Tecnología de imagenología intraoperatoria para maximizar el grado de resección del glioma
Appendices
Appendix 1. CENTRAL search strategy
#1. MeSH descriptor: [Central Nervous System Neoplasms] explode all trees
#2. ((central nervous system or CNS or brain* or cerebral* or intracerebral or intra‐cerebral or intracranial or intra‐cranial or spine or spinal or astrocytic or oligodendroglial or ependymal) near/5 (cancer* or tumor* or tumour* or malignan* or neoplas* or carcinoma* or metastat*))
#3. MeSH descriptor: [Neoplasms, Neuroepithelial] explode all trees
#4. ((cranial or paraspinal or meninges or haematopoietic system or germ cell or germ‐cell or sellar or glioneural or neuroectodermal or embryonal or neuroepithelial or pineal or choroid plexus or teratoid or rhabdoid) near/5 (tumor* or tumour*))
#5. MeSH descriptor: [Glioma] explode all trees
#6. glioma* or glial* or astrocytoma* or xanthoastrocytoma* or glioblastoma* or gliosarcoma* or oligodendrogli* or oligoastrocyt* or ependym* or subependym* or astroblastoma* or ganglioglioma* or gangliocytoma* or neurocytoma* or liponeurocytoma* or pineocytoma* or pineoblastoma* or medulloblastoma* or neuroblastoma* or ganglioneuroblastoma*or medulloepithelioma* or GBM*
#7. #1 or #2 or #3 or #4 or #5 or #6
#8. MeSH descriptor: [Magnetic Resonance Imaging] explode all trees
#9. intra operative magnetic resonance imag* or intra‐operative magnetic resonance imag* or intra operative MRI or intra‐operative MRI or iMRI or ioMRI or IOMRI or IoMRI or MRI or MRi or NMRI or NMRi or magnetic resonance imag* or tractography
#10. MeSH descriptor: [Ultrasonography] explode all trees
#11. (2D or 3D) near/5 (ultras* or US)
#12. ((intra‐operative or intraoperative) near/5 (ultras* or US or IOUS or imag* or navigat* or technolog* or modalit* or eval* or monitor*))
#13 volumetric reconstruction or Sonowand or SonoWand
#14. MeSH descriptor: [Neuronavigation] this term only
#15. MeSH descriptor: [Surgery, Computer‐Assisted] this term only
#16. navigat* or neuronavigat* or neuro‐navigat* or image guid*
#17. Brainlab or Stealth
#18. MeSH descriptor: [Monitoring, Intraoperative] explode all trees
#19. MeSH descriptor: [Fluorescence] this term only
#20. MeSH descriptor: [Aminolevulinic Acid] this term only
#21. fluorescen* or immunofluorescen*
#22. aminolevulinic acid or 5‐aminolevulinic acid
#23. ALA or 5‐ALA or Gliolan
#24. #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23
#25. #7 and #24
Appendix 2. MEDLINE RCT search strategy
1. exp Central Nervous System Neoplasms/
2. ((central nervous system or CNS or brain* or cerebral* or intracerebral or intra‐cerebral or intracranial or intra‐cranial or spine or spinal or astrocytic or oligodendroglial or ependymal) adj5 (cancer* or tumor* or tumour* or malignan* or neoplas* or carcinoma* or metastat*)).mp.
3. exp neoplasms, neuroepithelial/
4. ((cranial or paraspinal or meninges or haematopoietic system or germ cell or germ‐cell or sellar or glioneural or neuroectodermal or embryonal or neuroepithelial or pineal or choroid plexus or teratoid or rhabdoid) adj5 (tumor* or tumour*)).mp.
5. exp Glioma/
6. (glioma* or glial* or astrocytoma* or xanthoastrocytoma* or glioblastoma* or gliosarcoma* or oligodendrogli* or oligoastrocyt* or ependym* or subependym* or astroblastoma* or ganglioglioma* or gangliocytoma* or neurocytoma* or liponeurocytoma* or pineocytoma* or pineoblastoma* or medulloblastoma* or neuroblastoma* or ganglioneuroblastoma*or medulloepithelioma* or GBM*).mp.
7. 1 or 2 or 3 or 4 or 5 or 6
8. exp Magnetic Resonance Imaging/
9. (intra operative magnetic resonance imag* or intra‐operative magnetic resonance imag* or intra operative MRI or intra‐operative MRI or iMRI or ioMRI or IOMRI or IoMRI or MRI or MRi or NMRI or NMRi or magnetic resonance imag* or tractography).mp.
