- Email: [email protected]
MND
Journal of the Neurological Sciences 191 Ž2001. 115–119 www.elsevier.comrlocaterjns
Incidence and predictors of PEG placement in ALSrMND Steven M. Albert ) , Peregrine L. Murphy, Maura Del Bene, Lewis P. Rowland, Hiroshi Mitsumoto Eleanor and Lou Gehrig MDAr ALS Center, Neurological Institute, Columbia UniÕersity, New York, NY, USA
Abstract In the Project on Death in America ALS cohort, 121 patients were followed to examine the timing of key milestones in the course of the disease, such as tracheostomy and PEG placement. During the 2- to 4-year follow-up period, 26.5% of patients received PEG, yielding a cumulative incidence of 48%. PEG placement occurred, on average, 16 months after patients received confirmation of the diagnosis at our Center. Patients who received PEG were more likely to have tracheostomies than patients not using PEG Ž p - 0.01.. In multivariate proportional hazard models that included both sociodemographic and disease indicators, the strongest predictor of PEG use was a patient’s baseline preference for PEG: 57.1% of patients Aabsolutely in favorB went on to have PEG, compared to only 9.3% of those Aabsolutely againstB Ž p - 0.01.. PEG users were more likely to have initiated health care proxies. These findings suggest that patients who use PEG may be consistently proactive in the face of the disease. q 2001 Elsevier Science B.V. All rights reserved. Keywords: Amyotrophic lateral sclerosis; PEG; Incidence; Tracheostomy; Epidemiology; Patient decision-making
1. Introduction Difficulty with eating and weight loss are typical features of ALS. Eating becomes difficult when people with ALS are unable to handle utensils or when swallowing is affected. Dietary changes are inescapable, and patients eventually find they are only able to eat pureed foods. Meals begin to take up an increasingly larger part of the day, risk of aspiration becomes more frequent, and weight loss accelerates. A this point, patients and their families must consider supplemental tube feeding as an alternative avenue for nutrition. The most common is a percutaneous endoscopic gastrostomy, or PEG. Initially, patients may combine PEG feeding with oral intake, but eventually feeding becomes exclusively parenteral. Despite a number of recent studies of PEG placement in people with ALS w1–5x, we have been unable to identify studies that report on the incidence and timing of PEG placement. It is still unclear how common PEG use really is, when it is typically recommended and then implemented, how PEG use relates to use of other interventions available to ALS patients Žsuch as tracheostomy and inter-
)
Corresponding author. Gertrude H. Sergievsky Center, PH-19, P&S Box 16, Columbia University, 630 West 168th St., New York, NY 10032, USA. Tel.: q1-212-305-2503; fax: q1-212-305-2426. E-mail address: [email protected] ŽS.M. Albert..
mittent nasal ventilatory assistance., and what predisposes patients to choose PEG. We investigated these issues directly in a large, well-characterized cohort of ALS patients followed at the Eleanor and Lou Gehrig MDArALS Center in New York, USA.
