Group: Ireen Alam, Memona Ali, Sydney Antonawich, Keziah Babu, Lingqiao Chen

Evidence-Based Medicine

Mini-CAT

Scenario: You’ve just attended a dinner sponsored by a company that makes home blood pressure monitors for telehealth applications. It sounds interesting, but you want more information. What is the evidence that telehealth blood pressure monitoring improves blood pressure control in urban populations?

Clinical Question: Please state this as briefly as possible based on the scenario provided

Does telehealth blood pressure monitoring improve blood pressure control in urban populations?

PICO Question: Identify the PICO elements

P: hypertensive adults living in urban areas

I: home blood pressure monitor

C: office visit blood pressure monitor

O: controlled BP

What type of scenario is this?

□ Therapy/ Prevention           

Type of study best to answer this question: (think about the level of evidence)

□ Systematic Review              □ Randomized Controlled Trial         

PICO Search Terms

P	I	C	O
Urban	Home blood pressure monitoring	In-person visit	Controlled BP
Hypertension	Telehealth	Blood pressure monitoring	Stable BP
Adults		Health care professional
City		Office visit

Search Strategy:

Outline the terms used, databases or other tools used, how many articles returned, and how you selected the final articles to base your CAT on

            PubMed: hypertension, telehealth, /Limits: adults, last 10 years → 181 results

            PubMed: urban, hypertension, telehealth, /Limits: adults → 82 results

            Cochrane: telehealth, blood pressure monitoring, /Limits: adults → 14 results

Articles Chosen for Inclusion (please copy and paste the abstract with link):

Article 1 –  Home Blood Pressure Monitoring 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6159400/

Hypertension is the most common preventable cause of cardiovascular disease. Home blood pressure monitoring (HBPM) is a self-monitoring tool that can be incorporated into the care for patients with hypertension and is recommended by major guidelines. A growing body of evidence supports the benefits of patient HBPM compared with office-based monitoring: these include improved control of BP, diagnosis of white-coat hypertension, and prediction of cardiovascular risk. Furthermore, HBPM is cheaper and easier to perform than 24-hour ambulatory BP monitoring (ABPM). All HBPM devices require validation, however, as inaccurate readings have been found in a high proportion of monitors. New technology features a longer inflatable area within the cuff that wraps all the way around the arm, increasing the ‘acceptable range’ of placement and thus reducing the impact of cuff placement on reading accuracy, thereby overcoming the limitations of current devices.

Article 2 – Home blood pressure monitoring: primary role in hypertension management

https://pubmed.ncbi.nlm.nih.gov/24924993/

In the last two decades, considerable evidence on home blood pressure monitoring has accumulated and current guidelines recommend its wide application in clinical practice. First, several outcome studies have shown that the ability of home blood pressure measurements in predicting preclinical target organ damage and cardiovascular events is superior to that of the conventional office blood pressure measurements and similar to that of 24-hour ambulatory monitoring. Second, cross-sectional studies showed a considerable agreement of home blood pressure measurements with ambulatory monitoring in detecting the white-coat and masked hypertension phenomena, in both untreated and treated subjects. Third, studies have shown larger blood pressure decline by using home blood pressure monitoring instead of office measurements for treatment adjustment. Fourth, in treated hypertensives, home blood pressure monitoring has been shown to improve long-term adherence to antihypertensive drug treatment and thus, has improved hypertension control rates. These data suggest that home blood pressure should no longer be regarded as only a screening tool that requires confirmation by ambulatory monitoring. Provided that an unbiased assessment is obtained according to current recommendations, home blood pressure monitoring should have a primary role in diagnosis, treatment adjustment, and long-term follow-up of most cases with hypertension.

Article 3 – Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomized controlled trial     

https://pubmed.ncbi.nlm.nih.gov/33468518/

The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. Participants were randomized by using a minimization algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded.

Article 4 – Integrating Out-Of-Office Blood Pressure in the Diagnosis and Management of Hypertension

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5068246/

Guidelines for the diagnosis and monitoring of hypertension were historically based on in-office blood pressure measurements. However, the United States Preventive Services Task Force recently expanded their recommendations on screening for hypertension to include out-of-office blood pressure measurements to confirm the diagnosis of hypertension. Out-of-office blood pressure monitoring, including ambulatory blood pressure monitoring and home blood pressure monitoring, are important tools in distinguishing between normotension, masked hypertension, white-coat hypertension, and sustained (including uncontrolled or drug-resistant) hypertension. Compared to in-office readings, out-of-office blood pressures are a greater predictor of renal and cardiac morbidity and mortality. There are multiple barriers to the implementation of out-of-office blood pressure monitoring which need to be overcome in order to promote more widespread use of these modalities.

Article 5 – Telehealth interventions: remote monitoring and consultations for people with chronic obstructive pulmonary disease (COPD)

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013196.pub2/full?highlightAbstract=telehealth%7Cpressur%7Cmonitor%7Cpressure%7Cmonitoring%7Cblood

