title: Randomised controlled trials Do clinical guidelines introduced with practice based education improve care of asthmatic and diabetic patients? A randomised controlled trial in general practices in east London Development and evaluation of a Computer-Assisted Management Protocol (CAMP): improved compliance with care guidelines for diabetes mellitus. Sharing the care of diabetic patients between hospital and general practitioners: does it work? Implementing practice guidelines for diabetes care using problem-based learning. A prospective controlled trial using firm systems. Integrated care for diabetes: clinical, psychosocial, and economic evaluation Feasibility and effects of a diabetes type II protocol with blood glucose self-monitoring in general practice. Prompting the clinical care of non-insulin dependent (type II) diabetic patients in an inner city area: one model of community care. Diabetes management in a health maintenance organization. Efficacy of care management using cluster visits. Increasing Prescribed Office Visits: A Controlled Trial in Patients With Diabetes Mellitus Benefits provided by an integrated education and clinical diabetes centre: a follow-up study. The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long‐Term Complications in Insulin‐Dependent Diabetes Mellitus Computerized decision support based on a clinical practice guideline improves compliance with care standards. Using Telecommunication Technology to Manage Children with Diabetes: The Computer-Linked Outpatient Clinic (CLOC) Study Evaluation of a structured teaching and treatment programme for type 2 diabetes in general practice in a rural area of Austria. Renal assessment practices and the effect of nurse case management of health maintenance organization patients with diabetes. A computer-generated reminder system improves physician compliance with diabetes preventive care guidelines. Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future disease risk. The Diabetes Care From Diagnosis Research Team. Nurse Case Management To Improve Glycemic Control in Diabetic Patients in a Health Maintenance Organization Reducing lower-extremity amputations due to diabetes. Application of the staged diabetes management approach in a primary care setting. Evaluation of a Pharmaceutical Care Model on Diabetes Management The scope for cardiovascular disease risk factor intervention among people with diabetes mellitus in England: a population-based analysis from the Health Surveys for England 1991-94. Evaluation of general practice computer templates. Lessons from a pilot randomised controlled trial. Clinical pharmacy functions in ambulatory patient care. DIABEDS: a randomized trial of the effects of physician and/or patient education on diabetes patient outcomes. Is the Quality of Diabetes Care Better in a Diabetes Clinic or in a General Medicine Clinic? Reduction of Lower Extremity Clinical Abnormalities in Patients with Non-Insulin-Dependent Diabetes Mellitus A randomized controlled trial of an intervention designed to improve the care given in general practice to Type II diabetic patients: patient outcomes and professional ability to change behaviour. The use of a nurse practitioner in the management of patients with diabetes mellitus. A Telephone-Delivered Intervention for Patients With NIDDM: Effect on coronary risk factors Cholesterol Lowering With Simvastatin Improves Prognosis of Diabetic Patients With Coronary Heart Disease: A subgroup analysis of the Scandinavian Simvastatin Survival Study (4S) A Randomized Controlled Trial of Quality Assurance in Sixteen Ambulatory Care Practices No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. Improved care of patients with diabetes through telecommunications. Effect of multiple patient reminders in improving diabetic retinopathy screening. A randomized trial.
abstract: This week , a series of four articles considers the place of the r and omised controlled trial as we approach the second century of experience with the concept . Its basic principle is genuine uncertainty as to which treatment arm of the trial it would be in a patient 's best interests to enter . This is not necessarily an easy concept to transmit , Abstract Objective : To determine whether locally developed guidelines on asthma and diabetes disseminated through practice based education improve quality of care in non-training , inner city general practice s. Design : R and omised controlled trial with each practice receiving one set of guidelines but providing data on the management of both conditions . Subjects:24 inner city , non-training general practice s. Setting : East London . Main outcome measures : Recording of key variables in patient records ( asthma : peak flow rate , review of inhaler technique , review of asthma symptoms , prophylaxis , occupation , and smoking habit ; diabetes : blood glucose concentration , glycaemic control , funduscopy , feet examination , weight , and smoking habit ) ; size of practice disease registers ; prescribing in asthma ; and use of structured consultation “ prompts . ” Results : In practice s receiving diabetes guidelines , significant improvements in recording were seen for all seven diabetes variables . Both groups of practice s showed improved recording of review of inhaler technique , smoking habit , and review of asthma symptoms . In practice s receiving asthma guidelines , further improvement was seen only in recording of review of inhaler technique and quality of prescribing in asthma . Sizes of disease registers were unchanged . The use of structured prompts was associated with improved recording of four of seven variables on diabetes and all six variables on asthma . Conclusions : Local guidelines disseminated via practice based education improve the management of diabetes and possibly of asthma in inner city , non-training practice s. The use of simple prompts may enhance this improvement Disease-specific st and ards for directing patient management are becoming increasingly important . These st and ards , however , are often not followed because they are not sufficiently integrated into the clinical care setting . In this study we describe the development and evaluation of a Computer-Assisted Management Protocol ( CAMP ) of care guidelines for diabetes mellitus . While other studies have shown improved compliance with rule-based reminders , the CAMP customizes disease-specific care guidelines to individual patients over time . We evaluated the effect of the CAMP on compliance with guidelines in a prospect i ve , r and omized controlled study . The study was performed at a family practice clinic where much of the patient record is maintained electronically on The Medical Record ( TMR ) . The management protocol was developed from st and ards published by the American Diabetes Association . Fifty-eight providers were r and omized to either receive or not receive the CAMP for diabetes . Compliance with st and ards  was assessed by chart audits of all encounters with diabetic patients during the study interval . The following conclusion was made : the Computer-Assisted Management Protocol result ed in a statistically significant improvement in compliance with diabetes care st and ards A r and omized controlled trial was conducted to compare three forms of diabetes follow-up : ( 1 ) general practitioner care , ( 2 ) a system of care shared between the general practitioner ( GP ) and clinic and ( 3 ) conventional clinic care .  Two hundred and six diabetic patients without significant diabetes-related or other medical complications were r and omized to one of these follow-up systems .  Metabolic control and blood pressure improved significantly and equally in all three groups ( p < 0.05 ) . The shared care group performed as well as or better than either of the other two groups in all other outcome measures . In particular , final attendance rates were 72 % for shared care compared with only 35 % for GP care and 53 % for clinic care . Data collection rates for shared care were comparable with the clinic group for r and om blood glucose ( 88.9 % vs 95.1 % ) , weight ( 93.5 % vs 98.3 % ) , and blood pressure ( 94.8 % vs 92.7 % ) . Only in the case of glycosylated haemoglobin did shared care have poorer data collection ( 66.0 % vs 98.4 % ) . In all these parameters , except blood pressure , shared care out-performed the GP group . We conclude that with adequate support from and communication with hospital-based diabetes services , GPs are capable of providing care appropriate to the needs of uncomplicated diabetic patients OBJECTIVE A controlled trial with 15-month follow-up was conducted in two outpatient clinics to study the effects of using the problem-based learning technique to implement a diabetes clinical practice guideline . RESEARCH DESIGN AND METHODS A total of 144 patients with type 2 diabetes aged 25 - 65 years in two internal medicine outpatient clinics were enrolled in the study . African-Americans and Hispanics made up > 75 % of the patients . Doctors and staff in one of the clinics were trained in the use of a clinical practice guideline based on Staged Diabetes Management . A problem-based learning educational program was instituted to reach consensus on a stepped intensification scheme for glycemic control and to determine the st and ards of care used in the clinic . HbA1c was obtained at baseline and at 9 and 15 months after enrollment . RESULTS At 9 months , there was a mean -0.90 % within-subject change in HbA1c in the intervention group , with no significant changes in the control group . The 15-month mean within-subject change in HbA1c of -0.62 % in the intervention