- Email: [email protected]
Asking parents unaskable questions
Comment
factors (eg, fibre content, palatability) change with these choices. It is here that tightly controlled animal work can supplement the human studies. Pawlak and colleagues show that diets with a higher glycaemic index can have adverse effects on body composition, postprandial glycaemia and insulinaemia, and triglyceride concentrations. Although the researchers report that the insulintolerance test showed no change in insulin sensitivity, postprandial glucose and insulin concentrations rose convincingly in parallel, in keeping with decreasing insulin sensitivity. That result is consistent with other work in human beings,3,5 and shows a pattern that outweighs the findings of the insulin-tolerance tests. Most worryingly, the rats with higher post-prandial insulin concentrations at baseline were more susceptible to weight gain with the diets of higher glycaemic index. Interestingly, Pawlak and colleagues suggest that this increased susceptibility to weight gain might be related to improved insulin action in the periphery, because insulin sensitivity (in the insulin-tolerance test) was unchanged and insulin concentrations were increased. However a more mundane explanation might be that adequate insulin-secretory capacity was necessary to achieve weight gain on diets with a high glycaemic index. On the basis of the animal model of partial pancreatectomy, this correlation may simply reflect degree of pancreatectomy. However, the possibility remains that higher initial concentrations of insulin reflect reduced insulin sensitivity, and therefore the insulin-resistant rats gained the most weight on diets with a high glycaemic index. Perhaps a suitable parallel in human beings would be insulin-resistant individuals with impaired fasting glucose or impaired glucose tolerance, who are a group very susceptible to adverse changes in lipids, insulin, and, particularly, weight. Urgent research is needed to see if this human group has the same susceptibility to adverse changes in body composition when on a diet with a high glycaemic index as in these animal studies, and if there is a differential effect compared with other groups. Regrettably, funding for nutrition research is not endless, even in obesity and diabetes. Effective dietary change reduces the need for intervention with drugs and therefore gives no benefit to the pharmaceutical industry; and lower consumption of processed food does not benefit much of the food industry. Yet there is much potential for gain for global health if we find the right nutritional way to address the risks of obesity and diabetes. Detailed and adequately funded human research needs to examine the effects of diets with a low glycaemic index and glycaemic load on body composition, weight, insulin sensitivity, lipid profiles, and diabetes control.
For those clinicians seeking to give advice about diets with a low glycaemic index, implementation is simpler than the vast tables of numerical values would suggest. Janet Brandt-Miller,9 an early proponent of the glycaemic index, makes the following recommendations for lowering the glycaemic index of a diet: use breakfast cereals based on oats, barley, and bran; use grainy breads made with whole seeds; reduce the amount of potatoes; enjoy all types of fruit and vegetables (except potatoes); and eat plenty of salad vegetables with vinaigrette dressing. Pawlak and colleagues add an important study that will further fuel the nutritional debate around obesity and diabetes. Hopefully their work will inspire us to seek definitive answers with human research. We know the benefits of statin therapy for our patients with coronary heart disease, and can counsel them accurately. When will we be able to offer nutritional advice with the same confidence?
