Screening for Prostate Cancer

Introduction

Prostate cancer is cancer of the prostate gland, part of the male reproductive system. It is the second most common type of cancer in men worldwide.

In 2012, the United States Preventive Services Task Force published guidelines recommending against screening for prostate cancer [1]. These recommendations were in contraindication to earlier guidelines, and generated a significant debate both in the medical and non-medical community. [2][3]

Incidence and Risk Factors

The lifetime risk of prostate cancer diagnosis is 16% and the lifetime risk of death is 2.8%. Prostate cancer is rare before age 50, and few men die before age 60 [1]. Prostate cancer is more common in African-Americans and Hispanics. Furthermore, the age of onset in African-Americans is earlier, and the cancer is more aggressive.

There is a twofold increased of prostate cancer in patients that have at least one first degree relative with prostate cancer. This risk increases with a greater number of family members. Genetics also plays a role in development of prostate cancer. Patients with BRCA1/BRCA2 and Lynch syndrome have higher risk of prostate cancer. Smokers have a higher risk of prostate cancer.

Cost to US health care systems

In the USA, the total estimated expenditure on prostate cancer was 9.862 billion US dollars in 2006. The mean annual costs per patient in the USA were [4]:

  • $10,612 in the initial phase after diagnosis
  • $2134 for continuing care
  • $33,691 in the last year of life

Diagnosis and Early Detection of Prostate Cancer

Eighty percent of men diagnosed with prostate cancer undergo a biopsy because of a suspicious serum prostate specific antigen (PSA). Twenty percent of men have a prostate nodule detected during a digital rectal examination that prompts a biopsy.

Prostate Specific Antigen Test

PSA is a protein made by normal prostate cells. The detection of this protein, therefore, is not specific to prostate cancer. PSA may be elevated in any condition that leads to increased number of prostate cells (e.g. benign prostate hyperplasia), or any condition that leads to leakage of this protein from prostate cells (e.g., infections, trauma and even normal ejaculation).

The cutoff value for PSA used in screening for prostate cancer is 4.0ng/ml. This cutoff translates into [5]:

  • Sensitivity = 21%
  • Specificity = 91%
  • Positive Predictive Value (PPV) = 30%
  • Negative Predictive Value (NPV) = 85%

This test has poor discriminating ability between prostate cancer and benign prostate hyperplasia (BPH), [6] and PSA value may be elevated 5 to 10 years, or even earlier, before the cancer causes any symptoms. [7] Several attempts to improve the PSA test, such as by measuring PSA Velocity [8] or PSA Density [9], have not been found to be superior to standard PSA test.

In summary, the PSA test has a high false positive rate, and a negative test does not rule out the possibility of having prostate cancer.

Or, in other words [10]:

23 men need to be diagnosed with prostate cancer
18 men need to be treated for prostate cancer
To prevent one death

Consequences of PSA elevation

Most patients with elevated PSA will undergo a trans-rectal needle biopsy of the prostate gland. This biopsy is not a perfect gold standard and has a false negative rate of about 10–20%. Furthermore, prostate biopsy is not a benign procedure and may have many side effects, including [11]:

  1. Bleeding
  2. Infections that may lead to sepsis (and death)
  3. Urinary retention
  4. Anxiety

If the prostate biopsy is positive, then depending on a number of factors (histological grade of cancer, co-morbidities, metastases etc), men typically undergo surgery (most often radical prostatectomy), radiation therapy, or both. A subset of men may be monitored closely without any treatment.

Radical Prostatectomy has many of side effects, including [12]:

  • Urinary incontinence in 15% to 50%
  • Sexual dysfunction in 20% to 70%
  • Bowel problems
  • Operative mortality of 0.1% to 0.5%, which increases with age, especially for people over 75 years of age

Complications of radiation therapy include [12]:

  • Erectile dysfunction in 25% to 45%
  • Urinary incontinence in 2% to 16%
  • Bowel dysfunction in 6% to 25%

The Benefit to Risk ratio can be summarized by calculating the Number need to treat, and Number Needed to Harm [13]:

Number Needed to Treat to benefit = 0
Number Needed to Harm = 1 out of 5 patients who are screened

Prostate Cancer Screening Guidelines

Screening for Prostate Cancer: U. S. Preventive Services Task Force (USPSTF) Recommendation Statement

The USPSTF recommends against PSA based screening for prostate cancer. For high-risk populations, there is not enough data to recommend screening. [1]

The reduction in prostate cancer mortality after screening is very small, and the benefits do not outweigh the harms. The harms of screening include pain, fever, bleeding, infection, transient urinary difficulties associated with prostate biopsy, psychological harm of false positive results, and over-diagnosis.

