The Journal of Family Practice

ABSTRACT

Purpose This study sought to identify the needs and unmet needs of the growing number of adult cancer survivors.


Methods Vermont survivor advocates partnered with academic researchers to create a survivor registry and conduct a cross-sectional survey of cancer-related needs and unmet needs of adult survivors. The mailed survey addressed 53 specific needs in 5 domains based on prior research, contributions from the research partners, and pilot testing. Results were summarized by computing proportions who reported having needs met or unmet.

Results Survey participants included 1668 of 2005 individuals invited from the survivor registry (83%); 65.7% were ages 60 or older and 61.9% were women. These participants had received their diagnosis 2 to 16 years earlier; 77.5% had been diagnosed ≥5 years previously; 30.2% had at least one unmet need in the emotional, social, and spiritual (e) domain; just 14.4% had at least one unmet need in the economic and legal domain. The most commonly identified individual unmet needs were in the e and the information (i) domains and included “help reducing stress” (14.8% of all respondents) and “information about possible after effects of treatment” (14.4%).

Conclusions Most needs of these longer-term survivors were met, but substantial proportions of survivors identified unmet needs. Unmet needs such as information about late and long-term adverse effects of treatment could be met within clinical care with a cancer survivor care plan, but some survivors may require referral to services focused on stress and coping.

Following a successful course of treatment for cancer, many patients return to or remain in the care of their primary care physician (PCP). What often goes unrecognized, however, are these cancer survivors’ unique needs—physical, psychological, social, spiritual, economic, and legal—and the informational and professional services available to address them.^1,2

Increased cancer survival creates new needs. There are already >12 million cancer survivors in the United States and >30 million worldwide.³ As baby boomers age, the number of cancers diagnosed over the next 45 years will double⁴ and improved diagnosis and treatments are already prolonging survivors’ lives. With the greater number of cancer survivors and longer survival time, a cancer survivorship advocacy community has developed to help identify and address the concerns, needs, and benefits of having lived with, through, and beyond a cancer diagnosis.

The purpose of our study. Some of these areas of need have been studied extensively with childhood survivors, breast cancer survivors, and, more recently, prostate cancer survivors. However, few studies have examined adult survivors from all cancer types^5-9 or have had cohorts large enough to yield meaningful information.^5,7-9 The aim of this study was to describe the needs of adult survivors of all cancer types in a general population from Vermont and to determine whether these needs were met. The results of this study can help identify the services needed by cancer survivors.

METHODS

Population and sample

After effects
 of treatment, a big concern for most patients, 
is important to address not only at the outset 
of treatment but also at its conclusion
 and with documentation in a survivor care plan. In November 2009, we invited all survivors listed in a cancer survivor registry to complete a 12-page survey. The registry¹⁰ was created as part of the Cancer Survivor Community Study, a community-based participatory research project funded by the National Cancer Institute. The study’s Steering Committee was comprised of cancer survivors, cancer registrars, and researchers. We identified and invited cancer survivors from 4 hospital registries in northwest and central Vermont to participate. Registry participants who indicated willingness to enroll in research studies received an invitation letter and informed consent form, the 12-page survey, and an addressed and stamped return envelope. We obtained Institutional Review Board (IRB) approval for these procedures at the University of Vermont and at local hospital IRBs.

Instrument development

A working group from the Steering Committee reviewed a range of available instruments to assess cancer survivors’ needs.^9,11-15 We determined that the survey most relevant to our objectives was the Cancer Survivors’ Unmet Needs (CaSun) instrument.¹³ Because CaSun was developed in Australia, we carefully examined each question for appropriateness to our target audience. We eliminated several questions that we thought less important, added questions from other instruments, and simplified the survey format. Survivors from the Steering Committee pilot tested the draft questionnaire to identify awkward wording or concepts.

We piloted the revised draft using a standardized feedback form with cancer survivors who were not connected to our project and not enrolled in the survivor registry, and with residents at a senior center. Students and a teacher from an Adult Basic Education program helped to ensure easy readability. Our final instrument had 53 questions about needs in 5 domains. Questions within each domain completed the lead-in, “Since your cancer diagnosis, did you need....” We asked participants to check only 1 of the 3 boxes to the right of each question to indicate that there was no need in that area, that there was a need and it was met, or that there was a need and it was not met. We obtained self-reported demographic data during enrollment in the registry.

Data analysis

We summarized data by computing the percent of survivors who reported having each need (either met or unmet) and the percent for whom the need was unmet. The latter was computed both as a percent of all survivors and as a percent of those who had the need. We also calculated the percentage of survivors that had at least one need and at least one unmet need in each domain, as well as the average number of needs per survivor in each domain. We used SPSS for Unix, Release 6.1 (AIX 3.2)(IBM, Armonk, New York).

RESULTS

Of the 2005 cancer survivors invited into the study, 1668 responded, yielding a participation rate of 83%. TABLE 1 describes the self-reported demographic and cancer characteristics of participants in this study. Most respondents were female, ≥60 years old, urban dwellers, married or with a partner, well educated, and had household incomes of ≥$50,000. There were more breast cancer survivors than survivors of other cancers, and 14.6% of all survivors reported being diagnosed with more than one cancer. Cancer was diagnosed at stages 1 or 2 for 78.3% of the participants; 61.9% reported having undergone ≥2 treatment regimens.

The survey addressed needs in 5 domains: access to care and services (A); information (I); emotional, social, and spiritual (E); physical (P); and economic and legal (L). More than 80% of respondents reported having at least one need in the A, I, and E domains. The E domain had the most survivors with at least one unmet need (N=503), followed by the I (N=410) and P (N=375) domains.

Identifying unmet needs. TABLE 2 shows results for the specific questions within the domains in the order they were asked. Most participants who had a need also had it met. However, some needs that were not commonly reported were deemed unmet by a large proportion of those who expressed the need. For example, the A need for “A case manager to whom you could go to find out about services whenever they were needed” (A5) was reported by only 29.1% of survivors. But 32.1% of those reporting the need said it was unmet, which corresponds to 9.4% of all study participants having the need unmet. Similarly, the need for “More information about complementary and alternative medicine” (I3) was reported by about a quarter of the study population, 41.4% of whom (9.8% of all participants) reported it as unmet. In the P domain, the need for “Help to address problems with your sex life” (P4) was reported by only 26.5% of the respondents; yet 40.7% of those reporting the need had it unmet. Similarly, in the L domain, “Help with life insurance concerns as a result of your cancer” (L3) was only reported by 10.9% of the participants but was unmet for 46.4% of those who reported the need, or 5% of all study participants.

Most commonly expressed needs. TABLE 2 also identifies 12 needs reported by ≥50% of participants. Three of these needs were in the A domain, 6 in the I domain, and 3 in the E domain. The 2 most common needs related to A: the need “To feel like you were managing your health together with the medical team” (A3) was reported by 68.6% and was viewed as unmet by 5.2% of all respondents; the need for “Access to screening for recurrence or other cancers” (A7) was reported by 63.8% of the survivors but was deemed unmet by only 3.1% of all the respondents. “More information about possible after effects of your treatment” (I5) was a need for 63.2% that went unmet in 22.9% (14.4% of all participants). “Help managing your concerns about the cancer coming back” (E13) was reported as a need by 54.1% and as unmet by 11.8% of all participants.

The rank order of 7 unmet needs reported by ≥10% of the participants is shown in TABLE 3. Four of the 7 unmet needs were in the E domain. The most common unmet need in this domain was “Help reducing stress in your life” (E19).

Only 3 needs were both commonly reported and also unmet for at least 10% of the participants: “More information about possible after effects of your treatment” (I5), “More information about possible side effects of your treatment” (I4), and “Help managing your concerns about the cancer coming back” (E13).

DISCUSSION

Concern about cancer recurrence is 
a prominent patient need that might be addressed most adequately in the course of usual primary care. The survey instrument we used to assess the needs of cancer survivors in a large community-based registry included a detailed list of potential needs generated, in part, by representatives of the survivor community. Most cancer survivor needs mentioned in this survey were met. However, some needs were not met for substantial proportions of respondents and should be examined carefully to determine whether services could be improved to better address them. This study was planned and implemented by researchers and cancer survivors using community-based participatory principles to learn about local needs. The results of this study may be generalizable to similar populations of survivors and will inform the survivorship goals for the Vermont State Cancer Plan and future Vermont Cancer Survivor Network activities.

Acting on patients’ expressed needs. Over 80% of participants had needs in the A, I, and E domains. The most commonly reported need was in the A domain, “To feel like you were managing your health together with the medical team” (A3). It was also a top need in other studies that asked this question.^16,17 A cancer diagnosis may cause patients to feel out of control. Participation in the management of their health may help them gain a greater sense of control. PCP accommodation of expressed patient preferences may be an important part of a cancer survivor’s long-term adaptation to the disease.

Six of the 12 most frequently reported needs and 2 frequently reported unmet needs were in the I domain. Communication of information increases patients’ involvement in decision-making and enables them to cope better during diagnosis, treatment, and follow-up.¹⁸ “More information about possible after effects of your treatment” and “More information about possible side effects of your treatment” were reported by a high proportion of participants, and many also reported these needs as unmet. In another study about health-related information needs of survivors, 52% wanted more information about “What late and long-term side effects of cancer treatment are expected”¹⁹; and in a 2005 review of information needs, 12% of survivors reported similar needs.²⁰ Two recent articles also noted such needs in adolescent and young adult cancer survivors.^21,22 Based on current evidence, it would be advisable to discuss anticipated effects of treatment with patients not only at the outset but also at the end of treatment, and to write it in a cancer survivor care plan.

