Cost assumption decision: the evidence-to-decision framework, using the example of TENS
Using the example of pain treatment using transcutaneous electrical nerve stimulation (TENS), this Cochrane Corner illustrates how the GRADE* evidence-to-decision framework is used to help insurance carriers make decisions about the assumption of costs for treatment when the evidence from research is not conclusive. *GRADE stands for Grading of Recommendations, Assessment, Development and Evaluations (GRADE)
Content
The case
In your capacity as cost manager for an accident insurance provider, you have determined an increase of 30 per cent in prescriptions for transcutaneous electrical nerve stimulation (TENS) devices to treat neuropathic pain in the last six months. This rise could impact your budget. You determine that the increase in prescriptions comes from a pain centre and two practice groups specialising in the treatment of patients with spinal cord injuries, lumbar radiculopathies and amputations. You arrange a meeting with the doctors from the organisations and your insurance company’s medical director to analyse the situation.
In the discussion, the doctors refer to current research findings and their personal, positive experiences regarding the efficacy of TENS to reduce pain, thereby justifying their prescription. Your own search in the Cochrane Library uncovers a systematic review on “TENS for neuropathic pain in adults” by W. Gibson et al. (1), which found less optimistic results. You instruct the internal expert insurance committee to think about the question as to whether the insurer – taking into account the body of evidence – should continue to assume the costs for TENS treatment of patients with neuropathic pain, and ask the expert committee to use the GRADE evidence-to-decision (EtD) framework to help make its decision.
Background
Neuropathic pain is a common cause of chronic pain and loss of function. It is the result of nerve damage or diseases of the peripheral nerves, such as post-traumatic injuries. Central neuropathic pain is caused by injuries affecting the central nervous system, including pain following spinal cord injuries. Medical treatment is difficult and often requires the simultaneous application of more than one treatment approach. TENS is often recommended as a way to control the pain. TENS devices provide stimulation via electrodes attached to the skin which transmit a weak electric current. When treating with TENS, a range of device settings and different treatment schedules are used (e.g. high versus low frequency, high versus low intensity, treatment over multiple days or multiple months). Accordingly, research results purporting to support the effectiveness of TENS treatment are controversial.
Methods and main finding
The studies making up the systematic review – all randomised or quasi-randomised – used very different approaches to analyse the effectiveness of TENS for treating neuropathic pain. For example, they compared TENS with placebo TENS or no treatment, with standard care – such as sensorimotor rehabilitation or manual therapy –, or they compared standard care plus TENS with just standard care. The only condition included in the review was that the TENS devices had to produce a perceptible sensation in the patients. Otherwise, all types of device settings and treatment schedules were eligible. As part of the review, the effectiveness analysis investigated the pain intensity and health-related quality of life endpoints, the use of analgesics and adverse effects.
Eight studies investigated patients with injuries or symptoms with a relevance to accident insurance, such as lumbar or cervical radicular pain, spinal cord injuries or phantom pain. A significant limitation of all the studies was that the patients, and in part also the clinical staff, knew which treatment they were receiving. Since pain intensity is a highly subjective experience, the lack of the blind element on the part of patients and staff impedes interpretation and reduces our trust in the results. Patients who were treated with TENS had somewhat less pain compared to the placebo TENS group. Four studies could be analysed together. When measuring pain on a visual analogue scale (VAS) from 0 to 10 points, there was an average reduction in pain intensity by 1.88 points (95% confidence interval: 2.29 points to 1.38 points).* An improvement on this scale is generally considered to be relevant to patients. The majority of studies that compared TENS with standard care found no difference in the pain measurement results. In some cases, standard care even showed a better reduction in pain intensity than TENS. None of the studies reported on health-related quality of life or the use of analgesics. The side effects were minor and limited to slight skin irritations caused by the electrodes.
*Re-analysis of four studies on spinal cord injuries/radicular pain. The fifth study on post-herpetic pain (Barbarisi 2010), which was included in the Cochrane Review, was excluded due to the indication of “post-herpetic pain”.
Authors’ conclusions
On the whole, it remains unclear as to whether TENS treatment is successful in alleviating pain. Therefore, there is also no certainty regarding the role of TENS in treating neuropathic pain. This conclusion can be traced back to the very low quality of the studies. Future studies exhibiting a higher quality may mean that today’s findings change drastically.
