Staged diabetes management: a systematic evidence-based approach to the prevention and treatment of diabetes and its co-morbidities
2001; Wiley; Volume: 18; Issue: S7 Linguagem: Inglês
10.1002/pdi.240
ISSN2047-2900
AutoresRoger S. Mazze, Gregg D. Simonson, Ellie S. Strock, Richard M. Bergenstal, Manuel Idrogo, Sylvia Ramirez, Stephen I‐Hong Hsu,
Tópico(s)Diabetic Foot Ulcer Assessment and Management
ResumoThe rising incidence and prevalence of diabetes with its concomitant complications have become a global concern. The necessity for a comprehensive model targeting primary, secondary and tertiary prevention as well as all levels of care has become apparent. Staged Diabetes Management (SDM) was developed over a decade ago, anticipating the need to address diabetes in a systematic evidence-based manner so that new therapies and research findings could be rapidly translated into clinical practice.1, 2 SDM was founded on the principle that a detailed understanding of the natural history of diabetes and the underlying defects responsible for hyperglycaemia and its associated complications should form the basis of sound clinical decision-making. It relies on clinical pathways to guide the clinician through the detection, treatment and follow-up of each type of diabetes and associated macrovascular and microvascular complications. Unique to SDM is that each pathway is customized for utilization in collaboration with local physicians and allied health professionals. Thus far clinicians in 22 countries, using 11 translated versions of SDM, have participated in this process. Taking into account regional differences in medical practice, resource allocation, availability of pharmacologic agents and access to care, these regional versions of SDM have led to a reduction in variation in practice, improved screening and detection, tightened glycemic control and increased surveillance for complications. In use for more than five years in many sites, it has resulted in improved management of hypertension and dyslipidemia. Additionally, it has resulted in a significant decrease in the rate of such complications as foot ulcers and lower extremity amputation. It has been noted that diabetes contributes disproportionately to the cost of medical services throughout the world. In the United States, one-seventh of all medical care costs are consumed by less than 5% of the population with diabetes. A similar pattern has been noted throughout Latin America, Europe and in most of Asia. One way of reducing the financial burden is to find cost-effective approaches to prevention, detection and treatment of diabetes and its complications. The SDM model directly addresses this issue by seeking to optimize the limited resources available for diabetes care, prioritizing treatment, reducing medical error and expanding the role of allied health professionals. As SDM moves into the 21st century, its mission has expanded to encompass the principles of primary and secondary prevention. With the recent identification of an increasing number of novel disease susceptibility genes for type 2 diabetes, the substantial evidence related to the contribution of diet and lifestyle to the onset of disease, and a more complete understanding of the natural history and pathophysiology of all types of diabetes, the possibility of identifying with greater sensitivity and specificity individuals at high risk for diabetes may soon be realized. More important is the introduction of non-hypoglycaemic insulin sensitizing agents and the renewed emphasis on lifestyle changes as viable therapeutic interventions for the prevention of type 2 diabetes and perhaps gestational diabetes. These developments will not dampen the current emphasis on identifying those with undiagnosed disease. Rather, the goal is to accomplish this more systematically and at an earlier point in the natural history of diabetes, in order to prevent or slow the progression of complications. Nor does this portend a reduction in the utilization of resources devoted to the treatment of complications. With an increased understanding of the pathophysiology of cardiovascular, renal, neurological and retinal complications: there is a need to translate what we know into practical clinical processes that will assure the person with diabetes an opportunity to enjoy the highest possible quality of life. Thus, the goal of SDM is to develop and implement new approaches to the continuum of diabetes care. This takes into account an integrated strategy for the prevention, early detection and improved treatment of all forms of diabetes and associated complications. To achieve this goal, the results of research on complex interrelated genetic and environmental risk factors may one day be integrated into the SDM protocols. Simultaneously, efforts to slow the progression of complications have to continue. On 11–12 November 2000, 70 delegates who have worked with SDM, from Australia, Brazil, Canada, Japan, Mexico, Poland, Singapore, Pakistan, Taiwan and the United States, attended a two-day symposium. Held in Puebla, Mexico, following the International Diabetes Federation Congress, the symposium was sponsored by the International Diabetes Center (IDC), a World Health Organization Collaborating Center in Diabetes. The purpose of the symposium was to share recent international experience in the implementation of