Individual needs that were not met for at least 10% of respondents, regardless of how common the need (TABLE 3), provided additional insights. Among these 7 needs, 3 also were reported as a need by more than 50% of respondents (TABLE 2), and 4 by <50%, indicating that some less common needs are not being met adequately. Among these 7 prominent unmet needs, 4 were E Issues (TABLE 3) and 2 were I Issues.

Because of the wide range of patients that primary care physicians serve, they might be better prepared to help cancer patients address problems with their sex lives. Unmet needs are an opportunity to improve care. In our study and in others, E needs were most likely to be unmet.^17,23-26 Among the 4 common unmet E needs, 2 (E19 and E11) focused on generalized stress and worry, and one (E15) focused on concern about illness impact on family members or partners. Although these issues may be challenging to address successfully in a typical clinical environment, others have confirmed the importance of these needs and proposed ways to meet them.²⁷ The fourth most common unmet E need focused on concern about cancer recurrence, also a prominent need found in other studies.^15-17 These needs might be addressed more adequately in the course of usual clinical care by PCPs or specialists. In fact, the American College of Surgeons’ Commission on Cancer 2012 standards now require psychosocial distress screening and the provision of referral for psychosocial services.²⁴ Our results are consistent in many respects with prior studies of needs reported by cancer survivors in other countries. The CaSUN survey developed by Hodgkinson et al¹³ has been applied to several survivor populations in Australia. In a diverse survivor sample, specific E, I, and A issues were frequently reported as unmet needs.¹³ The most prominent unmet needs in a gynecologic cancer sample using CaSUN focused on emotional and social issues such as worry, stress, coping, and relationships with, and expectations of, others.²⁵

Barg et al²³ conducted a survey of unmet needs in the United States using a detailed list based on prior survivor research and targeting individuals in a cancer registry. The most prominent area of need expressed was “emotional,” similar to the high rank of E needs in our study. In contrast to our study, however, physical and financial issues also were prominent. The latter variances might be explained by differences in access to care, or perhaps the study’s low response rate (23.8%). A similar survey reported by Campbell et al¹² identified needs in the emotional domain as the most cited unmet survivor needs based on psychometrically developed subscales of a 152-item survey (29% response rate).

These results from several studies, including ours, call for more detailed exploration of the E needs of long-term cancer survivors. A useful framework developed by Stein et al²⁸ accounts for factors contributing to cancer stress and burden as well as resources available to survivors (intrapersonal, social, informational, and tangible services), with the interactions between these 2 domains determining how well a survivor will be able to cope. There clearly is a role for development of more effective communication channels and focused services to meet survivor needs.

The list of most common unmet needs in TABLE 3 also includes a focus on “problems with your sex life” (P4). This is an area that may be difficult to address in a cancer care setting because of the focus on disease management. Primary care providers might be better prepared to address this issue because they likely encounter similar issues among the wide range of patients they serve. However, a recent study reported that only 46% of internists were somewhat or likely to initiate a discussion about sexuality with cancer survivors.²⁹ Some additional preparation for physicians to address this need might be warranted.

The proportion in this sample reporting needs for access to, or information about, complementary and alternative medicine services fell below the thresholds chosen to designate common needs in this study. Although reported use is relatively common among cancer survivor in several studies,^30-32 it appears that in our survivor sample, those who were interested in these approaches encountered only moderate barriers.

Study limitations. We invited participants from a registry unlikely to include cancer survivors with lower educational attainment or from rural locations⁹—that is, our participants were less likely to have challenges in obtaining appropriate services and information. This sample limitation therefore likely underestimates the overall level of needs among cancer survivors.

This was a cross-sectional assessment of perceived needs among a diverse group of survivors, which may have overlooked needs that were met but only after considerable effort on the part of survivors. Longitudinal studies would provide more complete accounts of how readily needs are met and the changes in needs at different times in the continuum of care.

The Vermont population is less diverse racially and ethnically, but not with respect to household income or educational attainment, than the overall US population. Access to health care also is relatively high in Vermont compared with many other states. According to a 2009 Vermont Household Health Insurance Survey, only 7.6% of Vermonters are uninsured.³³

CORRESPONDENCE
Berta Geller, EdD, University of Vermont, Health Promotion Research/Family Medicine, 1 South Prospect Street, Burlington, VT 05401-3444; berta.geller@uvm.edu

ACKNOWLEDGEMENTS
We would like to thank Anne Dorwaldt, Kathy Howe, Mark Bowman and John Mace at the University of Vermont, and the Cancer Survivor Community Study Steering Committee for their contributions to the successful completion of this study. We also thank the cancer survivors who participated in the pilot testing and the overall survey.

ABSTRACT

Purpose This study sought to identify the needs and unmet needs of the growing number of adult cancer survivors.


Methods Vermont survivor advocates partnered with academic researchers to create a survivor registry and conduct a cross-sectional survey of cancer-related needs and unmet needs of adult survivors. The mailed survey addressed 53 specific needs in 5 domains based on prior research, contributions from the research partners, and pilot testing. Results were summarized by computing proportions who reported having needs met or unmet.

Results Survey participants included 1668 of 2005 individuals invited from the survivor registry (83%); 65.7% were ages 60 or older and 61.9% were women. These participants had received their diagnosis 2 to 16 years earlier; 77.5% had been diagnosed ≥5 years previously; 30.2% had at least one unmet need in the emotional, social, and spiritual (e) domain; just 14.4% had at least one unmet need in the economic and legal domain. The most commonly identified individual unmet needs were in the e and the information (i) domains and included “help reducing stress” (14.8% of all respondents) and “information about possible after effects of treatment” (14.4%).

Conclusions Most needs of these longer-term survivors were met, but substantial proportions of survivors identified unmet needs. Unmet needs such as information about late and long-term adverse effects of treatment could be met within clinical care with a cancer survivor care plan, but some survivors may require referral to services focused on stress and coping.

Following a successful course of treatment for cancer, many patients return to or remain in the care of their primary care physician (PCP). What often goes unrecognized, however, are these cancer survivors’ unique needs—physical, psychological, social, spiritual, economic, and legal—and the informational and professional services available to address them.^1,2

Increased cancer survival creates new needs. There are already >12 million cancer survivors in the United States and >30 million worldwide.³ As baby boomers age, the number of cancers diagnosed over the next 45 years will double⁴ and improved diagnosis and treatments are already prolonging survivors’ lives. With the greater number of cancer survivors and longer survival time, a cancer survivorship advocacy community has developed to help identify and address the concerns, needs, and benefits of having lived with, through, and beyond a cancer diagnosis.

The purpose of our study. Some of these areas of need have been studied extensively with childhood survivors, breast cancer survivors, and, more recently, prostate cancer survivors. However, few studies have examined adult survivors from all cancer types^5-9 or have had cohorts large enough to yield meaningful information.^5,7-9 The aim of this study was to describe the needs of adult survivors of all cancer types in a general population from Vermont and to determine whether these needs were met. The results of this study can help identify the services needed by cancer survivors.

METHODS

Population and sample

After effects
 of treatment, a big concern for most patients, 
is important to address not only at the outset 
of treatment but also at its conclusion
 and with documentation in a survivor care plan. In November 2009, we invited all survivors listed in a cancer survivor registry to complete a 12-page survey. The registry¹⁰ was created as part of the Cancer Survivor Community Study, a community-based participatory research project funded by the National Cancer Institute. The study’s Steering Committee was comprised of cancer survivors, cancer registrars, and researchers. We identified and invited cancer survivors from 4 hospital registries in northwest and central Vermont to participate. Registry participants who indicated willingness to enroll in research studies received an invitation letter and informed consent form, the 12-page survey, and an addressed and stamped return envelope. We obtained Institutional Review Board (IRB) approval for these procedures at the University of Vermont and at local hospital IRBs.

Instrument development

A working group from the Steering Committee reviewed a range of available instruments to assess cancer survivors’ needs.^9,11-15 We determined that the survey most relevant to our objectives was the Cancer Survivors’ Unmet Needs (CaSun) instrument.¹³ Because CaSun was developed in Australia, we carefully examined each question for appropriateness to our target audience. We eliminated several questions that we thought less important, added questions from other instruments, and simplified the survey format. Survivors from the Steering Committee pilot tested the draft questionnaire to identify awkward wording or concepts.

We piloted the revised draft using a standardized feedback form with cancer survivors who were not connected to our project and not enrolled in the survivor registry, and with residents at a senior center. Students and a teacher from an Adult Basic Education program helped to ensure easy readability. Our final instrument had 53 questions about needs in 5 domains. Questions within each domain completed the lead-in, “Since your cancer diagnosis, did you need....” We asked participants to check only 1 of the 3 boxes to the right of each question to indicate that there was no need in that area, that there was a need and it was met, or that there was a need and it was not met. We obtained self-reported demographic data during enrollment in the registry.

