethinyl estradiol and 150 μg of levonorgestrel.⁶ Women randomized to the patch had serum ethinyl estradiol levels 1.6 times higher than women randomized to an OC, and 3.4 times higher than women randomized to the ring.

These findings led the FDA to update package labeling of the patch to warn health-care providers and patients that the patch exposes women to 60% more estrogen and may increase the risk of thromboembolic events. Oddly, the FDA did not require any labeling change to combination OCs to indicate that they contain up to twice as much estrogen as the contraceptive ring.

A set of studies finds no elevated risk

Although the study by van den Heuvel and associates raised the possibility of increased blood clots in patch users, no association between the two had been corroborated at the time it was published.⁶ Since then, three epidemiological studies have explored the potential link between thromboembolic events and use of the patch.

In the first of these studies, Jick and colleagues used the PharMetrics database to extract data on users of the patch and norg-estimate-containing OCs. This database contains drug prescription information, patient demographic data, and ICD-9 billing codes submitted by managed care health plans. A nested case-control study design was used to compare patch and pill users and control for confounding variables.

The base population was women 15 to 44 years old who were new users of the patch or a norgestimate-containing OC. A thromboembolic event was diagnosed if the patient’s record included a diagnosis code for pulmonary embolus, deep vein thrombosis, or an emergency room visit or diagnostic testing indicating venous thromboembolism (VTE). These diagnosis codes, combined with the prescription of long-term anticoagulation therapy, strengthened the identification of cases. As many as four controls were selected for each case.

The 215,769 women included in this study contributed 147,323 woman-years of exposure to the drugs. There were 31 and 37 cases of VTE identified in the patch and pill groups, respectively, with an incidence of 52.8 for every 100,000 woman-years in the patch group and 41.8 for every 100,000 woman-years in the pill group and an unadjusted, matched odds ratio of VTE in patch versus pill users of 0.9. When the data were adjusted for duration of drug exposure, the odds ratio did not change.

A follow-up study by Jick and associates, published in 2007, had the same study design and included 17 additional months of data. Another 56 cases of VTE were diagnosed. The odds ratio for patch users, compared with pill users, was 1.1. When data from the two studies were combined, 73 and 51 total cases of VTE had occurred in the pill and patch groups, respectively. The overall odds ratio was 1.0.

A third study finds significantly heightened risk

Cole and associates studied insurance claims data from UnitedHealthcare, a database containing medical and prescription claim information as well as patient demographics. Because researchers used pharmacy dispensing records, they were able to include women 15 to 44 years old who had received at least one prescription for the contraceptive patch or a norgestimate-containing OC with 35 μg of ethinyl estradiol.

Unlike the studies by Jick and colleagues, the study by Cole and associates considered all women eligible, even if they had used OCs in the past. Cases of VTE, stroke, and acute myocardial infarction (AMI) were abstracted from this group, identified from insurance claim information, and confirmed by chart review. Review of medical records is an important strength of this study; no such review was done in the studies by Jick and colleagues. Four controls were matched to each case, by age and duration of contraceptive use.

 

(This study was commissioned in conjunction with both the FDA and Johnson & Johnson, makers of the contraceptive patch, but researchers had full control over the data and results and were not required to consult with Johnson & Johnson when reporting findings.)

There were 49,048 woman-years of exposure to the patch and 202,344 woman-years of exposure to the pill, with an incidence of VTE of 40.8 and 18.3 for every 100,000 woman-years in patch and pill users, respectively. The incidence of AMI was 6.1 and 3.5 for every 100,000 woman-years in patch and pill users, respectively. No ischemic strokes were noted in patch users.

The adjusted incidence ratio for VTE in patch users compared with pill users was 2.2, and for AMI it was 1.8. Following publication of this study, the FDA issued a statement in January of this year that women using the patch face an increased risk of VTE, compared with women using the pill. Package labeling was changed to reflect this heightened risk.

Reasons for different findings

The studies by Jick and colleagues and Cole and associates present very different findings. The studies by Jick and colleagues give the impression that there is no increased risk of VTE in patch users compared with pill users, but the studies have significant flaws. First, Jick and colleagues do not confirm the diagnosis of VTE in the medical record. This is particularly problematic because the reported number of pulmonary emboli (PE) is very high, compared with the number of deep vein thromboses. The 2006 study found 42 cases of PE and only 26 cases of deep vein thrombosis. Because the latter is more common than PE, this could indicate that deep vein thrombosis was underdiagnosed.

Another shortcoming is that Jick and colleagues included only nonfatal thromboembolic events, which may mean that they missed many cases of fatal VTE because they were not looking for this information. The inclusion of new initiators only also may have skewed the data. This would mean that former users of an OC may have been included in the patch group but were ineligible for inclusion in the pill group. This may bias the data toward experienced hormonal contraceptive users in the patch group, thereby falsely lowering the VTE rate.

The study by Cole and associates also has limitations. It included long-term users of hormonal contraceptives in both the patch and the OC groups, which may bias the data toward lower rates of VTE, AMI, and stroke for the same reasons cited above. One would assume that this bias was corrected, because prior use was allowed in both groups, making the bias equally distributed, but there is no way to confirm this with any degree of certainty.

All three studies have some flaws in common

All three studies used prescription information to determine exposure, but there is no guarantee that the women who filled the prescriptions actually used the agents. Patients given drug samples by their clinicians were overlooked because these samples are not tracked through pharmacy data.

Because the data were collected from insurance claims information of privately insured patients, it is impossible to generalize these findings to the general population. We cannot use the findings to determine whether the same results would be seen in uninsured women or women insured through nonprivate programs such as Medicaid or the Veterans Administration.

So what’s the bottom line?

Health-care providers should be cautious about citing these studies as “evidence” when advising patients about the risk of VTE while using the patch. The twofold increased risk of VTE observed in patch users and the almost twofold increased risk of AMI observed by Cole and associates cannot be completely ignored, however, particularly because this study was better designed than those by Jick and colleagues.

It is more important to remember that the incidence of VTE in patch users is extremely low. If a patient has been using the patch, is happy with the method, and has had no adverse effects, there is no reason, based on these findings, to discontinue it. When counseling new initiators, the best that can be done is to explain the potential risks and side effects associated with the method and allow the patient to make an informed choice using the information that is available.

If the increased risk of VTE is accurate, it would still be equal to or lower than the risk during pregnancy. A recent review found the overall incidence of VTE in pregnancy or the postpartum period to be 200 for every 100,000 woman-years.⁷

 

Why don’t American women choose long-acting reversible contraception?

Do American women not want to use long-acting reversible contraception (LARC), or are we, as providers, failing to properly educate them about its benefits?

The ParaGard copper IUD, the Mirena levonorgestrel intrauterine system (LNGIUS), and the Implanon etonorgestrel contraceptive implant are all highly effective, convenient, long-duration, and reversible (FIGURE). Despite substantial evidence indicating that these methods are well tolerated and highly effective, only about 2% of American women are choosing them to prevent pregnancy.¹ This rate lags far behind other countries in IUD utilization. In contrast, more than 50% of contraceptive users in China and Egypt are using intrauterine contraception.⁸

FIGURE

Copper IUD is effective for 12 years or longer

The copper IUD is FDA-approved for 10 years of use, although studies continue to support its continued efficacy for 12 years or longer.⁹ The 1-year perfect-use failure rate is 0.6%, and the typical use failure rate is 0.5% to 0.8%.¹⁰ The total failure rate over 12 years is 2.2%.⁹

Benefits. The copper IUD does not increase the risk of intrauterine infection and is safe to place in nulliparous patients.¹¹ It is an excellent choice for women who clearly prefer to have monthly menses and for women who have personal or medical contraindications to hormonal birth control. Women using this method of birth control can expect excellent efficacy, rapid reversibility, and minimal side effects.

Adverse effects. The most common adverse events in copper IUD users are heavier menses and dysmenorrhea. Approximately 4.5% of women discontinue the copper IUD in the first year of use because of these particular side effects.¹²

LNG-IUS: Highly effective, with important noncontraceptive benefits

This method of birth control is comparable to the copper IUD in terms of efficacy and tolerability. It is FDA-approved for 5 years of use, with a cumulative 5-year failure rate of 0.7 for every 100 women.¹³ One small study demonstrated that this method is potentially effective up to 7 years, with a 1.1% pregnancy rate.¹¹ With perfect use, the first-year pregnancy rate is 0.1% to 0.2%.¹⁴

Benefits. The progestin component provides noncontraceptive benefits, including a reduction in menstrual bleeding and dysmenorrhea,¹⁵ treatment of endometrial hyperplasia¹⁶ and endometrial cancer,¹⁷ endometrial protection in women using tamoxifen,¹⁸ treatment of endometriosis,¹⁹ and protection from pelvic inflammatory disease.²⁰

Adverse effects. The primary disadvantage of this device is a change in bleeding pattern in some women, who may experience irregular spotting, primarily in the first 3 to 6 months.²¹ About 20% of users will become amenorrheic by 12 months of use, a feature that is highly desirable for many, but troubling to some.

