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Feasibility of Quantitative Pain Assessment in Outpatient Oncology Practice

From the Johns Hopkins Hospital and St Agnes Hospital, Baltimore, MD.

Address reprint requests to Deborah J Rhodes, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; email rhodes.deborah@ mayo.edu.

	ABSTRACT

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
PURPOSE: Although physicians view failure to assess pain systematically as the most important barrier to outpatient cancer pain management, little is known about pain assessment in this setting. We sought to determine whether pain is routinely assessed and whether routine quantitative pain assessment is feasible in a busy outpatient oncology practice.

PATIENTS AND METHODS: We conducted a pre- and postintervention chart review of 520 randomly selected medical and radiation oncology patient visits at a community hospital-based private outpatient practice. The intervention consisted of training health assistants (HAs) to measure and document patient pain scores by using a visual analog scale. The main outcome measures included HA documentation of patient pain scores, quantitative and qualitative mention of pain in the physician note, and analgesic treatment before and after the intervention.

RESULTS: After the intervention, HA documentation of pain scores increased from 1% to 75.6% (P < .0001). Physician documentation increased from 0% to 4.8% for quantitative documentation (P < .01), and from 60.0% to 68.3% for qualitative documentation (not significant). Of all the patients, 23.1% reported significant pain. Subgroups with greater pain included patients actively receiving radiation treatments and patients with lung cancer. Of patients with signifi-cant pain, 28.2% had no mention of pain in the physician note and 47.9% had no documented analgesic treatment.

CONCLUSION: Quantitative pain assessment was virtually absent before our intervention but easily implemented and sustained in a busy outpatient oncology practice. Pain score collection identified a high prevalence of pain, patient subgroups at risk for pain, and a significant proportion of patients with pain that was neither evaluated nor treated by their oncologists.

	INTRODUCTION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
MORE THAN 70% OF patients with cancer develop significant pain during the course of their illness.¹ Data suggest that most cancer pain can be well controlled with oral analgesics; with supplemental therapeutic modalities, approximately 95% of patients can be free of significant pain.^2,3 However, despite the publication and widespread distribution of guidelines^4-6 for pain management, many patients with cancer receive inadequate analgesia.^7-9

Studies have documented that many patients do not report pain unless specifically asked.^10-12 Yet, in a large survey of physicians caring for outpatients with cancer, failure to conduct routine pain assessment was rated by 76% of physicians as the single most important barrier to adequate pain management.¹² Pain assessment, when based on the caregiver’s estimation of the patient’s pain, correlates poorly with the patient’s pain rating, and a discrepancy between physician perception and patient report of pain intensity has been shown to be predictive of inadequate pain management.^9,13,14

Numerical rating scales provide reliable and valid measures of pain intensity.³ Pain management has been shown to improve when routine pain assessment is based on a quantitative pain rating scale.¹⁴ The National Comprehensive Cancer Network Practice Guidelines for cancer pain base all therapeutic recommendations on a quantitative pain assessment.¹⁵ Furthermore, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently announced that all outpatient clinics will be called on to "recognize the right of patients to appropriate assessment and management of pain; assess the existence and...intensity of pain in all patients; and record the results of the assessment in a way that facilitates regular reassessment and follow-up".¹⁶

Despite this clear directive, little is known about the frequency or method of pain assessment in outpatient oncology practice, particularly in community-based settings. Furthermore, long-term feasibility of incorporating patient pain rating scales into oncology outpatient evaluation has not been studied. We sought to answer the following questions: Is pain routinely assessed in outpatient oncology practice? Is routine quantitative pain assessment and documentation feasible and sustainable in a busy outpatient oncology practice? Are routine quantitative pain assessment and documentation useful in influencing physician management of pain, characterizing the prevalence of pain, identifying patients with pain not noted by the physician, and identifying patients with untreated pain?