2. Materials and methods In 1996–1998, we enrolled 121 people with definite or probable ALS ŽEl Escorial criteria. w6x to the Project on Death in America ŽPDIA. ALS cohort. The Project on Death in America was part of an effort by the Open Society Institute ŽNew York City. to change attitudes toward death and dying in the United States. Patients were eligible for the PDIA Cohort if their treating neurologist referred them to the project, if they met El Escorial criteria, and if they spoke English. Eligible patients were approached by clinical staff, who explained the research study. Patients who expressed interest were then contacted by the research team. Patients were interviewed in a separate room during their clinic visit. About 60% of all eligible patients were enrolled: 5% were excluded because clinic staff thought participation might exacerbate psychiatric symptoms or threaten family supports, 15% were not approached because of difficulty scheduling or because patients came to the clinic only once and 20% were
0022-510Xr01r$ - see front matter q 2001 Elsevier Science B.V. All rights reserved. PII: S 0 0 2 2 - 5 1 0 X Ž 0 1 . 0 0 6 1 4 - 1
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approached but refused participation. The PDIA study protocol was reviewed and approved by the Institutional Review Board of Columbia UniversityrNew York Presbyterian Hospital. Features of the cohort have been reported elsewhere w7–9x. The majority of PDIA cohort patients Ž73%. were enrolled within 1 year of their diagnosis; other patients had the disease for over a year when they were first enrolled. This distribution reflects the status of patients who come to our tertiary care center; the clinic census reflects a mixture of patients coming to the clinic for confirmation of the diagnosis and patients who remain with the clinic for their follow-up care, management and clinical education. At the point of their enrollment, four patients already had PEG, and two tracheostomy; these patients were excluded from analyses used to examine the incidence of these endpoints. Patients enrolled into the PDIA cohort received an extensive baseline interview that elicited patient preferences for later use of PEG and tracheostomy, along with information on functional ability, mental health Žuse of psychiatric medicines, presence of depressive symptoms and degree of hopelessness., attitudes toward death and dying and sociodemographic status. Primary caregivers, when available, also completed a questionnaire that elicited perceived burden and satisfaction in caregiving. Usable data were available from caregivers for two-thirds of the patients. Burden was measured using a selection of structured items whose psychometric properties have been reported w10x. Neurologists treating each of the PDIA patients were also mailed a brief questionnaire about their approach to ALS management and diagnosis. Following the baseline interview, patients and their families were contacted every 4 months by telephone or during scheduled clinic visits. In these follow-up interviews, we surveyed a variety of outcomes associated with disease progression. These included new or continuing use of Ž1. technologies ŽPEG, Bi-Pap, tracheostomy, augmentative communication, mobility aides., Ž2. therapeutic services Žoccupational, physical, or speech therapy; psychiatric treatment, mental health or pastoral counseling, support group participation., Ž3. caregiving supports Žuse of paid home care, entry to nursing homes or hospice programs., Ž4. medical care Žhospitalization and emergency room use. and Ž5. legal planning Žestablishing health care proxies, consenting to autopsy.. We also recorded date and location of death. Because these were telephone interviews, often conducted with caregivers, we did not repeat baseline assessments of patient mental health and attitudes toward use of interventions. Patients were followed from 2 to 4 years, depending on their date of enrollment. Follow-up of the cohort was complete for 83.5% Ž101r121. of the cohort; that is, for all but 20 patients, a date for death or tracheostomy was available, or patients were known to be alive at their last follow-up interview. The 20 patients lost to follow-up include eight who had only a baseline visit and 12 who
had two or more visits but indeterminate status at the end of the follow-up period; these were considered censored observations. Throughout this 4-year period, patients receiving care at the clinic continued to receive clinical management and education at 3-month intervals. The Eleanor and Lou Gehrig MDArALS Center employs a comprehensive, interdisciplinary, coordinated system of care utilizing a model of patient and professional education well grounded in palliative care philosophy, clinical expertise and psychosocial programming. Patients are encouraged early in the disease course, through active education and counseling, to make informed decisions regarding the medical management of dysphagia and respiratory failure. At the clinic, the choice of management options for respiratory failure includes noninvasive ventilation, invasive mechanical ventilation, or natural death. Each pathway choice entitles the patient and their family access to continuous, comprehensive management of symptoms associated with the dying process.