group was also significant . Among intervention patients , those with the poorest glycemic control at baseline realized the greatest benefit in improvement of HbA1c . The intervention group also exhibited significant changes in physician adherence with American Diabetes Association st and ards of care . CONCLUSIONS Clinical practice guidelines are an effective way of improving the processes and outcomes of care for patients with diabetes . Problem-based learning is a useful strategy to gain physician support for clinical practice guidelines . More intensive interventions are needed to maintain treatment gains Abstract Objectives : To evaluate integrated care for diabetes in clinical , psychosocial , and economic terms . Design : Pragmatic r and omised trial . Setting : Hospital diabetic clinic and three general practice groups in Grampian . Patients : 274 adult diabetic patients attending a hospital clinic and registered with one of three general practice s. Intervention - R and om allocation to conventional hospital clinic care or integrated care . Integrated care patients seen in general practice every three or four months and in the hospital clinic annually . General practitioners were given written guidelines for integrated care . Main outcome measures : Metabolic control , psychosocial status , knowledge of diabetes , beliefs about control of diabetes , satisfaction with treatment , disruption of normal activities , numbers of consultations and admissions , frequency of metabolic monitoring , costs to patients and NHS . Results - A higher proportion of patients defaulted from conventional care ( 14 ( 10 % ) ) than from integrated care ( 4 ( 3 % ) , 95 % confidence interval of difference 2 % to 13 % ) . After two years no significant differences were found between the groups in metabolic control , psychosocial status , knowledge , beliefs about control , satisfaction with treatment , unscheduled admissions , or disruption of normal activities .  Integrated care was as effective for insulin dependent as non-insulin dependent patients . Patients in integrated care had more visits and higher frequencies of examination . Costs to patients were lower in integrated care ( mean pounds sterling 1.70 ) than in conventional care ( pounds sterling 8) . 88 % of patients who experienced integrated care wished to continue with it . Conclusions : This model of integrated care for diabetes was at least as effective as conventional hospital clinic care A diabetes protocol characterized by self-monitoring of blood glucose was introduced in four general practice s with the aim of making the frequency of consultations dependent on the metabolic regulation and emphasizing body weight reduction . The feasibility of the programme was investigated and the results after 1 year were compared with those of conventional care in four control practice s. In the experimental practice s , 13 patients switched from a medical specialist 's to a general practitioner 's supervision  , 20 remained under supervision of their GP  and 33 started self-monitoring .  The self-monitoring rate , the consultation frequency according to protocol , the low number of dropouts and inadequate referrals and adherence to the therapeutic scheme showed that the protocol was feasible for both the GPs and the patients . At the initial assessment , the regulation of the diabetes was worse in patients of the experimental group , compared with those of the control group ( mean HbA1 9.7 % vs 8.9 % ; p less than 0.05 ) . On average , patients in the experimental group ( n = 56 ) lost 0.4 kg of body weight , whereas those in the control group ( n = 73 ) gained 0.1 kg ( n.s . ) . The mean change in HbA1 , adjusted for the initial value , was -0.4 % in the experimental and + 0.5 % in the control group ( p less than 0.05 ) . The results of the protocol can be attributed to a combination of greater participation of the patient , the individualized consultation frequency and the prescription of oral hypoglycaemic agents according to body weight development OBJECTIVE --To evaluate the effectiveness and acceptability of central ly organised prompting for coordinating community care of non-insulin dependent diabetic patients . DESIGN --R and omised single centre trial . Patients allocated to prompted care in the community or to continued attendance at hospital diabetic clinic ( controls ) . Median follow up two years . SETTING --Two hospital outpatient clinics , 38 general practice s , and 11 optometrists in the catchment area of a district general hospital in Islington . PATIENTS --181 patients attending hospital outpatient clinics . NULL HYPOTHESIS -- There is no difference in process of medical care measures and medical outcome between prompted community care and hospital clinic care . RESULTS --14 hospital patients failed to receive a single review in the clinic as compared with three patients in the prompted group ( chi 2 = 6.1 , df = 1 ; p = 0.013 ) . Follow up for retinal screening was better in prompted patients than in controls ; two prompted patients defaulted as against 12 controls ( chi 2 = 6.9 , df = 1 ; p = 0.008 ) . Three measures per patient yearly were more frequent in prompted patients : tests for albuminuria ( median 3.0 v 2.3 ; p = 0.03 ) , plasma glucose estimations ( 3.1 v 2.5 ; p = 0.003 ) , and glycated haemoglobin estimations ( 2.4 v 0.9 ; p < 0.001 ) . Continuity of care was better in the prompted group ( 3.2 v 2.2 review s by each doctor seen ; p < 0.001 ) . The study ended with no significant differences between the groups in last recorded r and om plasma glucose concentration , glycated haemoglobin value , numbers admitted to hospital for a diabetes related reason , and number of deaths . Question naires revealed a high level of patient , general practitioner , and optometrist satisfaction . CONCLUSIONS --Six monthly prompting of non-insulin treated diabetic patients for care by inner city general practitioners and by optometrists is effective and acceptable OBJECTIVE To evaluate the effectiveness of a cluster visit model led by a diabetes nurse educator for delivering outpatient care management to adult patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS This study involved a r and omized controlled trial among patients of Kaiser Permanente 's Pleasanton , CA , center who were aged 16 - 75 years and had either poor glycemic control ( HbA1c > 8.5 % ) or no HbA1c test performed during the previous year . Intervention subjects received multidisciplinary outpatient diabetes care management delivered by a diabetes nurse educator , a psychologist , a nutritionist , and a pharmacist in cluster visit setting s of 10 - 18 patients /month for 6 months . Outcomes included change ( from baseline ) in HbA1c levels ; self-reported changes in self-care practice s , self-efficacy , and satisfaction ; and utilization of inpatient and outpatient health care . RESULTS After the intervention , HbA1c levels declined by 1.3 % in the intervention subjects versus 0.2 % in the control subjects ( P < 0.0001 ) . Several self-care practice s and several measures of self-efficacy improved significantly in the intervention group . Satisfaction with the program was high . Both hospital ( P = 0.04 ) and outpatient ( P < 0.01 ) utilization were significantly lower for intervention subjects after the program . CONCLUSIONS A 6-month cluster visit group model of care for adults with diabetes improved glycemic control , self-efficacy , and patient satisfaction and result ed in a reduction in health care utilization after the program Patients who fail to show for scheduled visits or who fail to contact their provider when warning symptoms occur pose important problems for the primary care physician . A group of interventions was examined to determine the effectiveness in increasing the number of prescribed office visits in patients with diabetes mellitus . This group of interventions included mailed packets with information on how to use the clinic , providers ' names and phone numbers , after-hours phone numbers , a list of early warning signs , and a booklet on managing diabetes mellitus ; mailed appointment reminders ; and intense followup of visit failures for prompt rescheduling .  