10. exp Ultrasonography/
11. ((2D or 3D) adj5 (ultras* or US)).mp.
12. ((intra‐operative or intraoperative) adj5 (ultras* or US or IOUS or imag* or navigat* or technolog* or modalit* or eval* or monitor*)).mp.
13. (volumetric reconstruction or Sonowand or SonoWand).mp.
14. Neuronavigation/
15. Surgery, Computer‐Assisted/
16. (navigat* or neuronavigat* or neuro‐navigat* or image guid*).mp.
17. (Brainlab or Stealth).mp.
18. exp Monitoring, Intraoperative/
19. Fluorescence/
20. Aminolevulinic Acid/
21. (fluorescen* or immunofluorescen*).mp.
22. (aminolevulinic acid or 5‐aminolevulinic acid).mp.
23. (ALA or 5‐ALA or Gliolan).mp.
24. 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23
25. 7 and 24
26. randomized controlled trial.pt.
27. controlled clinical trial.pt.
28. randomized.ab.
29. placebo.ab.
30. clinical trials as topic.sh.
31. randomly.ab.
32. trial.ti.
33. 26 or 27 or 28 or 29 or 30 or 31 or 32
34. (animals not (humans and animals)).sh.
35. 33 not 34
36. 25 and 35
Key
mp = title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier
ab = abstract
sh = subject heading
ti = title
pt = publication type
Appendix 3. Embase RCT strategy
1. exp central nervous system tumor/
2. ((central nervous system or CNS or brain* or cerebral* or intracerebral or intra‐cerebral or intracranial or intra‐cranial or spine or spinal or astrocytic or oligodendroglial or ependymal) adj5 (cancer* or tumor* or tumour* or malignan* or neoplas* or carcinoma* or metastat*)).mp.
3. exp neuroepithelioma/
4. ((cranial or paraspinal or meninges or haematopoietic system or germ cell or germ‐cell or sellar or glioneural or neuroectodermal or embryonal or neuroepithelial or pineal or choroid plexus or teratoid or rhabdoid) adj5 (tumor* or tumour*)).mp.
5. exp glioma/
6. (glioma* or glial* or astrocytoma* or xanthoastrocytoma* or glioblastoma* or gliosarcoma* or oligodendrogli* or oligoastrocyt* or ependym* or subependym* or astroblastoma* or ganglioglioma* or gangliocytoma* or neurocytoma* or liponeurocytoma* or pineocytoma* or pineoblastoma* or medulloblastoma* or neuroblastoma* or ganglioneuroblastoma*or medulloepithelioma* or GBM*).mp.
7. 1 or 2 or 3 or 4 or 5 or 6
8. exp nuclear magnetic resonance imaging/
9. (intra operative magnetic resonance imag* or intra‐operative magnetic resonance imag* or intra operative MRI or intra‐operative MRI or iMRI or ioMRI or IOMRI or IoMRI or MRI or MRi or NMRI or NMRi or magnetic resonance imag* or tractography).mp.
10. exp echography/
11. ((2D or 3D) adj5 (ultras* or US)).mp.
12. ((intra‐operative or intraoperative) adj5 (ultras* or US or IOUS or imag* or navigat* or technolog* or modalit* or eval* or monitor*)).mp.
13. (volumetric reconstruction or Sonowand or SonoWand).mp.
14. neuronavigation/
15. computer assisted surgery/
16. (navigat* or neuronavigat* or neuro‐navigat* or image guid*).mp.
17. (Brainlab or Stealth).mp.
18. exp intraoperative monitoring/
19. fluorescence/
20. aminolevulinic acid/
21. (fluorescen* or immunofluorescen*).mp.
22. (aminolevulinic acid or 5‐aminolevulinic acid).mp.
23. (ALA or 5‐ALA or Gliolan).mp.
24. 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23
25. 7 and 24
26. crossover procedure/
27. double‐blind procedure/
28. randomized controlled trial/
29. single‐blind procedure/
30. random*.mp.
31. factorial*.mp.
32. (crossover* or cross over* or cross‐over*).mp.
33. placebo*.mp.
34. (double* adj blind*).mp.
35. (singl* adj blind*).mp.
36. assign*.mp.
37. allocat*.mp.
38. volunteer*.mp.