3. Results In the PDIA cohort, 61% of patients were male, and 82% were white. The average level of education was 14.2 years and the mean age 59.7 ŽS.D. 12.7.. Two patients participated in the study without completing a baseline interview Žtheir caregivers completed a baseline interview and agreed to report on patient status at each follow-up.. Survival in the cohort, as well as loss to follow-up at each visit, is shown in Fig. 1. Taking into account patient censoring due to loss to follow-up, 22% of the cohort were alive at the end of the 4-year follow-up period. Fig. 2 shows the cumulative incidence of mortality, PEG placement and tracheostomy on a single time axis. The unadjusted cumulative incidence of PEG was 36%. However, taking into account differential length of follow-up Žusing Kaplan–Meier product–limit estimators., the cumulative incidence of PEG was actually 48%. This figure adjusts for loss to follow-up and death. The average length of time until PEG placement was 16 months from the point of study enrollment. Because estimation of incidence takes into account the different length of follow-up for each patient, the cumulative incidence figures are higher than the unadjusted proportion of patients reaching each endpoint Ž26.5% of patients had PEG placement and 11.7% tracheostomy.. The relationship between PEG, tracheostomy and Bi-Pap use is shown in Fig. 3a for patients who survived follow-up and in Fig. 3b for those who died. The Venn diagrams show a number of important features of the cohort’s experience with these technologies. For the 44 patients who survived follow up, more than half Ž n s 29. had not used any of the technologies ŽFig. 3a.; these were patients, for the most part, with relatively early-stage disease. Of
S.M. Albert et al.r Journal of the Neurological Sciences 191 (2001) 115–119
117
Fig. 1. Death and attrition in PDIA cohort.
surviving patients who had more advanced disease and had used the interventions Ž n s 15., eight had tracheostomy and all of these patients had used PEG or Bi-Pap Žor both. before the tracheostomy. For patients who died during follow-up Ž n s 75., nearly half Ž n s 36. died without using PEG, tracheostomy or
Bi-Pap. Two of these patients used tracheostomy but died. Notably, these two patients did not use PEG or Bi-Pap beforehand, suggesting that they sought tracheostomy emergently or perhaps in an unplanned way. Fig. 3b suggests that a number of patients chose PEG or Bi-Pap without going on to tracheostomy.
Fig. 2. Cumulative incidence: PDIA.
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Fig. 3. Use of tracheostomy, PEG, Bi-Pap: Ža. patients surviving follow-up and Žb. patients dying over follow-up.
Yet the likelihood of tracheostomy is related to PEG use. Ten patients had incident tracheostomy over the follow-up period. The majority of the tracheostomies occurred among patients who already had PEG: 7 of the 33 PEG patients Ž21.2%. had tracheostomy, compared to only 3 of the 86 non-PEG patients Ž3.5%., a highly significant difference Ž p - 0.01.. PDIA data are also useful for examining predictors of PEG placement. In proportional hazard models, we found that a patient’s attitude toward PEG at baseline was a significant predictor of PEG choice over follow-up. Less than 10% of patients who said they did not want PEG went on to have PEG later as their disease progressed. This stands in strong contrast to PEG rates greater than 50% among patients who initially reported they were Aleaning towardB or Aabsolutely wantedB PEG Ž p - 0.01.. The difference was highly significant in models that controlled for baseline differences in disease severity and sociodemo-
graphic differences. Patients Aleaning towardB or who Aabsolutely wantedB PEG were seven times as likely to have PEG as other patients Žrelative risk, 7.3; 95% confidence interval: 2.4, 22.0.. This finding supports prior research on the relationship between baseline preferences for tracheostomy and later use of tracheostomy w7x. By contrast, at baseline patients who later chose PEG and patients who did not were similar in sociodemographic features Žage, education, income, gender., self-reported mental health Ždepression and hopelessness., and caregiver reports of burden and satisfaction. The two groups did not significantly differ in any of these baseline measures. Finally, we examined baseline differences among three groups of patients in the PDIA cohort: those who never used PEG or tracheostomy Ž n s 83., those who used PEG but not tracheostomy Ž n s 24., and those who used tracheostomy Žwith or without PEG, n s 10.. Apart from expressed preferences for use of the interventions, the
S.M. Albert et al.r Journal of the Neurological Sciences 191 (2001) 115–119
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groups did not differ at baseline except in two areas. First, incident PEG patients were most likely to have health care proxies at baseline. More than half Ž54.2%. of this group had a health care proxy, compared to 25.3% in the nonintervention group and 20% in the tracheostomy group Ž p 0.05.. Second, family caregivers in the PEG group reported levels of burden similar to those in the nonintervention group. By contrast, caregivers to patients in the incident tracheostomy group reported greater burden at baseline w11x.
areas are worth further investigation, as they will help clinicians better understand the needs of different kinds of patients and their families.