Data analysis

We summarized data by computing the percent of survivors who reported having each need (either met or unmet) and the percent for whom the need was unmet. The latter was computed both as a percent of all survivors and as a percent of those who had the need. We also calculated the percentage of survivors that had at least one need and at least one unmet need in each domain, as well as the average number of needs per survivor in each domain. We used SPSS for Unix, Release 6.1 (AIX 3.2)(IBM, Armonk, New York).

RESULTS

Of the 2005 cancer survivors invited into the study, 1668 responded, yielding a participation rate of 83%. TABLE 1 describes the self-reported demographic and cancer characteristics of participants in this study. Most respondents were female, ≥60 years old, urban dwellers, married or with a partner, well educated, and had household incomes of ≥$50,000. There were more breast cancer survivors than survivors of other cancers, and 14.6% of all survivors reported being diagnosed with more than one cancer. Cancer was diagnosed at stages 1 or 2 for 78.3% of the participants; 61.9% reported having undergone ≥2 treatment regimens.

The survey addressed needs in 5 domains: access to care and services (A); information (I); emotional, social, and spiritual (E); physical (P); and economic and legal (L). More than 80% of respondents reported having at least one need in the A, I, and E domains. The E domain had the most survivors with at least one unmet need (N=503), followed by the I (N=410) and P (N=375) domains.

Identifying unmet needs. TABLE 2 shows results for the specific questions within the domains in the order they were asked. Most participants who had a need also had it met. However, some needs that were not commonly reported were deemed unmet by a large proportion of those who expressed the need. For example, the A need for “A case manager to whom you could go to find out about services whenever they were needed” (A5) was reported by only 29.1% of survivors. But 32.1% of those reporting the need said it was unmet, which corresponds to 9.4% of all study participants having the need unmet. Similarly, the need for “More information about complementary and alternative medicine” (I3) was reported by about a quarter of the study population, 41.4% of whom (9.8% of all participants) reported it as unmet. In the P domain, the need for “Help to address problems with your sex life” (P4) was reported by only 26.5% of the respondents; yet 40.7% of those reporting the need had it unmet. Similarly, in the L domain, “Help with life insurance concerns as a result of your cancer” (L3) was only reported by 10.9% of the participants but was unmet for 46.4% of those who reported the need, or 5% of all study participants.

Most commonly expressed needs. TABLE 2 also identifies 12 needs reported by ≥50% of participants. Three of these needs were in the A domain, 6 in the I domain, and 3 in the E domain. The 2 most common needs related to A: the need “To feel like you were managing your health together with the medical team” (A3) was reported by 68.6% and was viewed as unmet by 5.2% of all respondents; the need for “Access to screening for recurrence or other cancers” (A7) was reported by 63.8% of the survivors but was deemed unmet by only 3.1% of all the respondents. “More information about possible after effects of your treatment” (I5) was a need for 63.2% that went unmet in 22.9% (14.4% of all participants). “Help managing your concerns about the cancer coming back” (E13) was reported as a need by 54.1% and as unmet by 11.8% of all participants.

The rank order of 7 unmet needs reported by ≥10% of the participants is shown in TABLE 3. Four of the 7 unmet needs were in the E domain. The most common unmet need in this domain was “Help reducing stress in your life” (E19).

Only 3 needs were both commonly reported and also unmet for at least 10% of the participants: “More information about possible after effects of your treatment” (I5), “More information about possible side effects of your treatment” (I4), and “Help managing your concerns about the cancer coming back” (E13).

DISCUSSION

Concern about cancer recurrence is 
a prominent patient need that might be addressed most adequately in the course of usual primary care. The survey instrument we used to assess the needs of cancer survivors in a large community-based registry included a detailed list of potential needs generated, in part, by representatives of the survivor community. Most cancer survivor needs mentioned in this survey were met. However, some needs were not met for substantial proportions of respondents and should be examined carefully to determine whether services could be improved to better address them. This study was planned and implemented by researchers and cancer survivors using community-based participatory principles to learn about local needs. The results of this study may be generalizable to similar populations of survivors and will inform the survivorship goals for the Vermont State Cancer Plan and future Vermont Cancer Survivor Network activities.

Acting on patients’ expressed needs. Over 80% of participants had needs in the A, I, and E domains. The most commonly reported need was in the A domain, “To feel like you were managing your health together with the medical team” (A3). It was also a top need in other studies that asked this question.^16,17 A cancer diagnosis may cause patients to feel out of control. Participation in the management of their health may help them gain a greater sense of control. PCP accommodation of expressed patient preferences may be an important part of a cancer survivor’s long-term adaptation to the disease.

Six of the 12 most frequently reported needs and 2 frequently reported unmet needs were in the I domain. Communication of information increases patients’ involvement in decision-making and enables them to cope better during diagnosis, treatment, and follow-up.¹⁸ “More information about possible after effects of your treatment” and “More information about possible side effects of your treatment” were reported by a high proportion of participants, and many also reported these needs as unmet. In another study about health-related information needs of survivors, 52% wanted more information about “What late and long-term side effects of cancer treatment are expected”¹⁹; and in a 2005 review of information needs, 12% of survivors reported similar needs.²⁰ Two recent articles also noted such needs in adolescent and young adult cancer survivors.^21,22 Based on current evidence, it would be advisable to discuss anticipated effects of treatment with patients not only at the outset but also at the end of treatment, and to write it in a cancer survivor care plan.

Individual needs that were not met for at least 10% of respondents, regardless of how common the need (TABLE 3), provided additional insights. Among these 7 needs, 3 also were reported as a need by more than 50% of respondents (TABLE 2), and 4 by <50%, indicating that some less common needs are not being met adequately. Among these 7 prominent unmet needs, 4 were E Issues (TABLE 3) and 2 were I Issues.

Because of the wide range of patients that primary care physicians serve, they might be better prepared to help cancer patients address problems with their sex lives. Unmet needs are an opportunity to improve care. In our study and in others, E needs were most likely to be unmet.^17,23-26 Among the 4 common unmet E needs, 2 (E19 and E11) focused on generalized stress and worry, and one (E15) focused on concern about illness impact on family members or partners. Although these issues may be challenging to address successfully in a typical clinical environment, others have confirmed the importance of these needs and proposed ways to meet them.²⁷ The fourth most common unmet E need focused on concern about cancer recurrence, also a prominent need found in other studies.^15-17 These needs might be addressed more adequately in the course of usual clinical care by PCPs or specialists. In fact, the American College of Surgeons’ Commission on Cancer 2012 standards now require psychosocial distress screening and the provision of referral for psychosocial services.²⁴ Our results are consistent in many respects with prior studies of needs reported by cancer survivors in other countries. The CaSUN survey developed by Hodgkinson et al¹³ has been applied to several survivor populations in Australia. In a diverse survivor sample, specific E, I, and A issues were frequently reported as unmet needs.¹³ The most prominent unmet needs in a gynecologic cancer sample using CaSUN focused on emotional and social issues such as worry, stress, coping, and relationships with, and expectations of, others.²⁵

Barg et al²³ conducted a survey of unmet needs in the United States using a detailed list based on prior survivor research and targeting individuals in a cancer registry. The most prominent area of need expressed was “emotional,” similar to the high rank of E needs in our study. In contrast to our study, however, physical and financial issues also were prominent. The latter variances might be explained by differences in access to care, or perhaps the study’s low response rate (23.8%). A similar survey reported by Campbell et al¹² identified needs in the emotional domain as the most cited unmet survivor needs based on psychometrically developed subscales of a 152-item survey (29% response rate).

These results from several studies, including ours, call for more detailed exploration of the E needs of long-term cancer survivors. A useful framework developed by Stein et al²⁸ accounts for factors contributing to cancer stress and burden as well as resources available to survivors (intrapersonal, social, informational, and tangible services), with the interactions between these 2 domains determining how well a survivor will be able to cope. There clearly is a role for development of more effective communication channels and focused services to meet survivor needs.

The list of most common unmet needs in TABLE 3 also includes a focus on “problems with your sex life” (P4). This is an area that may be difficult to address in a cancer care setting because of the focus on disease management. Primary care providers might be better prepared to address this issue because they likely encounter similar issues among the wide range of patients they serve. However, a recent study reported that only 46% of internists were somewhat or likely to initiate a discussion about sexuality with cancer survivors.²⁹ Some additional preparation for physicians to address this need might be warranted.

The proportion in this sample reporting needs for access to, or information about, complementary and alternative medicine services fell below the thresholds chosen to designate common needs in this study. Although reported use is relatively common among cancer survivor in several studies,^30-32 it appears that in our survivor sample, those who were interested in these approaches encountered only moderate barriers.

Study limitations. We invited participants from a registry unlikely to include cancer survivors with lower educational attainment or from rural locations⁹—that is, our participants were less likely to have challenges in obtaining appropriate services and information. This sample limitation therefore likely underestimates the overall level of needs among cancer survivors.

This was a cross-sectional assessment of perceived needs among a diverse group of survivors, which may have overlooked needs that were met but only after considerable effort on the part of survivors. Longitudinal studies would provide more complete accounts of how readily needs are met and the changes in needs at different times in the continuum of care.