Eight hundred fifty-nine patients on drug therapy for diabetes mellitus were stratified by risk of hospitalization and r and omly assigned within strata to control and intervention groups . The intervention group received all interventions . After 1 year , the intervention group averaged 12 % more total contacts than the control group ( 5.8 vs. 5.2 , P = 0.01 ) , due largely to an increase in kept scheduled visits ( 4.1 vs. 3.6 , P = 0.006 ) . These effects were greatest in those patients at higher risk of hospitalization . Also , visit failures were reduced only in high-risk patients . The effect of the interventions did not diminish during the year of study . This systematic and repetitive intervention appears effective in increasing prescribed office visits and is especially effective in patients requiring more frequent care The effects of a new integrated system of diabetes care with an enhanced role of the diabetes specialist nurse based in a purpose d design diabetes centre , on diabetes control , attendance and cancellation rates , and admission for diabetic emergencies have been review ed . Glycaemic control was examined in : ( a ) a cohort of 163 insulin-treated and 47 non-insulin treated diabetic subjects ( age < 65 years ) studied prospect ively before and 3 years following the introduction of a new system of care ; ( b ) a second cohort of more elderly patients aged greater than 65 years studied for the 3 years after the change over ; ( c ) a cross-sectional study of the clinic population ( n = 700 ) the year before and 3 years after the changeover ; ( d ) a group of patients attending st and ard unaltered clinics in the same district ( n = 157 ) . Significant and sustained falls in HbA1 were observed in all groups of subjects attending the centre , with the means for those aged less than 65 falling from 11.9 + /- 2.3 % to 9.9 + /- 1.9 % and for those aged over 65 from a mean of 11.7 + /- 2.0 % to 10.3 + /- 2.3 % , 3 years later . The cross-sectional study provided similar results with a mean HbA1 of 12.2 + /- 3.0 % prior to changeover and 10.4 + /- 4.4 % , 3 years later . Smaller but significant changes were observed in patients continuing to attend the routine clinic ( from 12.2 + /- 2.3 % to 11.3 + /- 2.6 % ) over a similar period . Yearly admission rates for ketoacidosis and hypoglycaemia fell from 44 and 23 , to 33 and 5 per annum , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus ( IDDM ) . We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications . METHODS A total of 1441 patients with IDDM--726 with no retinopathy at base line ( the primary -prevention cohort ) and 715 with mild retinopathy ( the secondary -intervention cohort ) were r and omly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections . The patients were followed for a mean of 6.5 years , and the appearance and progression of retinopathy and other complications were assessed regularly . RESULTS In the primary -prevention cohort , intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent ( 95 percent confidence interval , 62 to 85 percent ) , as compared with conventional therapy . In the secondary -intervention cohort , intensive therapy slowed the progression of retinopathy by 54 percent ( 95 percent confidence interval , 39 to 66 percent ) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent ( 95 percent confidence interval , 14 to 67 percent ) . In the two cohorts combined , intensive therapy reduced the occurrence of microalbuminuria ( urinary albumin excretion of > or = 40 mg per 24 hours ) by 39 percent ( 95 percent confidence interval , 21 to 52 percent ) , that of albuminuria ( urinary albumin excretion of > or = 300 mg per 24 hours ) by 54 percent ( 95 percent confidence interval 19 to 74 percent ) , and that of clinical neuropathy by 60 percent ( 95 percent confidence interval , 38 to 74 percent ) . The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia . CONCLUSIONS Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy , nephropathy , and neuropathy in patients with IDDM PURPOSE Clinical guidelines are design ed to assist in the management of specific diseases ; however , these guidelines are often neglected in the delivery of care . The purpose of this study was to determine whether clinician use of an clinical practice guideline would increase in response to having , at the patient visit , a decision support system based on a practice guideline that generates a customized management protocol for the individual patient using data from the patient 's electronic medical record . SUBJECTS AND METHODS In a 6-month controlled trial at a primary care clinic , 58 primary care clinicians were r and omized to receive either a special encounter form with the computer-generated guideline recommendations or a st and ard encounter form . The effect of computer-generated advice on clinician behavior was measured as rate of compliance with guideline recommendations . Data from 30 clinicians were analyzed ; data from 28 clinicians were excluded because these clinicians did not meet predefined criteria for minimum exposure to diabetic patient care . RESULTS Availability of patient management recommendations generated by the decision support system result ed in a two-fold increase in clinician compliance with care guidelines for diabetes mellitus ( P = 0.01 ) . Median compliance for the group receiving the recommendations was 32.0 % versus 15.6 % for the control group . CONCLUSION Decision support based on a clinical practice guideline is an effective tool for assisting clinicians in the management of diabetic patients . This decision support system provides a model for how a clinical practice guideline can be integrated into the care process by computer to assist clinicians in managing a specific disease through helping them comply with care st and ards . Use of decision support systems based on clinical practice guidelines could ultimately improve the quality of medical care The purpose of this study was to evaluate the effrcacy of using a telecommunication system to assist in the outpatient management of pediatric patients with insulin- dependent diabetes .  Metabolic control , patients ' psychosocial status , family functioning , perceived quality of life , patterns of parental/child responsibility for daily diabetes maintenance , and nursing time-on-task were evaluated . One hundred six pediatric patients ( mean age= 13.3 years ) were r and omly assigned to an experimental or control outpatient clinic for 1 year . Experimental subjects transmitted self-monitoring blood glucose data by modem to the hospital every 2 weeks . Transmitted data were review ed by nurse practitioners who telephoned subjects to discuss regimen adjustments . Control subjects received st and ard care with regimen adjustments made by physicians . There were no significant between-group differences for metabolic control , rates of hospitalization or emergency-room visits , psychological status , general family functioning , quality of life , or parent-child responsibility . A significant decrease was noted in nursing time-on-task for experimental subjects The efficacy of a treatment and teaching programme for non-insulin-treated Type 2 diabetic patients in general practice was evaluated in a prospect i ve , controlled study . In a rural area in southern Austria , 53 patients from seven general practice s participated in a structured programme ( intervention group ) and 55 patients from seven general practice s without the programme served as the control group . After 6 months the weight reduction in the intervention group was 2.6 kg ( 1.6 - 3.7 kg , p < 0.001 ) and the difference in HbA1c between the groups was 0.92 % ( 0.23 - 1.61 % , p < 0.01 ) at follow-up . Systolic ( -16.6 mmHg ) and diastolic ( -11.1 mmHg ) blood pressure , serum triglycerides ( -0.63 mmol I-1 ) , and serum cholesterol ( -0.40 mmol I-1 ) were reduced significantly in the intervention group ( p < 0.006 ) . The number of patients with callus formation and poor nail care decreased significantly after participating in the teaching programme ( p < 0.001 ) . In the control group no reduction in body weight , metabolic control or in risk factors for diabetic foot complications were observed . Calculated health care costs per patient and year decreased in the intervention group ( -33 pounds ) and increased in the control group ( + 30 pounds ) mainly due to changes in prescription of oral hypoglycaemic agents in both groups . This programme may be an efficient and helpful model to increase overall quality of diabetes care according to the St Vincent Declaration OBJECTIVE To examine baseline renal screening practice s and the effect of nurse case management of patients with diabetes in a group model health maintenance organization ( HMO ) . RESEARCH DESIGN AND METHODS We performed both 1-year retrospective and 1-year prospect i ve studies of renal assessment practice s and ACE inhibitor usage in a cohort of 133 diabetic patients enrolled in a r and omized controlled trial of a diabetes nurse case management program in a group model HMO . In accordance with American Diabetes Association recommendations , urine dipstick and quantitative protein and microalbuminuria testing rates were calculated . RESULTS At baseline , 77 % of patients were screened for proteinuria with dipsticks or had quantitative urine testing . Of patients with negative dipstick findings , 30 % had appropriate quantitative protein or microalbumin follow-up at baseline . Baseline ACE inhibitor usage was associated with decreased follow-up testing ( relative risk = 0.47 ) . Nurse case management was associated with increased quantitative protein or or microalbumin testing and increased follow-up testing ( relative risk = 1.65 and 1.60 , respectively ) . CONCLUSIONS We found a higher degree of adherence to recommendations for renal testing than has been reported previously . Nurse case management intervention further increased renal screening rates . The inverse association between ACE inhibitor usage and microalbumin testing highlights a potentially ambiguous area of current clinical pathways Computerized reminder systems have been shown to be effective in improving physician compliance with preventive services guidelines . Very little has been published about the use of computerized reminders for preventive care in diabetes . We implemented a computer-generated reminder system for diabetes care guidelines in a r and omized controlled study in the outpatient clinics of 35 internal medicine residents at the University of Utah and Salt Lake Veterans Affairs Hospitals . After a six month study period , compliance with the recommended care significantly improved in both the intervention group that received patient-specific reminders about the guidelines ( 38.0 % at baseline , 54.9 % at follow-up ) and the control group that received a nonspecific report ( 34.6 % at baseline , 51.0 % at follow-up ) . There was no significant difference between the two groups . Both clinic sites showed similar improvement over baseline levels of compliance .  