	PATIENTS AND METHODS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
Setting and Measures
On January 30, 1995, the routine collection of patient pain scores was instituted at a community hospital–based outpatient oncology practice in Baltimore, Maryland, employing four medical oncologists and two radiation oncologists. Pain intensity was assessed by using the Hopkins Pain Rating Instrument, a plastic, two-sided instrument with a sliding marker that has been shown to be a reliable and valid tool to assess pain intensity ( Fig 1). ¹³ The side facing the patient is a traditional visual analog scale, while the side facing the observer is marked in centimeter increments from zero to 10. On the basis of previous studies, we defined a score 4 as "significant pain" and a pain score 7 as "severe pain."¹⁷ The medical and radiation oncology health assistants (HAs) participated in a brief in-service, during which the importance of patient pain assessment was emphasized and the use of the pain-rating instrument was demonstrated. The HAs were instructed to present the pain-rating instrument to the patient at the time of vital sign measurement and to state the following:

View larger version (77K): [in this window] [in a new window]   Fig 1. The Johns Hopkins Pain Rating Instrument.

HAs were asked to record the number corresponding to the position of the black marker in the medical record next to the vital signs. The HAs were advised not to question the patient’s response and to refer any patient questions regarding pain to the physician. The HAs received no further formal training or review in pain assessment or documentation.

The six oncology providers were made aware that the HAs would be recording patient pain scores in the chart next to the vital signs for the purpose of pain assessment and documentation. However, the physicians were neither instructed nor encouraged to alter their practice of patient evaluation or pain management, nor were they reminded of the pain score documentation thereafter.

Sample
Based on a predetermined sample of different days of the week and different weeks in each month, a random series of patient visits was selected from the appointment calendars of all six providers. All patients scheduled for a physician visit on the selected dates were eligible for sampling. Exclusion criteria are listed in Table 1. The most common reason for exclusion was that the patient missed or canceled the appointment. Patients included in the preintervention sample were excluded from the postintervention sample.

The sampling strategy for the Active Rad group differed from the above sampling strategies because patients generally were scheduled for daily rather than periodic visits during their treatment period and did not see a physician during most of these visits. To obtain a sample size that, when added to the Active Rad group, would approximate the size of the postintervention medical oncology group, we chose a 4-month interval for review. Beginning 19 months after the intervention, we reviewed every patient visit for the duration of radiation treatments for every patient who received radiation during that interval, regardless of whether that visit included a physician consultation.

Dependent and Independent Variables
The data were collected by using chart abstraction. Chart reviews were conducted by two of the investigators (D.J.R. and R.C.K.). In addition to the intervention, independent variables included patient age, sex, race, and cancer diagnosis. The primary dependent variable was the documentation of a pain score by the HA. Other dependent variables included (1) the pain score; (2) documentation of the pain score by the physician; (3) qualitative documentation of pain by the physician (defined as any mention of the presence or absence of pain or discomfort in the history or physical exam narrative, with the exception of the phrase "nontender/nondistended" to describe the abdominal exam, excluded because it is common usage even when pain is not specifically addressed); and (4) analgesic treatment documented in the chart (defined as nonopioid or opioid analgesics which the patient was taking at the time of the visit or which were prescribed as a result of the visit).

Data collection for the Active Rad group differed slightly from that of the other four groups. The primary dependent variable was the frequency of pain score documentation by the HA for all visits during the patient’s radiation treatment. Other dependent variables included (1) the maximum pain score recorded by the HA at any of the visits during the course of the patient’s radiation treatment; and (2) analgesic treatment documented in the chart (any analgesics prescribed during the course of radiation treatment). Qualitative pain assessment by physicians was not evaluated, because the majority of these patient visits did not include a physician consultation.

Analyses
To evaluate the feasibility of quantitative pain assessment, we used a ² test or a two-tailed Fisher’s exact test to compare the pre- and postintervention proportions of charts containing a pain score. To assess the sustainability of quantitative pain assessment, we used a ² test to compare the difference in the frequency of HA pain score documentation between the first and second halves of the chart review period. To assess pain treatment, we determined the proportion (and 95% confidence intervals) of patients for whom nonopioid and opioid analgesics were documented at the time of or as a result of the visit.

