Breakthrough Pain Assessment Tool Research Articles

Validation of the Spanish Version of the Breakthrough Pain Assessment Tool in Patients With Cancer.

Assessment of breakthrough pain is essential for adequate management of cancer pain. The Breakthrough Pain Assessment Tool (BAT) has been proven to be a brief, multidimensional, and reliable questionnaire for the assessment of breakthrough cancer pain (BTCP). Currently, there are no validated instruments in Spanish that allow assessing BTCP. The objective of this study was to validate the Breakthrough Pain Assessment Tool - Spanish (BAT-S) version of the BAT in adult patients with cancer. The BAT-S was tested in a prospective observational study conducted in adult patients with cancer-related pain and treated in a comprehensive cancer center in Mexico. We conducted a forward-backward translation and cross-cultural equivalence test in the Spanish language. The psychometric properties in patients with cancer were assessed using factor analysis, reliability, and validity. To assess reliability, the Kappa test and the intra-class correlation coefficient were used. For consistency, Cronbach's alpha test was used. Seventy patients participated in the study; 140 questionnaires were analyzed. The Spanish translation was well accepted by participants. Reliability was comprised between 0.746 for "use of analgesics" and 1.00 for "pain location." Thirteen of the 14 items had values above 0.8, and 12 above 0.9. Cronbach´s alpha coefficient was 0.7. This study confirms that BAT-S is a valid and reliable questionnaire to assess breakthrough pain in Mexican patients with cancer. This newly validated tool may be used to facilitate clinical management of primarily Spanish-speaking patients with breakthrough cancer pain. This study describes a prospective observational study to assess the validity and reliability of the Breakthrough Pain Assessment Tool in its Spanish version. The results support the use of this newly validated tool to facilitate clinical management of primarily Spanish-speaking patients with breakthrough cancer pain.

Validation of a French version of the Breakthrough Pain Assessment Tool in cancer patients: Factorial structure, reliability and responsiveness.

Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: "1-pain severity and impact" and "2-pain duration and medication". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.

Effects of Brain Wave Vibration Training on the Pain and Fatigue Disturbance Symptom Cluster in Persons with Cancer: A Randomized Controlled Trial.

Pain and fatigue disturbance constitute the most common symptom cluster in persons with cancer, causing physical and psychological problems associated with a decreased quality of life. This study investigated the effects of brain wave vibration (BWV) training on the pain and fatigue disturbance symptom cluster in persons with cancer. A total of 43 participants were voluntarily recruited and randomly assigned to the experimental group (BWV with therapeutic massage, n = 25) or the control group (conventional physical therapy with spontaneous physical activity, n = 18) (Randomized controlled trial registration number: KCT0005843). BWV with therapeutic massage was performed for a total of 24 sessions (70 min/day, 2 days/week for 12 weeks). The Breakthrough Pain Assessment Tool and Brief Fatigue Inventory were used to evaluate cancer-related pain (CRP) and cancer-related fatigue (CRF), respectively. Regarding CRP variables, the experimental group demonstrated significant improvements in the worst and typical episodes of breakthrough pain, pain distress, and interference with living a normal life compared to the control group. In CRF, there was no significant difference between the groups, although BWV training with therapeutic massage resulted in a significant difference between before and after the intervention. Therefore, our study suggests that BWV training with therapeutic massage is beneficial for improving CRP and CRF in cancer survivors.

Cultural adaptation and psychometric validation of the Portuguese breakthrough pain assessment tool with cancer patients.