Residents who completed encounter forms used by the system showed a significantly greater improvement in compliance than those who did not complete encounter forms ( 19.7 % vs. 7.6 % , p = 0.006 ) . The improvements in guideline compliance were seen in all areas of diabetes preventive care studied , and significant improvements were seen with recommended items from the medical history , physical exam , laboratory testing , referrals , and patient education . The use of encounter forms by the providers significantly improved documented compliance with the guidelines in almost all categories of preventive care . These results suggest that computerized reminder systems improve compliance with recommended care more by facilitating the documentation of clinical findings and the ordering of recommended procedures than by providing the clinician with patient-specific information about guideline compliance status . Further study is needed to underst and the implication s of these findings to the development of future computerized reminder systems for chronic diseases such as diabetes OBJECTIVE To assess the effect of additional training of  practice nurses and general practitioners  in patient centred care on the lifestyle and psychological and physiological status of patients with newly diagnosed type 2 diabetes . DESIGN Pragmatic parallel group design , with r and omisation between practice teams to routine care ( comparison group ) or routine care plus additional training ( intervention group ) ; analysis at one year , allowing for practice effects and stratifiers ; self reporting by patients on communication with practitioners , satisfaction with treatment , style of care , and lifestyle . SETTING 41 practice s ( 21 in intervention group , 20 in comparison group ) in a health region in southern Engl and . SUBJECTS 250/360 patients ( aged 30 - 70 years ) diagnosed with type 2 diabetes and completing follow up at one year ( 142 in intervention group , 108 in comparison group ) . INTERVENTION 1.5 days ' group training for the doctors and nurses-introducing evidence for and skills of patient centred care and a patient held booklet encouraging questions . MAIN OUTCOME MEASURES Quality of life , wellbeing , haemoglobin A1c and lipid concentrations , blood pressure , body mass index ( kg/m2 ) . RESULTS Compared with patients in the C group , those in the intervention group reported better communication with the doctors ( odds ratio 2.8 ; 95 % confidence interval 1.8 to 4.3 ) and greater treatment satisfaction ( 1.6 ; 1.1 to 2.5 ) and wellbeing ( difference in means ( d ) 2.8 ; 0.4 to 5.2 ) . However , their body mass index was significantly higher ( d=2.0 ; 0.3 to 3.8 ) , as were triglyceride concentrations ( d=0.4 mmol/l ; 0.07 to 0.73 mmol/l ) , whereas knowledge scores were lower ( d=-2.74 ; -0.23 to -5.25 ) . Differences in lifestyle and glycaemic control were not significant . CONCLUSIONS The findings suggest greater attention to the consultation process than to preventive care among trained practitioners ; those committed to achieving the benefits of patient centred consulting should not lose the focus on disease management The Diabetes Control and Complications Trial ( DCCT ) and the Kumamoto study [ 1 , 2 ] showed that near-normal glycemic control reduces the development and progression of microvascular and neuropathic complications by approximately 50 % in type 1 and type 2 diabetes mellitus . Additional analyses [ 3 - 5 ] indicate that therapy to achieve near normalization of blood glucose levels is cost-effective compared with other treatments . Thus , the American Diabetes Association has recommended that all persons with diabetes attempt to achieve near normalization of blood glucose levels [ 6 ] . This recommendation is not routinely followed in medical practice . In a 1989 national survey of physician practice behaviors in the United States , 64 % of physicians agreed that achieving target HbA1c values is very important but only 18 % reported that they ordered HbA1c tests every 2 to 3 months for patients with type 1 diabetes [ 7 ] . Although 98 % agreed that patient education improves glucose control , only 55 % reported that they routinely used a dietitian or a diabetes educator in patient care . Studies indicate that bringing clinical practice into line with scientific knowledge can be difficult . Methods used to achieve diabetes control in clinical trials are re source intensive . The American Diabetes Association currently recommends that patients with diabetes see their primary care physicians two to four times per year . Data from the National Health Interview Survey , a nationally representative survey [ 8 ] , indicate that most patients with diabetes are seen by nonspecialists and that 69 % of physician visits last less than 15 minutes . Algorithms for diabetes care exist but may be complex and difficult for physicians to follow , given patient load , diversity of patients seen , lack of information systems , and time constraints . Simple , low-cost methods of translating guidelines into clinical care are required . One solution may be to make greater use of personnel other than physicians . Nurse case management was an integral part of intensive therapy in the DCCT and has proven to be effective in reducing smoking and cholesterol levels after acute myocardial infa rct ion [ 3 , 9 ] . A nonr and omized study [ 10 ] of more than 700 patients with diabetes in a health maintenance organization suggests that nurse case management may be effective in improving metabolic control . Other studies [ 11 , 12 ] show a strong association between algorithm-directed nurse interventions and improved glycemic control . To our knowledge , no r and omized , controlled clinical trial of nurse case management in diabetes has yet been published . In a 12-month r and omized , controlled trial , we compared a nurse case management model of diabetes care with usual diabetes management in a primary care setting . Methods Patients Our study was approved by the institutional review board of the Prudential Center for Health Care Research , and all patients gave written informed consent . Participants were recruited from two of the largest clinics within the Jacksonville Health Care Group , which is the largest provider of primary care services for the Prudential HealthCare HMO plan of Jacksonville , Florida . The Jacksonville Health Care Group is a group of 43 primary care physicians who provide care in eight clinics to more than 75 000 Prudential HealthCare plan members . Potential study participants were identified through a data base used to support quality -improvement activities . Prudential HealthCare HMO members who had diabetes were included in the data base if they had visited a physician for diabetes ( International Classification of Diseases , 9th Revision , codes 250.0 to 250.9 ) , had had a hospital cl aim processed for diabetes , had been seen by the utilization management nurse , or had been referred to an ophthalmologist for a diabetic retinal examination . This data base is up date d regularly . A list with each member 's name , address , telephone number , medical record number , member identification number , age , sex , physician , and clinic was generated by merging the data from the data base with enrollment information . In addition , a list of members who may have had diabetes was created by using pharmacy data . Adult members with diabetes who were potential study participants each received a recruitment call and were invited to schedule an appointment with a research assistant to discuss participation in the study . We made a total of 14 calls at different times and on different days before coding a member as unavailable . After consent was given and the eligibility assessment was completed , baseline information was obtained and an HbA1c test was ordered if the result of one given within the previous 60 days was not available . Patients were ineligible for the study if they had a recent HbA1c value less than 7.0 % ; had uncontrolled hypertension ( blood pressure > 180/110 mm Hg ) ; had unstable angina ( class 4 ) ; had had a myocardial infa rct ion in the past 3 months ; had had two or more episodes of seizures ; had alcoholism or drug abuse documented in the chart ; had late-stage complications of diabetes or other chronic conditions , such as severe immunodeficiency or cirrhosis ; were pregnant or were planning to become pregnant in the next 12 months ; or were unable to perform self-management . Patients were r and omly assigned in blocks to either the nurse case management ( intervention ) group or the usual care group . R and omization was based on a 1:1 allocation ratio and a block size of three . Each block contained six patients , three in each study group . This r and omization scheme ensured that the desired allocation ratio-one intervention patient to one usual care patient-was maintained after sequential enrollment of every sixth patient . Outcome Measures Change in HbA1c value was the primary outcome measure . Decreased HbA1c values correlate directly with reduced risk for diabetes-related microvascular and neuropathic complications in type 1 and type 2 diabetes [ 1 , 3 ] . We also assessed health-related quality of life by using four generic questions developed by the Centers for Disease Control and Prevention for the Behavioral Risk Factor Surveillance System ( BRFSS ) [ 13 , 14 ] . These questions evaluate key conceptual domains of health-related quality of life : 1 ) patient-perceived general health status , 2 ) patient-perceived physical dysfunction during the previous 30 days , 3 ) patient-perceived mental