Chronic obstructive pulmonary disease (COPD, including bronchitis and emphysema) is a chronic condition causing shortness of breath, cough, and exacerbations leading to poor health outcomes. Face‐to‐face visits with health professionals can be hindered by the severity of COPD or frailty, and by people living at a distance from their healthcare provider and having limited access to services. Telehealth technologies aimed at providing health care remotely through monitoring and consultations could help to improve the health outcomes of people with COPD. To assess the effectiveness of telehealth interventions that allow remote monitoring and consultation and multi‐component interventions for reducing exacerbations and improving quality of life, while reducing dyspnoea symptoms, hospital service utilization, and death among people with COPD. Remote monitoring plus usual care provided asynchronously may not be beneficial overall compared to usual care alone. Some benefit is seen in the reduction of COPD‐related hospital re‐admissions, but moderate‐certainty evidence is based on one study. We have not found any evidence for dyspnoea symptoms nor harm, and there is no difference in fatalities when remote monitoring is provided in addition to usual care. Remote monitoring interventions alone are no better than usual care overall for health outcomes. Multi‐component interventions with asynchronous remote monitoring are no better than usual care but may provide short‐term benefit for quality of life and may result in fewer re‐admissions to the hospital for any cause. We are uncertain whether remote monitoring is responsible for the positive impact on re‐admissions, and we are unable to discern the long‐term benefits of receiving remote monitoring as part of patient care. Owing to the paucity of evidence, it is unclear which COPD severity subgroups would benefit from telehealth interventions. Given there is no evidence of harm, telehealth interventions may be beneficial as an additional health resource depending on individual needs based on professional assessment. Larger studies can determine the long‐term effects of these interventions.

Summary of the Evidence:

#	Author (Date)	Level of Evidence	Sample/Setting (# of subjects/ studies, cohort definition etc. )	Outcome(s) studied	Key Findings	Limitations and Biases
1	Jacob George and Thomas MacDonald (2015, June)	Systematic Review	RCT = 555   Retrospective analysis #1 = 163   Retro analysis #2 = 133   Prospective cohort	Screening for HTN and the advantages and limitations of HBPM	The use of HBPM devices is cost-effective and has stronger prognostic value in terms of CV risk when compared with clinic BP measurement.	Some automated devices are inaccurate in their readings (upper arm > wrist)   Inappropriate cuff size      Lack of nocturnal readings
2	George S Stergiou, Anastasios Kollias, Marilena Zeniodi, Nikos Karpettas, Angeliki Ntineri (2014, Aug)	Systematic review	RCT = 72 studies   Sample size = 1350	Prognostic ability   Usefulness in tx adjustment   Cost effectiveness	ABPM is expensive, not widely available, and less well-accepted by patients particularly for long-term use.   HBPM is accepted widely by pts, low cost, good for long term follow up.	Reliability of the patient data   Over and under reporting the BP values   Standardization to ensure recommended schedule is being followed
3	Richard J McManus, Paul Little, et al. (2020, Oct)	RCT	# of subjects: 622 people with poorly controlled hypertension Participants were randomised into intervention group and usual care group   Intervention group: self-monitoring of BP with a digital intervention (305 participant)   Usual care group: routine HTN care visits (317 participants)   Setting: 76 general practices in the United Kingdom	Primary outcome was the difference in systolic blood pressure after one year	Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2mmHg in the intervention group and from 151.6/85.3 to 141.8/79.8mmHg in the usual care group.   The Home and Online Management and Evaluation of Blood Pressure (HOME BP) led to better control of systolic blood pressure after one year than usual care.   Adverse events were similar to usual care.	Lack of data on drug adherence.   The effect size in the trial was slightly smaller compared to another trial in a similar population.
4	Jordana B. Cohen and Debbie L. Cohen (2016, Nov)	Systematic Review	Not mentioned in the article*	The effectiveness of out-of-office (including ambulatory and home)  blood pressure monitoring and how it improves care provided to patient	Out-of-office blood pressure monitoring provides superior prognostication of long-term renal and cardiac risk compared to in-office blood pressures. Additionally, ambulatory blood pressure monitoring and home blood pressure monitoring can have an important role in the verification and management of drug-resistant and pseudo resistant hypertensive patients.	Although the article mentions both automated and manual out-of-office blood pressures, the accuracy of these two methods are not mentioned. An improvement to this study would be to include which method of measuring BP is recommended, so that providers are not steered in the wrong direction.
5	Sadia Janjua, Deborah Carter, et al. (2021, July)	Systematic Review	29 studies were included in the review (5654 participants with diagnosed COPD; male proportion 36% to 96%; female proportion 4% to 61%)	Outcomes studied for these populations were COPD‐related hospital re‐admissions.	Asynchronous remote monitoring is no better than usual care but may provide short‐term benefit for quality of life and may result in fewer hospital re‐admissions	Does not separate which COPD sub-groups would benefit from telehealth interventions   Uncertain if the monitoring is directly responsible for reduced readmissions   Unsure of long-term benefits of monitoring

Conclusion(s):

Based on the conclusions of all of the articles, telehealth blood pressure monitoring improves blood pressure control in urban populations. It offers several benefits including low cost, convenience, prognostic ability, ease for long-term follow-ups, and treatment management. 

It has been shown to reduce COPD hospital readmissions and lower systolic blood pressure in poorly controlled patients. Additionally, home blood pressure improves blood pressure control, as it has been proven to improve long-term renal and cardiac risk. It was also shown to help manage drug-resistant hypertensive patients. While home blood pressure monitoring gains more popularity, there are several limitations that need to be addressed for better accuracy. Further studies should be conducted to evaluate. 2

Clinical Bottom Line: (Please include an assessment of the worth to practice)

Taking at-home blood pressure allows more frequent monitoring, and improves patient autonomy over their well-being. It reduces health care disparities among low-income urban communities caused by the high patient-to-physician ratio as well as lack of access to a health care provider.

References:

Cohen, J. B., & Cohen, D. L. (2016). Integrating Out-of-Office Blood Pressure in the Diagnosis and Management of Hypertension. Current cardiology reports, 18(11), 112. https://doi.org/10.1007/s11886-016-0780-3

Janjua S, Carter D, Threapleton CJD, Prigmore S, Disler RT. Telehealth interventions: remote monitoring and consultations for people with chronic obstructive pulmonary disease (COPD). Cochrane Database of Systematic Reviews 2021, Issue 7. Art. No.: CD013196. DOI: 10.1002/14651858.CD013196.pub2. Accessed 30 November 2021.https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013196.pub2/full?highlightAbstract=telehealth%7Cpressur%7Cmonitor%7Cpressure%7Cmonitoring%7Cblood.

