Brisk walking compared with an individualised medical fitness programme for patients with type 2 diabetes : a randomised controlled trial Aims/hypothesis Structured exercise is considered a cornerstone in type 2 diabetes treatment . However , adherence to combined resistance and endurance type exercise or medical fitness intervention programmes is generally poor . Group-based brisk walking may represent an attractive alternative , but its long-term efficacy as compared with an individualised approach such as medical fitness intervention programmes is unknown . We compared the clinical benefits of a 12-month exercise intervention programme consisting of either brisk walking or a medical fitness programme in type 2 diabetes patients . Introduction Regular exercise has been identified along with diet and medication as one of the three components of good diabetes therapy -LSB- 1 -RSB- . Structured exercise intervention programmes have been reported to be as effective as pharmaceutical strategies in improving glycaemic control -LSB- 2 -- 5 -RSB- and/or cardiovascular risk profile -LSB- 6 , 7 -RSB- in type 2 diabetes patients . Despite the growing body of scientific evidence on the health benefits of exercise intervention , most meta-analyses report a lack of studies that have tried to assess the long-term efficacy of exercise intervention in type 2 diabetes patients -LSB- 3 -- 5 , 7 -- 9 -RSB- . In general , exercise intervention studies implement endurance and resistance type exercise , supervised by a physical therapist -LSB- 10 -- 17 -RSB- . The long-term adherence to these -LRB- so-called -RRB- medical fitness programmes has been shown to range between 10 and 80 % -LSB- 11 , 18 -- 20 -RSB- . Financial costs per patient are considerable in such programmes . Brisk walking exercise has been proposed as a less expensive alternative , with a good clinical outcome when patients are frequently counselled by motivated , supportive physicians -LSB- 6 , 21 , 22 -RSB- . However , brisk walking programmes mainly consist of endurance type exercise activities . As combined endurance and resistance type exercise training has been reported to be of greater clinical benefit -LSB- 3 , 23 -RSB- , it is conceivable that the long-term efficacy of a medical fitness programme is greater than that of a brisk walking programme . In the present study , we compared the changes in glycaemic control and cardiovascular risk profile following the prescription of 12 months of either supervised group-based brisk-walking or of a more individualised medical fitness programme in a large population of type 2 diabetes patients -LRB- n = 92 -RRB- in a primary healthcare setting . We report our results for changes in HbA1c values as a primary outcome parameter , with blood pressure , plasma lipid levels , insulin sensitivity by homeostasis model assessment -LRB- HOMA -RRB- , body composition , physical fitness , programme adherence and health-related quality of life as secondary outcome parameters . Given the greater improvements in glycaemic control following combined endurance and resistance type exercise training as opposed to each separately -LSB- 3 , 23 -RSB- , we hypothesised that a medical fitness programme would result in a significantly greater decline in HbA1c than brisk walking . Methods Participants From June till December 2005 , 493 patients with type 2 diabetes were preselected from a population of 12,197 patients attending a primary healthcare centre that offers structured and guideline-based -LSB- 24 -RSB- diabetes care programmes . After 5 months of active recruitment by two nurse practitioners and four general practitioners , a total of 76 -LRB- = 15.4 % -RRB- patients were willing to participate in supervised exercise sessions three times a week for a period of at least 1 year . The type 2 diabetes patients selected had been diagnosed more than 3 months prior to screening according to the WHO criteria -LSB- 25 -RSB- . Exclusion criteria were : presence of -LRB- silent -RRB- cardiac or peripheral vascular disease , orthopaedic limitations and/or diabetic foot ulceration . To increase sample size , the exercise intervention programme was subsequently advertised in local newspapers , which yielded another 26 potential study candidates . In total , 99 type 2 diabetes patients agreed to participate in either brisk walking or medical fitness programmes . Potential study candidates performed a graded exercise test on a cycle ergometer -LRB- Medifit ; Medifit Systems , Maarn , the Netherlands -RRB- using a ramp protocol -LSB- 26 -RSB- . Cardiac function was monitored using a 12-lead electrocardiogram and blood pressure was measured to detect malignant hypertension . Of the 99 selected patients , three did not show up and four were excluded because of an abnormal stress-ECG . The remaining 92 volunteers were randomly allocated to either brisk walking -LRB- n = 49 -RRB- or medical fitness -LRB- n = 43 -RRB- programmes , by subsequently drawing a sequentially numbered opaque , sealed envelope -LRB- Fig. 1 -RRB- . Laboratory personnel and the physician in charge of the graded exercise tests and randomisation procedure were blinded to the selection outcome of each participant . Drug prescriptions of each patient were recorded through an electronic database system operated through a network of local pharmacies . As part of the diabetes protocol in the healthcare centre , all type 2 diabetes patients consulted a dietitian and/or diabetes nurse educator annually for dietary guidance . Baseline participant characteristics are provided in Table 1 . The nature and the risks of the exercise intervention were explained to all participants before written informed consent was obtained . This study was approved by the local Medical Ethical Committee of the Máxima Medical Centre , Veldhoven , the Netherlands . Since the study protocol was planned before 2005 , official pre-trial registration at international trial registers was not performed . Fig. 1Study flow diagramTable 1Participants ' baseline characteristicsCharacteristicTotal -LRB- n = 92 -RRB- Brisk walking -LRB- n = 49 -RRB- Medical fitness -LRB- n = 43 -RRB- Age -LRB- years -RRB- 60 ± 961 ± 959 ± 9Men/women -LRB- n -RRB- 47/4527/2220 / 23Duration of diabetes -LRB- years -RRB- 5 ± 55 ± 45 ± 5BW -LRB- kg -RRB- 94.3 ± 18.494.1 ± 18.194.5 ± 19.0 BMI -LRB- kg/m2 -RRB- 32.3 ± 5.532.1 ± 5.232.5 ± 6.0 Wmax -LRB- W -RRB- 156 ± 47155 ± 49157 ± 45Estimated -LRB- l/min -RRB- 2.1 ± 0.62.1 ± 0.62.1 ± 0.6 % Pred . 82 ± 1182 ± 1083 ± 11Participants treated with : Diet only -LRB- n -RRB- 1156 Hypoglycaemic agents -LRB- n -RRB- Total814437 Metformin432419 Sulfonylurea251312 Thiazolidinedione1046 Insulin1367 Antihypertensive agents -LRB- n -RRB- Total593227 ACEI/ARB392019 Beta-blocker17710 Diuretic19109 Calcium-channel blocker954 Other312 Lipid-lowering agents -LRB- n -RRB- Total543024 Statin532924 Fibrate110 Other000Data are n -LRB- number of participants -RRB- or means ± SD.Estimated was based on Wmax during cycling ergometry and the equation according to Storer et al. -LSB- 30 -RSB- . Relative age - , height - and sex-adjusted cardio-respiratory fitness -LRB- % Pred . -RRB- was based on the equation by Fairbarn et al. -LSB- 31 -RSB- . ACEI , ACE inhibitor ; ARB , angiotensin receptor blocker ; BW , body weight Exercise intervention Overview Two different exercise intervention programmes were implemented over a 12-month period , during which three brisk walking or medical fitness sessions were performed each week . The exercise load was progressive in nature and had components of resistance and endurance type exercise according to the American Diabetes Association/American College of Sports Medicine guidelines -LSB- 27 -RSB- . Brisk walking programme The weekly volume of brisk walking consisted of three 60 min exercise sessions . During the first 3 months participants were supervised by certified exercise trainers and a physical therapist . Group size varied between 15 and 25 patients . After 3 months , certified trainers guided and supervised the training sessions , while the physical therapist was visited on a consultation basis . The endurance type exercise consisted of brisk walking -LRB- 5 -- 6 km/h -RRB- , with a focus on interval type endurance exercise training . During the intervention period the intensity was gradually increased and averaged 75 ± 5 % of maximum heart frequency , as determined