The relationships of HA pain score documentation, pain scores, physician documentation, and analgesic treatment were examined by using a ² test of proportions. For analyses involving small sample sizes, a Fisher’s exact test was used. An odds ratio was used to examine the relationship between numerical pain score and (1) the likelihood of the physician note acknowledging patient pain; and (2) the likelihood of receiving analgesic treatment.

	RESULTS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
A total of 795 patient charts was selected for review. A total of 520 charts met the inclusion criteria and comprised the study sample (Table 1). Patient characteristics are listed in Table 2.

Both before and after the intervention, the majority of qualitative descriptions of pain in physician notes referred to the absence of pain, eg, "denies bone pain" or "no headache, no bone pain." Other notes provided a brief description of pain (usually confined to one sentence) which primarily concerned the anatomic location, such as "patient reports back pain, chest pain, and pain in left maxillary region," "aching in leg persists but no pain in lumbar region," "significant headache over the last few months is getting better," or "some nausea/vomiting, primarily abdominal pain."

Combining the postintervention medical and radiation oncology groups, 28.2% of patient visits with pain scores 4 had no acknowledgment of pain in the corresponding physician note. There were no statistically significant associations between the presence of a qualitative description of pain in the physician’s note and patient age, sex, or race. In the medical oncology group, patients with lung cancer were more likely to have a qualitative assessment of pain in the physician note than patients with the other common diagnoses (P = .003). This was not true in the radiation oncology group. The higher qualitative pain documentation among medical oncology patients with lung cancer was unrelated to sex, as the patients with lung cancer were fairly evenly distributed between the sexes (53% male patients). There was no statistically significant difference in the frequency of HA pain score documentation between the first and second halves of the chart review period (P > .05).

Pain Scores
Table 4 shows the distribution of HA-documented pain scores. Of medical oncology patient visits with a documented pain score, 21.6% had pain scores 4, and 12.8% had pain scores 7. Of patient visits with a documented pain score in the Inactive Rad group, 12.3% had pain scores 4, and 10.5% had pain scores 7. Of patients with at least one documented pain score in the Active Rad group, 31.4% had maximum pain scores 4 and 16.7% had maximum pain scores 7. For the groups combined, 23.1% had pain scores 4 and 13.7% had pain scores 7.

Pain Treatment
Before the intervention, the percentage of patients who were receiving or prescribed an analgesic at the time of their visit was 14.3% in the medical oncology group (3.3% nonopioid, 11.0% opioid or combination therapy) and 13.6% in the radiation oncology group (9.1% nonopioid, 4.5% opioid or combination therapy). After the intervention, the percentage of patients receiving or prescribed an analgesic at the time of their visit was 19.4% in the medical oncology group (4.7% nonopioid, 14.7% opioid or combination therapy) and 19.8% in the Inactive Rad group (6.2% nonopioid, 13.6% opioid or combination therapy). The difference between the proportion of patients receiving analgesics before and after the intervention was not statistically significant for either medical or radiation oncology (P = .37, P = .54). Although there was no comparable preintervention group for comparison, 33.3% in the Active Rad group were receiving or prescribed an analgesic at the time of their visit (14.9% nonopioid, 18.4% opioid or combination therapy).

Table 5 shows the percentage of postintervention patients with pain scores 4 who received only nonopioid analgesics, opioid analgesics (either alone or in combination with a nonopioid analgesic), or no recorded analgesic. Overall, 47.9% of patients with pain scores 4 had no analgesic treatment documented in their medical record.

View this table: [in this window] [in a new window]   Table 5. Patients With Pain Score 4 Receiving Nonopioid Analgesics, Opioid Analgesics (or both), and No Analgesic Therapy

For all three postintervention groups, the odds of receiving analgesic treatment was greater for patients with pain scores 4 than for patients with pain scores less than 4 (odds ratios [with 95% confidence intervals], 7.6 [3.2 to 18.3], 3.6 [0.7 to 21.3], and 3.7 [1.6 to 8.9] for medical oncology, Inactive Rad, and Active Rad, respectively).

