- Research article
- Open Access
- Open Peer Review
This article has Open Peer Review reports available.
The use of risk sharing tools for post adoption surveillance of a non pharmacological technology in routine practice: results after one year
- Carlos Campillo-Artero†1Email author and
- Francisco M Kovacs†2, 3
https://doi.org/10.1186/1472-6963-13-181
© Campillo-Artero and Kovacs; licensee BioMed Central Ltd. 2013
Received: 30 April 2012
Accepted: 13 May 2013
Published: 20 May 2013
Abstract
Background
To report results obtained by combining risk sharing tools with post-adoption surveillance mechanisms in order to control quality of care and implement a value-based reimbursement scheme for Neuro-reflexotherapy (NRT), a non-pharmacological treatment proven effective for neck pain (NP), thoracic pain (TP) and low back pain (LBP).
Methods
Pre-post prospective cohort study in routine clinical practice, carried out in primary care centers in the Spanish National Health Service in the Balearic Islands (Ib-Salut). Eight-hundred and seventy-one subacute and chronic NP, TP and LBP patients treated in Ib-Salut, who underwent NRT during 2011. A shared risk contract (SRC) was developed, where payments for NRT were linked to results on patients’ clinical evolution, reduction in medication and proportion of patients undergoing spinal surgery. Main outcome measures were local pain (NP, TP or LBP), referred pain, LBP-related disability and NP-related disability, measured using previously validated instruments at referral and 3 months later, use of medication assessed at referral and discharge, and rates of spinal surgery prescription after undergoing NRT.
Results
Median improvements at discharge corresponded to 57.1% of baseline value for local pain, 75.0% for referred pain, 53.8% for LBP-related disability and 45.0% for NP-related disability. Patients taking medication at discharge represented 29.0% of those taking it at referral. The proportion of patients in whom spinal surgery was prescribed after undergoing NRT was 0%. These results were consistent with those from previous randomised controlled trials (RCTs) and studies in routine practice, and complied with the standards set in the SRC.
Conclusions
It is feasible and effective to enhance post adoption surveillance methods with risk sharing tools to improve quality control and support value-based reimbursement decisions for NRT. The feasibility of generalising this approach to other settings and to other non-pharmacological treatments should be explored.
Keywords
Background
Clinical use of health technologies depends on regulatory frameworks which vary across countries. Nevertheless, the inappropriate use of both pharmacologic and non-pharmacologic procedures is widespread all over the world, leading to patients being unnecessarily exposed to potentially harmful procedures and risks, and to superfluous health costs [1–12].
The objective of shared risk contracts (SRCs) is that payers and providers share the risks deriving from the uncertainties associated with using a given health technology in routine practice. To this end, SRCs link payments to providers to whether results in practice reach pre-established goals. Providers may include health care providers or, more commonly, providers of products (e.g., the industry). The pre-established goals can be defined by levels of usage of a given technology, appropriateness of use, and/or clinical outcomes [13–18]. For instance, following a SRC payments for a new drug can be partially or totally reduced if clinical outcomes in routine practice do not reach the cut-off point previously established in the SRC.
Typically, SRCs have been developed as a pragmatic way of ensuring coverage for new drugs, usually highly expensive ones, designed to treat serious conditions, when: a) existing treatments have not shown to be effective, b) the evidence on the effectiveness and cost/effectiveness of the new drugs is either lacking or of low quality, and c) conducting high quality randomised controlled trials (RCTs) within a reasonable timeframe is unfeasible. Examples include conditions with a relatively low incidence or for which long follow-up periods are necessary for results to be clinically meaningful [19–21].
In these cases, SRCs allow the health system to provide treatments which are potentially effective or more cost-effective than existing alternatives, while: a) gathering data to assess whether the corresponding investment actually leads to expected outcomes (i.e., “coverage with evidence development” schemes), b) providing information for value-based pricing, c) limiting potential wastage of payers’ resources, by sharing costs with providers in the event that the technology does not reach expected outcomes, and d) strengthening post adoption surveillance.
When pharmacological or non-pharmacological technologies are implemented in routine practice, application conditions often vary from those used in RCTs. These differences may include training standards, indication criteria (such as “off label” use and other forms of treatment extension effects), and variations in compliance. As a result, outcomes (including adverse events) in clinical practice can deviate from those in previous RCTs.
Non-specific neck (NP), thoracic pain (TP) and low back pain (LBP) represent a major clinical, social and economic burden in industrialised countries [16, 22–28]. In routine practice, many treatments are used for these conditions, although very few are supported by solid evidence on efficacy, effectiveness, safety and cost/effectiveness [29–31].
Neuro-reflexotherapy (NRT) is one of the few LBP treatments supported by high quality evidence [32–35]. It involves temporary (up to 90 days) subcutaneous implantation of surgical material on specific trigger points [32–35]. The intervention is unrelated to acupuncture and is designed to deactivate the neurons involved in the mechanisms which prolong pain, neurogenic inflammation, and muscle dysfunction and contracture [20–23]. A more detailed description of the procedure and the mechanisms explaining its effect, have been published elsewhere [33]. The evidence available, including the corresponding Cochrane review, shows that NRT is safe, more effective than a sham procedure (i.e., implanting the same number of surgical devices ≤ 5 mm around the specific trigger points), and that its use in routine practice significantly increases the effectiveness and cost/effectiveness of treatment for subacute and chronic LBP in Spain, and specifically within the Spanish National Health Service [32–35]. All the evidence-based clinical guidelines which have reviewed the quality of the evidence on NRT, have rated it as “high” [29, 30, 36–39] In fact, NRT is the only non-pharmacological therapy for LBP for which the net benefit is considered to be “substantial” by the evidence review supporting the US evidence-based clinical guidelines for LBP [39]. Moreover, all the guidelines covering the geographical settings where the procedure was available have recommended its use in clinical practice [36–38].
The Spanish National Health Service (SNHS) provides free health care to every resident in Spain. The SNHS is managed at the regional level and fully financed by taxes, although regional governments can implement local taxes or copayments to provide additional funding. Decisions on coverage of non-pharmacological technologies can be made at the regional or national level.
In 2004, NRT was implemented in routine practice of the SNHS in the Balearic Islands (Ib-Salut) for treating subacute and chronic patients with non-specific NP, TP and LBP, in the same applications conditions and under the same post-adoption surveillance methods in which it had been previously assessed and test-piloted [32–35, 40–43]. The latter were designed in such a way that they do not interfere with routine practice; clinicians routinely gather all relevant data using validated instruments (e.g., pain severity, disability, etc.), and introduce them in a software package specifically designed for that purpose [40–43].
The implementation of NRT was based on a fee-for-service; the Ib-Salut paid providers a fixed amount for each patient referred for NRT who underwent the procedure, and a different amount for each patient who was referred but did not receive NRT (e.g., when patients did not comply with indication criteria or refused to sign the informed consent). However, in 2010, the Ib-Salut and providers agreed to enhance post-adoption surveillance methods by using risk sharing tools in order to improve quality of care and to support value-based reimbursement decisions, starting January 1st, 2011. The objective of this study was to describe these tools and their results one year after their implementation.
