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CRSToday Europe News – November/December 2008
Empathy Strengthens Doctor-Patient Relationship
Physicians rarely express empathy for their patients' concerns during clinical encounters, according to a recent study in the Archives of Internal Medicine found that.1
Diane Morse, MD, Assistant Professor of Psychiatry and Medicine at the University of Rochester, New York, analyzed transcripts of 20 consultations between patients with lung cancer and their thoracic surgeons or oncologists. Of 384 opportunities physicians had to show empathy during the encounters, they acknowledged patients' concerns only 39 times. "When empathy was provided, 50% of these statements occurred in the last one-third of the encounter, whereas patients' concerns were evenly raised throughout the encounter," Dr. Morse wrote in the study.
Although this study focused on oncologists and lung cancer patients, Cataract & Refractive Surgery Today Europe asked several ophthalmologists via e-mail how they show empathy to their patients.
Ming Wang, MD, PhD, said he believes that simply being courteous to patients is a powerful way for physicians to express empathy. Dr. Wang is Medical Director of Refractive Surgery, Aier Eye Hospital System, Shanghai, China; Clinical Associate Professor of Ophthalmology, University of Tennessee, Memphis; Attending Surgeon, Saint Thomas Hospital, Nashville, Tennessee; and Director, Wang Vision Institute, Nashville. "Not rushing consultations, closing the exam room door so that outside distractions do not interfere with concentrating on the patient, and sitting eye-to-eye with a patient are effective ways to show empathy," Dr. Wang wrote to CRST Europe.
"There is a lot to be said for practicing psychiatric ophthalmology, both in the satisfaction it gives the physician and the confidence it provides the patient," Lisa Brothers Arbisser, MD, a private practitioner at Eye Surgeons Associates in the Iowa and Illinois Quad Cities, and Adjunct Clinical Associate Professor at the John A. Moran Eye Center at the University of Utah, Salt Lake City wrote. "I will take the time to address issues of loneliness or hopelessness, not infrequently seen in our elderly patients, particularly when low vision compromises their lifestyle. Simple gestures, such as holding a hand or clasping a shoulder, and direct eye contact help put patients at ease."
"I find that empathy goes a long way with patients," wrote Mitchell C. Shultz, MD, an Assistant Clinical Professor at the Jules Stein Eye Institute, University of California, Los Angeles, and a private practitioner in Los Angeles. "If you gain patients' trust from the first minute, you can steadily navigate them through challenging situations that could, if handled differently, lead to litigation. A patient who trusts that you are doing everything possible to help is unlikely to fault you for complications that arise during treatment."
Some physicians find that expressing empathy helps them forge stronger relationships with their patients and improves patients' compliance with treatment. "Patients respect you more and respond positively to [an empathetic] attitude," wrote Erik L. Mertens, MD, Director and Ophthalmic Surgeon at Antwerp Eye Center in Belgium. Arthur B. Cummings, MD, Clinical Director of the Wellington Ophthalmic Laser Center in Dublin, Ireland, agreed with Dr. Mertens. "Showing empathy improves doctor-patient relationships more than any other aspect of the clinical interaction. There is no doubt that [empathy] increases patient volumes by increasing your word-of-mouth referrals," he wrote to CRST Europe.
These ophthalmologists identified time and patience as the biggest challenges physicians face when providing patients with emotional support. "Empathy and efficiency often cannot coexist. The modern market economy and [the business of] medicine has forced doctors to spend less time with patients," Dr. Wang wrote.
The standard consultation schedule is usually disrupted when patients are allowed to express their emotions—Drs. Mertens and Cummings both said. "Showing empathy in any sincere manner is always going to cost you time," Dr. Cummings wrote. For Dr. Mertens, this typically means doubling the time scheduled for a standard consultation.
Yet, falling behind schedule is an opportunity to show empathy, said Dr. Arbisser. "When I fall behind schedule, I go into the waiting room, apologize to patients, and explain that I take time with people when they need it and that I will do the same for them. People appreciate this kindness and are apt to forgive the wait."