SDM and to discuss a range of new initiatives pioneered by the developers of SDM at the IDC. Chairperson: Richard Bergenstal (USA) Donnell Etzwiler (USA) Roger Mazze (USA) Boniface J Lin (Taiwan) The importance of tight glycemic control in all forms of diabetes has been well documented.3-6 As early as 1967, the International Diabetes Center demonstrated that tight glycemic control was a critical component in the management of type 1 diabetes and that a multidisciplinary approach would be necessary to meet this goal. As a participant in the Diabetes Control and Complications Trial (DCCT), the IDC was able to demonstrate that an evidence-based multidisciplinary approach could achieve near normal glycemia in individuals with type 1 diabetes. During the course of this landmark study it became clear that an evidence-based systematic approach to clinical decision-making was needed if the findings of the DCCT were to be replicated in standard clinical practice. The development of SDM began by examining the manner in which clinical decisions were made, looking at the type of data required, the sequence of decisions and the criteria for selecting and changing therapies. These factors were then associated with outcomes.2 Research in 1983 at New York's Albert Einstein College of Medicine (AECOM) had produced findings that suggested successful clinical decision-making relied heavily on patient-generated self-monitored blood glucose (SMBG) data.7, 8 Indeed, such data, taken from patient logbooks, served as the principal criteria by which therapies were selected and abandoned. For example, complex algorithms based on patient SMBG data were derived for insulin adjustments in type 1 diabetes, abandonment of oral agent use in type 2 diabetes and initiation of insulin therapy in gestational diabetes. However, despite the collection of these data, no algorithms proved effective. In an effort to reduce one possible source of error, investigators at AECOM modified the reflectance meters used to monitor blood glucose by equipping them with onboard memories to record each blood glucose sample with the corresponding time and date.7, 8 Using these verified data, it was possible to identify blood glucose patterns that, in turn, contributed to algorithms that would guide therapeutic regimens. Tested first in gestational diabetes, the verified blood glucose data proved invaluable to determine when to initiate insulin therapy and when to change insulin dose as well as serving as a means of confirming the level of glycemic control needed to reduce the risk of adverse perinatal outcome.9 This same approach was then applied to clinical decision-making for patients with type 1 or type 2 diabetes at the IDC. There it was possible to identify the critical decisions that lead to improved glycemic control, reduction in hypoglycaemic events and increased patient adherence to regimen. These algorithms were further tested during the DCCT. The resulting standardised treatment modalities formed the basis for a new approach to clinical decision-making. This approach became known as Staged Diabetes Management, or simply SDM. At the core of the approach was recognition that all health care professionals and patients shared the responsibilities for clinical decision-making. Thus, key principles in the care process would have to be agreed upon in advance and based on objective criteria. Careful analysis of clinical decision-making for those patients who achieved glycemic control showed that there was an established sequence to treatment options and that the sequence was based on an expected improvement in glycemic control over a specified period. In contrast, clinical decision-making for those patients who had not achieved improvement in glycemic control appeared disorganized and inconsistent. For these patients, there appeared to be no set criteria for initiation or alteration of treatment, no specific sequence of therapies and no specific therapeutic goals. From its inception in 1989 to the present time, SDM was developed as an evidence-based disease state management programme with two major components: protocols and an implementation process. The protocols, composed of DecisionPaths (clinical pathways) and Practice Guidelines (standards of care), address the classification, detection and treatment of each form of diabetes and its complications (Figures 1 and 2). The DecisionPaths provide explicit information on the sequence of therapies (stages) and the criteria for initiating and changing treatment. These clinical pathways are in turn supported by scientific evidence, which is presented with each DecisionPath. Designed for use principally in the primary care setting, SDM facilitates a multidisciplinary approach in which physicians and patients work closely with other health care professionals and paraprofessionals to achieve agreed goals. The guiding principles of SDM involve treating to target (e.g. blood glucose, blood pressure and lipid), setting timelines to achieve these targets and adopting a systematic approach to changes in therapy when targets are not met. SDM takes into account the multifactorial nature of diabetes by providing practice guidelines and clinical pathways that appraise monitoring, evaluate adherence to regimen and provide psychosocial assessment and complications surveillance. Additionally, DecisionPaths for the