Methods
Study population
Patients with “red flags” suggesting that pain might be caused by fractures or systematic diseases (such as fever or unexplained weight loss), could be referred to NRT only once these conditions had been discarded (Figure 1) [22, 29, 30, 34, 40, 41].
All patients undergoing NRT following referral from Ib-Salut during 2011, and discharged before December 31st, 2011, were included in this study. Patients in whom adverse events required early extraction of the surgical material, were identified and excluded from the analyses.
Shared risk tools
Following the clauses established in the contract, the provider invoiced the Ib-Salut 48.57 € for each patient referred for NRT when the procedure was not performed, and 615.28 € for each NRT intervention. These prices match those which the Ib-Salut is invoiced for in routine practice. They were based on the costs associated with NRT in the RCT which showed this technology to be cost/effective [33], and have been adjusted for inflation thereafter.
Fixed payments represented 50% of the amount invoiced. Variable payments corresponded to the remaining 50%, payable only if results reached the standards defined in the contract.
The variable amount broke down as follows: reaching the standards for clinical evolution implied payment of 50% of the variable amount; reaching the standards on the reduction of use of drugs, 30%, and reaching the standards on rates of spinal surgery, 20%. For instance, if results did not meet any of the standards, only 50% of the invoice (the fixed amount) would be paid; if only the standards on pain and disability were met, only 75% of the invoice (the fixed amount plus 50% of the variable amount) would be paid.
The Ib-Salut defined three sets of standards; clinical standards for patients’ clinical evolution; standards for the reduction of medication intake; and standards for the proportion of patients in whom spinal surgery was prescribed after undergoing NRT.
Clinical standards focused on the most important clinical outcomes for patients with NP, TP or LBP: local pain (NP, TP or LBP), referred pain, and disability [45]. The standards for each of these variables was established by the person designated by the Ib-Salut for this task (CC-A), in collaboration with the first author of the studies which had identified the cut-off point for clinical relevance for these variables in Spanish LBP and NP patients (FMK). This cut-off point corresponds to 30% of baseline score of the corresponding variable (local pain, referred pain or disability), and matches the cut-off established in other settings [46–49]. Therefore, these standards were considered to be met if the median improvement at discharge for each one of these variables was ≥ 30% of baseline score [46–49].
Standards for reduction in medication and for the proportion of spinal surgery among NRT patients, were established in three phases. Firstly, the Ib-Salut defined the ideal standards which, if met, would generate savings above the cost of NRT. Subsequently, the person designated by the Ib-Salut for developing this SRC (CC-A), In collaboration with the first author of the RCTs on NRT (FMK), verified that these standards were realistic, based on the effect size reported for NRT in: these RCTs, previous studies conducted in routine practice, the Cochrane systematic review, and the evidence-based clinical guidelines [29, 32–35, 39–43, 50]. Finally, since the reported effect size was equal or above the ideal standards defined by the Ib-Salut, they were accepted by the provider and incorporated into the contract. Previous studies had shown that adverse events from NRT were minor (essentially, transient skin itching or limited skin infection) [32–35, 40–43]. Therefore, the contract did not include standards for adverse events. Nevertheless, the number of patients in whom adverse events required the extraction of the surgical material, was documented.
Standards for the use of medication focused on patients’ intake of non-steroidal anti-inflammatory drugs (NSAIDs), steroids, non-opioid analgesic, codeine, other opioids, anti-epileptic drugs, and muscle relaxants. Only use for NP, TP or LB was considered. The Ib-Salut established these standards as either: a) for each type of drug, the number of patients using it at discharge was ≤ 80% of those using it at baseline, or b) the number of patients using any of these drugs at discharge was ≤ 80% of those who did so at baseline.
Decompressive spinal surgery has proven effective for patients in whom conservative treatment fails to significantly improve radicular pain caused by disk herniation within 6 weeks, or caused by spinal stenosis within 3–6 months [45, 51–56]. Although the effectiveness of spinal fusion for LBP patients without radicular pain remains controversial [30], it is still considered when conservative treatments fail for ≥ 2 years [29]. These types of patients, are often referred to NRT as the “last resource” to avoid surgery [41, 43, 57]. Therefore, the Ib-Salut established that standards for the proportion of spinal surgery among NRT patients would be met if surgery, for the reason for which patients had been referred for NRT, was prescribed to ≤ 20% of the subjects who underwent the procedure.
Standards were assessed when patients were discharged, 3 months after having undergone the NRT treatment. Reaching the standards for each of the clinical outcomes (local pain, referred pain, NP-related disability and LBP-related disability) implied payment of 12.5% of the variable amount. Disability was not taken into account among TP patients because validated instruments to measure TP-related disability do not exist. Reaching the standards for reduction of medication intake implied payment of 30% of the variable amount, and reaching the standards for the proportion of NRT patients in whom spinal surgery was subsequently prescribed implied payment of 20% of the variable amount.
Intervention
Following the application conditions in which NRT had proven effective, safe, and cost-effective [40, 51, 57], specialists at the NRT units assessed indication criteria. Patients complying with indication criteria were presented written informed consents for undergoing NRT and for allowing the use of their data for this study. Units in which the interventions were performed, and physicians who performed them, had been certified following specialised professional standards [58]. According to the Spanish law, this study did not need to be submitted to an Institutional Review Board.
In the event of experiencing adverse events (e.g., itching or skin infection), patients were instructed to contact the specialised unit or their primary care centre [32, 34, 35, 40, 41]. Cases in which adverse events led to early extraction of the material, were identified. In the remaining patients, twelve weeks after the intervention was performed the surgical material was extracted and indication criteria for repeating the NRT intervention were assessed. These criteria are: [34, 41] having improved ≥ 2 VAS points after the first intervention, pain severity still ≥ 3 VAS points, and having patient’s written consent for repeating it. Patients not meeting these criteria were discharged.
Outcome assessment
The outcome assessment was based on previously validated post-adoption surveillance mechanisms which are used in routine clinical practice [40, 41]. Primary care physicians assessed patients’ clinical condition. Referral to the certified NRT Unit was determined by them using a standardised protocol (Figure 1) [40, 41].
On patient’s first visit the following data were gathered: gender, age (date of birth); reason for referral (NP, TP or LBP); time elapsed since first diagnosis (days); duration of the current pain episode (days); and date of referral for NRT.
On the first and all subsequent visits to the primary care centre and the certified NRT Unit, the following data were gathered: severity of local pain (LP) and referred pain (RP), disability, employment status (working, receiving financial compensation for LBP, TP or NP, or passive –student, housewife, unemployed, etc.-); pregnancy; comorbidities; involvement in work-related claims; involvement in litigation; diagnostic tests undergone (X-Rays, MRI, electromyogram, etc.); test results (e.g., imaging findings), and therapeutic procedures prescribed (including drug treatment and spinal surgery).
