Patient perspectives on macular hole surgery

Abstract

We would like to commend the Ophthalmic Technology Assessment Committee Retina Panel for the preparation of so clear a position statement regarding surgery for full thickness macular holes.1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar The balance of published evidence presented suggests that although this is an undertaking requiring considerable postoperative commitment from patients, and occasionally even resulting in morbidity,2Holekamp N.M Meredith T.A Landers M.B et al.Ulnar neuropathy as a complication of macular hole surgery.Arch Ophthalmol. 1999; 117 ([published erratum appears in Arch Ophthalmol 2000;118:549]): 1607-1610Crossref PubMed Scopus (51) Google Scholar the procedure will continue to be offered to many, especially in the light of appreciable3Ezra E Wells J.A Gray R.H et al.Incidence of idiopathic full-thickness macular holes in fellow eyes. A 5-year prospective natural history study.Ophthalmology. 1998; 105: 353-359Abstract Full Text PDF PubMed Scopus (74) Google Scholar risk to the fellow eye. Nevertheless, despite the wealth of published material presented, it remains surprisingly difficult to predict exactly what a given patient will gain from their surgery.Addressing the value of the intervention, as opposed to comparing modifications of surgical technique, only two studies addressed the issue of surgical success rates with a nonsurgical control group and randomization in stage 24Kim J.W Freeman W.R Azen S.P et al.Prospective randomized trial of vitrectomy or observation for stage 2 macular holes. Victrectomy for Macular Hole Study Group.Am J Ophthalmol. 1996; 121: 605-614Abstract Full Text PDF PubMed Scopus (131) Google Scholar and stage 3 or 4 holes.5Freeman W.R Azen S.P Kim J.W et al.Vitrectomy for the treatment of full-thickness stage 3 or 4 macular holes. Results of a multicentered randomized clinical trial. The Vitrectomy for Treatment of Macular Hole Study Group.Arch Ophthalmol. 1997; 115 ([published erratum appears in Arch Ophthalmol 1997;115:636]): 11-21Crossref PubMed Scopus (329) Google Scholar Both demonstrated surgery to be overwhelmingly superior to observation in achieving hole closure. The effectiveness of the intervention in reducing visual impairment in these studies was less clear. One study failed to observe a statistically significant increase in mean logarithm of the minimum angle of resolution acuity,4Kim J.W Freeman W.R Azen S.P et al.Prospective randomized trial of vitrectomy or observation for stage 2 macular holes. Victrectomy for Macular Hole Study Group.Am J Ophthalmol. 1996; 121: 605-614Abstract Full Text PDF PubMed Scopus (131) Google Scholar and in the other this benefit, statistically significant at the P = 0.05 level, was achieved at the cost of significantly more complications in the surgical group.5Freeman W.R Azen S.P Kim J.W et al.Vitrectomy for the treatment of full-thickness stage 3 or 4 macular holes. Results of a multicentered randomized clinical trial. The Vitrectomy for Treatment of Macular Hole Study Group.Arch Ophthalmol. 1997; 115 ([published erratum appears in Arch Ophthalmol 1997;115:636]): 11-21Crossref PubMed Scopus (329) Google Scholar Results from studies without a natural history control or adequate concealment were more favorable, but it is well known that the effect size of an intervention in which randomization or concealment is inadequate can be exaggerated, perhaps by as much as 40%.6Schulz K.F Chalmers I Hayes R.J Altman D.G Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.JAMA. 1995; 273: 408-412Crossref PubMed Scopus (3995) Google Scholar This is reflected in the hierarchy of evidence quality used by the Retina Panel in the review process.So how has this review helped in advising a patient considering surgery for a full-thickness macular hole? Hole closure rates divorced from functional measures of success are clearly an inadequate measure of success to a patient. How then can the literature best support a surgeon wishing to practice from a sound evidence base?Patients considering macular hole surgery want to know more than the average increase in letters on the chart achieved for a hundred such patients; at the very least they want to know their chance of achieving a meaningful level of vision (e.g., 20/40 or better) with the intervention. Furthermore, they want to know, if this can be achieved in 22% to 49% of patients,1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar will they be in that 22% to 49%?In actual fact even this will not fully answer patients’ questions. What they really wish to know is whether surgery will enable them to knit or mend the carburetor again or to carry on looking after an aging husband. This and whether the pain or worry necessary to achieve this goal will be justified by