dysfunction during the previous 30 days , and 4 ) patient-perceived functional incapacity during the previous 30 days for either mental or physical reasons . The BRFSS quality -of-life measures have been vali date d in a national sample of adults in the United States [ 15 ] . Patient-perceived health was found to be a good proxy indicator for chronic disease conditions . The other three domains further characterize general health functioning and quality of life [ 15 ] . In this analysis , we report findings related to the patient-perceived general health status domain . Intervention and Follow-up The nurse case manager was a registered nurse and a certified diabetes educator . She was trained to follow a set of detailed management algorithms under the direction of a board-certified family medicine physician and an endocrinologist who were responsible for all diabetes management decisions for patients in the intervention group but were not primary care providers for these patients . The algorithms were specific for type of diabetes and were developed by a multidisciplinary team on which endocrinology , family medicine , nursing , pharmacy , health services research , and epidemiology were represented . The algorithms progressively moved a patient toward improvement of glycemic control through adjustments in medication , meal planning , and reinforcement of exercise ( Figure 1 ) . Figure 1 . Algorithm for management of type 2 diabetes mellitus . Patients assigned to receive nurse case management met with the nurse for an initial assessment , were instructed about a blood glucose monitoring schedule , and returned for a follow-up visit 2 weeks later . The initial visit with the nurse averaged 45 minutes . At the 2-week follow-up visit , the nurse review ed the patient 's blood glucose log ; explained the algorithm step to which the patient had been assigned ; and used this information as the baseline for subsequent medication adjustments , meal planning , and exercise reinforcement . Patients receiving nurse case management  were also referred to a 5-week , 12-hour diabetes education program that included individual counseling by a dietitian , individual counseling by an exercise therapist , and group diabetes education classes . Subsequent in-person follow-up visits occurred quarterly . Patients in the nurse case management group  who were taking insulin  received weekly follow-up telephone calls . After the nurse review ed the blood glucose log and discussed glucose values with the patient , medication regimens were adjusted as needed and meal planning and exercise were reinforced . Patients treated with oral agents or diet and exercise  received follow-up telephone calls every 2 weeks . The nurse case manager met at least biweekly with the family medicine physician and the endocrinologist to review patient progress , medication adjustments , and other issues related to diabetes care . All medication adjustments or changes were communicated to the patients ' regular primary care physicians . Patients assigned to receive usual care were given blood glucose meters and strips , were encouraged to discuss enrollment in the diabetes education class with their physicians if they had not done so in the past year , and continued to receive diabetes care and follow-up from their primary care physicians . The 5-week diabetes education program is a st and ard , free-of-charge benefit for all HMO members with diabetes . All Jacksonville Health Care Group primary care physicians participate in an annual diabetes care seminar and undergo regular peer review of their adherence to published diabetes care st and ards . Tests to BACKGROUND While lower-extremity amputation ( LEA ) is a frequent complication of diabetes , effective strategies for the prevention of LEA in primary care setting s have not been extensively studied . METHODS This prospect i ve study of American Indians with diabetes in a rural primary care clinic was divided into three periods : the st and ard care period ( 1986 to 1989 ) , during which patients received foot care at the discretion of the primary care provider ; the public health period ( 1990 to 1993 ) , during which patients  were screened for foot problems and high-risk individuals received foot care education and protective footwear ; and the Staged Diabetes Management ( SDM ) period ( 1994 to 1996 ) , during which comprehensive guidelines for diabetic foot management were adapted by the primary care clinicians to their practice s and were systematic ally implemented . RESULTS A total of 639 individuals contributed 4322 diabetic person-years during the three periods of observation . Patient sex distribution , mean age , and mean duration of diabetes were similar i the three periods . The average annual LEA incidence was 29/1000 diabetic person-years for the st and ard care period ( n = 42 ) , 21/1000 for the public health period ( n = 33 ) , and 15/1000 for the SDM period ( n = 20 ) , an overall 48 % reduction ( P = .016 ) . Overall , the incidence of a first amputation declined from 21/1000 to 6/1000 ( P < .0001 ) . CONCLUSIONS The customization and systematic implementation of practice guidelines by local primary care providers was associated with improved diabetic foot care outcomes . SDM has relevance to primary care organizations seeking to improve outcomes for patients with diabetes OBJECTIVE : To assess the effectiveness of a pharmaceutical care model on the management of non-insulin-dependent diabetes mellitus ( NIDDM ) in urban African-American patients . DESIGN : Eligible patients were r and omized to either a pharmacist intervention or control group and followed over a 4-month period . Patients in the intervention group received diabetes education , medication counseling , instructions on dietary regulation , exercise , and home blood glucose monitoring , and evaluation and adjustment of their hypoglycemic regimen . Patients in the control group continued to receive st and ard medical care provided by their physicians . SETTING : A university-affiliated internal medicine outpatient clinic . PARTICIPANTS : The study population consisted of urban African-American patients with NIDDM currently attending the clinic . MAIN OUTCOME MEASURES : Primary outcome measures included fasting plasma glucose and glycated hemoglobin concentrations . Secondary outcome endpoints included blood pressure , serum creatinine , creatinine clearance , microalbumin to creatinine ratio , total cholesterol , triglycerides , high-density lipoprotein , and low-density lipoprotein concentrations . Quality -of-life assessment s were performed in both groups at baseline and at the end of the study . RESULTS : Thirty-nine patients ( 17 intervention , 22 control ) completed the study . The intervention group consisted of 12 women and 5 men with a mean ± SD age of 59 ± 12 years , total body weight ( TBW ) of 93 ± 22 kg , body mass index ( BMI ) of 34 ± 7 kg/m2 , and duration of NIDDM 6.8 ± 6.5 years . The control group consisted of 15 women and 7 men with a mean age of 65 ± 12 years , TBW of 88 ± 19 kg , BMI of 33 ± 7 kg/m2 , and a duration of NIDDM of 6.2 ± 4.8 y. Significant improvement in glycated hemoglobin ( p = 0.003 ) and fasting plasma glucose ( p = 0.015 ) was achieved in the intervention group . No change in glycemia was observed in the control subjects . Statistically significant differences in the final glycated hemoglobin ( p = 0.003 ) and fasting plasma glucose ( p = 0.022 ) concentrations were noted between groups . No significant changes in blood pressure control , lipid profile , renal function parameters , weight , or quality -of-life measures were noted within or between groups . CONCLUSIONS : Our data demonstrate the effectiveness of pharmaceutical care in the reduction of hyperglycemia associated with NIDDM in a group of urban African-American patients AIMS To examine the scope for cardiovascular disease risk factor intervention among diabetic patients in Engl and was examined using data from the Health Surveys for Engl and 1991 - 94 . This evaluation included calculating the proportion who require  lipid lowering therapy  according to the St and ing Medical Advisory Committee ( SMAC ) guidelines . METHODS The Health Survey for Engl and is an annual , nationwide household-based in which anthropomorphic data , blood pressure , lipids and details of cardiovascular risk factors are collected from households after r and om stratification for geographical and socio-economic factors within a population sample of 39639 adults , 970 ( 2.3 % ) diabetic subjects were identified . RESULTS Overall , 51 % of those with diabetes had hypertension  ( systolic blood pressure > or = 160 mmHg or a diastolic BP > or = 95 mmHg or being on antihypertensive therapy ) , 27 % were  obese  ( body mass index > or = 30 kg/m2 ) and 19 % were current smokers . One-third of those with hypertension were untreated and less than one-half of those on treatment had their hypertension controlled to below 160/ 95 mmHg . More than one-quarter had poor glycaemic control ( glycated Hb>11 % or an HbA1c>7.5 % ) . Of those aged < 70 years , 29 % required  lipid lowering therapy  according to the SMAC guidelines and almost all ( 94 % ) of these were not on treatment . An analysis showed that , because the SMAC guidelines do not require high density lipoprotein ( HDL ) cholesterol to be measured , their use is likely to result in substantial underestimation of the need for  lipid lowering  , particularly in diabetic women . CONCLUSION In Engl and , among those with diabetes there is considerable unmet need for cardiovascular risk factor intervention , particularly for