A. John Kannellopoulos, MD, Director of the Laservision.gr Eye Institute in Athens, Greece; attending surgeon at the Department of Ophthalmology, Manhattan Eye, Ear, and Throat Hospital in New York; and Clinical Associate Professor of Ophthalmology at New York University Medical School, said he values the significant increase in doctor-patient trust that results from showing patients empathy. "Remaining patient while clients discuss nontreatment issues, however, is often a challenge," he added.
Discussing nontreatment issues can become a problem in some instances. "Patients sometime abuse the situation when they find it easy to talk to a doctor, and you end up providing advice on more than ophthalmology," Dr. Cummings wrote. "Simply acknowledging their situation and the fact that what they are [personally and/or medically] going through is tough goes a long way toward building trust and strengthening the doctor-patient relationship."
US FDA to Open Overseas Offices
The US Department of Health and Human Services (HHS) will send the first US Food and Drug Administration (FDA) staff to China, India, Europe, and Latin America before the end of 2008, according to a recent news release.
"We're making steady progress to better safeguard our supply of food and medicines, although much work remains," said Mike Leavitt, Secretary of HHS, in a news release. "Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products."
The first overseas staff will be placed in Beijing this year, with staff placed in Shanghai and Guangzhou as well as additional staff in Beijing in 2009. The department anticipates a total of eight US nationals in China. The second overseas office will be established in New Delhi in 2008; at least one additional office will follow in 2009. Ten US nationals will be posted in India, for which the US government is currently pursuing that country's formal approval.
In both nations, FDA personnel will work with local authorities and industries to improve safety efforts for food and medical products shipped to the United States. Their activities will include providing technical advice, conducting additional inspections, and working with government agencies and private sector entities to develop certification programs.
The HHS and FDA will also reportedly be opening offices in Europe and Latin America before the end of 2008, with a fifth office in the Middle East to open in early to mid 2009.
"The globalization of the food supply and medical product manufacturing has demanded that we do things differently," said FDA Commissioner Andrew C. von Eschenbach, in a news release. "Through our Ôbeyond our borders' initiative, we won't have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight—we'll have staff living there and working on the ground 365 days a year."
Department officials are also forging relationships with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama to work together on product safety.
Intracameral Anesthesia May Improve Comfort in Long Eyes
Supplementing topical anesthesia with intracameral lidocaine may improve intraoperative comfort for patients with highly myopic eyes during cataract surgery.1
Giorgio Lofoco, MD, and colleagues at the San Pietro Fatebenefratelli Hospital in Rome, conducted a randomized, prospective, double-masked study of 120 highly myopic eyes with axial length greater than 26 mm. The control group (n=60) received balanced salt solution as a placebo. The other 60 eyes received a supplement of 0.1 mL preservative-free lidocaine hydrochloride 1% injected in the capsular bag during hydrodissection. Intraoperative pain was assessed by recording spontaneous patient reports of pain sensations or ocular discomfort throughout the surgery. Postoperative pain was assessed on a visual analog scale (range, 0–10).
The overall mean axial length was 28.58 mm (28.57 mm control group; 28.50 mm lidocaine group). Fewer patients in the lidocaine group reported intraoperative pain, ocular discomfort, or tissue manipulation (P=.019). The mean postoperative pain score was 1.88 ±2.17 standard deviation (SD) in the control group and 1.36 ±2.02 in the lidocaine group; this difference was not statistically significant (P=.21), investigators noted.
Toric ICL an Option for High Myopic Astigmatism
Implantation of a toric implantable contact lens (TICL) may produce better postoperative visual outcomes than wavefront-guided LASIK for patients with high myopic astigmatism.1
According to Kazutaka Kamiya, MD, PhD, and colleagues at Kitasato University, Kanagawa, Japan, collamer TICL implantation surpassed wavefront-guided LASIK in almost all measures of safety, efficacy, predictability, and stability.
The study, published in the Journal of Cataract & Refractive Surgery, included 30 eyes (18 patients) having TICL implantation and 24 eyes (17 patients) having wavefront-guided LASIK (Technolas 217z; Bausch & Lomb, Rochester, New York) to correct high myopic astigmatism. Dr. Kamiya and colleagues assessed patients at 1 week and 1, 3, and 6 months after surgery.
