Rheumatology Unit, Western General Hospital NHS Trust, Crewe Road, Edinburgh EH4 2XU,
1 Department of Public Health Sciences, Teviot Place, University of Edinburgh and
2 Ayrshire & Arran Health Board, Boswell House, 10 Arthur Street, Ayr KA7 1QJ, UK
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Abstract |
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Methods. The study was a randomized controlled clinical study evaluating a fast track appointment with a 6-week target waiting time against an ordinary appointment in the main city out-patient clinic of the rheumatology service for the Lothian and Borders region (population ~1 million). Health status was measured using the SF12 physical and mental summary component T-scores and pain was measured with a 100 mm visual analogue pain scale. Secondary outcomes were health utility and perceived health both measured with the EuroQol instrument, mental health measured with the Hospital Anxiety and Depression scale, disability with the modified Health Assessment Questionnaire and economic costs measured from a societal perspective.
Results. Mean waiting times were 43 days ( = ±16) and 105 days (
= ±51) for fast track and ordinary appointments, respectively. Both groups showed significant improvements in mean [95% confidence interval (CI)] scores for pain: 11 (7, 16)(P < 0.001); physical health status: 4 (2, 5) (P < 0.001); mental health status: 2 (0.1, 4) (P < 0.02); and health utility: 0.11 (0.07, 0.16) (P < 0.001) by the end of the 15-month period of the study, but there was no significant difference between either arm of the study.
Conclusions. Rationing by delay was not detrimental to either mental or physical health and patients in both arms of the study showed significant and similar improvement in health by 15 months. Expenditure of resources on waiting times without regard to clinical outcomes is likely to be wasteful and additional resources should be directed at achieving the greatest clinical benefit. More research into effective methods of controlling demand and better identification of those who would benefit from access to specialist care is needed.
KEY WORDS: Rationing, Waiting list, Arthritis, Health status, Health outcome, Economic cost.
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Introduction |
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In the UK, rationing methods include the constraints imposed by national and health authority cash allocations, the exclusion or severe limitations by health boards of certain treatments such as in vitro fertilization (IVF), and the control of demand through the management of waiting lists (rationing by delay) [2, 3]. To the extent that such rationing decisions are based on arbitrary and implicit preferences rather than on explicit criteria, they could be criticized as being unethical and inequitable [2, 4, 5]. Furthermore, the absence of any clear national policies and the devolution of rationing decisions to the local level, have led to wide variations in health care provision [4] and to increasing public concern and confusion about the process of rationing and priority setting.
The political focus on waiting lists, either in the form of national waiting time guarantees or the allocation of resources for waiting list initiatives, has further distorted priorities and expectations. These manipulate just one aspect of a dynamic system, and set artificial targets which bear no relation to health outcomes or quality of service, and fail to address the equally important problem of demand. Consequently they produce either little or no effect on waiting lists, distort clinical priorities and raise unrealistic public expectations of the health service. Investment in rheumatology services is clearly desirable, but such investment should be used to produce optimal clinical benefit and should satisfy unmet clinical needs. To test whether investment in waiting time reduction would be beneficial in terms of improved health outcomes, we have undertaken a randomized controlled trial.
This trial has examined the health impact of a reduction in rationing by delay for non-urgent referrals to a rheumatology service [3]. Non-urgent new patients were randomized either to an ordinary out-patient appointment with a mean waiting time of about 15 weeks or to an intervention arm in which they received a fast track appointment reducing their waiting time to approximately 6 weeks. The health status of each group and the resources incurred were measured at baseline, the time of their appointment and again 1 month post-appointment and 15 months post-referral. The hypothesis tested was that current waiting times do not adversely affect the health status of patients with non-urgent conditions. The secondary aim was to examine the effect of waiting time on economic costs from a societal perspective.
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Methods |
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Patient population
All general practitioner (GP) referral letters are graded urgent, soon or routine, by a consultant or experienced registrar, on the basis of the clinical information provided and using criteria which are locally agreed and made known to all local GPs [5]. These criteria are by necessity simple but practical, and their application is very dependent on the quality of the information provided. The criteria are urgentactive/acute recent onset inflammatory disease; soonpatients with subacute problems, e.g. poorly controlled rheumatic disorder needing management review, or non-urgent diagnostic problems; routinechronic non-acute problems, e.g. cervical spondylosis, soft tissue or regional disorders. Patients given an urgent priority are currently seen within 6 weeks and were excluded. Those eligible for entry to the trial were any new patients referred to either of two consultant rheumatologists or to any doctor, who had been allocated to a non-urgent (soon or routine) appointment and were over 18 yr of age. Eligible patients were randomized off-site by telephone, using consecutive sealed envelopes, either to an ordinary out-patient appointment or to a fast track appointment. To accommodate the fast track patients, additional clinic appointments were made available each week.