Evidence does not make decisions, people do:
The GRADE evidence-to-decision framework as a decision-making aid regarding the assumption of benefit costs by the insurer
The GRADE evidence-to-decision framework (2, 3) is designed to support users of evidence in systematically and transparently evaluating studies to make clinical recommendations and decisions for patient care, public health interventions or measures within the healthcare system. Nowadays, many health and accident insurers have an expert committee that prepares the content of the recommendations and carries out the assessment using the framework, and a committee of decision-makers that ultimately makes the decision.
The framework is applied in three steps: defining the research question (box), assessing the 12 criteria (table 1) that need to considered in the context of the assumption of costs by the insurer and should be addressed using research evidence and other evidence (e.g. resources and costs) (table 2) and, based on this, formulating conclusions. As well as this, the expert committee often provides thoughts on implementation, monitoring, re-evaluation of decisions and the need for more research. At this point, we provide a short overview of the EtD framework and apply the 12 criteria to our case as an example. All criteria have four to seven pre-defined possible responses. These serve to ensure the assessments of the expert committee are clearly communicated to the decision-makers.
Table 1: The 12 criteria of the evidence-to-decision framework for assumption of costs decisions
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Application of the EtD framework on the example of TENS for neuropathic pain
BOX: Formulation of the problem as a structured question with the most important aspects that should be addressed during the process
Question: Should an accident insurance provider (continue to) assume the costs for TENS treatment in the case of patients with neuropathic pain?
Patients:
- Insurees with neuropathic pain
Intervention:
- Treatment with transcutaneous electrical nerve stimulation (TENS)
Comparison:
- Standard care
Main findings:
- Pain intensity, (health-related) quality of life, use of analgesics, undesirable effects
Setting (context):
- Accident insurer/social insurer
Role (perspective):
- Cost bearer which is obligated to uphold the criteria of effectiveness, efficiency and economy (EEE) when assuming the costs of services
Table 2: Example application of the EtD framework on the question of cost assumption for pain treatment using TENS devices. The expert committee addresses the research question using the Cochrane Review “Transcutaneous Electrical Nerve Stimulation (TENS) for neuropathic pain in adults (1)”, internal utilisation and resource analyses and considerations regarding the acceptance of the decision options among the various interest groups, and justifies the decisions it makes.
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The 12 decision criteria of the EtD framework |
Justification: Findings from research and other considerations |
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1. Problem Is the problem a priority?
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Treating neuropathic pain is a challenge, as patients often do not achieve a satisfactory level of pain control. The intensity of the pain often requires the use of pharmacological and non-pharmacological measures to treat the pain. |
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2. Desired effects How substantial are the desirable anticipated effects?
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In light of the low quality of the studies and contradictory effects identified (some studies report less pain in the TENS group, others report less pain in the control group), the systematic review was not able to reach a reliable conclusion as to whether TENS is effective in treating neuropathic pain or not. Neither effectiveness nor non-effectiveness have been clarified. |
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3. Undesirable effects How substantial are the undesirable anticipated effects?
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The review found only minor skin irritations as an undesirable effect. |
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4. Trust in the evidence What is the overall certainty of the evidence of effects?
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Due to the very low quality of the studies, the trust in the evidence is very low. Future studies exhibiting a higher quality will likely find effects that differ considerably from the effects found in this review. |
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5. Values Is there important uncertainty about in how much people value the main outcomes?
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Patients with neuropathic pain often suffer very high levels of pain. All patients value satisfactory pain control and improved health-related quality of life as a minimum. There is good reason to assume that these endpoints are of great importance to all patients. |
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6. Weighting of desired and undesirable effects Does the balance between desirable effects and undesirable effects favour the option or the caparison?
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According to the review, the undesirable effects are trivial, even though not all studies addressed side effects. There is no meaningful evidence regarding the desired effects (pain reduction, quality of life, reduction in intake of pain medication). |
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7. Resources required How large are the resource requirements (costs)?
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The prices of TENS machines on the market lie between CHF 12 and 250. The assumption of costs for purchased devices is approx. CHF 200 per case and approx. CHF 36 per case for rented devices. Overall, considerably more devices are rented than purchased. |
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8. Trust in the evidence regarding the need for resources What is the certainty of the evidence of resource use?
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Selective detailed analyses show that the treatment method is becoming increasingly important. However, the effective use of this treatment method is difficult to assess, owing to different billing methods and a substantial number of direct payers. |
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9. Cost-effectiveness of the intervention Does the cost-effectiveness of the option favour the option or the comparison?