Implant is essentially 100% effective

The newest LARC device is the etonorgestrel implant, which was approved by the FDA in July 2006. The single-rod implant is typically placed in the subcuticular tissue of the non-dominant arm, although placement in the dominant arm is fine if the patient prefers.

 

Benefits. In a 3-year study involving 635 subjects, no pregnancies were reported.²² The reported Pearl index of 0.38 pregnancies for every 100,000 woman-years of use relates to pregnancies that occurred shortly after discontinuation rather than during actual use. These studies included only women below 130% of their ideal body weight who were not using liver enzyme-inducing medications. The pregnancy rate in women who use such medications, or weigh above 130% of their ideal body weight, is unknown. Postmarketing surveillance has reported some pregnancies, as would be expected. The device is easily inserted and easily removed as long as 3 years later.

Adverse effects. The primary adverse effect of this implant is bleeding disturbances; discontinuation was usually due to this side effect.²² The cumulative discontinuation rate was 10% at 6 months, 20% at 12 months, 31% at 2 years, and 32.2% at 3 years.²²

Training required. FDA approval included a stipulation that practitioners complete company-sponsored training (www.implanonusa.com) to insert and remove the device.

Overall benefits include minimal side effects, low cost

All LARC methods provide excellent protection against pregnancy (equal to or better than sterilization), have minimal side effects, and are rapidly reversible. They are also appropriate for women in whom combination hormonal contraception is contraindicated, such as smokers older than 35 years and women who have had VTE.

A final and important advantage: These methods are more cost-effective than other contraceptive methods, including combination OCs. They may require a higher initial investment, but the LNG-IUS and copper IUD are the least costly methods of contraception over 5 years of use.²³

As providers continue to educate themselves and help women gain a better understanding of which methods are truly highly effective, they will likely begin to recommend LARC more often. Use of these devices has the potential to significantly decrease the high rate of unintended pregnancy.

Authors’ note: The figure at right depicts how the efficacy and convenience of contraceptive options rise (and side effects fall) along a continuum. LARC methods are “high up the ladder”—an observation that serves as food for thought as we counsel patients about what methods of birth control are best for them.

The authors report no financial relationships relevant to this article.

We’ve heard that troubling statistic: Approximately 50% of pregnancies in the United States are unintended. But did you know that one half of those unintended pregnancies occur in women who were using some form of birth control at the time of conception?¹ Such pregnancies are due to discontinuation of the method, incorrect use, or method failure.² The focus of this article is contraceptive counseling, with special attention to:

• which methods of combination hormonal contraception women prefer
• the controversy surrounding the contraceptive patch in regard to thromboembolic disease
• long-acting reversible contraception (LARC), such as the intrauterine device (IUD) and the contraceptive implant, with an emphasis on how LARC is of benefit to both the patient and society.

The ultimate goal of good contraceptive counseling? To help women choose the easiest and most effective method with the fewest side effects.

In head-to-head comparison, women preferred the ring to the patch

Creinin MD, Meyn LA, Borgatta L, et al. Multicenter comparison of the contraceptive ring and patch. Obstet Gynecol. 2008;111:267–277.

The ethinyl estradiol/etonogestril vaginal ring (NuvaRing) and the ethinyl estradiol/norelgestromin patch (OrthoEvra)—both approved by the Food and Drug Administration (FDA) in 2001—are the only nonoral forms of combined hormonal contraception on the market. These methods are said to increase patient compliance and, potentially, efficacy, because they are nondaily forms of contraception.

Until recently, these methods had been compared only with the combination oral contraceptive (OC), but a recent trial compared them directly to each other. At the conclusion of the study, 71% of ring users and 26.5% of patch users planned to continue using the assigned method (P<.001).

This information should aid clinicians in counseling women about which combination hormonal method to choose.

Participants started out using the OC

The multicenter, randomized, controlled clinical trial comparing the patch and ring included 479 women who were using, and happy with, the combination OC. After rating their satisfaction with the OC, women were randomized to the patch or ring and given 3 months’ worth of product. Follow-up involved only two telephone calls and one visit at the end of the third cycle, because this degree of monitoring was thought to mimic clinical practice.

The percentages of women who completed three cycles of their assigned product were 94.6% and 88.2% in the ring and patch groups, respectively (P=.03). The most common reasons for early discontinuation in the ring group were discomfort and adverse effects. In the patch group, the most common reasons were adverse effects, skin irritation, and adherence problems.

Even after adjusting for age, education, and whether an OC was actively being used at the time the study began, patch users were twice as likely to discontinue the patch at the end of three cycles and seven times more likely to state that they did not want to continue the patch.

Adverse effects were greater than with the pill

Women switching from pill to patch were significantly more likely to report breast pain, nausea, skin rash, longer menstrual bleeding, and menstrual pain than women who switched from the pill to the ring (P<.001).

Women who switched from the pill to the ring were more likely to experience vaginal discharge (P=.003) and a larger amount of vaginal discharge than patch users (P<.001).

These findings are similar to those of previous studies that compared the patch with the pill, noting that breast discomfort, application-site reaction, and dysmenorrhea were more common in patch than pill users.³ Earlier studies also found the ring to be associated with complaints of vaginal discharge.^4,5

Findings may not be generalizable

The most important finding from this direct comparison is the difference in patient satisfaction between groups. Visual analog scales showed that women using the ring were happier with the ring than with the pill, whereas women using the patch were happier with the pill than with the patch (P<.001). Questionnaires revealed that women were more satisfied with the ring than they were with the patch, and were more likely to recommend the ring than the patch to a friend (P<.001).

Based on continuation rates, patient satisfaction, and adverse-effect profiles, women in this study clearly preferred the ring to the pill, and the pill to the patch. When using this information to counsel patients, however, it is important to recall that this population was specific. The women had been using an OC, with which they were happy. This study cannot necessarily be generalized to women who are just initiating combination hormonal contraception, but it can be helpful in counseling a patient who may want to switch from an OC to a method that involves nondaily dosing.

 

Does the contraceptive patch raise the risk of thromboembolism?

Jick SS, Kaye JA, Russman S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006;73:223–228.

Jick S, Kaye JA, Li L, Jick H. Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2007;76:4–7.

Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive users. Obstet Gynecol. 2007;109(2 Pt 1):339–346.

Both the media and regulatory agencies have raised concerns about whether the contraceptive patch heightens the risk of thromboembolism and is less effective in women above a certain body weight.

The controversy surrounding thromboembolic disease stems from a pharmacokinetics study by van den Heuvel and colleagues that compared serum ethinyl estradiol levels in users of the patch, vaginal ring, and a combination OC containing 30 μg of ethinyl estradiol and 150 μg of levonorgestrel.⁶ Women randomized to the patch had serum ethinyl estradiol levels 1.6 times higher than women randomized to an OC, and 3.4 times higher than women randomized to the ring.

These findings led the FDA to update package labeling of the patch to warn health-care providers and patients that the patch exposes women to 60% more estrogen and may increase the risk of thromboembolic events. Oddly, the FDA did not require any labeling change to combination OCs to indicate that they contain up to twice as much estrogen as the contraceptive ring.

A set of studies finds no elevated risk

Although the study by van den Heuvel and associates raised the possibility of increased blood clots in patch users, no association between the two had been corroborated at the time it was published.⁶ Since then, three epidemiological studies have explored the potential link between thromboembolic events and use of the patch.

In the first of these studies, Jick and colleagues used the PharMetrics database to extract data on users of the patch and norg-estimate-containing OCs. This database contains drug prescription information, patient demographic data, and ICD-9 billing codes submitted by managed care health plans. A nested case-control study design was used to compare patch and pill users and control for confounding variables.

The base population was women 15 to 44 years old who were new users of the patch or a norgestimate-containing OC. A thromboembolic event was diagnosed if the patient’s record included a diagnosis code for pulmonary embolus, deep vein thrombosis, or an emergency room visit or diagnostic testing indicating venous thromboembolism (VTE). These diagnosis codes, combined with the prescription of long-term anticoagulation therapy, strengthened the identification of cases. As many as four controls were selected for each case.

