Basic Erosive Wear Examination (BEWE): a new scoring system for scientific and clinical needs

A new scoring system, the Basic Erosive Wear Examination (BEWE), has been designed to provide a simple tool for use in general practice and to allow comparison to other more discriminative indices. The most severely affected surface in each sextant is recorded with a four level score and the cumulative score classified and matched to risk levels which guide the management of the condition. The BEWE allows re-analysis and integration of results from existing studies and, in time, should initiate a consensus within the scientific community and so avoid continued proliferation of indices. Finally, this process should lead to the development of an internationally accepted, standardised and validated index. The BEWE further aims to increase the awareness of tooth erosion amongst clinicians and general dental practitioners and to provide a guide as to its management.
Introduction
The objective of tooth wear indices is to classify and record the severity of tooth wear or dental erosion in prevalence and incidence studies. There are a myriad of indices [1] which vary in type of assessment, scale, choice of teeth and other styles, resulting in non-comparability [4]. The main aim of these indices has been in research and health service planning, but since so many indices have been published it has not been possible to compare the outcomes of different studies and so provide an international overview of the present status of this condition. The variation in these indices, and for some their complexity, means that they remain a research tool of limited relevance. Further, there are no convenient and simple methods for general dental practitioners (GDPs) to record the level of tooth wear and erosion apart from using subjective terms such as mild, moderate and severe. The very nature of these terms means that their interpretation varies considerably between clinicians.
These are valid reasons for the need to establish a simple, repeatable and convenient index that is a valid research tool for the dental academic community but also of use in day-to-day dental practice for screening. Ideally, an index would have a basic structure that would allow for more sophisticated categories to be developed for specific research purposes, which could then be broken down again to the simplified version for clinical needs or for screening procedures. An example is the FDI DDE index [8] for enamel defects that has a basic screening index and an expanded epidemiological index.
The Basic Periodontal Examination (BPE) [5] or the Periodontal Screening Index adopted from the Community Periodontal Index [14] was developed to allow a convenient, repeatable method of recording periodontal diseases. Uniquely, these indices have been accepted not only by academics but also as part of the routine clinical examinations by GDPs. Development of these indices allows dentists not only to screen for periodontal diseases in a simple and effective manner but also to improve awareness and understanding of the disease. The same objectives are now needed for erosive tooth wear. Unlike caries and periodontitis, however, there is uncertainty about the validity of the criteria [9, 12] to define and grade tooth wear, erosion, abrasion and attrition, and at present, there is no conclusive knowledge how much erosive wear is physiological or can be accepted in relation to age [2, 19].
The Basic Erosive Wear Examination (BEWE) has therefore been designed to provide a simple scoring system that can be used with the diagnostic criteria of all existing indices aiming to transfer their results into one unit which is the BEWE score sum. The aim of the BEWE is to be a simple, reproducible and transferable scoring system for recording clinical findings and for assisting in the decision-making process for the management of erosive tooth wear.
Basic Erosive Wear Examination (BEWE)
The BEWE is a partial scoring system recording the most severely affected surface in a sextant and the cumulative score guides the management of the condition for the practitioner. The four level score (Table 1) grades the appearance or severity of wear on the teeth from no surface loss (0), initial loss of enamel surface texture (1), distinct defect, hard tissue loss (dentine) less than 50% of the surface area (2) or hard tissue loss more than 50% of the surface area (3). The differentiation between lesions restricted to enamel and dentine can be difficult particularly in the cervical area [11, 12]. Buccal/facial, occlusal, and lingual/palatal surfaces are examined with the highest score recorded.
Table 1Criteria for grading erosive wearScore 0No erosive tooth wear1Initial loss of surface texture2*Distinct defect, hard tissue loss <50% of the surface area3*Hard tissue loss ≥50% of the surface area*in scores 2 and 3 dentine often is involved
The examination is repeated for all teeth in a sextant but only the surface with the highest score is recorded for each sextant. Once all the sextants have been assessed, the sum of the scores is calculated as indicated on the grid that follows:
BEWE scores
Highest scoreHighest scoreHighest score 1. Sextant (17–14)2. Sextant (13–23)3. Sextant (24–27) Highest scoreHighest scoreHighest scoreScore sum4. Sextant (37–34)5. Sextant (33–43)6. Sextant (44–47)
The result of the BEWE is not only a measure of the severity of the condition for scientific purposes but, when transferred into risk levels, also a possible guide towards management (Table 2).