4. Discussion
References
This research shows that PEG placement is common in ALS patients treated at our Center, with nearly half expected to use PEG over the course of the disease. Patients who choose PEG use tracheostomy at a higher rate than other patients and are more likely to have health care proxies in place early in the course of disease. Despite the overlap in PEG and tracheostomy use, our findings suggest important differences between the two. PEG-only users were more likely to have executed health care proxies than tracheostomy users. Also, caregivers to patients who received tracheostomy reported significantly greater burden at baseline than caregivers to patients who did not use either technology or who only used PEG. This pattern of results suggests that PEG use is more planned than tracheostomy, and that clinical education efforts are more successful in the case of PEG than tracheostomy. Together, these results suggest that PEG use is part of a broader, consistently proactive approach to disease management undertaken by patients and families. If this is the case, we might hypothesize that PEG users will also be more active in other areas of disease management, such as participation in clinical trials w11x, receptivity to clinical education efforts, use of alternativercomplementary medicine, and assertiveness in patient–physician communication. It would also be valuable to examine correlates of such proactivity in the face of terminal disease. For example, are PEG users more likely to score higher on measures of control, as in health locus of control measures? These
w1x Kasarskis EJ, Scarlata D, Hill R, Fuller C, Stambler N, Cedarbaum JM. A retrospective study of percutaneous endoscopic gastrostomy in ALS patients during the BDNF and CNTF trials. J Neurol Sci 1999;169:118–25. w2x Chio A, Finocchiaro E, Meineri P, Bottacchi E, Schiffer D. Safety and factors related to survival after percutaneous endoscopic gastrostomy in ALS. ALS Percutaneous Endoscopic Gastrostomy Study Group. Neurology 1999;53:1123–5. w3x Mazzini L, Corra T, Zacala M, Mora G, Del Piano M, Glante M. Percutaneous endoscopic gastrostomy and enteral nutrition in amyotrophic lateral sclerosis. J Neurol 1995;242:695–8. w4x Desport JC, Preux PM, Truong CT, Vallat JM, Couratier P. Nutritional assessment and survival in ALS patients. Amyotrophic Lateral Sclerosis 2000;1:91–6. w5x ALS CARE Study Group, Miller RG, Anderson FA, Bradley WG, Mitsumoto H, Munsat TL, Ringel SP. The ALS patient care database. Goals, design, and early results. Neurology 2000;54:53–7. w6x World Federation of Neurology, El Escorial Criteria for Diagnosis of ALS. J Neurol Sci 1994;124Žsuppl..:96–107. w7x Albert SM, Murphy PL, Del Bene ML, Rowland LP. A prospective study of preferences and actual treatment choices in amyotrophic lateral sclerosis. Neurology 1999;53:278–83. w8x Albert SM, Murphy PL, Del Bene DL, Rowland LP. Prospective study of palliative care in ALS: choice, timing, outcomes. J Neurol Sci 1999;169:108–13. w9x Murphy PL, Albert SM, Weber CM, Del Bene ML, Rowland LP. Impact of spirituality and religiousness on outcomes in patients with ALS. Neurology 2000;55:1581–3. w10x Lawton MP, Kleban MH, Moss MS, Rovine M, Glicksman A. Measuring caregiver appraisal. J Gerontol, Psychol Sci 1989;44: P61–70. w11x Albert SM, Murphy PL, Del Bene ML, Rowland LP. Family caregiver burden and tracheostomy decisions. 10th International Sumposium on ALSrMND, Vancouver, CA, Nov. 1999.
Acknowledgements This project was supported by funds from the Project on Death in America and Fetzer Institute. This project was presented at the 11th International Symposium on ALSr MND, Arhus, Denmark.