American Cancer Society (ACS) for Early Detection of Prostate Cancer

The ACS recommends that asymptomatic men with at least a 10-year life expectancy have an opportunity to make an informed decision with their healthcare provider about screening for prostate cancer, after they receive information about the uncertainties, risks, and potential benefits associated with prostate cancer screening. [14]

The ACS observes that a good screening test does not exist, but still continues to recommend the PSA test with a cutoff value of 4.0 ng/ml for screening.

Early Detection of Prostate Cancer: American Urological Association (AUA) Guideline

The AUA’s major recommendations are age based. The do not recommend screening in patients less than 40 years of age, men of average risk less than 50 years of age, and men greater than 70 years of age. For men between 55–69, the AUA recommends shared decision-making. [15]

Screening for Prostate Cancer: A Guidance Statement from the Clinical Guidelines Committee of the American College of Physicians (ACP)

The ACP recommends that providers inform men age 50–69 years about the limited potential benefits and substantial harms of screening. They recommend that clinicians base the decision to screen for prostate cancer using PSA test based on patients risk of prostate cancer, life expectancy and preferences. [16]

Conclusion

Given the current research, all medical societies acknowledge that there is minimal benefit in screening the general population for prostate cancer, and there is a greater potential for harm.

All medical societies, except USPSTF, endorse shared decision making in people with high risk of prostate cancer, such as people with positive family history, African-Americans, genetic predisposition and other risk factors. The USPSTF guidelines discourage use of PSA test in all patients, and recommend discussion and shared decision-making only when the patients bring up the topic.


  1. Moyer, V. A. (2012). Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med, 157(2), 120–134.  ↩

  2. Gomella, L. G., Liu, X. S., Trabulsi, E. J., Kelly, W. K., Myers, R., Showalter, T. et al. (2011). Screening for prostate cancer: the current evidence and guidelines controversy. Can J Urol, 18(5), 5875–5883.  ↩

  3. Kaffenberger, S. D., & Penson, D. F. (2014). The politics of prostate cancer screening. Urol Clin North Am, 41(2), 249–255.  ↩

  4. Roehrborn, C. G., & Black, L. K. (2011). The economic burden of prostate cancer. BJU Int, 108(6), 806–813.  ↩

  5. Wolf, A. M., Wender, R. C., Etzioni, R. B., Thompson, I. M., D’Amico, A. V., Volk, R. J. et al. (2010). American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin, 60(2), 70–98.  ↩

  6. Meigs, J. B., Barry, M. J., Oesterling, J. E., & Jacobsen, S. J. (1996). Interpreting results of prostate-specific antigen testing for early detection of prostate cancer. J Gen Intern Med, 11(9), 505–512.  ↩

  7. Draisma, G., Boer, R., Otto, S. J., van der Cruijsen, I. W., Damhuis, R. A., Schroder, F. H. et al. (2003). Lead times and overdetection due to prostate-specific antigen screening: estimates from the European Randomized Study of Screening for Prostate Cancer. J Natl Cancer Inst, 95(12), 868–878.  ↩

  8. Vickers, A. J., Savage, C., O’Brien, M. F., & Lilja, H. (2009). Systematic review of pretreatment prostate-specific antigen velocity and doubling time as predictors for prostate cancer. J Clin Oncol, 27(3), 398–403  ↩

  9. Catalona, W. J., Richie, J. P., deKernion, J. B., Ahmann, F. R., Ratliff, T. L., Dalkin, B. L. et al. (1994). Comparison of prostate specific antigen concentration versus prostate specific antigen density in the early detection of prostate cancer: receiver operating characteristic curves. J Urol, 152(6 Pt 1), 2031–2036.  ↩