39. 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38
40. 25 and 39
41. (exp animal/ or nonhuman/ or exp animal experiment/) not human/
42. 40 not 41
Key
mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier
ab=abstract
sh=subject heading
ti=title
pt=publication type
Appendix 4. MEDLINE economic search strategy
1. exp Central Nervous System Neoplasms/
2. ((central nervous system or CNS or brain* or cerebral* or intracerebral or intra‐cerebral or intracranial or intra‐cranial or spine or spinal or astrocytic or oligodendroglial or ependymal) adj5 (cancer* or tumor* or tumour* or malignan* or neoplas* or carcinoma* or metastat*)).mp.
3. exp neoplasms, neuroepithelial/
4. ((cranial or paraspinal or meninges or haematopoietic system or germ cell or germ‐cell or sellar or glioneural or neuroectodermal or embryonal or neuroepithelial or pineal or choroid plexus or teratoid or rhabdoid) adj5 (tumor* or tumour*)).mp.
5. exp Glioma/
6. (glioma* or glial* or astrocytoma* or xanthoastrocytoma* or glioblastoma* or gliosarcoma* or oligodendrogli* or oligoastrocyt* or ependym* or subependym* or astroblastoma* or ganglioglioma* or gangliocytoma* or neurocytoma* or liponeurocytoma* or pineocytoma* or pineoblastoma* or medulloblastoma* or neuroblastoma* or ganglioneuroblastoma*or medulloepithelioma* or GBM*).mp.
7. 1 or 2 or 3 or 4 or 5 or 6
8. exp Magnetic Resonance Imaging/
9. (intra operative magnetic resonance imag* or intra‐operative magnetic resonance imag* or intra operative MRI or intra‐operative MRI or iMRI or ioMRI or IOMRI or IoMRI or MRI or MRi or NMRI or NMRi or magnetic resonance imag* or tractography).mp.
10. exp Ultrasonography/
11. ((2D or 3D) adj5 (ultras* or US)).mp.
12. ((intra‐operative or intraoperative) adj5 (ultras* or US or IOUS or imag* or navigat* or technolog* or modalit* or eval* or monitor*)).mp.
13. (volumetric reconstruction or Sonowand or SonoWand).mp.
14. Neuronavigation/
15. Surgery, Computer‐Assisted/
16. (navigat* or neuronavigat* or neuro‐navigat* or image guid*).mp.
17. (Brainlab or Stealth).mp.
18. exp Monitoring, Intraoperative/
19. Fluorescence/
20. Aminolevulinic Acid/
21. (fluorescen* or immunofluorescen*).mp.
22. (aminolevulinic acid or 5‐aminolevulinic acid).mp.
23. (ALA or 5‐ALA or Gliolan).mp.
24. 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23
25. 7 and 24
26. economics/
27. exp "costs and cost analysis"/
28. economics, dental/
29. exp "economics, hospital"/
30. economics, medical/
31. economics, nursing/
32. economics, pharmaceutical/
33. (economic$ or cost or costs or costly or costing or price or prices or pricing or pharmacoeconomic$).ti,ab.
34. (expenditure$ not energy).ti,ab.
35. (value adj1 money).ti,ab.
36. budget$.ti,ab.
37. 26 or 27 or 28 or 29 or 30 or 31 or 32 or 33 or 34 or 35 or 36
38. ((energy or oxygen) adj cost).ti,ab.
39. (metabolic adj cost).ti,ab.
40. ((energy or oxygen) adj expenditure).ti,ab.
41. 38 or 39 or 40
42. 37 not 41
43. letter.pt.
44. editorial.pt.
45. historical article.pt.
46. 43 or 44 or 45
47. 42 not 46
48. Animals/
49. Humans/
50. 48 not (48 and 49)
51. 47 not 50
52. 25 and 51
Key
mp = title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier
ab = abstract
sh = subject heading
ti = title
pt = publication type
Appendix 5. Embase economic search strategy
1. exp central nervous system tumor/
2. ((central nervous system or CNS or brain* or cerebral* or intracerebral or intra‐cerebral or intracranial or intra‐cranial or spine or spinal or astrocytic or oligodendroglial or ependymal) adj5 (cancer* or tumor* or tumour* or malignan* or neoplas* or carcinoma* or metastat*)).mp.
3. exp neuroepithelioma/
4. ((cranial or paraspinal or meninges or haematopoietic system or germ cell or germ‐cell or sellar or glioneural or neuroectodermal or embryonal or neuroepithelial or pineal or choroid plexus or teratoid or rhabdoid) adj5 (tumor* or tumour*)).mp.