The Vermont population is less diverse racially and ethnically, but not with respect to household income or educational attainment, than the overall US population. Access to health care also is relatively high in Vermont compared with many other states. According to a 2009 Vermont Household Health Insurance Survey, only 7.6% of Vermonters are uninsured.³³

CORRESPONDENCE
Berta Geller, EdD, University of Vermont, Health Promotion Research/Family Medicine, 1 South Prospect Street, Burlington, VT 05401-3444; berta.geller@uvm.edu

ACKNOWLEDGEMENTS
We would like to thank Anne Dorwaldt, Kathy Howe, Mark Bowman and John Mace at the University of Vermont, and the Cancer Survivor Community Study Steering Committee for their contributions to the successful completion of this study. We also thank the cancer survivors who participated in the pilot testing and the overall survey.

ABSTRACT

Purpose This study sought to identify the needs and unmet needs of the growing number of adult cancer survivors.


Methods Vermont survivor advocates partnered with academic researchers to create a survivor registry and conduct a cross-sectional survey of cancer-related needs and unmet needs of adult survivors. The mailed survey addressed 53 specific needs in 5 domains based on prior research, contributions from the research partners, and pilot testing. Results were summarized by computing proportions who reported having needs met or unmet.

Results Survey participants included 1668 of 2005 individuals invited from the survivor registry (83%); 65.7% were ages 60 or older and 61.9% were women. These participants had received their diagnosis 2 to 16 years earlier; 77.5% had been diagnosed ≥5 years previously; 30.2% had at least one unmet need in the emotional, social, and spiritual (e) domain; just 14.4% had at least one unmet need in the economic and legal domain. The most commonly identified individual unmet needs were in the e and the information (i) domains and included “help reducing stress” (14.8% of all respondents) and “information about possible after effects of treatment” (14.4%).

Conclusions Most needs of these longer-term survivors were met, but substantial proportions of survivors identified unmet needs. Unmet needs such as information about late and long-term adverse effects of treatment could be met within clinical care with a cancer survivor care plan, but some survivors may require referral to services focused on stress and coping.

Following a successful course of treatment for cancer, many patients return to or remain in the care of their primary care physician (PCP). What often goes unrecognized, however, are these cancer survivors’ unique needs—physical, psychological, social, spiritual, economic, and legal—and the informational and professional services available to address them.^1,2

Increased cancer survival creates new needs. There are already >12 million cancer survivors in the United States and >30 million worldwide.³ As baby boomers age, the number of cancers diagnosed over the next 45 years will double⁴ and improved diagnosis and treatments are already prolonging survivors’ lives. With the greater number of cancer survivors and longer survival time, a cancer survivorship advocacy community has developed to help identify and address the concerns, needs, and benefits of having lived with, through, and beyond a cancer diagnosis.

The purpose of our study. Some of these areas of need have been studied extensively with childhood survivors, breast cancer survivors, and, more recently, prostate cancer survivors. However, few studies have examined adult survivors from all cancer types^5-9 or have had cohorts large enough to yield meaningful information.^5,7-9 The aim of this study was to describe the needs of adult survivors of all cancer types in a general population from Vermont and to determine whether these needs were met. The results of this study can help identify the services needed by cancer survivors.

METHODS

Population and sample

After effects
 of treatment, a big concern for most patients, 
is important to address not only at the outset 
of treatment but also at its conclusion
 and with documentation in a survivor care plan. In November 2009, we invited all survivors listed in a cancer survivor registry to complete a 12-page survey. The registry¹⁰ was created as part of the Cancer Survivor Community Study, a community-based participatory research project funded by the National Cancer Institute. The study’s Steering Committee was comprised of cancer survivors, cancer registrars, and researchers. We identified and invited cancer survivors from 4 hospital registries in northwest and central Vermont to participate. Registry participants who indicated willingness to enroll in research studies received an invitation letter and informed consent form, the 12-page survey, and an addressed and stamped return envelope. We obtained Institutional Review Board (IRB) approval for these procedures at the University of Vermont and at local hospital IRBs.

Instrument development

A working group from the Steering Committee reviewed a range of available instruments to assess cancer survivors’ needs.^9,11-15 We determined that the survey most relevant to our objectives was the Cancer Survivors’ Unmet Needs (CaSun) instrument.¹³ Because CaSun was developed in Australia, we carefully examined each question for appropriateness to our target audience. We eliminated several questions that we thought less important, added questions from other instruments, and simplified the survey format. Survivors from the Steering Committee pilot tested the draft questionnaire to identify awkward wording or concepts.

We piloted the revised draft using a standardized feedback form with cancer survivors who were not connected to our project and not enrolled in the survivor registry, and with residents at a senior center. Students and a teacher from an Adult Basic Education program helped to ensure easy readability. Our final instrument had 53 questions about needs in 5 domains. Questions within each domain completed the lead-in, “Since your cancer diagnosis, did you need....” We asked participants to check only 1 of the 3 boxes to the right of each question to indicate that there was no need in that area, that there was a need and it was met, or that there was a need and it was not met. We obtained self-reported demographic data during enrollment in the registry.

Data analysis

We summarized data by computing the percent of survivors who reported having each need (either met or unmet) and the percent for whom the need was unmet. The latter was computed both as a percent of all survivors and as a percent of those who had the need. We also calculated the percentage of survivors that had at least one need and at least one unmet need in each domain, as well as the average number of needs per survivor in each domain. We used SPSS for Unix, Release 6.1 (AIX 3.2)(IBM, Armonk, New York).

RESULTS

Of the 2005 cancer survivors invited into the study, 1668 responded, yielding a participation rate of 83%. TABLE 1 describes the self-reported demographic and cancer characteristics of participants in this study. Most respondents were female, ≥60 years old, urban dwellers, married or with a partner, well educated, and had household incomes of ≥$50,000. There were more breast cancer survivors than survivors of other cancers, and 14.6% of all survivors reported being diagnosed with more than one cancer. Cancer was diagnosed at stages 1 or 2 for 78.3% of the participants; 61.9% reported having undergone ≥2 treatment regimens.

The survey addressed needs in 5 domains: access to care and services (A); information (I); emotional, social, and spiritual (E); physical (P); and economic and legal (L). More than 80% of respondents reported having at least one need in the A, I, and E domains. The E domain had the most survivors with at least one unmet need (N=503), followed by the I (N=410) and P (N=375) domains.

Identifying unmet needs. TABLE 2 shows results for the specific questions within the domains in the order they were asked. Most participants who had a need also had it met. However, some needs that were not commonly reported were deemed unmet by a large proportion of those who expressed the need. For example, the A need for “A case manager to whom you could go to find out about services whenever they were needed” (A5) was reported by only 29.1% of survivors. But 32.1% of those reporting the need said it was unmet, which corresponds to 9.4% of all study participants having the need unmet. Similarly, the need for “More information about complementary and alternative medicine” (I3) was reported by about a quarter of the study population, 41.4% of whom (9.8% of all participants) reported it as unmet. In the P domain, the need for “Help to address problems with your sex life” (P4) was reported by only 26.5% of the respondents; yet 40.7% of those reporting the need had it unmet. Similarly, in the L domain, “Help with life insurance concerns as a result of your cancer” (L3) was only reported by 10.9% of the participants but was unmet for 46.4% of those who reported the need, or 5% of all study participants.

Most commonly expressed needs. TABLE 2 also identifies 12 needs reported by ≥50% of participants. Three of these needs were in the A domain, 6 in the I domain, and 3 in the E domain. The 2 most common needs related to A: the need “To feel like you were managing your health together with the medical team” (A3) was reported by 68.6% and was viewed as unmet by 5.2% of all respondents; the need for “Access to screening for recurrence or other cancers” (A7) was reported by 63.8% of the survivors but was deemed unmet by only 3.1% of all the respondents. “More information about possible after effects of your treatment” (I5) was a need for 63.2% that went unmet in 22.9% (14.4% of all participants). “Help managing your concerns about the cancer coming back” (E13) was reported as a need by 54.1% and as unmet by 11.8% of all participants.

The rank order of 7 unmet needs reported by ≥10% of the participants is shown in TABLE 3. Four of the 7 unmet needs were in the E domain. The most common unmet need in this domain was “Help reducing stress in your life” (E19).

Only 3 needs were both commonly reported and also unmet for at least 10% of the participants: “More information about possible after effects of your treatment” (I5), “More information about possible side effects of your treatment” (I4), and “Help managing your concerns about the cancer coming back” (E13).

DISCUSSION

Concern about cancer recurrence is 
a prominent patient need that might be addressed most adequately in the course of usual primary care. The survey instrument we used to assess the needs of cancer survivors in a large community-based registry included a detailed list of potential needs generated, in part, by representatives of the survivor community. Most cancer survivor needs mentioned in this survey were met. However, some needs were not met for substantial proportions of respondents and should be examined carefully to determine whether services could be improved to better address them. This study was planned and implemented by researchers and cancer survivors using community-based participatory principles to learn about local needs. The results of this study may be generalizable to similar populations of survivors and will inform the survivorship goals for the Vermont State Cancer Plan and future Vermont Cancer Survivor Network activities.

Acting on patients’ expressed needs. Over 80% of participants had needs in the A, I, and E domains. The most commonly reported need was in the A domain, “To feel like you were managing your health together with the medical team” (A3). It was also a top need in other studies that asked this question.^16,17 A cancer diagnosis may cause patients to feel out of control. Participation in the management of their health may help them gain a greater sense of control. PCP accommodation of expressed patient preferences may be an important part of a cancer survivor’s long-term adaptation to the disease.