  10. Welch, H. G., & Albertsen, P. C. (2009). Prostate cancer diagnosis and treatment after the introduction of prostate-specific antigen screening: 1986–2005. J Natl Cancer Inst, 101(19), 1325–1329.  ↩

  11. Stroumbakis, N., Cookson, M. S., Reuter, V. E., & Fair, W. R. (1997). Clinical significance of repeat sextant biopsies in prostate cancer patients. Urology, 49(3A Suppl), 113–118.  ↩

  12. UpToDate - Prostate Cancer Screening  ↩

  13. TheNNT.com, Prostate Specific Antigen (PSA) Test to Screen for Prostate Cancer  ↩

  14. Brooks, D. D., Wolf, A., Smith, R. A., Dash, C., & Guessous, I. (2010). American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 2010. J Natl Med Assoc, 102(5), 423–429.  ↩

  15. Carter, H. B., Albertsen, P. C., Barry, M. J., Etzioni, R., Freedland, S. J., Greene, K. L. et al. (2013). Early detection of prostate cancer: AUA Guideline. J Urol, 190(2), 419–426.  ↩

  16. Qaseem, A., Barry, M. J., Denberg, T. D., Owens, D. K., & Shekelle, P. (2013). Screening for prostate cancer: a guidance statement from the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med, 158(10), 761–769.  ↩

Communication in healthcare

Communication between healthcare providers can be divided into synchronous and asynchronous.

Synchronous Communication

Synchronous communication occurs when different parties interact in real time. The most common methods of synchronous communication (in a hospital setting) includes:

  1. Face to face communication
  2. Active telephone call
  3. Tele-health

The first two modalities already exist, and tele-conferencing is now starting to gain "market share." 

Synchronous communication is very useful in critical care areas such as ICU, emergency department and operating rooms. Tele-conferencing is starting to gain a foothold in some of these areas to to expand coverage, or when providers are not available on site (e.g., Tele-neurology to cover ED, Tele-ICU to cover ICU at night).

Asynchronous Communication

This communication method occurs when the different parties do not communicate concurrently. Several types of asynchronous communication tools already exist in healthcare today:

  1. Pagers
  2. Voicemail functionality in cell phones
  3. Text messages (especially HIPAA compliant text message apps on smartphones such as TigerText)
  4. Email
  5. Messages sent within EHR's

Traditional asynchronous communication has multiple failure points as it is not a closed loop communication system. A nurse sending a text page to a physician has no way of knowing if the physician received the message, and if the message has been read. This may potentially lead to delay in patient care and is a safety risk.

HIPAA compliant apps on smartphones help create a closed loop system by logging sent/delivered/read status, which is viewable to the sender. Other ways to improve the asynchronous messaging system include:

  • Escalation of the message to another responsible person, if the message is not delivered within a pre-defined span of time (e.g., message gets escalated to cross covering physician or an administrator)
  • Link on-call provider schedule to web/mobile front-end messaging system (e.g., paging system website), so that messages are automatically redirected to on call coverage
  • Ability to initiate messages directly from the EHR, which should also be linked to the on-call schedule

Therefore, we already have a number of communication tools at our disposal, and our arsenal is getting bigger. The challenge will be to implement these tools so that they are smarter and better integrated with healthcare delivery workflows.

Clinical Trials using EHR Databases

Randomized Controlled Trials (RCT’s) are considered the gold standard for clinical trials, esp., when the effect of an intervention on a disease process is being measured. RCT’s allow the investigator to control for confounding factors, which can create a bias in observational studies. This aspect is crucial for a new intervention to be approved.

Observational studies, on the other hand, are generally retrospective, and prone to biases. These biases originate as the investigator may not have access to all the data, and/or cannot control for a particular variable in historical data. Furthermore, initial observational studies were not conducted well and did not control for confounding factors. As knowledge of the limitations of observational studies have become more apparent in recent years, researchers have looked for ways to eliminate these limitations. Newer observational studies are much better at controlling confounding variables. A recent article published in the Cochrane Methodology Review Group1 concluded that there was little difference between RCT’s and observational studies. Furthermore, there is now an international coalition of researchers that have released guidelines on conducting observational studies2.