Kario K. (2020). Management of Hypertension in the Digital Era: Small Wearable Monitoring Devices for Remote Blood Pressure Monitoring. Hypertension (Dallas, Tex. : 1979), 76(3), 640–650. https://doi.org/10.1161/HYPERTENSIONAHA.120.14742

McManus, R. J., Little, P., Stuart, B., Morton, K., Raftery, J., Kelly, J., Bradbury, K., Zhang, J., Zhu, S., Murray, E., May, C. R., Mair, F. S., Michie, S., Smith, P., Band, R., Ogburn, E., Allen, J., Rice, C., Nuttall, J., Williams, B., … HOME BP investigators (2021). Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial. BMJ (Clinical research ed.), 372, m4858. https://doi.org/10.1136/bmj.m4858

Stergiou GS, Kollias A, Zeniodi M, Karpettas N, Ntineri A. Home blood pressure monitoring: primary role in hypertension management. Curr Hypertens Rep. 2014 Aug;16(8):462. doi: 10.1007/s11906-014-0462-8. PMID: 24924993. https://pubmed.ncbi.nlm.nih.gov/24924993/

Policy Brief

To:  Bob Cook-Deegan
From:  Lingqiao Chen
Date:  July 18, 2021
Re:  Expanding Dental Coverage for Medicare Beneficiaries

Statement of Issue: Based on the report from US Census, the number of US adults aged 65 years or older is expected to reach 24% of the overall population by 2060. Their health and well-being should be a priority in public health. Oral conditions particularly affect older adults, especially those who are economically disadvantaged. 96% of adults aged 65 years or older have had a cavity and 1 in 5 of them have untreated tooth decay. 68% of adults aged 65 years or older have gum disease. Despite the prevalence of dental disease, dental care is excluded from Medicare coverage. Medicare does not cover cleaning, treatment, dental filling, removal, or replacement. 65% of Medicare beneficiaries don’t have any dental converge. Even though some Medicare Advantage plans offer dental benefits, the coverage is often limited. Without adequate dental coverage, many Medicare beneficiaries choose to forgo non-urgent dental care, which exposes them to potentially preventable complications and expensive out-of-pocket expenses.

• Dental problems significantly decrease the quality of life. Dental problem is a chronic disease that’s often being overlooked. Oral conditions cause pain and infection that affect eating, speaking, and social interaction. About 1 in 5 adults aged 65 years or older are edentulous and the prevalence increases with age. Having missing teeth can lead to nutritional deficiencies and social isolation.
• The cost of dentist visits without insurance coverage is a great barrier to access. 10% of the Medicare beneficiaries forgo dental care in 2016 due to cost. The financial barrier causes more problems for those with low income and poor health. Average out-of-pocket spending on dental services was $922 in 2016. This is expensive considering half of the Medicare beneficiaries had income below $26,200 per year.
• Preventative dental care curtails future dental costs. Many dental complications are preventable. Cigna Health calculates that adults who don’t receive preventive care will have a 43% increase in their annual dental cost over the same period of time.
• Untreated dental conditions can lead to other health conditions. According to Mayo Clinic, oral bacteria and inflammation seen in periodontitis might contribute to various diseases such as endocarditis, cardiovascular disease, and pneumonia.

Policy Options:

• Standardize dental benefits across Medicare Advantage plans. For Medicare Advantage plans that offer dental benefits, the dental benefit package is standardized to include annual oral exams, cleaning, dental x-rays, diagnostic services, restorative services, treatments of dental conditions, and prosthodontics.
  • Advantage: Medicare Advantage beneficiaries who signed up for plans that include dental coverage will receive a more comprehensive benefit package. The benefits are standardized across plans, making the choices less complicated for these enrollees. Since this approach only makes changes to the Medicare Advantage plan, the impact on Medicare spending will be less. 
  • Disadvantage: This policy only targets a limited population. Dental care access does not improve for those who don’t have Medicare Advantage plans. With a standardized package, the premiums will rise for every participant. People who only need basic dental care will end up paying for services that they don’t need.

• Adding only essential dental service to Medicare as a separate plan (Like Plan D). The benefit package will be similar to the ones covered by Medicaid, which includes one annual preventative care visit, one cleaning every six months, routine procedures, and three total dental office visits per year. 
  • Advantage: This approach expands Medicaid-covered dental benefits to all Medicare enrollees regardless of their income level. The preventative services covered under this plan will detect oral conditions at an earlier stage, and prevent more costly complications in the future. The plan is voluntary; people can choose not to enroll if they are covered by private dental insurance. 
  • Disadvantage: There will still be a portion of people without dental insurance because this plan is not mandatory. Enrollees will still be financially responsible for expensive procedures such as root canals and implants. The plan doesn’t benefit people who are dually eligible for Medicare and Medicaid because they already have these benefits under Medicaid. Since this will be a new part under Medicare, extra effort needs to be put in to determine the premium and cost-sharing method. In addition, having a new part under Medicare can make Medicare policy more complicated for the enrollees.  

• Adding a comprehensive dental benefit package to Medicare as a separate plan. The dental benefit package will cover one annul preventative care visit, other necessary procedures, treatments, and prosthodontics. Patients who qualify for Medicare and Medicaid will be automatically enrolled in this dental plan. Other Medicare beneficiaries can voluntarily sign up. 
  • Advantage: This policy will help low-income patients get comprehensive benefits that are not originally covered by Medicaid. The plan is voluntary; people have the option to not sign up. Costly but necessary procedures will be covered under this policy. People will less likely to forgo needed treatment due to cost. 
  • Disadvantage: The disadvantages of this policy will be similar to the above option; the plan is not mandatory, so it’s unlikely that it will cover all Medicare beneficiaries. With more intensive coverage, the premium and Medicare spending will likely increase. This is likely to replace Medicare Advantage plans and other private dental insurance, which further shifts the cost to Medicare.