At 6 months, the mean safety index was 1.28 ±0.25 SD in the TICL group and 1.01 ±0.16 in the LASIK group, and the mean efficacy index was 0.87 ±0.15 and 0.83 ±0.23, respectively. Also at 6 months, all eyes in the TICL group and 71% of eyes in the LASIK group were within ±1.00 D of the targeted spherical equivalent correction. The mean change in manifest refraction from 1 week to 6 months was -0.04 ±0.24 D in the TICL group and -0.60 ±0.49 D in the LASIK group. There were no significant complications in the TICL group; however two eyes (8.3%) in the LASIK group required enhancement ablations, investigators said.
Visual Rehabilitation Faster After LASEK Than Epi-LASIK
Patients' UCVA at 1 day and 1 month postoperatively was better after LASEK than epi-LASIK in a retrospective study.1 The difference was statistically and clinically significant (ie, two lines of Snellen visual acuity).
Miguel A. Teus, MD, PhD, and colleagues also suggested that LASEK may be associated with greater safety and efficacy than epi-LASIK. The study evaluated age- and refraction-matched (-9.00 D or less) patients who underwent LASEK or epi-LASIK using the Esiris excimer laser (Schwind eye-tech-solutions, Kleinostheim, Germany). The epithelial flap was repositioned after the ablation in all cases. Patients' UCVA was measured at each postoperative visit, and their BCVA and refraction were measured 3 months after surgery.
UCVA was 20/40 or better in 30 of 47 (63.8%) epi-LASIK eyes and in 41 of 47 (87.2%) LASEK eyes 1 day after surgery (P<.001). At 1 week, these numbers increased to 41 (87.2%) eyes treated with epi-LASIK and 42 (89.3%) LASEK-treated eyes (P=.1). One month after surgery, 45 (95.7%) eyes in the epi-LASIK group and all eyes in the LASEK group had a UCVA of 20/40 or better (P<.001). The researchers found no significant difference in mean UCVA between the two procedures at 3 months. Even so, they wrote, "the percentages of eyes with an UCVA equal to or better than 20/40 and 20/20 were higher in the LASEK-treated group at every postoperative examination."1 They also stated that efficacy and safety indices were significantly better after LASEK than epi-LASIK at 3 months.
Dry Eye Common in Diabetics
Dry eye syndrome and diabetic retinopathy (DR) may have a common association, according to a study published in BMC Ophthalmology.1
The study included 199 patients with type 2 diabetes (80 men, 119 women) referred to the Yazd Diabetes Research Center in Yazd, Iran. Of the patients, 108 (54.3%) had dry eye syndrome. Investigators observed a significant association between dry eye syndrome and the duration of diabetes. The mean duration of diabetes in patients with dry eye syndrome was 11.48 ±7.4 years, whereas individuals without dry eye syndrome had diabetes for 9 ±6.5 years (P=.01).
Dry eye syndrome was also more prevalent in patients with diabetic retinopathy (P=.02), which was found in 140 patients (70.35%), including 34 (17.1%) with mild nonproliferative DR, 22 patients (11.1%) with severe nonproliferative DR, and 25 patients (25.1%) with proliferative DR. The frequency of DR was reportedly highest among patients aged 55 to 64 years (84.9%) and lowest in 24- to 49-year-old individuals (51.5%). Lower grades of DR were more common in women, and higher grades of DR were more common in men. Furthermore, researchers found that diabetes affected the frequency with DR occuring in 31.9% of patients whose history of diabetes was less than 5 years, in 12.48% of patients with diabetes for 5 to 14 years, and 100% of patients with diabetes for 15 years or more (P<.0001).
Masoud R. Manaviat, MD, first author of the study, is an Associate Professor of Ophthalmology at the Yazd Diabetes Research Center. "In our study, prevalence of dry eye among diabetic patients was 54.3%, and there was a significant association found between dry eye and duration of diabetes," Dr. Manaviat wrote in an e-mail to Cataract & Refractive Surgery Today Europe. "Therefore, we think that dry eye examination should be an integral part of the evaluation of diabetic patients."