Electronic medical databases allow researchers to conduct observational studies using the data captured at the point of care. When compared to RCT’s, there may be a discrepancy in data collection in the medical record because, 1) Busy clinicians may not enter accurate or complete data in the record, 2) Patients may be non-compliant and may not follow through with the intervention (e.g. Not take prescribed drugs). Well done RCT’s are generally not prone to these issues.

On the other hand, EHR’s capture more real world scenarios. The patient population in these databases may have different demographics, more co-morbid conditions, and may be on many other drugs. Using data gleaned from EHR’s, therefore, allows observational studies to better estimate the effect of an intervention in the real world.

Due to reasons mentioned above, it is very unlikely that observational studies conducted using data from EHR databases will substitute RCT’s. The controlled environment in which an RCT is conducted is crucial for approval of interventions (i.e. Drugs and devices). However, observational studies using data gleaned from EHR’s will be very useful to understand the real life impact of these interventions.

References:

  1. Anglemyer, A., Horvath, H. T., & Bero, L. (2014). Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev, 4, MR000034. doi:10.1002/14651858.MR000034.pub2
  2. The PLOS Medicine Editors. (2014). Observational Studies: Getting Clear about Transparency. PLoS Med, 11(8), e1001711. doi:10.1371/journal.pmed.1001711

The Effect of Patient Portals on Healthcare Utilization

(I wrote this article on Patient Portals for my Masters in Health Informatics Program, and am posting here as others may find it useful.)

Introduction

The passage of Health Information Technology for Economic and Clinical Health (HITECH) Act as part of American Recovery and Reinvestment Act (ARRA) has led to a dramatic increase in the usage of Electronic Health Records (EHR’s). “Meaningful Use” guidelines proposed as part of the HITECH Act require providers to adopt EHR’s with features that will improve quality of healthcare delivered and reduce costs at the same time. Meaningful Use Stage 2 requires Eligible Hospitals and Eligible Providers to implement a Patient Portal, and to release pertinent information to this portal.

Since the passage of the HITECH Act, adoption the usage of EHR’s has been growing steadily.[1] Many hospitals have already implemented Patient Portals, as part of their EHR strategy.

Personal Health Records and the Patient Portal

Traditionally patients would seek out healthcare information either from healthcare professionals or their friends and family.[2] Increasingly, patients are receiving information about their healthcare from the Internet. Much of this information obtained from the Internet may be incorrect or misleading. Patient Portals allow hospitals and healthcare providers to provide high quality information personalized to their patients.

The Markle foundation in 2003 defined the Personal Health Record as “An electronic application through which individuals can access, manage and share their health information, and that of others for whom they are authorized, in a private, secure, and confidential environment.” [3]

The definitions of Personal Health Record and Patient Portal, however, are broad and evolving. The author defines a Personal Health Record as a “repository of an individual’s health information controlled by the individual or by a designated proxy”. The Patient Portal is defined as “a Personal Health Record that is part of their providers Electronic Health Record”. The terminologies Personal Health Record and Patient Portal are commonly applied to online web based repositories due to their evolution on the web platform, but these repositories may also be offline, stored on personal devices such as computers, smartphones and even paper. The definitions proposed by the author remove constraints from earlier definitions that define the purpose and use of these repositories, thereby allowing the proposed definitions to incorporate new use cases and technological developments.

The National Learning Consortium (NLC), a body of the Office of the National Coordinator (ONC) believes that Patient Portals will improve healthcare by: 1) Improved patient activation, 2) More efficient and effective communication, 3) Better and more timely self care among patients, 4) Ability to focus better on high priority patients, and 5) Improved patient satisfaction.[4]

Assuming that Patient Portals do have the ability to affect all the intended changes, we still do not know if these changes will increase, decrease or have no effect on healthcare utilization. To understand these effects, we need to understand the capabilities and functionality of Patient Portals, and how they are being used.

Capabilities and Functionality Offered by Patient Portals

Patient facing information and services can be grouped into categories; 1) information and transactions, 2) expert care, and 3) self care and community.[2]

Information and Transaction

This category is represents the low hanging fruit and provides basic functionality that is already established in other industries. Examples of such functionality include managing appointments with caregivers, medication refill requests, managing financial information and co-pays, and requesting health information.