• Adding dental care package to existing Medicare Part B benefits. The package will include one annual preventative care visit, other necessary procedures, treatments, and prosthodontics. This additional dental care package will be subjected to Part B’s cost-sharing method. Preventative care will be provided without cost-sharing; other services and treatments will be subjected to 20% coinsurance. 
  • Advantage: All Medicare beneficiaries with Part B benefit will get dental coverage under this policy. Low-income patients who are dually eligible for Medicare and Medicaid will receive a more comprehensive benefit package. This policy will build on existing Medicare Part B; no additional policy is needed to decide on cost-sharing methods.
  • Disadvantage: With extensive dental coverage, the premium for Part B and Medicare spending will likely increase. The dental coverage will be embedded in Part B. Therefore Part B enrollees don’t have a choice to not enroll in this dental plan. They will need to pay a higher premium for this additional service that they might not use. 

Policy Recommendation:

With a rising Medicare-eligible population and the prevalence of dental conditions in this age group, Medicare should expand its coverage to provide dental services. Adding a dental care package to the existing Medicare Part B benefit will be the best option. This approach will bring dental coverage to almost all Medicare beneficiaries. It covers a wide scope of services that will meet each enrollee’s individual needs. This policy especially improves the access to quality dental care for low-income patients. Their premium will be waived under standard Part B policy and they will receive a more comprehensive benefit package. This helps to address the health disparity issue seen in the low-income group. Compare to other options, this approach is easier to implement because it builds upon the existing policy. Moreover, Medicare Part B is financed through both individual premium and federal revenue. The expected increase in premium will be within a reasonable range because individual premium only contributes to 25% of the total cost. 

Sources:

Carter, Julie. “Lack of Dental Coverage Has Real Costs and Consequences for People with Medicare.” Medicare Rights Center, 14 Mar. 2019, www.medicarerights.org/medicare-watch/2019/03/14/blog-lack-dental-coverage-real-costs-consequences-people-medicare.

“Dental Care and Medicare Beneficiaries: Access Gaps, Cost Burdens, and Policy Options.” Commonwealth Fund, 6 Dec. 2016, www.commonwealthfund.org/publications/journal-article/2016/dec/dental-care-and-medicare-beneficiaries-access-gaps-cost.

“Drilling Down on Dental Coverage and Costs for Medicare Beneficiaries.” KFF, 13 Mar. 2019, www.kff.org/medicare/issue-brief/drilling-down-on-dental-coverage-and-costs-for-medicare-beneficiaries.

“Oral Health: A Window to Your Overall Health.” Mayo Clinic, 4 June 2019, www.mayoclinic.org/healthy-lifestyle/adult-health/in-depth/dental/art-20047475?reDate=06072021.

“Oral Health for Older Americans | Adult Oral Health | Basics | Division of Oral Health | CDC.” CDC, www.cdc.gov/oralhealth/basics/adult-oral-health/adult_older.htm. Accessed 6 July 2021.

“Policy Options for Improving Dental Coverage for People on Medicare.” KFF, 18 Sept. 2019, www.kff.org/medicare/issue-brief/policy-options-for-improving-dental-coverage-for-people-on-medicare.

The patient, Mr. L, is a 47-year-old father of 2 with a history of alcohol abuse. He needed a cholecystectomy after being diagnosed with pancreatitis and biliary colic. Before the surgery could take place, Mr. L indicated that he didn’t want pain medication after the surgery because God wants him to suffer. Mr. L’s physician, Dr. J, spoke to Mr. L about the importance of pain medication to his recovery after surgery. In addition, Dr. J asked the chaplain, Mr. K, to speak to Mr. L, hoping to understand more about his spiritual concerns. From the conversation, Mr. L told Mr. K that God wanted him to be in pain because he had done so much wrong in his life, so he didn’t deserve the pain medication.

This case from the AMA Journal of Ethics illustrates a dilemma between autonomy and beneficence. Autonomy allows the patient to make medically informed decisions for himself based on his own values and beliefs. Beneficence requires the physician to provide procedures or recommendations that are good for the patient. With the intention of doing good, Dr. J will need to give Mr. L pain medication so Mr. L can recover properly with minimum suffering. However, this recommendation conflicts with Mr. L’s decision of not to receive any pain medication.

Even though Dr. J’s recommendation justifies beneficence, Mr. L’s autonomy should still be respected. Respect for autonomy trumps beneficence because Mr. L is a legal adult with the mental capability of making his own decisions. He understands that not receiving pain medication will result in excruciating pain and possible post-op complications like pneumonia because the pain can prevent him from taking deep breaths. Knowing the risks, Mr. L is capable of making an informed decision about his medical care, and this decision should be respected even though it goes against the physician’s advice. The purpose of shifting from a paternalism model to a patient-centered model is to give patients greater autonomy. The main difference between these two models is that patients are encouraged to make decisions that best fit their own values and beliefs. Religion is an important part of many people’s life. It shapes people’s views and can often influence one’s decision-making. Other than being a patient, Mr. L is also a believer. He sees this as a punishment from God and a chance of redemption. Thus, he made a decision to comply with his religious beliefs and not to comply with the doctor’s order.