Recruitment and informed consent
Because waiting time was the main intervention under investigation, consent to gather health status and other data was obtained from patients after they had been randomized into either a fast track or ordinary appointment; patients remained blind to the randomization procedure and intervention. Recruitment continued until 250 patients had been randomized. Patients who declined to participate did not have their allocated appointment changed. The protocol received institutional ethical approval.
Health status assessment
Patients were mailed their appointment, consent form and a baseline set of health status questionnaires to be completed and returned as soon as possible if they consented. Further questionnaires were completed on the day of the booked clinic appointment, 1 month post-appointment and 15 months post-referral. Patients were asked to complete health status questionnaires without assistance. Non-respondents were sent a second letter within 14 days and also telephoned. If still no response was obtained, details of the patients' age and sex were recorded.
Pain and physical function were the primary health outcome indicators and were assessed using a visual analogue pain scale (VA-pain) [6] and the SF12 physical component summary score (SF12-PCS) [7]. The VA-pain scale measures joint pain on a 100 mm visual analogue scale where a score of 100 indicates worst possible pain and 0 no pain. The SF12 scores are expressed as T-scores with standardized normal population mean of 50 and standard deviation () of 10. Low scores indicate worse health.
Secondary outcome measures were collected, including the SF12 mental component summary score (SF12-MCS) [7], the Hospital Anxiety and Depression scale (HAD) [8], EuroQol (EQ-5D) [9] and the modified Health Assessment Questionnaire (MHAQ) [6]. The SF12-MCS and the HAD both measure psychological distress, the SF12-MCS is expressed as a T-score, whilst the HAD ranges from 0 to 42, 0 indicating no symptoms of anxiety or depression. The EQ-5D is a generic measure of health-related quality of life [9]. Part I of EQ-5D is a questionnaire from which a value for health utility can be obtained by applying preference weightings [10] and part II is a visual analogue scale. The utility scores (EQ-5Dutility) value health on a scale from 0 to 1, where 1 represents perfect health and 0 represents death. The visual analogue scores (EQ-5D VAS) indicate perceived health and range from 0 (worst imaginable health) to 100 (best imaginable health). The MHAQ is scored from 0 to 3, high scores represent worse disability.
Clinicians remained blind to all assessments. If one or two items were missing from any questionnaire, the patient was asked if they would complete them. If more than two items were missing no such attempt was made and the questionnaire was rejected as invalid. Published SF12 scoring rules were followed [7].
Age, sex, post code, provisional diagnosis of inflammatory or non-inflammatory disease based on GP referral letter, and the final diagnosis after consultation were recorded.
Economic data collection
At each time point employment status was categorized as employed, self-employed, looking after family, sick and either intending or not intending to seek work, retired or performing alternative unpaid work. Those in employment were asked how many hours/week they worked. Health resource use in the community was recorded as the number of visits patients made to National Health Service or other health workers (GP, nurse, physiotherapist, occupational therapist, osteopath, chiropracter, etc). This information was obtained by asking patients, at the clinic and follow-up assessments, to recall the number of visits made to health professionals during the preceding month. Health resource use arising as a direct result of the consultation, i.e. laboratory investigations (haematology, biochemistry, immunology), radiology, procedures, prescribed drugs and orthotics, referral to other specialists or paramedicals, was also recorded.
Patients were asked about expenditure on over the counter (OTC) medication, medical aids, home adaptations and alternative therapies for a 1-month period at baseline and at the end of the study.
Statistical methods
To test the hypothesis that waiting time did not adversely affect the health status of patients awaiting their appointment, the largest acceptable clinical differences between groups were chosen as 15 mm on the 100 mm VA-pain scale or a five-point difference on the SF12-PCS. Seventy subjects are required per group to detect these differences with a power of 90% for the VA-pain scale and 80% for the SF12-PCS scale (alpha = 0.05, two-tailed t-test) [11, 12]. A total of 250 patients were randomized which, allowing for a 30% non-response or drop-out rate, would provide approximately 80 patients in the two arms of the trial.