Breakthrough cancer pain (BTcP) is a transient exacerbation of pain that occurs over persistent, stable, and adequately controlled cancer background pain. It is prevalent and bears severe consequences to patients' quality-of-life. The effective management of BTcP depends on fast and reliable (re)assessment. The Breakthrough pain Assessment Tool (BAT) is one of the most concise and reliable self-report instruments adapted to clinical contexts so far, showing goodpsychometric qualities in the United Kingdom, the Netherlands, and South Korea. As to promote the effective management of BTcP in Portuguese-speaking communities this study, first aimed to culturally adapt and validate the Portuguese version of the BAT (BAT-Pt). Second, and most importantly, it sought to provide novel evidence on its criterion validity by investigating its association with measures of psychological distress, which has not been yet investigated. The BAT was translated into European Portuguese, using the back-translation method, and culturally adapted. Its psychometric properties (factor structure, internal consistency, construct and criterion validity) were analyzed in a cross-sectional multicenter study, with a sample of 65 cancer patients (49.2% women) recruited from eight hospitals in mainland Portugal (a priori power analysis determined a minimum sample of 50). Health professionals collected patients' clinical information, assessed their functional disability (ECOG Performance Status) and the adequacy of pain control. In addition to the Portuguese version of the BAT (BAT_Pt), patients completed the Portuguese versions of the Brief Pain Inventory, the Hospital Anxiety and Depression Scale, a Distress Thermometer and answered questions about the adequacy of pain control. The BAT-Pt was very well accepted by experts and patients. As hypothesized, a Principal Axis Factor Analysis revealed two underlying factors accounting for 55.2% of the variance: (1) Pain Severity and Impact of BTcP and (2) Duration of BTcP and Medication Inefficacy. Two items (on episode frequency and medication efficacy) were analyzed separately given their lower/cross loadings. The BAT-Pt showed good internal consistency overall (α=0.79) and for each sub-scale, namely, Pain Severity and Impact of BTcP (n=5 items; α=0.86) and Duration of BTcP and Medication Inefficacy (n=2 items; rsb=0.62). The BAT-Pt showed good convergent validity, being moderately to strongly associated with overall pain severity and interference (0.46<r<0.77, p<0.001). It also showed good concurrent validity by being associated not only with physical outcomes- such as functional disability (r=0.40, p<0.001) and patient- and physician-determined adequacy of BTcP control (|0.25<rpb<0.63|, p s <0.05)- but also, with distress (0.33<r<0.46, p s <0.001), anxiety (0.28<r<0.44, p s <0.05) and depression (r=0.47, p<0.001). The BAT-Pt is a reliable and valid measure of breakthrough pain in Portuguese cancer patients and it is strongly associated to physical and psychological outcomes. This study confirms and extends the psychometric validation of the BAT to a new cultural context, promoting its diffusion and use by researchers and clinicians in Portuguese-speaking communities. The BAT-Pt may be an invaluable tool for daily clinical practice by tapping multiple aspects of BTcP experiences that are associated to patients' physical and psychological outcomes.

Validation of the Dutch Version of the Breakthrough Pain Assessment Tool in Patients With Cancer

ContextEssential for adequate management of breakthrough cancer pain is a combination of accurate (re-)assessment and a personalized treatment plan. The Breakthrough Pain Assessment Tool (BAT) has been proven to be a brief, multidimensional, reliable, and valid questionnaire for the assessment of breakthrough cancer pain. ObjectivesThe aim of this study was to examine the validity and reliability of the Dutch Language version of the BAT (BAT-DL) in patients with cancer. MethodsThe BAT was forward-backward translated into the Dutch language. Thereafter, the psychometric properties of the BAT-DL were tested, that is factor structure, reliability (internal consistency and test-retest reliability), validity (content validity and construct validity), and the responsiveness to change. ResultsThe BAT-DL confirmed the two-factor structure in 170 patients with cancer: pain severity/impact factor and pain duration/medication efficacy factor. The Cronbach's alpha coefficient was 0.72, and the intraclass correlation for the test-retest reliability was 0.81. The BAT-DL showed to be able to differentiate between different group of patients and correlated significantly with the Brief Pain Inventory. In addition, the BAT-DL was capable to detect clinically important changes over time. ConclusionThe BAT-DL is a valid and reliable questionnaire to assess breakthrough pain in Dutch patients with cancer and is a relevant questionnaire for daily practice.

Prevalence and characterization of breakthrough pain in patients with cancer in Spain: the CARPE-DIO study

We aimed to evaluate the prevalence, characteristics and impact of breakthrough pain (BTP) in patients with cancer attending the main specialties involved in the diagnosis and management of BTP in Spain using a multicenter, observational, cross-sectional, multidisciplinary study. Investigators had to record all patients seen at the clinic during 1 month, determine whether the patients had cancer pain, and apply the Davies algorithm to ascertain whether the patients were suffering from BTP. Of the 3,765 patients with cancer, 1,117 (30%) had cancer-related pain, and of these patients, 539 had BTP (48%, 95%CI:45–51). The highest prevalence was found in patients from palliative care (61%, 95%CI:54–68), and the lowest was found in those from hematology (25%, 95%CI:20–31). Prevalence varied also according to sex and type of tumor. According to the Alberta Breakthrough Pain Assessment Tool duration, timing, frequency, location, severity, quality, causes, and predictability of the BTP varied greatly among these patients. BTP was moderate (Brief Pain Inventory [BPI]-severity median score = 5.3), and pain interference was moderate (BPI-interference median score = 6.1) with a greater interference with normal work, general activity, and enjoyment of life. Patients with BTP showed a mean ± standard deviation score of 28.5 ± 8.0 and 36.9 ± 9.5 in the physical and mental component, respectively, of the SF-12 questionnaire. In conclusion, prevalence of BTP among patients exhibiting cancer-related pain is high. Clinical presentation is heterogeneous, and therefore, BTP cannot be considered as a single entity. However, uniformly BTP has an important impact on a patient’s functionality, which supports the need for early detection and treatment.