Table 2Risk levels as a guide to clinical managementRisk levelCumulative score of all sextantsManagementNoneLess than or equal to 2aRoutine maintenance and observationRepeat at 3-year intervalsLowBetween 3 and 8aOral hygiene and dietary assessment, and advice, routine maintenance and observationRepeat at 2-year intervalsMediumBetween 9 and 13aOral hygiene and dietary assessment, and advice, identify the main aetiological factor(s) for tissue loss and develop strategies to eliminate respective impactsConsider fluoridation measures or other strategies to increase the resistance of tooth surfacesIdeally, avoid the placement of restorations and monitor erosive wear with study casts, photographs, or silicone impressionsRepeat at 6–12-month intervalsHigh14 and overaOral hygiene and dietary assessment, and advice, identify the main aetiological factor(s) for tissue loss and develop strategies to eliminate respective impactsConsider fluoridation measures or other strategies to increase the resistance of tooth surfacesIdeally, avoid restorations and monitor tooth wear with study casts, photographs, or silicone impressionsEspecially in cases of severe progression consider special care that may involve restorationsRepeat at 6–12-month intervalsaThe cut-off values are based on experience and studies of one of the authors (A. L.) and have to be reconsidered.
The management would include identification and elimination of the main aetiological factor(s), prevention and monitoring, as well as symptomatic and operative intervention where appropriate. It does not provide guidance for the most appropriate prosthodontic or operative technique as there is too much variation at this level of decision making between clinicians. However, for the highest risk levels special care is suggested.
The repetition of the BEWE will vary according to the severity and the relative importance of aetiological and risk factors. For patients particularly exposed to intrinsic or extrinsic acids [17], the procedure should be repeated at 6-month intervals, but for most other cases, annually is acceptable.
Discussion
The need for a standardised and internationally accepted index is obvious, but there continues to be research needs which may not be fulfilled with a simplified index. Over the past 20 to 30 years, different researchers have developed indices which suit their own research needs but do not allow comparison to assess the prevalence of tooth wear between countries and regions. Therefore, this new scoring system has been designed to allow existing and hopefully future indices to be collapsed and re-analysed. It will be important that this proposed system is validated against existing data or in field trials. In time, it should initiate a consensus within the scientific community and so avoid continued proliferation of indices. Finally, this process should lead to the development of an internationally accepted, standardised and validated index.
The structure of the BEWE is designed to allow fulfilling of most formal requirements generally formulated for indices. The grading includes four levels which is neither too precise nor too crude, and the threshold values should be easy to learn and to calibrate. In addition by removing the clear distinction between “enamel loss” and “dentine” exposed, it will not only evade diagnostic uncertainties but will open a broad applicability beyond the clinical situation. It can be used with study models or photographs which appear suitable for erosive wear as a surface phenomenon. Erosion already has been documented or diagnosed on study models and on photographs [10, 13, 15], and this could be of particular value in cross-sectional and incidence studies as well as for the monitoring of individual cases.
It will further allow a more reliable estimation of the severity of tooth surface loss on an individual basis rather than the current way to give data as “x% of the subjects had at least one tooth with grade x or grade y erosion”, and so avoid an overestimate of the problem. The BEWE is ideal for screening studies, but a longer version is required for a more detailed investigation.
As to the field of dental care, the clinical value of the BEWE, as with the BPE, should be highly significant as a convenient diagnostic tool for GDPs and as a model to increase awareness assuming that this relatively new entity is not well recognised. Even in UK, where the prevalence and incidence of erosive wear is relatively high [7, 18], a questionnaire survey has shown that only one third of the practitioners noted erosion on a frequent basis and the majority underestimated the prevalence of the condition [6]. The benefit of a system that encourages the more careful examination of the dental hard tissues other than for caries is therefore obvious and is one further aim of the BEWE.
In addition to diagnosis and scoring, also a strategy for treatment is included in the BEWE. There are a number of reviews with respect to the prevention and therapy of erosive wear (e.g. [3, 16]), but it is not only the variety of recommendations which makes the management of the condition difficult for the GDP, but also the fact that these recommendations were not made with respect to the severity of tooth surface loss in an individual. The risk levels presented aim to guide the management of erosive wear and allow sufficient flexibility so that different countries can adapt the index without compromising their unique needs. The levels defined, however, are suggestions at the present stage and need an ongoing review process.