during the maximal cycle ergometer test . The resistance type exercise training consisted of resistance and floor exercises using individual body weight and/or elastic bands -LRB- The Hygenic Corporation , Akron , OH , USA -RRB- . Further details on the brisk walking programme are provided in Electronic supplementary material -LRB- ESM -RRB- Table 1 . Medical fitness programme The medical fitness programme consisted of three exercise sessions per week . Endurance type exercise consisted of interval type exercise on a home trainer , elliptical trainer or rowing ergometer with an average intensity of 73 ± 2 % of maximum heart frequency . All training sessions were tailored to individual performance capacity . Resistance type exercise consisted of a selection of eight different exercises targeting upper and lower body muscle groups . Over a period of 6 months the training volume of the medical fitness programme was progressively increased from three times 30 min per week -LRB- 90 min/week -RRB- towards a total of 180 to 225 min per week . Further details on the medical fitness programme are provided in ESM Table 1 . Energy expenditure and monitoring blood glucose Based on average heart rate and indirect calorimetry measurements performed during either brisk walking -LSB- 28 -RSB- or circuit resistance training in elderly -LSB- 29 -RSB- participants , energy expenditure in both exercise interventions was estimated to range between 0.23 and 0.33 kJ kg − 1 min − 1 . Given the participants ' bodyweights , the exercise interventions should be regarded as moderate intensity . Participants were provided with blood glucose monitor systems and test strips -LRB- A. Menarini Diagnostics , Valkenswaard , the Netherlands -RRB- and during the first month of brisk walking or medical fitness were advised to assess capillary blood glucose levels ∼ 30 min before and after exercise . Patients were instructed to report recurrent hypoglycaemic events to their diabetes nurse educator or general practitioner . For logistic reasons no systematic enquiries on mild hypoglycaemic events were performed . Financial cost of the intervention programmes Direct yearly costs for the individualised medical fitness programme were Euro 853 per participant and consisted of an ECG-stress test , supervision and consultations by a physical therapist , and the use of fitness centre facilities . The direct costs of the group-based brisk walking programme averaged Euro 396 per participant . Costs consisted of an ECG-stress test , supervision and consultation by a physical therapist , and a brisk walking membership fee . Other healthcare-related costs were not assessed . Outcome variables Resting heart rate and blood pressure Resting heart rate and blood pressure were determined in a supine position before and at 6 and 12 months after initiating the exercise programme . Heart rate was stored and averaged through a heart rate monitoring system -LRB- CO2ntrol ; Tildesign , Zeewolde , the Netherlands -RRB- . Average systolic and diastolic blood pressure were determined -LRB- HEM-907 ; Omron Healthcare , Hoofddorp , the Netherlands -RRB- from five successive measurements . Physical fitness Before and at 12 months after the start of the exercise programme , peak oxygen uptake capacity -LRB- -RRB- was estimated based on maximum workload capacity -LRB- Wmax -RRB- during cycling ergometry according to Storer et al. -LSB- 30 -RSB- . Relative age - , height - and sex-adjusted cardio-respiratory fitness -LRB- % Pred . -RRB- was defined as the ratio between estimated and predicted as determined in a healthy non-diabetic population -LSB- 31 -RSB- . Blood analyses Two weeks before and at 3 , 6 , 9 and 12 months after initiating the exercise programme , fasting blood samples were collected . Blood samples collected before and after 3 and 9 months of intervention were analysed for HbA1c and basal glucose concentration . On the evening prior to blood sampling , participants remained fasted from 00:00 hours onwards . They arrived at the laboratory at 08:00 hours , having travelled by car or public transport . After 5 to 10 min of rest , a venous blood sample was collected from an antecubital vein . Blood samples were collected in tubes containing a glycolytic inhibitor -LRB- sodium fluoride -RRB- and an anticoagulant -LRB- potassium oxalate -RRB- , immediately centrifuged for 5 min at 1,000 × g and 4 °C , after which aliquots of plasma were immediately frozen in liquid nitrogen and stored at − 80 °C until analyses . Plasma glucose -LRB- dehydrogenase assay -RRB- , triacylglycerol -LRB- lipase/peroxidase assay -RRB- concentrations , and total serum cholesterol -LRB- peroxidase/cholesterol-esterase assay -RRB- , HDL-cholesterol -LRB- peroxidase esterase assay -RRB- and LDL-cholesterol -LRB- according to the Friedewald formula if triacylglycerol was < 4.5 mmol/l , otherwise through direct peroxidase esterase assay -RRB- were analysed -LRB- Synchron LX20 ; Beckman Coulter , Fullerton , CA , USA -RRB- . Plasma insulin was determined in duplicate by electrochemiluminescence-immunoassay -LRB- Elecsys 2010 ; Roche , Mannheim , Germany -RRB- . Because of cross-sensitivity in the latter assay , exogenous insulin users were excluded from this analysis . HOMA insulin resistance index -LSB- 32 -RSB- was assessed to monitor changes in insulin sensitivity -LSB- 33 -RSB- . To determine HbA1c , 3 ml blood samples were collected and analysed by high-performance liquid chromatography -LRB- HA8160 Menarini ; A. Menarini Diagnostics , Florence , Italy -RRB- . Quality-of-life assessment Health-related quality-of-life was measured with the RAND 36-Item Health Survey 1.0 -LSB- 34 , 35 -RSB- before and after 12 months of exercise intervention . Statistical analyses We calculated that 74 persons -LRB- 37 per group -RRB- were needed to have 80 % power to detect a moderate 0.65 SD difference in HbA1c as primary endpoint parameter between brisk walking and medical fitness programme , with an α of 0.05 . Sample size was exceeded to allow for an estimated withdrawal of ∼ 15 % . Data were analysed according to the intention-to-treat -LRB- ITT -RRB- principle . To minimise type I errors and loss of power -LSB- 36 -RSB- , endpoint analyses according to the last observation carried forward principle were performed for missing values at 12 months follow-up . To assess whether physiological differences existed between the long-term application of brisk walking and medical fitness programme , post hoc analyses were performed for individuals actively participating for 10 months or more . Data are expressed as means ± SD . ANOVA repeated measures was used to determine differences between baseline and status after 12 months of exercise intervention . Unpaired Student 's t , χ2 and Mann -- Whitney U tests were used to test whether long-term changes observed in brisk walking differed from those seen in the medical fitness programme . Significance was set at the 0.05 level of confidence . Pearson 's correlation calculation was used to test for linear relationships between long-term changes in dependent variables . All statistical calculations were performed using SPSS 10.1 -LRB- SPSS , Chicago , IL , USA -RRB- . Results Characteristics of the study population Following randomisation there were no significant differences in baseline characteristics , sex and anthropometry between brisk walking and medical fitness programme groups -LRB- Table 1 -RRB- . Programme adherence , follow-up and adverse events After 6 months of intervention , 22 -LRB- 45 % -RRB- brisk walking participants and 13 -LRB- 30 % -RRB- medical fitness programme participants -LRB- p = 0.15 -RRB- were no longer participating -LRB- ESM Table 2 -RRB- . After 12 months , 18 -LRB- 37 % -RRB- brisk walking and 19 -LRB- 44 % -RRB- medical fitness participants respectively were still actively participating with mean adherence levels of 75 ± 16 % and 68 ± 13 % -LRB- p > 0.05 -RRB- for the 156 available exercise sessions -LRB- ESM Table 2 -RRB- . Besides motivational reasons -LRB- 25 % -RRB- , orthopaedic-related co-morbidities , such as overuse injuries and/or subclinical osteoarthritis of the lower extremities , formed the main reason for dropout in 48 and 50 % of the brisk walking and medical fitness programme participants , respectively -LRB- Fig. 1 , Table 2 -RRB- . The distribution of missing data points was similar and not statistically