Data on pain and disability were provided by patients. They rated these variables on their own and without assistance or interference from clinicians or auxiliary personnel. Separate 10-cm VAS were used for local pain (NP, TP or LBP) and referred pain (RP) [44]. The Spanish version of the Roland-Morris Questionnaire (RMQ) was used to score LBP-related disability [59]. The Neck Disability Index (NDI) was used to assess NP-related disability [60]. From best to worst, value ranges for these instruments are 0–10 for VAS, 0–24 for RMQ and 0–100 for NDI [44, 48, 59].
Data were introduced into a database by auxiliary staff independent from the clinicians. Clinicians had access to these data (since they are useful for clinical decisions –e.g., repeating the NRT intervention-), but could not alter them.
Every month, patients who were discharged were identified, and data on their clinical status, drug use and prescription of surgery during the follow-up period were transferred to the team in charge of analysing results.
Analysis
Analysis of results was performed by a team who had no contact with the clinicians involved in performing the interventions or with the administrative staff in charge of payments at the Ib-Salut.
Absolute and relative frequencies were calculated for categorical variables. Values for continuous variables were described through their median and interquartile range (IQR).
According to the available evidence, data on duration of the current pain episode were categorised as subacute (14–90 days), and chronic pain (> 90 days) [61, 62]. There is no evidence for categorising the time elapsed since first diagnosis. Data on this variable were categorised as ≤ 1 year, 1–5 years, 5–10 years, and > 10 years.
Analyses were limited to data from patients who had undergone NRT, excluding those who had been referred for the procedure but did not undergo it (e.g., those not complying with indication criteria), and those in whom adverse events required early extraction of the surgical material implanted. The total number of these patients was registered.
At the design phase of this study, it was decided that the number of patients with missing values for data relevant to assess whether the standards had been met (e.g., patients not answering the VAS, RMQ or NDI questionnaires) would be registered and, if ≥ 10%, a sensitivity analysis would be performed assuming that all missing data had been failures.
In order to assess whether standards were met, the following procedures were used. The median and IQR of VAS scores for local pain (NP, TP or LBP) at baseline and at the end of the follow-up period were calculated. The same procedure was repeated for the VAS scores for referred pain, the RMQ scores for LBP-related disability (including only data from patients referred to NRT for LBP) and NDI scores for NP-related disability (including only data from patients referred to NRT for NP). The number of patients who were using NSAID, steroids, non-opioid analgesic, codeine, other opioids, anti-epileptic drugs, and muscle relaxants when referred for NRT and at discharge, was determined. The number of patients using any kind of drug at baseline and discharge, was also identified. Finally, patients in whom spinal surgery had been prescribed for the reason why they had previously been referred to NRT, were identified.
The number of patients with missing data (e.g., patients who did not answer the instruments to assess pain and disability at baseline and at discharge) was also identified.
Since outcome assessment occurred 3 months after performing the NRT intervention, variable payments related were delayed for at least that period. Therefore, in order to prevent delays in payments which might have compromised feasibility of the contract, invoicing and preliminary assessment of results were performed monthly from April onwards, based on the data from patients discharged during the previous month. Analyses comprising all data of patients treated during 2011 were repeated in April 2012, when data and outcomes for all NRT interventions performed during that year became available.
Each month, the analysts assessed whether the standards had been met and listed the names of the patients discharged, grouping those who complied and did not comply with each of the standards, separately. The administrative staff of the Ib-Salut had full access to the database containing all patients’ data, checked that data on patients’ use of medication and prescription of surgery coincided with those from the Ib-Salut’s database, double-checked that lists of patients complying and not complying with the standards was correct, and verified that the global assessment of whether each standard was met, was correct. It had been planned that if discrepancies or doubts arose, providers, analysts and the administrative staff of the Ib-Salut would meet to discuss them. All data were transferred to the person designated by the Ib-Salut to monitor results from NRT (CC), who authorised the administrative of the Ib-Salut to pay the amount corresponding to the standards which had been met.
According to the post-adoption surveillance mechanisms, data were routinely captured in daily practice [40, 41]. Therefore, analyses only involved assessing whether results matched the standards established in the contract, which required less than 30 minutes per month. The team responsible for data analysts was employed full-time and paid a fixed monthly salary. Hence, the cost of conducting the analyses was considered negligible and was not measured.
Results
During 2011, 909 patients referred by the Ib-Salut for NP (244 patients), TP (61) and LBP (604), underwent NRT and were discharged before the 31st of December 2011. All patients complying with indication criteria for NRT, signed their informed consents.
Adverse events required early extraction of the surgical material in only 38 (4.2%) patients. All adverse events consisted of skin reactions; in 7 patients, they were triggered by a previously unknown allergy to metal, and in 31 cases they consisted of recurrent or persistent local skin infection, despite topical treatment with an antibiotic cream. None of the cases required systemic treatment and the reaction disappeared after the surgical devices were extracted in all cases.