Based on the principle of beneficence, Dr. J believed the proper post-op care includes prescribing pain medication. Dr. J also made the effort to understand more about Mr. L’s spiritual concerns by asking a chaplain to be involved in the case. Dr. J did the right thing in trying to find a common ground to best accommodate the patient’s beliefs. But, if an agreement still cannot be made, Dr. J should respect Mr. L’s decision.

One might argue that beneficence should trump autonomy because respecting autonomy is allowing patient suffering in this case. However, go against the patient’s will and administering pain medication is disrespecting the patient’s religious belief. This would cause harm in a spiritual way, which is as destructive as physical harm. This would also jeopardize the therapeutic relationship between physician and patient. Moreover, Mr. L will less likely to seek medical advice in the future knowing that his decision will not be respected.

Religion plays a significant role in influencing one’s judgment. When medical and religious perspective contradicts each other, the physician should make effort to best accommodate the patient’s spiritual needs. In the above case, autonomy trumps beneficence. The patient has the ability to make decisions that are in their best interest. Thus, they should decide what ought to be done.

Reference

What Should Physicians and Chaplains Do When a Patient Believes God Wants Him to Suffer? (2018). AMA Journal of Ethics, 20(7), 613–620. https://doi.org/10.1001/amajethics.2018.613

The Ethical Complications to Surrogacy and How PA’s Can Facilitate it.

By: Mosammat Alam, Lingqiao Chen, Daniel Crosby, Tiffany Liang, and Sophia Lobo

HPPA 514: Biomedical Ethics

Prof. Bridget McGarry

July 14, 2021

Introduction

Surrogacy has become a popular option for the LGBTQ community and families facing infertility or other conception-related issues. While it provides a solution to many, the key issues arise from the lack of centralized guidelines that dictate these practices and the role of the physician in moderating these situations. Oftentimes, problems arise when individuals involved either break their contract or come across an issue not previously addressed in their contracts. The laws for surrogacy vary by state, with many having little to no guidelines to monitor these procedures. New York, for instance, has legalized and set specific guidelines on gestational surrogacy as recently as February 2021 (“The Child-Parent Security Act: Gestational Surrogacy”). What we propose is a more centralized system to facilitate surrogate practices, based on medical collaboration with legal protocols to guide the interest of the intended parents, surrogate, and fetus.

Standardized Screening Process & Care – A Medicine Centered Approach

The first step to starting the surrogacy process is finding a suitable surrogate mother.  Some families already have a personal connection while others may use a surrogacy agency. Currently, surrogacy agencies exist as full or partial-service establishments. A full-service agency is responsible for the screening, matching, delivery, and return-to-home plans with legal and clinical coordinations. A partial-service agency provides only some of these services with less step-by-step guidance (Mello, 2019). The main complication with these varying pathways to finding a surrogate mother is a disjunctive process with no central oversight. There is a lack of protocol in determining if a surrogate mother is suitable for carrying a baby to full-term and delivery. Furthermore, over ten percent of gestational surrogates are not properly informed of the risk of multiple pregnancies and the demands on their body (White, 2017). This presents the issue of a lack of informed consent by both the surrogate mother and intended parents before proceeding with the contract. For this reason, the medical community can play a crucial role in developing a standardized screening plan for potential surrogacy mothers.

A thorough medical screening process should be implemented before a surrogate mother is cleared to carry a child to minimize health complications and provide concise documentation in case of legal ramifications as seen in the Johnson vs. Calvert lawsuit of Orange County. In this case, the couple sued the surrogate mother for concealing pregnancy complications that included several miscarriages and alleged that the agency failed to perform a proper background check of the mother (NeJaime, 2017). There are two sides to this case. First, the agency failed to conduct a thorough background check and standardized screening tests to ensure that the mother was healthy to proceed. Second, the lack of documentation of health status failed to protect the surrogate mother and agency in the event that they are sued on an unfounded basis.

To better protect the legal rights of the surrogate mother, the health of the fetus, and the expectations of the intended parents, a standardized screening process should consist of a mental health status exam and a complete physical exam. A thorough past medical and social history should also be obtained and documented. This would ensure that the mother is in full mental and physical status to proceed with the pregnancy and has the capacity to comply with healthy practices. Ultimately, the medical provider holds the responsibility to ensure that these screening tests are performed. A physician should not perform implantation until the documentation of a completed screening test is provided.

Creating Uniform Federal Guidelines

As surrogacy presents with such intricate and personal matters and inevitable complications, we must turn to laws and regulations to resolve them. Unfortunately, the laws guiding the process are not always clear-cut and currently vary among agencies, states, and countries. This makes it even harder to maneuver the various roadblocks that may occur.

In the United States, surrogacy laws are determined at the state level. In “Green Light” states, such as California and Connecticut, surrogacy is permitted for all parents, pre-birth orders are permissible, and the names of both parents are included on the birth certificate. “Yellow Light ” states such as Tennessee and Idaho, allow surrogacy, but present with legal limitations. For example, in Indiana, another yellow light state, surrogacy contracts are not enforceable but some courts have granted pre-birth orders for intended parents, which establish the intended parents as the baby’s legal parents (Trolice, et al., 2019). Lastly, “Red Light” states such as Michigan and Louisiana completely prohibit compensated surrogacy, only allow altruistic surrogacies, and deem anything beyond those limits a criminal offense. For instance, intended parents in Michigan can be fined up to $50,000 and imposed a penalty of up to one-year imprisonment. Surrogacy arrangements are so restricted in Louisiana that it is limited to married heterosexual couples (Gonzalez, 2019).

