Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2013

Open Access 01-12-2013 | Research

Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire?

Authors: Ingela Wiklund, Stefan Holmstrom, Malcolm Stoker, Kathleen W Wyrwich, Mary Devine

Published in: Health and Quality of Life Outcomes | Issue 1/2013

Login to get access

Abstract

Background/objective

The Self Assessment of Treatment (SAT) questionnaire was developed to reflect key patient reported outcomes of Neuropathic Pain (NP) treatments. This study aimed to understand how patients perceived the relevance and ease of understanding of the questions in the SAT and to recommend modifications based on patient and clinician interviews.

Methods

Semi-structured interviews were conducted with clinicians and NP patients to provide information regarding treatment attributes and the impact of pain. Patients were debriefed on the SAT, a 5-item scale evaluating pain, activity level, quality of life (QoL) and satisfaction with treatment (recommend treatment and undergo treatment again). The SAT has a recall period reflecting back to the start of treatment. The qualitative analysis software ATLAS.ti 5.0 was used to analyze patient transcripts. Changes to the SAT were integrated into the questionnaire for a second round of debriefing interviews.

Results

Three NP clinicians and 44 patients (20 painful diabetic neuropathy, 16 HIV-associated neuropathy and 8 post herpetic neuralgia) with a mean age of 60.3 (12.3) years and an even gender distribution were interviewed. Patient treatment experience included anticonvulsants (73%), antidepressants (34%), opioids (25%), and topical medications (41%). Pain descriptors and treatment attributes were similar across the three NP groups. Pain relief was judged the most important treatment attribute, followed by ability to undertake activities. Sleep improvement was another important attribute. Activity limitations and QOL were perceived as too broad and non-specific, and were split into 3 concepts each (activity limitations was split into self care, daily and physical activities and QOL was split into sleep, emotions, and social function). A 7-day recall period was introduced. The item stem and response options were made consistent, and a baseline and follow-up questionnaires were developed (except for the satisfaction items) to enable monitoring onset of treatment benefit and change over time.