Patient characteristics (n = 871)
Variables | N | Value |
|---|---|---|
Gender (male) * | 871 | 270 (31.0 |
Age (years) ¥ | 871 | 56 (45; 67 |
Reason for referral to NRT * | 871 | |
Neck Pain (NP) | 235 (26.9) | |
Thoracic pain (TP) | 60 (6.9) | |
Low Back Pain (LBP) | 576 (66.2) | |
Employment status * | ||
Passive (students, housewife, etc.) | 535 | 320 (59.8) |
Receiving financial compensation for LBP, TP or NP | 34 (6.3) | |
Working | 215 (40.2) | |
Duration of pain, since first diagnosis (days) ¥ | 763 | 2,555 (730; 4,380) |
Duration of pain since first diagnosis, categorised * | 763 | |
≤ 1 year | 136 (17.8) | |
1-5 years | 219 (28.7) | |
5-10 years | 204 (26.7) | |
>10 years | 204 (26.7) | |
Duration of current pain episode (days) ¥ | 809 | 180 (60; 365) |
Duration of current pain episode (days), categorised * | 809 | |
Subacute (≤ 90 days) | 309 (38.2) | |
Chronic (>90 days) | 500 (61.7) | |
Pregnancy * | 2 (0.3) | |
Other comorbidities * | 601 | 677 (84.4) |
Involved in work-related claims * | 802 | 14 (3.3) |
Involved in litigation * | 427 | 8 (1.9) |
Baseline severity of local pain (NP, TP or LBP) (VAS score) ¥ | 426 | 7.0 (6.0: 9.0) |
870 | 660 (75.8) | |
Reporting referred pain at baseline* | 871 | 6.0 (2.0; 8.0) |
Baseline severity of referred pain (VAS score) ¥♦ | 660 | 13 (9.0; 17.0) |
Baseline lumbar disability (RMQ score) ¥♦ | 574 | 40 (30.0; 50.0) |
Baseline neck disability (NDI score) ¥♦ | 229 | |
Diagnostic procedures undergone during the current pain episode, before being referred for NRT* | 69 (7.9) | |
X-Ray | 871 | 98 (11.2) |
MRI | 871 | 21 (2.4) |
Other¤ | 871 | |
Imaging findings * | 698 (80.1) | |
Disc degeneration | 871 | 137 (15.7) |
Facet joint degeneration | 871 | 68 (7.8) |
Scoliosis | 871 | 3 (0.3) |
Difference in leg length | 871 | 14 (1.6) |
Spondylolisis | 871 | 50 (5.7) |
Spondylolisthesis | 871 | 87 (9.9) |
Spinal stenosis | 871 | 229 (26.3) |
Disc protrusion | 871 | 340 (39.0) |
Disc herniation (extrusion) | 871 | 419 (48.1) |
Other findings ∞ | 871 | 30 (3.4) |
No findings | 871 | |
Ongoing treatments when referred for NRT | 751 (86.2) | |
Drugs* | 871 | 721 (82.8) |
Analgesics | 712 (81.7) | |
Non-opioid | 0 (0.0) | |
Codeine | 78 (9.0) | |
Other opioids | 568 (65.2) | |
NSAIDs | 25 (2.8) | |
Steroids | 132 (15.1) | |
Muscle relaxants | 164 (18.8) | |
Otherɣ | ||
Non pharmacological treatments* | 871 | 42 (4.9) |
Physical therapy/Rehabilitation | 7 (0.8) | |
Had undergone surgery for the current episode, before being referred for NRT* |
Some patients did not respond to the questionnaires on baseline severity of local pain (one patient), LBP-related disability (two patients) and NP-related disability (six patients). At discharge, some patients left some questionnaires unanswered; the VAS for local pain (one patient), the VAS for referred pain (three patients), the questionnaire assessing LBP-related disability (RMQ) (three patients), and the one assessing NP-related disability (NDI) (16 patients). Some patients left some questionnaires unanswered at baseline and discharge. The numbers for VAS for local pain, VAS for referred pain, RMQ and NDI were one, two, two and five, respectively. In total, twenty-four patients (2.8%) failed to respond to at least one of the questionnaires. Data on medication were checked against invoicing data held at the Ib-Salut, and data on prescription of surgery were checked against hospital registries. Therefore, there were no missing data for these variables.
Results on clinical outcomes (N=871)
Clinical outcome¥ | N¤ | Baseline score | Score at discharge | Improvement |
|---|---|---|---|---|
Local pain (NP, TP or LBP) (VAS) | 870 | 7 (6–9) | 3 (1–5) | 57.1% |
Referred pain (VAS) ♦ | 657 | 6 (2–8) | 1.5 (0–4) | 75.0% |
LBP-related disablity (RMQ) ♦ | 573 | 13 (9–17) | 6 (2–12) | 53.8% |
NP-related disability (NDI) ♦ | 219 | 40 (30–50) | 22 (15–34) | 45.0% |
Results on the use of medication (N=871)
Patients using medication | At baseline | At discharge | Proportion of patients using medication at discharge |
|---|---|---|---|
Any type | 751 | 218 | 29.0% |
NSAIDs | 568 | 125 | 22.0% |
Analgesics* | 712 | 198 | 27.8% |
Muscle relaxants | 132 | 13 | 9.9% |
Other drugsɣ | 145 | 32 | 11.9% |
Results on rates of spinal surgery prescribed after NRT intervention
Patients who underwent NRT | Patients in whom surgery was prescribed after having undergone NRT | % |
|---|---|---|
871 | 0 | 0 |
There were no discrepancies between providers, analysts and the administrative staff of the Ib-Salut. Given these results, the Ib-Salut paid 100% of the amount invoiced for NRT interventions.
Discussion
Shared risks contracts (SRCs) have taken center stage in the regulatory framework related to the adoption of new technologies, and numerous publications have described them in depth, reporting many obstacles for their generalisation into routine practice [63–70]. These obstacles include: providers and the industry can perceive SRCs as a threat to their income, which may stifle research and innovation; payers may be unenthusiastic because of the added burden in their administrative workload; in the case of certain technologies, concerns may exist over the balance between potential savings and monitoring costs; follow-up of relevant outcomes through validated instruments in routine practice may be difficult; and SRCs may be used for implementing technologies which lack evidence on effectiveness in specific geographic areas, while patients are denied access to them in other settings, leading to inequities across health areas within a single Health Service [13–18, 71, 72].
NRT was selected for exploring the feasibility and effectiveness of using risk sharing tools for quality control and value-based reimbursement of a non-pharmacological technology in Spain, because it complied with the following three requisites: a) the efficacy, effectiveness and cost/effectiveness of the procedure had been assessed through high quality RCTs and studies in clinical practice [32–35, 40–43], which made it feasible for the contract to establish evidence-based, realistic standards, b) it had been implemented in routine practice in the same application conditions which were used in those studies, with the same indication criteria and education and training standards [32–35, 40–43, 58], c) post-adoption surveillance mechanisms already existed and had shown to be comprehensive and valid [40–42], which made it possible to use risk sharing tools at virtually no additional cost. Generalising this approach to technologies which do not comply with these pre-requisites may be difficult and require additional costs. However, results from the current study show that it is indeed feasible to use this approach for a non-pharmacological health technology, and set a precedent for exploring the feasibility of generalising this approach to other treatments for NP, TP and LBP, and potentially treatments for other conditions across the SNHS.
Many treatments for NP, TP and LBP, such as some rehabilitation or surgical procedures [1, 30], are not supported by solid evidence on effectiveness and cost/effectiveness, but are nevertheless used in routine clinical practice, both in Europe and the US, without any post-adoption surveillance mechanisms. Applying the approach described in this study to these technologies may prove challenging, but may also lead to larger savings and potentially better outcomes and reduced risks for patients. In fact, available data suggest that, for instance, the use and cost of spinal fusion for common low back pain are soaring, without any evidence that this increase is associated with an improvement in clinical outcome [26, 73]. Implementing post-marketing surveillance mechanisms for each of these technologies separately may be more efficient in the case of the most expensive technologies, such as spinal fusion [26], than in the case of low-cost ones, such as some physical therapy treatments [1]. A more efficient strategy might be to establish a prospective registry for patients with NP, TP and LBP, gathering data on all procedures relative to their condition. In fact, one of the top priorities recommended by the Institute of Medicine for investing the $1.1 billion devoted to comparative effectiveness research by the 2009 American Recovery and Reinvestment Act, was to “establish a prospective registry to compare the effectiveness of treatment strategies for low back pain without neurological deficit or spinal deformity” [74]. A pilot test in 17 primary care and specialty centres, shows that it is feasible to implement a valid registry for these patients within the SNHS [75]. Generalising this registry might facilitate the use of risk sharing tools for quality control and value-based reimbursement.