Incidence and predictors of PEG placement in ALSrMND Steven M. Albert ) , Peregrine L. Murphy, Maura Del Bene, Lewis P. Rowland, Hiroshi Mitsumoto Eleanor and Lou Gehrig MDAr ALS Center, Neurological Institute, Columbia UniÕersity, New York, NY, USA
Abstract In the Project on Death in America ALS cohort, 121 patients were followed to examine the timing of key milestones in the course of the disease, such as tracheostomy and PEG placement. During the 2- to 4-year follow-up period, 26.5% of patients received PEG, yielding a cumulative incidence of 48%. PEG placement occurred, on average, 16 months after patients received confirmation of the diagnosis at our Center. Patients who received PEG were more likely to have tracheostomies than patients not using PEG Ž p - 0.01.. In multivariate proportional hazard models that included both sociodemographic and disease indicators, the strongest predictor of PEG use was a patient’s baseline preference for PEG: 57.1% of patients Aabsolutely in favorB went on to have PEG, compared to only 9.3% of those Aabsolutely againstB Ž p - 0.01.. PEG users were more likely to have initiated health care proxies. These findings suggest that patients who use PEG may be consistently proactive in the face of the disease. q 2001 Elsevier Science B.V. All rights reserved. Keywords: Amyotrophic lateral sclerosis; PEG; Incidence; Tracheostomy; Epidemiology; Patient decision-making
1. Introduction Difficulty with eating and weight loss are typical features of ALS. Eating becomes difficult when people with ALS are unable to handle utensils or when swallowing is affected. Dietary changes are inescapable, and patients eventually find they are only able to eat pureed foods. Meals begin to take up an increasingly larger part of the day, risk of aspiration becomes more frequent, and weight loss accelerates. A this point, patients and their families must consider supplemental tube feeding as an alternative avenue for nutrition. The most common is a percutaneous endoscopic gastrostomy, or PEG. Initially, patients may combine PEG feeding with oral intake, but eventually feeding becomes exclusively parenteral. Despite a number of recent studies of PEG placement in people with ALS w1–5x, we have been unable to identify studies that report on the incidence and timing of PEG placement. It is still unclear how common PEG use really is, when it is typically recommended and then implemented, how PEG use relates to use of other interventions available to ALS patients Žsuch as tracheostomy and inter-
)
Corresponding author. Gertrude H. Sergievsky Center, PH-19, P&S Box 16, Columbia University, 630 West 168th St., New York, NY 10032, USA. Tel.: q1-212-305-2503; fax: q1-212-305-2426. E-mail address: [email protected] ŽS.M. Albert..
mittent nasal ventilatory assistance., and what predisposes patients to choose PEG. We investigated these issues directly in a large, well-characterized cohort of ALS patients followed at the Eleanor and Lou Gehrig MDArALS Center in New York, USA.