Mark E Daly Royal Devon and Exeter Hospital, Exeter EX2 5DW, UK [email protected] I have received honoraria from the Sugar Bureau and the International Life Sciences Institute (an organisation supported by members of the food industry) for lectures, workshops, and commissioned articles. I receive a research grant from the Sugar Bureau, and some of my previous research has been funded by National Starch (USA). 1
2
3
4
5
6
7 8
9
Brynes AE, Mark Edwards C, Ghatei MA, et al. A randomised fourintervention crossover study investigating the effect of carbohydrates on daytime profiles of insulin, glucose, non-esterified fatty acids and triacylglycerols in middle-aged men. Br J Nutr 2003; 89: 207–18. Frost G, Wilding J, Beecham J. Dietary advice based on the glycaemic index improves dietary profile and metabolic control in type 2 diabetic patients. Diabet Med 1994; 11: 397–401. Frost G, Leeds A, Trew G, Margara R, Dornhorst A. Insulin sensitivity in women at risk of coronary heart disease and the effect of a low glycemic diet. Metab Clin Exp 1998; 47: 1245–51. Brynes AE, Lee JL, Brighton RE, Leeds AR, Dornhorst A, Frost GS. A Low glycemic diet significantly improves the 24-h blood glucose profile in people with type 2 diabetes, as assessed using the continuous glucose MiniMed Monitor. Diabetes Care 2003; 26: 548–49. Frost G, Leeds A, Trew G, Margara R, Dornhorst A. Insulin sensitivity in women at risk of coronary heart disease and the effect of a low glycemic diet. Metab Clin Exp 1998; 47: 1245–51. Frost G, Leeds AA, Dore CJ, Madeiros S, Brading S, Dornhorst A. Glycaemic index as a determinant of serum HDL-cholesterol concentration. Lancet 1999; 353: 1045–48. Salmeron J, Ascherio A, Rimm EB, et al. Dietary fiber, glycemic load, and risk of NIDDM in men. Diabetes Care 1997; 20: 545–50. Liu S, Willet WC, Stampfer MJ, et al. A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. Am J Clin Nutr 2000; 71: 1455–61. Brand-Miller J. Home of the glycaemic index. Sydney: University of Sydney. http://www.glycemicindex.com (accessed June 9, 2004).
Asking parents unaskable questions Approval or rejection of research into the death of children poses particular challenges for ethics committees. Such work explores painful experiences; to ascertain if and for whom this type of study does harm is difficult. Furthermore, since little research has been done in the area, ethics committees have few guidelines and, in our experience, generally err on www.thelancet.com Vol 364 August 28, 2004
the side of caution. Hence the reason Ulrika Kreicbergs and colleagues’ study, in this week’s Lancet, was initially rejected by an ethics committee. The group eventually obtained permission for their trial about parental perception of participation in research into their child’s death from cancer by doing a pilot study. The main concern for their ethics
See Research Letters page 787
737
Comment
Science Photo Library
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
committee, and others previously,1 related to the harm to the parents that might arise from involvement in the trial. What is it about questioning parents over their child’s death that concerns ethics committees? Acknowledging the importance of understanding parents’ perceptions of their child’s death should not create concern.2 Issues that surround parental recruitment and informed consent are more complex. Potential participants might, for example, be encouraged or even coerced by spouses and family members to participate because of a belief that such involvement will be helpful or even therapeutic.3 Furthermore, obtaining fully informed consent before participation, as would be done in a drug trial, is not feasible, since there is no way to predict how all parents will feel as they answer the research questions or how difficult they will find it to respond. Although this scenario is particularly true for face-to-face interviews, the same concern occurs in questionnaire-based studies.4 We cannot, therefore, fully support Kreicbergs and colleagues in their enthusiasm for pilot studies as predictive. Although a pilot study might establish what questions not to ask, it could never guarantee the appropriateness of any particular question. In our opinion, in bereavement research, informed consent should be an ongoing process—participants’ understanding of the process should be checked regularly and their right to ignore any particular question and to withdraw at any time mentioned often. Researchers should also take care not to encourage unrealistic expectations in participants, and should make it clear that they are doing research, not providing therapy.3,4 Finally, particular care should be taken in the interpretation of results; the most vulnerable parents might be those who opt not to take part (in the study published this week, 142 of 574 parents declined to participate). Hence any conclusions reached cannot be generalised to all mothers and fathers.5 The greatest concern among the professionals who care for these patients and their families seems to centre on the pain 738
that is inflicted on the parents. So great is their concern, in fact, that access to parents is sometimes blocked even in studies approved by an ethics committee.1 The implicit assumption is that questioning parents increases their pain without sufficient benefit either to the parent individually or to parents collectively. Such professional paternalism takes full responsibility for decisions about the importance of the research and risk assessment without any reference to the parents themselves.6 Bereaved parents do find participating in research that focuses on their child’s death painful. However, they are often comforted by the belief that such participation yields positive outcomes—for instance, the opportunity to tell their story and the hope that their story will help other bereaved parents.7 Not infrequently, we have gained the impression that parents are sometimes more robust than their professional attendants. Health professionals also probably worry about not being able to cope with the answers parents give to their questions, which can be painful or difficult—eg, the researchers find themselves sharing some of the parents’ pain.4,5 However, these difficulties for researchers can be foreseen and, in many instances, appropriately managed through good methodology, and adequate training and supervision of the research team. In their honest and sometimes painful answers, parents invite professionals into their experiences. The true harm associated with research with bereaved parents arises when the parents cannot contribute fully to our understanding of the death of their child. Parents should guide the development of research proposals in partnership with researchers. Dyregrov’s report7 of the experience of research by parents whose children have died, which discusses bereaved parent recommendations for researchers, should greatly assist both researchers and research ethics committees. Most parents who have lost a child want to tell their story; we have a responsibility to listen.
