Clinical effect of continuous corrective force delivery in the non-operative treatment of idiopathic scoliosis : a prospective cohort study of the triac-brace A prospective cohort study of skeletally immature idiopathic scoliotic patients treated with the TriaC brace . To determine if the TriaC brace is effective in preventing curve progression in immature adolescent idiopathic scoliotic patients with a very high risk of curve progression based on reported natural history data . The aim of the newly introduced TriaC brace is to reverse the pathologic transverse force pattern by externally applied and continuously present orthotic forces . In the frontal plane the force system used in the TriaC brace is similar to the force system of the conventional braces . However , in the sagittal plane the force system acts only on the thoracic region . In addition , the brace allows upper trunk flexibility without affecting the corrective forces during body motion . In a preliminary study it is demonstrated that the brace prevents further progression of both the Cobb angle and axial rotation in idiopathic scoliosis . Skeletally immature patients with idiopathic scoliosis with curves between 20 and 40 ° were studied prospectively . Skeletally immature was defined as a Risser sign 0 or 1 for both boys and girls , or pre-menarche or less than 1-year post-menarche for girls . Curves of less than 30 ° had to have documented progression before entry . The mean age of the patients at the start of treatment was 11.3 ± 3.1 years . All measurements were collected by a single observer , and all patients were followed up to skeletal maturity . Treatment was complete for all participants when they had reached Risser sign 4 and did not show any further growth at length measurements . This was at a mean age of 15.6 ± 1.1 years , with a mean follow-up of 1.6 years post bracing . In our study a successful outcome was obtained in 76 % of patients treated with the TriaC brace . Comparing our data to literature data on natural history of a similar cohort shows that the TriaC brace significantly alters the predicted natural history . The current study demonstrates that treatment with the TriaC brace reduces the scoliosis , and that the achieved correction is maintained in some degree after skeletal maturity is reached and bracing is discontinued . It also prevents further progression of the Cobb angle in idiopathic scoliosis . The new brace does not differ from the conventional braces as far as maintaining the deformity is concerned . Introduction The purpose of this paper is to present the results of a prospective study of a new orthotic device for the non-operative treatment of idiopathic scoliosis . Data are provided in a format to facilitate comparison with natural history data . The main concern in patients with idiopathic scoliosis relates to curve progression and the resulting cosmetic deformity . The risk of curve progression is correlated primarily to periods of rapid skeletal growth -LSB- 3 , 5 , 6 , 11 , 14 , 41 , 42 -RSB- . Factors related to growth potential , such as patient age at the time of diagnosis , status of menarche , and Risser sign , have been shown to be important predictors of the progression of scoliosis -LSB- 3 , 15 , 29 , 39 -RSB- . In addition to future skeletal growth , curve magnitude and curve shape are further predictors of progression of idiopathic scoliosis . Large initial curves , thoracic curves , and double major curves are more likely to progress -LSB- 3 , 29 , 39 -RSB- . Currently bracing is the accepted nonoperative treatment to prevent curve progression in mild to moderate scoliosis during the growth period . A prospective multicenter study , performed by the Scoliosis Research Society , reported that brace treatment has a significant effect on curve progression of idiopathic scoliosis -LSB- 36 -RSB- . However , others doubt the effectiveness of braces -LSB- 12 , 16 , 19 , 32 -RSB- . Just as for the natural history of untreated curves , Lonstein and Winter -LSB- 30 -RSB- found a relationship between the final outcome of brace treatment and curve factors and factors that predict future skeletal growth . In biomechanical theories describing the patho-physiological mechanism of scoliosis , spinal growth is thought to be the main driving force responsible for curve progression -LSB- 35 , 42 , 44 , 47 , 48 -RSB- . Throughout history , external devices have been used to correct deformities and immobilize the spine . Brace designs have changed periodically over the years , but most modifications have solely focused on improved efficacy and failed to acknowledge the importance , especially to teenagers , of physical appearance . This age group resists acting or looking different from their peers , which obviously occurs when a visible brace is worn . Modern materials , lower profiles , and reduced wearing times have been tried in attempts to reduce resistance to and the emotional difficulties encountered with wearing braces . The aim in the design of a new orthosis was to create a system which is at least as effective as the TLSO 's , with improved comfort for the wearer . The newly introduced brace should reverse the transverse force pattern by externally applied and constantly present orthotic forces without limiting the normal body motions of the patient and an increased comfort level for the patient . Construction and working principle of the TriaC orthosis The name TriaC is based on the three C 's of Comfort , Control , and Cosmetics . Currently , the orthosis is produced by Somas International , St Anthonis , the Netherlands . For this orthosis , the choice has been made to apply continuous correction forces on the chest with the aim to prevent curve progression during the growth period . A basic requirement for such a brace is that the brace force must be able to follow the main body motions of the patient . To achieve this goal required the use of a flexible coupling , connecting the thoracic and lumbar parts of the orthosis . The thoracic part and lumbar sections each generate their own corrective force on the body of the patient . Both parts are connected to each other by a flexible coupling that is placed on the opposite side of the thoracic force pad -LRB- Fig. 1 -RRB- . This coupling enables the patient to bend forward , backward and sideways while the correction forces are maintained -LRB- Fig. 2 -RRB- . The thoracic force pad is located just below the shoulder blade and applies a corrective force in a lateral -- anterior direction . The lumbar force pad is placed between the pelvis and the lower ribs and acts on the lumbar muscles in a lateral direction . A third counter force on the hip region ensures that the orthosis is in equilibrium . Fig. 1The TriaC orthosis , with a thoracic part , a lumbar part and a flexible couplingFig . 2The flexible coupling Placing a flexible coupling between the thoracic and the lumbar part of the orthosis determines the unique force pattern on the patient both with respect to the location of the forces as with respect to the relation between the forces -LRB- Fig. 2 -RRB- . Modelling and clinical use have shown that the TriaC is suitable for all curve types , with the exception of curves with an apex at the 12th thoracic and the 1st lumbar vertebra . For these curve type the Lumbar force pad must be placed at the location of the flexible coupling which is not possible in the current construction of the orthosis . The construction as described , makes the orthosis force driven . When the patient moves her or his body in any direction -LRB- e.g. flexion , extension , rotation or lateral bending -RRB- , the force pattern exerted by the orthosis moves along with the patient and thus is maintained constant . For this reason we defined the orthosis as `` dynamic '' because the orthosis moves dynamically along with the body motions of the patient . In contrast , conventional orthoses are displacement driven . A rigid shell shaped in the desired corrected position of the patient applies a corrective force only when the thorax of the patient presses against the pads of the brace . When the body of the patient moves away from these pads the rigid brace is not able to follow the body motion of the patient and therefore the brace no longer generates forces on the patient . Therefore , we defined these orthosis as `` static '' . Materials and methods From 1997 to 2005 all consecutive patients who met the inclusion criteria were treated nonoperatively with the TriaC orthosis and studied prospectively . The indication for treatment was a progressive curve with a Cobb angle between 25 and 40 ° . All curves , except curves already at > 30 ° , had to show documented progression of at least 5 ° . Patients had to be skeletally immature , defined as a Risser sign 0 or 1 for both boys and girls ; in addition , girls are pre-menarche or less than 1-year post-menarche . All the curves had to be flexible as demonstrated by at least a 40 % correction on the bending radiograph at the first visit . Patients with the apex of the curve at T12 and L1 were excluded , as were patients with a systemic disease that could possibly influence the outcome of the study -LRB- Table 1 -RRB- . Table 1The in and exclusion criteria for the treatment with the TriaC orthosisInclusion criteria Idiopathic scoliosis with a Cobb-angle between 20 and 40 ° Skeletally immature Risser 0 -- 1 status Pre-menarche Post-menarche < 1 year Primary thoracic apex between the 7th and 11th thoracic vertebra Primary lumbar apex between the 2nd and 5th lumbar vertebraFlexible spinal column as evidenced by at least 40 % correction on bending filmsExclusion criteria Idiopathic