different between groups -LRB- p > 0.05 -RRB- . Table 2Adverse medical eventsEventsBrisk walking -LRB- n = 49 -RRB- Medical fitness -LRB- n = 43 -RRB- Adverse events related to exercise intervention1512 Shoulder pain/chronic tendinopathy of rotator cuff01 -LRB- Aggravation of -RRB- low back pain22 Aggravation of pre-existing osteoarthritis in hip or knee joint64 Shin splints/lower leg pain10 Chronic tendinopathy of Achilles tendon/plantar fascia31 Other/generalised musculoskeletal discomfort33Adverse events not related to exercise intervention46 Medical event requiring hospitalisationa33 Other serious medical eventb13Participants with adverse event resulting in withdrawal1917Data are number of participating diabetes patients that experienced an adverse event throughout the 12 months follow-up periodaHospitalisations were related to : arthroscopic knee surgery -LRB- brisk walking , n = 1 -RRB- , elective surgery for chronic abdominal aortic aneurysm -LRB- brisk walking , n = 1 -RRB- , elective cataract surgery -LRB- brisk walking , n = 1 -RRB- , elective knee joint replacement -LRB- medical fitness , n = 1 -RRB- , bacterial pneumonia -LRB- medical fitness , n = 1 -RRB- , elective varicose veins surgery -LRB- medical fitness , n = 1 , did not result in withdrawal from study -RRB- . bOther serious medical events requiring medical attention were : otitis externa -LRB- brisk walking -RRB- n = 1 , atrial fibrillation -LRB- medical fitness -RRB- n = 1 , newly diagnosed myocardial ischaemia -LRB- medical fitness -RRB- n = 1 , and newly diagnosed carcinoma of the mammary gland -LRB- medical fitness -RRB- n = 1 Glycaemic control According to ITT analyses , changes in HbA1c values following the prescription of brisk walking or medical fitness intervention were identical -LRB- 95 % CI − 0.42 , 0.43 ; p = 0.99 -RRB- -LRB- Table 3 -RRB- . A total of 12 patients -LRB- brisk walking , n = 5 ; medical fitness , n = 7 -RRB- had been prescribed higher doses of blood glucose-lowering medication throughout the follow-up period . When these participants were excluded from our ITT analysis , HbA1c increased by 0.05 % -LRB- 95 % CI − 0.41 , 0.51 ; p = 0.82 -RRB- in brisk walking as compared with medical fitness programme . Post hoc analyses of long-term active participants -LRB- ≥ 10 months with mean adherence level of 62 ± 17 and 70 ± 18 % in brisk walking and medical fitness groups , respectively -RRB- showed that , independently of changes in prescribed blood glucose-lowering drugs , HbA1c in the brisk walking group increased by 0.53 % -LRB- 95 % CI 0.07 , 1.00 ; p = 0.025 -RRB- as compared with the medical fitness group -LRB- ESM Table 3 -RRB- . Table 3Changes in diabetes outcome -LRB- ITT analysis -RRB- VariableChange from baseline to 12 monthsMean ± SDnMean ± SDnDifference95 % CIp ValueHbA1c -LRB- % -RRB- Total7 .13 ± 1.36926.99 ± 1.2671 Brisk walking group7 .18 ± 1.42497.08 ± 1.3738 Medical fitness group7 .08 ± 1.29436.89 ± 1.1333 Intragroup comparisons Intragroup comparison total − 0.14 − 0.39 , 0.030.153 Intragroup comparison brisk walking − 0.11 − 0.51 , 0.150.464 Intragroup comparison medical fitness − 0.18 − 0.45 , 0.090.176 Brisk walking vs medical fitness 0.00 − 0.42 , 0.430.985 BMI -LRB- kg/m2 -RRB- Total32 .3 ± 5.59231.8 ± 5.489 Brisk walking group32 .1 ± 5.24931.9 ± 5.048 Medical fitness group32 .5 ± 6.04331.7 ± 5.941 Intragroup comparisons Intragroup comparison total − 0.5 − 1.1 , 0.10.108 Intragroup comparison brisk walking − 0.2 − 0.6 , 0.30.471 Intragroup comparison medical fitness − 0.8 − 2.0 , 0.30.152 Brisk walking vs medical fitness 0.7 − 0.5 , 1.90.237 Fasting plasma glucose -LRB- mmol/l -RRB- Total8 .44 ± 2.81928.21 ± 2.3771 Brisk walking group8 .64 ± 2.83498.33 ± 2.6438 Medical fitness group8 .21 ± 2.80438.06 ± 2.0533 Intragroup comparisons Intragroup comparison total − 0.23 − 0.72 , 0.250.345 Intragroup comparison brisk walking − 0.31 − 0.96 , 0.340.344 Intragroup comparison medical fitness − 0.15 − 0.91 , 0.610.699 Brisk walking vs. medical fitness − 0.16 − 1.14 , 0.820.744 HOMAa Total5 .55 ± 3.68685.60 ± 3.3854 Brisk walking group5 .86 ± 3.56375.75 ± 3.2030 Medical fitness group5 .19 ± 3.58315.43 ± 3.6424 Intragroup comparisons Intragroup comparison total 0.05 − 0.50 , 0.620.833 Intragroup comparison brisk walking − 0.12 − 1.11 , 0.850.794 Intragroup comparison medical fitness 0.24 − 0.19 , 0.740.241 Brisk walking vs medical fitness − 0.40 − 1.52 , 0.720.479 Resting heart rate -LRB- bpm -RRB- Total73 .4 ± 11.89169.6 ± 13.977 Brisk walking group72 .6 ± 11.84868.3 ± 15.041 Medical fitness group74 .4 ± 11.84371.0 ± 12.436 Intragroup comparisons Intragroup comparison total − 3.9 − 5.9 , − 1.80.000 Intragroup comparison brisk walking − 4.3 − 7.4 , − 1.10.009 Intragroup comparison medical fitness − 3.4 − 5.9 , − 0.90.010 Brisk walking vs medical fitness − 0.9 − 4.9 , 3.20.678 Systolic blood pressure -LRB- mmHg -RRB- Total148 .5 ± 18.191137.5 ± 15.577 Brisk walking group150 .3 ± 18.948138.9 ± 16.341 Medical fitness group146 .3 ± 17.143135.9 ± 14.636 Intragroup comparisons Intragroup comparison total − 10.9 − 14.0 , − 7.80.000 Intragroup comparison brisk walking − 11.4 − 15.9 , − 6.80.000 Intragroup comparison medical fitness − 10.4 − 14.7 , 6.20.000 Brisk walking vs medical fitness − 0.9 − 7.1 , 5.3 -RRB- 0.768 Diastolic blood pressure -LRB- mmHg -RRB- Total81 .9 ± 10.69176.6 ± 8.377 Brisk walking group81 .3 ± 10.84875.9 ± 8.841 Medical fitness group82 .6 ± 10.44377.4 ± 7.736 Intragroup comparisons Intragroup comparison total − 5.3 − 7.1 , − 3.60.000 Intragroup comparison brisk walking − 5.4 − 7.8 , 2.90.000 Intragroup comparison medical fitness − 5.2 − 7.8 , − 2.70.000 Brisk walking vs medical fitness − 0.1 − 3.6 , 3.40.949 Total cholesterol level -LRB- mmol/l -RRB- Total4 .70 ± 0.86884.53 ± 0.9465 Brisk walking group4 .83 ± 0.89474.61 ± 0.9235 Medical fitness group4 .54 ± 0.12414.44 ± 0.9630 Intragroup comparisons Intragroup comparison total − 0.16 − 0.32 , − 0.010.035 Intragroup comparison brisk walking − 0.22 − 0.45 , 0.010.064 Intragroup comparison medical fitness − 0.10 − 0.30 , 0.100.307 Brisk walking vs medical fitness − 0.12 − 0.42 , 0.190.453LDL-cholesterol level -LRB- mmol/l -RRB- Total2 .83 ± 0.76882.70 ± 0.7964 Brisk walking group2 .90 ± 0.82472.72 ± 0.8535 Medical fitness group2 .74 ± 0.69412.68 ± 0.7229 Intragroup comparisons Intragroup comparison total − 0.12 − 0.26 , 0.010.070 Intragroup comparison brisk walking − 0.18 − 0.38 , 0.020.080 Intragroup comparison medical fitness − 0.06 -- 0.25 , 0.120.493 Brisk walking vs medical fitness − 0.11 − 0.38 , 0.160.401HDL-cholesterol level -LRB- mmol/l -RRB- Total1 .09 ± 0.28881.10 ± 0.2965 Brisk walking group1 .10 ± 0.23471.09 ± 0.2635 Medical fitness group1 .07 ± 0.33411.11 ± 0.3230 Intragroup comparisons Intragroup comparison total − 0.01 -- 0.02 , 0.040.570 Intragroup comparison brisk walking − 0.01 − 0.06 , 0.040.629 Intragroup comparison medical fitness 0.03 − 0.01 , 0.080.129 Brisk walking vs medical fitness − 0.05 − 0.12 , 0.020.172 Triacylglycerol level -LRB- mmol/l -RRB- Total1 .88 ± 0.99881.79 ± 0.9164 Brisk walking group2 .00 ± 1.08471.94 ± 0.9835 Medical fitness group1 .74 ± 0.88411.61 ± 0.7929 Intragroup comparisons Intragroup comparison total − 0.09 − 0.25 , 0.060.239 Intragroup comparison brisk walking − 0.06 − 0.33 , 0.170.646 Intragroup comparison medical fitness − 0.13 − 0.27 , 0.060.120 Brisk walking vs medical fitness − 0.02 − 0.29 , 0.330.892RAND-36 -LRB- score 0 -- 100 scale -RRB- Total71 ± 158970 ± 1558 Brisk walking group69 ± 154668 ± 1531 Medical fitness group73 ± 154371 ± 1427 Intragroup comparisons Intragroup comparison total − 0.6 − 2.4 , 1.20.503 Intragroup comparison brisk walking 0.1 -- 2.7 , 2.80.969 Intragroup comparison medical fitness − 1.4 − 3.8 , 1.10.261 Brisk walking vs medical fitness 1.4 − 2.2 , 5.00.438 Data are means ± SD . n = number of valid measurements . aFor HOMA calculations exogenous insulin users -LRB- n = 13 -RRB- were excluded Resting heart rate and blood pressure Following the 12 month exercise intervention , resting heart rate in the brisk walking group was reduced by 0.9 beats per min -LRB- bpm -RRB- -LRB- CI − 7.1 , 5.3 ; p = 0.68 -RRB- as compared with medical fitness group . No significant differences in blood pressure response were observed between the two interventions -LRB- Table 3 -RRB- . After excluding participants who were prescribed higher doses of antihypertensive drugs -LRB- brisk walking , n = 5 ; medical fitness , n = 7 -RRB- , mean arterial blood pressure decreased by 0.9 mmHg -LRB- 95 % CI − 5.6 , 3.9 ; p = 0.94 -RRB- in the brisk walking as compared with medical fitness group . A post hoc analysis of 46 long-term active participants showed a non-significant difference in mean arterial blood pressure of − 3.5 mmHg -LRB- 95 % CI − 9.2 , 2.2 ; p = 0.22 -RRB- in the brisk walking compared with the medical fitness programme -LRB- ESM Table 3 -RRB- . Blood lipid profile After 12 months , the overall fasting lipid profile did not differ between the two groups -LRB- Table 3 -RRB- . When participants -LRB- brisk walking , n = 9 , medical fitness , n = 7 -RRB- who were prescribed more blood lipid-lowering agents were excluded , HDL-cholesterol had changed by − 0.05 mmol/l -LRB- 95 % CI − 0.12 , 0.02 ; p = 0.17 -RRB- in the medical fitness compared with the brisk walking group . Body composition and workload capacity Body composition -LRB- BMI -RRB- did not change -LRB- Table 3 -RRB- . Workload capacity as measured during cycle ergometry averaged 155 ± 49 and 157 ± 45 W in the brisk walking and medical fitness programme groups , respectively , changing by − 4.3 W -LRB- 95 % CI − 9.1 , 0.5 ; p = 0.078 -RRB- in the former and by − 2.5 W -LRB- 95 % CI − 10 , 5.6 ; p = 0.53 -RRB- in the latter , with a non-significant difference of − 1.8 W -LRB- 95 % CI − 10.5 , 6.9 ; p = 0.68 -RRB- in brisk walking compared with medical fitness programme participants . Maximum heart rates recorded during ergometry averaged 146 ± 22 and 152 ± 19 bpm at baseline , and 152 ± 21 and 149 ± 22 bpm following 12 months of exercise intervention in the brisk walking and medical fitness groups , respectively -LRB- p > 0.05 -RRB- . In our long-term active brisk walking participants , Wmax changed by − 6.3 W -LRB- 95 % CI − 16.5 , 3.9 ; p = 0.22 -RRB- as compared with their medical fitness programme counterparts . No significant correlations were found between changes in HbA1c values and changes in workload capacity -LRB- ΔWmax , Pearson 's R = 0.02 , p = 0.93 , n = 38 -RRB- or body weight -LRB- Pearson 's R = 0.18 , p = 0.225 , n = 45 -RRB- . Quality of life assessment A total of 89 and 58 participants completed the RAND-36 questionnaire at baseline and after 12 months of intervention , respectively . Reliability and internal consistency was excellent with Cronbach 's alpha of 0.93 and 0.91 respectively . No significant difference in changes of total RAND-36 scores were observed between the two intervention groups -LRB- p > 0.05 ; Table 3 -RRB- . Discussion It has been firmly established that physical activity counselling -LSB- 37 -RSB- and participation in structured exercise intervention programmes -LSB- 15 , 19 -RSB- improves glycaemic control . However , long-term intervention studies on the clinical benefits of different types of exercise intervention programmes in type 2 diabetes patients are lacking . In the present study , we compared the clinical benefits of 12 months of a group-based brisk walking programme versus a more individualised medical fitness programme . ITT analysis showed that the prescription of a group-based , brisk walking programme is not necessarily inferior to a more individualised medical fitness programme with regard to glycaemic control and markers for cardiovascular risk profile -LRB- Table 3 -RRB- . Our data therefore imply that most patients with type 2 diabetes will achieve more or less equal long-term therapeutic benefits from a low-impact brisk walking programme as opposed to a more individualised medical fitness programme . Nevertheless , long-term programme adherence and the possibility of dropout should be taken into consideration when prescribing either type of exercise intervention for a patient with type 2 diabetes . Independently of the provided level of guidance and infrastructure , 60 % of the patients dropped out of the exercise programme during the 12 month intervention period , with no differences in adherence and dropout patterns between brisk walking and medical fitness programme . Although motivational factors explained 25 % of the dropout in both exercise programmes , almost 50 % of the dropout was attributed to orthopaedic-related co-morbidities and overuse injuries of the lower extremities . The latter was not anticipated , since clinically relevant orthopaedic limitations , such as a history of osteoarthritis of the hip or knee joint , were defined as exclusion criteria for participation in either exercise intervention programme . Apparently , subclinical joint disease and/or degeneration of myotendineous structures become apparent when physical activity levels are increased . Stiffening of connective tissue due to non-enzymatic advanced glycation end-product formation -LSB- 38 -RSB- , as well as decreased collagen turnover due to ageing and chronic disuse -LSB- 39 -RSB- , could be responsible for the impaired response to increased musculoskeletal loading in these patients . Although more fundamental clinical research is warranted , the high incidence of overuse injuries in the present study adds to the results described in another study -LSB- 23 -RSB- , suggesting that in unselected , non-study populations dropout will be even greater . Therefore , it might be advisable to implement a more gradual and less intense exercise regimen to allow myotendineous structures to adapt to increased loading . Moreover , before prescribing therapeutic exercise , diabetes healthcare workers should carefully consider obesity - and diabetes-related musculoskeletal deconditioning -LSB- 40 -- 42 -RSB- . Such programmes should probably focus even more on resistance type exercise activities -LSB- 43 , 44 -RSB- to bring patients to a level at which they are able to participate and adhere to more generic diabetes intervention programmes . It has also been suggested that psychological strategies such as motivational interviewing -LSB- 45 -RSB- or booster sessions -LSB- 21 , 46 -RSB- might help to further improve programme adherence . Nevertheless , more long-term , tailored exercise intervention studies are warranted to further define the most effective and feasible exercise interventional strategy . The absence of a significant decline in blood HbA1c levels in brisk walking participants does not imply that the prescription of low-impact , endurance type exercise has no therapeutic value -LSB- 3 , 7 , 27 , 47 -- 49 -RSB- . In fact , we observed significant improvements in blood pressure control following either type of exercise intervention -LRB- Table 3 -RRB- . Although reliable assessment of actual drug use was not possible in the present study , the improvements in blood pressure occurred independently of changes in the prescription of antihypertensive medication . However , the lack of a non-exercise control group in the present study makes it impossible to speculate on cause and effect , since changes in blood pressure from baseline might also , or at least partly , be explained by the Hawthorne effect , for example , or by familiarisation with blood pressure measurement protocols . Nevertheless , our data suggest that the structured application of group-based brisk walking and supervised medical fitness programmes tends to have a similar impact on cardiovascular risk profile . In conclusion , the prescription of group-based brisk walking represents an equally effective interventional strategy to modulate glycaemic control and cardiovascular risk profile in type 2 diabetes patients compared with a more individualised medical fitness programme . General deconditioning , musculoskeletal overuse injuries and lack of motivation limit the benefits of long-term exercise intervention as an add-on to a comprehensive diabetes care programme . Future diabetes exercise intervention programmes in primary healthcare settings should consider diabetes-related co-morbidities and patient motivation as important factors , which determine both long-term programme adherence and the associated clinical benefits . Electronic supplementary material Below is the link to the electronic supplementary material . Table 1 Exercise programme -LRB- PDF 60.7 KB -RRB- Table 2 Individual follow-up data for primary outcome variable -LRB- HbA1c -RRB- and active programme participation -LRB- PDF 69.9 KB -RRB- Table 3 Changes in diabetes outcome in long-term active participants -LRB- PDF 160 KB -RRB-

