Breakthrough Cancer Pain
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an unselected, representative cohort of cancer outpatients with or without pain who attend consultations.
Detailed description
This study has been designed as a non-interventional, non post-authorization, cross-sectional, epidemiological study to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an non-selected, representative cohort of cancer outpatients with or without pain. The study enrolled 3765 patients. This multicenter trial will be conducted in Spain. Data from participants will be collected through questionnaire and medical history in a single visit (up to 1 month).
Interventions
OTHERNo Intervention
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants≥ 18 years old * Participants with baseline cancer pain that is adequately controlled with opioids * Presence of episodes of breakthrough pain associated with the cancer pain * Meeting the diagnostic criteria for breakthrough cancer pain (participant history and Portenoy's criteria) and the Davies algorithm * Participants who are not receiving treatment for breakthrough cancer pain. It is not permitted the inclusion of participants receiving treatment for breakthrough cancer pain in order to avoid bias that may affect the characterization or taxonomy of breakthrough cancer pain * Signing of the informed consent
Exclusion criteria
* Severe mental illness * Any medical condition or situation complicating the collection of study data as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation | Month 1 | Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain. |
| Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation | Month 1 | Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Characterization With the Alberta Breakthrough Pain Assessment | Month 1 | The Alberta Breakthrough Pain Assessment Tool (ABPAT) consisted of a participant's self-reporting section (15 questions) out of which 4 questions of the tool were not included as they were related to the treatment for breakthrough cancer pain. The questions included: Q1-Relationship to baseline pain, Q2a-Last time experienced, Q3b-Frequency, Q4b-Intensity of pain at peak, Q5-Location (most frequent - ≥5%), Q6-Quality (those present in ≥20%), Q7-Time from onset to peak intensity, Q8-Time from onset \[take medication\] to end of episode, Q9-Cause(s) (triggers) (Those present in ≥20%), Q10-Predictability, Q11-General relief (those present in ≈20% or more participants) and questions completed by nurse/physician (N/P), Q1-Etiology of breakthrough pain, Q2-Inferred pathophysiology of breakthrough pain. Percentage of participants were categorized into the answers for each of these questions. |
| Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score | Month 1 | The BPI questionnaire was used to assess the pain intensity (4 items) and interference with activities of daily living (7 items). Each item was given a score on a numerical scale from 0 (no pain/interference with activities of daily living) to 10 (worst pain imaginable/maximum impact on activities of daily living). The total score for pain intensity is the average of the four pain items. The total score of pain interference is the average score of the seven interference items. The higher score represents high impact. |
| Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation | Month 1 | Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain. |
| Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score | Month 1 | The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 (poor mental and physical quality of life) and 100 (better mental and physical quality of life). |
| Participant's Performance as Assessed by the Karnofsky Scale Score | Month 1 | Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (participant asymptomatic with no evidence of illness). Higher score means higher ability to perform daily tasks. Participants with missing values in the Karnofsky scale were assigned to the worst score of 0, however, in these cases it is not 'death'. |
| Pain Assessment Using the Numeric Rating Scale | Month 1 | — |
| Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation | Month 1 | Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain. |
Countries
Spain
Participant flow
Recruitment details
Participants took part in the study at 32 investigative sites in Spain from 14 November 2016 to 16 July 2018.
Pre-assignment details
Participants with a diagnosis of cancer pain were enrolled and observed to characterize the participants with breakthrough pain.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study. | 3,765 |
| Total | 3,765 |
Baseline characteristics
| Characteristic | Cohort 1 | — |
|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Spain | 3765 Participants | — |
| Sex: Female, Male Female | 1789 Participants | — |
| Sex: Female, Male Male | 1947 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Time frame: Month 1
Population: Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation | 48.3 percentage of participants |
Primary
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Time frame: Month 1
Population: Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation | 14.3 percentage of participants |
Secondary
Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Time frame: Month 1
Population: Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database. Number analyzed is the total number of participants with data available for the time of diagnosis of breakthrough cancer pain.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 | Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation | 105 Participants |
Secondary
Pain Assessment Using the Numeric Rating Scale
Time frame: Month 1
Population: Data was not collected for this outcome measure.
Secondary
Pain Characterization With the Alberta Breakthrough Pain Assessment
The Alberta Breakthrough Pain Assessment Tool (ABPAT) consisted of a participant's self-reporting section (15 questions) out of which 4 questions of the tool were not included as they were related to the treatment for breakthrough cancer pain. The questions included: Q1-Relationship to baseline pain, Q2a-Last time experienced, Q3b-Frequency, Q4b-Intensity of pain at peak, Q5-Location (most frequent - ≥5%), Q6-Quality (those present in ≥20%), Q7-Time from onset to peak intensity, Q8-Time from onset \[take medication\] to end of episode, Q9-Cause(s) (triggers) (Those present in ≥20%), Q10-Predictability, Q11-General relief (those present in ≈20% or more participants) and questions completed by nurse/physician (N/P), Q1-Etiology of breakthrough pain, Q2-Inferred pathophysiology of breakthrough pain. Percentage of participants were categorized into the answers for each of these questions.