scoliosis < 20 ° and > 40 ° Other types of scoliosis Skeletal age > Risser 1 Rigid curves Thoraco-lumbar curves with an apex at the 12th thoracic and the 1st lumbar vertebra Patients with a systemic disease which could influence the study parameters All patients who met the in - and exclusion criteria were treated with the TriaC orthosis . An informed consent form was obtained from all parents of the subjects in regard of the treatment with a new orthosis . According to the medical ethics committee no informed consent was necessary in case of the follow-up schedule because there is no difference with the patients treated with a Boston brace in our clinic . If during the treatment period the orthosis failed to stop progression and the curve increased significantly , the patient was placed into a Boston Brace . This procedure was chosen to get a first indication whether a Boston brace would be able to prevent curve progression in patients where the TriaC failed . Failure was defined as either a Cobb angle of > 45 ° , i.e. the generally accepted indication for surgery , or if the curve progressed 5 ° or more compared with the measurement at study entry -LSB- 16 , 24 -- 31 -RSB- . During the nonoperative treatment patients were checked by an orthotist at the outpatient clinic every 4 months , where the subjective compliance was documented . At every visit a PA and lateral radiographs were made . The patients were allowed to wean of the braces at skeletally maturity , i.e. when the radiographs showed Risser sign 4 or , for girls , 2 years post-menarche and patients did not show any further growth at length measurements . At every visit standing and sitting height of the patient was recorded as an additional measurement , and these had to show no further increase . Because the TriaC is designed as a dynamic orthosis , it possibly preserves the muscle status of the patient . As a result the weaning process could be faster than with rigid Boston type orthoses . In this study , weaning was generally complete within 4 weeks , whereas for rigid braces this process may take up to one year . After terminating the treatment patients were seen once a year with an AP and lateral X-ray . Radiographic analysis All radiographs were obtained in a standing position . The posterior -- anterior projection was used to minimize the radiation dose to the breast . All radiographs were made , using a standardized protocol . Anatomical vertebral landmarks are identified and manually marked on a 21 in . high resolution monitor using a pointer -LSB- 46 -RSB- . Following the placement of the markers the Cobb angle is calculated , using automatic detection of the apex and end vertebrae -LSB- 8 -RSB- . In this article , only the Cobb-angle data are used for comparison with literature data on the natural history . Results Out of a total of 212 patients that were treated at the University Hospital of Groningen during the study period , 63 , or 30 % , met all the in - and exclusion criteria and form the study group . There were seven patients -LRB- 11 % -RRB- with a single curve and 56 -LRB- 89 % -RRB- with a double curve . The group included six boys and 57 girls . The mean age of the patients at the start of treatment was 11.3 ± 3.1 years . The treatment was complete when the patients had reached Risser 4 with a mean age of 15.6 ± 1.1 years . The mean Cobb angle of the primary curves before the brace treatment was started was 30.2 ° ± 7.5 ° . The secondary curves had a mean Cobb angle of 22.3 ° ± 6.4 ° . The distribution of the location of the apex vertebra of the primary curves is shown in Fig. 3 . Fig. 3The distribution of the apex level of the primary curves in the study group The patient group was divided into a success group and a failure group whereby failure was defined as a Cobb angle of > 45 ° or curve progression of more than 5 ° compared to baseline -LSB- 2 , 7 , 9 , 18 , 21 , 33 , 34 , 36 , 40 -RSB- . The X-rays showed a mean initial correction of 22 ± 26 % for the primary curves , and a mean correction of and 28 ± 35 % for the secondary curves . The large variation was primarily caused by the big difference between the initial corrections seen in patients that were considered a success in comparison to patients that were considered a failure . In the success group the initial correction of the primary curve was 34 ± 17 % whereas the initial correction in the failure group was − 16 ± 17 % . For the entire study group the success rate is 76 % -LRB- 48 successes -RRB- for a failure rate of 24 % -LRB- 15 failures -RRB- . In the single curve group the mean Cobb angle at start of the treatment was 35 ° ± 11 . The mean initial correction achieved in this group was 23 ± 9 % . There were no failures in this group . Although this difference is remarkable compared to the double curved group the single curve group is too small to draw conclusions . In Table 2 an overview of the success rate is shown , divided per initial Risser sub group -LRB- Risser 0 and Risser 1 -RRB- and divided by the initial Cobb angle at start of the treatment . Table 2Number of successes/total patients in subgroupsCobb angleSuccess rateRisser 0Risser 120 -- 29 ° 76 % -LRB- 16 of 21 patients -RRB- 30 -- 39 ° 74 % -LRB- 26 of 35 patients -RRB- 86 % -LRB- 6 of 7 patients -RRB- Total75 % -LRB- 42 of 65 patients -RRB- 86 % -LRB- 6 of 7 patients -RRB- The actual number of failures in our patient population was 15 out of 63 patients , or 24 % . All patients in whom the brace failed went on to surgery , including the nine patients who were also treated with a Boston style brace after the TriaC brace had failed . A more detailed view of the correction of the primary Cobb angle is presented in Fig. 4 . In this figure the mean correction percentage of the Cobb angle is shown as a function of the percentage of the total treatment brace period . The treatment period is considered to be at 0 % at the start of the treatment and at 100 % at the time the brace is discontinued . Fig. 4Percent correction of the Cobb angle over the entire TriaC treatment period in the success group It is shown that it was not possible to completely maintain the initial correction for the whole treatment period . At the end of treatment , the mean correction of the Cobb angle in the success patients had decreased to 19 ± 13 % . This decrease in correction does not appear to follow a linear pattern . When a relation between the time that the patient wears the brace , and the loss of correction in the brace is assumed the correlation is only -LRB- very -RRB- weak -LRB- ρ = − 0.33 -RRB- . The mean correction at the first visit after discontinuation of the brace the treatment was 20 ± 15 % . All patients in whom the brace treatment was a success were followed with a mean follow-up of 1.6 years and longest follow-up of 6 years post-bracing . Figure 5 shows the mean correction at different follow-up periods postbracing . Fig. 5The mean correction during follow-up after termination of successful brace treatment Because the orthosis does not affect the lateral curvature no significant changes were expected . The analysis of the sagittal curve is displayed in Fig. 6 . Fig. 6Lateral curve during treatment Discussion Braces are the oldest recorded method of treatment for spinal injury and deformity . The primary goal in treating patients with scoliosis deformities is to stabilize the curves to prevent further progression of the deformity . Closely related to this is the goal of achieving correction of the spinal deformity , although this is not part of the therapeutic regimen for every patient . Brace treatments do not generally correct the scoliosis , but prevent further progression , i.e. bracing has a `` holding effect '' -LSB- 49 -RSB- . In most published studies , the brace treatment has been considered a failure if the patient needed operative stabilisation or if the curve progressed 5 ° or more after the initiation of treatment -LSB- 2 , 7 , 9 , 18 , 21 , 30 , 33 , 34 , 40 -RSB- . However , these should not be the only criteria to determine whether brace treatment is successful . The treatment should also improve the patient 's outcome when compared with the expected natural history . The aim of this study was to investigate whether the TriaC-brace affects the natural history of idiopathic scoliosis . Bunnell -LSB- 3 -RSB- , studied the natural history of idiopathic scoliosis in a group of patients with similar characteristics to our study group with respect to curve magnitude and age at the first visit . He showed that for the group as a whole 68 % show a curve progression of 5 ° or more and only 34 % of the patients showed a curve progression of 10 ° or more . The latter progression rate is in the same range as the failure rate reported in most of the retrospective studies , regarding overall brace effectiveness . However , the progression rates are not equal for every sub group of scoliotic patients . Lonstein and Carlson -LSB- 29 -RSB- reported that patients with Risser 0 or 1 maturity and curves larger than 20 ° are three times more likely to experience curve progression than those with curves smaller than 20 ° . For those with curves exceeding 20 ° , patients with Risser 0 or 1 maturity also are three times more likely to experience curve progression than are patients with Risser 2 -- 5 maturity . They classified Risser 0 -- 1 patients with curves between 20 and 29 ° as high risk -LRB- 40 -- 70 % -RRB- and Risser 0 -- 1 patients with curves between 29 and 39 as very high risk -LRB- 70 -- 90 % -RRB- . Bunnell -LSB- 3 -RSB- also found Risser sign and curve size to be good prognostic factors for curve progression in untreated idiopathic scoliosis . In his series