the end result. What is needed is research showing that their quality of life can or will be improved. They can then decide if the price is worth paying.Modern medicine has awakened to the need to distinguish between impairment (measurable abnormality of function), disability (a subjective evaluation of how such impairment impacts life), and handicap (which occurs when disability leads to difficulties in fulfilling the role of mother, employee, care giver etc.). It is perhaps ironic that an inverse relationship exists between those outcomes most easily measured and those that matter most to patients. It transpires from the current review of the literature that the best documented measure (universally recorded in published studies) of successful intervention (hole closure) is the one that arguably matters least. Published data clearly support the ability of surgeons to improve anatomy. It is somewhat less clear whether they can improve visual acuity (reduce impairment). Apparently whether they can improve quality of life (reduce disability and handicap) has not been adequately addressed. It was stated by the Retina Panel that no publications addressing patient satisfaction (“inconvenience, preference and quality of life”) were found,1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar although one article is cited. This showed an improvement in the ease of performing various common tasks in daily life and satisfaction with surgery for most patients (level III evidence).7Pearce I.A Branley M Groenewald C et al.Visual function and patient satisfaction after macular hole surgery.Eye. 1998; 12: 651-658Crossref PubMed Scopus (24) Google Scholar When significant quality of life implications were anticipated with the intervention as much as the outcome in the Diabetes Control and Complication Trial, quality of life measures8The DCCT Research GroupReliability and validity of a diabetes quality-of-life measure for the Diabetes Control and Complications Trial (DCCT).Diabetes Care. 1988; 11: 725-732Crossref PubMed Scopus (485) Google Scholar were incorporated; perhaps it is time to incorporate such measures of outcome into trials in ophthalmology with instruments that are currently being evaluated.9Ruta D.A Garratt A.M Wardlaw D Russell I.T Developing a valid and reliable measure of health outcome for patients with low back pain.Spine. 1994; 19: 1887-1896Crossref PubMed Scopus (158) Google ScholarIn truth, however, all those working with such patients have observed that some achieve remarkable improvement in vision and, just as informatively perhaps, that patient satisfaction may exceed measured improvement in monocular visual acuity. In a small study in our unit, we reported that 14 of 28 (50%; 95% confidence interval [CI], 31%–69%) patients reported a considerable improvement in quality of life after surgery and in a further 10 of 28 (36%; 95% CI, 18%–53%) quality of life had improved somewhat. We also noted that removal or reduction of metamorphopsia, reported by 24 of 28 (86%, 95% CI, 73%–99%), seemed to correlate more closely with likelihood of a perceived successful outcome than Snellen acuity.10Ellis J.D Malik T.Y Taubert M.A et al.Surgery for full-thickness macular holes with short-duration prone posturing: results of a pilot study.Eye. 2000; 14: 307-312Crossref PubMed Scopus (43) Google Scholar We further noted, soberingly, that 15 of 28 patients (54%; 95% CI, 35%–72%) found posturing difficult or very difficult and almost half were tempted to give up at some point. We used a 5-day posturing regimen. It is perhaps instructive that a peer reviewer suggested that reference to reduction in metamorphopsia be removed, because this was “too subjective.” The implication was that a subjective (patient reported) outcome cannot be recorded in a valid manner.In conclusion, we would submit that rather than being a weakness of the review process, the demonstrated absence of published material in this area in fact achieves one of the Academy’s stated intentions for such a review: namely to “help define and refine the important questions to be answered by future investigations.”1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar Perhaps we will see these outcome measures recorded more often in future studies. We may even find that by performing such surgery we are doing more good than the improvement in acuity alone would suggest.7Pearce I.A Branley M Groenewald C et al.Visual function and patient satisfaction after macular hole surgery.Eye. 1998; 12: 651-658Crossref PubMed Scopus (24) Google Scholar, 10Ellis J.D Malik T.Y Taubert M.A et al.Surgery for full-thickness macular holes with short-duration prone posturing: results of a pilot study.Eye. 2000; 14: 307-312Crossref PubMed Scopus (43) Google Scholar We would like to commend the Ophthalmic Technology Assessment Committee Retina Panel for the preparation of so clear a position statement regarding surgery for full thickness macular holes.1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar The balance of published evidence presented suggests that although this is an undertaking requiring considerable postoperative commitment from patients, and occasionally even resulting in morbidity,2Holekamp N.M Meredith T.A Landers M.B et al.Ulnar neuropathy as a complication of macular hole surgery.Arch Ophthalmol. 