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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O B O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O B I O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O

blood pressure
exercise
physical fitness

hyperglycaemia
lipid metabolism
randomised controlled clinical trial
type 2 diabetes mellitus


Gastrointestinal

Endoscopic

Terminology

Coding

-LRB-

GET-C

-RRB-

A

WHO-Approved

Extension

of

the

Technological

developments

have

greatly

promoted

interest

in

the

use

of

computer

systems

for

recording

findings

and

images

at

endoscopy

and

creating

databases

The

aim

of

this

study

was

to

develop

a

comprehensive

WHO-approved

code

system

for

gastrointestinal

endoscopic

terminology

The

International

Classification

of

Diseases

edition

-LRB-

-RRB-

and

the

clinical

modification

-LRB-

-RRB-

were

expanded

to

allow

description

of

every

possible

gastrointestinal

endoscopic

term

under

conditions

defined

by

the

WHO

Classifications

of

specific

gastrointestinal

disorders

and

endoscopic

locations

were

added

A

new

chapter

was

developed

for

frequently

used

terminology

that

could

not

be

classified

in

the

existing

such

as

descriptions

of

therapeutic

procedures

The

new

extended

code

system

was

named

Gastrointestinal

Endoscopic

Terminology

Coding

-LRB-

GET-C

-RRB-

The

GET-C

is

a

complete

code

system

that

can

be

used

within

every

endoscopic

database

program

for

all

specific

endoscopic

terms

The

GET-C

is

available

for

free

at

Introduction

Technological

developments

and

the

introduction

of

hospital

information

systems

have

greatly

promoted

interest

in

the

use

of

computer

systems

for

recording

findings

and

images

at

endoscopy

Several

database

systems

have

been

developed

for

this

purpose

most

working

only

as

a

report

generator

These

systems

are

however

hampered

by

the

lack

of

a

specific

code

system

for

endoscopic

diagnoses

and

terminology

As

a

result

of

this

shortcoming

the

composition

of

reports

and

storage

of

data

differ

considerably

between

systems

Systems

use

different

database

structures

and

variable

terminology

and

are

thus

not

compatible

or

comparable

The

International

Classification

of

Diseases

-LRB-

ICD

-RRB-

is

designed

to

promote

international

comparability

in

the

collection

processing

classification

and

presentation

of

mortality

statistics

This

ICD

is

developed

published

and

maintained

by

the

World

Health

Organization

-LRB-

WHO

-RRB-

The

system

is

in

its

current

setting

not

applicable

for

endoscopy

as

it

does

not

include

descriptive

terminology

However

endoscopic

findings

are

classified

according

to

their

appearance

Adequate

description

of

this

appearance

in

uniform

terminology

is

essential

for

the

interpretation

of

endoscopy

reports

and

allows

important

conclusions

to

be

made

with

respect

to

therapy

and

prognosis

Thus

it

is

important

to

uniformly

store

and

code

endoscopic

findings

This

is

however

hampered

by

the

lack

of

a

specific

uniformly

applicable

code

system

for

endoscopic

terminology

and

findings

In

addition

only

about

of

report

systems

are

able

to

use

a

code

in

their

database

-LSB-

-RSB-

Different

coding

systems

for

medical

data

are

being

used

The

ICD

edition

-LRB-

-RRB-

and

the

clinical

modification

of

the

-LRB-

-RRB-

have

already

been

used

and

proven

to

be

of

value

in

a

specific

and

defined

gastrointestinal

endoscopic

setting

-LSB-

-RSB-

The

ICD

has

been

revised

periodically

to

incorporate

changes

in

the

medical

field

The

tenth

edition

-LRB-

-RRB-

differs

from

the

ninth

edition

in

several

ways

although

the

overall

content

is

similar

First

the

has

alphanumeric

categories

rather

than

numeric

categories

Second

some

chapters

have

been

rearranged

some

titles

changed

and

conditions

have

been

regrouped

Third

the

has

almost

twice

as

many

categories

as

the

The

has

been

available

since

and

was

translated

into

Dutch

in

-LSB-

-RSB-

Other

medical

specialities

such

as

oncology

and

dentistry

have

produced

an

extended

code

system

for

their

field

of

interest

based

on

the

-LSB-

-RSB-

The

aim

of

this

project

is

to

develop

a

comprehensive

code

system

for

gastrointestinal

endoscopic

terminology

based

on

the

widely

accepted

code

system

that

can

be

used

in

any

gastrointestinal

endoscopic

information

system

Methods

As

a

basis

for

the

new

coding

system

the

latest

edition

of

the

ICD

the

was

chosen

The

reason

for

choosing

this

code

system

was

that

a

predecessor

has

already

been

in

use

for

some

gastrointestinal

endoscopic

databases

-LSB-

-RSB-

In

addition

the

current

version

of

the

ICD

is

now

accepted

in

a

majority

of

countries

throughout

the

world

-LSB-

-RSB-

Extensions

of

the

are

made

according

to

the

recommendations

of

the

WHO

without

changing

the

structure

of

the

The

first

four

characters

are

never

changed

but

one

or

more

characters

are

added

behind

these

first

four

descriptors

In

this

way

it

is

always

possible

to

delete

the

extension

to

come

back

to

the

original

We

used

the

Dutch

translation

of

the

Also

the

draft

version

of

the

of

the

National

Center

for

Health

Statistics

-LRB-

NCHS

-RRB-

was

studied

which

is

available

on

the

Internet

-LSB-

-RSB-

Conflicts

with

this

CM

system

were

avoided

to

rule

out

coding

conflicts

A

working

group

the

TRANS.IT

working

group

was

founded

comprised

of

representatives

from

two

academic

hospitals

-LRB-

Utrecht

Amsterdam

-RRB-

and

four

general

hospitals

This

working

group

used

the

Endobase

III

system

-LRB-

Olympus

-RRB-

In

this

system

the

endoscopist

can

choose

among

three

methods

of

writing

reports

Besides

the

Minimal

Standard

Terminology

-LRB-

MST

-RRB-

-LSB-

-RSB-

text-blocks

and

standard

reports

are

also

available

A

standard

report

is

a

complete

report

based

on

a

diagnosis

or

a

combination

of

diagnoses

With

text-blocks

different

portions

of

the

text

are

combined

to

compose

a

complete

report

These

two

variants

enable

more

rapid

generation

of

reports

and

are

well

accepted

and

widely

used

in

the

Netherlands

-LSB-

-RSB-

In

the

TRANS.IT

project

group

which

was

founded

as

a

peer

reference

group

standard

reports

text-blocks

and

linkage

to

the

new

code

system

were

discussed

A

list

of

every

endoscopic

finding

intervention

or

complication

described

using

one

of

the

three

methods

of

report

writing

available

for

TRANS.IT

users

was

generated

All

items

on

this

list

were

linked

to

a

specific

code

Results

We

first

generated

a

list

of

the

different

fields

necessary

for

evaluation

of

endoscopic

data

-LRB-

Table

-RRB-

The

program

automatically

generated

the

data

during

the

composition

of

endoscopic

reports

All

these

fields

are

necessary

to

generate

a

comprehensive

anonymous

database

with

endoscopic

information

for

extensive

research

In

addition

demographic

data

such

as

gender

and

age

of

patients

and

specialty

of

referring

doctor

are

recorded.Table

fields

that

need

a

specific

code

in

endoscopic

information

systemsReason

for

endoscopyMedication

useSedation

and

medication

during

endoscopyPreparationProcedure

for

investigationEndoscopic

diagnosis/findingsTherapeutic

and

diagnostic

interventionsHistology

resultsTherapy

startedAdvice

to

referring

doctorComplications

We

included

all

available

standard

reports

text-blocks

and

diagnoses

of

Minimal

Standard

Terminology

-LRB-

MST

-RRB-

accepted

by

the

TRANS.IT

group

The

endoscopic

findings

interventions

and

complications

were

extracted

and

linked

to

a

specific

code

In

this

way

a

total

of

standard

reports

and

text-blocks

were

coded

to

assure

coding

of

every

item

within

this

project

In

total

different

items

were

extracted

and

received

a

specific

code

Of

these

items

-LRB-

-RRB-

could

be

coded

with

the

existing

Thus

new

codes

were

required

and

added

to

the

system

in

order

to

be

able

to

specifically

code

every

endoscopic

term

The

used

was

originally

designed

for

mortality

and

discharge

statistics

The

problem

with

that

design

is

that

the

structure

used

in

the

is

not

very

detailed

This

is

true

especially

for

gastrointestinal

endoscopic

terms

which

do

not

always

include

a

mortality

risk

but

most

of

the

time

descriptive

items

essential

for

prognosis

and

therapy

For

example

specific

descriptions

of

peptic

ulcers

are

relevant

for

determination

of

outcome

risks

therapy

and

prognosis

We

therefore

introduced

the

Forrest

classification

for

description

of

gastric

and

duodenal

ulcers

-LSB-

-RSB-

We

thus

for

instance

changed

the

diagnosis

-LRB-

acute

gastric

ulcer

with

both

hemorrhage

and

perforation

-RRB-

to

-LRB-

acute

gastric

ulcer

with

spurting

bleeding

and

perforation

Forrest

Ia

-RRB-

in

the

Gastrointestinal

Endoscopic

Terminology

Coding

-LRB-

GET-C

Table

-RRB-

Table

of

and

GET-C

codes

for

gastric

ulcerICD-10DescriptionGET-CDescriptionK25.0

Gastric

ulcer

acute

with

Gastric

ulcer

acute

with

Gastric

ulcer

acute

with

spurting

bleeding

-LRB-

Forrest

Ia

-RRB-

Gastric

ulcer

acute

with

nonspurting

active

bleeding

-LRB-

Forrest

Ib

-RRB-

Gastric

ulcer

acute

with

Gastric

ulcer

acute

with

Gastric

ulcer

acute

with

both

hemorrhage

and

Gastric

ulcer

acute

with

both

hemorrhage

and

Gastric

ulcer

acute

with

spurting

bleeding

and

perforation

-LRB-

Forrest

Ia

-RRB-

Gastric

ulcer

acute