patients with a Risser 0 at the time of diagnosis had a 68 % risk of progression 10 ° or more . This risk was decreased to 52 % in those who had a Risser sign of 1 or 2 and was further decreased to 18 % for those with Risser 3 or 4 . Nachemson et al. -LSB- 36 -RSB- reported that 66 % of skeletally immature female patients with untreated idiopathic curves between 25 ° and 35 ° will experience curve progression greater than 5 . All patients in our study started at Risser 0 -- 1 maturity and had a curve above 30 ° or , if they had an initial curve below 30 ° had to show documented progression of ≥ 5 ° before enrolment in this study . Wever et al. -LSB- 47 -RSB- showed that there is a strong correlation between the curve progression and spinal growth of the patients . Usually the spinal growth is highest around the beginning of the menarche and therefore we only included female patients when they were before or less than 1 year after menarche . By using these inclusion criteria we aimed to include only patients at the highest risk for curve progression . In order to evaluate whether the TriaC brace alters the natural history of the high-risk patients , we estimated the natural progression rate of our patient group based on the literature as discussed . Our estimates are based on the calculation of a progression factor for all patients in the cohort as suggested by Lonstein and Carlson -LSB- 29 -RSB- . According to their algorithm , all our patients individually would have a change of 70 -- 100 % of progression of their curves . Based on these data we chose the low end of this range and assumed that in our patient group 70 % of the curves would progress without treatment . The actual number of failures in our patient population was 15 out of 63 patients , or 24 % , which is a significantly different from the expected number of 44 -LRB- P < 0.001 -RRB- . The validity of the sample size was evaluated by calculating the 95 % confidence interval for the failure rate , which was between 11 and 36 % -LRB- 7 -- 23 patients -RRB- . Thus , the difference in outcomes remains statistically significant . These data show that the TriaC brace significantly altered the predicted natural history of curve progression . The comparison of the results of this study and other brace studies reported in the literature is difficult because of differences in sample size , skeletal maturity and curve magnitudes at the initiation of bracing . Furthermore , some reports excluded those patients who were not compliant with their bracing regimen . These large variations render the value of a statistical comparison of the results doubtful -LSB- 51 -RSB- . By applying the inclusion criteria used in this study to the literature data , a more uniform group has been created , making the statistical comparison more reliable . Nachemson et al. -LSB- 36 -RSB- prospectively compared 111 adolescent idiopathic scoliotic female patients with curves between 25 ° and 35 ° , who were treated with an underarm plastic brace , to 129 patients who were not treated . All patients were followed for 4 years . The patient 's thoracic or thoracolumbar curves were during this period evaluated for curve progression of more than 5 ° . Of the brace treated patients , 23 patients where lost to follow-up . Using survivorship analysis , a successful outcome was estimated in 74 % of patients treated with a brace , compared to 34 % of those who had no treatment ; this difference was significant -LRB- P < 0.0001 -RRB- . In a retrospective study Lonstein and Winter -LSB- 30 -RSB- evaluated the result of brace treatment in a group of 1,020 patients over 35 years . From these patients a sub group of 177 had a curve between 20 and 29 ° and a Risser sign of 0 -- 1 . Using the natural history data of a similar group of non treated patients from their previous report -LSB- 29 -RSB- they where able to show in this sub-group a significant difference -LRB- P = 0.0001 , chi-square test -RRB- of the failure rate between the group of treated patients and not treated patients . The not treated patients had a predicted failure rate of 68 % and the failure rate of the braced patients in the sub group was 40 % . We used the same report to predict the failure rate in our cohort . Although our results are promising , it is known that 5 % of patients with a curve of less than 30 ° still progress to surgery during mature life -LSB- 34 -RSB- . We will follow our patients in whom the TriaC treatment effectively stopped curve progression before the surgical cut-off of 45 ° during mature life . Besides affecting the lateral curve , most traditional braces reduce lordosis and kyphosis by tilting the pelvis . The purpose of pelvic tilt is to move the lumbar spine closer to the correction pads within the brace . According to Lindh et al. -LSB- 28 -RSB- reducing the lumbar lordosis may automatically lead to a reduction of the scoliosis as a result of a coupling mechanism between sagittal and lateral motions of the vertebra -LSB- 38 -RSB- . However , reduction of lumbar lordosis will also reduce thoracic kyphosis . The reduction of thoracic kyphosis is an unwanted effect , as reduced thoracic kyphosis already is an integral component of the scoliotic deformity -LSB- 50 -RSB- . Schaal et al. therefore , emphasise the need for a system that diminishes the effect of pelvic tilt on the thoracic kyphosis -LSB- 43 -RSB- . In the Triac brace the choice has been made to continuously apply corrective forces with the aim of reversing the deforming forces , without affecting the lordosis of the spine -LSB- 37 -RSB- . Growth is a continuous process and therefore , the correction forces should be applied continuously as well , even during the normal body motions of the patient . In order to meet this requirement a flexible coupling , connecting the thoracic and lumbar parts of the brace is incorporated in the device . Most importantly , the forces exerted by the brace must be applied in such a way that they are maintained during all body motions of the patient . The new brace incorporates three separate functional elements : frame , springs and pelottes . The springs generate the orthotic forces , which are distributed by the frame and transmitted to the skin by the pelottes . The flexible coupling connects the thoracic and lumbar frame parts resulting in the application of constant forces that can not be modified by the patients themselves -LRB- Fig. 7 -RRB- . The strength of the externally applied forces was chosen on the basis of literature data -LSB- 10 , 20 , 27 -RSB- Fig. 8 . Fig. 7TriaC-braceFig . 8Pre-brace Cobb-angle : 30 ° and 19 ° apical axial rotation . In the brace Cobb-angle : 17 ° and 9 ° apical axial rotation , sagittal curvature unchanged The TriaC-brace provides a good primary correction of idiopathic scoliosis . There was a mean initial correction within the brace of 22 ± 26 % for the primary curves and 28 ± 35 % for the secondary curves , which is slightly less than reported in the literature -LSB- 2 , 30 , 33 , 34 -RSB- . In the beginning of the study , we were not certain how patients would respond to the application of constant forces . Therefore , we started very carefully using relatively low forces . As we found that patients tolerated these forces well we subsequently increased the amount of force which resulted in improved initial corrections . According to the literature , achieved corrections gradually are lost following the termination of the brace treatment -LSB- 7 , 23 , 30 , 34 , 49 -RSB- . However , being efficacious is not all that is required of a brace ; it should also be as comfortable as possible and cosmetically acceptable so that teenagers who require this treatment will actually use it . Non-acceptance of a brace by patients is a real and serious problem . Houghton et al. -LSB- 24 -RSB- placed a hidden transducer in their braces and found that actual compliance was considerably less than was reported by the patient ; and only 20 % of patients wore the brace as prescribed . Modern materials , lower profiles and reduced wearing times have all been tried to improve compliance and reduce the emotional difficulties experienced with brace wear . According to some authors , there is little difference in effect between part-time -LRB- 12 -- 16 h -RRB- and full-time -LRB- 23 h -RRB- wearing of a brace -LSB- 13 , 21 -RSB- . Kahanowitz -LSB- 25 -RSB- reported such findings but only if the pre-brace Cobb-angle were less than 35 ° ; if larger than this more than 50 % of curves would progress to such an extent that surgery became necessary . The current study demonstrates that the TriaC brace reduces the scoliosis , and the achieved correction is maintained during brace treatment . It prevents further progression of the Cobb angle in idiopathic scoliosis . The new brace does not differ from the conventional braces as far as maintaining the deformity in the coronal plane is concerned . This is expected as the force system of the TriaC brace in the frontal plane is in accordance with the force system in the conventional braces . The new brace offers more comfort to the patient and a better cosmetic appearance . With TriaC brace there are no restrictions regarding daily or sporting activities , and it can be worn with all types of clothing . Summary Compared with published studies on the natural history of idiopathic scoliosis , use of the Triac brace appeared to significantly improve the course of curves between 20 and 40 ° in skeletally immature individuals . Control or net correction of idiopathic scoliotic curves was achieved in 76 % of patients . The new dynamic brace offers more comfort to the patient and a better cosmetic appearance .