1999; 117 ([published erratum appears in Arch Ophthalmol 2000;118:549]): 1607-1610Crossref PubMed Scopus (51) Google Scholar the procedure will continue to be offered to many, especially in the light of appreciable3Ezra E Wells J.A Gray R.H et al.Incidence of idiopathic full-thickness macular holes in fellow eyes. A 5-year prospective natural history study.Ophthalmology. 1998; 105: 353-359Abstract Full Text PDF PubMed Scopus (74) Google Scholar risk to the fellow eye. Nevertheless, despite the wealth of published material presented, it remains surprisingly difficult to predict exactly what a given patient will gain from their surgery. Addressing the value of the intervention, as opposed to comparing modifications of surgical technique, only two studies addressed the issue of surgical success rates with a nonsurgical control group and randomization in stage 24Kim J.W Freeman W.R Azen S.P et al.Prospective randomized trial of vitrectomy or observation for stage 2 macular holes. Victrectomy for Macular Hole Study Group.Am J Ophthalmol. 1996; 121: 605-614Abstract Full Text PDF PubMed Scopus (131) Google Scholar and stage 3 or 4 holes.5Freeman W.R Azen S.P Kim J.W et al.Vitrectomy for the treatment of full-thickness stage 3 or 4 macular holes. Results of a multicentered randomized clinical trial. The Vitrectomy for Treatment of Macular Hole Study Group.Arch Ophthalmol. 1997; 115 ([published erratum appears in Arch Ophthalmol 1997;115:636]): 11-21Crossref PubMed Scopus (329) Google Scholar Both demonstrated surgery to be overwhelmingly superior to observation in achieving hole closure. The effectiveness of the intervention in reducing visual impairment in these studies was less clear. One study failed to observe a statistically significant increase in mean logarithm of the minimum angle of resolution acuity,4Kim J.W Freeman W.R Azen S.P et al.Prospective randomized trial of vitrectomy or observation for stage 2 macular holes. Victrectomy for Macular Hole Study Group.Am J Ophthalmol. 1996; 121: 605-614Abstract Full Text PDF PubMed Scopus (131) Google Scholar and in the other this benefit, statistically significant at the P = 0.05 level, was achieved at the cost of significantly more complications in the surgical group.5Freeman W.R Azen S.P Kim J.W et al.Vitrectomy for the treatment of full-thickness stage 3 or 4 macular holes. Results of a multicentered randomized clinical trial. The Vitrectomy for Treatment of Macular Hole Study Group.Arch Ophthalmol. 1997; 115 ([published erratum appears in Arch Ophthalmol 1997;115:636]): 11-21Crossref PubMed Scopus (329) Google Scholar Results from studies without a natural history control or adequate concealment were more favorable, but it is well known that the effect size of an intervention in which randomization or concealment is inadequate can be exaggerated, perhaps by as much as 40%.6Schulz K.F Chalmers I Hayes R.J Altman D.G Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.JAMA. 1995; 273: 408-412Crossref PubMed Scopus (3995) Google Scholar This is reflected in the hierarchy of evidence quality used by the Retina Panel in the review process. So how has this review helped in advising a patient considering surgery for a full-thickness macular hole? Hole closure rates divorced from functional measures of success are clearly an inadequate measure of success to a patient. How then can the literature best support a surgeon wishing to practice from a sound evidence base? Patients considering macular hole surgery want to know more than the average increase in letters on the chart achieved for a hundred such patients; at the very least they want to know their chance of achieving a meaningful level of vision (e.g., 20/40 or better) with the intervention. Furthermore, they want to know, if this can be achieved in 22% to 49% of patients,1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar will they be in that 22% to 49%? In actual fact even this will not fully answer patients’ questions. What they really wish to know is whether surgery will enable them to knit or mend the carburetor again or to carry on looking after an aging husband. This and whether the pain or worry necessary to achieve this goal will be justified by the end result. What is needed is research showing that their quality of life can or will be improved. They can then