The follow-up period in this study was 3 months, which may be seen as relatively short. However, NRT focuses on treating the current pain episode, not on preventing relapses, and this period appears to be clinically relevant and appropriate for this purpose. In fact, the prognosis of chronic low back pain is determined by changes in pain and disability occurring in the initial period [76]. Moreover, previous studies have shown that NRT can be repeated if relapses occur, although the proportion of subjects who suffer from relapse after NRT within three years, is below 10% [41]. In addition, three months is the clinical follow-up period which has been used in most studies on NRT in routine practice and, therefore, the follow-up period for which data on results to be expected were available when this study was developed [40–43]. Finally, studies with NP and LBP patients conducted in routine practice within the Spanish National Health Service have shown that losses to follow-up are minimal up to 3 months [34, 43, 60, 61, 77, 78], but start to rise at 6 months [61, 77–79], and are substantial thereafter [34, 78]. For these reasons, a 3-month follow-up period was deemed appropriate when designing this study.
Validity of data determining whether standards established in the agreement have been met (Tables 2, 3 and 4) should be discussed. Patients’ clinical evolution was assessed through previously validated methods [44, 48, 59], and are consistent with data from previous RCTs and studies in clinical practice [32–35, 40–43]. Data on use of medication and rates of spinal surgery was shown to be accurate after having been checked against the Ib-salut activity and pharmacy registries. The later include data on all drugs prescribed as well as those dispensed and invoiced by pharmacies. Moreover, standards on use of medication and surgery rates which were agreed upon, were calculated to ensure that funds invested by the Ib-Salut in NRT were cost-effective.
High rates of excluded patients, losses to follow-up and missing data, may introduce bias; in this study, less than 5% of the patients who underwent NRT were excluded because adverse events required early extraction of the surgical material, there were no losses to follow-up, and missing data were below 3% (Tables 1, 2, 3 and 4). These features suggest that generalisability of these results to LBP patients treated with NRT within the SNHS should not be a concern.
The provider of NRT for the Ib-Salut is a not for profit institution which specialises in NP, TP and LBP research and, in fact, is responsible for most Spanish research in this field [57]. The staff of the Ib-Salut in charge of post-adoption surveillance for NRT, members of the team analysing results, researchers involved in this study, and clinicians performing NRT are paid a fixed salary and have no economic incentives for applying the procedure in cases in which it is not indicated, or for biasing analysis of results. The use of post-adoption surveillance and shared risk tools in routine practice may be more difficult when for-profit providers are involved, in settings where these conditions are not met, or in which clinicians are paid on a fee-for-service basis [13–15]. Nevertheless, the potential of savings may be larger in these settings.
Randomised controlled trials (RCTs) are the gold standard for assessing the efficacy, effectiveness and cost/effectiveness of any health technology. In an ideal world, all health technologies would be assessed through high quality RCTs before being used in the clinical environment, and post-adoption surveillance methods would be applied from the start of their use in routine practice. However, strong incentives against this approach exist and, as many examples show, many technologies are implemented in routine practice in the absence of such an evidence, or even disregarding the evidence against implementation [2, 3, 80]. No form of post-adoption surveillance can substitute the evidence deriving from RCTs, but using post adoption surveillance combined with risk sharking tools for all technologies that lack long term effectiveness and safety data and for which costs of usage are higher than monitoring costs, is likely to improve the efficiency of health resources.
This approach is especially needed for technologies which lack the support of robust evidence on efficacy, effectiveness. In the field of NP and LBP this includes, for instance, ultrasound for LBP, most forms of conservative treatment for lumbar spinal stenosis or spinal fusion for common LBP [26, 30, 53, 73, 81, 82]. Moreover, even in the case of technologies for which there is evidence on effectiveness or cost/effectiveness, this approach would pave the way to comparative effectiveness research and would likely contribute to reducing inappropriate use (including off-label use, inappropriate referral, over-prescription of drugs and slim clinical outcomes in some subgroups of patients), since it would financially penalize any worsening in outcomes. Examples within the same field in which this approach would be suitable, include the inappropriate use of magnetic resonance imaging, or the prescription of spinal surgery in cases other than symptomatic disc herniation or spinal stenosis complying with surgical criteria [51–53, 55, 56, 83, 84].
The absence of guidelines regarding the use of SRC and the expected increase in its use in the near future in Spain, calls for regulatory action. Some preliminary work has been done in this direction [85].
Conclusions
Results from this experience show that it is feasible an effective to combine post adoption surveillance methods with risk sharing tools for controlling quality of care and support value-based reimbursement decisions for NRT. The feasibility of generalizing this approach to other settings and to other non-pharmacological treatments should be explored, since this is likely to improve the efficiency of health resources.
Notes
Declarations
Authors’ Affiliations
References
- Serrano-Aguilar P, Kovacs FM, Cabrera-Hernández JM, Ramos-Goñi JM, García-Pérez L: Avoidable costs of physical treatments for chronic back, neck and shoulder pain within the Spanish National Health Service: a cross-sectional study. BMC Musculoskelet Disord. 2011, 12: 287-10.1186/1471-2474-12-287.View ArticlePubMedPubMed CentralGoogle Scholar
- Carragee EJ, Deyo RA, Kovacs FM, Wilco CP, Lurie JD, Urrútia G: Clinical research. Is the spine field a mine field?. Spine. 2009, 34: 423-440. 10.1097/BRS.0b013e318198c962.View ArticlePubMedGoogle Scholar
- Carragee EJ, Hurwitz EL, Weiner BK: A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011, 11: 471-491. 10.1016/j.spinee.2011.04.023.View ArticlePubMedGoogle Scholar