Richard H Burnell, *Maree O’Keefe Department of Paediatrics, University of Adelaide, Women’s and Children's Hospital, North Adelaide, South Australia 5006, Australia [email protected] We declare we have no conflict of interest. 1 2 3 4
5
6 7
Dent A, Condon L, Blair P, Fleming P. A study of bereavement care after a sudden and unexpected death. Arch Dis Child 1996; 74: 522–26. Parkes CM. Guidelines for conducting ethical bereavement research. Death Stud 1995; 19: 171–81. Roseblatt PC. Ethics of qualitative interviewing with grieving families. Death Stud 1995; 19: 139–55. Evans M, Robling M, Maggas Rapport F, Houston H, Kinnersley P, Wilkinson C. It doesn’t cost anything just to ask, does it? The ethics of questionnaire-based research. J Med Ethics 2002; 28: 41–44. Vance JC, Najman JM, Thearle MJ, Embelton G, Foster WJ, Boyle FM. Psychological changes in parents eight months after the loss of an infant from stillbirth, neonatal death, or sudden infant death syndrome: a longitudinal study. Pediatrics 1995; 96: 933–38. Edwards SJL, Kirchen S, Huxtable R. Research ethics committees and paternalism. J Med Ethics 2004; 30: 88–91. Dyregrov K. Bereaved parents’ experience of research participation. Soc Sci Med 2004; 58: 391–400.
www.thelancet.com Vol 364 August 28, 2004
factors (eg, fibre content, palatability) change with these choices. It is here that tightly controlled animal work can supplement the human studies. Pawlak and colleagues show that diets with a higher glycaemic index can have adverse effects on body composition, postprandial glycaemia and insulinaemia, and triglyceride concentrations. Although the researchers report that the insulintolerance test showed no change in insulin sensitivity, postprandial glucose and insulin concentrations rose convincingly in parallel, in keeping with decreasing insulin sensitivity. That result is consistent with other work in human beings,3,5 and shows a pattern that outweighs the findings of the insulin-tolerance tests. Most worryingly, the rats with higher post-prandial insulin concentrations at baseline were more susceptible to weight gain with the diets of higher glycaemic index. Interestingly, Pawlak and colleagues suggest that this increased susceptibility to weight gain might be related to improved insulin action in the periphery, because insulin sensitivity (in the insulin-tolerance test) was unchanged and insulin concentrations were increased. However a more mundane explanation might be that adequate insulin-secretory capacity was necessary to achieve weight gain on diets with a high glycaemic index. On the basis of the animal model of partial pancreatectomy, this correlation may simply reflect degree of pancreatectomy. However, the possibility remains that higher initial concentrations of insulin reflect reduced insulin sensitivity, and therefore the insulin-resistant rats gained the most weight on diets with a high glycaemic index. Perhaps a suitable parallel in human beings would be insulin-resistant individuals with impaired fasting glucose or impaired glucose tolerance, who are a group very susceptible to adverse changes in lipids, insulin, and, particularly, weight. Urgent research is needed to see if this human group has the same susceptibility to adverse changes in body composition when on a diet with a high glycaemic index as in these animal studies, and if there is a differential effect compared with other groups. Regrettably, funding for nutrition research is not endless, even in obesity and diabetes. Effective dietary change reduces the need for intervention with drugs and therefore gives no benefit to the pharmaceutical industry; and lower consumption of processed food does not benefit much of the food industry. Yet there is much potential for gain for global health if we find the right nutritional way to address the risks of obesity and diabetes. Detailed and adequately funded human research needs to examine the effects of diets with a low glycaemic index and glycaemic load on body composition, weight, insulin sensitivity, lipid profiles, and diabetes control.