management of diabetic ketoacidosis, severe hypoglycaemia and hyperosmolar non-ketotic coma as well as management during surgery are included as part of the programme. Staged Diabetes Management Type 2 Diabetes Master DecisionPath customized for United States Staged Diabetes Management Type 2 Diabetes Practice Guidelines customized for United States. SDM, as a process, facilitates the adoption of these DecisionPaths through a series of steps designed to engage community health professionals in the customization of these pathways. By allowing full participation in the adaptation of SDM to the community, programme ownership passes to the medical facility. Because the process takes into account the limited resources and practice patterns unique to each community, it improves the likelihood of overall acceptance and implementation. In 1989 three challenges lay before the SDM programme. Could SDM (i) work at a primary care level, (ii) deliver high-quality care at a low cost and (iii) work in various clinical settings both within and outside the United States? During the following 12 years, SDM was implemented in more than 400 individual clinics associated with over 50 major hospitals, health care systems, medical schools and government health departments throughout the United States. The IDC has collaborated with such organizations as the United States Indian Health Service, the United States Centers for Disease Control, Geisinger Health System, Kaiser Permanente and Henry Ford Medical Center and such medical schools as the University of Minnesota, Tufts University and the University of Washington. Internationally, SDM has been implemented in more than 600 sites in Japan, South Korea, Pakistan, Thailand, the Philippines, Mexico, Brazil, Poland, Germany, France, Australia, Malaysia, Taiwan, Indonesia, China, Russia, Turkey and Singapore. Ellie Strock (USA) Gregg Simonson (USA) Ysue Omari (Japan) Since its first implementation in community clinics in the United States and in health care institutions in Poland, Japan, Brazil, Mexico and Russia, the key to the adoption of SDM has been the customization of this approach through modifications in the original Master DecisionPaths and Practice Guidelines. This customization process has been able to take into account the unique perspective towards health care delivery of each community, region and country (Figure 3). Our study of the implementation process revealed that all sites were able to adapt the Master DecisionPaths and Practice Guidelines to meet the limited resources in their community, while maintaining similar approaches to diabetes care. For example, the majority of sites adopted multiple injection regimens, beginning with a minimum of two injections per day for patients with type 1 diabetes. All United States, Japanese, Polish, German and French sites adopted use of rapid-acting insulin as well as the option of an insulin infusion pump . With respect to type 2 diabetes, specific blood glucose criteria for starting insulin therapy were adopted by most sites, i.e. fasting plasma glucose criteria of 13.8 to 19.4 mmol/L at diagnosis. Virtually all sites in industrialized countries adopted insulin initiation in GDM at fasting plasma glucose levels ranging from 5.8 to 6.3 mmol/L. Additionally, all sites customized practice guidelines to include criteria for screening and diagnosis, treatment therapies, blood glucose targets, monitoring and follow-up, as well as surveillance for complications. Staged Diabetes Management Type 2 Diabetes Master DecisionPath customized under the supervision of Drs. Klinge and Dreyer for the Hamburg area of Germany When the variation between sites was measured, no significant differences in diabetes care processes with respect to screening and diagnostic procedures were found, despite geographical differences and limited resources. However, available pharmacological agents differed widely, with industrialized countries having virtually all therapies available, while developing areas reported shortages in insulin secretagogues and insulin sensitizing agents and limited insulin supplies (especially with regard to type 2 diabetes and GDM). Self-monitoring of blood glucose by reflectance meter was readily available to patients in industrialized countries as well as to a small number of patients in Brazil and Mexico receiving care in private clinics. Testing by urine glucose appeared common practice in developing countries. HbA1c assays, while easily obtainable in industrialized countries, were generally limited to academic centres in developing countries. Complication surveillance varied from region to region. In developing countries surveillance was rarely available prior to the SDM programme. Reine M Chaves-Fonesca (Brazil) Silmara Leite (Brazil) SDM implementation began in 1995 with the formation of a committee of leading Brazilian diabetes experts. Working closely with the IDC, SDM was customized to allow for urine glucose testing, health aid participation in care, greater reliance on primary care surveillance for complications and physician-initiated patient education. Over the next two years, pilot studies were initiated in public diabetes centres located in northern Brazil (Fortaleza, Ceara, and Salvador, Bahia). Based on these early experiences, SDM was introduced at Brazilian Diabetes Society meetings in 1997. At that time, the