Expert Care

This category includes services that allow patients to connect with their healthcare provider using online technology, such as secure messaging/email and video conferencing. Secure messaging and video conferencing have been slow to start and have been hampered by the fact that either they are non-reimbursable services, or the reimbursement is lower that office visits. Many states have now started reimbursing providers under the fee for service model.

Some institutions have attempted to utilize Internet and Patient Portals for targeted interventions such as medication[5] and disease management for common diseases such as diabetes[6] and mental health.[7]

Self-care and Community

This category of services is very different from traditional medicine. Traditional methods of delivering care are provider initiated, whereas this category of care is patient initiated.

Healthcare systems offer a few basic services via the patient portal in this category, such as health library allowing patients to find relevant health information, and “just in time” information (e.g. linking a medication in the patients medication list to information about that drug).

However, this category is very rapidly advancing outside the traditional walls of healthcare. A number of health parameters monitoring devices have been released in the market in the last few years and are being used by consumers. These devices can measure activity levels, calories intake and burnt, sleep hygiene, oxygen saturation, heart rate, respiration and other health parameters. EHR vendors are starting to incorporate data from these devices by allowing patients to upload it to the EHR via the patient portal. With the advent of smart phones with always on internet capability, these monitoring devices have the potential to always be connected to the providers EHR, enabling providers with access to real-time (or near real time) information on patients health indices.

Online health oriented social networks like “Patients Like Me” allow patients to share their health and treatment experiences with others. These social health portals allow patients to compare treatments, and bring this information back to their providers. Patient Portals have yet to capitalize on this opportunity.

Utilization of Patient Portals

Use of Patient Portals is still increasing in the United States. Patients who use the Internet Portals are generally younger, more affluent, lived in urban areas, and were more educated and healthier than the average patient.[8][9] The most commonly used functionality included, requesting medication refills, viewing laboratory results, sharing information with other healthcare providers.[10]

Kaiser Permanante, U.S. Department of Veteran Affairs (VA) and Geisenger Health System were some of the early health networks to implement a patient portal. KP HealthConnect Online, Kaiser Permanante’s Portal was implemented in 2002 for its members in the Northwest region. Kaiser reported a 6% registration rate by 2005 and 25% by 2009. The tripling of registrants was attributed to improved functionality. MyHealtheVet had over 976,000 registered members as of March 2010.[11]

Patient Portals offering secure messaging functionality with their providers saw a decrease in the number of telephone calls and increase in patient satisfaction,[2][12] but may lead to an increase in the total number of patient contacts (i.e. office visits, telephone calls, emails). [13] This decrease in call volume may lead to increased provider productivity and allow staff members to take care of patients with more urgent needs. [14][15]

As mentioned earlier, Internet based portals are increasingly being utilized to target disease intervention programs such as diabetes and mental health. These programs have had mostly encouraging results, especially when these portals are used in conjunction with case managers or patient care coordinators. Such programs will become more popular due to the changing healthcare landscape, with the formation of Accountable Care Organizations (ACO’s) and attention of population management. These programs generally target gaps in care and screening for diseases. Both these activities, by their very nature, increase health care utilization in the short term, but have the potential to decrease utilization in the future, as patients remain healthier.

Some vendors such as Epic Systems Corporation have started offering video conferencing and virtual visit capability in their patient portal. The quantified-self movement is gaining traction and people are using multiple devices to track their health parameters as mentioned earlier. Some vendors such as Epic Systems allow patients to upload data collected by these devices to the EHR. However, this technology is very new and does not follow any standards or protocols for collecting and communicating data. Apple Inc. recently announced HealthKit for their iOS platform, [16] which aims to bring the data captured by these various devices under one umbrella, and effortlessly share it with their provider. [17] This avalanche of data being captured by patients and shared with providers will need to be interpreted and acted upon, thereby increasing utilization of resources in the near term.

Conclusion

The use and functionality of Patient Portals is still evolving. These portals have the potential to decrease healthcare utilization for traditionally reimbursable services rendered by providers. However, as these portals gain more features, especially features that enable patient to initiated care, healthcare utilization will increase. However, this utilization will require different types of healthcare resources, such as patient care coordinators, case managers, educators etc., and most of these services are non-reimbursable under the current fee for service system.