- U.S. Department of Justice: Former executives of international medical device maker sentenced to prison in unlawful clinical trials case. 2011, Eastern District of Pennsylvania: United States AttorneyGoogle Scholar
- US Department of Justice: International medical device maker agrees to plead guilty in connection with shipments of adulterated and misbranded bone cement products as part of unlawful clinical trials. 2010, Philadelphia, PA: US Department of JusticeGoogle Scholar
- Kmietowicz Z: Senators question Medtronic about unreported side effects of spinal protein. BMJ. 2011, 343: d4284-10.1136/bmj.d4284.View ArticlePubMedGoogle Scholar
- Oakie S: A To-Do List for the New FDA Commissioner. N Engl J Med. 2009, 360 (14): 1373-1378. 10.1056/NEJMp0810755.View ArticleGoogle Scholar
- Deyo RA: Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice. J Am Board Fam Pract. 2004, 17: 142-149. 10.3122/jabfm.17.2.142.View ArticlePubMedGoogle Scholar
- Institute of Medicine: Public health effectiveness of the FDA 510(k) clearance process: Measuring postmarket performance and other selected topics: Workshop Report. 2010, Washington, DC: National Academies PressGoogle Scholar
- Institute of Medicine: Public health effectiveness of the FDA 510(k) clearance process: Balancing patient safety and innovation: Workshop Report. 2010, Washington, DC: National Academies PressGoogle Scholar
- Institute of Medicine: Medical devices and the public’s health. The FDA 510(k) clearance process at 35 years. 2011, Washington, DC: National Academies PressGoogle Scholar
- Horton R: Offline: A serious regulatory failure, with urgent implications. Lancet. 2012, 379: 106-10.1016/S0140-6736(12)60032-4.View ArticleGoogle Scholar
- Breckemridge A, Walley T: Risk sharing and payment by results. Nature. 2008, 83: 666-667.Google Scholar
- Wlodarczyk J, Reid CM, Pater G: Funding linked to ongoing research: impact of the bosentan patient registry on pricing in Australia. Value Health. 2011, 14: 961-963. 10.1016/j.jval.2011.02.1177.View ArticlePubMedGoogle Scholar
- Puig-Junoy J, Meneu R: Aplicación de los contratos de riesgo compartido a la financiación de nuevos medicamentos. Ges Clin Sanit. 2005, 7: 88-94.Google Scholar
- Cook JP, Vernon JA, Manning R: Pharmaceutical risk-sharing agreements. Pharmacoecon. 2008, 26: 551-556. 10.2165/00019053-200826070-00002.View ArticleGoogle Scholar
- De Pouvourville G: Risk-sharing agreements for innovative drugs. Eur J Health Econ. 2006, 7: 155-157. 10.1007/s10198-006-0386-6.View ArticlePubMedGoogle Scholar
- Maroney M: Innovative pricing agreements to enhance access prospects. Pharma pricing & reimbursement Magazine. 2009, http://www.nextlevelpharma.com/files/pdf/nextlevel_pharma_risk_sharing_brussels_april09_ims_health_article.pdf, last accessed March 23, 2012Google Scholar
- McCabe C, Ebers GC, Compston A: Continuing the scheme is unjustified. BMJ. 2010, 340: 1285-1288.View ArticleGoogle Scholar
- Scolding N: The multiple sclerosis risk sharing scheme. Despite being flawed, has had unintended beneficial consequences. BMJ. 2010, 340: 1255-1256.View ArticleGoogle Scholar
- Boggild M, Palace J, Barton P, Ben-Shlomo Y, Bregenzer T, Dobson C, Gray R: Multiple sclerosis risk sharing scheme: two years results of clinical cohort study with historical comparator. BMJ. 2009, 339: 1359-1363.View ArticleGoogle Scholar
- Waddell G: The Back Pain Revolution. 2004, London: Churchill-Livingstone, 1-61.Google Scholar
- Andersson GBJ: The epidemiology of spinal disorders. The adult spine: principles and practice. Edited by: Frymoyer JW. 1997, New York: Raven Press, 93-141. 2Google Scholar
- Ivanova JI, Birnbaum HG, Schiller M, Kantor E, Johnstone BM, Swindle RW: Real-world practice patterns, health-care utilization, and costs in patients with low back pain: the long road to guideline-concordant care. Spine J. 2011, 11: 622-632. 10.1016/j.spinee.2011.03.017.View ArticlePubMedGoogle Scholar
- Hoy DG, Protani M, De R, Buchbinder R: The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010, 24: 783-792. 10.1016/j.berh.2011.01.019.View ArticlePubMedGoogle Scholar
- Martin BI, Deyo RA, Mirza SK, Turner J, Comstock BA, Hollingwoth W, Sullivan SD: Expenditures and Health Status Among Adults With Back and Neck Problems. JAMA. 2008, 299: 656-664. 10.1001/jama.299.6.656.View ArticlePubMedGoogle Scholar
- Van Tulder MW, Koes BW, Bouter LM: A cost-of-illness study of back pain in The Netherlands. Pain. 1995, 62: 233-240. 10.1016/0304-3959(94)00272-G.View ArticlePubMedGoogle Scholar
- Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D: The Burden of Chronic Low Back Pain: Clinical Comorbidities, Treatment Patterns, and Healthcare Costs in Usual Care Settings. Spine. 2011, 37 (11): E668-E677.View ArticleGoogle Scholar
- Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G: European guidelines for the management of chronic non-specific low back pain. Eur Spine J. 2006, 15: S192-S299. 10.1007/s00586-006-1072-1.View ArticlePubMedPubMed CentralGoogle Scholar
- Chou R, Qaseem A, Snow V, Cassey D, Cross JT, Shekelle P, Owens DK: Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007, 147: 478-491. 10.7326/0003-4819-147-7-200710020-00006.View ArticlePubMedGoogle Scholar
- Haldeman S, Carroll L, Cassidy JD: Findings from the bone and joint decade 2000 to 2010 task force on neck pain and its associated disorders. J Occup Environ Med. 2010, 52: 424-427. 10.1097/JOM.0b013e3181d44f3b.View ArticlePubMedGoogle Scholar
- Kovacs FM, Abraira V, López-Abente G, Pozo F: Neuroreflexotherapy intervention for treating common low back pain: a double-blind, randomized controlled trial. Med Clin (Barc). 1993, 101: 570-575.Google Scholar
- Kovacs FM, Abraira V, Pozo F, Kleinbaum DG, Beltrán J, Mateo I, Pérez de Ayala C, Peña A, Zea A, González-Lanza M, Morillas L: Local and Remote Sustained Trigger Point Therapy for Exarcebations of Chronic Low Back Pain. A randomized, Double-Blind, Controlled, Multicenter Trial. Spine. 1997, 22: 786-797. 10.1097/00007632-199704010-00017.View ArticlePubMedGoogle Scholar
- Kovacs FM, Llobera J, Abraira V, Lázaro P, Pozo F, Kleinbaum D, KAP Group: Effectiveness and cost effectiveness analysis of neuroreflexotherapy for subacute and chronic low back pain in routine general practice. A cluster randomized, controlled trial. Spine. 2002, 27: 1149-1159. 10.1097/00007632-200206010-00004.View ArticlePubMedGoogle Scholar
- Urrútia G, Burton AK, Morral Fernández A, Bonfill Cosp X, Zanoli G: Neuroreflexotherapy for non-specific low-back pain. Cochrane Database of Systematic Reviews. 2004, 10.1002/14651858.CD003009.pub2. Art. No.: CD003009., 2View ArticleGoogle Scholar