Because the surrogacy industry is still relatively new, many U.S. laws have room for improvement and must keep up with other ongoing advancements in medicine.  There are a number of factors and variables that can complicate surrogacy law, so it is extremely important to work with an assisted reproduction attorney in the state where surrogacy is taking place (Radcliff, 2019). Currently, the absence of federal surrogacy laws and competing views can impede transparency and obscure predictability. The establishment of federal regulations with medical committee advice can oversee surrogate agencies, offering clearer and more consistent guidance to the legal and medical terrains of surrogacy.

Rights of the Intended Parents

To further complicate matters, there is a difference between traditional and gestational surrogacy. In traditional surrogacy, the surrogate mother is artificially inseminated with the sperm of the intended father. In gestational surrogacy, a fertilized embryo of the intended parents is implanted in the surrogate mother. The child is not genetically related to the surrogate mother. This is a legally complex process that is carried out based on the contract between the intended parents and the surrogate to define the difference between legal and biological parents.

 The contract lists out the roles and responsibilities of each party involved in the surrogate process and outlines the expected behavior of the surrogate during pregnancy. In the event where the surrogate mother violates the agreement, the obstetrician faces the dilemma of whether to disclose the information to the intended parents or not (Daar, 2014). During the course of treatment, the clinician may learn previously unrevealed medical history about the surrogate, the surrogate’s intention to keep the resulting child, or dangerous behaviors like tobacco or alcohol use. Dr. Daar described the dilemma as between “the duty to obtain informed consent and the duty to maintain patient confidentiality.”

First, it is strongly recommended that the surrogate and the intended parents see different clinicians to avoid overlapping patient-physician relationships. This will avoid conflict of interest so that both parties are cared for in their best interests. Next, the use of a written agreement is necessary to resolve any conflict. Disclosure is permitted if the surrogate waived her right to confidentiality. Most surrogate contracts require surrogates to waive certain HIPAA rights to reassure the intended parents that the child is healthy throughout the pregnancy.

If there is a breach in the contract, the clinician would ideally encourage the surrogate to discuss the breach with the intended parents. If the surrogate refuses and the agreement does not include a waiver of confidentiality, the clinician should weigh the harm and benefit of revealing the information. The intended parents are genetically related to the fetus and are ultimately responsible for the outcome of the pregnancy. Therefore, protecting the patient’s confidentiality may cause potential harm to the baby as well as the intended parents. Nonconsensual disclosure should be justified to obtain informed consent and to avoid harm.

Rights of the Surrogate

A written legal contract between the surrogate mother and intended parents becomes especially imperative if disagreements should arise on the decision for abortion.  Difficult as these scenarios may be for traditional biological parents, the potential for conflict increases in cases of surrogacy.  From the perspective of the surrogate mother, she has to go through many lifestyle changes in caring for her fetus, such as avoiding certain fish, tobacco, and alcohol as well as modifying her daily activities. After nine months of this, she then has to emotionally detach herself from the child after delivery. While all this may be previously agreed upon, it does not account for everything. And none of this strips the surrogate of certain basic rights, such as the autonomous right to her body and her own gametal development.

As many intended parents will have a financial interest in achieving a pregnancy on the first attempt, the process of multiple embryo implantation is common in order to increase the odds of just that.  Multiple implantations introduce greater chances of a multiple fetus pregnancy, resulting in potential conflicts between surrogate and parents. Multiple gestations come with increased risks for both the fetuses and the mother carrying them. Additionally, if the surrogate happens to carry twins or triplets, the parents may insist on what is called “fetal reduction,” the process of terminating one or more fetuses with the intention of increasing the odds of a viable pregnancy.  With this comes the risk of psychological distress to the surrogate as well as the potential for a complete termination of pregnancy (Tanderup et al., 2015). In a high-profile case of 2016, surrogate Melissa Cook refused the requests of the commissioning parents to abort one of her triplets.  The surrogate mother decided she wished to deliver and seek custody of that triplet, defying the authority of the future parents (as per the contract) along with their concerns over the risks of carrying all three to term (O’Reilly, 2016). With stipulations of binding contracts involved, financial and legal concerns may complicate the counseling of patients who are weighing options in an already stressful situation. Ultimately, the risks of carrying multiple gestations and the surrogate mother’s autonomous rights to her body must be evaluated before coming to a definitive conclusion.

Another case that arose in 2017 speaks of a California-based surrogate mother who did not  “have sexual intercourse from the first day of her menstrual cycle before the embryo transfer until the date that pregnancy has been confirmed by the IVF Physician”  still went on to conceive a second child in a process of superfetation (NeJaime, 2017). In such rare cases, having the definite and autonomous right to one’s body through the different states helps streamline the custody battle and process. Allen should have had full right to conduct her life as planned despite entering a surrogacy contract. 

As a medical provider in situations such as this, our consideration of a patient’s autonomy, goal of beneficence toward that patient, and respect for the legally documented wishes of the parents are all in play.  The aim of informed consent is not so clear when a medical decision, traditionally made by one party, has been fractured into two.  The health of a patient can take primacy over contractual disagreements, however, efforts should be made to establish this consent with the patient as well as to communicate effectively all of the risks and benefits to both parties so that decisions can be made sensibly and amicably.  In instances of surrogacy, our ability to communicate clearly and consistently among multiple parties is crucial.

Rights of the Fetus

In all the debate about surrogate mothers and the intended parent’s rights, one important factor we seem to overlook is the rights of the fetus or resulting child. As someone who is unable to speak their mind at the time the contracts are drafted, the fetus is both vulnerable and dependent on the decisions of a proxy (Rafique and DeCherney, 2014). Under normal circumstances, that proxy would be the intended parents who have a vested emotional and psychological interest in the wellbeing of the child. However, multiple cases have arisen that put that proxy status in question and beg the need for a third-party proxy. This third-party proxy may be taken on by a physician so that the health and safety of the surrogate mother and fetus are prioritized.