with

nonspurting

active

bleeding

and

perforation

-LRB-

Forrest

Ib

-RRB-

Gastric

ulcer

acute

without

hemorrhage

or

Gastric

ulcer

acute

without

hemorrhage

or

Gastric

ulcer

acute

with

visible

vessel

-LRB-

Forrest

IIa

-RRB-

Gastric

ulcer

acute

nonbleeding

with

overlying

clot

-LRB-

Forrest

IIb

-RRB-

Gastric

ulcer

acute

with

hematin-covered

basis

-LRB-

Forrest

IIc

-RRB-

Gastric

ulcer

acute

with

clean

ulcer

ground

-LRB-

Forrest

III

-RRB-

Gastric

ulcer

chronic

or

unspecified

with

Gastric

ulcer

chronic

or

unspecified

with

Gastric

ulcer

chronic

or

unspecified

with

both

hemorrhage

and

Gastric

ulcer

chronic

or

unspecified

with

both

hemorrhage

and

Gastric

ulcer

chronic

or

unspecified

with

spurting

bleeding

and

perforation

-LRB-

Forrest

Ia

-RRB-

Gastric

ulcer

chronic

or

unspecified

with

non

spurting

active

bleeding

and

perforation

-LRB-

Forrest

Ib

-RRB-

Gastric

ulcer

chronic

without

hemorrhage

or

Gastric

ulcer

chronic

without

hemorrhage

or

Gastric

ulcer

chronic

with

visible

vessel

-LRB-

Forrest

IIa

-RRB-

Gastric

ulcer

chronic

non-bleeding

with

overlying

clot

-LRB-

Forrest

IIb

-RRB-

Gastric

ulcer

chronic

with

hematin-covered

basis

-LRB-

Forrest

IIc

-RRB-

Gastric

ulcer

chronic

with

clean

ulcer

ground

-LRB-

Forrest

III

-RRB-

Gastric

ulcer

unspecified

without

hemorrhage

or

Gastric

ulcer

unspecified

without

hemorrhage

or

Gastric

ulcer

unspecified

with

visible

vessel

-LRB-

Forrest

IIa

-RRB-

Gastric

ulcer

unspecified

nonbleeding

with

overlying

clot

-LRB-

Forrest

IIb

-RRB-

Gastric

ulcer

unspecified

with

hematin-covered

basis

-LRB-

Forrest

IIc

-RRB-

Gastric

ulcer

unspecified

with

clean

ulcer

ground

-LRB-

Forrest

III

-RRB-

Besides

such

an

adaptation

of

the

system

endoscopy

is

still

developing

and

new

terms

and

endoscopic

techniques

are

continuously

being

created

For

example

new

disease

classifications

are

being

introduced

from

time

to

time

such

as

the

semirecent

Los

Angeles

classification

for

reflux

esophagitis

-LSB-

-RSB-

For

several

fields

there

was

no

code

available

and

the

item

thus

could

not

be

categorized

under

an

existing

code

For

example

the

procedure

for

investigation

and

interventions

could

not

be

covered

within

the

or

even

the

system

Because

these

items

are

essential

for

good

analysis

of

endoscopic

data

a

new

chapter

with

the

same

structure

as

the

was

developed

The

items

in

this

new

chapter

start

with

the

letters

OG

We

chose

to

categorize

therapeutic

interventions

in

this

new

chapter

also

because

new

therapies

are

developed

frequently

and

can

now

be

adapted

Adaptations

were

made

in

different

chapters

of

the

In

Chapter

Certain

Infectious

and

Parasitic

Diseases

-LRB-

-RRB-

the

exact

locations

in

the

gastrointestinal

tract

of

some

specific

infections

were

added

In

Chapter

Neoplasms

-LRB-

-RRB-

besides

the

exact

locations

in

the

gastrointestinal

tract

the

endoscopic

characteristics

of

polyps

were

described

and

coded

in

more

detail

It

is

important

to

register

whether

a

polyp

is

pedunculated

sessile

or

flat

or

has

a

villous

endoscopic

aspect

Also

the

number

of

polyps

found

in

a

specific

part

of

the

intestine

must

be

coded

because

of

important

diagnostic

and

therapeutic

options

for

patients

and

the

follow-up

of

these

patients

In

Chapter

Diseases

of

the

Circulatory

System

-LRB-

-RRB-

hemorrhoids

and

varices

were

described

according

to

a

classification

Different

gradings

of

protrusion

were

used

for

hemorrhoids

Paquet

's

endoscopic

classification

for

esophageal

varices

was

coded

-LSB-

-RSB-

Most

changes

were

however

made

in

Chapter

Diseases

of

the

Digestive

System

-LRB-

-RRB-

The

description

of

esophagitis

was

divided

into

different

origins

and

severity

Gastric

and

duodenal

ulcers

were

coded

according

to

the

Forrest

classification

and

their

specific

location

in

the

stomach

or

duodenum

Gastritis

and

duodenitis

were

coded

according

to

their

specific

location

and

the

endoscopically

suspected

cause

Inflammatory

bowel

diseases

were

coded

according

to

their

endoscopic

severity

and

location

Some

complications

related

to

gastrointestinal

procedures

were

coded

in

more

detail

In

Chapter

symptoms

signs

and

abnormal

clinical

and

laboratory

findings

that

are

an

indication

for

endoscopic

investigations

were

coded

in

more

detail

In

Chapter

postoperative

situations

important

for

gastrointestinal

endoscopic

investigations

such

as

gastric

and

colon

operations

were

extensively

coded

In

the

new

thirteenth

chapter

of

the

GET-C

about

new

codes

were

generated

These

codes

start

with

the

letters

OG

The

first

part

of

this

chapter

includes

coding

of

various

indications

for

endoscopy

that

could

not

be

categorized

in

the

The

second

part

consists

of

specific

codes

for

detailed

locations

in

the

gastrointestinal

tract

The

third

part

includes

procedures

which

are

divided

into

diagnostic

and

therapeutic

procedures

Diagnostic

procedures

include

for

example

sampling

of

histology

and

culture

specimens

Examples

of

therapeutic

procedures

are

different

kinds

of

polypectomies

endoscopic

mucosal

resections

placement

of

endoprotheses

and

dilatation

of

stenoses

Another

aspect

of

these

therapeutic

interventions

was

used

for

the

management

of

gastrointestinal

bleeding

such

as

injection

therapy

with

or

without

coagulation

band

ligations

and

clipping

Preparation

and

procedure

for

the

endoscopic

examination

are

also

coded

in

this

chapter

The

extensions

of

the

GET-C

were

checked

by

the

Dutch

translation

board

of

the

to

preclude

any

conflicts

between

the

two

code

systems

Discussion

The

increased

use

of

computer

systems

in

health

care

and

the

need

for

communication

between

these

systems

necessitate

the

availability

of

generally

accepted

code

systems

Good

coding

provides

epidemiological

information

for

research

purposes

Coding

is

of

importance

for

hospitals

and

professionals

because

most

of

the

financial

systems

used

in

health

care

are

based

on

different

codes

In

addition

good

coding

makes

statistical

analysis

of

different

diagnoses

and

collection

of

rare

diagnoses

easier

With

an

internationally

accepted

code

it

is

possible

to

compare

and

share

information

in

one

field

of

interest

Most

currently

used

coding

systems

are

regional

or

national

Only

some

coding

systems

such

as

the

are

translated

into

different

languages

and

used

in

different

countries

For

endoscopic

report

writing

and

endoscopic

databases

different

systems

have

been

developed

These

systems

are

now

being

used

at

many

hospitals

We

used

the

Endobase

III

system

from

Olympus

Europe

in

our

project

to

compose

reports

and

record

different

codes

The

system

runs

as

a

network

version

with

different

workstations

as

well

as

a

stand-alone

unit

The

Endobase

III

system

enables

the

generation

of

reports

via

three

pathways

in

addition

to

standard

reports

and

text-blocks

the

latest

translated

version

of

the

MST

is

also

used

to

compose

an

endoscopic

report

Thus

it

is

essential

that

all

differently

generated

data

are

coded

in

the

same

way

to

enable

analysis

of

the

data

anonymously

In

this

system

all

standard

reports

and

text-blocks

are

linked

to

one

or

more

specific

GET-C

codes

The

choice

of

a

standard

report

or

text-block

leads

directly

to

the

recording

of

the

correct

GET-C

code

in

the

Endobase

III

database

Due

to

the

structure

of

the

MST

the

automatic

link

for

it

is

more

complex

to

realize

We

chose

to

link

the

diagnoses

with

the

GET-C

code

which

is

separately

selected

within

the

MST

by

the

endoscopist

at

the

end

of

the

report

Automatic

linking

is

essential

to

ensure

correct

and

complete

selection

of

codes

and

to

make

the

system

workable

for

endoscopists

In

the

TRANS.IT

project

an

anonymous

central

database

of

endoscopic

investigations

was

built

In

this

central

database

only

coded

data

instead

of

free

text

can

be

collected

for

privacy

reasons

After

years

of

use

a

database

of

about

investigations

using

the

same

coding

system

has

been

built

by

this

working

group

The

GET-C

system

allows

the

encoding

of

any

data

collected

during

endoscopic

investigations

and

recorded

in

any

endoscopic

database

By

extending

the

with

respect

to

the

structure

developed

by

the

WHO

it

is

always

possible

to

extract

the

original

code

from

the

GET-C

Thus

it

is

possible

to

link

the

endoscopic

database

with

other

health-care

systems

throughout

the

world

Because

endoscopy

is

an

evolving

medical

specialty

new

techniques

are

continuously

becoming

available

These

require

new

codes

which

will

be

discussed

within

the

TRANS.IT

project

The

Dutch

Association

of

Gastroenterologists

has

accepted

the

GET-C

The

GET-C

will

be

available

for

use

in

other

systems

and

was

discussed

at

the

WHO

Family

of

International

Classifications

Network

meeting

in

October

-LSB-

-RSB-

The

GET-C

is

available

for

free

at

We

hope

that

this

coding

system

will

help

to

make

endoscopic

databases

and

endoscopic

report

writing

programs

more

meaningful

O O B B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O B B O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O B O O O B O O O O O O O O O B I I I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O B O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O