Conclusion
The BEWE is a basic structure to initiate the development of an internationally accepted, standardised and validated index. This is to provide on one hand a clear and defined structure for scientific and clinical use, but on the other to be amenable for further development. It will encourage clinicians, students and GDPs to pay more attention to erosive wear and hence will be beneficial for patient care.

erosion
examination
index
tooth wear
epidemiology
diagnosis


Efficacy and patient satisfaction with autoadjusting CPAP with variable expiratory pressure vs standard CPAP: a two-night randomized crossover trial

Expiratory pressure relief (C-Flex) technology monitors the patient’s airflow during expiration and reduces the pressure in response to the patient. Increased comfort levels associated with C-Flex therapy have potential to improve patient adherence to therapy. The purpose of this study was to assess the combination of autoadjusting CPAP (APAP) and C-Flex in terms of (1) treatment efficacy, and (2) patient preference when compared to standard CPAP. Fifteen patients who had previously undergone formal CPAP titration polysomnography were treated with either one night of the APAP with C-Flex or one night of conventional CPAP, in a crossover trial. Patient satisfaction levels were recorded using visual analog scales (VAS) on the morning after the study. Mean patient age was 50 ± 12 years, body mass index (BMI) was 36 ± 6 kg/m2, baseline AHI was 53 ± 31 events/h, and CPAP Pressure was 11 ± 2 cm/H2O. APAP with C-Flex was as effective as CPAP, with no differences detected in sleep latency (17 ± 5 vs 12.3 ± 3 min, p = 0.4), or respiratory indices (AHI of 4.2 ± 2 vs 2.4 ± 0.7 events/h, p = 0.1). VAS scores (scale 0–10) indicated a trend towards increased patient satisfaction while using APAP with C-Flex (7.9 vs 7.2, p = 0.07). 10 patients expressed a preference for APAP with C-Flex (VAS, 0 to10) over standard CPAP (total positive score of 68, mean score of 4.8 ± 4.3). One patient expressed no preference. Four patients expressed a preference for CPAP (total positive score of 13, mean score of 0.9 ± 1.9) (APAP with C-Flex vs standard CPAP, p < 0.01 paired t test). APAP with C-Flex eliminates sleep disordered breathing as effectively as standard CPAP. Patients indicated a preference for APAP with C-Flex suggesting a possible advantage in terms of patient adherence for this mode of treatment.
Introduction
Continuous positive airway pressure (CPAP) is the most commonly prescribed treatment for patients with obstructive sleep apnea (OSA). CPAP is effective in reducing sleep fragmentation, resolving nocturnal desaturation, and improving daytime sleepiness [1]; moreover, CPAP is a cost-effective use of healthcare resources, and may reduce risks of motor vehicle crashes and the development of cardiovascular morbidity [2–5].
The efficacy of CPAP is compromised by relatively poor compliance. A variety of measures have been shown to improve compliance with CPAP; these include aggressive follow-up of patients prescribed CPAP, group education, heated humidification, and mask adjustments [6–11]. Modifications in the algorithm, by which positive pressure is delivered, have been attempted to improve comfort and compliance with therapy.
A typical complaint by those using conventional CPAP is that it is difficult to exhale against positive pressure. Therefore, reducing pressure during exhalation may improve tolerance with therapy. C-Flex (Respironics, Murrysville, PA, USA) is a novel algorithm designed to provide pressure relief during expiration, while maintaining optimal pneumatic splinting for effective therapy.
Another modification is the development of autoadjusting (APAP) devices. In contrast to conventional CPAP, APAP devices modify applied pressure in response to patient needs. APAP devices, through varied mechanisms, are able to detect obstructive events and change pressure accordingly to relieve the obstruction. This results in a reduction in mean applied CPAP pressure [12], and may be useful in patients who have difficulty tolerating CPAP. Furthermore, APAP may be useful for ambulatory titration of CPAP pressure in patients in whom in-laboratory therapy titration is either delayed or impossible [13–15]. The newest iteration of the REMStar Auto employs both the REMStar Auto CPAP algorithm and the C-Flex dynamic expiratory pressure relief.
This is the first study to evaluate the REMStar Auto with C-Flex (RSA C-Flex) as a therapy for patients with OSA. The major purpose of the study was to assess the ability of RSA C-Flex to effectively treat the sleep apnea events. Satisfaction and preference from the patients’ perspective, and the number of required interactions per night by technicians were also determined.