5. exp glioma/
6. (glioma* or glial* or astrocytoma* or xanthoastrocytoma* or glioblastoma* or gliosarcoma* or oligodendrogli* or oligoastrocyt* or ependym* or subependym* or astroblastoma* or ganglioglioma* or gangliocytoma* or neurocytoma* or liponeurocytoma* or pineocytoma* or pineoblastoma* or medulloblastoma* or neuroblastoma* or ganglioneuroblastoma*or medulloepithelioma* or GBM*).mp.
7. 1 or 2 or 3 or 4 or 5 or 6
8. exp nuclear magnetic resonance imaging/
9. (intra operative magnetic resonance imag* or intra‐operative magnetic resonance imag* or intra operative MRI or intra‐operative MRI or iMRI or ioMRI or IOMRI or IoMRI or MRI or MRi or NMRI or NMRi or magnetic resonance imag* or tractography).mp.
10. exp echography/
11. ((2D or 3D) adj5 (ultras* or US)).mp.
12. ((intra‐operative or intraoperative) adj5 (ultras* or US or IOUS or imag* or navigat* or technolog* or modalit* or eval* or monitor*)).mp.
13. (volumetric reconstruction or Sonowand or SonoWand).mp.
14. neuronavigation/
15. computer assisted surgery/
16. (navigat* or neuronavigat* or neuro‐navigat* or image guid*).mp.
17. (Brainlab or Stealth).mp.
18. exp intraoperative monitoring/
19. fluorescence/
20. aminolevulinic acid/
21. (fluorescen* or immunofluorescen*).mp.
22. (aminolevulinic acid or 5‐aminolevulinic acid).mp.
23. (ALA or 5‐ALA or Gliolan).mp.
24. 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23
25. 7 and 24
26. Health Economics/
27. exp Economic Evaluation/
28. exp Health Care Cost/
29. pharmacoeconomics/
30. 26 or 27 or 28 or 29
31. (econom$ or cost or costs or costly or costing or price or prices or pricing or pharmacoeconomic$).ti,ab.
32. (expenditure$ not energy).ti,ab.
33. (value adj2 money).ti,ab.
34. budget$.ti,ab.
35. 31 or 32 or 33 or 34
36. 30 or 35
37. letter.pt.
38. editorial.pt.
39. note.pt.
40. 37 or 38 or 39
41. 36 not 40
42. (metabolic adj cost).ti,ab.
43. ((energy or oxygen) adj cost).ti,ab.
44. ((energy or oxygen) adj expenditure).ti,ab.
45. 42 or 43 or 44
46. 41 not 45
47. 25 and 46
48. (exp animal/ or nonhuman/ or exp animal experiment/) not human/
49. 47 not 48
Key
mp=title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier
ab=abstract
sh=subject heading
ti=title
pt=publication type
Study flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
| iMRI image‐guided surgery compared to standard surgery for high‐grade glioma | ||||||
| Patient or population: high‐grade glioma | ||||||
| Outcomes | Illustrative comparative risk* (95% CI) | Relative effect | No. of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Control | Image‐guided surgery | |||||
| Extent of resection: complete resection | 321 per 100 | 4 per 100 | RR 0.13 (0.02 to 0.96) | 49 participants | ⊕⊝⊝⊝1,2,3 | Small trial of highly selected participants with potential bias in allocation and performance. One other trial reported this outcome but did not contribute towards the analysis. |
| Adverse events | Inadequately and inconsistently reported in the trial | ⊕⊝⊝⊝4 | Adverse events were reported in an inconsistent manner and not according to the manner prespecified in our protocol. Additionally, we were mainly interested in identifying serious adverse events, which were inadequately reported | |||
| Overall survival | Not estimable | ⊕⊝⊝⊝4 | Not reported by trial authors so graded as very low quality evidence | |||
| Progression‐free survival | Not estimable | ⊕⊝⊝⊝4 | Progression‐free survival or time to progression was not adequately reported in the trial | |||
| Quality of life | Not estimable | ⊕⊝⊝⊝4 | Quality of life was not reported in the trial | |||
| *The basis for the assumed risk is only based on individual trials as only single trial reports were available. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Expressed in terms of risk of incomplete resection (bad outcome). | ||||||
| 5‐ALA image‐guided surgery compared to standard surgery for high‐grade glioma | ||||||
| Patient or population: high‐grade glioma | ||||||
| Outcomes | Illustrative comparative risk* (95% CI) | Relative effect | No. of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Control | Image‐guided surgery | |||||
| Extent of resection: complete resection | 641 per 100 | 35 per 100 | RR 0.55 (0.42 to 0.71) | 270 participants (1 study) | ⊕⊕⊝⊝2 | Highly selected participants with potential bias in allocation and performance |