The 215,769 women included in this study contributed 147,323 woman-years of exposure to the drugs. There were 31 and 37 cases of VTE identified in the patch and pill groups, respectively, with an incidence of 52.8 for every 100,000 woman-years in the patch group and 41.8 for every 100,000 woman-years in the pill group and an unadjusted, matched odds ratio of VTE in patch versus pill users of 0.9. When the data were adjusted for duration of drug exposure, the odds ratio did not change.

A follow-up study by Jick and associates, published in 2007, had the same study design and included 17 additional months of data. Another 56 cases of VTE were diagnosed. The odds ratio for patch users, compared with pill users, was 1.1. When data from the two studies were combined, 73 and 51 total cases of VTE had occurred in the pill and patch groups, respectively. The overall odds ratio was 1.0.

A third study finds significantly heightened risk

Cole and associates studied insurance claims data from UnitedHealthcare, a database containing medical and prescription claim information as well as patient demographics. Because researchers used pharmacy dispensing records, they were able to include women 15 to 44 years old who had received at least one prescription for the contraceptive patch or a norgestimate-containing OC with 35 μg of ethinyl estradiol.

Unlike the studies by Jick and colleagues, the study by Cole and associates considered all women eligible, even if they had used OCs in the past. Cases of VTE, stroke, and acute myocardial infarction (AMI) were abstracted from this group, identified from insurance claim information, and confirmed by chart review. Review of medical records is an important strength of this study; no such review was done in the studies by Jick and colleagues. Four controls were matched to each case, by age and duration of contraceptive use.

 

(This study was commissioned in conjunction with both the FDA and Johnson & Johnson, makers of the contraceptive patch, but researchers had full control over the data and results and were not required to consult with Johnson & Johnson when reporting findings.)

There were 49,048 woman-years of exposure to the patch and 202,344 woman-years of exposure to the pill, with an incidence of VTE of 40.8 and 18.3 for every 100,000 woman-years in patch and pill users, respectively. The incidence of AMI was 6.1 and 3.5 for every 100,000 woman-years in patch and pill users, respectively. No ischemic strokes were noted in patch users.

The adjusted incidence ratio for VTE in patch users compared with pill users was 2.2, and for AMI it was 1.8. Following publication of this study, the FDA issued a statement in January of this year that women using the patch face an increased risk of VTE, compared with women using the pill. Package labeling was changed to reflect this heightened risk.

Reasons for different findings

The studies by Jick and colleagues and Cole and associates present very different findings. The studies by Jick and colleagues give the impression that there is no increased risk of VTE in patch users compared with pill users, but the studies have significant flaws. First, Jick and colleagues do not confirm the diagnosis of VTE in the medical record. This is particularly problematic because the reported number of pulmonary emboli (PE) is very high, compared with the number of deep vein thromboses. The 2006 study found 42 cases of PE and only 26 cases of deep vein thrombosis. Because the latter is more common than PE, this could indicate that deep vein thrombosis was underdiagnosed.

Another shortcoming is that Jick and colleagues included only nonfatal thromboembolic events, which may mean that they missed many cases of fatal VTE because they were not looking for this information. The inclusion of new initiators only also may have skewed the data. This would mean that former users of an OC may have been included in the patch group but were ineligible for inclusion in the pill group. This may bias the data toward experienced hormonal contraceptive users in the patch group, thereby falsely lowering the VTE rate.

The study by Cole and associates also has limitations. It included long-term users of hormonal contraceptives in both the patch and the OC groups, which may bias the data toward lower rates of VTE, AMI, and stroke for the same reasons cited above. One would assume that this bias was corrected, because prior use was allowed in both groups, making the bias equally distributed, but there is no way to confirm this with any degree of certainty.

All three studies have some flaws in common

All three studies used prescription information to determine exposure, but there is no guarantee that the women who filled the prescriptions actually used the agents. Patients given drug samples by their clinicians were overlooked because these samples are not tracked through pharmacy data.

Because the data were collected from insurance claims information of privately insured patients, it is impossible to generalize these findings to the general population. We cannot use the findings to determine whether the same results would be seen in uninsured women or women insured through nonprivate programs such as Medicaid or the Veterans Administration.

So what’s the bottom line?

Health-care providers should be cautious about citing these studies as “evidence” when advising patients about the risk of VTE while using the patch. The twofold increased risk of VTE observed in patch users and the almost twofold increased risk of AMI observed by Cole and associates cannot be completely ignored, however, particularly because this study was better designed than those by Jick and colleagues.

It is more important to remember that the incidence of VTE in patch users is extremely low. If a patient has been using the patch, is happy with the method, and has had no adverse effects, there is no reason, based on these findings, to discontinue it. When counseling new initiators, the best that can be done is to explain the potential risks and side effects associated with the method and allow the patient to make an informed choice using the information that is available.

If the increased risk of VTE is accurate, it would still be equal to or lower than the risk during pregnancy. A recent review found the overall incidence of VTE in pregnancy or the postpartum period to be 200 for every 100,000 woman-years.⁷

 

Why don’t American women choose long-acting reversible contraception?

Do American women not want to use long-acting reversible contraception (LARC), or are we, as providers, failing to properly educate them about its benefits?

The ParaGard copper IUD, the Mirena levonorgestrel intrauterine system (LNGIUS), and the Implanon etonorgestrel contraceptive implant are all highly effective, convenient, long-duration, and reversible (FIGURE). Despite substantial evidence indicating that these methods are well tolerated and highly effective, only about 2% of American women are choosing them to prevent pregnancy.¹ This rate lags far behind other countries in IUD utilization. In contrast, more than 50% of contraceptive users in China and Egypt are using intrauterine contraception.⁸

FIGURE

Copper IUD is effective for 12 years or longer

The copper IUD is FDA-approved for 10 years of use, although studies continue to support its continued efficacy for 12 years or longer.⁹ The 1-year perfect-use failure rate is 0.6%, and the typical use failure rate is 0.5% to 0.8%.¹⁰ The total failure rate over 12 years is 2.2%.⁹

Benefits. The copper IUD does not increase the risk of intrauterine infection and is safe to place in nulliparous patients.¹¹ It is an excellent choice for women who clearly prefer to have monthly menses and for women who have personal or medical contraindications to hormonal birth control. Women using this method of birth control can expect excellent efficacy, rapid reversibility, and minimal side effects.

Adverse effects. The most common adverse events in copper IUD users are heavier menses and dysmenorrhea. Approximately 4.5% of women discontinue the copper IUD in the first year of use because of these particular side effects.¹²

LNG-IUS: Highly effective, with important noncontraceptive benefits

This method of birth control is comparable to the copper IUD in terms of efficacy and tolerability. It is FDA-approved for 5 years of use, with a cumulative 5-year failure rate of 0.7 for every 100 women.¹³ One small study demonstrated that this method is potentially effective up to 7 years, with a 1.1% pregnancy rate.¹¹ With perfect use, the first-year pregnancy rate is 0.1% to 0.2%.¹⁴

Benefits. The progestin component provides noncontraceptive benefits, including a reduction in menstrual bleeding and dysmenorrhea,¹⁵ treatment of endometrial hyperplasia¹⁶ and endometrial cancer,¹⁷ endometrial protection in women using tamoxifen,¹⁸ treatment of endometriosis,¹⁹ and protection from pelvic inflammatory disease.²⁰

Adverse effects. The primary disadvantage of this device is a change in bleeding pattern in some women, who may experience irregular spotting, primarily in the first 3 to 6 months.²¹ About 20% of users will become amenorrheic by 12 months of use, a feature that is highly desirable for many, but troubling to some.

Implant is essentially 100% effective

The newest LARC device is the etonorgestrel implant, which was approved by the FDA in July 2006. The single-rod implant is typically placed in the subcuticular tissue of the non-dominant arm, although placement in the dominant arm is fine if the patient prefers.

 

Benefits. In a 3-year study involving 635 subjects, no pregnancies were reported.²² The reported Pearl index of 0.38 pregnancies for every 100,000 woman-years of use relates to pregnancies that occurred shortly after discontinuation rather than during actual use. These studies included only women below 130% of their ideal body weight who were not using liver enzyme-inducing medications. The pregnancy rate in women who use such medications, or weigh above 130% of their ideal body weight, is unknown. Postmarketing surveillance has reported some pregnancies, as would be expected. The device is easily inserted and easily removed as long as 3 years later.