2. Materials and methods In 1996–1998, we enrolled 121 people with definite or probable ALS ŽEl Escorial criteria. w6x to the Project on Death in America ŽPDIA. ALS cohort. The Project on Death in America was part of an effort by the Open Society Institute ŽNew York City. to change attitudes toward death and dying in the United States. Patients were eligible for the PDIA Cohort if their treating neurologist referred them to the project, if they met El Escorial criteria, and if they spoke English. Eligible patients were approached by clinical staff, who explained the research study. Patients who expressed interest were then contacted by the research team. Patients were interviewed in a separate room during their clinic visit. About 60% of all eligible patients were enrolled: 5% were excluded because clinic staff thought participation might exacerbate psychiatric symptoms or threaten family supports, 15% were not approached because of difficulty scheduling or because patients came to the clinic only once and 20% were
0022-510Xr01r$ - see front matter q 2001 Elsevier Science B.V. All rights reserved. PII: S 0 0 2 2 - 5 1 0 X Ž 0 1 . 0 0 6 1 4 - 1
116
S.M. Albert et al.r Journal of the Neurological Sciences 191 (2001) 115–119
approached but refused participation. The PDIA study protocol was reviewed and approved by the Institutional Review Board of Columbia UniversityrNew York Presbyterian Hospital. Features of the cohort have been reported elsewhere w7–9x. The majority of PDIA cohort patients Ž73%. were enrolled within 1 year of their diagnosis; other patients had the disease for over a year when they were first enrolled. This distribution reflects the status of patients who come to our tertiary care center; the clinic census reflects a mixture of patients coming to the clinic for confirmation of the diagnosis and patients who remain with the clinic for their follow-up care, management and clinical education. At the point of their enrollment, four patients already had PEG, and two tracheostomy; these patients were excluded from analyses used to examine the incidence of these endpoints. Patients enrolled into the PDIA cohort received an extensive baseline interview that elicited patient preferences for later use of PEG and tracheostomy, along with information on functional ability, mental health Žuse of psychiatric medicines, presence of depressive symptoms and degree of hopelessness., attitudes toward death and dying and sociodemographic status. Primary caregivers, when available, also completed a questionnaire that elicited perceived burden and satisfaction in caregiving. Usable data were available from caregivers for two-thirds of the patients. Burden was measured using a selection of structured items whose psychometric properties have been reported w10x. Neurologists treating each of the PDIA patients were also mailed a brief questionnaire about their approach to ALS management and diagnosis. Following the baseline interview, patients and their families were contacted every 4 months by telephone or during scheduled clinic visits. In these follow-up interviews, we surveyed a variety of outcomes associated with disease progression. These included new or continuing use of Ž1. technologies ŽPEG, Bi-Pap, tracheostomy, augmentative communication, mobility aides., Ž2. therapeutic services Žoccupational, physical, or speech therapy; psychiatric treatment, mental health or pastoral counseling, support group participation., Ž3. caregiving supports Žuse of paid home care, entry to nursing homes or hospice programs., Ž4. medical care Žhospitalization and emergency room use. and Ž5. legal planning Žestablishing health care proxies, consenting to autopsy.. We also recorded date and location of death. Because these were telephone interviews, often conducted with caregivers, we did not repeat baseline assessments of patient mental health and attitudes toward use of interventions. Patients were followed from 2 to 4 years, depending on their date of enrollment. Follow-up of the cohort was complete for 83.5% Ž101r121. of the cohort; that is, for all but 20 patients, a date for death or tracheostomy was available, or patients were known to be alive at their last follow-up interview. The 20 patients lost to follow-up include eight who had only a baseline visit and 12 who
had two or more visits but indeterminate status at the end of the follow-up period; these were considered censored observations. Throughout this 4-year period, patients receiving care at the clinic continued to receive clinical management and education at 3-month intervals. The Eleanor and Lou Gehrig MDArALS Center employs a comprehensive, interdisciplinary, coordinated system of care utilizing a model of patient and professional education well grounded in palliative care philosophy, clinical expertise and psychosocial programming. Patients are encouraged early in the disease course, through active education and counseling, to make informed decisions regarding the medical management of dysphagia and respiratory failure. At the clinic, the choice of management options for respiratory failure includes noninvasive ventilation, invasive mechanical ventilation, or natural death. Each pathway choice entitles the patient and their family access to continuous, comprehensive management of symptoms associated with the dying process.