hypertension and raised cholesterol . With this baseline established , future improvements can be monitored We conducted a pilot r and omised trial of computerised templates for the management of asthma and diabetes in general practice in six general practice s in North London . Uptake of the guidelines by general practitioners and practice nurses was assessed using qualitative ( semi-structured interviews design ed to assess the users ' views ) and quantitative ( change in use of the template during the study period ) outcome measures . The practice nurses used the templates frequently but general practitioners rarely used them . Several reasons were offered for non-use of the templates , such as the length of the template and non-involvement in the care of asthma or diabetes . Despite this , however , health professionals were favourably disposed to the use of templates for general clinical care . Pilot investigations of computerised templates are best achieved by observational or quasi-experimental methods rather than a r and omised controlled trial . The use of both qualitative and quantitative methods in this study allowed exploration of the barriers to use of computers A functional interpretation of clinical pharmacy as an implementing mechanism for extending the objectives and responsibilities of clinical pharmacology in ambulatory patient care is presented . Evidence is given to support the effectiveness of the clinical pharmacist in assisting primary care physicians with the design of optimal drug regimens and evaluating and managing patients on chronic drug therapy . Opportunities for the clinical pharmacist to carry out long-term drug trials and participate in the design and execution of epidemiological drug studies are also discussed . The clinical pharmacist can make important contributions to ambulatory patient care in areas of drug treatment and evaluation by working in concert with primary care physicians and clinical pharmacologists To examine the effects of intensive patient and /or physician diabetes education on patient health outcomes , a controlled trial was conducted in which internal medicine residents and their 532 diabetic patients were r and omly assigned to : routine care ; patient education ; physician education ; or both patient and physician education . Patient outcome data were analyzed either by analysis of covariance on post intervention values ( 2-hour post-pr and ial plasma glucose [ PPG ] ; body weight [ BW ] ; blood pressure [ BP ] ; or analysis of variance conducted on change values ( fasting plasma glucose [ FPG ] and glycosylated hemoglobin [ A1Hgb ] ) . After patient education , significant improvements were observed in FPG , A1Hgb , BW , and systolic and diastolic BP . Physician education result ed in significant decreases in FPG , A1Hgb and BW . The combination of patient plus physician education result ed in the greatest improvements in patients ' health outcomes including FPG , A1Hgb , PPG , BW and diastolic BP . Adjusted systolic BPs were not significantly different in the two groups . While these physiologic improvements were statistically and probably clinical ly significant , hyperglycemia and obesity still persisted . Thus , achieving optimal patient outcomes for a chronic disease like diabetes mellitus may require a greater or more effective use of re sources than currently estimated OBJECTIVE To compare the quality of ambulatory diabetes care delivered by physicians in the diabetes clinic versus the general medicine clinic of a university-affiliated Veterans Administration medical center . RESEARCH DESIGN AND METHODS This is a retrospective study that involved the review of medical records against predetermined process-of-care criteria . A total of 112 patients with diabetes were r and omly selected , of whom 56 were cared for in the general medicine clinic and 56 in the diabetes clinic . The following main outcome measures were examined : 1 ) the compliance with individual criteria ; and 2 ) the proportion of patient visits in each clinic receiving minimally acceptable quality , defined as a blood pressure measurement , a record of type of hypoglycemic medication  , a glycated hemoglobin measurement within the past year , a urinalysis within the past year , an  ophthalmologist or optometrist eye examination within the past year or scheduled in the next six months , a record of change in therapeutic management , and a scheduled return visit . RESULTS The diabetes clinic performed significantly better than the general medicine clinic on the following criteria : a record of a patient 's self-monitoring of blood glucose levels ; a foot examination ; a comprehensive eye examination ; a glycated hemoglobin measurement ; and a referral for diabetic education . The proportion of patient visits meeting the minimally acceptable levels of quality was better in the diabetes clinic than the general medicine clinic ( 73 vs. 52 % , P = 0.02 ) . CONCLUSIONS Patients cared for by physicians in the diabetes clinic receive better quality of diabetes care than do patients cared for by physicians in the general medical clinic . If patient care is to be shifted from specialists to generalists , additional attention needs to be paid to ensure that generalists have the knowledge and system re sources necessary to deliver an acceptable quality of diabetes care Given that 14 million Americans have diabetes [ 1 ] , the common complications of this disorder , such as foot ulcers and lower extremity amputations , are of major concern to the medical community . Approximately 20 % of all diabetic patients hospitalized in the United States are admitted because of foot complications [ 2 , 3 ] . Furthermore , about 50 % of all nontraumatic amputations in the United States are done in patients with diabetes [ 1 , 4 ] . This proportion equates to about 55 000 amputations a year [ 1 ] or 59.7 amputations for every 10 000 persons with diabetes [ 5 ] . Patients who undergo an amputation are at greater risk for a second similar procedure on either the same or the other leg [ 6 , 7 ] . Yet , it has been estimated that about one half of the amputations in patients with diabetes , or about one fourth of the total amputations done in the United States , are preventable [ 1 , 4 ] . Recently , the focus has been on preventive strategies that minimize foot damage in diabetic patients and thereby reduce the rates of ulcers and amputations . These preventive strategies are based on two observations : first , that simple efforts on the part of the health care provider or patient can reduce the likelihood of subsequent amputation due to diabetes-associated foot disease [ 8 ] ; and second , that many of these simple procedures are not being systematic ally applied by health care providers or patients [ 9 ] . For example , studies indicate that physicians infrequently examine the feet of patients with diabetes [ 9 , 10 ] . Also , most patients with diabetes do not engage in simple foot-care assessment s to identify lesions requiring early treatment [ 11 ] . Preventive strategies are not systematic ally applied for several reasons : First , patients may not be aware of foot-care procedures or how to do them , or they may not believe that such procedures can make a difference ; second , podiatry and orthopedics services that could assist in foot salvage in diabetic patients may not be available ; and , finally , the health care system may make it difficult for patients or health care providers to examine the feet of patients with diabetes [ 10 ] . Several uncontrolled studies found that implementation of improved foot-care programs can significantly reduce lower extremity complications in patients with diabetes ; these studies showed a 44 % to 85 % reduction in the rate of lower extremity amputations [ 4 , 12 - 14 ] . A recent casecontrol study also supports the implementation of preventive strategies , such as foot care , use of protective footwear , and aggressive treatment of foot  infection by patients or health care providers , to decrease the risk for lower extremity amputation [ 15 ] . The intervention in our study was design ed to reduce the prevalence of risk factors for lower extremity amputations  in patients with noninsulin-dependent diabetes and involved the three major elements of a prevention program : the patient , health care providers , and the health care system . Specifically , we did a r and omized , controlled trial to determine whether a comprehensive foot-care intervention could improve patients ' knowledge and performance of appropriate foot care ; increase the number of referrals to specialty clinics such as the podiatry clinic ; increase the frequency of foot examinations by health care providers and the documentation of risk factors in the medical record ; and improve short-term patient outcomes such as skin and nail conditions known to be risk factors for ulcers and amputations . Methods Setting Our study , the design of which is summarized in Figure 1 , was done from April 1989 to March 1991 in the academic general medicine practice of the Regenstrief Health Center in Indianapolis , Indiana [ 16 ] . The practice is subdivided into four primary care teams ( labeled A , B , C , and D ) , each with its own nursing and clerical staff . Each team sees patients for eight half-day sessions per week , with each session staffed by one or two faculty internists and two to four housestaff . Teams A and C were r and omly assigned to the intervention group ; teams B and D were assigned to the control group . Previous studies in which this method of r and omization was used have shown no baseline interteam differences