international classification of diseases

gastrointestinal endoscopy
10th edition (icd-10)
icd-10 clinical modification


Surgery

did

not

improve

the

subjective

neuropsychological

symptoms

of

patients

with

incidentally

detected

mild

primary

hyperparathyroidism

Primary

hyperparathyroidism

-LRB-

PHPT

-RRB-

is

known

to

cause

diverse

subjective

symptoms

in

addition

to

those

related

to

osteitis

fibrosa

cystica

and

kidney

stones

The

treatment

of

the

disease

ameliorates

the

subjective

symptoms

and

improves

the

patients

quality

of

life

In

this

prospective

study

patients

undergoing

surgery

for

incidentally

detected

mild

asymptomatic

PHPT

were

assessed

to

determine

whether

subjective

neuropsychological

symptoms

are

improved

even

in

patients

with

asymptomatic

PHPT

From

October

to

March

patients

who

had

one

or

more

neuropsychological

symptoms

preoperatively

and

were

followed

up

year

after

parathyroidectomy

were

enrolled

The

subjective

symptoms

were

identified

using

questionnaires

distributed

to

patients

eight

questions

were

used

to

determine

the

presence

or

absence

of

psychoneurological

symptoms

Compared

to

their

preoperative

status

patients

responded

that

their

general

health

perceptions

year

after

surgery

were

improved

-LRB-

cases

-RRB-

unchanged

-LRB-

cases

-RRB-

or

aggravated

-LRB-

case

-RRB-

There

were

no

statistically

significant

differences

in

the

patients

responses

before

and

after

surgery

with

respect

to

individual

neuropsychological

symptoms

such

as

tiring

easily

forgetfulness

decreased

concentration

depression

irritability

uneasiness

and

sleeplessness

Therefore

subjective

neuropsychological

symptoms

did

not

improve

in

otherwise

asymptomatic

PHPT

patients

following

parathyroidectomy

However

patients

questionnaire

responses

may

not

reflect

their

actual

status

as

accurately

as

laboratory

examination

results

Overall

of

patients

were

subjectively

satisfied

with

surgery

this

may

result

from

patients

expectations

of

treatment

Introduction

Since

calcium

concentration

is

now

included

in

the

serum

biochemical

analyses

done

by

multichannel

autoanalyzers

it

is

possible

to

detect

patients

with

hypercalcemia

Consequently

an

increased

incidence

of

mild

cases

of

primary

hyperparathyroidism

-LRB-

PHPT

-RRB-

has

been

noted

More

than

of

PHPT

patients

are

essentially

asymptomatic

-LSB-

-RSB-

Currently

resection

of

the

pathologic

parathyroid

gland

continues

to

be

the

sole

therapeutic

modality

available

for

curing

PHPT

However

the

surgical

procedure

is

not

necessarily

easy

for

surgeons

with

limited

experience

particularly

in

certain

patients

with

mild

PHPT

Under

these

circumstances

several

investigators

-LSB-

-RSB-

have

reported

based

on

surveys

on

the

natural

history

of

patients

with

asymptomatic

PHPT

who

had

been

conservatively

followed

up

Some

patients

reported

no

signs

or

symptoms

during

observation

periods

of

various

durations

although

some

patients

developed

complications

specific

to

PHPT

that

required

surgery

PHPT

has

been

known

to

produce

diverse

subjective

symptoms

in

addition

to

those

related

to

osteitis

fibrosa

cystica

and

kidney

stones

The

treatment

of

the

disease

ameliorates

these

symptoms

which

improves

patients

quality

of

life

-LRB-

QOL

-RRB-

From

the

clinical

standpoint

based

on

patient

self-reporting

after

surgery

most

surgeons

have

had

the

impression

that

parathyroidectomy

improves

psychological

and

mental

deficits

This

prospective

study

of

patients

undergoing

surgery

for

incidentally

detected

mild

asymptomatic

PHPT

determined

whether

subjective

neuropsychological

symptoms

improved

postoperatively

in

patients

with

asymptomatic

PHPT

Patients

and

methods

From

October

to

March

patients

with

PHPT

were

treated

at

the

Cancer

Institute

Hospital

All

patients

underwent

surgery

In

patients

the

pathological

parathyroid

glands

were

successfully

removed

the

pathology

was

adenoma

in

patients

hyperplasia

in

and

cancer

in

Of

the

patients

whose

parathyroid

adenoma

was

removed

had

kidney

stones

and

had

osteitis

fibrosa

cystica

Thirty-seven

patients

without

any

signs

and/or

symptoms

of

classic

PHPT

were

diagnosed

as

asymptomatic

because

all

were

incidentally

found

to

have

hypercalcemia

on

laboratory

testing

and

their

subsequent

serum

examinations

showed

inappropriately

elevated

intact

parathyroid

hormone

concentrations

without

concomitant

clinical

biochemical

or

radiological

evidence

of

osteitis

fibrosa

cystica

or

renal

stone

colic

Of

these

patients

reported

one

or

more

neuropsychological

symptoms

preoperatively

patients

reported

no

neuropsychological

symptoms

preoperatively

and

these

patients

were

excluded

from

the

postoperative

survey

Twelve

months

after

successful

parathyroidectomy

patients

responded

to

our

questionnaire

-LRB-

Fig.

-RRB-

distributed

at

the

outpatient

clinic

or

by

mail

They

included

males

and

females

ranging

in

age

from

to

-LRB-

mean

-RRB-

years

The

other

patients

were

requested

to

respond

by

mail

Of

these

patients

gave

no

response

and

responded

to

less

than

half

of

the

questions

thus

these

patients

were

excluded

from

the

study

Fig.