- Grupo de Trabajo Español del Programa Europeo COST B13, on behalf of the Spanish Association of Generalist Physicians, Spanish Association of Family and Community Medicine, Spanish Association of Rheumathologists, Spanish Association of Neurosurgeons, Spanish Association of Radiologists, Spanish Association of Occupational Medicine, Spanish Association of Public Health and Health Administration, Spanish General Council of Physical Therapists, Evidence-based Medicine Network, and Iberoamerican Cochrane Centre: Clinical Practice Guideline. Common low back pain. Spanish version of the Clinical Practice Guideline of the European Program COST B13. 2005, Palma de Mallorca: Fundación KovacsGoogle Scholar
- Grupo de Trabajo Balear del Programa Europeo COST B13: Clinical Guideline Practice. Low Back Pain. Summary of the recommendations of the adapted version to the Balearic Islands of the COST B13 Clinical Practice Guideline for Low Back Pain. 2012, Palma de Mallorca: Direcció General d’Avaluació i Acreditació. Conselleria de Salut y ConsumGoogle Scholar
- Servicio Navarro de Salud Osasunbidea: Common low back pain. Clinical Practice Guideline. Bol Inform Farmacoter Navarra. 2006, 14 (1): 45-48.Google Scholar
- Chou R, Huffman LH: Evaluation and Management of Low Back Pain: Evidence Review. 2007, Portland, Oregon, American Pain Society: Oregon Evidence-Based Practice Center. Oregon Health & Science UniversityGoogle Scholar
- Grupo para el Pilotaje de la Intervención NRT en el Sistema Nacional de Salud (PINS): Intervención neurorreflejoterápica para el tratamiento de las enfermedades mecánicas del raquis. Resultados de una experiencia piloto. Gac Sanit. 2004, 18: 275-286. 10.1016/S0213-9111(04)72014-2.View ArticleGoogle Scholar
- Corcoll J, Orfila J, Tobajas P, Alegre L: Implementation of neuroreflexotherapy for subacute and chronic neck and back pain within the Spanish public health system: audit after one year. Health Pol. 2006, 79: 345-357. 10.1016/j.healthpol.2005.11.001.View ArticleGoogle Scholar
- Pallicer A, Corcoll J, Orfila J: Implementation and post-marketing surveillance of neuroreflexotherapy in the routine practice of the Spanish Public Health System. 2007, Palma de Mallorca: IX International Forum on Low Back Pain Research, http://www.lbpforum.org/Abstracts/Abstract103.jpg, last accessed Feb 25th, 2008Google Scholar
- Kovacs FM, Abraira V, Muriel A, Corcoll J, Alegre L, Tomas M, Mir MA, Tobajas P, Gestoso M, Mufraggi N, Del Real MT G, Zamora J: Prognostic Factors for Neuroreflexotherapy in the Treatment of Subacute and Chronic Neck and Back Pain. A Study of Predictors of Clinical Outcome in Routine Practice of the Spanish National Health Service. Spine. 2007, 32: 1621-1628. 10.1097/BRS.0b013e318074c3b5.View ArticlePubMedGoogle Scholar
- Huskinson EC: Measurement of pain. Lancet. 1974, 2: 1127-1131.View ArticleGoogle Scholar
- Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G: Outcome measures for low back pain research. A proposal for standardized use. Spine. 1998, 23: 2003-2013. 10.1097/00007632-199809150-00018.View ArticlePubMedGoogle Scholar
- Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Cano A, Muriel A, Zamora J, Del Real MT G, Gestoso M, Mufraggi N, Spanish Back Pain Research Network: Minimal clinically important change for pain intensity and disability in patients with nonspecific low back pain. Spine. 2007, 32: 2915-2920. 10.1097/BRS.0b013e31815b75ae.View ArticlePubMedGoogle Scholar
- Pool JJM, Ostelo RWJG, Hoving JL, Bouter LM, De Vet HCW: Minimal clinically important change of the neck disability index and the numerical rating scale for patients with neck pain. Spine. 2007, 32: 3047-3051. 10.1097/BRS.0b013e31815cf75b.View ArticlePubMedGoogle Scholar
- Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Tomás M, Mir MA, Cano A, Muriel A, Zamora J, Del Real MT, Gestoso M, Mufraggi N, Spanish Back Pain Research Network: Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain. BMC Musculoskelet Disord. 2008, 9: 43-10.1186/1471-2474-9-43.View ArticlePubMedPubMed CentralGoogle Scholar
- Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, De Vet HC: Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008, 33: 90-94. 10.1097/BRS.0b013e31815e3a10.View ArticlePubMedGoogle Scholar
- Van Tulder M, Becker A, Bekkering T, Breen A, Del Real MT G, Hutchinson A, Koes B, Laerum E, Malmivaara A, COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care: European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006, 15: S169-19. 10.1007/s00586-006-1071-2.View ArticlePubMedPubMed CentralGoogle Scholar
- van den Hout WB, Peul WC, Koes BW, Brand R, Kievit J, Thomeer RT, Leiden-The Hague Spine Intervention Prognostic Study Group: Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial. BMJ. 2008, 336: 1351-1354. 10.1136/bmj.39583.709074.BE.View ArticlePubMedPubMed CentralGoogle Scholar
- Peul WC, Van den Hout WB, Brand R, Thomeer RT, Koes BW, Leiden-The Hague Spine-Intervention-Prognostic-Study Group: Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial. BMJ. 2008, 336: 1355-1358. 10.1136/bmj.a143.View ArticlePubMedPubMed CentralGoogle Scholar
- Kovacs FM, Urrútia G, Alarcón JD: Surgery versus conservative treatment for symptomatic lumbar spinal stenosis. A systematic review of randomized controlled trials. Spine. 2011, 36: E1335-E1351. 10.1097/BRS.0b013e31820c97b1.View ArticlePubMedGoogle Scholar
- Flynn TW, Smith B, Chou R: Appropriate use of diagnostic imaging in low back pain: a reminder that unnecessary imaging may do as much harm as good. J Orthop Sports Phys Ther. 2011, 41: 838-846.View ArticlePubMedGoogle Scholar
- Jarvik JG, Hollingworth W, Martin B, Emerson SS, Gray DT, Overman S, Robinson D, Staiger T, Wessbecher F, Sullivan SD, Kreuter W, Deyo RA: Rapid magnetic resonance imaging vs radiographs for patients with low back pain: a randomized controlled trial. JAMA. 2003, 289: 2810-2818. 10.1001/jama.289.21.2810.View ArticlePubMedGoogle Scholar
- Gray DT, Hollingworth W, Blackmore CC, Alotis MA, Martin BI, Sullivan SD, Deyo RA, Jarvik JG: Conventional radiography, rapid MR imaging, and conventional MR imaging for low back pain: activity-based costs and reimbursement. Radiol. 2003, 227: 669-680. 10.1148/radiol.2273012213.View ArticleGoogle Scholar
- Urrútia G, Bonfill X: Analysis of Spanish research about neck and back complaints (1992–2006). Med Clin (Barc). 2010, 135: 215-221. 10.1016/j.medcli.2009.10.038.View ArticleGoogle Scholar
- AEMEN-Asociación Española de Médicos Neurorreflejoterapeutas [Spanish Association of Neuro-reflexotherapy Physicians]. 2012, http://www.aemen.es/formacion.html, last accessed February 1st