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


Does

the

English

NHS

have

a

Health

Benefit

Basket

A

health

benefit

basket

is

a

range

of

publicly

entitled

health-related

goods

and

services

Primary

legislation

ensures

the

provision

of

broad

categories

of

healthcare

but

this

provision

is

subject

to

political

discretion

Case

law

has

established

that

healthcare

organisations

may

not

operate

a

blanket

ban

for

particular

services

This

means

that

the

English

health

basket

currently

has

very

few

specific

services

explicitly

included

or

excluded

Regulation

may

however

be

important

in

determining

citizens

rights

With

reference

to

services

of

curative

care

this

paper

explores

whether

the

NHS

is

moving

towards

a

more

explicit

definition

of

a

health

basket

The

English

National

Health

Service

-LRB-

NHS

-RRB-

was

established

in

to

provide

healthcare

for

all

free

at

the

point

of

use

and

irrespective

of

ability

to

pay

Legislation

outlines

the

broad

categories

of

healthcare

service

that

should

or

could

be

provided

within

the

NHS

However

the

legal

duties

and

powers

of

provision

are

not

absolute

but

tempered

by

powers

of

discretion

as

to

what

is

a

reasonable

requirement

and

by

the

right

to

take

into

account

NHS

financial

capacity

Strictly

speaking

this

means

that

patients

have

no

entitlement

to

specific

services

this

partly

explains

the

existence

of

variation

in

local

provision

known

as

the

postcode

lottery

-LSB-

-RSB-

Furthermore

the

courts

have

established

that

NHS

organisations

may

not

operate

a

blanket

ban

on

the

provision

of

particular

services

-LSB-

-RSB-

Consequently

there

are

few

services

that

are

explicitly

unavailable

to

all

NHS

patients

Within

a

health

service

with

no

specific

entitlements

but

few

explicit

exclusions

internal

quality

control

mechanisms

are

important

to

ensure

that

citizens

rights

to

health

care

established

under

international

law

are

honoured

-LSB-

-RSB-

National

standards

embodied

in

guidance

from

National

Service

Frameworks

-LRB-

NSFs

-RRB-

the

National

Institute

for

Health

and

Clinical

Excellence

-LRB-

NICE

-RRB-

and

waiting

time

guarantees

are

regulated

by

the

Healthcare

Commission

which

monitors

NHS

organisations

compliance

The

regulatory

framework

contributes

to

what

may

be

considered

as

reasonable

requirements

for

health

care

provision

and

helps

to

specify

entitlement

Fixed

charges

or

payments

whilst

in

no

way

guaranteeing

provision

implicitly

brand

services

with

an

NHS

label

and

may

therefore

also

serve

to

signal

the

service

is

or

should

be

in

the

health

basket

Incentive

payments

for

clinicians

may

be

seen

in

a

similar

light

This

paper

describes

the

statutory

and

regulatory

frameworks

and

discusses

how

these

may

impact

upon

patient

entitlement

to

NHS

services

of

curative

care

of

the

International

Classification

for

Health

Accounts

-LRB-

ICHA

-RRB-

taxonomy

-LSB-

-RSB-

An

overview

of

the

legal

and

regulatory

framework

defining

benefits

for

England

is

given

in

Table

Table

Documents

defining

the

English

Health

Basket

type

of

document

actors

and

contentsCriteria

used

for

defining

benefitsType

of

documentLegally

bindingPositive/negative

definition

of

benefitsDegree

of

explicitnessaUpdatingNCECEBOtherActs

of

amended

by

further

legislation

Political

judgement

necessary

to

meet

all

reasonable

requirements

Statutory

instruments

-LRB-

SI

-RRB-

YesP

or

amended

by

further

legislation

National

Service

or

NICE

technology

appraisalsYesbP

or

years

NICE

clinical

or

to

years

NICE

interventional

proceduresNoP

or

small

amendments

more

frequent

Waiting

time

HRG

or

evolving

Devices

Safety

quality

appropriatenessFee

-LRB-

at

least

-RRB-

N

need

C

costs

E

effectiveness

CE

cost-effectiveness

B

budget

-LRB-

from

-LSB-

-RSB-

DH

website

-LRB-

-RRB-

HMSO

website

-LRB-

-RRB-

expert

advice

-LRB-

see

Acknowledgements

-RRB-

-RRB-

a

Explicit

is

subdivided

as

all

necessary

areas

of

care

items.b

The

statutory

duty

is

upon

PCTs

to

ensure

funding

is

available

to

facilitate

implementation

not

upon

doctors

to

adopt

the

approved

technology.c

The

dominant

instrument

for

securing

these

are

performance

ratings

prepared

by

the

Healthcare

Commission

England

's

Health

Benefit

Basket

the

case

of

services

of

curative

care

Services

of

curative

care

are

defined

as

those

where

the

principal

medical

intent

of

care

is

to

relieve

symptoms

or

reduce

severity

or

protect

against

exacerbation

or

complication

of

illness

or

injury

In

addition

to

in-patient

and

day

care

includes

out-patient

care

defined

as

basic

medical

and

diagnostic

services

out-patient

dental

care

and

other

specialist

health

care

provided

to

outpatients

by

physicians

or

paramedics

including

services

provided

at

home

-LSB-

-RSB-

The

legal

framework

Primary

legislation

addresses

the

establishment

and

promotion

of

a

comprehensive

health

service

requiring

the

Secretary

of

State

for

Health

to

provide

or

secure

the

effective

provision

of

services

However

discretion

is

at

the

heart

of

these

duties

and

politicians

are

entitled

to

take

into

account

the

resources

available

to

them

Under

the

National

Health

Service

Act

-LRB-

chap

-RRB-

the

Secretary

of

State

has

a

duty

to

provide

to

such

extent