in patient characteristics and physician practice behavior and no effect of the team on the study outcome [ 16 - 19 ] . Figure 1 . Summary of the study design . Patient Identification and Recruitment The computerized Regenstrief Medical Record System [ 20 ] was used to identify approximately 3000 patients with noninsulin-dependent diabetes , as well as the date and time of their next appointment . Only patients with noninsulin-dependent diabetes who were seen at least two times in the preceding year by the same provider were included in the study . Additional criteria for inclusion were as follows : an age greater than 40 years ; a diagnosis of diabetes after 30 years of age ; a diagnosis of diabetes based on National Diabetes Data Group criteria [ 21 ] or the presence of disease requiring medication for the control of hyperglycemia ; an intention to obtain care at the general medicine practice for the next 2 years ; and a body weight that was either ideal or heavier than ideal . Exclusion criteria included pregnancy ; major psychiatric illness , including dementia ; terminal illness likely to cause death within 1 year ; renal failure ( serum creatinine > 440 mol/L ) ; previous bilateral amputations above or below the knee ; or an inability to provide any self-care . Patients of investigators involved in the protocol were also excluded from the study . Of the 728 eligible patients , 244 refused to participate , 89 enrolled in the study but failed to keep their appointments for assessment , and 395 were assessed by trained nurse-clinicians . Of the 395 patients assessed , 352 ( 89 % ) completed the study ; 43 patients ( 11 % ) did not complete the study for the following reasons : death ( 11 patients ) ; change of residence ( 15 patients ) ; illness ( 6 patients ) ; transportation problems ( 3 patients ) ; and miscellaneous reasons ( 8 patients ) . Patient Assessment Sample s for determining fasting plasma glucose , cholesterol , triglyceride , high-density lipoprotein , hemoglobin A1C , and C-peptide levels were obtained from enrolled patients and immediately transported to a certified laboratory for analysis . Patients gave a history and had a physical examination at study entry and approximately 1 year later ( mean , 11.8 1.5 months ) . These examinations focused on risk factors for amputation and were administered by two trained nurse-clinicians who were blinded to the patients ' experimental conditions . Foot-related data derived from the history and physical examination included the patient 's self-reported foot-care behaviors ; the quality of the patient 's examination of his or her feet ; the severity of any foot lesions ; and the presence of musculoskeletal abnormalities , dermatologic conditions , peripheral vascular disease , and peripheral neuropathy ( the neuropathy assessment included quantitative measures of pressure and temperature sensation ) . Patients were question ed about their regular foot-care routine and were asked to show how they examined their feet . During this self-examination , nurse-clinicians observed whether patients ' scrutinized the toenails , the soles of the feet , and the area between toes . Musculoskeletal and dermatologic abnormalities were assessed using st and ard definitions of findings such as callus , hammer toe , and Charcot foot [ 3 , 22 ] . The nurse-clinicians palpated the dorsalis pedis , posterior tibial , and femoral pulses bilaterally in their assessment for peripheral vascular disease . If a pulse was absent at any one of the six sites palpated , the assessment was considered abnormal . Foot lesions were rated for severity using the Seattle Wound Classification System [ 23 ] , which ranges from a grade of 1.1 ( absence of lesions ) to a grade of 10 ( entire foot or leg is gangrenous ) . In our study , a foot lesion was defined as any wound , with or without functional interruption of the protective cutaneous barrier , ranging from a superficial scratch to an ulcer involving the epidermis . A serious foot lesion was defined by a severity grade of at least 1.3 , which indicates a minor , nonulcerated lesion with clinical evidence of healing sufficient to close previous interruption of the cutaneous barrier [ 23 ] or a blister . Pressure and temperature sensations were measured using the 5.07-log ( 0.1 mg)-force Semmes-Weinstein monofilament and the thermal sensitivity testing apparatus , according to st and ard techniques [ 24 - 26 ] . Thermal sensitivity was considered abnormal if the patient had a value greater than 2 st and ard deviations from the mean value for a group of healthy persons without diabetes ( warm > 2.04 C ; cool > 1.58 C ) . Practice Patterns of Health Care Providers Immediately after each scheduled visit , study patients had a structured interview [ 10 ] with a research assistant , who asked about foot self-examination and foot-care education given by health care providers ( the primary care physician or nursing personnel ) . In addition , a chart audit was conducted by a nurse-clinician who was blinded to the patients ' experimental condition . Information abstract ed from the medical record included the physician 's documentation of the findings from the history and physical examination ; any referral to podiatry , orthopedics , or vascular surgery clinics ; and diagnostic-test ordering related to the evaluation and treatment of diabetes-associated foot problems . Intervention The intervention cohort was exposed to several risk-reduction strategies . The nurse-clinicians conducted the patient education session with one to four patients , covering appropriate foot-care behaviors and footwear , using a commercially available slide and audiotape presentation [ 27 ] and pamphlets [ 28 ] . Behavioral contracts regarding desired foot-care behaviors were negotiated with each patient . Follow-up was done by telephone 2 weeks after the education sessions to remind patients AIM Our objective was to evaluate the effect of training in a patient-centred intervention for GPs and practice nurses on outcomes for patients with Type II diabetes .  METHODS We carried out a r and omized controlled trial within general practice s as the basis for r and omization and a before- and -after design for measures of patient outcome . A parallel process study examined the use of the method by professionals . The study was carried out in 29 general practice s in South Glamorgan who had participated for at least 2 years in a local scheme of audit and CME in relation to Type II diabetes care . The subjects were 252 Type II diabetic patients recruited by 15 experimental and 14 control practice s. The main outcome measures were changes in glycosylated haemoglobin , patient satisfaction with care and treatment , functional health status and professional ability to apply the intervention . RESULTS Professionals adopted the innovative method with enthusiasm , but after 2 years only 19 % continued to apply the method systematic ally . The trial was , therefore , unable to demonstrate significant biochemical or functional improvements . This highlights the need to underst and the factors associated with professional uptake and subsequent ability to sustain changes in behaviour . CONCLUSIONS The efficacy of this behavioural intervention remains unproved , despite its acceptability to professional staff . Detailed and prolonged development and testing of behavioural interventions is an essential first step before embarking on r and omized controlled trials which involve complex behavioural changes in professionals or patients Shortages in health care personnel have caused the expansion of nurses * duties . Physician acceptance of this augmented role for the nurse will depend in fact on appropriate studies . Extending the responsibilities of the nurse practitioner to active patient treatment is the basis of this report . OBJECTIVE To examine whether a telephone-delivered intervention ( TDI ) , design ed to improve glycemie control in patients with non-insulin-dependent diabetes mellitus ( N1DDM ) , improved coronary risk factors in high-risk patients . RESEARCH DESIGN AND METHODS This r and omized controlled trial involved 275 veterans with N1DDM followed in a general medical clinic .  Intervention ( TDI ) patients were telephoned at least monthly by a nurse . Calls emphasized compliance with the medical regimen ( diet , medications , and exercise ) , encouraged behavioral changes , and facilitated referrals to a dietitian or smoking cessation clinic .  