Materials and methods
Study subjects
Consecutive, recently diagnosed, adult patients (≥18 years of age) with moderate to severe OSA [apnea hypopnea index (AHI) >15 events/h of sleep as determined by PSG] [16] were asked to participate in our study. All subjects had a titration PSG that determined the effective pressure (i.e., AHI <5 events/h during all sleep stages and positions). All subjects were using conventional CPAP at home on a regular basis with an average nightly usage >4 h, confirmed by objective evaluation of CPAP machines. Exclusion criteria included patients who were medically unstable, using oxygen, had surgery of the upper airway or nose within the previous 90 days, or who could not provide informed consent.
The study was approved by the Ethics Board at the University of British Columbia.
Procedures and techniques
Sleep laboratory rooms were configured with a device that could deliver either conventional CPAP or RSA C-Flex. The study occurred on two separate nights, within 2 weeks of each other. For the first night, patients were randomized to either conventional CPAP at the previously determined effective pressure or RSA C-Flex. The patient was not aware of which of the therapies they would be receiving. However, the technician, by necessity, was aware of the therapy choice. On the second experimental night, subjects received the alternative therapy (crossover design).
For each night, all subjects were instrumented for polysomnography and PAP titration according to practice parameters published by the American Sleep Disorders Association Standards of Practice Committee [17]. Chest and abdominal excursion was measured using respiratory impedence plethysmography (Respitrace; Ambulatory Monitoring Equipment, Ardsley, New York, USA). Oxygen saturation was recorded using a pulse oximeter (Model N-100; Nellcor, Hayward, California, USA). Airflow was measured directly from the CPAP machine. Respiratory events were defined by standard criteria [16]. Obstructive apneas were defined as absence of airflow for greater than 10 s. Obstructive hypopneas as a 50% decrease in airflow, or a clear but lesser decrease in airflow if coupled with either a desaturation of >3% or an arousal in the context of ongoing respiratory effort. Central apneas were defined as absence of airflow and respiratory effort for greater than 10 s. Central hypopneas as a 50% decrease in airflow with concomitant reduction in respiratory effort, or a clear but lesser decrease in airflow if coupled with either a desaturation of >3% or an arousal. Arousals were counted per hour of total sleep time. Sleep efficiency index was defined as total sleep time/total time in bed.
Satisfaction with devices was assessed on the morning after the study (see attached surveys, Appendix 1). All subjects completed a visual analog satisfaction (VAS) questionnaire. VAS scores are useful in assessing subjective patient experience and have been used for this purpose in a previous crossover trial comparing conventional CPAP and APAP [18]. Patients scored satisfaction (0–10) with different aspects of their experience from the previous night. Questions included: (1) How well did you sleep last night? (2) How rested do you feel this morning? (3) How often did you wake during the night? (4) How uncomfortable was your CPAP pressure? (5) How difficult was it to get to sleep? (6) Overall, how satisfied were you with your quality of sleep last night? Mean score was calculated for all 15 patients on both nights.
Preference for device was assessed on the morning after the second experimental night. Subjects were asked “In comparison to the first night of the study, please state a preference for the CPAP machine set-up”. Subjects were asked to place a mark on a line to indicate the degree of preference for the first night (0–10) or the second night (0–10). Mean score was calculated for both nights, with a score of less than 0 indicating preference for the other night.
The technicians recorded any required interactions with the subject, during the night.
Conventional CPAP without C-Flex
CPAP pressure was set to the therapy pressure determined during a previous titration study. A 20-min ramp was used with the initial pressure being set as 66% of the previously titrated pressure.
RSA with C-Flex
The REMStar Auto algorithm (Respironics, Murrysville, PA, USA) is a proactive, flow-based algorithm. The basic algorithm evaluates inspiratory flow, and determines impending or actual flow limitation. This flow evaluation occurs in concert with a program of pressure adjustments designed to evaluate the critical pressures (at which airways are susceptible to collapse) and resolve therapy pressures slightly above these critical pressures. The patient is protected from “break-through” events with a full complement of intelligent responses to airflow events and snoring. C-Flex technology monitors the patient’s airflow during expiration and reduces the pressure in response to the patient. The relief pressure may vary on a breath-to-breath basis, depending on the actual patient airflow (Fig. 1). The device can be preset to deliver varying degrees of C-Flex pressure relief (settings of 1–2–3).