Six of the 12 most frequently reported needs and 2 frequently reported unmet needs were in the I domain. Communication of information increases patients’ involvement in decision-making and enables them to cope better during diagnosis, treatment, and follow-up.¹⁸ “More information about possible after effects of your treatment” and “More information about possible side effects of your treatment” were reported by a high proportion of participants, and many also reported these needs as unmet. In another study about health-related information needs of survivors, 52% wanted more information about “What late and long-term side effects of cancer treatment are expected”¹⁹; and in a 2005 review of information needs, 12% of survivors reported similar needs.²⁰ Two recent articles also noted such needs in adolescent and young adult cancer survivors.^21,22 Based on current evidence, it would be advisable to discuss anticipated effects of treatment with patients not only at the outset but also at the end of treatment, and to write it in a cancer survivor care plan.

Individual needs that were not met for at least 10% of respondents, regardless of how common the need (TABLE 3), provided additional insights. Among these 7 needs, 3 also were reported as a need by more than 50% of respondents (TABLE 2), and 4 by <50%, indicating that some less common needs are not being met adequately. Among these 7 prominent unmet needs, 4 were E Issues (TABLE 3) and 2 were I Issues.

Because of the wide range of patients that primary care physicians serve, they might be better prepared to help cancer patients address problems with their sex lives. Unmet needs are an opportunity to improve care. In our study and in others, E needs were most likely to be unmet.^17,23-26 Among the 4 common unmet E needs, 2 (E19 and E11) focused on generalized stress and worry, and one (E15) focused on concern about illness impact on family members or partners. Although these issues may be challenging to address successfully in a typical clinical environment, others have confirmed the importance of these needs and proposed ways to meet them.²⁷ The fourth most common unmet E need focused on concern about cancer recurrence, also a prominent need found in other studies.^15-17 These needs might be addressed more adequately in the course of usual clinical care by PCPs or specialists. In fact, the American College of Surgeons’ Commission on Cancer 2012 standards now require psychosocial distress screening and the provision of referral for psychosocial services.²⁴ Our results are consistent in many respects with prior studies of needs reported by cancer survivors in other countries. The CaSUN survey developed by Hodgkinson et al¹³ has been applied to several survivor populations in Australia. In a diverse survivor sample, specific E, I, and A issues were frequently reported as unmet needs.¹³ The most prominent unmet needs in a gynecologic cancer sample using CaSUN focused on emotional and social issues such as worry, stress, coping, and relationships with, and expectations of, others.²⁵

Barg et al²³ conducted a survey of unmet needs in the United States using a detailed list based on prior survivor research and targeting individuals in a cancer registry. The most prominent area of need expressed was “emotional,” similar to the high rank of E needs in our study. In contrast to our study, however, physical and financial issues also were prominent. The latter variances might be explained by differences in access to care, or perhaps the study’s low response rate (23.8%). A similar survey reported by Campbell et al¹² identified needs in the emotional domain as the most cited unmet survivor needs based on psychometrically developed subscales of a 152-item survey (29% response rate).

These results from several studies, including ours, call for more detailed exploration of the E needs of long-term cancer survivors. A useful framework developed by Stein et al²⁸ accounts for factors contributing to cancer stress and burden as well as resources available to survivors (intrapersonal, social, informational, and tangible services), with the interactions between these 2 domains determining how well a survivor will be able to cope. There clearly is a role for development of more effective communication channels and focused services to meet survivor needs.

The list of most common unmet needs in TABLE 3 also includes a focus on “problems with your sex life” (P4). This is an area that may be difficult to address in a cancer care setting because of the focus on disease management. Primary care providers might be better prepared to address this issue because they likely encounter similar issues among the wide range of patients they serve. However, a recent study reported that only 46% of internists were somewhat or likely to initiate a discussion about sexuality with cancer survivors.²⁹ Some additional preparation for physicians to address this need might be warranted.

The proportion in this sample reporting needs for access to, or information about, complementary and alternative medicine services fell below the thresholds chosen to designate common needs in this study. Although reported use is relatively common among cancer survivor in several studies,^30-32 it appears that in our survivor sample, those who were interested in these approaches encountered only moderate barriers.

Study limitations. We invited participants from a registry unlikely to include cancer survivors with lower educational attainment or from rural locations⁹—that is, our participants were less likely to have challenges in obtaining appropriate services and information. This sample limitation therefore likely underestimates the overall level of needs among cancer survivors.

This was a cross-sectional assessment of perceived needs among a diverse group of survivors, which may have overlooked needs that were met but only after considerable effort on the part of survivors. Longitudinal studies would provide more complete accounts of how readily needs are met and the changes in needs at different times in the continuum of care.

The Vermont population is less diverse racially and ethnically, but not with respect to household income or educational attainment, than the overall US population. Access to health care also is relatively high in Vermont compared with many other states. According to a 2009 Vermont Household Health Insurance Survey, only 7.6% of Vermonters are uninsured.³³

CORRESPONDENCE
Berta Geller, EdD, University of Vermont, Health Promotion Research/Family Medicine, 1 South Prospect Street, Burlington, VT 05401-3444; berta.geller@uvm.edu

ACKNOWLEDGEMENTS
We would like to thank Anne Dorwaldt, Kathy Howe, Mark Bowman and John Mace at the University of Vermont, and the Cancer Survivor Community Study Steering Committee for their contributions to the successful completion of this study. We also thank the cancer survivors who participated in the pilot testing and the overall survey.

Failure to properly manage
 a patient’s hypertension


A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.

PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.


THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.


VERDICT $136,000 New Jersey verdict.

COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.

Did the patient’s age discourage proper evaluation?

Be sure to document when you tell patients to “come back to see me right away if this happens again.” THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.

PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.

THE DEFENSE No information about the defense is available.


VERDICT $2.5 million Maryland verdict.

COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”

23-year-old dies when myocarditis is mistaken for bronchitis


A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.

PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.

THE DEFENSE The patient was evaluated properly. An EKG was not necessary.

VERDICT $2.9 million Massachusetts verdict.

COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.

Failure to properly manage
 a patient’s hypertension


A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.

PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.


THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.


VERDICT $136,000 New Jersey verdict.

COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.

Did the patient’s age discourage proper evaluation?

Be sure to document when you tell patients to “come back to see me right away if this happens again.” THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.

PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.

THE DEFENSE No information about the defense is available.


VERDICT $2.5 million Maryland verdict.

COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”

23-year-old dies when myocarditis is mistaken for bronchitis


A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.

PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.

THE DEFENSE The patient was evaluated properly. An EKG was not necessary.

VERDICT $2.9 million Massachusetts verdict.

COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.

Failure to properly manage
 a patient’s hypertension


A 44-YEAR-OLD MAN WHO WEIGHED >450 POUNDS went to his internist for treatment of hypertension. At a work-related physical the previous day, his blood pressure had been 160/110 mm Hg. After examination, the internist wrote a 30-day prescription for amlodipine, 5 mg/d, with 3 refills. The patient saw the physician 2 weeks later but not again until 3 months later. At that visit, the internist prescribed amlodipine, 5 mg/d, for 90 days with 2 refills. The patient missed his next appointment, which was set for 4 months later, but when his medication was about to run out, he was able to get a prescription for 10 months’ worth of amlodipine by phone. The patient died 2 months before the prescription ran out.

PLAINTIFF’S CLAIM The physician failed to properly manage and monitor the patient’s hypertension. The dosage of amlodipine was insufficient.


THE DEFENSE The patient was noncompliant and failed to show for follow-up appointments. The dosage of amlodipine was sufficient. The cause of death was unknown because no autopsy was performed.


VERDICT $136,000 New Jersey verdict.

COMMENT If we accept a patient into our practice, we need to have reasonable policies for patients to show up for follow-up, and to consider having them find another physician if they do not.

Did the patient’s age discourage proper evaluation?

Be sure to document when you tell patients to “come back to see me right away if this happens again.” THREE MONTHS AFTER NOTICING BLOOD IN HER STOOL, a 19-year-old woman went to see her physician. Without ordering a flexible sigmoidoscopy or colonoscopy, the physician diagnosed a healing anal fissure. Approximately 4 years later, the patient developed bloody diarrhea and went to a gastroenterologist, who found a 2.6 cm lesion in her rectum during a flexible sigmoidoscopy. Biopsy confirmed a low-grade adenocarcinoma. Imaging studies revealed that the cancer had spread to her lungs and liver, and she was diagnosed with Stage IV rectal cancer. After 2 years of extensive treatment that included surgical resection, conventional and experimental chemotherapy, and radiation therapy, the patient died.

PLAINTIFF’S CLAIM If the physician had ordered endoscopy exams when the patient first presented for treatment, testing could have identified a polyp or early-stage cancer.

THE DEFENSE No information about the defense is available.


VERDICT $2.5 million Maryland verdict.

COMMENT Colon cancer in a 19-year-old is extraordinarily rare. I doubt that the patient didn’t experience any more rectal bleeding until 4 years after she first sought treatment. A lesson in this tragic case is to be sure to document when you tell patients to “come back to see me right away if this happens again.”

23-year-old dies when myocarditis is mistaken for bronchitis


A 23-YEAR-OLD MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) with chest tightness, cough, and fever. After a chest x-ray, the ED physician diagnosed bronchitis and sent the patient home with prescriptions for hydrocodone/acetaminophen and antibiotics. He was found dead in his bed less than 24 hours later. An autopsy determined the cause of death was myocarditis.