  1. Hsiao, C.-J., & Hing, E. (2012). Use and Characteristics of Electronic Health Record Systems Among Office-based Physician Practices, United States, 2001–2012. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics.  ↩

  2. Ahern, D. K., Woods, S. S., Lightowler, M. C., Finley, S. W., & Houston, T. K. (2011). Promise of and potential for patient-facing technologies to enable meaningful use. Am J Prev Med, 40(5 Suppl 2), S162-S172. doi:10.1016/j.amepre.2011.01.005  ↩

  3. Tang, P. C., Ash, J. S., Bates, D. W., Overhage, J. M., & Sands, D. Z. (2006). Personal health records: definitions, benefits, and strategies for overcoming barriers to adoption. Journal of the American Medical Informatics Association, 13(2), 121–126.  ↩

  4. HealthIT.gov. (2013). How to Optimize Patient Portals for Patient Engagement and Meet Meaningful Use Requirements.  ↩

  5. Osborn, C. Y., Mayberry, L. S., Wallston, K. A., Johnson, K. B., & Elasy, T. A. (2013). Understanding patient portal use: implications for medication management. J Med Internet Res, 15(7), e133. doi:10.2196/jmir.2589  ↩

  6. Osborn, C. Y., Mayberry, L. S., Mulvaney, S. A., & Hess, R. (2010). Patient web portals to improve diabetes outcomes: a systematic review. Curr Diab Rep, 10(6), 422–435. doi:10.1007/s11892–010–0151–1  ↩

  7. Druss, B. G., Ji, X., Glick, G., & von Esenwein, S. A. (2014). Randomized trial of an electronic personal health record for patients with serious mental illnesses. Am J Psychiatry, 171(3), 360–368. doi:10.1176/appi.ajp.2013.13070913  ↩

  8. McInnes, D. K., Gifford, A. L., Kazis, L. E., & Wagner, T. H. (2010). Disparities in health-related internet use by US veterans: results from a national survey. Inform Prim Care, 18(1), 59–68.  ↩

  9. Weingart, S. N., Rind, D., Tofias, Z., & Sands, D. Z. (2006). Who uses the patient internet portal? The PatientSite experience. J Am Med Inform Assoc, 13(1), 91–95. doi:10.1197/jamia.M1833  ↩

  10. Turvey, C., Klein, D., Fix, G., Hogan, T. P., Woods, S., Simon, S. R., … Nazi, K. (2014). Blue Button use by patients to access and share health record information using the Department of Veterans Affairs’ online patient portal. J Am Med Inform Assoc. doi:10.1136/amiajnl–2014–002723  ↩

  11. Emont, S. (2011). Measuring the impact of patient portals.  ↩

  12. Goldzweig, C. L., Orshansky, G., Paige, N. M., Towfigh, A. A., Haggstrom, D. A., Miake-Lye, I., … Shekelle, P. G. (2013). Electronic patient portals: evidence on health outcomes, satisfaction, efficiency, and attitudes: a systematic review. Ann Intern Med, 159(10), 677–687. doi:10.7326/0003–4819–159–10–201311190–00006  ↩

  13. Chen, C., Garrido, T., Chock, D., Okawa, G., & Liang, L. (2009). The Kaiser Permanente Electronic Health Record: transforming and streamlining modalities of care. Health Affairs, 28(2), 323–333.  ↩

  14. Stone, J. H. (2007). Communication between physicians and patients in the era of E-medicine. N Engl J Med, 356(24), 2451–2454. doi:10.1056/NEJMp068198  ↩

  15. Liederman, E. M., Lee, J. C., Baquero, V. H., & Seites, P. G. (2005). Patient-physician web messaging. The impact on message volume and satisfaction. J Gen Intern Med, 20(1), 52–57. doi:10.1111/j.1525–1497.2005.40009.x  ↩

  16. Apple. HealthKit  ↩

  17. Munro, D. (2014). Apple Gives Epic And Mayo Bear Hug With HealthKit. Forbes.  ↩