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There are currently no formal cost-effectiveness analyses as effectiveness is unclear. If, in the absence of data on effectiveness, it were urgently required, such an analysis could be carried out using various assumptions on effectiveness and costs and various typical clinical scenarios could be calculated, such as the option of assuming the costs for a TENS machine versus renting a TENS machine. |
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10. Impacts on the distributional justice in healthcare What would be the impact on health equity?
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As long as the effectiveness of the measure is not clear, none of the two decision options (cost assumption yes or no) would have an impact on distributional justice within the healthcare system. |
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11. Acceptance among important interest groups Is the option acceptable to key stakeholders?
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A decision against continued cost assumption would likely be unacceptable for injured persons, pain therapists, patient representatives, manufacturers and various expert medical societies. A decision in favour of continued cost assumption may not be desired from the insurers’ point of view and would need to be weighed up against other advantages (cost savings, albeit minor) and disadvantages (reputational damage). |
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12. Feasibility of implementation Is the option feasible to implement?
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Continuation of cost assumption: This decision would not need to be implemented. Options: case-by-case decisions by case manager or insurance physician; the administration costs for case-by-case decisions could be higher than simply assuming the costs of a rented machine. Revoking the assumption of costs with reference to non-compliance with the criteria of the three Es – effectiveness, efficiency and economy – could lead to protest on the part of the interest groups and end in reputational damage for the insurers, with potentially very low savings in resources. Interest groups may point to the fact that, due to the unresolved effectiveness, injured persons could potentially be denied an effective treatment. |
Resolving the case
After working through the criteria, the expert committee recommends that the decision-makers continue to assume the costs of TENS treatment. The most important considerations are: Neuropathic pain can negatively impact an injured person’s quality of life, daily activities and even capacity to work; the benefits of TENS to alleviate pain intensity are unknown, but some patients can experience positive effects. There are no serious undesirable events. The cost assumption for purchasing a machine is quite high, whereas renting a machine is a practical and already well-accepted alternative. Overall, the care may not have significant effects on your budget.
The implementation and provision of TENS do not represent any challenges, while ceasing to assume the costs of TENS could lead to reputational damage with very low gains for the insurers. However, the expert committee recommends that TENS should only be prescribed by pain specialists. Moreover, patients with neuropathic pain should be informed of the uncertainties surrounding the effectiveness of TENS. The treatment costs department will continue to review and monitor TENS prescriptions and their impact on the budget.
Disclaimer:
As a technology that is established within the care of pain patients, even though there is no certainty regarding its effectiveness in reducing pain, TENS is well-suited to illustrate the evidence-to-decision framework for decisions on cost assumption for insurers.
Abbreviations
TENS Transcutaneous electrical nerve stimulation
EtD framework Evidence-to-decision framework
GRADE Grading of recommendations, assessment, development and evaluations
EEE Effectiveness, efficiency, economy
Correspondence address
Cochrane Insurance Medicine
Department of Clinical Research | University and University Hospital Basel
Spitalstrasse 8+12
4031 Basel
1 Regina Kunz, Insurance Medicine Competence Centre, Suva Lucerne
2 Michael Widmer, Treatment Cost Management, Insurance Benefits Division, Suva Lucerne
Bibliography
- Gibson W, Wand BM, O'Connell NE. Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults. Cochrane Database Syst Rev. 2017;9:CD011976.
- Nussbaumer-Streit B, Grillich L, Glechner A, Affengruber L, Gartlehner G, Morche J, et al. GRADE: Von der Evidenz zur Empfehlung oder Entscheidung – ein systematischer und transparenter Ansatz, um gut informierte Entscheidungen im Gesundheitswesen zu treffen. 1: Einleitung. Z Evid Fortbild Qual Gesundhwes. 2018;134:57-66.
- Lietz M, Angelescu K, Markes M, Molnar S, Runkel B, Schell L, et al. GRADE: Von der Evidenz zur Empfehlung oder Entscheidung – Entscheidungen zur Kostenerstattung. Z Evid Fortbild Qual Gesundhwes. 2020;150-152:134-41.
Further English-language literature
Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, et al and the GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016;353:i2016. doi: 10.1136/bmj.i2016.
Parmelli E, Amato L, Oxman AD, Alonso-Coello P, Brunetti M, Moberg J, et al. GRADE: Evidence to Decision (EtD) framework for coverage decisions. Int J Technol Assess Health Care. 2017;33(2):176-82.