Fig. 1Pressure relief is shown on a breath by breath basis for the three standard gain settings. Pressure relief is dependant on patient flow according to the formulae—pdelivered = pbase−prelief. prelief = (flow*gain)
RSA C-Flex was set at a minimum pressure of 66% of previously titrated therapy pressure and a maximum pressure of 20 cm H2O. Patients were arbitrarily set to a C-Flex setting of 3 (maximum pressure relief). If the patient commented about any sensation of “breathlessness” due to the pressure relief, comfort settings were adjusted to 2 or 1 by the night technician.
Statistical analysis
Baseline characteristics were described using means and standard deviations for continuous variables. Differences between the CPAP and RSA C-Flex arms were compared using paired t tests. Two-tailed tests were used to assess significance (at the 0.05 level).
Results
Fifteen patients were included in the trial. Baseline characteristics included (mean±SD) age 50 ± 12 years, BMI 36 ± 6 kg/m2. Overall, the patients had substantial sleep apnea with a mean baseline AHI of 53 ± 31 with a mean CPAP pressure of 11 ± 2 cm H20.
Results for the RSA C-Flex vs standard CPAP are shown in Table 1. Overall, RSA C-Flex was as effective as standard CPAP in relieving upper airway obstruction with a mean AHI of 4.2 vs 2.4/h (p = 0.1, Fig. 2). One patient had central apneas during the RSA C-Flex night (index 10.2/h). When these central events were excluded, the mean AHI during the RSA C-Flex night decreased to 3.2 events/h (Fig. 2). Furthermore, 12 out of 15 patients had an AHI of less than five on the APAP night, which is similar to the proportion on standard CPAP therapy (13/15). Measures of sleep efficiency were similar between the groups. Although patients had more slow-wave sleep during the RSAC night, this was not statistically significant.
Table 1Outcomes with RSA C-Flex vs standard CPAP RSA C-FlexCPAPP valueAHI (events/h)4.2 ± 2.4 ± 0.70.1Sleep latency (min)17.0 ± 512.3 ± 30.4Sleep efficiency (%)82 ± 283 ± 20.6WASO (min)67 ± 1465 ± 120.9REM %25 ± 224 ± 20.7Stage 3/4 (%)4 ± 1.51.6 ± 0.50.13Mean oxyhemoglobin saturation (%)97.3 ± 0.397.2 ± 0.30.93PLMI (events/h)2.8 ± 1.03.8 ± 1.50.59Values given as mean±SEMAHI Apnea hypopnea index, WASO wake after sleep onset, PLMI periodic limb movement indexFig. 2Mean oxygen saturation and AHI were compared between the treatments. Mean AHI was 4.5 in the C-Flex arm, as compared to 2.5 in the standard CPAP arm (p = 0.1). When central events were excluded, this decreased to 3.5 in the C-Flex arm compared to 2.5 in the CPAP arm (p = 0.12)
Patient satisfaction levels were measured using a visual analog scale (Fig. 3). In general, VAS scores tended to be higher on the RSA C-Flex night, although none of the scales individually demonstrated a significant difference. However, when Mean VAS scores were calculated for individual patients and compared using a paired t test, a trend towards an increased score was noted in the C-Flex group (7.9 vs 7.2, p = 0.07, Fig. 4a).
Fig. 3Visual analog scales were used to determine patient comfort levels. Scales ranged from 0–10 and were administered on the morning post sleep study. Although VAS scores were higher on the C-Flex night, differences were not significant using a paired t test (p > 0.1 for all outcomes)Fig. 4a Mean VAS scores were calculated for individual patients and compared using a paired t test. A trend towards increased score was noted in the C-Flex group (7.9 vs 7.2, p = 0.07). b Patient scored their preference using VAS scores (1–10). A significant preference was noted for C-Flex (p < 0.01)
In addition, patients were asked to rate their preference for the treatment mode. Ten patients expressed a preference for the RSAC night with the sum of positive scores favoring the RSAC of 68 (mean 4.8 ± 4.3). Four patients expressed a preference for CPAP with the sum of positive scores favoring CPAP of 13 (mean 0.9 ± 1.9). One patient expressed no preference. A significant difference was found in preference between these two arms (paired t test, p < 0.01) (Fig. 4b).
Sleep technicians recorded the number of interactions with each patient during the night. The majority of these interactions were to adjust recording leads, and a minority of occasions to adjust mask position. Technician interactions did not differ between nights (1.4 vs 2.3 per night, p = 0.14).