For those clinicians seeking to give advice about diets with a low glycaemic index, implementation is simpler than the vast tables of numerical values would suggest. Janet Brandt-Miller,9 an early proponent of the glycaemic index, makes the following recommendations for lowering the glycaemic index of a diet: use breakfast cereals based on oats, barley, and bran; use grainy breads made with whole seeds; reduce the amount of potatoes; enjoy all types of fruit and vegetables (except potatoes); and eat plenty of salad vegetables with vinaigrette dressing. Pawlak and colleagues add an important study that will further fuel the nutritional debate around obesity and diabetes. Hopefully their work will inspire us to seek definitive answers with human research. We know the benefits of statin therapy for our patients with coronary heart disease, and can counsel them accurately. When will we be able to offer nutritional advice with the same confidence?
Mark E Daly Royal Devon and Exeter Hospital, Exeter EX2 5DW, UK [email protected] I have received honoraria from the Sugar Bureau and the International Life Sciences Institute (an organisation supported by members of the food industry) for lectures, workshops, and commissioned articles. I receive a research grant from the Sugar Bureau, and some of my previous research has been funded by National Starch (USA). 1
2
3
4
5
6
7 8
9
Brynes AE, Mark Edwards C, Ghatei MA, et al. A randomised fourintervention crossover study investigating the effect of carbohydrates on daytime profiles of insulin, glucose, non-esterified fatty acids and triacylglycerols in middle-aged men. Br J Nutr 2003; 89: 207–18. Frost G, Wilding J, Beecham J. Dietary advice based on the glycaemic index improves dietary profile and metabolic control in type 2 diabetic patients. Diabet Med 1994; 11: 397–401. Frost G, Leeds A, Trew G, Margara R, Dornhorst A. Insulin sensitivity in women at risk of coronary heart disease and the effect of a low glycemic diet. Metab Clin Exp 1998; 47: 1245–51. Brynes AE, Lee JL, Brighton RE, Leeds AR, Dornhorst A, Frost GS. A Low glycemic diet significantly improves the 24-h blood glucose profile in people with type 2 diabetes, as assessed using the continuous glucose MiniMed Monitor. Diabetes Care 2003; 26: 548–49. Frost G, Leeds A, Trew G, Margara R, Dornhorst A. Insulin sensitivity in women at risk of coronary heart disease and the effect of a low glycemic diet. Metab Clin Exp 1998; 47: 1245–51. Frost G, Leeds AA, Dore CJ, Madeiros S, Brading S, Dornhorst A. Glycaemic index as a determinant of serum HDL-cholesterol concentration. Lancet 1999; 353: 1045–48. Salmeron J, Ascherio A, Rimm EB, et al. Dietary fiber, glycemic load, and risk of NIDDM in men. Diabetes Care 1997; 20: 545–50. Liu S, Willet WC, Stampfer MJ, et al. A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. Am J Clin Nutr 2000; 71: 1455–61. Brand-Miller J. Home of the glycaemic index. Sydney: University of Sydney. http://www.glycemicindex.com (accessed June 9, 2004).