3. Results In the PDIA cohort, 61% of patients were male, and 82% were white. The average level of education was 14.2 years and the mean age 59.7 ŽS.D. 12.7.. Two patients participated in the study without completing a baseline interview Žtheir caregivers completed a baseline interview and agreed to report on patient status at each follow-up.. Survival in the cohort, as well as loss to follow-up at each visit, is shown in Fig. 1. Taking into account patient censoring due to loss to follow-up, 22% of the cohort were alive at the end of the 4-year follow-up period. Fig. 2 shows the cumulative incidence of mortality, PEG placement and tracheostomy on a single time axis. The unadjusted cumulative incidence of PEG was 36%. However, taking into account differential length of follow-up Žusing Kaplan–Meier product–limit estimators., the cumulative incidence of PEG was actually 48%. This figure adjusts for loss to follow-up and death. The average length of time until PEG placement was 16 months from the point of study enrollment. Because estimation of incidence takes into account the different length of follow-up for each patient, the cumulative incidence figures are higher than the unadjusted proportion of patients reaching each endpoint Ž26.5% of patients had PEG placement and 11.7% tracheostomy.. The relationship between PEG, tracheostomy and Bi-Pap use is shown in Fig. 3a for patients who survived follow-up and in Fig. 3b for those who died. The Venn diagrams show a number of important features of the cohort’s experience with these technologies. For the 44 patients who survived follow up, more than half Ž n s 29. had not used any of the technologies ŽFig. 3a.; these were patients, for the most part, with relatively early-stage disease. Of
S.M. Albert et al.r Journal of the Neurological Sciences 191 (2001) 115–119
117
Fig. 1. Death and attrition in PDIA cohort.
surviving patients who had more advanced disease and had used the interventions Ž n s 15., eight had tracheostomy and all of these patients had used PEG or Bi-Pap Žor both. before the tracheostomy. For patients who died during follow-up Ž n s 75., nearly half Ž n s 36. died without using PEG, tracheostomy or
Bi-Pap. Two of these patients used tracheostomy but died. Notably, these two patients did not use PEG or Bi-Pap beforehand, suggesting that they sought tracheostomy emergently or perhaps in an unplanned way. Fig. 3b suggests that a number of patients chose PEG or Bi-Pap without going on to tracheostomy.
Fig. 2. Cumulative incidence: PDIA.
118
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Fig. 3. Use of tracheostomy, PEG, Bi-Pap: Ža. patients surviving follow-up and Žb. patients dying over follow-up.
Yet the likelihood of tracheostomy is related to PEG use. Ten patients had incident tracheostomy over the follow-up period. The majority of the tracheostomies occurred among patients who already had PEG: 7 of the 33 PEG patients Ž21.2%. had tracheostomy, compared to only 3 of the 86 non-PEG patients Ž3.5%., a highly significant difference Ž p - 0.01.. PDIA data are also useful for examining predictors of PEG placement. In proportional hazard models, we found that a patient’s attitude toward PEG at baseline was a significant predictor of PEG choice over follow-up. Less than 10% of patients who said they did not want PEG went on to have PEG later as their disease progressed. This stands in strong contrast to PEG rates greater than 50% among patients who initially reported they were Aleaning towardB or Aabsolutely wantedB PEG Ž p - 0.01.. The difference was highly significant in models that controlled for baseline differences in disease severity and sociodemo-
graphic differences. Patients Aleaning towardB or who Aabsolutely wantedB PEG were seven times as likely to have PEG as other patients Žrelative risk, 7.3; 95% confidence interval: 2.4, 22.0.. This finding supports prior research on the relationship between baseline preferences for tracheostomy and later use of tracheostomy w7x. By contrast, at baseline patients who later chose PEG and patients who did not were similar in sociodemographic features Žage, education, income, gender., self-reported mental health Ždepression and hopelessness., and caregiver reports of burden and satisfaction. The two groups did not significantly differ in any of these baseline measures. Finally, we examined baseline differences among three groups of patients in the PDIA cohort: those who never used PEG or tracheostomy Ž n s 83., those who used PEG but not tracheostomy Ž n s 24., and those who used tracheostomy Žwith or without PEG, n s 10.. Apart from expressed preferences for use of the interventions, the
S.M. Albert et al.r Journal of the Neurological Sciences 191 (2001) 115–119
119
groups did not differ at baseline except in two areas. First, incident PEG patients were most likely to have health care proxies at baseline. More than half Ž54.2%. of this group had a health care proxy, compared to 25.3% in the nonintervention group and 20% in the tracheostomy group Ž p 0.05.. Second, family caregivers in the PEG group reported levels of burden similar to those in the nonintervention group. By contrast, caregivers to patients in the incident tracheostomy group reported greater burden at baseline w11x.
areas are worth further investigation, as they will help clinicians better understand the needs of different kinds of patients and their families.