as

he

considers

necessary

to

meet

all

reasonable

requirements

-LRB-

a

-RRB-

hospital

accommodation

-LSB-

s.

-LRB-

-LRB-

a

-RRB-

-RRB-

-RSB-

including

high

security

psychiatric

services

-LRB-

s.

-RRB-

-LRB-

b

-RRB-

other

accommodation

necessary

for

the

purpose

of

any

other

services

required

by

the

Act

-LSB-

s.

-LRB-

-LRB-

b

-RRB-

-RRB-

-RSB-

-LRB-

c

-RRB-

medical

dental

and

nursing

services

-LSB-

s.

-LRB-

-LRB-

c

-RRB-

-RRB-

-RSB-

-LRB-

N.B.

medical

includes

surgical

-RRB-

and

-LRB-

d

-RRB-

such

other

services

as

are

required

for

the

treatment

of

illness

-LSB-

s.

-LRB-

-LRB-

f

-RRB-

-RRB-

-RSB-

-LRB-

N.B.

illness

includes

a

mental

disorder

and

any

injury

or

disability

requiring

medical

or

dental

treatment

or

nursing

-RRB-

The

Secretary

of

State

for

Health

also

has

powers

to

provide

as

he

considers

appropriate

facilities

for

the

care

of

persons

suffering

from

illness

-LSB-

s.

-LRB-

-LRB-

e

-RRB-

-RRB-

-RSB-

The

responsibility

for

providing

these

services

has

passed

to

local

health

authorities

which

in

the

current

organisational

structure

are

known

as

Primary

Care

Trusts

-LRB-

PCTs

-RRB-

The

NHS

Act

also

places

a

duty

on

PCTs

to

provide

general

medical

services

-LRB-

s.

-RRB-

general

dental

services

-LRB-

s.

-RRB-

pharmaceutical

services

-LRB-

s.

-RRB-

and

general

ophthalmic

services

-LRB-

s.

-RRB-

In

the

law

courts

R

v

NW

Lancashire

Health

authority

ex

p

A

D

and

G

examined

the

case

of

three

applicants

suffering

from

gender

identity

dysphoria

-LSB-

-RSB-

The

Health

Authority

had

identified

this

illness

as

amongst

the

bottom

in

terms

of

need

-LRB-

together

with

cosmetic

surgery

reversal

of

sterilisation

correction

of

myopia

and

most

alternative

medicines

-RRB-

and

therefore

transsexual

surgery

would

be

provided

only

in

cases

of

overriding

clinical

need

The

court

acknowledged

the

need

for

priority

setting

in

which

issues

of

effectiveness

the

seriousness

of

the

condition

and

cost

were

taken

into

account

However

the

court

found

that

the

Health

Authority

had

in

practice

adopted

a

blanket

ban

and

recommended

the

authorities

introduced

a

fair

and

consistent

policy

for

decision

making

that

adequately

assessed

exceptional

cases

by

considering

each

request

for

treatment

on

its

individual

merits

The

case

therefore

made

it

illegal

for

health

authorities

to

refuse

to

provide

specific

services

with

the

possible

exception

of

a

treatment

where

the

clinical

evidence

of

its

inefficacy

is

overwhelming

-LSB-

-RSB-

The

case

implies

that

costs

and

benefits

should

be

evaluated

on

an

individual

patient

basis

rather

basing

entitlement

on

the

typical

or

average

case

Primary

legislation

and

case

law

have

therefore

not

prescribed

which

services

are

to

be

included

in

or

excluded

from

the

English

health

basket

However

secondary

legislation

on

professional

contracts

goes

some

way

towards

defining

entitlement

to

specific

services

For

example

the

National

Health

Service

-LRB-

General

Medical

Services

Contracts

-RRB-

Regulations

provide

details

of

the

terms

of

service

for

general

practitioners

-LRB-

GPs

-RRB-

and

state

that

essential

services

must

be

provided

covering

emergency

treatment

and

treatment

for

patients

with

chronic

terminal

and

self-limiting

disease

-LSB-

National

Health

Service

General

Medical

Services

Contracts

regulation

SI

reg

-LRB-

-RRB-

see

Table

-RSB-

Table

Eligibility

for

primary

care

essential

services

under

the

General

Medical

Services

Contract

-LRB-

from

-LSB-

-RSB-

-RRB-

Type

of

essential

serviceEligibility

for

treatmentImmediate

and

necessary

emergency

treatment

Any

person

to

whom

the

contractor

has

been

requested

to

provide

treatment

at

any

place

in

its

practice

area

-LSB-

reg

-LRB-

-RRB-

-RSB-

Management

of

terminal

illnessRegistered

patients

and

temporary

residentsTreatment

of

conditions

from

which

recovery

is

generally

expectedRegistered

patients

and

temporary

residentsTreatment

of

chronic

diseaseRegistered

patients

and

temporary

residentsAdvice

in

connection

with

the

patient

's

health

including

relevant

health

promotion

adviceRegistered

patients

and

temporary

residentsReferral

of

the

patient

for

other

services

under

the

ActRegistered

patients

and

temporary

residentsHome

visitsWhere

contractor

considers

it

inappropriate

because

of

a

patient

's

medical

condition

for

the

patient

to

attend

the

practice

premisesAnnual

health

checksPatients

aged

over

yearsPatients

not

seen

within

years

newly

registered

patients

For

dental

practitioners

the

National

NHS

-LRB-

General

Dental

Services

-RRB-

Regulations

make

provision

for

the

Secretary

of

State

for

Health

to

determine

dentists

remuneration

including

a

scale

of

fees

for

providing

particular

services

-LSB-

reg

-LRB-

-RRB-

-RSB-

Updated

at

least

annually

the

Statement

of

Dental

Remuneration

describes

over

services

covered

by

the

fees

including

clinical

examinations

and

treatment

planning

diagnostic

procedures

such

as

radiographic

examinations

preventative

periodontal

conservation

and

surgical

treatments

and

the

supply

of

prostheses

patients

pay

of

the

charge

up

to

a

stated

maximum

although

some

exemptions

apply

-LRB-

Department

of

Health

Statement

of

Dental

Remuneration

amendment

no.