Between-group comparison of change in health status over time was performed using analysis of covariance (ANCOVA). For categorical or ordinal data, non-parametric methods were used. Analyses were performed on the basis of intention to treat. Data were analysed using SPSS for Windows version 7.5.2.
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Results |
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Health status at baseline
Baseline health status questionnaires were returned promptly (mean 17 days; 95% CI 15, 20). At baseline there was no significant difference between the fast track and ordinary appointment categories either in mean age (t-test, P = 0.36), sex ratio (P = 0.41), proportion with a provisional diagnosis of inflammatory vs non-inflammatory disease (P = 0.9) or mean health status scores (Table 3).
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Effect of waiting time on health status
Two patients did not attend the first consultation, and three of the 178 who attended failed in error to complete health questionnaires. The mean waiting times were 43 days ( = ±16) for fast track appointments and 105 days (
= ±51) for ordinary appointments. One month after the consultation 154 of 178 patients (86%) completed further questionnaires; a final assessment was undertaken 15 months post-referral by 138 (77%) patients.
There was no significant difference between either arm of the study in change in health status over time measured at the clinic appointment, 1 month post-consultation (not shown) or at the final 15-month review (ANCOVA) (Table 3). There was no improvement in health status between baseline and the 1 month post-consultation assessment, but by 15 months, there were significant improvements in mean (95% CI) pain [11 (7, 16) P < 0.001], physical health status [4 (2, 5) P < 0.001], mental health status [2 (0.1, 4) P < 0.02] and health utility [0.11 (0.07, 0.16) P < 0.001] (Table 3
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Overall health change was also analysed according to final clinical diagnosis. Patients with rheumatoid arthritis showed large and significant improvements over 15 months in both of the primary outcome measures and each secondary outcome except mental health (Table 4). Those with spondylarthritis also improved in terms of physical health. Patients with non-specific arthralgia improved in mental health and health utility but in contrast, patients with osteoarthritis showed no significant improvement in any of the outcomes.
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Employment status and use of health resources
The employment status of subjects at baseline is summarized in Table 1. There was no significant change in patient's employment status or hours of work between either arm of the study over the 15 months (
2 test; P > 0.1). There was no significant difference in community resource use between fast and ordinary track groupsthese groups made a total of 171 and 157 visits, respectively, to GPs, and 136 and 83 visits, respectively, to other health professionals during the three sampling periods (P > 0.1). Use of community resources by both groups was significantly less during the final sampling period at 15 months than during the two earlier sampling periods (Friedman test P = 0.000).
At the consultation, fewer patients in the fast track group were prescribed analgesics or underwent routine laboratory tests. Thus, in the fast track group 35% of patients were prescribed analgesics compared with 55% of patients in the ordinary group (P < 0.01), and 29% underwent routine laboratory tests compared with 53% of patients in the ordinary group (P < 0.001). In both groups, those who required tests underwent a mean of 2.5 tests per patient. Prescription of other drugs, use of radiology and referral to paramedical services did not differ significantly between the two groups. The median number (range) of visits to out-patients during the study period did not differ between the fast track [1 (15)] and ordinary arms [1 (19)] (MannWhitney P > 0.1).
Patient costs
The median [interquartile range (IQR)] expenditure on home adaptations, medical aids, OTC medication and alternative therapies was £2.30 (11.60) per patient in the fast track and £1.55 (11.75) per patient in the ordinary appointment arm (P > 0.1). Expenditure on OTC items was lower at 15 months than at baseline (Wilcoxon P = 0.012), but for other items was the same during the two sample periods.
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Discussion |
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Study design
The patients in each arm of this study were well matched for all important demographic and health characteristics. The overall case mix and distribution of waiting times was typical of other UK rheumatology units and the follow-up period was sufficiently long to capture health change. The criteria used to prioritize patients were locally agreed and may differ from criteria used by other units. The method is also clearly very dependent on the quality of information provided by the GP letter and the judgement of the doctor assessing this informationboth processes are subject to error. The case mix of non-urgent appointments was dominated by non-inflammatory disease and only 14 patients (8%) had rheumatoid arthritis. In contrast, an audit of urgent appointments showed that the majority (70%) had inflammatory disease and 26% had rheumatoid arthritis. Thus, although there was clearly a failure rate in our selection process, it was not unduly high.