- Kovacs FM, Llobera J, Del Real MT G, Abraira V, Gestoso M, Fernandez C, Kovacs-Atención Primaria Group: Validation of the Spanish version of the Roland Morris Questionnaire. Spine. 2002, 27: 538-542. 10.1097/00007632-200203010-00016.View ArticlePubMedGoogle Scholar
- Kovacs FM, Bagó J, Royuela A, Seco J, Giménez S: Spanish Back Pain Research Network. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008, 9: 42-10.1186/1471-2474-9-42.View ArticlePubMedPubMed CentralGoogle Scholar
- Kovacs FM, Abraira V, Zamora J, Fernández C, Spanish Back Pain Research Network: The transition from acute to subacute and chronic low back pain. A study based on determinants of quality of life and prediction of chronic disability. Spine. 2005, 30: 1786-1792. 10.1097/01.brs.0000172159.47152.dc.View ArticlePubMedGoogle Scholar
- Merskey H, Bogduk N: Classification of Chronic Pain. Description of chronic pain syndromes and definitions of pain terms. 1994, Seattle: IASP Press, 2Google Scholar
- Walker S, Sculpher M, Claxton K, Palmer S: Coverage with evidence development, only in research, risk sharing, or patient access scheme? A framework for coverage decisions. Value Health. 2012, 15: 570-579. 10.1016/j.jval.2011.12.013.View ArticlePubMedGoogle Scholar
- Henshall C, Mardhani-Bayne L, Frønsdal KB, Klemp M: Interactions between health technology assessment, coverage, and regulatory processes: emerging issues, goals, and opportunities. Int J Technol Assess Health Care. 2011, 27: 253-260. 10.1017/S0266462311000262.View ArticlePubMedGoogle Scholar
- Hutton J, Trueman P, Henshall C: Coverage with evidence development: an examination of conceptual and policy issues. Int J Technol Assess Health Care. 2007, 23: 425-432.View ArticlePubMedGoogle Scholar
- Adamski J, Godman B, Ofierska-Sujkowska G, Osińska B, Herholz H, Wendykowska K, Laius O, Jan S, Sermet C, Zara C, Kalaba M, Gustafsson R, Garuolienè K, Haycox A, Garattini S, Gustafsson LL: Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res. 2010, 10: 153-10.1186/1472-6963-10-153.View ArticlePubMedPubMed CentralGoogle Scholar
- Campillo C: A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe. Health Policy. 2013, 10.1016/j.healthpol.2013.03.017. Epub ahead of printGoogle Scholar
- Clayton J, Azlanpour Z, Barnes N: Commissioning policy on risk sharing/patient access schemes for drugs. 2010, NHS Bedfordshire: BedfordshireGoogle Scholar
- National Services Scotland, National Services Division: List of drugs included in orphan drugs risk share arrangement. 2011, Edinburgh: NSS, NSDGoogle Scholar
- National Services Scotland, National Services Division: General principles of risk sharing for medicines. 2007, Edinburgh: NSS, NSDGoogle Scholar
- Campillo C: Risk share agreements: atractives in theory, intrincate in practice. Ges Clín Sanit. 2011, 13: 153.Google Scholar
- Campillo C, Del Llano J, Poveda JL: Share risk agreements. With orphan drugs?. Pharm Hospit. 2012, 36: 455-463.Google Scholar
- Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI: United States Trends in Lumbar Fusion Surgery for Degenerative Conditions. Spine. 2005, 30: 1441-1445. 10.1097/01.brs.0000166503.37969.8a.View ArticlePubMedGoogle Scholar
- Institute of Medicine, Committee on comparative effectiveness research prioritization: Initial national priorities for comparative effectiveness research. 2009, Washington, DC: National Academies PressGoogle Scholar
- Kovacs FM, Seco J, Royuela A, Corcoll J, Abraira V, Spanish Back Pain Research Network: Predicting the evolution of low back pain patients in routine clinical practice. Results from a registry within the Spanish National Health Service. Spine J. 2012, 12: 1008-1020. 10.1016/j.spinee.2012.10.007.View ArticlePubMedGoogle Scholar
- Heymans MW, Van Buuren S, Knol DL, Anema JR, Van Mechelen W, De Vet HCW: The prognosis of chronic low back pain is determined by changes in pain and disability in the initial period. Spine J. 2010, 10: 847-856. 10.1016/j.spinee.2010.06.005.View ArticlePubMedGoogle Scholar
- Kovacs FM, Muriel A, Abraira V, Medina JM, Castillo Sanchez MD, Olabe J, Spanish Back Pain Research Network: The influence of fear avoidance beliefs on disability and quality of life is sparse in Spanish low back pain patients. Spine. 2005, 30: E676-E682. 10.1097/01.brs.0000186468.29359.e4.View ArticlePubMedGoogle Scholar
- Kovacs FM, Fernandez C, Cordero A, Muriel A, González-Luján L, Spanish Back Pain Research Network: Non-specific low back pain in primary care in the Spanish National Health Service: a prospective study on clinical outcomes and determinants of management. BMC Health Serv Res. 2006, 6: 57-10.1186/1472-6963-6-57.View ArticlePubMedPubMed CentralGoogle Scholar
- Albadalejo C, Kovacs FM, Royuela A, Del Pino R, Zamora J, Spanish Back Pain Research Network: The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care. A cluster randomized trial. Spine. 2010, 35: 483-496. 10.1097/BRS.0b013e3181b9c9a7.View ArticleGoogle Scholar
- Kovacs FM, Abraira V, Gérvas J, Arana E, Peul WC, Schoene M, Corbin T: Overenthusiastic interpretations of a nonetheless promising study. Transplantation. 2012, 93: e6-10.1097/TP.0b013e31823f14f1.View ArticlePubMedGoogle Scholar
- Rajaee SS, Bae HW, Kanim LEA, Delamarter RB: Spinal Fusion in the United States. Analysis of Trends From 1998 to 2008. Spine. 2012, 37: 67-76. 10.1097/BRS.0b013e31820cccfb.View ArticlePubMedGoogle Scholar
- Seco J, Kovacs FM, Urrutia G: The efficacy, safety, effectiveness, and cost/effectiveness of ultrasound and shock wave therapies for low back pain: A systematic review. Spine J. 2011, 11: 966-977. 10.1016/j.spinee.2011.02.002.View ArticlePubMedGoogle Scholar
- Kovacs F, Abraira V, Santos S: A Comparison of Two Short Education Programs for Improving Low Back Pain-Related Disability in the Elderly. A Cluster Randomized Controlled Trial. Spine. 2007, 32: 1053-1059. 10.1097/01.brs.0000261556.84266.0f.View ArticlePubMedGoogle Scholar
- Deyo RA, Mirza SK, Turner JA, Martin BI: Overtreating chronic back pain: time to back off?. J Am Board Fam Med. 2009, 22: 62-68. 10.3122/jabfm.2009.01.080102.View ArticlePubMedPubMed CentralGoogle Scholar
- Varela Lema L, Ruano Raviña A, Cerdá Mota T, Blasco Amaro JA, Gutiérrez Ibarluzea I, Ibargoyen Roteta N, Imaz Iglesia I, Sampietro Colom L, Soto Pedre E, Villegas PR: Post-introduction Observation of HealthTechnologies A methodological guideline. Abridged version. Quality Plan for the National Health System. 2007, Santiago de Compostela: Galician Health Technology Assessment AgencyGoogle Scholar
- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/13/181/prepub
Pre-publication history
Copyright
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