Adverse effects. The primary adverse effect of this implant is bleeding disturbances; discontinuation was usually due to this side effect.²² The cumulative discontinuation rate was 10% at 6 months, 20% at 12 months, 31% at 2 years, and 32.2% at 3 years.²²

Training required. FDA approval included a stipulation that practitioners complete company-sponsored training (www.implanonusa.com) to insert and remove the device.

Overall benefits include minimal side effects, low cost

All LARC methods provide excellent protection against pregnancy (equal to or better than sterilization), have minimal side effects, and are rapidly reversible. They are also appropriate for women in whom combination hormonal contraception is contraindicated, such as smokers older than 35 years and women who have had VTE.

A final and important advantage: These methods are more cost-effective than other contraceptive methods, including combination OCs. They may require a higher initial investment, but the LNG-IUS and copper IUD are the least costly methods of contraception over 5 years of use.²³

As providers continue to educate themselves and help women gain a better understanding of which methods are truly highly effective, they will likely begin to recommend LARC more often. Use of these devices has the potential to significantly decrease the high rate of unintended pregnancy.

Authors’ note: The figure at right depicts how the efficacy and convenience of contraceptive options rise (and side effects fall) along a continuum. LARC methods are “high up the ladder”—an observation that serves as food for thought as we counsel patients about what methods of birth control are best for them.

The authors report no financial relationships relevant to this article.

We’ve heard that troubling statistic: Approximately 50% of pregnancies in the United States are unintended. But did you know that one half of those unintended pregnancies occur in women who were using some form of birth control at the time of conception?¹ Such pregnancies are due to discontinuation of the method, incorrect use, or method failure.² The focus of this article is contraceptive counseling, with special attention to:

• which methods of combination hormonal contraception women prefer
• the controversy surrounding the contraceptive patch in regard to thromboembolic disease
• long-acting reversible contraception (LARC), such as the intrauterine device (IUD) and the contraceptive implant, with an emphasis on how LARC is of benefit to both the patient and society.

The ultimate goal of good contraceptive counseling? To help women choose the easiest and most effective method with the fewest side effects.

In head-to-head comparison, women preferred the ring to the patch

Creinin MD, Meyn LA, Borgatta L, et al. Multicenter comparison of the contraceptive ring and patch. Obstet Gynecol. 2008;111:267–277.

The ethinyl estradiol/etonogestril vaginal ring (NuvaRing) and the ethinyl estradiol/norelgestromin patch (OrthoEvra)—both approved by the Food and Drug Administration (FDA) in 2001—are the only nonoral forms of combined hormonal contraception on the market. These methods are said to increase patient compliance and, potentially, efficacy, because they are nondaily forms of contraception.

Until recently, these methods had been compared only with the combination oral contraceptive (OC), but a recent trial compared them directly to each other. At the conclusion of the study, 71% of ring users and 26.5% of patch users planned to continue using the assigned method (P<.001).

This information should aid clinicians in counseling women about which combination hormonal method to choose.

Participants started out using the OC

The multicenter, randomized, controlled clinical trial comparing the patch and ring included 479 women who were using, and happy with, the combination OC. After rating their satisfaction with the OC, women were randomized to the patch or ring and given 3 months’ worth of product. Follow-up involved only two telephone calls and one visit at the end of the third cycle, because this degree of monitoring was thought to mimic clinical practice.

The percentages of women who completed three cycles of their assigned product were 94.6% and 88.2% in the ring and patch groups, respectively (P=.03). The most common reasons for early discontinuation in the ring group were discomfort and adverse effects. In the patch group, the most common reasons were adverse effects, skin irritation, and adherence problems.

Even after adjusting for age, education, and whether an OC was actively being used at the time the study began, patch users were twice as likely to discontinue the patch at the end of three cycles and seven times more likely to state that they did not want to continue the patch.

Adverse effects were greater than with the pill

Women switching from pill to patch were significantly more likely to report breast pain, nausea, skin rash, longer menstrual bleeding, and menstrual pain than women who switched from the pill to the ring (P<.001).

Women who switched from the pill to the ring were more likely to experience vaginal discharge (P=.003) and a larger amount of vaginal discharge than patch users (P<.001).

These findings are similar to those of previous studies that compared the patch with the pill, noting that breast discomfort, application-site reaction, and dysmenorrhea were more common in patch than pill users.³ Earlier studies also found the ring to be associated with complaints of vaginal discharge.^4,5

Findings may not be generalizable

The most important finding from this direct comparison is the difference in patient satisfaction between groups. Visual analog scales showed that women using the ring were happier with the ring than with the pill, whereas women using the patch were happier with the pill than with the patch (P<.001). Questionnaires revealed that women were more satisfied with the ring than they were with the patch, and were more likely to recommend the ring than the patch to a friend (P<.001).

Based on continuation rates, patient satisfaction, and adverse-effect profiles, women in this study clearly preferred the ring to the pill, and the pill to the patch. When using this information to counsel patients, however, it is important to recall that this population was specific. The women had been using an OC, with which they were happy. This study cannot necessarily be generalized to women who are just initiating combination hormonal contraception, but it can be helpful in counseling a patient who may want to switch from an OC to a method that involves nondaily dosing.

 

Does the contraceptive patch raise the risk of thromboembolism?

Jick SS, Kaye JA, Russman S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006;73:223–228.

Jick S, Kaye JA, Li L, Jick H. Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2007;76:4–7.

Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive users. Obstet Gynecol. 2007;109(2 Pt 1):339–346.

Both the media and regulatory agencies have raised concerns about whether the contraceptive patch heightens the risk of thromboembolism and is less effective in women above a certain body weight.

The controversy surrounding thromboembolic disease stems from a pharmacokinetics study by van den Heuvel and colleagues that compared serum ethinyl estradiol levels in users of the patch, vaginal ring, and a combination OC containing 30 μg of ethinyl estradiol and 150 μg of levonorgestrel.⁶ Women randomized to the patch had serum ethinyl estradiol levels 1.6 times higher than women randomized to an OC, and 3.4 times higher than women randomized to the ring.

These findings led the FDA to update package labeling of the patch to warn health-care providers and patients that the patch exposes women to 60% more estrogen and may increase the risk of thromboembolic events. Oddly, the FDA did not require any labeling change to combination OCs to indicate that they contain up to twice as much estrogen as the contraceptive ring.

A set of studies finds no elevated risk

Although the study by van den Heuvel and associates raised the possibility of increased blood clots in patch users, no association between the two had been corroborated at the time it was published.⁶ Since then, three epidemiological studies have explored the potential link between thromboembolic events and use of the patch.

In the first of these studies, Jick and colleagues used the PharMetrics database to extract data on users of the patch and norg-estimate-containing OCs. This database contains drug prescription information, patient demographic data, and ICD-9 billing codes submitted by managed care health plans. A nested case-control study design was used to compare patch and pill users and control for confounding variables.

The base population was women 15 to 44 years old who were new users of the patch or a norgestimate-containing OC. A thromboembolic event was diagnosed if the patient’s record included a diagnosis code for pulmonary embolus, deep vein thrombosis, or an emergency room visit or diagnostic testing indicating venous thromboembolism (VTE). These diagnosis codes, combined with the prescription of long-term anticoagulation therapy, strengthened the identification of cases. As many as four controls were selected for each case.

The 215,769 women included in this study contributed 147,323 woman-years of exposure to the drugs. There were 31 and 37 cases of VTE identified in the patch and pill groups, respectively, with an incidence of 52.8 for every 100,000 woman-years in the patch group and 41.8 for every 100,000 woman-years in the pill group and an unadjusted, matched odds ratio of VTE in patch versus pill users of 0.9. When the data were adjusted for duration of drug exposure, the odds ratio did not change.

A follow-up study by Jick and associates, published in 2007, had the same study design and included 17 additional months of data. Another 56 cases of VTE were diagnosed. The odds ratio for patch users, compared with pill users, was 1.1. When data from the two studies were combined, 73 and 51 total cases of VTE had occurred in the pill and patch groups, respectively. The overall odds ratio was 1.0.

A third study finds significantly heightened risk

Cole and associates studied insurance claims data from UnitedHealthcare, a database containing medical and prescription claim information as well as patient demographics. Because researchers used pharmacy dispensing records, they were able to include women 15 to 44 years old who had received at least one prescription for the contraceptive patch or a norgestimate-containing OC with 35 μg of ethinyl estradiol.

Unlike the studies by Jick and colleagues, the study by Cole and associates considered all women eligible, even if they had used OCs in the past. Cases of VTE, stroke, and acute myocardial infarction (AMI) were abstracted from this group, identified from insurance claim information, and confirmed by chart review. Review of medical records is an important strength of this study; no such review was done in the studies by Jick and colleagues. Four controls were matched to each case, by age and duration of contraceptive use.