PLAINTIFF’S CLAIM The physician didn’t perform an electrocardiogram (EKG), which is a routine evaluation for a patient with chest pain. The EKG would have detected myocarditis.

THE DEFENSE The patient was evaluated properly. An EKG was not necessary.

VERDICT $2.9 million Massachusetts verdict.

COMMENT I think the jury got this one wrong. I don’t think an EKG is necessary for every case of acute bronchitis. However, I do wonder if the chest x-ray showed a large heart shadow.

In “Colicky baby? Here’s a surprising remedy” (J Fam Pract. 2011;60:34-36), we summarized a 2010 double-blind randomized controlled trial (RCT) that found the probiotic Lactobacillus reuteri DSM 17938 reduced daily crying time in colicky, exclusively breastfed infants.¹

A recently published RCT of the same probiotic by Sung et al² adds to the body of evidence and suggests that the jury may still be out as to the value of probiotics for colicky babies.

The newer study (which also measured colic using modified Wessel’s criteria) included babies who were formula-fed as well as those who were breastfed. When researchers looked at all babies as a single group, those who received probiotics fussed significantly more than those who received placebo at nearly all of the postintervention time points. However, when they delved deeper, the researchers noted that an increase in fussing occurred only among infants on formula. On the other hand, the time that breastfed infants spent crying or fussing did not vary significantly between those who received probiotics and those who received placebo.

Both the 2010 and 2014 studies used valid RCT methods with low risk for bias, so we’re not clear why the results (especially for breastfed infants) differed. The 2010 study was done in Italy and required breastfeeding moms 
to avoid cow’s milk, while the 2014 Sung et al² study was conducted in Australia and did not have this requirement, so environmental factors may have played a role. The reporting method in the Sung et al² study—a well-validated, detailed diary of infant behaviors—may have led to less parent recall error than the diary used in the 2010 study. All in all, we can only conclude that it is unclear whether probiotics work to reduce crying in colicky infants.

A safe bet may be to avoid recommending probiotics for colicky formula-fed infants, since no study of this population has shown probiotics are effective, and in the Sung et al² study, they appeared to worsen symptoms. For breastfed babies, there is no evidence of harm, and mixed evidence on whether probiotics help.

In “Colicky baby? Here’s a surprising remedy” (J Fam Pract. 2011;60:34-36), we summarized a 2010 double-blind randomized controlled trial (RCT) that found the probiotic Lactobacillus reuteri DSM 17938 reduced daily crying time in colicky, exclusively breastfed infants.¹

A recently published RCT of the same probiotic by Sung et al² adds to the body of evidence and suggests that the jury may still be out as to the value of probiotics for colicky babies.

The newer study (which also measured colic using modified Wessel’s criteria) included babies who were formula-fed as well as those who were breastfed. When researchers looked at all babies as a single group, those who received probiotics fussed significantly more than those who received placebo at nearly all of the postintervention time points. However, when they delved deeper, the researchers noted that an increase in fussing occurred only among infants on formula. On the other hand, the time that breastfed infants spent crying or fussing did not vary significantly between those who received probiotics and those who received placebo.

Both the 2010 and 2014 studies used valid RCT methods with low risk for bias, so we’re not clear why the results (especially for breastfed infants) differed. The 2010 study was done in Italy and required breastfeeding moms 
to avoid cow’s milk, while the 2014 Sung et al² study was conducted in Australia and did not have this requirement, so environmental factors may have played a role. The reporting method in the Sung et al² study—a well-validated, detailed diary of infant behaviors—may have led to less parent recall error than the diary used in the 2010 study. All in all, we can only conclude that it is unclear whether probiotics work to reduce crying in colicky infants.

A safe bet may be to avoid recommending probiotics for colicky formula-fed infants, since no study of this population has shown probiotics are effective, and in the Sung et al² study, they appeared to worsen symptoms. For breastfed babies, there is no evidence of harm, and mixed evidence on whether probiotics help.

In “Colicky baby? Here’s a surprising remedy” (J Fam Pract. 2011;60:34-36), we summarized a 2010 double-blind randomized controlled trial (RCT) that found the probiotic Lactobacillus reuteri DSM 17938 reduced daily crying time in colicky, exclusively breastfed infants.¹

A recently published RCT of the same probiotic by Sung et al² adds to the body of evidence and suggests that the jury may still be out as to the value of probiotics for colicky babies.

The newer study (which also measured colic using modified Wessel’s criteria) included babies who were formula-fed as well as those who were breastfed. When researchers looked at all babies as a single group, those who received probiotics fussed significantly more than those who received placebo at nearly all of the postintervention time points. However, when they delved deeper, the researchers noted that an increase in fussing occurred only among infants on formula. On the other hand, the time that breastfed infants spent crying or fussing did not vary significantly between those who received probiotics and those who received placebo.

Both the 2010 and 2014 studies used valid RCT methods with low risk for bias, so we’re not clear why the results (especially for breastfed infants) differed. The 2010 study was done in Italy and required breastfeeding moms 
to avoid cow’s milk, while the 2014 Sung et al² study was conducted in Australia and did not have this requirement, so environmental factors may have played a role. The reporting method in the Sung et al² study—a well-validated, detailed diary of infant behaviors—may have led to less parent recall error than the diary used in the 2010 study. All in all, we can only conclude that it is unclear whether probiotics work to reduce crying in colicky infants.

A safe bet may be to avoid recommending probiotics for colicky formula-fed infants, since no study of this population has shown probiotics are effective, and in the Sung et al² study, they appeared to worsen symptoms. For breastfed babies, there is no evidence of harm, and mixed evidence on whether probiotics help.

Illustrative case

A 23-year-old woman who was diagnosed with irritable bowel syndrome (IBS) comes to your clinic with complaints of increased frequency of defecation with watery stools and generalized, cramping abdominal pain. She also notes increased passage of mucus and a sensation of incomplete evacuation. She says the only thing that relieves her pain is defecation. She has tried loperamide, acetaminophen, and ibuprofen without relief. She does not have Crohn’s disease or ulcerative colitis. What else can you offer her that is safe and effective?

IBS is a chronic, episodic functional gastrointestinal disorder characterized by abdominal pain or discomfort and altered bowel habits (constipation [IBS-C], diarrhea [IBS-D], or alternating periods of both—mixed [IBS-M]).² It is diagnosed based on Rome III criteria—recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with ≥2 of the following: improvement with defecation, onset associated with a change in frequency of stool, and onset associated with a change in form (appearance) of stool.³ IBS often is unrecognized or untreated, and as few as 25% of patients with IBS seek care.⁴

IBS-D affects approximately 5% of the general population in North America.^5,6 IBS-D is associated with a considerably decreased quality of life and is a common cause of work absenteeism.^7,8 Because many conditions can cause diarrhea, patients typically undergo numerous tests before receiving an accurate diagnosis, which creates a financial burden.⁹

For many patients, current IBS treatments, which include fiber supplements, laxatives, antidiarrheal medications, antispasmodics, and antidepressants such as tricyclics and selective serotonin reuptake inhibitors, are unsatisfactory.¹⁰ Alosetron, a 5-hydroxytryptamine 3 (5HT3) receptor antagonist, has been used to treat IBS-D,¹¹ but this medication was voluntarily withdrawn from the US market in 2000 due to concerns of ischemic colitis and severe constipation.¹² It was reintroduced in 2002, but can be prescribed only by physicians who enroll in a prescribing program provided by the manufacturer, and the drug has restrictions on its use.

Ondansetron—a different 5HT3 receptor antagonist used to treat nausea and vomiting caused by chemotherapy—may be another option for treating IBS-D. Garsed et al¹ recently conducted a RCT to evaluate the efficacy of ondansetron for patients with IBS-D.

STUDY SUMMARY: Ondansetron improves stool consistency, severity of IBS symptoms


In a 5-week, double-blind crossover RCT, Garsed et al¹ compared ondansetron vs placebo for symptom relief in 120 patients who met Rome III criteria for IBS-D. All patients were ages 18 to 75 and had no evidence of inflammatory bowel disease. Exclusion criteria were pregnancy or breastfeeding, unwillingness to stop antidiarrheal medication, prior abdominal surgery other than appendectomy or cholecystectomy, or being in another trial. Patients were started on ondansetron 4 mg/d with dose titration up to 24 mg/d based on response; no dose adjustments were allowed during the last 2 weeks of the study. There was a 2- to 3-week washout between treatment periods.

The primary endpoint was average stool consistency in the last 2 weeks of treatment, as measured by the Bristol Stool Form (BSF) scale.¹³ The BSF is a visual scale that depicts stool as hard (Type 1) to watery (Type 7); types 3 and 4 describe normal stools. The study also looked at urgency and frequency of defecation, bowel transit time, and pain scores.

Treatment with ondansetron resulted in a small but statistically significant improvement in stool consistency. The mean difference in BSF score between ondansetron and placebo was -0.9 (95% confidence interval [CI], -1.1 to -0.6; P<.001), indicating slightly more formed stool with use of ondansetron. The IBS Severity Scoring System score (maximum score 500 points, with mild, moderate, and severe cases indicated by scores of 75-175, 175-300, and >300, respectively) was reduced by more points with ondansetron than placebo (83 ± 9.8 vs 37 ± 9.7; P=.001). Although this mean difference of 46 points fell just short of the 50-point threshold that is considered clinically significant, many patients exceeded this threshold.