-RRB-

The

Doctors

and

Dentists

Review

Body

reviews

existing

fee

scales

and

makes

recommendations

regarding

uplift

The

Department

of

Health

then

considers

these

recommendations

and

the

Chief

Dental

Officer

for

England

notifies

Strategic

Health

authorities

PCTs

NHS

Trusts

-LRB-

groups

of

NHS

hospitals

each

operating

as

a

single

legal

entity

-RRB-

and

all

general

dental

practitioners

of

the

updated

fee

scales

-LRB-

ibid

-RRB-

Similarly

the

NHS

-LRB-

General

Ophthalmic

Services

-RRB-

Regulations

make

provision

for

opticians

and

ophthalmic

medical

practitioners

to

charge

for

sight

tests

and

for

optical

appliances

-LRB-

National

Health

Service

General

Ophthalmic

Services

regulation

SI

-RRB-

Charges

are

determined

by

the

Secretary

of

State

in

consultation

with

professional

bodies

updated

at

least

annually

and

amended

by

secondary

legislation

For

certain

patients

vouchers

are

available

that

reduce

or

remove

the

charge

incurred

by

patients

Eligibility

for

general

ophthalmic

services

outlined

in

section

of

the

Health

and

Medicines

Act

is

determined

by

age

disease

-LRB-

or

risk

of

disease

-RRB-

or

income

Voucher

values

are

updated

at

least

annually

by

secondary

legislation

Quasi-law

In

addition

to

legislation

NHS

provision

is

shaped

by

a

considerable

amount

of

quasi-law

Quasi-law

is

defined

as

rules

which

are

not

usually

legally

binding

although

they

may

have

some

legal

force

but

which

will

in

practice

determine

the

way

in

which

people

act

-LSB-

-RSB-

Amongst

the

regulation

helping

to

define

patient

entitlement

to

services

are

NSFs

NICE

guidance

waiting

time

guarantees

fee

schedules

and

incentive

schemes

The

Healthcare

Commission

is

the

key

regulator

assessing

the

performance

of

NHS

organisations

against

national

standards

in

its

annual

health

check

a

monitoring

process

that

assesses

both

existing

performance

-LRB-

core

standards

-RRB-

and

capacity

to

improve

-LRB-

developmental

standards

-RRB-

-LSB-

-RSB-

The

programme

of

NSFs

launched

by

the

Department

of

Health

in

April

usually

produces

one

new

framework

a

year

NSFs

set

national

standards

identify

key

interventions

for

a

defined

service

or

care

group

that

should

be

available

establish

strategies

to

support

implementation

and

outline

ways

to

ensure

progress

within

an

agreed

time

scale

-LSB-

-RSB-

Frameworks

cover

some

services

of

curative

care

-LRB-

Table

-RRB-

Each

NSF

is

developed

with

the

assistance

of

an

external

reference

group

-LRB-

ERG

-RRB-

which

seeks

to

engage

a

range

of

views

from

health

professionals

service

users

and

carers

health

service

managers

partner

agencies

and

other

advocates

However

the

economic

input

into

NSFs

is

sometimes

weak

The

Department

of

Health

supports

the

ERGs

and

manages

the

overall

process

It

is

unclear

how

NSFs

are

to

be

updated

to

reflect

changes

in

the

evidence

base

that

underpins

them.Table

Services

of

curative

care

covered

by

selected

National

Service

Frameworks

ICHA

category

HC

services

of

curative

careCategoryServicesChildrenStandard

Guidance

on

hospital-based

services

for

childrenStandard

Guidance

on

community-based

careCoronary

heart

diseaseStandard

NHS

Trusts

to

provide

appropriate

investigations

and

treatments

for

patients

with

suspected

or

confirmed

coronary

heart

diseaseDiabetesStandard

NHS

to

provide

rapid

and

effective

treatment

for

diabetic

emergenciesMental

healthIn-patient

hospital

beds

for

persons

needing

a

short

period

of

intensive

intervention

and

observationElderlyStandard

Need

for

appropriate

specialist

careStandard

Effective

diagnosis

treatment

and

support

for

those

with

mental

health

problemsRenal

diseaseQuality

requirement

Timely

appropriate

and

effective

investigation

treatment

and

follow-up

for

those

with

chronic

kidney

diseaseStandard

All

likely

to

benefit

from

a

kidney

transplant

to

receive

a

high

quality

service

which

supports

them

in

managing

their

transplant

-LRB-

from

DH

website

accessed

July

-RRB-

There

is

no

statutory

obligation

on

health

care

organisations

to

implement

NSF

standards

However

the

Health

And

Social

Care

-LRB-

Community

Health

And

Standards

-RRB-

Act

-LSB-

Health

and

Social

Care

-LRB-

Community

Health

and

Standards

-RRB-

Act

Chap

-RRB-

gave

the

Secretary

of

State

powers

to

publish

standards

for

health

care

-LSB-

s.

-LRB-

-RRB-

-RSB-

that

NHS

bodies

are

bound

to

take

into

account

-LSB-

s.

-LRB-

-RRB-

-RSB-

NSFs

could

inform

these

standards

Furthermore

the

Healthcare

Commission

reviews

health

care

organisations

implementation

of

NSFs

as

part

of

its

annual

health

check

-LSB-

-RSB-

reinforcing

the

quasi-legislative

nature

of

NSF

guidance

NICE

the

organisation

responsible

for

assessing

whether

new

or

existing

technologies

should

be

available

on

the

NHS

produces

three

types

of

guidance

which

help

define

the

availability

of

NHS

services

of

curative

care

Firstly

technology

appraisals

give

guidance

on

the

use

of

new

and

existing

treatments

within

the

NHS

Of

the

technology

appraisals

published

to

date

-LRB-

July

-RRB-

some

relate

to

in-patient

care

such

as

Appraisal

No.

-LRB-

the

use

of

implantable

cardioverter

defibrillators

for

arrhythmias

-RRB-

to

day

care

such

as

Appraisal

No.

-LRB-

home

compared

with

hospital

haemodialysis

for

patients

with

end-stage

renal

failure

-RRB-

and

to

out-patient

care

such

as

Appraisal

No.