As previously stated, abortion or pregnancy reduction procedures are often common in gestational surrogates where multiple implantations may overburden the parents. We know that in entering a surrogacy agreement, both parties want to produce a healthy and viable child. Then if the health of the child or the surrogate mother is not a contention, can abortion or reduction still be an ethical option? What if the intended parents change their minds halfway through the pregnancy and wish to abort?

Furthermore, in a normal pregnancy, the mother’s health is paramount, fetal health is, therefore, dependent on the mother who has a shared interest. In the case of gestational surrogacy, the surrogate has no gametal involvement or interest in the resulting child, creating a paradigm of two separate patients that the obstetrician must cater to (Horner and Burcher, 2021). A third proxy physician may step in to conclude that although the surrogate mother does not have genetic ties to the child, the health of her body ensures the survival of the child.

With multiparity fetuses normally detected between 11-14 weeks of gestation (Bora, et al 2008), the decision to abort or reduce comes after significant emotional involvement of both parties in the contract. At such a time, a third-party proxy or physician could be a valuable resource in addressing: the need for a fetal health advocate, a council for the surrogate, and guide the intended parent’s decision. 

Conclusion

Surrogacy is a delicate, yet complex topic that requires a significant amount of time to discuss and prepare for. Emotional, financial, medical, ethical and legal aspects contribute to the decision and continue to play a role throughout the journey and beyond. With so many moving parts, the need for standardized legal and medical guidance is important in ensuring a smooth transition and optimal care for all parties involved. A standardized system that can address the autonomy and nonmaleficence nature of care given to the surrogate, the justifiable right of all intended parents to surrogacy, and the dual role of beneficence in caring for both surrogate and fetus. It is because of this that we support a more physician-involved central guide to advocate for the ethical health rights of all parties involved in the surrogacy process.

References:

Bora SA, Papageorghiou AT, Bottomley C, Kirk E, Bourne T. (2008). Reliability of transvaginal ultrasonography at 7-9 weeks’ gestation in the determination of chorionicity and amnionicity in twin pregnancies. Ultrasound Obstet Gynecol. 32(5):618-21

F., S., Alvarez, N., & Trolice , M. (2019, October 18). Surrogacy in the USA – Is It Legal in All 50 States? https://babygest.com/en/united-states/#surrogacy-laws-by-state

​​Gonzalez, A. (2019, June 12). Commercial Surrogacy in the United States. law.georgetown.edu.

https://www.law.georgetown.edu/gender-journal/wp-content/uploads/sites/20/2019/11/Ali ia_Surrogacy-6.pdf.

Horner C, Burcher P. (2021) A surrogate’s secrets are(n’t) safe with me: patient confidentiality in the care of a gestational surrogate. Journal of Medical Ethics. 47:213-217

Judith Daar (2014). “Physician Duties in the Face of Deceitful Gamete Donors, Disobedient Surrogate Mothers, and Divorcing Parents.” AMA Journal of Ethics, vol. 16, no. 1, 2014, pp. 43–48.

Mello L. Everything You Need to Know About Surrogacy Agencies. Circle Surrogacy. https://www.circlesurrogacy.com/blog/circle-surrogacy/everything-to-know-surrogacy-agencies/. Published May 22, 2020. Accessed July 6, 2021.

NeJaime D. The Nature of Parenthood. 2017;126(8). https://www.yalelawjournal.org/article/the-nature-of-parenthood. Accessed July 5, 2021.

O’Reilly, K. (2016, February 18). When Parents and Surrogates Disagree on Abortion. The Atlantic. https://www.theatlantic.com/health/archive/2016/02/surrogacy-contract-melissa-cook/463323/

Radcliffe, S. (2019, April 55). Lawsuit Filed by Surrogate Mother Raises New Legal, Moral … healthline.com.https://www.healthline.com/health-news/lawsuit-filed-by-surrogate-mother-raises-new-legal-moral-issues-012016.

Rafique, S, and DeCherney, A.H. (2014) Physician Responsibility when a Surrogate Mother Breaks her Contract. AMA Journal of Ethics. Virtual Mentor. 16(1):10-16.

Tanderup, M., Reddy, S., Patel, T., & Nielsen, B. B. (2015). Reproductive Ethics in Commercial Surrogacy: Decision-Making in IVF Clinics in New Delhi, India. Journal of Bioethical Inquiry, 12(3), 491–501. https://doi.org/10.1007/s11673-015-9642-8

The Child-Parent Security Act: Gestational Surrogacy. New York State Department of Health. (2021, March). https://health.ny.gov/community/pregnancy/surrogacy/.

White PM. (2017) “One for Sorrow, Two for Joy?”: American embryo transfer guideline recommendations, practices, and outcomes for gestational surrogate patients. J Assist Reprod Genet. 34(4):431-443.

It’s been over a year since the first case of COVID-19 was confirmed in the United States. The virus spread rapidly, infected more than 1 million people in just three months after the first confirmed case ^[1]. Very few countries were spared from this pandemic. Ironically, the United States was ranked first on epidemic preparedness based on the GHS index but bears the most human toll from Coronavirus with over 600,000 deaths as of today ^[1,7]. Since the first awareness of the outbreak in Wuhan China, the U.S. lagged in public health response. As other countries took more aggressive measures on containing the spread during the initial phase of the pandemic, the U.S. underestimated the deadly impact of the virus and took a “wait-and-observe” approach. The delayed response exacerbated the situation, giving the virus ample time to circulate the country. If the U.S. had accurate diagnostic testing available on a mass-scale early on during the pandemic, the spread can be contained more efficiently and many lives can be saved.