For patients with IBS-D, ondansetron reduced frequency of defecation and bloating, but did not relieve pain. Compared to those who received placebo, patients who took ondansetron also had less frequent defecation (P=.002) and lower urgency scores (P<.001). Gut transit time was lengthened in the ondansetron group by 10 hours more than in the placebo group (95% CI, 6-14 hours; P<.001). Pain scores did not change significantly for patients taking ondansetron, although they experienced significantly fewer days of urgency and bloating. Symptoms typically improved in as little as 7 days but returned after stopping ondansetron, typically within 2 weeks. Sixty-five percent of patients reported adequate relief with ondansetron, compared to 14% with placebo.

Patients whose diarrhea was more severe at baseline didn’t respond as well to ondansetron as did those whose diarrhea was less severe. The only frequent adverse effect was constipation, which occurred in 9% of patients receiving ondansetron and 2% of those on placebo.

WHAT’S NEW: Another option for IBS patients
 with diarrhea


A prior, smaller study of ondansetron that used a lower dosage (12 mg/d) suggested benefit in IBS-D.¹⁴ In that study, ondansetron decreased diarrhea and functional dyspepsia. The study by Garsed et al¹ is the first large RCT to show significantly improved stool consistency, less frequent defecation, and less urgency and bloating from using ondansetron to treat IBS-D.

CAVEATS: Ondansetron doesn’t appear 
to reduce pain


In Garsed et al,¹ patients who received ondansetron did not experience relief from pain, which is one of the main complaints of IBS. However, this study did find slight improvement in formed stools, symptom relief that approached—but did not quite reach—clinical significance, fewer days with urgency and bloating, and less frequent defecation. This study did not evaluate the long-term effects of ondansetron use. However, ondansetron has been used for other indications for more than 25 years and has been reported to have a low risk of adverse effects.¹⁵

CHALLENGES TO IMPLEMENTATION: Remember ondansetron 
is not for IBS patients with constipation

Proper use of this drug among patients with IBS is key. The primary benefits of ondansetron are limited to IBS patients who suffer from diarrhea, and not constipation. Ondansetron should not be prescribed to IBS patients who experience constipation, or those with mixed symptoms.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Click here to view PURL METHODOLOGY

Illustrative case

A 23-year-old woman who was diagnosed with irritable bowel syndrome (IBS) comes to your clinic with complaints of increased frequency of defecation with watery stools and generalized, cramping abdominal pain. She also notes increased passage of mucus and a sensation of incomplete evacuation. She says the only thing that relieves her pain is defecation. She has tried loperamide, acetaminophen, and ibuprofen without relief. She does not have Crohn’s disease or ulcerative colitis. What else can you offer her that is safe and effective?

IBS is a chronic, episodic functional gastrointestinal disorder characterized by abdominal pain or discomfort and altered bowel habits (constipation [IBS-C], diarrhea [IBS-D], or alternating periods of both—mixed [IBS-M]).² It is diagnosed based on Rome III criteria—recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with ≥2 of the following: improvement with defecation, onset associated with a change in frequency of stool, and onset associated with a change in form (appearance) of stool.³ IBS often is unrecognized or untreated, and as few as 25% of patients with IBS seek care.⁴

IBS-D affects approximately 5% of the general population in North America.^5,6 IBS-D is associated with a considerably decreased quality of life and is a common cause of work absenteeism.^7,8 Because many conditions can cause diarrhea, patients typically undergo numerous tests before receiving an accurate diagnosis, which creates a financial burden.⁹

For many patients, current IBS treatments, which include fiber supplements, laxatives, antidiarrheal medications, antispasmodics, and antidepressants such as tricyclics and selective serotonin reuptake inhibitors, are unsatisfactory.¹⁰ Alosetron, a 5-hydroxytryptamine 3 (5HT3) receptor antagonist, has been used to treat IBS-D,¹¹ but this medication was voluntarily withdrawn from the US market in 2000 due to concerns of ischemic colitis and severe constipation.¹² It was reintroduced in 2002, but can be prescribed only by physicians who enroll in a prescribing program provided by the manufacturer, and the drug has restrictions on its use.

Ondansetron—a different 5HT3 receptor antagonist used to treat nausea and vomiting caused by chemotherapy—may be another option for treating IBS-D. Garsed et al¹ recently conducted a RCT to evaluate the efficacy of ondansetron for patients with IBS-D.

STUDY SUMMARY: Ondansetron improves stool consistency, severity of IBS symptoms


In a 5-week, double-blind crossover RCT, Garsed et al¹ compared ondansetron vs placebo for symptom relief in 120 patients who met Rome III criteria for IBS-D. All patients were ages 18 to 75 and had no evidence of inflammatory bowel disease. Exclusion criteria were pregnancy or breastfeeding, unwillingness to stop antidiarrheal medication, prior abdominal surgery other than appendectomy or cholecystectomy, or being in another trial. Patients were started on ondansetron 4 mg/d with dose titration up to 24 mg/d based on response; no dose adjustments were allowed during the last 2 weeks of the study. There was a 2- to 3-week washout between treatment periods.

The primary endpoint was average stool consistency in the last 2 weeks of treatment, as measured by the Bristol Stool Form (BSF) scale.¹³ The BSF is a visual scale that depicts stool as hard (Type 1) to watery (Type 7); types 3 and 4 describe normal stools. The study also looked at urgency and frequency of defecation, bowel transit time, and pain scores.

Treatment with ondansetron resulted in a small but statistically significant improvement in stool consistency. The mean difference in BSF score between ondansetron and placebo was -0.9 (95% confidence interval [CI], -1.1 to -0.6; P<.001), indicating slightly more formed stool with use of ondansetron. The IBS Severity Scoring System score (maximum score 500 points, with mild, moderate, and severe cases indicated by scores of 75-175, 175-300, and >300, respectively) was reduced by more points with ondansetron than placebo (83 ± 9.8 vs 37 ± 9.7; P=.001). Although this mean difference of 46 points fell just short of the 50-point threshold that is considered clinically significant, many patients exceeded this threshold.

For patients with IBS-D, ondansetron reduced frequency of defecation and bloating, but did not relieve pain. Compared to those who received placebo, patients who took ondansetron also had less frequent defecation (P=.002) and lower urgency scores (P<.001). Gut transit time was lengthened in the ondansetron group by 10 hours more than in the placebo group (95% CI, 6-14 hours; P<.001). Pain scores did not change significantly for patients taking ondansetron, although they experienced significantly fewer days of urgency and bloating. Symptoms typically improved in as little as 7 days but returned after stopping ondansetron, typically within 2 weeks. Sixty-five percent of patients reported adequate relief with ondansetron, compared to 14% with placebo.

Patients whose diarrhea was more severe at baseline didn’t respond as well to ondansetron as did those whose diarrhea was less severe. The only frequent adverse effect was constipation, which occurred in 9% of patients receiving ondansetron and 2% of those on placebo.

WHAT’S NEW: Another option for IBS patients
 with diarrhea


A prior, smaller study of ondansetron that used a lower dosage (12 mg/d) suggested benefit in IBS-D.¹⁴ In that study, ondansetron decreased diarrhea and functional dyspepsia. The study by Garsed et al¹ is the first large RCT to show significantly improved stool consistency, less frequent defecation, and less urgency and bloating from using ondansetron to treat IBS-D.

CAVEATS: Ondansetron doesn’t appear 
to reduce pain


In Garsed et al,¹ patients who received ondansetron did not experience relief from pain, which is one of the main complaints of IBS. However, this study did find slight improvement in formed stools, symptom relief that approached—but did not quite reach—clinical significance, fewer days with urgency and bloating, and less frequent defecation. This study did not evaluate the long-term effects of ondansetron use. However, ondansetron has been used for other indications for more than 25 years and has been reported to have a low risk of adverse effects.¹⁵

CHALLENGES TO IMPLEMENTATION: Remember ondansetron 
is not for IBS patients with constipation

Proper use of this drug among patients with IBS is key. The primary benefits of ondansetron are limited to IBS patients who suffer from diarrhea, and not constipation. Ondansetron should not be prescribed to IBS patients who experience constipation, or those with mixed symptoms.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Click here to view PURL METHODOLOGY

Illustrative case

A 23-year-old woman who was diagnosed with irritable bowel syndrome (IBS) comes to your clinic with complaints of increased frequency of defecation with watery stools and generalized, cramping abdominal pain. She also notes increased passage of mucus and a sensation of incomplete evacuation. She says the only thing that relieves her pain is defecation. She has tried loperamide, acetaminophen, and ibuprofen without relief. She does not have Crohn’s disease or ulcerative colitis. What else can you offer her that is safe and effective?