-LRB-

debriding

agents

for

difficult

to

heal

surgical

wounds

-RRB-

Secondly

NICE

clinical

guidelines

offer

guidance

on

the

appropriate

treatment

and

care

of

people

with

specific

diseases

and

conditions

within

the

NHS

Clinical

guidelines

are

based

on

the

best

available

evidence

and

are

intended

to

help

health

care

professionals

in

their

work

but

not

to

replace

their

knowledge

and

skills

Services

of

curative

treatment

are

included

amongst

the

currently

published

guidelines

For

example

the

dyspepsia

guideline

-LRB-

Clinical

Guideline

CG

-RRB-

recommends

life-style

advice

and

appropriate

medication

as

secondary

preventative

measures

and

the

guideline

on

head

injury

-LRB-

-RRB-

specifies

treatment

pathways

covering

emergency

out-patient

and

in-patient

care

Thirdly

NICE

produces

guidance

on

whether

interventional

procedures

used

for

diagnosis

or

treatment

are

sufficiently

safe

and

effective

for

routine

use

in

the

NHS

Of

the

currently

published

topics

most

relate

to

hospital-based

care

such

as

radiotherapy

for

age-related

macular

degeneration

-LRB-

Interventional

Procedure

Guidance

IPG

-RRB-

and

auditory

brainstem

implants

-LRB-

-RRB-

The

three

types

of

NICE

guidance

are

developed

and

updated

using

distinct

methodologies

Guidance

on

technology

appraisals

is

formulated

by

the

NICE

Appraisal

Committee

an

independent

advisory

body

with

individuals

from

a

range

of

professional

backgrounds

Preliminary

guidance

is

based

on

evidence

from

an

academic

assessment

group

and

from

company

submissions

Following

consultation

the

Final

Appraisal

Determination

is

developed

approved

by

the

NICE

Guidance

Executive

and

put

out

again

for

consultation

An

appeal

process

may

ensue

after

which

the

guidance

is

published

All

guidance

is

reviewed

at

regular

intervals

-LSB-

-RSB-

To

develop

a

guideline

NICE

commissions

one

of

the

National

Collaborating

Centres

to

establish

a

Guideline

Development

Group

The

Group

appraises

clinical

and

cost-effectiveness

evidence

from

systematic

reviews

of

the

research

evidence

Views

of

clinicians

consumers

and

stakeholders

also

inform

the

guideline

-LSB-

-RSB-

To

produce

guidance

on

interventional

procedures

the

Interventional

Procedures

Advisory

Committee

an

independent

body

of

members

with

a

range

of

expertise

considers

the

safety

and

efficacy

of

procedures

but

does

not

examine

clinical

or

cost

effectiveness

-LSB-

-RSB-

The

Committee

produces

a

Consultation

document

and

published

guidance

reflects

comments

received

over

the

consultation

period

NICE

guidance

generally

acts

as

quasi-law

but

one

aspect

of

guidance

on

technology

appraisals

is

supported

by

statute

If

NICE

guidance

is

that

a

new

technology

should

be

made

available

to

certain

NHS

patients

the

funding

bodies

-LRB-

PCTs

-RRB-

are

obliged

by

law

to

ensure

there

are

adequate

resources

to

facilitate

the

implementation

of

NICE

guidance

-LRB-

Secretary

of

State

for

Health

National

Health

Service

Act

Directions

to

Health

Authorities

Primary

Care

Trusts

and

NHS

Trusts

in

England

-RRB-

However

the

guidance

is

not

binding

on

individual

clinicians

who

must

assess

whether

the

technology

is

appropriate

for

the

patients

they

treat

-LSB-

-RSB-

Another

illustration

of

quality

standards

impacting

upon

patient

rights

is

Public

Service

Agreements

Published

annually

these

specify

national

goals

within

the

public

sector

including

waiting

time

targets

-LRB-

or

guarantees

-RRB-

for

the

NHS

-LSB-

-RSB-

-LRB-

a

-RRB-

By

the

end

of

patients

will

wait

a

maximum

of

months

for

in-patient

admission

and

no

more

than

weeks

for

an

out-patient

appointment

-LRB-

b

-RRB-

By

the

end

of

the

maximum

wait

from

GP

referral

to

hospital

treatment

will

be

weeks

Targets

that

should

already

be

achieved

and

henceforth

maintained

include

the

maximum

wait

for

emergency

care

and

the

target

for

accessing

primary

care

-LRB-

The

target

refers

to

patients

being

able

to

see

a

general

practitioner

within

working

days

or

another

primary

care

professional

within

working

day

whilst

the

wait

target

is

that

patients

should

spend

no

more

than

hours

in

an

accident

and

emergency

hospital

department

from

arrival

to

admission

transfer

or

discharge

-RRB-

Where

fee

schedules

exist

for

NHS

care

patient

entitlement

to

services

might

be

inferred

For

example

the

new

national

tariff

system

of

payments

for

hospital

services

whilst

in

no

way

guaranteeing

provision

suggests

services

that

should

be

accessible

on

the

NHS

The

national

price

schedule

for

patient

services

is

classified

by

Health

Care

Resource

Group

-LRB-

HRG

-RRB-

codes

A

range

of

clinical

procedures

treatments

and

diagnoses

is

included

in

the

current

list

of

HRG

tariffs

for

elective

in-patient

care

-LSB-

-RSB-

The

Quality

and

Outcomes

Framework

part

of

the

GP

contract

is

a

voluntary

mechanism

for

encouraging

primary

care

provision

of

some

services

of

curative

care

such

as

antiplatelets

for

patients

with

coronary

heart

disease

-LSB-

-RSB-

With

total

payments

amounting

to

of

available

total

practice

remuneration

-LSB-

-RSB-

there

is

a

clear

incentive

for

GPs

to

make

these

services

available

to

NHS

patients

Discussion

The

NHS

is

a

complex

and

heavily

regulated

health

care

system

in

which

the

roles

of

actors

are

in

general

clearly

defined

As

the

primary

emphasis

has

historically

been

upon

local

cost

control

rather

than

quality

or

access

issues

geographical

variations

in

quality

and

quantity

of

provision

have

emerged

-LSB-

-RSB-

The

lack

of

explicitness

in

the

definition

of

the

health

basket

has

led

to

a

great

deal

of

uncertainty

about

entitlement

Even

if

there

is

a

statutory

duty

governing

provision

this

does

not

necessarily

guarantee

access

to

NHS

services

For

example

the

NHS

Act

obliges

PCTs

to

provide

or

to

arrange

for

the

provision

of

general

dental

services

-LRB-

National

Health

Service

Act

Chap

-RRB-

However

a

large

proportion

of

the

population

is

unable

to

access

NHS

dental

services

because

of

a

shortage

of

dentists

willing

to

provide

these

services

for

the

NHS

The

rapid

growth

of

private

practice

since

was

apparently

precipitated

by

a

cut

in

NHS

fees

which

was

designed

to

redress

perceived

excessive

income

-LSB-

-RSB-

Access

problems

to

NHS

dentistry

have

triggered

an

urgent

review

of

the

regulations

governing

the

dentists

terms

of

service

with

a

recent

cash

injection

of

over

-LRB-

-RRB-

million

aimed

at

increasing

the

number

of

dentists

working

for

the

NHS

-LSB-

-RSB-

The

British

Dental

Association

in

is

negotiations

with

the

Department

of

Health

to

develop

a

new

contract

which

is

expected

in

April

This

example

illustrates

the

general

principle

that

private

practice

flourishes

where

there

are

access

or

quality

problems

within

the

NHS

The

use

of

regulation

to

address

quality

and

access

issues

has

had

mixed

results

A

national

evaluation

of

compliance

by

NHS

organisations

with

NICE

guidance

found

variable

implementation

Looking

at

rates

of

prescribing

and

use

of

procedures

and

medical

devices

the

time-series

analysis

found

significantly

increased

prescribing

of

some

taxanes

for

cancer

and

orlistat

for

obesity

in

line

with

guidance

However

prescribing

practice

frequently

appeared

to

have

little

relation

to

detailed

guidance

-LSB-

-RSB-

NICE

guidance

specifies

entitlement

in

terms

of

patient

groups

and

PCTs

are

obliged

to

provide

funding

only

for

these

patients

Whether

this

practice

is

equivalent

to

the

PCT

operating

a

blanket

ban

for

patients

whose

condition

lies

outside

the

specified

guidance

is

debatable

and

has

not

been

tested

in

the

courts

Over

the

past

decade

the

growth

in

quasi-law

suggests

that

the

English

system

is

heading

towards

a

more

formal

statement

of

benefits

and

entitlements

NICE

guidance

on

new

and

existing

technologies

is

in

effect

establishing

a

positive

list

of

technologies

that

the

NHS

should

fund

NSFs

describe

interventions

that

should

be

implemented

to

achieve

standards

of

care

The

Payment

by

Results

system

will

be

expanded

to

cover

non-elective

care

and

the

Healthcare

Commission

will

increasingly

encourage

NICE

and

NSF

implementation

reinforcing

standards

through

the

annual

health

check

-LSB-

-RSB-

These

factors

together

will

take

the

NHS

forward

in

defining

a

more

explicit

health

basket

for

England

However

variations

in

local

capacity

to

comply

with

national

standards

may

result

in

a

more

explicit

rationing

of

healthcare

services

at

the

local

level

O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O

health services
national health programmes
united kingdom
health benefit plans
public policy