 

(This study was commissioned in conjunction with both the FDA and Johnson & Johnson, makers of the contraceptive patch, but researchers had full control over the data and results and were not required to consult with Johnson & Johnson when reporting findings.)

There were 49,048 woman-years of exposure to the patch and 202,344 woman-years of exposure to the pill, with an incidence of VTE of 40.8 and 18.3 for every 100,000 woman-years in patch and pill users, respectively. The incidence of AMI was 6.1 and 3.5 for every 100,000 woman-years in patch and pill users, respectively. No ischemic strokes were noted in patch users.

The adjusted incidence ratio for VTE in patch users compared with pill users was 2.2, and for AMI it was 1.8. Following publication of this study, the FDA issued a statement in January of this year that women using the patch face an increased risk of VTE, compared with women using the pill. Package labeling was changed to reflect this heightened risk.

Reasons for different findings

The studies by Jick and colleagues and Cole and associates present very different findings. The studies by Jick and colleagues give the impression that there is no increased risk of VTE in patch users compared with pill users, but the studies have significant flaws. First, Jick and colleagues do not confirm the diagnosis of VTE in the medical record. This is particularly problematic because the reported number of pulmonary emboli (PE) is very high, compared with the number of deep vein thromboses. The 2006 study found 42 cases of PE and only 26 cases of deep vein thrombosis. Because the latter is more common than PE, this could indicate that deep vein thrombosis was underdiagnosed.

Another shortcoming is that Jick and colleagues included only nonfatal thromboembolic events, which may mean that they missed many cases of fatal VTE because they were not looking for this information. The inclusion of new initiators only also may have skewed the data. This would mean that former users of an OC may have been included in the patch group but were ineligible for inclusion in the pill group. This may bias the data toward experienced hormonal contraceptive users in the patch group, thereby falsely lowering the VTE rate.

The study by Cole and associates also has limitations. It included long-term users of hormonal contraceptives in both the patch and the OC groups, which may bias the data toward lower rates of VTE, AMI, and stroke for the same reasons cited above. One would assume that this bias was corrected, because prior use was allowed in both groups, making the bias equally distributed, but there is no way to confirm this with any degree of certainty.

All three studies have some flaws in common

All three studies used prescription information to determine exposure, but there is no guarantee that the women who filled the prescriptions actually used the agents. Patients given drug samples by their clinicians were overlooked because these samples are not tracked through pharmacy data.

Because the data were collected from insurance claims information of privately insured patients, it is impossible to generalize these findings to the general population. We cannot use the findings to determine whether the same results would be seen in uninsured women or women insured through nonprivate programs such as Medicaid or the Veterans Administration.

So what’s the bottom line?

Health-care providers should be cautious about citing these studies as “evidence” when advising patients about the risk of VTE while using the patch. The twofold increased risk of VTE observed in patch users and the almost twofold increased risk of AMI observed by Cole and associates cannot be completely ignored, however, particularly because this study was better designed than those by Jick and colleagues.

It is more important to remember that the incidence of VTE in patch users is extremely low. If a patient has been using the patch, is happy with the method, and has had no adverse effects, there is no reason, based on these findings, to discontinue it. When counseling new initiators, the best that can be done is to explain the potential risks and side effects associated with the method and allow the patient to make an informed choice using the information that is available.

If the increased risk of VTE is accurate, it would still be equal to or lower than the risk during pregnancy. A recent review found the overall incidence of VTE in pregnancy or the postpartum period to be 200 for every 100,000 woman-years.⁷

 

Why don’t American women choose long-acting reversible contraception?

Do American women not want to use long-acting reversible contraception (LARC), or are we, as providers, failing to properly educate them about its benefits?

The ParaGard copper IUD, the Mirena levonorgestrel intrauterine system (LNGIUS), and the Implanon etonorgestrel contraceptive implant are all highly effective, convenient, long-duration, and reversible (FIGURE). Despite substantial evidence indicating that these methods are well tolerated and highly effective, only about 2% of American women are choosing them to prevent pregnancy.¹ This rate lags far behind other countries in IUD utilization. In contrast, more than 50% of contraceptive users in China and Egypt are using intrauterine contraception.⁸

FIGURE

Copper IUD is effective for 12 years or longer

The copper IUD is FDA-approved for 10 years of use, although studies continue to support its continued efficacy for 12 years or longer.⁹ The 1-year perfect-use failure rate is 0.6%, and the typical use failure rate is 0.5% to 0.8%.¹⁰ The total failure rate over 12 years is 2.2%.⁹

Benefits. The copper IUD does not increase the risk of intrauterine infection and is safe to place in nulliparous patients.¹¹ It is an excellent choice for women who clearly prefer to have monthly menses and for women who have personal or medical contraindications to hormonal birth control. Women using this method of birth control can expect excellent efficacy, rapid reversibility, and minimal side effects.

Adverse effects. The most common adverse events in copper IUD users are heavier menses and dysmenorrhea. Approximately 4.5% of women discontinue the copper IUD in the first year of use because of these particular side effects.¹²

LNG-IUS: Highly effective, with important noncontraceptive benefits

This method of birth control is comparable to the copper IUD in terms of efficacy and tolerability. It is FDA-approved for 5 years of use, with a cumulative 5-year failure rate of 0.7 for every 100 women.¹³ One small study demonstrated that this method is potentially effective up to 7 years, with a 1.1% pregnancy rate.¹¹ With perfect use, the first-year pregnancy rate is 0.1% to 0.2%.¹⁴

Benefits. The progestin component provides noncontraceptive benefits, including a reduction in menstrual bleeding and dysmenorrhea,¹⁵ treatment of endometrial hyperplasia¹⁶ and endometrial cancer,¹⁷ endometrial protection in women using tamoxifen,¹⁸ treatment of endometriosis,¹⁹ and protection from pelvic inflammatory disease.²⁰

Adverse effects. The primary disadvantage of this device is a change in bleeding pattern in some women, who may experience irregular spotting, primarily in the first 3 to 6 months.²¹ About 20% of users will become amenorrheic by 12 months of use, a feature that is highly desirable for many, but troubling to some.

Implant is essentially 100% effective

The newest LARC device is the etonorgestrel implant, which was approved by the FDA in July 2006. The single-rod implant is typically placed in the subcuticular tissue of the non-dominant arm, although placement in the dominant arm is fine if the patient prefers.

 

Benefits. In a 3-year study involving 635 subjects, no pregnancies were reported.²² The reported Pearl index of 0.38 pregnancies for every 100,000 woman-years of use relates to pregnancies that occurred shortly after discontinuation rather than during actual use. These studies included only women below 130% of their ideal body weight who were not using liver enzyme-inducing medications. The pregnancy rate in women who use such medications, or weigh above 130% of their ideal body weight, is unknown. Postmarketing surveillance has reported some pregnancies, as would be expected. The device is easily inserted and easily removed as long as 3 years later.

Adverse effects. The primary adverse effect of this implant is bleeding disturbances; discontinuation was usually due to this side effect.²² The cumulative discontinuation rate was 10% at 6 months, 20% at 12 months, 31% at 2 years, and 32.2% at 3 years.²²

Training required. FDA approval included a stipulation that practitioners complete company-sponsored training (www.implanonusa.com) to insert and remove the device.

Overall benefits include minimal side effects, low cost

All LARC methods provide excellent protection against pregnancy (equal to or better than sterilization), have minimal side effects, and are rapidly reversible. They are also appropriate for women in whom combination hormonal contraception is contraindicated, such as smokers older than 35 years and women who have had VTE.

A final and important advantage: These methods are more cost-effective than other contraceptive methods, including combination OCs. They may require a higher initial investment, but the LNG-IUS and copper IUD are the least costly methods of contraception over 5 years of use.²³

As providers continue to educate themselves and help women gain a better understanding of which methods are truly highly effective, they will likely begin to recommend LARC more often. Use of these devices has the potential to significantly decrease the high rate of unintended pregnancy.

Authors’ note: The figure at right depicts how the efficacy and convenience of contraceptive options rise (and side effects fall) along a continuum. LARC methods are “high up the ladder”—an observation that serves as food for thought as we counsel patients about what methods of birth control are best for them.

As increasing numbers of people work in windowless environments and as computer time, gaming consoles, and TV viewing keep more of them indoors during their leisure hours, many are losing access to their natural source of vitamin D: sunshine. In response to the justifiably publicized risk of skin cancers, people avoid sunlight or take great care to cover the skin with sunscreen—minimizing the risk of sun-related skin cancer, but greatly increasing the risk of vitamin D deficiency.