Discussion
In our study, RSA C-Flex was as effective as standard CPAP in treating sleep-disordered breathing. There were no differences in sleep-related breathing or architecture variables between the arms. However, the RSA C-Flex arm was associated with a trend in improvement in patient satisfaction as assessed by VAS scores. Patients preferred RSA C-Flex over standard CPAP.
To our knowledge, only one other published study has looked at the use of C-Flex in OSA. In a nonrandomized study of 89 patients, Aloia et al. [19] examined treatment adherence in patients with OSA assigned to either standard CPAP or C-Flex therapy. Clinical outcomes were measured at 3 months and although functional outcomes associated with sleep did not differ, adherence was significantly greater in the C-Flex group (4.8 vs 3.1 h/night, p < 0.01). The crossover design of our trial using random treatment order guaranteed patient matching while allowing us to assess patient preference. Our study is not directly comparable to that of Aloia et al. as they examined long-term compliance. However, our results are consistent in that our two-night study demonstrated a preference of the patient for RSA C-Flex.
Our findings are consistent with other studies of autoadjusting CPAP therapy. A metaanalysis of nine randomized controlled trials demonstrated that APAP is as effective as standard CPAP in treating sleep apnea (in terms of reducing apnea hypopnea index) [12]. Although this metaanalysis did not demonstrate a significant improvement in compliance with APAP, other studies have suggested that APAP may be preferred by patients, especially if their baseline CPAP pressures are elevated [20]. To control this, we used 20-min ramps during CPAP nights in an attempt to match initial pressures with the RSA C-Flex night.
In this two-night study, we showed that RSA C-Flex is as effective as standard CPAP in reducing AHI. We noted that one patient with a treatment AHI of >20 had a high proportion of central sleep apnea. Review of this patient’s diagnostic study revealed a very high baseline AHI (>100/h) with the presence of central apneas (index>20/h). As such we feel that residual central apneas in this patient reflect baseline disease rather than being caused by RSA C-Flex. However, the possibility that the RSA C-Flex may predispose to central events in a subgroup of patients cannot be excluded.
Patients preferred RSA C-Flex over standard CPAP, and may have found it more comfortable. As such, we speculate that RSA C-Flex may improve compliance if used as chronic therapy. Furthermore, one of the major determinants of long-term compliance with CPAP is the early experience with the therapy. For many patients, in-laboratory titration represents the first exposure of any duration to CPAP therapy (Appendix 2). Any positive impact on this initial experience has the potential to improve compliance in the longer term. Use of RSA C-flex may thus be useful for initial titration of CPAP in the laboratory. For similar reasons, RSA C-flex may be useful in patients who are being titrated at home with APAP. The impact of RSA C-Flex on long-term compliance with chronic use, as “salvage” therapy of patients intolerant of standard CPAP, or its utility as part of a laboratory/ambulatory CPAP titration need to be studied in larger clinical trials.
We acknowledge that there are a number of limitations to our study. First, although the patient was not told of the nightly treatment assignment, the technician was not blinded. For our study, it was not possible for the technician to be unaware of the treatment. Second, we have studied a relatively small number of patients. Third, we have only studied patients for two nights in the laboratory and as such, we cannot extrapolate our study to chronic treatment. We have not tested CPAP adherence in this study; our results merely suggest a reasonable hypothesis for future study—that use of the RSA C-Flex may have a favorable effect on compliance. Finally, this study included patients with predominately severe disease who were compliant with CPAP. We may not be able to extrapolate our results to patients with less severe sleep apnea, or to patients with other concomitant respiratory diseases (such as COPD).
Conclusion
In this small short-term study, both RSA C-Flex and standard CPAP (with pressure defined by an in-laboratory CPAP titration) were effective in treating sleep apnea. Most patients preferred RSA C-flex. Future studies with this technology are warranted to assess its effects on long-term compliance and its potential as rescue therapy for those initially noncompliant with standard CPAP therapy.