4. Discussion
References
This research shows that PEG placement is common in ALS patients treated at our Center, with nearly half expected to use PEG over the course of the disease. Patients who choose PEG use tracheostomy at a higher rate than other patients and are more likely to have health care proxies in place early in the course of disease. Despite the overlap in PEG and tracheostomy use, our findings suggest important differences between the two. PEG-only users were more likely to have executed health care proxies than tracheostomy users. Also, caregivers to patients who received tracheostomy reported significantly greater burden at baseline than caregivers to patients who did not use either technology or who only used PEG. This pattern of results suggests that PEG use is more planned than tracheostomy, and that clinical education efforts are more successful in the case of PEG than tracheostomy. Together, these results suggest that PEG use is part of a broader, consistently proactive approach to disease management undertaken by patients and families. If this is the case, we might hypothesize that PEG users will also be more active in other areas of disease management, such as participation in clinical trials w11x, receptivity to clinical education efforts, use of alternativercomplementary medicine, and assertiveness in patient–physician communication. It would also be valuable to examine correlates of such proactivity in the face of terminal disease. For example, are PEG users more likely to score higher on measures of control, as in health locus of control measures? These
w1x Kasarskis EJ, Scarlata D, Hill R, Fuller C, Stambler N, Cedarbaum JM. A retrospective study of percutaneous endoscopic gastrostomy in ALS patients during the BDNF and CNTF trials. J Neurol Sci 1999;169:118–25. w2x Chio A, Finocchiaro E, Meineri P, Bottacchi E, Schiffer D. Safety and factors related to survival after percutaneous endoscopic gastrostomy in ALS. ALS Percutaneous Endoscopic Gastrostomy Study Group. Neurology 1999;53:1123–5. w3x Mazzini L, Corra T, Zacala M, Mora G, Del Piano M, Glante M. Percutaneous endoscopic gastrostomy and enteral nutrition in amyotrophic lateral sclerosis. J Neurol 1995;242:695–8. w4x Desport JC, Preux PM, Truong CT, Vallat JM, Couratier P. Nutritional assessment and survival in ALS patients. Amyotrophic Lateral Sclerosis 2000;1:91–6. w5x ALS CARE Study Group, Miller RG, Anderson FA, Bradley WG, Mitsumoto H, Munsat TL, Ringel SP. The ALS patient care database. Goals, design, and early results. Neurology 2000;54:53–7. w6x World Federation of Neurology, El Escorial Criteria for Diagnosis of ALS. J Neurol Sci 1994;124Žsuppl..:96–107. w7x Albert SM, Murphy PL, Del Bene ML, Rowland LP. A prospective study of preferences and actual treatment choices in amyotrophic lateral sclerosis. Neurology 1999;53:278–83. w8x Albert SM, Murphy PL, Del Bene DL, Rowland LP. Prospective study of palliative care in ALS: choice, timing, outcomes. J Neurol Sci 1999;169:108–13. w9x Murphy PL, Albert SM, Weber CM, Del Bene ML, Rowland LP. Impact of spirituality and religiousness on outcomes in patients with ALS. Neurology 2000;55:1581–3. w10x Lawton MP, Kleban MH, Moss MS, Rovine M, Glicksman A. Measuring caregiver appraisal. J Gerontol, Psychol Sci 1989;44: P61–70. w11x Albert SM, Murphy PL, Del Bene ML, Rowland LP. Family caregiver burden and tracheostomy decisions. 10th International Sumposium on ALSrMND, Vancouver, CA, Nov. 1999.
Acknowledgements This project was supported by funds from the Project on Death in America and Fetzer Institute. This project was presented at the 11th International Symposium on ALSr MND, Arhus, Denmark.