The importance of vitamin D was first recognized in the prevention of rickets and its role in absorption of calcium and phosphate in the diet.¹ In recent decades, however, the growing understanding of vitamin D's influence on leukocytes, vascular smooth muscle cells, and other tissues² has led to an increased awareness of this nutrient's contribution to numerous processes and functions.

Considering vitamin D's subtle but substantial impact on mental, cardiovascular, musculoskeletal, and autoimmune health (not to mention bone disorders and calcium deficiency), vitamin D deficiency is overlooked and undertreated with surprising frequency in the clinical setting, where clinicians are more likely to screen for and treat other disorders.

The Facts
Exposure of the skin to sunlight or ultraviolet (UV) light is the human body's natural way to synthesize vitamin D3.^1,3 This nutrient can also be ingested in fish and fish liver oils; in the form of vitamin D2, which has been used since the 1930s in efforts to reduce rickets and other bone disorders by fortifying milk, cereals, and a variety of food products^4,5; and in dietary supplements.

Unfortunately, the intake of vitamin D–fortified foods and/or supplements is often insufficient for the average person to maintain an adequate level of this essential substance.³ Fatty fish, including sardines, mackerel, tuna, and salmon,⁶ are among the few foods that represent a valuable source of vitamin D, but these are not commonly considered a staple in today's American diet. Additionally, it has been questioned whether the current recommended daily allowance guidelines for vitamin D intake are adequate for most of the population.⁷

Widespread Effects
The impact of vitamin D deficiency or insufficiency affects patients of both genders across the life span. Exclusive breastfeeding without adequate vitamin D supplementation can result in rickets in infants, children, and adolescents.^3,4,8 Research indicates that even healthy-appearing adolescents may be deficient in this nutrient.⁹ Inadequate intake or supplementation of vitamin D during pregnancy has been shown to increase women's risk of preeclampsia, with potential impact on their infants' well-being.¹⁰

Adults with inadequate levels of vitamin D are at risk for periodontal disease and other dental concerns,^11,12 hypertension and cardiovascular disease,^2,13-16 musculoskeletal disorders, depression,¹⁷ and malignancies of the breast,¹⁸ colon,^1,19,20 and prostate.¹³ Older persons with insufficient levels of this essential substance are at increased risk of falls and fractures,^12,21 osteoporosis,^21,22 hyperparathyroidism,²³ impaired cognitive function, and depression.²⁴

Vitamin D Synthesis
Vitamin D is synthesized in the skin by UV light between wavelengths of 290 and 315 nm,^4,13 converting 7-dehydrocholesterol to previtamin D3, then by thermal isomerization to vitamin D3.^1,3 Both vitamin D3 and vitamin D2 are incorporated into chylomicrons and absorbed by the lymph system, then put into systemic circulation by vitamin D–binding protein.^4,13

Two additional steps—one that occurs in the liver, the other in the kidneys—are needed to complete the conversion from an inert form to usable vitamin D. In the liver, the molecule is hydroxylated by enzymes called the vitamin D-25-hydroxylases to form 25-hydroxyvitamin D. Then in the kidneys, the cytochrome P-450 enzyme 25-hydroxyvitamin D-1 alpha-hydroxylase continues the hydroxylation process, converting the molecule to vitamin D's biologically active form, 1,25-dihydroxyvitamin D.^4,13,25 It is next bound to the vitamin D receptors and in an additional step is transcribed in RNA and replicated.

The known actions of vitamin D include increasing calcium and phosphorus absorption from the small bowel, enhancement of renal tubule resorption of phosphate, and maturation of osteoclasts to resorb calcium from the bones. Vitamin D also improves measurable bone mineral density.¹

Who Is at Risk?
Many individuals may not recognize their risk for vitamin D deficiency or insufficiency. Clinicians must be aware of the conditions and factors that increase the risk. Many of these are identified in Table 1.^{3,5,6,8,10,24,26-31}

Assessment
Clinicians in any number of specialties may encounter patients with vitamin D deficiency or insufficiency. Thus, it is important during the interview and review of systems to ask routinely about the patient's occupation, sun exposure, and use of sunscreen. Clinicians should also ask about dietary habits and dietary supplements, including multivitamins and supplemental vitamin D (eg, calcium with vitamin D).

The examining clinician should also key in on fatigue, bone pain, and muscle pain or weakness. While reviewing the patient's medical history and the current problem list, the clinician should maintain an awareness of disease processes that may mimic vitamin D insufficiency. These include fibromyalgia, chronic fatigue syndrome, myositis, hyperparathyroidism, and depression.^13,17,23 Comorbidities that often coexist with vitamin D deficiency include hypertension and cardiovascular disease,¹⁶ obesity, type 1 diabetes mellitus,¹³ multiple sclerosis,⁵ secondary hyperparathyroidism,¹³ and prostate, breast, or colorectal cancer.^1,2,9,13

 

Assessment of the patient's constitution, of course, includes vital signs and general appearance. As mentioned earlier, hypertension may coexist with vitamin D deficiency.^2,13-16 Obesity, it is also important to note, has been associated with reduced vitamin D bioavailability.²⁸ The type and coverage of the patient's clothing can provide an important clue to a potential lack of sunlight exposure and its impact on his or her vitamin D status.²⁹ As for inspection of the integument, it should be noted that darker skin pigmentation is included among the risk factors for vitamin D insufficiency, as melanin in darker skin reduces vitamin D synthesis.^9,31

Testing for Vitamin D
The most accurate means of meassuring the patient's vitamin D status is 25-hydroxyvitamin D, also known as serum 25(OH)D.^4,25 With a relative half-life of two weeks,⁴ this marker reliably indicates the body's stores of vitamin D. Some laboratories report three aspects—total serum 25(OH)D, 25[OH]D3, and 25[OH]D2—while others report only total serum 25(OH)D. Interpretation of the latter is shown in Table 2.^4,25

Additional research suggests that higher levels of serum 25(OH)D (ie, 36 to 48 ng/mL) may be desirable for the prevention of cancer.¹²

Treatment
Vitamin D insufficiency and deficiency are relatively easy and inexpensive to treat. With a target treatment goal of serum 25(OH)D greater than 30 ng/mL, the patient can be advised to increase his or her sunlight or UV exposure in moderate amounts, such as exposure of the hands and face to bright sunlight for 15 minutes daily. During winter or at northern latitudes with reduced sunlight, moderate exposure in a tanning bed (ie, one emitting 2% to 6% UVB radiation) can be helpful.^6,32 For recommended supplementation to correct vitamin D deficiency or insufficiency, see Table 3.^6,32

Oral supplementation for adults is an inexpensive, well-tolerated solution. A conscious effort to increase dietary intake of fortified dairy products and cereals or fatty fish may be adequate. OTC oral vitamin D3 supplements are available in 200, 400, and 1,000 IU for a few cents per dose. Prescription vitamin D2 ergocalciferol is also available.⁶

Infants who are exclusively breastfed or who consume less than 500 mL/d of vitamin D–fortified formula can be given a combination multivitamin containing 400 IU/mL for adequate supplementation^3,6; Hollis and Wagner⁸ recommend that breastfeeding women have 4,000 IU/d of vitamin D intake to protect both themselves and their infants. Single-source or concentrated vitamin D is not recommended for infants.³ Gartner and Greer³ recommend a vitamin D intake of 200 IU/d from childhood through adolescence.

Research indicates that higher levels of vitamin D supplementation than previously recommended are needed for most people and are safe.^7,12 Additionally, higher doses of vitamin D are not as toxic as were previously believed, as excess amounts are stored.³³ Daily doses of no less than 1,000 IU (with or without sunlight exposure and/or dietary intake) may improve the serum 25(OH)D levels in the majority of the population.¹² Results from one study suggest that a total of 3,600 to 4,200 IU/d from all sources is desirable and safe.³³

Reevaluation
The serum 25(OH)D test should be repeated after six to eight weeks to ensure adequate vitamin D absorption, targeting a level of at least 30 ng/mL. If serum 25(OH)D falls persistently below that level, the clinician should consider vitamin D in an injectable form and reassess the patient for malabsorption or other interference issues.³⁴

Conclusion
The health benefits of vitamin D are frequently overlooked in everyday practice. Screening and treatment are simple, cost-effective, and beneficial for patients' wellness.

As increasing numbers of people work in windowless environments and as computer time, gaming consoles, and TV viewing keep more of them indoors during their leisure hours, many are losing access to their natural source of vitamin D: sunshine. In response to the justifiably publicized risk of skin cancers, people avoid sunlight or take great care to cover the skin with sunscreen—minimizing the risk of sun-related skin cancer, but greatly increasing the risk of vitamin D deficiency.