Characteristics of Breakthrough Pain and Its Impact on Quality of Life in Terminally Ill Cancer Patients.

Purpose. This study aimed to characterize breakthrough pain (BTP) and investigate its impact on quality-of-life (QoL) in terminally-ill cancer patients. Similarities and differences between high and low predictable BTP were also tested. Methods. Secondary analysis of a multicenter longitudinal observational study included 92 patients at their end-of-life. BTP was assessed with a short form of the Italian version of the Alberta Breakthrough Pain Assessment Tool. QoL was assessed with the Palliative Outcome Scale (0-40). Patients were stratified by self-reported BTP predictability into unpredictable BTP (never or rarely able to predict BTP) and predictable BTP (sometimes to always able to predict BTP). Results. In all, 665 BTP episodes were recorded (median 0.86 episodes/day). A median duration of 30 minutes and a median peak intensity score of 7 out of 10 were reported. Time to peak was <10 minutes, 10 to 30 minutes, and ≥30 minutes in 267 (41.1%), 259 (39.9%), and 30 (4.6%) of the episodes, respectively. Onset of relief occurred after a median of 30 minutes. Time to peak (P < .001) and duration (P = .046) of BTP was shorter in patients with predictable pain (n = 31), who usually were younger than those with unpredictable pain (P = .03). The mean (SD) QoL score was 14.6 (4.6). No difference in QoL between patients with predictable and unpredictable BTP was found (P = .49). Conclusions. In terminally-ill cancer patients, BTP is a severe problem with a negative impact on QoL and has different characteristics according to its predictability.

Validation of the Korean Version of the Breakthrough Pain Assessment Tool in Cancer Patients

ContextBreakthrough cancer pain has not been properly evaluated and treated because there are relatively few available measurements. The Breakthrough Pain Assessment Tool (BAT) is currently recognized as a brief, multidimensional, and reliable measurement. ObjectivesThe objective of this study was to validate the Korean version of the BAT (BAT-K) in adult cancer patients. MethodsWe conducted a forward-backward translation and cross-cultural equivalence test. The psychometric properties with 120 cancer patients were assessed using factor analysis, reliability, and validity. ResultsThe Korean translation was well accepted by participants. Factor analysis revealed the presence of two underlying factors: frequency/severity and duration/medication efficacy. Cronbach alpha coefficient was 0.743. Severity, distress, and disruption of normal life showed strong reliability. The intraclass correlation for the test-retest reliability was 0.782 (95% confidence interval 0.694–0.854). The BAT-K had significant correlations with the Brief Pain Inventory, Pain Management Index, and Eastern Cooperative Oncology Group performance status (all P values < 0.05). ConclusionThe BAT-K is a valid and reliable measurement of breakthrough cancer pain in Korean cancer patients.

Characteristics of breakthrough cancer pain and its influence on quality of life in an international cohort of patients with cancer

ObjectivesBreakthrough cancer pain (BTP) represents a treatment challenge. Objectives were to examine the prevalence and characteristics of BTP in an international sample of patients with cancer, and to investigate the...

Disparities Between Clinician and Patient Perception of Breakthrough Pain Control

ContextThere are disparities in the level of symptom severity as perceived by patients and health professionals. There is limited information about patients' and clinicians' global assessment of breakthrough pain control, the need to change analgesics, and change in breakthrough pain over time. ObjectivesTo establish whether patients and clinicians independently agree on adequacy of breakthrough pain control, management strategy, and impression of change over time. MethodsOne hundred patients with breakthrough cancer pain were assessed and followed up one week later by a palliative medicine specialist. The patient and clinician independently answered the same questions about the adequacy of the patient's breakthrough pain control and breakthrough pain management. The results were compared with items on the Breakthrough Pain Assessment Tool (BAT). ResultsAt initial consultation, 35% of patients rated their breakthrough cancer pain as inadequately controlled compared with 72% of clinicians. Breakthrough pain analgesics were changed in 68% of cases. At one-week follow-up consultation, 62% of patients considered their breakthrough cancer pain to be better, and in 57% of cases, the clinicians also categorized the pain this way. ConclusionThere are significant differences in global impressions of breakthrough pain between patients and pain clinicians that become less disparate as a therapeutic relationship evolves. Therapeutic decisions were based on clinical rather than patient perceptions.