Time frame: Month 1
Population: Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given question.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1:N/P,Pain Related to Anticancer Treatment | 9.7 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1, Brief Flare-up of Baseline Pain | 53.2 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1, Different from Baseline Pain | 36.3 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1, Not Sure | 10.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q2a, Today | 57.7 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q2a, Yesterday | 33.0 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q2a, Before then | 9.3 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q3b, Usual | 62.6 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q3b, Better | 8.4 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q3b, Worse | 29.1 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q4b, Mild | 1.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q4b, Moderate | 16.0 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q4b, Severe | 82.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q5, Lumbar | 20.0 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q5, Hips | 6.7 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q5, Abdominal | 6.7 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q5, Back | 6.2 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q5, Thoracolumbar | 5.1 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q5, Thoracic | 5.1 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q6, Stabbing | 57.9 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q6, Splitting | 29.7 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q6, Sharp | 29.2 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q6, Punishing-Cruel | 27.2 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q6, Heavy | 26.7 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q6, Hot-Burning | 25.6 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q6, Fearful | 21.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q7, More than 0 and Up to 10 Minutes | 57.4 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q7, More than 10 and Up to 30 Minutes | 24.1 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q7, More than 30 Minutes | 8.2 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q7, It is Hard to Say Exactly When It Started | 10.3 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q8, More than 0 and Up to 10 minutes | 18.8 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q8, More than 10 and Up to 30 minutes | 37.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q8, More than 30 Minutes | 33.3 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q8, I am Not on Any Breakthrough Pain Medication | 10.4 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q9, Movement in Bed | 33.3 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q9, Walking | 31.8 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q9, Standing | 29.7 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q9, Sitting | 19.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q9, Coughing | 19.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q10, I Can Never Predict When It will Occur | 19.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q10, I Can Rarely Predict When It will Occur | 17.4 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q10, I Can Sometimes Predict When It will Occur | 20.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q10, I Can Often Predict When It will Occur | 30.3 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q10, I Can Always Predict When It will Occur | 12.3 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q11, Lying | 37.4 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q11, Use of Scheduled Pain Medication | 19.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q11, Unsure | 19.5 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1:N/P,Pain Related to the Site of Active Cancer | 78.0 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1:N/P, Related to Body/Cancer's Systemic Effects | 5.9 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1:N/P,Pain Caused by a Concurrent Disorder | 4.8 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q1:N/P,Unknown or Uncertain at this Time | 1.6 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q2:N/P,Somatic Nociceptive | 55.9 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q2:N/P,Visceral Nociceptive | 16.1 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q2:N/P,Neuropathic | 19.9 percenatge of participants |
| Cohort 1 | Pain Characterization With the Alberta Breakthrough Pain Assessment | Q2:N/P,Unknown or Uncertain at this Time | 8.1 percenatge of participants |
Secondary
Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score
The BPI questionnaire was used to assess the pain intensity (4 items) and interference with activities of daily living (7 items). Each item was given a score on a numerical scale from 0 (no pain/interference with activities of daily living) to 10 (worst pain imaginable/maximum impact on activities of daily living). The total score for pain intensity is the average of the four pain items. The total score of pain interference is the average score of the seven interference items. The higher score represents high impact.
Time frame: Month 1
Population: Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score | Pain Severity | 5.33 score on a scale | Standard Deviation 1.78 |
| Cohort 1 | Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score | Pain Interference | 6.07 score on a scale | Standard Deviation 2.05 |
Secondary
Participant's Performance as Assessed by the Karnofsky Scale Score
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (participant asymptomatic with no evidence of illness). Higher score means higher ability to perform daily tasks. Participants with missing values in the Karnofsky scale were assigned to the worst score of 0, however, in these cases it is not 'death'.
Time frame: Month 1
Population: Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 70 | 11.9 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 80 | 22.6 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 90 | 25.7 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 100 | 25.2 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 0 | 0.2 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 10 | 0.5 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 20 | 0.8 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 30 | 1.4 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 40 | 2.2 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 50 | 2.9 percentage of participants |
| Cohort 1 | Participant's Performance as Assessed by the Karnofsky Scale Score | Score 60 | 6.7 percentage of participants |
Secondary
Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Time frame: Month 1
Population: Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database, with data available for the time of diagnosis of breakthrough cancer pain.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation | 19.3 percentage of participants |
Secondary
Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score
The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 (poor mental and physical quality of life) and 100 (better mental and physical quality of life).
Time frame: Month 1
Population: Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale with data available for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 | Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score | Mental Component SF-12 | 36.87 score on a scale | Standard Deviation 9.51 |
| Cohort 1 | Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score | Physical Component SF-12 | 28.53 score on a scale | Standard Deviation 7.97 |