The importance of vitamin D was first recognized in the prevention of rickets and its role in absorption of calcium and phosphate in the diet.¹ In recent decades, however, the growing understanding of vitamin D's influence on leukocytes, vascular smooth muscle cells, and other tissues² has led to an increased awareness of this nutrient's contribution to numerous processes and functions.

Considering vitamin D's subtle but substantial impact on mental, cardiovascular, musculoskeletal, and autoimmune health (not to mention bone disorders and calcium deficiency), vitamin D deficiency is overlooked and undertreated with surprising frequency in the clinical setting, where clinicians are more likely to screen for and treat other disorders.

The Facts
Exposure of the skin to sunlight or ultraviolet (UV) light is the human body's natural way to synthesize vitamin D3.^1,3 This nutrient can also be ingested in fish and fish liver oils; in the form of vitamin D2, which has been used since the 1930s in efforts to reduce rickets and other bone disorders by fortifying milk, cereals, and a variety of food products^4,5; and in dietary supplements.

Unfortunately, the intake of vitamin D–fortified foods and/or supplements is often insufficient for the average person to maintain an adequate level of this essential substance.³ Fatty fish, including sardines, mackerel, tuna, and salmon,⁶ are among the few foods that represent a valuable source of vitamin D, but these are not commonly considered a staple in today's American diet. Additionally, it has been questioned whether the current recommended daily allowance guidelines for vitamin D intake are adequate for most of the population.⁷

Widespread Effects
The impact of vitamin D deficiency or insufficiency affects patients of both genders across the life span. Exclusive breastfeeding without adequate vitamin D supplementation can result in rickets in infants, children, and adolescents.^3,4,8 Research indicates that even healthy-appearing adolescents may be deficient in this nutrient.⁹ Inadequate intake or supplementation of vitamin D during pregnancy has been shown to increase women's risk of preeclampsia, with potential impact on their infants' well-being.¹⁰

Adults with inadequate levels of vitamin D are at risk for periodontal disease and other dental concerns,^11,12 hypertension and cardiovascular disease,^2,13-16 musculoskeletal disorders, depression,¹⁷ and malignancies of the breast,¹⁸ colon,^1,19,20 and prostate.¹³ Older persons with insufficient levels of this essential substance are at increased risk of falls and fractures,^12,21 osteoporosis,^21,22 hyperparathyroidism,²³ impaired cognitive function, and depression.²⁴

Vitamin D Synthesis
Vitamin D is synthesized in the skin by UV light between wavelengths of 290 and 315 nm,^4,13 converting 7-dehydrocholesterol to previtamin D3, then by thermal isomerization to vitamin D3.^1,3 Both vitamin D3 and vitamin D2 are incorporated into chylomicrons and absorbed by the lymph system, then put into systemic circulation by vitamin D–binding protein.^4,13

Two additional steps—one that occurs in the liver, the other in the kidneys—are needed to complete the conversion from an inert form to usable vitamin D. In the liver, the molecule is hydroxylated by enzymes called the vitamin D-25-hydroxylases to form 25-hydroxyvitamin D. Then in the kidneys, the cytochrome P-450 enzyme 25-hydroxyvitamin D-1 alpha-hydroxylase continues the hydroxylation process, converting the molecule to vitamin D's biologically active form, 1,25-dihydroxyvitamin D.^4,13,25 It is next bound to the vitamin D receptors and in an additional step is transcribed in RNA and replicated.

The known actions of vitamin D include increasing calcium and phosphorus absorption from the small bowel, enhancement of renal tubule resorption of phosphate, and maturation of osteoclasts to resorb calcium from the bones. Vitamin D also improves measurable bone mineral density.¹

Who Is at Risk?
Many individuals may not recognize their risk for vitamin D deficiency or insufficiency. Clinicians must be aware of the conditions and factors that increase the risk. Many of these are identified in Table 1.^{3,5,6,8,10,24,26-31}

Assessment
Clinicians in any number of specialties may encounter patients with vitamin D deficiency or insufficiency. Thus, it is important during the interview and review of systems to ask routinely about the patient's occupation, sun exposure, and use of sunscreen. Clinicians should also ask about dietary habits and dietary supplements, including multivitamins and supplemental vitamin D (eg, calcium with vitamin D).

The examining clinician should also key in on fatigue, bone pain, and muscle pain or weakness. While reviewing the patient's medical history and the current problem list, the clinician should maintain an awareness of disease processes that may mimic vitamin D insufficiency. These include fibromyalgia, chronic fatigue syndrome, myositis, hyperparathyroidism, and depression.^13,17,23 Comorbidities that often coexist with vitamin D deficiency include hypertension and cardiovascular disease,¹⁶ obesity, type 1 diabetes mellitus,¹³ multiple sclerosis,⁵ secondary hyperparathyroidism,¹³ and prostate, breast, or colorectal cancer.^1,2,9,13

 

Assessment of the patient's constitution, of course, includes vital signs and general appearance. As mentioned earlier, hypertension may coexist with vitamin D deficiency.^2,13-16 Obesity, it is also important to note, has been associated with reduced vitamin D bioavailability.²⁸ The type and coverage of the patient's clothing can provide an important clue to a potential lack of sunlight exposure and its impact on his or her vitamin D status.²⁹ As for inspection of the integument, it should be noted that darker skin pigmentation is included among the risk factors for vitamin D insufficiency, as melanin in darker skin reduces vitamin D synthesis.^9,31

Testing for Vitamin D
The most accurate means of meassuring the patient's vitamin D status is 25-hydroxyvitamin D, also known as serum 25(OH)D.^4,25 With a relative half-life of two weeks,⁴ this marker reliably indicates the body's stores of vitamin D. Some laboratories report three aspects—total serum 25(OH)D, 25[OH]D3, and 25[OH]D2—while others report only total serum 25(OH)D. Interpretation of the latter is shown in Table 2.^4,25

Additional research suggests that higher levels of serum 25(OH)D (ie, 36 to 48 ng/mL) may be desirable for the prevention of cancer.¹²

Treatment
Vitamin D insufficiency and deficiency are relatively easy and inexpensive to treat. With a target treatment goal of serum 25(OH)D greater than 30 ng/mL, the patient can be advised to increase his or her sunlight or UV exposure in moderate amounts, such as exposure of the hands and face to bright sunlight for 15 minutes daily. During winter or at northern latitudes with reduced sunlight, moderate exposure in a tanning bed (ie, one emitting 2% to 6% UVB radiation) can be helpful.^6,32 For recommended supplementation to correct vitamin D deficiency or insufficiency, see Table 3.^6,32

Oral supplementation for adults is an inexpensive, well-tolerated solution. A conscious effort to increase dietary intake of fortified dairy products and cereals or fatty fish may be adequate. OTC oral vitamin D3 supplements are available in 200, 400, and 1,000 IU for a few cents per dose. Prescription vitamin D2 ergocalciferol is also available.⁶

Infants who are exclusively breastfed or who consume less than 500 mL/d of vitamin D–fortified formula can be given a combination multivitamin containing 400 IU/mL for adequate supplementation^3,6; Hollis and Wagner⁸ recommend that breastfeeding women have 4,000 IU/d of vitamin D intake to protect both themselves and their infants. Single-source or concentrated vitamin D is not recommended for infants.³ Gartner and Greer³ recommend a vitamin D intake of 200 IU/d from childhood through adolescence.

Research indicates that higher levels of vitamin D supplementation than previously recommended are needed for most people and are safe.^7,12 Additionally, higher doses of vitamin D are not as toxic as were previously believed, as excess amounts are stored.³³ Daily doses of no less than 1,000 IU (with or without sunlight exposure and/or dietary intake) may improve the serum 25(OH)D levels in the majority of the population.¹² Results from one study suggest that a total of 3,600 to 4,200 IU/d from all sources is desirable and safe.³³

Reevaluation
The serum 25(OH)D test should be repeated after six to eight weeks to ensure adequate vitamin D absorption, targeting a level of at least 30 ng/mL. If serum 25(OH)D falls persistently below that level, the clinician should consider vitamin D in an injectable form and reassess the patient for malabsorption or other interference issues.³⁴

Conclusion
The health benefits of vitamin D are frequently overlooked in everyday practice. Screening and treatment are simple, cost-effective, and beneficial for patients' wellness.