cpap
c-flex
patient preference
auto-cpap


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 (NHS) was established in 1948 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’ [1]. Furthermore, the courts have established that NHS organisations may not operate a ‘blanket ban’ on the provision of particular services [2]. 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 [3]. National standards, embodied in guidance from National Service Frameworks (NSFs), the National Institute for Health and Clinical Excellence (NICE) 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’, ‘HC1’ of the International Classification for Health Accounts (ICHA) taxonomy [4]. An overview of the legal and regulatory framework defining benefits for England is given in Table 1.Table 1 Documents defining the English Health Basket, 2005Catalogue: type of document, actors and contentsCriteria used for defining benefitsType of documentLegally bindingPositive/negative definition of benefitsDegree of explicitnessaUpdatingNCECEBOtherActs of ParliamentYesP1Irregular, amended by further legislation+––––Political judgement ‘necessary to meet all reasonable requirements’Statutory instruments (SI)YesP or N1–3Irregular, amended by further legislation+–+++SafetyDirectionsYesP2No+–+–+–National Service FrameworksNoP2 or 3Unclear+–+–––NICE technology appraisalsYesbP or N3Every 4 years–+++––NICE clinical guidelinesNoP2 or 3Every 4 to 6 years–+++––NICE interventional proceduresNoP or N3Unclear––+––SafetyContractsYesP1–3Infrequent-although small amendments more frequent+–––+–Waiting time guaranteescNoP2Irregular+–+–––HRG tariffsNoP2 or 3Still evolving–+––+–Devices tariffNoP3Monthly–+–++Safety, quality, appropriatenessFee schedulesNoP3Annually (at least)+–––+–N need, C costs, E effectiveness, CE cost-effectiveness,
B budget (from [1, 2, 3], DH website (http://www.dh.gov.uk/home/fs/en), HMSO website (http://www.hmso.gov.uk/), expert advice (see Acknowledgements))
a “Explicit is subdivided as 1: all necessary”; 2: areas of care; 3: 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, HC1 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 [4].
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 1977 National Health Service Act (chap. 49), the Secretary of State has a duty to provide ‘to such extent as he considers necessary to meet all reasonable requirements’: (a) hospital accommodation [s. 3 (1(a))], including high security psychiatric services (s. 4); (b) other accommodation necessary for the purpose of any other services required by the Act [s. 3 (1(b))]; (c) medical, dental and nursing services [s. 3 (1(c))] (N.B.: ‘medical’ includes ‘surgical’); and (d) such other services as are required for the treatment of illness [s. 3 (1(f))] (N.B.: ‘illness’ includes a mental disorder and any injury or disability requiring medical or dental treatment or nursing). The Secretary of State for Health also has powers to provide ‘as he considers appropriate’ facilities for the care of persons suffering from illness [s. 3 (1(e))]. The responsibility for providing these services has passed to local health authorities, which in the current organisational structure are known as Primary Care Trusts (PCTs). The 1977 NHS Act also places a duty on PCTs to provide general medical services (s. 29), general dental services (s. 35), pharmaceutical services (s. 41) and general ophthalmic services (s. 38).
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’ [2]. The Health Authority had identified this illness as amongst the bottom 10% in terms of need (together with cosmetic surgery, reversal of sterilisation, correction of myopia and most ‘alternative’ medicines) 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’ [2]. 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 2004 National Health Service (General Medical Services Contracts) Regulations provide details of the terms of service for general practitioners (GPs) and state that ‘essential services’ must be provided, covering emergency treatment and treatment for patients with chronic, terminal and self-limiting disease [National Health Service, General Medical Services Contracts, regulation SI 2004/291, reg. 15 (3:5,6:8), 2004; see Table 2].Table 2 Eligibility for primary care ‘essential services’ under the 2004 General Medical Services Contract (from [19])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’ [reg.15 (6)]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 1977 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 75 yearsPatients not seen within 3 years; newly registered patients
For dental practitioners the National NHS (General Dental Services) Regulations 1992 make provision for the Secretary of State for Health to determine dentists’ remuneration, including a ‘scale of fees’ for providing particular services [reg. 19 (1)]. Updated at least annually, the Statement of Dental Remuneration describes over 400 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 80% of the charge up to a stated maximum, although some exemptions apply (Department of Health, Statement of Dental Remuneration, amendment no. 93, 2005). 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 (groups of NHS hospitals, each operating as a single legal entity) and all general dental practitioners of the updated fee scales (ibid.).
Similarly, the 1986 NHS (General Ophthalmic Services) Regulations make provision for opticians and ophthalmic medical practitioners to charge for sight tests and for optical appliances (National Health Service, General Ophthalmic Services, regulation SI 1986/975, 1986). 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 13 of the Health and Medicines Act 1988, is determined by age, disease (or risk of disease) 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’ [3]. 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 (‘core’ standards) and capacity to improve (‘developmental’ standards) [5].