of

primary

hyperparathyroid

patients

-LRB-

pts

-RRB-

treated

surgically

during

an

period

-LRB-

-RRB-

Preoperative

bone

mineral

density

was

measured

in

the

lumbar

spine

-LRB-

-RRB-

using

a

dual-energy

X-ray

absorptiometer

The

serum

calcium

level

was

-LRB-

mean

-RRB-

mg/dl

the

urinary

calcium

excretion

rate

was

-LRB-

mean

-RRB-

h

the

creatinine

clearance

rate

was

-LRB-

mean

-RRB-

ml/min

and

the

bone

mineral

density

was

to

-LRB-

mean

-RRB-

SD

The

subjective

symptoms

were

assessed

by

distributing

questionnaires

that

contained

eight

questions

dealing

with

the

presence

or

absence

of

neuropsychological

symptoms

-LRB-

Table

-RRB-

The

eight

questions

were

formulated

based

on

a

textbook

-LSB-

-RSB-

and

dealt

with

tiring

easily

forgetfulness

decreased

concentration

depression

irritability

uneasiness

sleeplessness

and

general

health

Uneasiness

was

defined

as

feeling

worried

or

unhappy

about

a

particular

situation

especially

because

one

thinks

something

bad

or

unpleasant

might

happen

The

questionnaires

were

distributed

before

and

year

after

surgery

To

ensure

that

the

patients

understood

the

questions

the

meaning

of

each

question

was

thoroughly

explained

prior

to

surgery

To

ascertain

patients

perceptions

of

their

general

health

they

were

asked

whether

they

felt

better

year

after

surgery

than

before

surgery

Patients

were

asked

to

select

one

of

the

following

responses

to

each

question

the

symptom

is

totally

absent

or

occurs

rarely

-LRB-

score

-RRB-

the

symptom

is

slight

or

occurs

only

occasionally

-LRB-

score

-RRB-

or

the

symptom

has

recently

been

aggravated

or

occurs

frequently

-LRB-

score

-RRB-

Table

Do

you

tire

easily

Are

you

forgetful

Do

you

lack

the

ability

to

concentrate

Do

you

feel

depressed

Do

you

feel

irritable

Do

you

feel

uneasiness

Do

you

experience

sleeplessness

How

do

you

perceive

your

general

health

compared

with

that

before

surgery?aaThis

question

was

asked

only

once

year

postoperatively

Statistical

analysis

A

two-sided

Wilcoxon

's

signed-rank

test

was

used

to

detect

statistically

significant

differences

among

the

responses

the

significance

level

was

set

at

P

Results

General

health

perceptions

year

after

parathyroidectomy

When

compared

to

their

preoperative

responses

the

patients

general

health

perceptions

year

after

surgery

were

improved

in

cases

-LRB-

-RRB-

unchanged

in

cases

-LRB-

-RRB-

and

aggravated

in

case

-LRB-

-RRB-

these

changes

were

statistically

significant

-LRB-

P

-RRB-

Comparison

of

the

individual

subjective

neuropsychological

symptoms

grade

Table

shows

the

preoperative

and

postparathyroidectomy

comparison

of

individual

subjective

neuropsychological

symptoms

Preoperatively

patients

-LRB-

-RRB-

reported

tiring

easily

and

year

postoperatively

the

symptom

had

resolved

in

and

was

still

reported

by

although

all

perceived

the

symptom

as

mild

However

of

the

patients

who

did

not

report

tiring

easily

preoperatively

reported

a

mild

degree

of

tiring

easily

year

postoperatively

These

changes

in

the

number

of

patients

who

reported

tiring

easily

were

not

statistically

significant

Table

of

pre

and

postoperative

scoresNeuropsychological

year

postoperativeP

valueNo

of

No

of

No

of

No

of

No

of

No

of

of

of

Changes

in

the

number

of

patients

reporting

other

neuropsychological

symptoms

such

as

forgetfulness

decreased

concentration

depression

irritability

uneasiness

and

sleeplessness

before

and

after

surgery

were

also

not

statistically

significant

-LRB-

Table

-RRB-

Discussion

In

normal

subjects

the

serum

calcium

concentration

is

always

kept

within

a

narrow

normal

range

and

plays

an

important

role

in

the

physiological

control

of

neuropsychological

functions

In

PHPT

patients

even

in

those

with

the

mild

form

the

abnormally

elevated

serum

calcium

concentration

returns

to

the

normal

level

postparathyroidectomy

It

has

been

assumed

that

some

subjective

improvement

in

neuropsychological

function

must

occur

following

surgery

In

the

present

prospective

study

of

patients

with

incidentally

detected

mild

PHPT

of

all

patients

who

had

successful

parathyroidectomy

reported

improved

general

health

year

after

surgery

This

result

was

statistically

significant

Pasieka

and

Parsons

-LSB-

-RSB-

reported

that

general

health

improved

following

surgery

in

of

PHPT

patients

Talpos

et

al.

-LSB-

-RSB-

studied

patients

with

asymptomatic

hyperparathyroidism

who

were

randomized

into

a

parathyroidectomy

group

or

an

observation

alone

group

they

were

evaluated

every

months

for

years

using

the

health

survey

The

patients

who

had

parathyroidectomy

had

improved

social

and

emotional

function

scores

compared

to

the

observation

alone

group

Edwards

et

al.

-LSB-

-RSB-

who

studied

patients

with

PHPT

found

that

parathyroidectomy

for

hyperparathyroidism

was

associated

with

significant

lasting

improvement

in

subjective

symptoms

they

stated

that

the

potential

for

long-term

improvement

of

these

QOL

symptoms

was

a

valid

indication

for

parathyroidectomy

However

contrary

to

reports

of

long-term

postoperative

improvement

in

subjective

symptoms

Okamoto

et

al.

using

the

in

patients

with

mild

PHPT

found

no

improvement

in

symptoms

except

for

severe

depression

months

after

surgery

though

they

found

improvement

in

the

total

GHQ

score

somatic

symptoms

anxiety

and

severe

depression

months

following

parathyroid

surgery

-LSB-

-RSB-

Okamoto

et

al.

hypothesized

that

the

transient

short-term

improvement

in

symptoms

after

surgery

may

have

been

a

consequence

of

patients

expectations

of

treatment

The

results

of

the

present

study

showed

that

approximately

half

of

the

patients

reported

improvement

in

general

health

perceptions

and

there

was

no

statistically

significant

improvement

in

any

of

the

individual

neuropsychological

symptoms

The

subjective

satisfaction

with

surgery

reported

by

of

our

patients

may

also

reflect

their

expectations

of

treatment

Bollerslev

et

al.

in

a

randomized

study

using

the

involving

patients

with

asymptomatic

PHPT

who

were

assigned

to

surgery

or

medical

observation

found

that

no

benefit

of

operative

treatment

compared

with

medical

observation

was

found

-LSB-

-RSB-

In

the

present

study

the

numbers

of

patients

required

for

comparison

of

differences

before

and

after

surgery

using

a

significance

level

of

and

a

power

of

were

calculated

as

follows

tiring

easily

n

forgetful

n

decreased

concentration

n

depression

n

irritability

n

uneasiness

n

and

sleeplessness

n

Therefore

between

and

patients

would

be

required

to

have

adequate

statistical

power

to

determine

whether

surgery

improves

psychoneurological

symptoms

The

sample

size

of

the

present

study

was

patients

which

was

too

low

to

determine

whether

surgery

improves

psychoneurological

symptoms

However

the

present

findings

were

similar

to

those

of

Bollerslev

et

al.

There

is

a

recognized

need

to

determine

the

surgical

indications

for

PHPT

In

the

guidelines

of

the

US

National

Institutes

of

Health

-LRB-

NIH

-RRB-

were

published

The

results

from

a

questionnaire

given

to

the

members

of

the

Society

of

Surgical

Endocrinology

of

America

showed

that

several

practices

were

not

precisely

in

accordance

with

the

NIH

guidelines

-LSB-

-RSB-

Sywak

et

al.

conducted

a

comparative

study

involving

one

group

that

met

the

criteria

of

the

NIH

guidelines

and

one

group

that

did

not

They

reported

that

nonspecific

symptoms

such

as

fatigue

depression

irritability

mood

swings

and

forgetfulness

improved

in

both

groups

-LSB-

-RSB-

The

guidelines

were

revised

in

and

a

workshop

panel

promulgated

six

criteria

for

PHPT

surgery

-LSB-

-RSB-

Since

there

is

uncertainty

concerning

the

specificity

of

subjective

symptoms

the

NIH

conference

excluded

them

from

the

criteria

for

parathyroidectomy

Although

the

present

study

did

not

find

that

subjective

neuropsychological

symptoms

were

improved

in

patients

with

asymptomatic

PHPT

following

parathyroidectomy

patients

responses

to

questionnaires

may

not

reflect

their

actual

status

as

accurately

as

laboratory

test

results

such

as

the

serum

calcium

level

the

urinary

calcium

excretion

rate

the

creatinine

clearance

rate

and

bone

mineral

density

Nevertheless

obtaining

information

on

changes

in

subjective

symptoms

is

clinically

important

The

difficulty

in

quantitatively

evaluating

nonspecific

symptoms

has

been

previously

identified

and

some

studies

have

used

the

Visual

Analogue

Scale

-LSB-

-RSB-

or

the

-LSB-

-RSB-

We

devised

an

original

questionnaire

based

on

a

textbook

-LSB-

-RSB-

This

questionnaire

has

not

been

validated

as

a

research

tool

and

was

not

tested

on

the

normal

population

However

the

five

questions

related

to

tiring

easily

forgetfulness

depression

irritability

and

general

health

are

identical

to

those

used

by

Pasieka

et

al.

-LSB-

-RSB-

and

the

other

three

questions

dealing

with

decreased

concentration

uneasiness

and

sleeplessness

are

all

easily

understandable

neuropsychological

symptoms

To

ensure

that

all

patients

understood

the

questions

the

meaning

of

each

question

was

thoroughly

explained

to

the

patient

prior

to

surgery

however

year

postoperatively

the

questionnaires

were

simply

sent

by

mail

to

the

patients

with

no

further

explanations

To

allow

nonspecific

symptoms

to

be

more

readily

evaluated

simple

quantitative

methods

are

required

Bollerslev

et

al.

-LSB-

-RSB-

reported

that

asymptomatic

patients

with

mild

PHPT

have

more

psychological

symptoms

than

normal

controls

and

decreased

QOL

In

the

present

study

of

the

patients

who

underwent

parathyroid

surgery

for

asymptomatic

PHPT

had

one

or

more

neuropsychological

symptoms

preoperatively

though

it

was

not

confirmed

that

these

symptoms

were

due

to

the

PHPT

itself

The

results

of

the

survey

done

year

after

successful

parathyroidectomy

did

not

show

any

definite

improvement

in

any

of

the

individual

neuropsychological

symptoms

The

main

reason

for

this

might

be

the

mild

nature

of

the

patients

PHPT

Two

reasons

may

explain

why

six

patients

gave

incomplete

answers

and

three

patients

did

not

respond

to

the

second

questionnaire

the

questionnaires

were

mailed

to

patients

who

had

stopped

visiting

the

out-patient

clinic

and

patients

may

have

found

the

questionnaire

bothersome

If

the

patients

had

been

truly

symptomatic

they

would

have

visited

our

hospital

O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O 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O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O B I O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O B O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O B I O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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