As increasing numbers of people work in windowless environments and as computer time, gaming consoles, and TV viewing keep more of them indoors during their leisure hours, many are losing access to their natural source of vitamin D: sunshine. In response to the justifiably publicized risk of skin cancers, people avoid sunlight or take great care to cover the skin with sunscreen—minimizing the risk of sun-related skin cancer, but greatly increasing the risk of vitamin D deficiency.

The importance of vitamin D was first recognized in the prevention of rickets and its role in absorption of calcium and phosphate in the diet.¹ In recent decades, however, the growing understanding of vitamin D's influence on leukocytes, vascular smooth muscle cells, and other tissues² has led to an increased awareness of this nutrient's contribution to numerous processes and functions.

Considering vitamin D's subtle but substantial impact on mental, cardiovascular, musculoskeletal, and autoimmune health (not to mention bone disorders and calcium deficiency), vitamin D deficiency is overlooked and undertreated with surprising frequency in the clinical setting, where clinicians are more likely to screen for and treat other disorders.

The Facts
Exposure of the skin to sunlight or ultraviolet (UV) light is the human body's natural way to synthesize vitamin D3.^1,3 This nutrient can also be ingested in fish and fish liver oils; in the form of vitamin D2, which has been used since the 1930s in efforts to reduce rickets and other bone disorders by fortifying milk, cereals, and a variety of food products^4,5; and in dietary supplements.

Unfortunately, the intake of vitamin D–fortified foods and/or supplements is often insufficient for the average person to maintain an adequate level of this essential substance.³ Fatty fish, including sardines, mackerel, tuna, and salmon,⁶ are among the few foods that represent a valuable source of vitamin D, but these are not commonly considered a staple in today's American diet. Additionally, it has been questioned whether the current recommended daily allowance guidelines for vitamin D intake are adequate for most of the population.⁷

Widespread Effects
The impact of vitamin D deficiency or insufficiency affects patients of both genders across the life span. Exclusive breastfeeding without adequate vitamin D supplementation can result in rickets in infants, children, and adolescents.^3,4,8 Research indicates that even healthy-appearing adolescents may be deficient in this nutrient.⁹ Inadequate intake or supplementation of vitamin D during pregnancy has been shown to increase women's risk of preeclampsia, with potential impact on their infants' well-being.¹⁰

Adults with inadequate levels of vitamin D are at risk for periodontal disease and other dental concerns,^11,12 hypertension and cardiovascular disease,^2,13-16 musculoskeletal disorders, depression,¹⁷ and malignancies of the breast,¹⁸ colon,^1,19,20 and prostate.¹³ Older persons with insufficient levels of this essential substance are at increased risk of falls and fractures,^12,21 osteoporosis,^21,22 hyperparathyroidism,²³ impaired cognitive function, and depression.²⁴

Vitamin D Synthesis
Vitamin D is synthesized in the skin by UV light between wavelengths of 290 and 315 nm,^4,13 converting 7-dehydrocholesterol to previtamin D3, then by thermal isomerization to vitamin D3.^1,3 Both vitamin D3 and vitamin D2 are incorporated into chylomicrons and absorbed by the lymph system, then put into systemic circulation by vitamin D–binding protein.^4,13

Two additional steps—one that occurs in the liver, the other in the kidneys—are needed to complete the conversion from an inert form to usable vitamin D. In the liver, the molecule is hydroxylated by enzymes called the vitamin D-25-hydroxylases to form 25-hydroxyvitamin D. Then in the kidneys, the cytochrome P-450 enzyme 25-hydroxyvitamin D-1 alpha-hydroxylase continues the hydroxylation process, converting the molecule to vitamin D's biologically active form, 1,25-dihydroxyvitamin D.^4,13,25 It is next bound to the vitamin D receptors and in an additional step is transcribed in RNA and replicated.

The known actions of vitamin D include increasing calcium and phosphorus absorption from the small bowel, enhancement of renal tubule resorption of phosphate, and maturation of osteoclasts to resorb calcium from the bones. Vitamin D also improves measurable bone mineral density.¹

Who Is at Risk?
Many individuals may not recognize their risk for vitamin D deficiency or insufficiency. Clinicians must be aware of the conditions and factors that increase the risk. Many of these are identified in Table 1.^{3,5,6,8,10,24,26-31}

Assessment
Clinicians in any number of specialties may encounter patients with vitamin D deficiency or insufficiency. Thus, it is important during the interview and review of systems to ask routinely about the patient's occupation, sun exposure, and use of sunscreen. Clinicians should also ask about dietary habits and dietary supplements, including multivitamins and supplemental vitamin D (eg, calcium with vitamin D).

The examining clinician should also key in on fatigue, bone pain, and muscle pain or weakness. While reviewing the patient's medical history and the current problem list, the clinician should maintain an awareness of disease processes that may mimic vitamin D insufficiency. These include fibromyalgia, chronic fatigue syndrome, myositis, hyperparathyroidism, and depression.^13,17,23 Comorbidities that often coexist with vitamin D deficiency include hypertension and cardiovascular disease,¹⁶ obesity, type 1 diabetes mellitus,¹³ multiple sclerosis,⁵ secondary hyperparathyroidism,¹³ and prostate, breast, or colorectal cancer.^1,2,9,13

 

Assessment of the patient's constitution, of course, includes vital signs and general appearance. As mentioned earlier, hypertension may coexist with vitamin D deficiency.^2,13-16 Obesity, it is also important to note, has been associated with reduced vitamin D bioavailability.²⁸ The type and coverage of the patient's clothing can provide an important clue to a potential lack of sunlight exposure and its impact on his or her vitamin D status.²⁹ As for inspection of the integument, it should be noted that darker skin pigmentation is included among the risk factors for vitamin D insufficiency, as melanin in darker skin reduces vitamin D synthesis.^9,31

Testing for Vitamin D
The most accurate means of meassuring the patient's vitamin D status is 25-hydroxyvitamin D, also known as serum 25(OH)D.^4,25 With a relative half-life of two weeks,⁴ this marker reliably indicates the body's stores of vitamin D. Some laboratories report three aspects—total serum 25(OH)D, 25[OH]D3, and 25[OH]D2—while others report only total serum 25(OH)D. Interpretation of the latter is shown in Table 2.^4,25

Additional research suggests that higher levels of serum 25(OH)D (ie, 36 to 48 ng/mL) may be desirable for the prevention of cancer.¹²

Treatment
Vitamin D insufficiency and deficiency are relatively easy and inexpensive to treat. With a target treatment goal of serum 25(OH)D greater than 30 ng/mL, the patient can be advised to increase his or her sunlight or UV exposure in moderate amounts, such as exposure of the hands and face to bright sunlight for 15 minutes daily. During winter or at northern latitudes with reduced sunlight, moderate exposure in a tanning bed (ie, one emitting 2% to 6% UVB radiation) can be helpful.^6,32 For recommended supplementation to correct vitamin D deficiency or insufficiency, see Table 3.^6,32

Oral supplementation for adults is an inexpensive, well-tolerated solution. A conscious effort to increase dietary intake of fortified dairy products and cereals or fatty fish may be adequate. OTC oral vitamin D3 supplements are available in 200, 400, and 1,000 IU for a few cents per dose. Prescription vitamin D2 ergocalciferol is also available.⁶

Infants who are exclusively breastfed or who consume less than 500 mL/d of vitamin D–fortified formula can be given a combination multivitamin containing 400 IU/mL for adequate supplementation^3,6; Hollis and Wagner⁸ recommend that breastfeeding women have 4,000 IU/d of vitamin D intake to protect both themselves and their infants. Single-source or concentrated vitamin D is not recommended for infants.³ Gartner and Greer³ recommend a vitamin D intake of 200 IU/d from childhood through adolescence.

Research indicates that higher levels of vitamin D supplementation than previously recommended are needed for most people and are safe.^7,12 Additionally, higher doses of vitamin D are not as toxic as were previously believed, as excess amounts are stored.³³ Daily doses of no less than 1,000 IU (with or without sunlight exposure and/or dietary intake) may improve the serum 25(OH)D levels in the majority of the population.¹² Results from one study suggest that a total of 3,600 to 4,200 IU/d from all sources is desirable and safe.³³

Reevaluation
The serum 25(OH)D test should be repeated after six to eight weeks to ensure adequate vitamin D absorption, targeting a level of at least 30 ng/mL. If serum 25(OH)D falls persistently below that level, the clinician should consider vitamin D in an injectable form and reassess the patient for malabsorption or other interference issues.³⁴

Conclusion
The health benefits of vitamin D are frequently overlooked in everyday practice. Screening and treatment are simple, cost-effective, and beneficial for patients' wellness.