	DISCUSSION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
In this study of the frequency and method of pain assessment in a community hospital–based outpatient oncology practice, we found that patient pain intensity was rarely assessed quantitatively by physicians or HAs. Before the intervention, no method was used routinely to ascertain the intensity of patients’ pain or their response to treatment. We found that it was feasible to implement routine patient pain intensity rating documentation in a busy outpatient oncology practice. With minimal training of the HAs, pain score documentation increased from 0% to more than 70% for the groups combined.

Furthermore, we found that documentation of numerical pain ratings by the HAs could be sustained over time. This is important for two reasons. First, to assess a patient’s changing need for and response to analgesic treatment, quantitative patient pain intensity ratings must be documented at each successive patient visit, just as serial blood pressure measurements are used to titrate antihypertensive medications. Second, the sustained collection of patient pain intensity ratings is an important means of tracking the longitudinal performance of a practice in regard to pain management: pain scores provide an indicator for both the prevalence of pain in the patient population and the effectiveness of individual physicians in managing pain. Large-scale studies and guidelines addressing the undertreatment of cancer pain may be less meaningful to individual physicians than numerical data tracking pain prevalence among their own patients. By collecting these data for all providers, pain assessment could be used as a quality assessment tool to provide important feedback to individual physicians and the group.

However, our study suggests that merely documenting the pain score is not sufficient to change physician behavior in regard to pain management. Our study was not designed to effect or assess change in physician behavior as a result of pain score documentation. Nevertheless, we found that very few of the physicians included a numerical pain rating in their notes, either before or after the intervention. Qualitative acknowledgment of pain in the physician notes increased only marginally after the intervention. Given the minimal impact that pain score documentation had on physician documentation, it is unlikely that pain score documentation influenced pain management.

These findings are consistent with other studies that document that the provision of functional status information to physicians does not, itself, lead to improved patient outcomes.¹⁸ Physicians rarely receive training in the use and interpretation of standardized patient assessment tools (such as quality of life scales or functional status scales), and so must be educated about their interpretation and convinced of their utility. Au et al¹⁴ demonstrated, in the inpatient setting, that regular use of a numerical pain scale did not improve caregivers’ understanding of oncology inpatient pain intensity until it was accompanied by an "intensive educational effort." Similarly intensive educational efforts may also be necessary to improve oncologists’ use of quantitative pain scores in the outpatient setting. However, it would be premature to design or assess such educational efforts before determining whether pain was routinely assessed in outpatient practice and whether routine quantitative documentation was feasible and sustainable. Having demonstrated that pain was not routinely assessed in this outpatient practice, but was readily introduced through a simple intervention, we must now turn our attention to determining the most effective way to improve physician use of patient pain scores in the outpatient setting.

Pain score documentation provided information about this oncology practice that could be used to direct pain management initiatives. First, pain was common in this practice: overall, almost a quarter of the patients reported significant pain. Estimates of pain prevalence in our study population are not as high as those of a recent large study in outpatients with cancer by Cleeland et al,⁹ but the difference is most likely related to a difference in study subjects: Cleeland et al, examined patients with metastatic or recurrent cancer, whereas our study examined all patients seen in an outpatient oncology practice, many of whom had no evidence of disease at the time of evaluation.

Second, pain was often undocumented by the physician. In this age of utilization review, failure to document is tantamount to failure to address. At midyear 2000, the JCAHO will begin to monitor the ability of accredited outpatient clinics to assess and document patient pain intensity.¹⁶ We found that, for more than one fourth of the patients with moderate to severe pain (defined by a pain score 4), pain was either denied or unacknowledged in the corresponding physician note. Thus, the routine collection of pain scores could identify a significant proportion of patients with pain that might otherwise go undetected.

