Quality of life in patients with diabetic macular oedema and low vision treated with antiangiogenic drugs

de Juan-Marcos, Lourdes; Hernández-Galilea, Emiliano; López-Gálvez, M. Isabel
doi:10.1016/j.medcle.2016.07.011
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Diabetic macular oedema &#40;DME&#41; is the leading cause of visual impairment in patients with diabetic retinopathy&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">1</span></a> It is a chronic disease that requires treatment with multiple and repeated intravitreal antiangiogenic injections&#44; which represents an enormous healthcare workload&#44; a relative risk for the patient and a significant investment of financial resources to the health system&#46; The visual acuity &#40;VA&#41; and central macular thickness &#40;CMT&#41; as measured by optical coherence tomography are clinical benchmarks used to modify the injection regimen&#46; Now these clinically objective measures may be insufficient to indicate the need for treatment and assess its outcome&#44; since they do not always reflect the degree of visual impairment of the person in his&#47;her activities of daily living&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">2</span></a> For this reason&#44; it would be advisable to use quality of life questionnaires in routine clinical practice&#44; since they provide detailed information on the impact of visual dysfunction and patient satisfaction after treatment&#44; as they consider different dimensions&#44; not just the purely visual one&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">A prospective longitudinal study was conducted to evaluate the change in the quality of life of 65 patients with DME and moderate&#47;severe visual loss&#44; treated with antiangiogenic &#40;ranibizumab&#41; injections as monotherapy according to the standard dose &#40;0&#46;5<span class="elsevierStyleHsp" style=""></span>mg&#41;&#44; establishing as treatment criteria the clinical practice protocols&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">4</span></a> The EuroQol-5D &#40;EQ-5D&#41;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">5</span></a> quality of life questionnaire was applied to all patients by trained personnel before starting treatment and at 6 months&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">After measuring the VA&#44; the CMT and the quality of life with the EQ-5D questionnaire&#44; a positive development was observed in patients with DME after treatment with antiangiogenic agents&#59; not only improving their VA and CMT&#44; facts already known&#44; but a general improvement in the perception of quality of life &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41; was also associated to treatment&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">The EQ-5D revealed the negative impact of DME perceived by patients in the 5 quality of life dimensions analysed&#46; After treatment administration&#44; there were less statements related to problems in all the dimensions&#44; which demonstrates a certain disability to develop activities of daily living that depend on vision in patients with DME and who benefit from antiangiogenic therapy&#46; However&#44; significant differences were only found in the &#8220;activities of daily living&#8221; dimension&#44; indicating that&#44; for diabetic patients with DME and moderate&#47;severe visual loss&#44; the EQ-5D questionnaire could be a useful marker to assess how the disease impacts on their daily activity&#44; but it may not be the best tool to assess changes that occur after treatment with ranibizumab&#46; Some studies have already pointed out that a generic quality of life questionnaire may not be sensitive enough to detect small&#44; but sometimes clinically important gains in a specific function induced by the treatments being administered&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">6</span></a> In this case&#44; the use of specific visual function questionnaires&#44; which individually analyse changes in the various activities of daily living&#44; may be more appropriate to determine the ability of these patients to function in each of their daily tasks and to estimate how treatment affects their perception regarding performing these activities and&#44; therefore&#44; in their quality of life&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The correlation between improved binocular VA and CMT with the score indicated on the visual analogue scale of the EQ-5D was weak &#40;<span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;20&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#59; <span class="elsevierStyleItalic">r</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;0&#46;14&#44; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#44; respectively&#41;&#46; Therefore&#44; evaluating the results in these patients only through clinical indicators may underestimate the total benefits obtained&#44; and&#44; more so&#44; in people with severe visual loss&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">This study adds to the evidence that diabetes mellitus is associated with a worse perception of the patient&#39;s health status&#44; and that the visual loss produced by the DME is related to a negative impact on the quality of life of diabetics&#46; An improvement in visual function leads to an increased independent living capacity&#44; thus&#44; a greater personal well-being and a better health status perception&#46; All this shows the significant weight of vision impairment in quality of life perceived by patients&#44; and the need for prevention and early detection of diabetic retinopathy&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In this context&#44; the use of quality of life questionnaires&#44; whose results can be understood by all those involved in health care&#44; would facilitate communication between patients&#44; doctors and health authorities&#46; Thus&#44; important data would be available which could help in decision making and the planning of treatments&#44; services and programmes focused on the needs of individuals&#44; as perceived by them&#46;</p></span>"
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          "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">BVA&#44; binocular visual acuity&#59; MVA&#44; monocular visual acuity&#59; DME&#44; diabetic macular oedema&#59; VAS&#44; visual analogue scale&#59; CMT&#44; central macular thickness&#46;</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Data are shown as mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>standard deviation&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The MVA and BVA are expressed in decimal scale&#46;</p>"
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                  \t\t\t\t</th><th class="td" title="table-head  " colspan="4" align="center" valign="top" scope="col" style="border-bottom: 2px solid black">Patients with DME &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>65&#41;</th></tr><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Before&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">After&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Improvement&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black"><span class="elsevierStyleItalic">p</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">MVA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;23<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;42<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;18&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;19<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;15&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#60;0&#46;01&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">BVA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;34<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;48<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;16&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;14<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>0&#46;15&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#60;0&#46;01&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">CMT &#40;&#956;m&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">43&#46;401<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>77&#46;41&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">316&#46;67<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>51&#46;40&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#8722;117&#46;34<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>77&#46;64&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#60;0&#46;01&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">VAS&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">60&#46;8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>10&#46;5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">67&#46;7<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>11&#46;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">6&#46;9<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>7&#46;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#60;0&#46;01&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Mean values of monocular visual acuity&#44; binocular visual acuity&#44; central macular thickness and visual analogue scale before and after treatment&#46;</p>"
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