decide if the price is worth paying. Modern medicine has awakened to the need to distinguish between impairment (measurable abnormality of function), disability (a subjective evaluation of how such impairment impacts life), and handicap (which occurs when disability leads to difficulties in fulfilling the role of mother, employee, care giver etc.). It is perhaps ironic that an inverse relationship exists between those outcomes most easily measured and those that matter most to patients. It transpires from the current review of the literature that the best documented measure (universally recorded in published studies) of successful intervention (hole closure) is the one that arguably matters least. Published data clearly support the ability of surgeons to improve anatomy. It is somewhat less clear whether they can improve visual acuity (reduce impairment). Apparently whether they can improve quality of life (reduce disability and handicap) has not been adequately addressed. It was stated by the Retina Panel that no publications addressing patient satisfaction (“inconvenience, preference and quality of life”) were found,1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar although one article is cited. This showed an improvement in the ease of performing various common tasks in daily life and satisfaction with surgery for most patients (level III evidence).7Pearce I.A Branley M Groenewald C et al.Visual function and patient satisfaction after macular hole surgery.Eye. 1998; 12: 651-658Crossref PubMed Scopus (24) Google Scholar When significant quality of life implications were anticipated with the intervention as much as the outcome in the Diabetes Control and Complication Trial, quality of life measures8The DCCT Research GroupReliability and validity of a diabetes quality-of-life measure for the Diabetes Control and Complications Trial (DCCT).Diabetes Care. 1988; 11: 725-732Crossref PubMed Scopus (485) Google Scholar were incorporated; perhaps it is time to incorporate such measures of outcome into trials in ophthalmology with instruments that are currently being evaluated.9Ruta D.A Garratt A.M Wardlaw D Russell I.T Developing a valid and reliable measure of health outcome for patients with low back pain.Spine. 1994; 19: 1887-1896Crossref PubMed Scopus (158) Google Scholar In truth, however, all those working with such patients have observed that some achieve remarkable improvement in vision and, just as informatively perhaps, that patient satisfaction may exceed measured improvement in monocular visual acuity. In a small study in our unit, we reported that 14 of 28 (50%; 95% confidence interval [CI], 31%–69%) patients reported a considerable improvement in quality of life after surgery and in a further 10 of 28 (36%; 95% CI, 18%–53%) quality of life had improved somewhat. We also noted that removal or reduction of metamorphopsia, reported by 24 of 28 (86%, 95% CI, 73%–99%), seemed to correlate more closely with likelihood of a perceived successful outcome than Snellen acuity.10Ellis J.D Malik T.Y Taubert M.A et al.Surgery for full-thickness macular holes with short-duration prone posturing: results of a pilot study.Eye. 2000; 14: 307-312Crossref PubMed Scopus (43) Google Scholar We further noted, soberingly, that 15 of 28 patients (54%; 95% CI, 35%–72%) found posturing difficult or very difficult and almost half were tempted to give up at some point. We used a 5-day posturing regimen. It is perhaps instructive that a peer reviewer suggested that reference to reduction in metamorphopsia be removed, because this was “too subjective.” The implication was that a subjective (patient reported) outcome cannot be recorded in a valid manner. In conclusion, we would submit that rather than being a weakness of the review process, the demonstrated absence of published material in this area in fact achieves one of the Academy’s stated intentions for such a review: namely to “help define and refine the important questions to be answered by future investigations.”1Benson W.E Cruickshanks K.C Fong D.S et al.Surgical management of macular holes a report by the American Academy of Ophthalmology.Ophthalmology. 2001; 108: 1328-1335Abstract Full Text Full Text PDF PubMed Scopus (145) Google Scholar Perhaps we will see these outcome measures recorded more often in future studies. We may even find that by performing such surgery we are doing more good than the improvement in acuity alone would suggest.7Pearce I.A Branley M Groenewald C et al.Visual function and patient satisfaction after macular hole surgery.Eye. 1998; 12: 651-658Crossref PubMed Scopus (24) Google Scholar, 10Ellis J.D Malik T.Y Taubert M.A et al.Surgery for full-thickness macular holes with short-duration prone posturing: results of a pilot study.Eye. 2000; 14: 307-312Crossref PubMed Scopus (43) Google Scholar