Third, documentation of patient pain scores identified patient subgroups at risk for pain. A greater percentage of patients actively receiving radiation treatment reported significant pain (31.4%) compared with patients seen before initiation or after completion of their radiation treatment (12.3%). Men in the inactive radiation oncology group were less likely to receive analgesic therapy than women in this group, despite similar reports of pain. Medical oncology patients with breast and ovarian cancer were less likely to have pain than patients with lung cancer. Because of the interdependence of sex and breast/ovarian cancers, it is not possible to determine the degree to which sex contributed to the paucity of pain among patients with these diagnoses. Lung cancer patients were both more likely to report pain and more likely to receive analgesics than medical oncology patients with other diagnoses. It is unlikely that sex influenced pain scores among patients with lung cancer, because patients were fairly evenly distributed between the sexes (55.6% men). Alternatively, these relationships among cancer type, pain, and treatment may be related to severity of illness. However, because we did not collect information on stage of disease, we are not able to determine whether this is a confounding variable.

Finally, the findings suggest a strong likelihood that this group of patients was receiving inadequate pain treatment. In the postintervention groups combined, almost half of the patients (47.9%) reporting significant pain received no analgesic. These data support Cleeland et al’s⁹ finding that almost half of the oncology outpatients with significant pain were not given adequate analgesic therapy.

This study has several strengths. First, we studied a large, demographically diverse group of patients in a community-based setting. Second, this study expands on Cleeland et al’s⁹ finding that physicians caring for cancer patients perceived poor pain assessment to be central to inadequate pain management: our study documents that pain was not routinely assessed by the health providers at an outpatient oncology practice until the intervention.

Third, to our knowledge, this is the first study to demonstrate that routine pain assessment can be incorporated into outpatient oncology practice through an intervention that is both easy to implement and to sustain. The ease of implementation renders pain score documentation feasible in a wide variety of practice settings. While a previous study by Trowbridge et al¹⁹ has demonstrated that provision of outpatient pain assessment scales to oncologists did alter analgesic prescription patterns, the method of supplying such pain data was more labor intensive than in our intervention. In this study, patients completed assessments that described their estimates of average and worst pain in the previous seven days, their pain regimens, and the degrees of relief received. This information was then translated into a summary sheet of completed pain scales that was given to the oncologists to review before an evaluation. The translation of each patient survey into a summary sheet for the oncologist requires additional steps relative to our intervention and may therefore be less feasible or cost-effective in a busy practice.

Finally, our study demonstrates that routine pain assessment can be sustained over time, whereas other interventions to document pain intensity have been limited by short duration of assessment of pain documentation.^14,19 This is a critical advantage, as the JCAHO has emphasized that outpatient clinics must record results of pain assessment in a way that "facilitates regular reassessment and follow-up."¹⁶

Our study has several limitations. First, our data on cancer pain prevalence and treatment practices may not be generalized to all outpatient oncology settings. However, this only underscores the need for each individual practice to collect practice-specific data based on routine pain score documentation. Second, the Hopkins Pain Rating Instrument measures only the intensity component of the sensory dimension of pain, as opposed to the multiple dimensions addressed by more comprehensive instruments, such as the McGill Pain Questionnaire.^17,20,21 However, lengthy questionnaires are less suited to repeated clinical assessments and are impractical instruments for routine pain assessment. Furthermore, the severity of pain is one dimension of pain of particular significance to patients.

Third, we relied on the medications documented in the physician notes to determine whether a patient was prescribed analgesic therapy, which may be an inaccurate proxy for the number of patients actually taking analgesics. Nevertheless, it is likely that we underestimated the discrepancy between patients with pain and the provision of analgesic treatment, given our liberal definition of treatment. For instance, patients who had pain scores consistent with moderate or severe pain were classified as having received analgesic treatment even if their existing analgesic regimen was not altered at the time of the visit in response to their uncontrolled pain.

Finally, we did not distinguish between cancer-related pain and noncancer-related pain in this study because it was often impossible to determine the source of the patient’s reported pain from the corresponding physician note. However, it is appropriate for the oncologist to evaluate and treat all symptoms of pain, regardless of whether the pain is subsequently determined to be unrelated to the patient’s cancer.