Control patients received no such calls . Baseline and 12-month follow-up measurements included fasting lipid profiles , weight , smoking status ( self-reported ; cessation verified by measurement of exhaled CO ) , adherence to diet and exercise ( self-reported ) , appointments , and medications ( hospital computerized data base ) . RESULTS After 12 months , equal numbers of obese patients in the two groups reported adhering to a diabetic diet and exercising  , although more obese TDI patients had seen a dietitian ( 30 vs. 7 % , P = 0.003 ) . Weight loss was not seen in either group ( —0.9 ± 5.3 vs. —0.1 ± 3.6 kg , P = 0.202 ) . Hyperlipidemic TDI patients were more likely to see a dietitian ( 31 vs. 6 % , P = 0.003 ) and receive lipid-lowering medications ( 22 vs. 9 % , P = 0.096 ) , but serum cholesterol reduction was similar between groups ( –11.7 ± 33.4 vs. –4.3 ± 32.7 mg/dl , P = 0.270 ) ; comparable results were seen for high-density lipoprotein , low-density lipoprotein , and triglyceride levels . More TDI group smokers reported quitting ( 26 vs. 0 % , P = 0.033 ) , but the difference was not significant for CO-verified abstention ( 10 vs. 0 % , P = 0.231 ) . CONCLUSIONS The TDI improved self-reported adherence to regimens that might reduce coronary risk , but had little effect on objective measures of risk OBJECTIVE To assess in diabetic patients with coronary heart disease ( CHD ) the effect of cholesterol lowering with simvastatin on mortality and the risk of CHD and other atherosclerotic events . RESEARCH DESIGN AND METHODS A post hoc subgroup analysis was carried out on data from 202 diabetic patients and 4,242 nondiabetic patients with previous myocardial infa rct ion or angina pectoris , serum total cholesterol 5.5–8.0 mmol/l , and serum triglycerides ≤ 2.5 mmol/l who were participating in the Sc and inavian Simvastatin Survival Study ( 4S ) . Participants in the 4S were r and omly assigned to double-blind treatment with simvastatin , 20 mg daily , with blinded dosage titration up to 40 mg daily , according to cholesterol response during the first 6–18 weeks , or placebo . Endpoints were 1 ) total mortality , 2 ) major CHD events ( CHD death or nonfatal myocardial infa rct ion ) , 3 ) other acute atherosclerotic events , 4 ) myocardial revascularization procedures . RESULTS Over the 5.4-year median follow-up period , simvastatin treatment produced mean changes in serum lipids in diabetic patients similar to those observed in nondiabetic patients . The relative risks ( RRs ) of main endpoints in simvastatin-treated diabetic patients were as follows : total mortality 0.57 ( 95 % CI , 0.30–1.08 ; P = 0.087 ) , major CHD events 0.45 ( 95 % CI , 0.27–0.74 ; P = 0.002 ) , and any atherosclerotic event 0.63 ( 95 % CI , 0.43–0.92 ; P = 0.018 ) . The corresponding RRs in nondiabetic patients were the following : 0.71 ( 95 % CI , 0.58–0.87 ; P = 0.001 ) , 0.68 ( 95 % CI , 0.60–0.77 ; P < 0.0001 ) , and 0.74 ( 95 % CI , 0.68–0.82 ; P < 0.0001 ) . CONCLUSIONS The results strongly suggest that cholesterol lowering with simvastatin  improves the prognosis of diabetic patients with CHD . The absolute clinical benefit achieved by cholesterol lowering may be greater in diabetic than in nondiabetic patients with CHD because diabetic patients have a higher absolute risk of recurrent CHD events and other atherosclerotic events A crossover r and omized controlled trial of cycles of quality assurance in 16 primary care ( 8 medical , 8 pediatric ) group practice s was conducted . Of four medical and four pediatric tasks important to patient outcome , two were r and omly assigned to experimental intervention ( a quality assurance cycle ) , and two were also measured and used as blinded controls for each medical or pediatric group practice . Task performance was measured in each group for 12 months prior to , 9 months during , and 9 months after the experimental intervention , using as a performance score the percentage of evaluation criteria failed of those applicable to a case . As a result of quality assurance intervention , quality of performance was significantly improved in two of the tasks ( P<0.0001 , with 6.7 , and 9.8 percentage points improvement ) , and marginally improved in one task ( P=0.06 , 5.7 percentage points improvement ) . Surprisingly , tasks with lower perceived effect on patient health ( low physician motivation ) had greater improvement in quality . Unimproved tasks were associated with the perceived need for delivery system changes beyond the immediate control of the individual practitioner OBJECTIVE To determine the effectiveness of different types of interventions in improving  health professional performance and health outcomes . DATA SOURCES MEDLINE , SCI SEARCH , CINAHL and the Research and Development Re source Base in CME were search ed for trials of  educational interventions in the health care professions published between 1970 and 1993 inclusive . STUDY SELECTION Studies were selected if they provided objective measurements of  health professional performance or health outcomes  and employed r and om or quasi-r and om allocation methods in their study design s to assign individual subjects or groups . Interventions included such activities as conferences , outreach visits , the use of local opinion leaders , audit and feedback , and reminder systems . DATA EXTRACTION Details extracted from the studies included the study design ; the unit of allocation ( e.g. , patient , provider , practice , hospital ) ; the characteristics of the targeted health care professionals , educational interventions and patients ( when appropriate ) ; and the main outcome measure . DATA SYNTHESIS The inclusion criteria were met by 102 trials . Areas of behaviour change included general patient management , preventive services , prescribing practice s , treatment of specific conditions such as hypertension or diabetes , and diagnostic service or hospital utilization . Dissemination-only strategies , such as conferences or the mailing of unsolicited material s , demonstrated little or no changes in health professional behaviour or health outcome when used alone . More complex interventions , such as the use of outreach visits or local opinion leaders , ranged from ineffective to highly effective but were most often moderately effective ( result ing in reductions of 20 % to 50 % in the incidence of inappropriate performance ) . CONCLUSION There are no " magic bullets " for improving the quality of health care , but there are a wide range of interventions available that , if used appropriately , could lead to important improvements in professional practice and patient outcomes This project tested the importance of enhanced information transfer of home monitoring results to health care providers . The study tested whether computer-assisted communication of medical information between the chronic care patient and the physician can result in health care benefit . The information tools were constructed/adapted as a test of this hypothesis for diabetes mellitus . Patients connected a glucometer to an intelligent modem weekly for six to nine months . Graphical and mathematical tools extracted and emphasized the information content of the home monitoring data arriving at the central site . Data smoothing , trend analysis , and calculation of quality control statistics were incorporated into a graphical time series oriented report that was used by the health care provider during an outpatient visit . The integrated home monitoring system was tested on 20 patients with diabetes in a double cross-over design over a 15-month period . A significant improvement in serum glucose control as measured by glycated hemoglobin was shown in the study group , but not in the control group OBJECTIVE To determine whether multiple mailed patient reminders can produce an increase in the rate of diabetic retinal examinations ( DRE ) over that seen with a single reminder . RESEARCH DESIGN AND METHODS All diabetic members > or = 18 years who were enrolled in a large network-based health maintenance organization ( HMO ) in California from August 1996 to July 1997 were identified using cl aims and pharmacy data bases . Members who had no record of DRE in the HMO 's cl aims data base were then r and omized into two groups . Both groups received mailed educational material s and a reminder to obtain the examination . Their physician groups also received a letter explaining the program , current guidelines for DRE , and a list of their diabetes patients with their DRE status . The single intervention group received no additional reminders . The multiple intervention group received additional reminders at 3 , 6 , and 9 months after baseline if they continued with no record of service , as determined from the cl aims data base . RESULTS The study cohort comprised 19,523 diabetic members , which were r and omized into single ( n = 9,614 ) and multiple ( n = 9,909 ) intervention groups . There was an increase in monthly DRE rates after the intervention in August 1996 for both intervention groups . After the second reminder was sent to the multiple intervention group , the percentage of diabetic members receiving  DRE  was higher than the single intervention group . Rates before and after the third intervention were not significantly different , nor were monthly differences found . There was a significant difference in overall annual DRE rates between the groups ( P = 0.023 ) . CONCLUSIONS Multiple patient reminders are more effective than single reminders in improving DRE rates in a managed care setting . However , the improvement noted was clinical ly small and appeared only after the second reminder ; no incremental improvement was seen with additional reminders . Re sources used for multiple reminders aim ed at diabetic retinopathy might better be spent on other approaches to reducing complications of diabetes
target: Complex professional interventions improved the process of care , but the effect on patient outcomes remained less clear because such outcomes were rarely assessed .
  Organizational interventions that facilitated the structured and regular review of patients also showed a favorable effect on process measures .
  Complex interventions in which patient education was added and /or the role of a nurse was enhanced led to improvements in patient outcomes as well as the process of care .
  CONCLUSIONS Multifaceted professional interventions and organizational interventions that facilitate structured and regular review of patients were effective in improving the process of care .
  The addition of patient education to these interventions and the enhancement of the role of nurses in diabetes care led to improvements in patient outcomes and the process of care
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