Ocular Anesthetic Approved in the United States
Akorn, Inc. (Buffalo Grove, Illinois) announced the US FDA approval of its New Drug Application (NDA) for Akten Ophthalmic Gel 3.5%, a topical, unit dose, preservative-free lidocaine gel designed for complete ocular anesthesia. The agent is stored at room temperature and can be used as a topical anesthetic for cataract and refractive surgery and intravitreal injection.
Akorn has reportedly filed two US patents and one international patent on the formulation and method of use of Akten, the first NDA ocular anesthetic approved by the FDA in 4 decades.
The company submitted the NDA on June 29, 2007. The approval follows the positive results of a randomized, placebo-controlled, phase 3 clinical trial that evaluated the effectiveness of Akten in 209 patients at 1.5%, 2.5%, and 3.5% dosing levels. The primary efficacy endpoint for achieving ocular anesthesia (P<.001) and the secondary endpoint for duration of anesthesia (P<.001) were both statistically significant.1 Also, all three doses were well tolerated and corneal toxicity was not observed.
Akorn reportedly anticipates a market size of approximately 11 million procedures annually. The company plans to launch Akten in October 2008.
Corneal Endothelium Unaffected by Intraoperative Mitomycin-C
The use of intraoperative topical mitomycin-C 0.02% after LASEK did not affect the corneal endothelium, in a study by researchers at Changzheng Hospital in Shanghai, China.1
Researchers treated 174 eyes of 89 patients who did not previously wear contact lenses. After LASEK, topical mitomycin-C 0.02% was applied for 15 seconds immediately following surgery. Preoperatively, the patients' mean endothelial cell density measured 2,755 ±373 cells/mm², the mean coefficient of variation in cell size was 31.45 ±8.26, and the mean percentage of hexagram cells was 66.03 ±25.83. After LASEK, no statistically significant changes were observed in any of these indices (P>.05). Additionally, multiple linear regression analysis did not identify ablation depth or residual stromal bed thickness as predictor of change in endothelial central cell density, variation in cell size, or percentage of hexagram cells (P>.05).
Corneal Incisions Contribute to Transient Negative Dysphotopsia Symptoms
A long-term study designed to research the etiology of negative dysphotopsia, a postoperative symptom traditionally attributed to the edge of the IOL, suggested that corneal edema associated with a beveled temporal incision contribute to the symptoms of transient negative dysphotopsia.1
A total of 250 consecutive patients underwent phacoemulsification and received a one-piece acrylic IOL (AcrySof SN60WF or SN60AT; Alcon Laboratories, Inc., Fort Worth, Texas) at the University of Cincinnati, College of Medicine, and were followed for 3 years. Negative dysphotopsias were present in 38 eyes 1 day after surgery. By the second month, the shadows had disappeared in 27 eyes. Shadows remained in 10 eyes of seven patients at 6 months and decreased to seven eyes of five patients at 1 year. Negative dysphotopsias were still present in four patients at years 2 and 3. Common symptoms included a shallow orbit, prominent globe (greater than 0.45 mm between the iris and IOL), and perimetric comet-shaped light in the area corresponding to the shadow.
"Because 15% of patients interviewed on the first postoperative day were aware of a temporal shadow that quickly disappeared for all but 3% of the patients, the search for an alternate explanation consistent with this timeline was necessary," Robert H. Osher, MD, author of the study, wrote to Cataract & Refractive Surgery Today Europe. Dr. Osher is a Professor at the University of Cincinnati College of Medicine and Medical Director Emeritus at the Cincinnati Eye Institute. "Fortuitously, I identified a new finding, the shadow sign, in which light from the slit lamp transforms a linear shadow into a crescent-shaped shadow projected through the pupil when the slit beam is rotated toward the temporal field. [This suggests that] the transient negative dysphotopsia is due to the broad-based corneal edema of the temporal incision, [whereas] permanent negative dysphotopsia is a result of a complex interaction of factors that involve the edge of the IOL."
Vision Loss After Nonocular Surgery
The incidence of postoperative visual loss has been as high as 4.5% in cardiac surgery and 0.2% in spine surgery, according to a report published in Neuro-Ophthalmology.1 The report reviewed data from two large retrospective studies conducted in the late 1990s and a report from the Scoliosis Research Study.