Using a target of 6 weeks the mean waiting time was reduced in the fast track group to 43 days compared with 105 days in the ordinary group. While this was perhaps not a large absolute reduction, it was associated with a major shift in the distribution of waiting times. The result was that virtually all fast track patients were seen within 13 weeks compared with less than 50% in the ordinary appointment group.
A sampling method was used to estimate community costs because it was not considered practical to ask patients to maintain diaries on expenditure and use of community services for the whole 15 months. Although our data suggest it is unlikely, we cannot exclude the possibility that we have failed to capture additional demands placed on GPs and community health services while patients were waiting for their appointment.
Although no change in employment status was found, we did not document days lost from work due to sickness. There are methodological difficulties in identifying the impact of sickness on productivity [13, 14]. For example, it may be difficult to determine whether days off sick are directly attributable to the illness, social factors or even misguided advice from other health professionals. Conversely, some patients may avoid taking time off, but work at a much lower capacity. Quantifying this loss of productivity is therefore difficult and for these reasons we chose the cruder but less ambiguous end-point of actual change in work status.
Health change
With respect to health benefits, it could be argued that those patients who benefited from treatment in the fast track arm received that benefit some 6 weeks earlier. This issue would be of most importance to the small number of rheumatoid arthritis patients, who showed the biggest clinical improvement. However, this earlier benefit can only be assumed since our trial design did not permit a detailed study of the time course of health change. Also the numbers in the diagnostic subgroups were small and comparisons of outcome between these groups should therefore be interpreted with caution. None the less these data emphasize the need to identify, at the time of referral, patients who may have rheumatoid arthritis and who require more urgent specialist attention.
Waiting lists and referral thresholds
Musculoskeletal disease is a common and important public health problem [15, 16], and represents one area where long waiting times have been particularly evident. Demand for specialist services is high and in many units, including our own, is controlled using a triage system giving different priority to different clinical problems, resulting in waiting times which greatly exceed the 9-week target set in the National Health Service out-patient's charter. It appears that where demand for more rheumatology resources has been met by increased provision of consultants, the effect has been to reduce both waiting times and the threshold for referring patients with, arguably, less serious complaints [17, 18]. However, there is no evidence that shortening waiting times has a beneficial effect on health or reduces disability in this group of patients, and the direct and indirect costs and benefits are unknown. In patients with less severe forms of osteoarthritis, for example, conservative interventions have only limited benefit [19] and it should be possible to deliver these at primary care level. It may therefore reasonably be asked to what extent rising demand for musculoskeletal services should be dealt with by increasing resource allocation rather than by continuing control through waiting lists and clinical prioritization?
Implications for health policy
We believe that this is the only randomized controlled trial to have explicitly tested the impact of waiting on health and our results may have significant consequences for health policy. A long waiting time may not affect health status, but is, at the very least, inconvenient to the individual patient. In the 1997/1998 year, the median waiting time in Lothian for new referrals to consultant-led out-patient clinics was 63 days with 32% of patients waiting longer than 13 weeks and 8% waiting longer than 26 weeks. These times are comparable to other UK units. Waiting lists of this magnitude are difficult to reduce and despite the government introducing a number of high profile waiting list initiatives during recent years the effects appear to be only temporary. Referral thresholds are dynamic [17, 18] and evidence from other centres [20], and anecdotally from our own is that reduction of waiting times is short lived both because this encourages additional referrals and because there is a rising background demand for rheumatology out-patient appointments [21]. The policy implication is that waiting lists will only be eliminated by a substantial increase in capacity so that any patient can be seen at any referral threshold. Given that this is unrealistic, and the evidence that waiting is not detrimental to the health of non-urgent patients, a delay may be efficient in that it ensures that urgent cases are seen promptly and that hospital services are used to capacity. For less serious rheumatic complaints, further work exploring patient preferences and attitudes is clearly needed to inform policy on access to health care. Patients may prefer additional resources to be spent on improving aspects of care other than waiting lists. The only conclusion that can be drawn from these data is that longer waiting times, within the limits studied, do not compromise the health status of non-urgent referrals and do not increase economic costs. Thus, investment aimed solely at reduction in waiting lists is an inefficient use of resources. Investment in waiting time reduction would be better directed at improving services for specific conditions such as rheumatoid arthritis, for which there is evidence that early intervention is beneficial [22, 23].
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Conclusions |
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Acknowledgments |
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Notes |
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References |
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