Asking parents unaskable questions Approval or rejection of research into the death of children poses particular challenges for ethics committees. Such work explores painful experiences; to ascertain if and for whom this type of study does harm is difficult. Furthermore, since little research has been done in the area, ethics committees have few guidelines and, in our experience, generally err on www.thelancet.com Vol 364 August 28, 2004
the side of caution. Hence the reason Ulrika Kreicbergs and colleagues’ study, in this week’s Lancet, was initially rejected by an ethics committee. The group eventually obtained permission for their trial about parental perception of participation in research into their child’s death from cancer by doing a pilot study. The main concern for their ethics
See Research Letters page 787
737
Comment
Science Photo Library
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
committee, and others previously,1 related to the harm to the parents that might arise from involvement in the trial. What is it about questioning parents over their child’s death that concerns ethics committees? Acknowledging the importance of understanding parents’ perceptions of their child’s death should not create concern.2 Issues that surround parental recruitment and informed consent are more complex. Potential participants might, for example, be encouraged or even coerced by spouses and family members to participate because of a belief that such involvement will be helpful or even therapeutic.3 Furthermore, obtaining fully informed consent before participation, as would be done in a drug trial, is not feasible, since there is no way to predict how all parents will feel as they answer the research questions or how difficult they will find it to respond. Although this scenario is particularly true for face-to-face interviews, the same concern occurs in questionnaire-based studies.4 We cannot, therefore, fully support Kreicbergs and colleagues in their enthusiasm for pilot studies as predictive. Although a pilot study might establish what questions not to ask, it could never guarantee the appropriateness of any particular question. In our opinion, in bereavement research, informed consent should be an ongoing process—participants’ understanding of the process should be checked regularly and their right to ignore any particular question and to withdraw at any time mentioned often. Researchers should also take care not to encourage unrealistic expectations in participants, and should make it clear that they are doing research, not providing therapy.3,4 Finally, particular care should be taken in the interpretation of results; the most vulnerable parents might be those who opt not to take part (in the study published this week, 142 of 574 parents declined to participate). Hence any conclusions reached cannot be generalised to all mothers and fathers.5 The greatest concern among the professionals who care for these patients and their families seems to centre on the pain 738
that is inflicted on the parents. So great is their concern, in fact, that access to parents is sometimes blocked even in studies approved by an ethics committee.1 The implicit assumption is that questioning parents increases their pain without sufficient benefit either to the parent individually or to parents collectively. Such professional paternalism takes full responsibility for decisions about the importance of the research and risk assessment without any reference to the parents themselves.6 Bereaved parents do find participating in research that focuses on their child’s death painful. However, they are often comforted by the belief that such participation yields positive outcomes—for instance, the opportunity to tell their story and the hope that their story will help other bereaved parents.7 Not infrequently, we have gained the impression that parents are sometimes more robust than their professional attendants. Health professionals also probably worry about not being able to cope with the answers parents give to their questions, which can be painful or difficult—eg, the researchers find themselves sharing some of the parents’ pain.4,5 However, these difficulties for researchers can be foreseen and, in many instances, appropriately managed through good methodology, and adequate training and supervision of the research team. In their honest and sometimes painful answers, parents invite professionals into their experiences. The true harm associated with research with bereaved parents arises when the parents cannot contribute fully to our understanding of the death of their child. Parents should guide the development of research proposals in partnership with researchers. Dyregrov’s report7 of the experience of research by parents whose children have died, which discusses bereaved parent recommendations for researchers, should greatly assist both researchers and research ethics committees. Most parents who have lost a child want to tell their story; we have a responsibility to listen.
Richard H Burnell, *Maree O’Keefe Department of Paediatrics, University of Adelaide, Women’s and Children's Hospital, North Adelaide, South Australia 5006, Australia [email protected] We declare we have no conflict of interest. 1 2 3 4
5
6 7
Dent A, Condon L, Blair P, Fleming P. A study of bereavement care after a sudden and unexpected death. Arch Dis Child 1996; 74: 522–26. Parkes CM. Guidelines for conducting ethical bereavement research. Death Stud 1995; 19: 171–81. Roseblatt PC. Ethics of qualitative interviewing with grieving families. Death Stud 1995; 19: 139–55. Evans M, Robling M, Maggas Rapport F, Houston H, Kinnersley P, Wilkinson C. It doesn’t cost anything just to ask, does it? The ethics of questionnaire-based research. J Med Ethics 2002; 28: 41–44. Vance JC, Najman JM, Thearle MJ, Embelton G, Foster WJ, Boyle FM. Psychological changes in parents eight months after the loss of an infant from stillbirth, neonatal death, or sudden infant death syndrome: a longitudinal study. Pediatrics 1995; 96: 933–38. Edwards SJL, Kirchen S, Huxtable R. Research ethics committees and paternalism. J Med Ethics 2004; 30: 88–91. Dyregrov K. Bereaved parents’ experience of research participation. Soc Sci Med 2004; 58: 391–400.
www.thelancet.com Vol 364 August 28, 2004