One of the reasons that make Coronavirus hard to control is its incubation period. The incubation period ranges from 2-14 days ^[2], which is long enough that the infection rate wouldn’t spike until it’s too late. In addition, it is estimated that 30% of the infected population are asymptomatic ^[3], making the disease even less notifiable. Given this unique nature of SARS-CoV-2, epidemiologic surveillance cannot solely depend on reports of symptomatic cases. A mass scale of diagnostic testing needs to be available to carry out the epidemiologic investigation within the U.S. In a public health crisis like the COVID-19 pandemic, epidemiologic surveillance is extremely important especially during the early stages, when the virus has not yet penetrated the country. Prompt reporting of newly confirmed cases allows public health officials to get ahead of the coronavirus by identifying hotspots and taking control measures before it turns into a full-blown outbreak.

South Korea and the U.S. had their first confirmed case on the same day, January 21, 2020. Compared to the U.S., South Korea was much more successful at controlling the spread, which largely contributed to their rapid early response. After 4 confirmed cases, South Korea started to inform private companies to develop testing kits on January 27th.  The first test was approved one week later and started to roll out immediately ^[4]. With a high testing capacity, South Korea was able to quickly identify the ones who were infected and take follow-up actions such as contact tracing and mandatory quarantine to minimize the spread. The early response to the initial cases and prompt development of testing kits effectively prevented the wider spread of transmission.

When South Korea was testing more than 10,000 people each day in February, the US had just started to develop its testing kits. After recalling the initial flawed batches, more reliable testing kits were distributed in late February ^[5]. At that point, the virus had already been spreading unimpededly for over a month since the first confirmed case. Moreover, the supply didn’t meet the demand. With a limited amount of kits, people had to meet certain criteria to be tested. When the testing capacity finally ramped up, the widespread transmission had already occurred; contact tracing became extremely difficult and containment was no longer an option. Symptomatic patients had already overburdened the hospitals while asymptomatic carriers continued to spread the virus unintentionally. According to research from National Center for Disaster Preparedness, if the U.S. response had mirrored that of South Korea’s, the U.S. might have avoided 215,000 deaths. Without timely development of diagnostic testing, the U.S. failed to recognize the actual extent of the infection, and miss the best window to confine the disease ^[6].

Shortly after the wide deployment of diagnostic testing, states started to implement many useful policies including lockdown orders, quarantine, mask mandates, social distancing, and hand hygiene. The impact of these mitigation strategies can be easily appreciated by the flattening of the curve. However, it is important to realize that these interventions came after the rolled out of testing kits. As testing revealed more positive cases, the public started to realize the aggressiveness of SARS-CoV-2. With a collective effort, Americans followed these non-pharmaceutical interventions and we finally saw a slow down in transmission. Had we had the capability to conduct more testing during the initial phase of the pandemic, we could have implemented these non-pharmaceutical interventions sooner. A study examined the effects of intervention timing during COVID-19 and concluded that a longer response time leads to a stronger rebound of infection and death. If these same interventions had been implemented 1-2 weeks earlier, “a substantial number of cases and death could have been averted”^[8].

At the beginning of the pandemic, very little was known about this novel virus. When there is no treatment available to respond to the pandemic, public health measures become the most essential tool to keep people safe. Unlike therapeutic medicine, the public health approach focuses on prevention rather than treatments. Preferably, recognition and containment of an epidemic would occur before the death rate starts to rise. This requires the government to act fast during the initial period. One of the most important measures that should have been taken was wide diagnostic testing to unmask the actual number of infected. From there, a more targeted intervention such as contact tracing and quarantine can be implemented to monitor the infected while keeping the uninfected people healthy. Sadly, the U.S. fell behind to respond during the crucial phase. The U.S. only accounts for 4% of the world’s total population but constitutes 15% of the total death toll relative to COVID-19 ^[1]. After a wide adoption and stricter enforcement on non-pharmaceutical interventions, we finally curtail the infection rate. However, these measures are not designed for damage control; they should take place early on during the pandemic to have maximum impact. If the U.S. had engaged in testing efforts from the very beginning, it would consequentially lead to better disease identification and containment.

Reference:

1. “United States COVID: 34,677,662 Cases and 622,225 Deaths – Worldometer.” Worldmeters, 2021, www.worldometers.info/coronavirus/country/us.

2. “Healthcare Workers.” Centers for Disease Control and Prevention, 11 Feb. 2020, www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html.

3. “Pandemic Planning Scenarios” Centers for Disease Control and Prevention, 11 Feb. 2020, www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html.

4. Berger, Matt. “How South Korea Successfully Battled COVID-19 While the U.S. Didn’t.” Healthline, 30 Mar. 2020, www.healthline.com/health-news/what-south-korea-has-done-correctly-in-battling-covid-19#Late-January:-Tests-come-online.

5. Myers, Philip Wallach, And Justus. “The Federal Government’s Coronavirus Actions and Failures.” Brookings, 1 Apr. 2020, www.brookings.edu/research/the-federal-governments-coronavirus-actions-and-failures-timeline-and-themes.

6. Redlener, Irwin. “130,000-210,000 Avoidable COVID-19 Deaths and Counting – in the U.S..” ncdp.columbia.edu, October 2021. https://ncdp.columbia.edu/custom-content/uploads/2020/10/Avoidable-COVID-19-Deaths-US-NCDP.pdf

7. “The Global Health Security Index Is Not Predictive of Coronavirus Pandemic Responses among Organization for Economic Cooperation and Development Countries.” PubMed Central (PMC), 2020, www.ncbi.nlm.nih.gov/pmc/articles/PMC7540886.

8.  Pei, Sen. “Differential Effects of Intervention Timing on COVID-19 Spread in the United States.” PubMed, 20 May 2020, pubmed.ncbi.nlm.nih.gov/32511526.