Is it possible to detect an improvement in cancer pain management? A comparison of two Norwegian cross-sectional studies conducted 5years apart.

Cancer pain (CP) management is challenging. In recent years, efforts were undertaken to achieve better CP management, e.g. clinical research, new treatment modalities, development of guidelines, education and focus on implementation. The aim of the present study was to compare the prevalence and characteristics of pain and breakthrough pain (BTP) between cross-sectional studies conducted in 2008 and 2014. It was hypothesized that an improvement in pain control would be observed the years in between. Two cross-sectional studies were conducted where adult cancer patients answered questions from Brief Pain Inventory and the Alberta Breakthrough Pain Assessment Tool for cancer patients. Physicians reported socio-demographic and medical data. Regression models were applied for analysis. In total, 168 inpatients, 92 in 2008 and 76 in 2014, and 675 outpatients, 301 in 2008 and 374 in 2014, were included. The patient characteristics of the samples were comparable. Prevalence of CP among inpatients was 55% in 2008 and 53% in 2014, and among outpatients, 39 and 35%, respectively. Inpatients reported average pain intensity (0-10 numerical rating scale, NRS) of 3.60 (standard deviation, SD 1.84) (2008) and 4.08 (SD 2.11) (2014); prevalence of BTP was 52% (2008) and 41% (2014). For outpatients, average pain intensity was 3.60 (SD 2.04) (2008) and 3.86 (SD 2.20) (2014); prevalence of BTP was 43% (2008) and 37% (2014). None of the differences were statistically significant. Unexpectedly, no improvement in pain control was observed. Efforts are still needed to improve cancer pain management.

Alberta Breakthrough Pain Assessment Tool: A validation multicentre study in cancer patients with breakthrough pain.

Cancer-related breakthrough pain (BTP) is a common and quite challenging pain syndrome, with significant impact on quality of life. To date, no widely recognized and validated tool for the diagnosis and evaluation of BTP exists. The Alberta Breakthrough Pain Assessment Tool (ABPAT) underwent a validation process during its development, but no experience of its implementation in clinical practice has been reported. ABPAT was tested in a cohort of cancer patients suffering from chronic severe cancer-related pain in order to assess its acceptability and efficacy as a tool for the characterization of BTP. A total of consecutive 249 patients from seven different centres were included in a 2-month study period and all completed the questionnaire; 231 out of the 249 (92.8%) stated that questions were easily understandable and 217 out of the 249 (87.1%) stated that the tool allowed to explain extensively the BTP problem. Physician-patient correlation tests about baseline BTP intensity and BTP relief by medication showed statistical significance at the level of p = 0.001 and p = 0.0001, respectively. Evaluation of the efficacy of BPT medication revealed a 78.2% of patients declaring a good relief from BTP, with a significant reduction of mean BTP numeric rating scale score (p = 0.0001), but only 55.9% of patients responded to be satisfied about time for onset of the relief. In this study, ABPAT resulted to be a well-accepted tool for BTP assessment and characterization in a relatively large cohort of cancer patients. It is effective in discovering the unmet needs of cancer patients and in exploring the outcomes of BTP treatment.

Development of the Breakthrough pain Assessment Tool (BAT) in cancer patients

Development of the Breakthrough pain Assessment Tool (BAT) in cancer patients

Development and Validation of the Breakthrough Pain Assessment Tool (BAT) in Cancer Patients

ContextThe successful management of breakthrough pain depends on a combination of adequate assessment, appropriate (individualized) treatment, and adequate re-assessment. Currently, there is no fully validated clinical assessment tool for breakthrough pain in cancer patients. ObjectivesThe aim of this project was to develop and validate a breakthrough pain assessment tool (the BAT) for use in the clinical setting. MethodsThe content of the BAT was determined by reviewing the medical literature, conducting a Delphi process with experts in breakthrough pain and/or pain assessment and conducting semi-structured interviews with cancer patients with breakthrough pain. The tool was then subjected to a series of standard psychometric tests to assess its factor structure, validity (i.e., content validity, construct validity), reliability (i.e., internal consistency, test-retest reliability), and responsiveness to change. ResultsThe BAT comprised two pages with 14 questions. Factor analysis confirmed the presence of two underlying factors. Psychometric testing confirmed that the tool is valid, reliable, and responsive to change. ConclusionThis study provides initial evidence for the validity and reliability of the breakthrough pain assessment tool which may be used to facilitate the management of patients with breakthrough cancer pain in the clinical setting.

