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Study 2 Citation:  Chang VT, Hwang SS, Kasimis B

Longitudinal documentation of cancer pain management outcomes: a pilot study at a VA medical center

J Pain Symptom Manage. 2002;24(5):494-505

 

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Abstract:
This study was completed to demonstrate that pain management efforts in severe cancer-related pain could result in beneficial effects to quality of life and pain-related evaluations.  Patients who experienced severe cancer-related pain (n=74) were recruited to participate in this evaluation of pain treatment according to the United States Agency for Health Care Policy and Research (AHCPR).  After one week, pain evaluations showed a pain relief of 80% or more.  After three weeks of treatment significant changes were seen in distress and quality of life scores.

  Key Words:

Pain relief, pain management, pain-related distress, cancer-related pain, quality of life, outcomes, US AHCPR guidelines

 

Discussion:

Cancer patients at the Veterans Administration New Jersey Health Care System are routinely evaluated for pain.  Researchers conducted this study to assess pain relief outcomes of pain management strategies outlined by the AHCPR.  More recently, the AHCPR guidelines have been placed in archives and are no longer considered to be the basis for recommended clinical care (see Introduction section for more information on recent guidelines). 

Out of the 89 patients originally screened for study enrollment four were either too sick or refused to enroll, four did not qualify for a diagnosis of cancer-related pain, and seven were unable to complete patient surveys.  Demographics and pain inventories were conducted on the remaining 74 patients with a pain score of >4 on the Brief Pain Inventory (BPI) numerical scale rating pain from 0-10.  Additional pain inventories included the Visual Analogue Scale Global Quality of Life (VASQOL).  Satisfaction and therapy expectation surveys consisted of questions on therapy satisfaction and how well pain management met expectations scored on a Likert scale of 0-4.  Satisfaction, expectation, and pain inventories were conducted weekly for the duration of the three-week study.  The Functional Assessment Cancer Therapy (FACT-G) was used to assess physical, emotional, social, and functional status.  The Memorial Symptom Assessment Scale-Short Form (MSAS-SF) was used to evaluate symptom distress through a number of symptoms, physical and psychological distress, and a global distress index.  The FACT-G and MSAS-SF were conducted at day one and week three of the study.  Patient satisfaction consisted of expectations for pain therapy and satisfaction with effectiveness of treatments.  Side effects included a survey of items most often attributed to the use of opioids such as loss of appetite, nausea and vomiting, constipation, dry mouth, fatigue, and others.  The clinicians received information on the BPI and side effects questionnaires but were blinded to the other surveys.  Patients completed baseline surveys in approximately 20 minutes with follow-up surveys taking an average of about 10 minutes to complete.

Demographic data showed that there were 39 inpatients and 35 outpatients enrolled, most of who had lung or prostate sites for their primary cancer.  It was determined that 45/74 had caregivers at home.  At baseline the median number of pain sites was 1, mostly in the abdomen, chest, and shoulder, which remained the same during the study.  Primary pain syndromes were mostly bone pain and local disease.  Forty patients had a single pain diagnosis and 34 had two pain diagnoses.  Pain classification of the only or primary pain diagnosis included 32/74 with neuropathic pain, 32/74 with somatic pain, and 10/74 with visceral pain.  Additional pain categories reported as secondary included neuropathic (11/34), somatic (18/34), and visceral (4/34).  By week three, eight participants reported no sites of pain while 28 developed new pain sites.  The dropout rate was high in this study with a loss of approximately 10% of the patients per week of the study mostly due to disease progression.  

AHCPR guidelines were used to guide treatment of pain, and follow-up visits provided the opportunity to evaluate changes in the medication regimens, side effects, satisfaction with pain management, pain severity, and quality of life items.  The most common interventions included an increase or change in opioid medications.  An average of 5 side effects related to opioid use were seen at each evaluation including dry mouth, drowsiness, fatigue, constipation, and anorexia as the most commonly reported problems.

Pain relief was seen in most patients with significant improvement in the weekly assessment parameters (BPI and VASQOL) with slight changes seen after week one.  Most were able to experience an 80% level of pain relief after doubling the Morphine Equivalent Daily dose (MEDD) with other pain relief strategies.  The variable of substance abuse did not result in significant differences in pain relief.  Quality of life measures were improved significantly between day 1 and the first weekly evaluation, an effect that was maintained through week three. 

Analysis completed on the final 53 patients who remained alive and in the study showed a persistent improvement in pain intensity and relief and interference by pain.  Despite patients developing new pain, differences for quality of life, global distress index, and psychological parameters remained significant for change from baseline.

Patients expressed a desire to have 100% of their pain relieved.  When asked how much they thought pain could be relieved, 67% expected 80-100% relief while 20% were more skeptical about the potential for pain relief.  The remaining 34% did not know what to expect for pain relief.  There were similar results in surveys on satisfaction with pain relief at weeks one, two, and three.  Approximately 43% said that they were very satisfied with their pain relief while 30-40% said they were “quite a bit satisfied” and 10-20% noted that they were “somewhat satisfied.”  The researchers found a strong correlation between expectation scores and satisfaction scores (p<0.0001) for week one and two and continued significant association in week three (p<0.002). 

Summary of Study 2

Patients with severe cancer-related pain were able to achieve a level of 80% pain relief by the first week of treatment utilizing AHCPR guidelines for pain management. Even though there are new pain management guidelines recommended for clinical settings, this study nicely illustrates the validity of pain management evaluation tools that may easily be transferred to another set of guidelines. It also suggests that each of the assessment tools show similar trends, making each useful alone or in conjunction with other tools to determine a level of pain management effectiveness within a short period of time.

Evaluations showed significant improvements in pain severity, pain interference, and many quality of life scores.  The improvements persisted over the three-week period despite newly reported pain sites.  The authors suggest that this and other studies support the ability of assessment to determine successful pain relief within one week.

Previous research suggested that pain relief, pain severity, and satisfaction with pain treatment represented different aspects of pain management that should be measured separately.  In this study, researchers suggested that these types of measures, while different, tend to move in the same direction.  The researchers suggested a need for further studies to define the relationships between pain relief constructs.

This study showed a number of patients who reported new pain and a high attrition rate for each of the three weeks of the study.  Authors suggest that underlying disease may be a factor and early diagnosis and treatment of pain, both of these factors demonstrating the complex and labor-intense process involved in pain management.  Interestingly, the increased dose of opioids did not appear to increase the number of side effects reported by patients.  The researchers noted the difficulty in administering side effect measures because of the complexity of disease and pain.  For instance, it was difficult to determine if a side effect was related more to underlying disease, or due to pain treatment.

While physical functioning did not significantly improve in measures, psychological factor improvement was seen.  Patients who achieved pain relief to their expectations had a high level of satisfaction with treatment. 

Limitations of the study include the access care providers had to BPI results during the study, attrition due to progressive disease, and the fact that the study was conducted at a Veterans Administration Medical Center where patients tended to be older, male, and have more confounding co-factors that are not representative of the general advanced cancer patient population.  There was a small subpopulation of substance abusers that were not different from non-substance abusers.  The authors suggest that patients with distant histories for substance abuse may be able to successfully achieve adequate pain relief. 

From the results of this research authors suggest that future studies may be able to adequately evaluate the success of pain relief in one week or less.  Pain relief of 80% or an improvement in pain severity of two points by BPI may be adequate endpoints.  The authors also suggest that inclusion of psychological and other quality of life parameters may be important to plan treatment and anticipate outcomes.

 

 

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