Our study raises several issues for further study. Clearly, the documentation of pain scores is useful to patients only if physicians use them to improve pain management. A controlled trial, in which patients were randomly assigned either to evaluation by a HA instructed to collect pain scores or to a HA not instructed to collect pain scores, would be needed to determine the efficacy of pain score collection in improving pain management. If efficacy could not be demonstrated, it would be important to determine why physicians do not use pain intensity ratings to establish appropriate treatment plans and how to influence physician pain assessment and management patterns. A study examining pain score documentation as a quality assessment tool would shed light on the utility of pain score documentation for influencing practice patterns. It would also be interesting to determine whether routine pain score collection was associated with improved patient satisfaction, decreased patient visits and hospitalizations, and/or decreased cost of care.

Failure to assess pain is a major cause of untreated pain. In general, oncologists and other physicians are unaccustomed to using standardized, patient-reported measures in their practice.²² However, the pain assessment tool applied in this study requires little more effort than taking a blood pressure measurement, with minimal demands on the patient. Scoring is automatic, and the results are readily interpretable. Routine pain score documentation could reduce rather than add to the physician’s workload by providing a "flag" to identify patients in whom pain needs to be addressed in detail, just as HA documentation of an elevated temperature should prompt a search for an infectious source. Indeed, the method of pain assessment described in this article is well suited to satisfy the JCAHO mandate that "pain is considered the ‘fifth’ vital sign," and that "pain intensity ratings are recorded along with temperature, pulse, respiration, and blood pressure."²³

Routine assessment and documentation of pain intensity is the foundation of pain evaluation and treatment, but its effectiveness depends on a commitment from the physician to acknowledge the pain score and make appropriate inquiries and interventions. The JCAHO has made it clear that such a commitment will no longer be optional: accreditation of ambulatory care organizations will be linked to provision of appropriate assessment and management of pain. While more study is needed to determine the optimal methods of educating physicians in the effective use of quantitative pain ratings, the potential rewards are numerous. Routine pain assessment encourages patients to communicate symptoms of pain that may otherwise go unreported, alerts physicians to new sources of pain that may require emergent treatment or have diagnostic import, provides physicians with an ongoing measure of response to pain treatments, yields data for feedback to individual physicians within the group about their evaluation and management of pain, and serves as a quality assessment tool for physician groups. Most important, patient pain intensity ratings could be used to ensure that the prevalence of untreated cancer pain in any practice is decreasing, and that individual patients receive pain assessment, evaluation, and appropriate treatment at every visit.

	ACKNOWLEDGMENTS

 
Supported by the Robert Wood Johnson Clinical Scholars Program.

We thank Yen-Hong Kuo for his assistance with statistical analysis.

	REFERENCES

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION REFERENCES

 
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4. Jacox A, Carr DB, Payne R, et al: Management of Cancer Pain: Clinical Practice Guideline No. 9. Rockville, MD, Agency for Health Care Policy and Research, US Department of Health and Human Services, 1994 (AHCPR Publication No. 94-0592)

5. World Health Organization: Cancer Pain Relief. Geneva: World Health Organization, 1986

6. American Pain Society Quality of Care Committee: Quality improvement guidelines for the treatment of acute pain and cancer pain. JAMA 274:1874-1880, 1995

7. Zhukovsky DS, Gorowski E, Hausdorff J, et al: Unmet analgesic needs in cancer patients. J Pain Symptom Manage 10: 113-119, 1995[Medline]

8. Daut RL, Cleeland CS: The prevalence and severity of pain in cancer. Cancer 50: 1913-1918, 1982[Medline]

9. Cleeland CS, Gonin R, Hatfield AK, et al: Pain and its treatment in outpatients with metastatic cancer. N Engl J Med 330: 592-596, 1994[Abstract/Free Full Text]

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11. Cleeland CS: The impact of pain on the patient with cancer. Cancer 54: 2635-2641, 1984[Medline]

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23. Joint Commission on Accreditation of Healthcare Organizations: 1999-2000 Comprehensive Accreditation Manual for Ambulatory Care (CAMAC): Patient Rights and Organization Ethics. August 3, 1999, Available at: http://www.jcaho.org.

Submitted February 11, 1999; accepted August 14, 2000.

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