The programme of NSFs, launched by the Department of Health in April 1998, 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 [6]. Frameworks cover some services of curative care (Table 3). Each NSF is developed with the assistance of an external reference group (ERG), 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 3 Services of curative care covered by selected National Service Frameworks; ICHA category HC.1: services of curative careCategoryServicesChildrenStandard 7: Guidance on hospital-based services for childrenStandard 3: Guidance on community-based careCoronary heart diseaseStandard 7: NHS Trusts to provide appropriate investigations and treatments for patients with suspected or confirmed coronary heart diseaseDiabetesStandard 7: 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 4: Need for appropriate specialist careStandard 7: Effective diagnosis, treatment and support for those with mental health problemsRenal diseaseQuality requirement 2: Timely, appropriate and effective investigation, treatment and follow-up for those with chronic kidney diseaseStandard 5: All likely to benefit from a kidney transplant to receive a high quality service which supports them in managing their transplant(from: DH website, http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/HealthAndSocialCareArticle/fs/en?CONTENT_ID=4070951&chk=W3ar/W, accessed 12 July 2005)
There is no statutory obligation on health care organisations to implement NSF standards. However, the Health And Social Care (Community Health And Standards) Act 2003 [Health and Social Care (Community Health and Standards) Act, Chap. 43, 2003) gave the Secretary of State powers to publish standards for health care [s. 46 (1)] that NHS bodies are bound to take into account [s. 46 (4)]; NSFs could inform these standards. Furthermore, the Healthcare Commission reviews health care organisations’ implementation of NSFs as part of its annual health check [5], 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 91 technology appraisals published to date (July 2005) some relate to in-patient care, such as Appraisal No. 11 (the use of implantable cardioverter defibrillators for arrhythmias); to day care, such as Appraisal No. 48 (home compared with hospital haemodialysis for patients with end-stage renal failure); and to out-patient care, such as Appraisal No. 24 (debriding agents for difficult to heal surgical wounds). 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 40 currently published guidelines. For example, the dyspepsia guideline (Clinical Guideline, CG, 18) recommends life-style advice and appropriate medication as secondary preventative measures and the guideline on head injury (CG4) 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 127 currently published topics most relate to hospital-based care, such as radiotherapy for age-related macular degeneration (Interventional Procedure Guidance, IPG, 048) and auditory brainstem implants (IPG108).
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 [7]. 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 [8]. To produce guidance on interventional procedures, the Interventional Procedures Advisory Committee, an independent body of 24 members with a range of expertise, considers the safety and efficacy of procedures, but does not examine clinical or cost effectiveness [9]. The Committee produces a Consultation document and published guidance reflects comments received over the 4-week 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 (PCTs) are obliged by law to ensure there are adequate resources to facilitate the implementation of NICE guidance (Secretary of State for Health “National Health Service Act 1977: Directions to Health Authorities, Primary Care Trusts and NHS Trusts in England”, 2001). However, the guidance is not binding on individual clinicians, who must assess whether the technology is appropriate for the patients they treat [10].
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 (or ‘guarantees’) for the NHS [11]: (a) By the end of 2005, patients will wait a maximum of 6 months for in-patient admission and no more than 13 weeks for an out-patient appointment. (b) By the end of 2008 the maximum wait from GP referral to hospital treatment will be 18 weeks.
Targets that should already be achieved, and henceforth maintained, include the 4-hour maximum wait for emergency care and the 24/48 target for accessing primary care. (The 24/48 target refers to patients being able to see a general practitioner within 2 working days or another primary care professional within 1 working day, whilst the 4-hour wait target is that patients should spend no more than 4 hours in an accident and emergency hospital department from arrival to admission, transfer or discharge.)
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 (HRG) codes. A range of clinical procedures, treatments and diagnoses is included in the current list of 550 HRG tariffs for elective in-patient care [12].
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 [13]. With total payments amounting to 15–20% of available total practice remuneration [14], 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 [1]. 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 1977 NHS Act obliges PCTs to provide, or to arrange for the provision of, general dental services (National Health Service Act, Chap. 49, 1977). 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 1992 was apparently precipitated by a 7% cut in NHS fees, which was designed to redress perceived excessive income [15, 16]. 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 £350 (€504) million, aimed at increasing the number of dentists working for the NHS [17]. The British Dental Association in is negotiations with the Department of Health to develop a new contract which is expected in April 2006. 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 [18]. 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’ [5]. 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.

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