customized materials were translated into Portuguese and distributed to conference participants. The first study was conducted at a public clinic, Centro Integrado de Diabetes and Hipertensao de Ceara, Fortaleza, Ceara. Using limited data for clinical decision-making and relying principally on physicians, after eight months the mean random blood glucose had decreased from 14.8 to 9.8 mmol/L (Figure 4) in SDM-managed patients. SDM in Fortaleza, Brazil. Random blood glucose reduction over 8 months The second study of SDM occurred also at a public clinic – the Centro de Diabetes e Endocrinologia do Estado da Bahia (CEDEBA). There, the customized algorithms were further modified to reduce reliance on insulin therapy for type 2 diabetes, to optimize urine testing and accommodate the local subsistence diet. The six month study compared the metabolic control of 121 patients with type 2 diabetes using SDM with 101 patients who received non-SDM (usual) care.10 In order to obtain comparable data, HbA1c was measured by the HPLC method in all study patients. At completion, HbA1c decreased for the SDM treated group from 8.0 to 7.0% – with 50% of patients reaching their established HbA1c targets. In this study population the average fasting blood glucose decreased from 10.4 to 8.8 mmol/L. In the non-SDM group, average HbA1c increased from 8.7 to 9.1%. The study concluded that, despite severe limitation in testing and medications, SDM could effectively lower blood glucose levels and thereby serve as a model for other public health care systems where urine glucose remains the basis for adjusting treatment. A third study was carried out in the private sector (Hospital Nossa Senhora das Grasas Diabetes Centre) where the health care team included endocrinologists, dietitians, nurses and a social assistant. Flowcharts were developed as part of the SDM intervention in order to track the progress of each team member in documenting 11 quality of care measures (adapted from the American Diabetes Association).11 At one year follow-up the 78 patients with either type 1 or type 2 diabetes under investigation had a decrease in HbA1c from 8.1 to 7.5% (p=0.045) without significant change in BMI, with lipid profiles remaining normal and blood pressure 2.2 ng/mL), the middle third (1.3–2.2 ng/mL) and the lowest third (<1.3 ng/mL). Patients in the upper group were assigned dietary interventions only, those in the middle group were given sulphonylurea therapy and those in the lowest group were assigned insulin treatment by multiple injections. A significant (p<0.005) decrease in HbA1c was recorded for each group: diet from 7.8±4% to 6.9±0.9%; oral agent from 9.7±2.0% to 7.8±1.1%; and insulin from 11.0±1.8% to 8.0±1.2%. At the completion of the study the findings showed that the C-peptide groups correlated with the glucose levels set by SDM and that the treatment assignments based on glucose criteria enabled achievement of glucose targets. Based on these findings, SDM QuickGuides were introduced at the 1999 Japan Diabetes Society meeting, as the means of implementing the standards of care. During the next two years a series of regional symposia was held to train general physicians in SDM. Andreas Klinge (Germany) Manfred Dreyer (Germany) The introduction of SDM in Germany took on yet another approach. Interest by the local health authority for the Hamburg region raised the question of whether SDM could be used to improve glucose levels in well controlled patients with either type 1 or type 2diabetes without causing hypoglycaemia and patient dissatisfaction. A second question relating to the cost of the intervention was also studied. Diabetes specialists associated with the local health authority customized and translated SDM. A study of 370 well controlled patients (mean HbA1c 7.5±1.0%) was initiated. Subjects with type 1 (59) or type 2 (311) diabetes were randomized to either SDM (196) or routine care (174) by general practitioners and followed for 6 months. Twelve community physicians who had been trained by diabetes specialists treated the SDM group. They were compared with a routine care group, also treated by community physicians unfamiliar with SDM. Glycaemic control improved in both groups, with the SDM improvement slightly (0.3%) greater. In contrast, both patient satisfaction and quality of life were significantly (p 65 years of age severe hypoglycaemia was threefold more likely under routine treatment. Finally, no increase in care costs was recorded when SDM was compared to routine treatment.15 Following this study, the implementation was carried out in two steps. First, 55 diabetes specialists were given ‘train-the-trainer’ SDM seminars. These specialists then held seminars for GPs and hospital staff. Over the next 18 months, the SDM trainers instructed more than 260 medical doctors in Hamburg in the use of SDM DecisionPaths. This number represents over half the total target of 450 physicians serving the area. Joel Rodriguez-Saldana (Mexico) Manual Idrogo (USA) Mexico represented a unique challenge for SDM implementation. A two-tier health care system exists, in which the majority of people seek health care services in public clinics, where medical students serve along with community clinicians as the principal health care providers. A lack of consistency and high staff turnover made for inadequate diabetes care