Growth charts for Wolf-Hirschhorn syndrome -LRB- 0 -- 4 years of age -RRB- Wolf-Hirschhorn syndrome is characterized by severe growth and mental retardation , microcephaly , seizures and ` Greek helmet ' facies , caused by partial deletion of the short arm of chromosome 4 . Growth charts are given from 0 -- 4 years of age , based on the study of 101 individuals . Use of these specific growth charts is recommended , because standard growth charts are inapplicable for patients with WHS . Introduction Wolf-Hirschhorn syndrome -LRB- WHS -RRB- is caused by partial deletion of the short arm of chromosome 4 -LRB- 4p - syndrome -RRB- -LSB- 3 -- 5 , 7 -RSB- . Cardinal features of this rare syndrome are severe growth and mental retardation , microcephaly , seizures , `` Greek helmet '' facies and closure defects -LRB- Fig. 1 -RRB- -LSB- 1 , 2 , 4 , 5 , 7 -RSB- . Growth in children with Wolf-Hirschhorn syndrome differs from that of normal children -LSB- 1 -RSB- . Up to date , there are no Wolf-Hirschhorn specific growth charts available . Fig. 1A 7-year-old boy with Wolf-Hirschhorn syndrome Materials and methods The study is based on data from 1,057 examinations of 101 children with WHS , 35 males and 66 females , born between 1975 and 2002 . Data from 32 children were collected from records of individuals with WHS in the Netherlands . Another set of data was obtained from 69 children with WHS from Great Britain , North America , Germany and Australia who were contacted through WHS support groups . There were no exclusion criteria except growth hormone treatment . Thus , all children regardless of complicating disease such as heart defects , renal disease or feeding problems , were included . The number of observations in the Dutch group of children was higher than in the group of children from other countries . No difference in parameters related to growth was observed between Dutch and non-Dutch patients . The data used for creation of the growth charts were age at examination , height -LRB- cm -RRB- , weight -LRB- kg -RRB- and head circumference -LRB- cm -RRB- . The growth charts cover the time period from birth until 4 years of age . The data for each sex were divided into 30 different age groups , with 1-month intervals during the first 2 years of life , 3-month intervals during the 3rd and 4th years of life . Each child contributed only one single set of data for each age group . If data from more than one examination within an interval were available , the data from the first examination were used . The growth data were compared to standard growth charts for healthy children based upon the fourth Dutch growth study of 1997 -LSB- 6 -RSB- . As there are no growth charts for children with WHS elsewhere in the world , no comparison could be made with growth charts from children with WHS from other countries . Data for weight and height were transformed into logarithms before statiscal analysis in order to obtain normal distributions . All growth charts are based on means and standard deviations . The software used was SPSS version 10 and Sigmaplot version 8.02 bij SPSS Inc. . Results Figures 2 and 3 present growth charts for height for boys and girls . Mean birth length was 43.0 cm in girls and 41.5 cm in boys , corresponding to − 3 SDS on growth charts for healthy Dutch children . Mean height at 4 years was 87.2 cm for girls and 85.8 cm for boys , corresponding to − 4 and − 4.5 SDS , respectively . Fig. 2Growth chart for height for girlsFig . 3Growth chart for height for boys Figures 4 and 5 represent growth charts for weight for boys and girls . Mean birth weight was 1.9 kg for girls and 2.1 kg for boys , corresponding to − 3 SDS on growth charts for healthy Dutch children . Mean weight at 4 years was 9.8 kg for girls and 9.7 kg for boys , corresponding to − 4 SDS and − 4.5 SDS respectively . Figure 6 represents the growth chart for head circumference for boys and girls . Mean head circumference at birth was 30.5 cm for girls and boys , corresponding to − 3.5 SDS for both sexes on normal growth charts . Mean head circumference at 4 years was 45.8 cm for girls and boys , corresponding to − 3.5 SDS , respectively . Fig. 4Growth chart for weight for girlsFig . 5Growth chart for weight for boysFig . 6Growth chart for head circumference for boys and girls Discussion Growth is used in pediatrics as a marker of health and is an important tool in the medical care for children . Severe growth retardation is one of the cardinal features of WHS -LSB- 1 -RSB- . It might be caused by genetic factors , poor feeding status , inherited parental factors and associated diseases . Whether patients with WHS suffer from an additional endocrine disorder is not known and is beyond the scope of this study . Up to date there are no WHS-specific growth charts available in contrast to more common chromosomal disorders like Down 's syndrome , Turner syndrome and Prader-Willi syndrome . Although the ideal manner in constructing growth charts would be a prospective , longitudinal study based on a large study group , this method can not be implied for rare syndromes such as WHS . To increase the number of observations we combined the available longitudinal data with cross-sectional measurements . We have used data from all children with WHS , including those receiving tube-feeding . Several other associated diseases such as heart or renal disease theoretically could influence growth of the patients . Although 33 % of children with WHS have congenital heart defects , these defects are in most cases not complex in nature -LSB- 1 -RSB- . Closure defects , hypotonia , gastro-eosphageal reflux , epilepsia , repeated infections and surgical procedures all can have a significant influence on growth . Not all patients with WHS have the same deletion size . Until now there has been no evidence of an influence of the deletion size on growth , but all studies have only involved small numbers of children . Deletion size can be expected to be of influence on growth , and therefore we tried not to include patients with a known microdeletion . However , this study inevitably includes patients with different deletion sizes , but the number of included children was too small to show an effect on growth . Based on the available data from the Dutch cohort , we could not identify a major co-morbidity risk factor aggravating growth retardation . Almost all children with WHS showed a marked intra-uterine growth retardation . Despite adequate feeding none of the children with WHS , demonstrated catch-up growth ; all remained short with a profound microcephaly . The developed specific growth charts should be used for children with WHS from birth to 4 years of age for the estimation of their growth and health condition as standard growth charts are inapplicable in these patients . At present the authors are constructing growth charts for older children with WHS .

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 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 B 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 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 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 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 B 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 O O O O O O 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 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 O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O 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 B O O O O O O O O O B 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 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 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 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 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 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 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 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 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 O O 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 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 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 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 B 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 B O O O O O O B O O O O B O O O O O O O O O O B O O O B 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 B 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 B O