Conclusions

The content validity of the revised SAT was improved by the qualitative research, and NP treatment benefits are reflected in a more consistent fashion by the changes. Baseline and follow-up versions make it possible to perform assessments of change over time.
Literature
1.
Campbell JN, Meyer RA: Mechanisms of neuropathic pain. Neuron 2006, 52: 77–92. 10.1016/j.neuron.2006.09.021PubMedCrossRef
2.
Dworkin RH, Backonja M, Rowbotham MC, Allen RR, Argoff CR, Bennett GJ, Bushnell MC, Farrar JT, Galer BS, Haythornthwaite JA: Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. Arch Neurol 2003, 60: 1524–1534. 10.1001/archneur.60.11.1524PubMedCrossRef
3.
Wall PD, Melzack R (Eds): Textbook of pain. 4th edition. Edinburgh; New York: Churchill Livingstone; 1999.
4.
5.
Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J: Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology 2008, 70: 1630–1635. 10.1212/01.wnl.0000282763.29778.59PubMedCrossRef
6.
7.
Dworkin RH, O'Connor AB, Backonja M, Farrar JT, Finnerup NB, Jensen TS, Kalso EA, Loeser JD, Miaskowski C, Nurmikko TJ: Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 2007, 132: 237–251. 10.1016/j.pain.2007.08.033PubMedCrossRef
8.
Gore M, Dukes E, Rowbotham DJ, Tai KS, Leslie D: Clinical characteristics and pain management among patients with painful peripheral neuropathic disorders in general practice settings. Eur J Pain 2007, 11: 652–664. 10.1016/j.ejpain.2006.10.004PubMedCrossRef
9.
Sadosky A, McDermott AM, Brandenburg NA, Strauss M: A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions. Pain Pract 2008, 8: 45–56. 10.1111/j.1533-2500.2007.00164.xPubMedCrossRef
10.
Manca A, Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E: Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). Eur J Pain 2008, 12: 1047–1058. 10.1016/j.ejpain.2008.01.014PubMedCrossRef
11.
McCarberg BH, Billington R: Consequences of neuropathic pain: quality-of-life issues and associated costs. Am J Manag Care 2006, 12: S263-S268.PubMed
12.
McDermott AM, Toelle TR, Rowbotham DJ, Schaefer CP, Dukes EM: The burden of neuropathic pain: results from a cross-sectional survey. Eur J Pain 2006, 10: 127–135. 10.1016/j.ejpain.2005.01.014PubMedCrossRef
13.
O'Connor AB: Neuropathic pain: quality-of-life impact, costs and cost effectiveness of therapy. PharmacoEconomics 2009, 27: 95–112. 10.2165/00019053-200927020-00002PubMedCrossRef
14.
Tarride J, Collet J, Choinière M, Rousseau C, Gordon A: The economic burden of neuropathic pain in canada. J Med Econ 2006, 9: 55–68. 10.3111/200609055068CrossRef
15.
Jensen MP, Chodroff MJ, Dworkin RH: The impact of neuropathic pain on health-related quality of life: review and implications. Neurology 2007, 68: 1178–1182. 10.1212/01.wnl.0000259085.61898.9ePubMedCrossRef
16.
Meyer-Rosberg K, Kvarnstrom A, Kinnman E, Gordh T, Nordfors LO, Kristofferson A: Peripheral neuropathic pain–a multidimensional burden for patients. Eur J Pain 2001, 5: 379–389. 10.1053/eujp.2001.0259PubMedCrossRef
17.
Hoffman DL, Sadosky A, Alvir J: Cross-national burden of painful diabetic peripheral neuropathy in asia, latin america, and the middle east. Pain Pract 2009, 9: 35–42. 10.1111/j.1533-2500.2008.00249.xPubMedCrossRef
18.
Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS: Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 2003, 106: 337–345. 10.1016/j.pain.2003.08.001PubMedCrossRef
19.
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN: Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008, 9: 105–121. 10.1016/j.jpain.2007.09.005PubMedCrossRef
20.
Afilalo M, Cantees K, Ducharme J: Current pain-control practices and research. Ann Emerg Med 1996, 27: 404–407. 10.1016/S0196-0644(96)70215-9PubMedCrossRef
21.
Dieleman JP, Kerklaan J, Huygen FJ, Bouma PA, Sturkenboom MC: Incidence rates and treatment of neuropathic pain conditions in the general population. Pain 2008, 137: 681–688. 10.1016/j.pain.2008.03.002PubMedCrossRef
22.
European Medicines Agency: Qutenza-authorisation details. London, UK: European Medicines Agency; 2009.
23.
24.
Wyrwich KW, Kawata AK, Thompson C, Holmstrom S, Stoker M, Wiklund I: Validation of the Self-Assessment of Treatment questionnaire among patients with postherpetic neuralgia. Pain Res Treat 2012, 2012: 621619.PubMed
25.
26.
27.
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94: 149–158. 10.1016/S0304-3959(01)00349-9PubMedCrossRef
28.
Cleeland C: The brief pain inventory: user guide. Houston, TX: The University of Texas MD Anderson Cancer Center; 2009.
29.
Cleeland CS: Pain assessment in cancer. In Effect of Cancer on Quality of Life. Edited by: Osoba D. Boca Raton, Fla: CRC Press; 1991:293–305.
30.
Muhr T: User's Manual for ATLAS.ti 5.0. 2004.
31.
Carlson J, Youngblood R, Dalton JA, Blau W, Lindley C: Is patient satisfaction a legitimate outcome of pain management? J Pain Symptom Manage 2003, 25: 264–275. 10.1016/S0885-3924(02)00677-2PubMedCrossRef
32.
Evans CJ, Trudeau E, Mertzanis P, Marquis P, Pena BM, Wong J, Mayne T: Development and validation of the pain treatment satisfaction scale (PTSS): a patient satisfaction questionnaire for use in patients with chronic or acute pain. Pain 2004, 112: 254–266. 10.1016/j.pain.2004.09.005PubMedCrossRef
33.
Leidy NK, Vernon M: Perspectives on patient-reported outcomes: content validity and qualitative research in a changing clinical trial environment. PharmacoEconomics 2008, 26: 363–370. 10.2165/00019053-200826050-00002PubMedCrossRef
34.
Magasi S, Ryan G, Revicki D, Lenderking W, Hays RD, Brod M, Snyder C, Boers M, Cella D: Content validity of patient-reported outcome measures: perspectives from a PROMIS meeting. Qual Life Res 2012, 21: 739–746. 10.1007/s11136-011-9990-8PubMedCrossRef
35.
Food and Drug Administration: Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 2009, 74: 65132–65133.
36.
37.
Melzack R: The short-form McGill pain questionnaire. Pain 1987, 30: 191–197. 10.1016/0304-3959(87)91074-8PubMedCrossRef
38.
Taylor-Stokes G, Pike J, Sadosky A, Chandran A, Toelle T: Association of patient-rated severity with other outcomes in patients with painful diabetic peripheral neuropathy. Diabetes Metab Syndr Obes 2011, 4: 401–408.PubMed
39.
Ko KS, Cha BY, Kim CH, Kwon HS, Lee JH, Park TS, Won JC, Ko SK, Park HJ: Patient-reported outcomes in subjects with painful diabetic peripheral neuropathy: pain description and quality of life. Value in Health 2011, 14: A66.CrossRef
40.
Turk DC, Dworkin RH, Revicki D, Harding G, Burke LB, Cella D, Cleeland CS, Cowan P, Farrar JT, Hertz S: Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain. Pain 2008, 137: 276–285. 10.1016/j.pain.2007.09.002PubMedCrossRef
41.
Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L: Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2–assessing respondent understanding. Value Health 2011, 14: 978–988. 10.1016/j.jval.2011.06.013PubMedCrossRef
42.
Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L: Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1–eliciting concepts for a new PRO instrument. Value Health 2011, 14: 967–977. 10.1016/j.jval.2011.06.014PubMedCrossRef
Metadata
Title
Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire?
Authors
Ingela Wiklund
Stefan Holmstrom
Malcolm Stoker
Kathleen W Wyrwich
Mary Devine
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2013
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-11-8

Other articles of this Issue 1/2013

Health and Quality of Life Outcomes 1/2013 Go to the issue

Research

Construct validity of the Assessment of Quality of Life - 6D (AQoL-6D) in community samples

Research

Changes in quality of life into adulthood after very preterm birth and/or very low birth weight in the Netherlands

Research

Development of the Adult PedsQL™ Neurofibromatosis Type 1 Module: Initial Feasibility, Reliability and Validity

Short report

Validation of the Korean version of the European Organization for Research and Treatment of Cancer brain cancer module (EORTC QLQ-BN20) in patients with brain tumors

Study protocol

Diagnostic and treatment delay, quality of life and satisfaction with care in colorectal cancer patients: a study protocol

Research

Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study