services. The question was whether SDM could provide a structure for consistency in care and thus contribute to improved outcome. A one-year study to investigate the efficacy of SDM was undertaken. Over 3240 patients (with either types 1 or 2 diabetes) were treated in participating clinics in which a new team approach was introduced. When baseline was compared to the end of the study a significant decrease in mean blood glucose was recorded (from 12.3α6.2 to 9.0±3.8 mmol/L, p=0.01). This improvement was associated with a reassignment of therapy based on glucose level at entry: diet from 37.0 to 9.7%; metformin from 4.8 to 9.0%; sulphonylureas from 47.5 to 34.6%; acarbose from 1.8 to 0.8%); insulin from 14.2 to 27.3% and oral agent combination therapy from 19.9 to 25.7%. Furthermore, while at baseline 12% of the patients had received no therapy, at the completion of this phase all patients were in treatment. Guillaume Charpentier (France) Barry Ginsberg (USA) Kenneth Strauss (Belgium) In France, prior to implementation of SDM, a series of research questions focusing on the role of primary care physicians emerged. Following customization and translation by diabetes specialists, 66 primary care physicians working in the region of Paris were randomized to either SDM (30) or usual care (36) for a one-year study of the efficacy of SDM. Six hundred and nine patients were enrolled, with 285 in the SDM group. At the onset of the study, due to the differences in physician practices, entry HbA1c was significantly (p=0.01) higher in the SDM group (7.3±1.7%) than in the routine care group (6.8±1.8%). Patients were followed at 6 and 12 months. At 6 months the SDM group had lowered HbA1c by 0.5% while the routine care group had increased HbA1c by approximately the same amount. At the completion of the study the SDM group had a mean decrease of 0.8±0.1% while the control group had a mean increase of 0.45±0.2%. The absolute difference in HbA1c of 1.25 percentage points was significant (p=0.001). This was accompanied by a significant difference (p=0.01) in all processes of care measures (Table 2). Significant differences were also found in patient knowledge of diabetes, nutrition, and SMBG. Rozmin Jamal (Canada) Ellie Strock RN, ANP, CDE (USA) Boniface J Lin (Taiwan) Pakistan, not unlike Mexico, faces two major problems: a rising incidence of diabetes with limited resources. Working in co-operation with the Aga Khan Foundation through the Aga Khan University Medical School and Aga Khan Community Clinics, a five-year plan was established in 1999 that focused on the implementation of SDM as part of a comprehensive educational initiative. In year one, an infrastructure for diabetes services utilizing a team approach with greater authority given to nurses was agreed upon. During the second year, diabetes programmes were developed. Next, key physicians from the University Medical Centre and the community clinics participated in a three-day SDM training program. During the third (current) year supply and training centres will be established. Through this programme and another initiative over 3000 physicians have participated in SDM training programmes. Collaboration between government, regional and national diabetes organizations and industry in Asia has led to SDM implementation in many countries in this region. In Taiwan a study was carried out at the Diabetic Centre, Taichung Veterans General Hospital, in which 115 Chinese patients with type 2 diabetes entered the SDM programme for six to nine months and were compared with 79 controls. The results showed that SDM significantly reduced the levels of fasting plasma glucose (p<0.001) and HbA1c (p<0.04) with no significant change in BMI. The control group showed no alteration in glycemic control. One year later, 108 of the SDM group and 75 of the control group were re-evaluated. The SDM group showed further reductions in fasting plasma glucose (p<0.001). This study suggested that the SDM programme was applicable in Chinese patients with type 2 diabetes. In Thailand, a partnership between the Diabetes Educator Society, Diabetes Association and Endocrine Society resulted in over 200 primary care physicians being trained in SDM. In the Philippines, collaboration is under way with the Philippine Diabetes Association and in South Korea with the Korean Diabetes Association. Other SDM international initiatives have been launched in Indonesia (introduction completed May 1999), China (SDM being utilized through Project Hope), Turkey, Russia (a collaborative project through SDM Germany) and Malaysia (where there are 15 SDM centres). Future plans include SDM implementation among the aboriginal population of New South Wales, Australia (in a project with the Health Ministry), a country-wide diabetes and hypertension prevention project under the auspices of the National Kidney Foundation of Singapore and a comprehensive training programme in India with the Madras Diabetes Foundation in collaboration with Lions International. Gregg Simonson (USA) Renea Bradley, MSN, ARNP, CDE (USA) Stuart Sundem, MS (USA) Rachel Robinson, PHN, MPH, CDE (USA) Mary Johnson RN, CDE (USA) SDM has been implemented throughout the United States through collaborations with (i) healthcare systems, (ii) university residency training programmes, (iii) Native American communities and (iv) the Lions Diabetes
Referência(s)