IBS is a chronic, episodic functional gastrointestinal disorder characterized by abdominal pain or discomfort and altered bowel habits (constipation [IBS-C], diarrhea [IBS-D], or alternating periods of both—mixed [IBS-M]).² It is diagnosed based on Rome III criteria—recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with ≥2 of the following: improvement with defecation, onset associated with a change in frequency of stool, and onset associated with a change in form (appearance) of stool.³ IBS often is unrecognized or untreated, and as few as 25% of patients with IBS seek care.⁴

IBS-D affects approximately 5% of the general population in North America.^5,6 IBS-D is associated with a considerably decreased quality of life and is a common cause of work absenteeism.^7,8 Because many conditions can cause diarrhea, patients typically undergo numerous tests before receiving an accurate diagnosis, which creates a financial burden.⁹

For many patients, current IBS treatments, which include fiber supplements, laxatives, antidiarrheal medications, antispasmodics, and antidepressants such as tricyclics and selective serotonin reuptake inhibitors, are unsatisfactory.¹⁰ Alosetron, a 5-hydroxytryptamine 3 (5HT3) receptor antagonist, has been used to treat IBS-D,¹¹ but this medication was voluntarily withdrawn from the US market in 2000 due to concerns of ischemic colitis and severe constipation.¹² It was reintroduced in 2002, but can be prescribed only by physicians who enroll in a prescribing program provided by the manufacturer, and the drug has restrictions on its use.

Ondansetron—a different 5HT3 receptor antagonist used to treat nausea and vomiting caused by chemotherapy—may be another option for treating IBS-D. Garsed et al¹ recently conducted a RCT to evaluate the efficacy of ondansetron for patients with IBS-D.

STUDY SUMMARY: Ondansetron improves stool consistency, severity of IBS symptoms


In a 5-week, double-blind crossover RCT, Garsed et al¹ compared ondansetron vs placebo for symptom relief in 120 patients who met Rome III criteria for IBS-D. All patients were ages 18 to 75 and had no evidence of inflammatory bowel disease. Exclusion criteria were pregnancy or breastfeeding, unwillingness to stop antidiarrheal medication, prior abdominal surgery other than appendectomy or cholecystectomy, or being in another trial. Patients were started on ondansetron 4 mg/d with dose titration up to 24 mg/d based on response; no dose adjustments were allowed during the last 2 weeks of the study. There was a 2- to 3-week washout between treatment periods.

The primary endpoint was average stool consistency in the last 2 weeks of treatment, as measured by the Bristol Stool Form (BSF) scale.¹³ The BSF is a visual scale that depicts stool as hard (Type 1) to watery (Type 7); types 3 and 4 describe normal stools. The study also looked at urgency and frequency of defecation, bowel transit time, and pain scores.

Treatment with ondansetron resulted in a small but statistically significant improvement in stool consistency. The mean difference in BSF score between ondansetron and placebo was -0.9 (95% confidence interval [CI], -1.1 to -0.6; P<.001), indicating slightly more formed stool with use of ondansetron. The IBS Severity Scoring System score (maximum score 500 points, with mild, moderate, and severe cases indicated by scores of 75-175, 175-300, and >300, respectively) was reduced by more points with ondansetron than placebo (83 ± 9.8 vs 37 ± 9.7; P=.001). Although this mean difference of 46 points fell just short of the 50-point threshold that is considered clinically significant, many patients exceeded this threshold.

For patients with IBS-D, ondansetron reduced frequency of defecation and bloating, but did not relieve pain. Compared to those who received placebo, patients who took ondansetron also had less frequent defecation (P=.002) and lower urgency scores (P<.001). Gut transit time was lengthened in the ondansetron group by 10 hours more than in the placebo group (95% CI, 6-14 hours; P<.001). Pain scores did not change significantly for patients taking ondansetron, although they experienced significantly fewer days of urgency and bloating. Symptoms typically improved in as little as 7 days but returned after stopping ondansetron, typically within 2 weeks. Sixty-five percent of patients reported adequate relief with ondansetron, compared to 14% with placebo.

Patients whose diarrhea was more severe at baseline didn’t respond as well to ondansetron as did those whose diarrhea was less severe. The only frequent adverse effect was constipation, which occurred in 9% of patients receiving ondansetron and 2% of those on placebo.

WHAT’S NEW: Another option for IBS patients
 with diarrhea


A prior, smaller study of ondansetron that used a lower dosage (12 mg/d) suggested benefit in IBS-D.¹⁴ In that study, ondansetron decreased diarrhea and functional dyspepsia. The study by Garsed et al¹ is the first large RCT to show significantly improved stool consistency, less frequent defecation, and less urgency and bloating from using ondansetron to treat IBS-D.

CAVEATS: Ondansetron doesn’t appear 
to reduce pain


In Garsed et al,¹ patients who received ondansetron did not experience relief from pain, which is one of the main complaints of IBS. However, this study did find slight improvement in formed stools, symptom relief that approached—but did not quite reach—clinical significance, fewer days with urgency and bloating, and less frequent defecation. This study did not evaluate the long-term effects of ondansetron use. However, ondansetron has been used for other indications for more than 25 years and has been reported to have a low risk of adverse effects.¹⁵

CHALLENGES TO IMPLEMENTATION: Remember ondansetron 
is not for IBS patients with constipation

Proper use of this drug among patients with IBS is key. The primary benefits of ondansetron are limited to IBS patients who suffer from diarrhea, and not constipation. Ondansetron should not be prescribed to IBS patients who experience constipation, or those with mixed symptoms.

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Click here to view PURL METHODOLOGY

I think today’s EHRs are like an old-fashioned crank phone and what we really need is an iPhone. Clicking on a checklist of symptoms seldom provides sufficient information about the patient’s illness. “Hypertension” and “type 2 diabetes” are not assessments; they are diagnoses that do not tell the person reading the electronic health record (EHR) how the patient is doing. A diagnosis of “abdominal pain” without a prioritized differential is inadequate, especially in court.

Why is visit documentation too often inadequate? I am convinced it is rarely due to clinician incompetence, laziness, or lack of knowledge, but nearly always due to a combination of inadequate EHR formats and billing documentation requirements that encourage quantity rather than quality. Documentation is no longer driven by the essential need to record the care provided.

I’m sure a lot of you are nodding your heads in agreement. You all know what those EHR notes look like—cluttered with cut-and-pasted information drawn from prior encounters that document no end of details regarding medical, family, and social histories, facts that are often completely irrelevant to the reason the patient is in the office today. And unless one meticulously updates those other elements of the patient’s record, this information pulled into the note may be inaccurate.

I am not the only one complaining. The American Medical Association just published Improving Care: Priorities to Improve Electronic Health Record Usability,¹ which outlines 8 priorities for EHR improvement. The first is to “Enhance physicians’ ability to provide high-quality patient care.” I could not agree more. I think today’s EHRs are like an old-fashioned crank phone and what we really need is an iPhone.

Something has got to change.

So tell me: Have any of you figured out how to use your EHR to enhance the quality of your documentation?

I think today’s EHRs are like an old-fashioned crank phone and what we really need is an iPhone. Clicking on a checklist of symptoms seldom provides sufficient information about the patient’s illness. “Hypertension” and “type 2 diabetes” are not assessments; they are diagnoses that do not tell the person reading the electronic health record (EHR) how the patient is doing. A diagnosis of “abdominal pain” without a prioritized differential is inadequate, especially in court.

Why is visit documentation too often inadequate? I am convinced it is rarely due to clinician incompetence, laziness, or lack of knowledge, but nearly always due to a combination of inadequate EHR formats and billing documentation requirements that encourage quantity rather than quality. Documentation is no longer driven by the essential need to record the care provided.

I’m sure a lot of you are nodding your heads in agreement. You all know what those EHR notes look like—cluttered with cut-and-pasted information drawn from prior encounters that document no end of details regarding medical, family, and social histories, facts that are often completely irrelevant to the reason the patient is in the office today. And unless one meticulously updates those other elements of the patient’s record, this information pulled into the note may be inaccurate.

I am not the only one complaining. The American Medical Association just published Improving Care: Priorities to Improve Electronic Health Record Usability,¹ which outlines 8 priorities for EHR improvement. The first is to “Enhance physicians’ ability to provide high-quality patient care.” I could not agree more. I think today’s EHRs are like an old-fashioned crank phone and what we really need is an iPhone.

Something has got to change.

So tell me: Have any of you figured out how to use your EHR to enhance the quality of your documentation?

I think today’s EHRs are like an old-fashioned crank phone and what we really need is an iPhone. Clicking on a checklist of symptoms seldom provides sufficient information about the patient’s illness. “Hypertension” and “type 2 diabetes” are not assessments; they are diagnoses that do not tell the person reading the electronic health record (EHR) how the patient is doing. A diagnosis of “abdominal pain” without a prioritized differential is inadequate, especially in court.

Why is visit documentation too often inadequate? I am convinced it is rarely due to clinician incompetence, laziness, or lack of knowledge, but nearly always due to a combination of inadequate EHR formats and billing documentation requirements that encourage quantity rather than quality. Documentation is no longer driven by the essential need to record the care provided.

I’m sure a lot of you are nodding your heads in agreement. You all know what those EHR notes look like—cluttered with cut-and-pasted information drawn from prior encounters that document no end of details regarding medical, family, and social histories, facts that are often completely irrelevant to the reason the patient is in the office today. And unless one meticulously updates those other elements of the patient’s record, this information pulled into the note may be inaccurate.

I am not the only one complaining. The American Medical Association just published Improving Care: Priorities to Improve Electronic Health Record Usability,¹ which outlines 8 priorities for EHR improvement. The first is to “Enhance physicians’ ability to provide high-quality patient care.” I could not agree more. I think today’s EHRs are like an old-fashioned crank phone and what we really need is an iPhone.

Something has got to change.

So tell me: Have any of you figured out how to use your EHR to enhance the quality of your documentation?