Abstract
Purpose
This study aims to explore the changes in pain intensity and quality of life (QoL) experienced by patients with painful diabetic neuropathy (PDN) treated with spinal cord simulation (SCS) and conventional medical practice (CMP).
Methods
Patient-reported pain intensity and QoL data were obtained from participants in an international multicentre randomised controlled trial comparing SCS versus CMP. Data were collected at randomisation and 6 month follow up by means of a visual analogue scale for pain intensity (VASPI), the EuroQoL Visual Analogue Scale (EQ VAS) and the EuroQol EQ-5D index. Quality-adjusted life years (QALYs) were calculated for each treatment using the ‘area under the curve’ method. Differences in QALYs were calculated after adjusting for between-treatment imbalances in baseline QoL.
Results
At six months, patients allocated to SCS reported larger reductions in pain intensity and improvements in QoL measured by the EQ-5D utility score and EQ-VAS as compared to those allocated to CMP. Initial calculations of QALYs for the SCS and CMP groups suggested no statistical differences between the groups. Adjusting for imbalances in baseline EQ-5D scores showed SCS to be associated with significantly higher QALYs compared to CMP.
Conclusions
SCS resulted in significant improvement in pain intensity and QoL in patients with PDN, offering further support for SCS as an effective treatment for patients suffering from PDN. From a methodological point of view, different results would have been obtained if QALY calculations were not adjusted for baseline EQ-5D scores, highlighting the need to account for imbalances in baseline QoL.
This study aims to explore the changes in pain intensity and quality of life (QoL) experienced by patients with painful diabetic neuropathy (PDN) treated with spinal cord simulation (SCS) and conventional medical practice (CMP).
Methods
Patient-reported pain intensity and QoL data were obtained from participants in an international multicentre randomised controlled trial comparing SCS versus CMP. Data were collected at randomisation and 6 month follow up by means of a visual analogue scale for pain intensity (VASPI), the EuroQoL Visual Analogue Scale (EQ VAS) and the EuroQol EQ-5D index. Quality-adjusted life years (QALYs) were calculated for each treatment using the ‘area under the curve’ method. Differences in QALYs were calculated after adjusting for between-treatment imbalances in baseline QoL.
Results
At six months, patients allocated to SCS reported larger reductions in pain intensity and improvements in QoL measured by the EQ-5D utility score and EQ-VAS as compared to those allocated to CMP. Initial calculations of QALYs for the SCS and CMP groups suggested no statistical differences between the groups. Adjusting for imbalances in baseline EQ-5D scores showed SCS to be associated with significantly higher QALYs compared to CMP.
Conclusions
SCS resulted in significant improvement in pain intensity and QoL in patients with PDN, offering further support for SCS as an effective treatment for patients suffering from PDN. From a methodological point of view, different results would have been obtained if QALY calculations were not adjusted for baseline EQ-5D scores, highlighting the need to account for imbalances in baseline QoL.
| Original language | English |
|---|---|
| Pages (from-to) | 1771–1777 |
| Number of pages | 7 |
| Journal | Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation |
| Volume | 25 |
| Issue number | 7 |
| Early online date | 22 Dec 2015 |
| DOIs | |
| Publication status | Published - Jun 2016 |
Keywords
- EuroQoL-5D
- Neuropathic pain
- Painful diabetic neuropathy
- Quality Of Life
- Spinal cord stimulation
Access to Document
- Duarte_et_al_quality_of_life_increase_Quality_of_Life_Research_2015
Checked for eligibility: 05/01/2016. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.