Although postoperative visual loss is an uncommon complication, reports of vision loss after nonocular surgery increased over the past 10 to 15 years, reported Molly E. Gilbert, MD. She suggested that interest in understanding and quantifying postoperative visual loss is due to the devastating impact this rare complication has on the quality of life for patients who, in many cases, are undergoing elective surgery. The medicolegal implications for surgeons and patients alike also raised awareness of this complication.Ê
"Determining the actual overall incidence of postoperative visual loss is difficult since it is not known what percentage of cases are reported," said Dr. Gilbert, Assistant Professor of Ophthalmology at the University of Illinois-Chicago Eye and Ear Infirmary.Ê"A wide variety of surgical interventions have been associated with postoperative visual loss, including cardiopulmonary bypass, lumbar spine surgery, neck dissection, abdominal procedures, hip surgery, cholecystectomy, parathyroidectomy, prostate surgery, pleurodesis, and rotator cuff surgery."
Investigators have described several causes of postoperative visual loss after nonocular surgery, including ischemic optic neuropathy, central retinal artery occlusion, central retinal vein occlusion, and cortical blindness. Factors such as deliberate hypotension, direct pressure on the eye, prone positioning, duration of anesthesia, and long surgical times, can cause postoperative visual loss.
"Based on the information that is currently available, there is no good treatment for postoperative vision loss," Dr. Gilbert stated. "Therefore, education of colleagues in anesthesia and surgery is essential to help prevent this devastating complication." Other recommendations include gathering a careful preoperative history to identify any preexisting risk factors that predispose the patient to postoperative vision loss; use of deliberate hypotension; avoidance of eye, abdomen, or chest compression when the patient is in the prone position; and correction of anemia and/or hypotension as early as is feasible upon the identification of these risk factors.
Vision Problems Increase Risk of Hospital Admission
A recent prospective study suggested an increased risk of hospital admission in visually impaired older people due to higher levels of comorbidity and reduced functional ability from impaired vision.1
The study, conducted by Jennifer R. Evans, PhD, of the International Centre for Eye Health and London School of Hygiene and Tropical Medicine, and colleagues, included 14,394 patients aged 75 years and older living in Britain who participated in the Medical Research Council Trial of Assessment and Management of Older People in the Community.
Older people with visual impairments had 238.7 admissions per 1,000 person-years compared with 169.7 admissions per 1,000 person-years in older people with good vision. The reason for hospital admission was specified for 87% of admissions, including 303 admissions recorded as ophthalmology. Individuals with visual impairment were more likely to be admitted for one or more ophthalmology admissions, investigators said. Also, visually impaired patients had a longer median duration of hospital stay compared with people with good vision (12 days vs 8 days; P<.001). After adjustment for explanatory factors, visually impaired patients stayed in the hospital on average 2 days longer (P=.408).
Myopic Shift Associated With Pars Plana Vitrectomy
Some pseudophakic patients who undergo pars plana vitrectomy develop significant persistent refractive changes, according to a retrospective study published in BMC Ophthalmology.1 The mean change was a small myopic shift; however, the range was large, according to Sinead Byrne, MD, first author of the study.
The study included 87 eyes (84 patients). Before vitrectomy, mean spherical equivalent refraction was -0.20 D; this changed to a mean of -0.65 D after surgery (SD refractive change ± 0.60; range 0.75 to -2.13 D; P<.001). Sixty-one of the 87 eyes (70%) experienced a myopic shift and 45 eyes (52%) had a myopic shift of -0.50 D or more. Mean fellow eye refraction in 37 eyes was -0.14 D preoperatively and -0.12 D postoperatively (P=.51). In 32 eyes, mean anterior chamber depth was 3.29 mm preoperatively and 3.27 mm postoperatively (P=.87). The investigators did not observe any correlation between the pre-, intra-, and postoperative factors and refractive change after vitrectomy.
The etiology of the refractive change is uncertain, the study concluded.
– Compiled by Jennifer Kreatsoulas, News and Contributing Editor
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