A cross-sectional study on prevalence of pain and breakthrough pain among an unselected group of outpatients in a tertiary cancer clinic

Systematic knowledge about the prevalence and the treatment effects of cancer pain in patients attending a general oncology outpatient department is limited. The purpose of this study was to investigate the prevalence of pain in a large representative cohort of patients attending a general oncology outpatient department in order to guide further screening, classification, and treatment of pain. A cross-sectional study among patients visiting the outpatient clinic with histologically verified cancer, age≥18 years, adequate cognitive function, and no surgical procedures last 24 h were included. Pain was assessed by the Brief Pain Inventory and the Alberta Breakthrough Pain Assessment Tool. Three hundred five patients were included. The mean age was 60 years, 94% had a WHO performance status of 0-1 and 59% received oncological treatment with a curative intent. The mean score for average pain last 24 h (numerical rating scale, 0-10) and current pain was 1.84 and 1.08, respectively. Twenty-two percent reported pain score of ≥4 as their average pain in the previous 24 h. Twenty-one percent reported breakthrough pain (BTP). In multivariate analyses, sleep, BTP, age, treatment intent, and comorbidity was significantly associated with mean average pain in the previous 24 h and explained 29% of the variability of average pain in the previous 24 h. Of the patients at an oncology outpatient clinic, 22% reported clinically significant pain. These findings indicate that all patients are candidates to be screened for pain and, if present, a more detailed pain diagnosis should be established before any interventions can be recommended.

The Alberta Breakthrough Pain Assessment Tool for Cancer Patients: A Validation Study Using a Delphi Process and Patient Think-Aloud Interviews

Breakthrough pain is a prevalent cancer pain syndrome, and research is needed to identify more effective interventions to manage it. A validated tool to assess breakthrough pain in a standard and reliable manner is urgently needed to support the conduct of clinical trials in breakthrough pain. To address this need, we developed a breakthrough pain assessment tool for research purposes. The current study was undertaken to gather validity evidence for this breakthrough pain assessment tool, using a Delphi process involving an expert panel review, followed by a think-aloud process involving patients with cancer-related breakthrough pain. Two expert panels were formed: a national panel (within Canada; n = 16) and an international panel (including experts from North America, UK, Europe, the Middle East, Australia, and New Zealand; n = 22). Each panel participated in one anonymous survey round. Response rates were 56% (national panel) and 73% (international panel). The Delphi process revealed substantial consensus on the content of the tool, which increased between rounds of review. The overall level of agreement with the tool, averaged over the four evaluated aspects of all items, was 80% among national panelists and 88% among international panelists. Nine patients completed the think-aloud study. They were able to understand and complete the tool and provided specific direction on its improvement. The validity evidence gathered in this study suggests the Alberta Breakthrough Pain Assessment Tool is conceptually grounded and is understandable by patients and clinicians. Further validation of this tool as an assessment measure within clinical trials research is warranted.

Applying the Delphi process to palliative care tool development: lessons learned

The Delphi technique is an effective method for collecting and synthesizing informed opinions on a highly focused task, from a diverse group of experts who have specialized knowledge in an area of interest. This method has been successfully applied to palliative care research but not commonly to palliative care tool development. The Delphi technique has recently been employed in the development of two palliative pain assessment tools: the Edmonton Classification System for Cancer Pain (ECS-CP) and the Alberta Breakthrough Pain Assessment Tool for Research (ABPAT-R). The purpose of this paper is to: (a) report on our experience of using the Delphi technique for gathering validity evidence for the ECS-CP and ABPAT-R; (b) identify challenges in using this technique including sampling, study and survey design, consensus setting and response rates; and (c) suggest approaches that can add to its effectiveness in national and international collaborations in palliative care instrument development and research. Depending on the design, the Delphi technique can facilitate national or international cooperation both asynchronously (e.g., with mail-out or electronic surveys) and synchronously (e.g., with face-to-face meetings or videoconferencing). International input can assure palliative care tools are relevant in diverse clinical settings and practice cultures. The use of the Delphi technique in palliative care tool development may thereby facilitate international collaborations, rapid knowledge transfer, and effective uptake of novel tools across diverse palliative care settings.