| Adverse events | Inadequately and inconsistently reported in the trial | ⊕⊝⊝⊝3 | Adverse events were reported in an inconsistent manner and not according to the manner prespecified in our protocol. Additionally, we were mainly interested in identifying serious adverse events, which were inadequately reported | |||
| Overall survival | Not estimable due to reporting of HR and since just a single trial reported on this outcome we did not arbitrarily choose a snap shot in time in which to use as basis to calculate the assumed and corresponding risks as this may be misleading. | HR 0.82 (0.62 to 1.07) | 270 participants (1 study) | ⊕⊕⊝⊝2 | The overall quality of this outcome was low in this trial and was downgraded for highly selected participants with potential bias in allocation and performance | |
| Progression‐free survival | Not adequately reported in the trials | ⊕⊝⊝⊝3 | Progression‐free survival or time to progression was not adequately reported in the trial | |||
| Quality of life | Inadequately reported or not assessed at all in the included trials | ⊕⊝⊝⊝3 | Quality of life was not reported in the trial | |||
| *The basis for the assumed risk is only based on individual trials as only single trial reports were available. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Expressed in terms of risk of incomplete resection (bad outcome). | ||||||
| Neuronavigation image‐guided surgery compared to standard surgery for high‐grade glioma | ||||||
| Patient or population: high‐grade glioma | ||||||
| Outcomes | Illustrative comparative risk* (95% CI) | Relative effect | No. of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Control | Image‐guided surgery | |||||
| Extent of resection: complete resection | Not estimable | Not estimable | Not reported | 45 participants | ⊕⊝⊝⊝1,2,4 | Small study of highly selected participants at very high risk of allocation bias.Complete resection was achieved in three participants in the control group and five participants in the neuronavigation group. However, there was significant attrition, with not all participants completing imaging, and the denominators for these figures were not stated, precluding formal analysis |
| Adverse events | Inadequately and inconsistently reported in the trial | ⊕⊝⊝⊝2 | Adverse events were reported in an inconsistent manner and not according to the manner prespecified in our protocol. Additionally, we were mainly interested in identifying serious adverse events, which were inadequately reported | |||
| Overall survival | Not estimable | ⊕⊝⊝⊝3 | Not reported by trial authors so graded as very low quality evidence | |||
| Progression‐free survival | Not estimable | ⊕⊝⊝⊝2 | Progression‐free survival or time to progression was not reported in the trial | |||
| Quality of life | Inadequately reported or not assessed at all in the included trials | ⊕⊝⊝⊝3 | Quality of life was reported in the trial but only 19 participants (8 in the neuronavigation arm and 11 in the standard surgery arm) completed questionnaires postoperatively at 3 months', constituting only 64.5% of all eligible participants, and no statistical analysis was presented | |||
| *The basis for the assumed risk is only based on individual trials as only single trial reports were available. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Small trial so quality of the evidence downgraded by one level. | ||||||
| Score | Definition |
|---|---|
| 100 | Normal, no complaints, no evidence of disease |
| 90 | Able to carry on normal activity: minor symptoms of disease |
| 80 | Normal activity with effort: some symptoms of disease |
| 70 | Cares for self: unable to carry on normal activity or active work |
| 60 | Requires occasional assistance but is able to care for needs |
| 50 | Requires considerable assistance and frequent medical care |
| 40 | Disabled: requires special care and assistance |
| 30 | Severely disabled: hospitalisation is indicated, death is not imminent |
| 20 | Very sick, hospitalisation is necessary: active treatment is necessary |
| 10 | Moribund, fatal processes are progressing rapidly |
| 0 | Dead |
| Grade | Definition |
|---|---|
| 0 | Fully active, able to carry on all pre‐disease performance without restriction |
| 1 | Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. |
| 2 | Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of |
| 3 | Capable of only limited self care, confined to bed or chair more than 50% of waking hours |
| 4 | Completely disabled. Cannot carry out any self care. Totally confined to bed or chair |
| 5 | Dead |
