bs_bs_banner
Journal of Evaluation in Clinical Practice ISSN 1365-2753
Feasibility study for the introduction of a new treatment method for benign thyroid nodules in a teaching and research hospital Marcella Longo MD,1 Ing Paolo Cassoli Eng,2 Laura Fugazzola MD,3 Guia Vannucchi MD,3 Monica Lanzoni PhD4 and Silvana Castaldi MD5 1
Medical Doctor, Health Management Board, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy Clinical Engineer, Department of Clinical Engineering, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy 3 Medical Doctor, Endocrine Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico – Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy 4 Biostatistician, Quality Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy 5 Head of the Unit, Medical Doctor, Quality Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico – Department of Biomedical Sciences for Health, University of Milan, Milan, Italy 2
Keywords feasibility, new treatment, thyroid disease Correspondence Dr Silvana Castaldi Department of Biomedical Sciences for Health University of Milan via Pascal 36 Milano 20133 Italy E-mail: [email protected] Accepted for publication: 17 April 2014 doi:10.1111/jep.12177
Abstract Rationale, aims and objectives Numerous scientific publications have confirmed that percutaneous laser thermal ablation (LTA) represents a possible therapeutic option in selected patients with benign thyroid nodules. A study was carried out to evaluate the feasibility of adopting the LTA technique to treat benign thyroid nodules in a teaching and research hospital in northern Italy. Methods A cost analysis from a company’s perspective determined the impact of adoption of the new technique on the overall Hospital budget, considering currently available equipment, infrastructure and personnel, equipment costs and treatment tariffs. Results The cost analysis shows that, strictly from an economic point of view, any provision of the LTA technique will result as a loss on the Hospital’s balance sheet. However, it does not estimate the extent of the impact on the overall budget because it did not evaluate the savings that such a technique would make with respect to alternative therapeutic treatments. Therefore, the Hospital policy management decided to extend the current agreement with a private authorized health care structure that already carries out LTA. Also, although difficult to express in economic terms, this new technique would undoubtedly raise the profile and enhance the reputation of the Hospital. Conclusions Using the new technique in these patients could cut costs for the entire regional health care system, widen the experience of the Hospital’s endocrinology team and offer the potential for the procedure also to be provided by operators on a freelance basis within the Hospital.
Introduction The choice whether to allocate the limited resources available to the health care system to provide alternative treatment approaches is becoming increasingly difficult given the current world economic crisis. What happens in the system as a whole is also reflected in the choices concerning the allocation of resources and management made by individual providers of health care. These find themselves in a situation in which they must guarantee quality of care but have less and less funds available to do so. Therefore, they have to evaluate alternative and efficient methods of providing
care, above all when they have to deal with pathologies that have a low prevalence or that are extremely costly to treat. In recent years, in Italy and indeed worldwide, the number of cases of benign and malignant thyroid disease has increased by up to 5% each year. The causes of this increase can be attributed to higher average life expectancy, to improved diagnostic procedures and, as far as malignant disease is concerned, to the greater impact of risk factors such as the increase in environmental radioactivity [1]. Over the last few years, for some thyroid diseases (e.g. benign nodules), alongside the medical or surgical options, non-invasive conservative treatments have also been developed. These include
Journal of Evaluation in Clinical Practice 20 (2014) 617–621 © 2014 John Wiley & Sons, Ltd.
617
Treatment thyroid nodules hospital
M. Longo et al.
cutaneous alcoholization for cystic nodules and this has been carried out at the ‘Fondazione Ca’ Granda Ospedale Maggiore Policlinico’ (the Hospital), Milan, Italy, for around 10 years. More recently, a new minimally invasive technique has been developed: percutaneous laser thermal ablation (LTA). This is indicated for the treatment of benign non-cystic thyroid nodules. This new method is suitable for those patients considered at high risk for conventional surgical techniques, those who have multiple co-pathologies or who are elderly. LTA is already in routine use both in Italy and in other countries. The Hospital is a research hospital in the centre of Milan, northern Italy. It has just over 700 beds and three accident and emergency units (adult, paediatric and obstetric). It is a reference centre for 262 rare diseases. It also offers a degree course in medicine and surgery, various medical and surgical postgraduate schools and five degree courses for health care workers. The endocrinology and diabetes unit of the Hospital is considered a centre of excellence, in particular, in the medical and surgical treatment of malignant thyroid diseases. This quality profile has been achieved over the years thanks to the multidisciplinary collaboration with the surgical team. This has resulted in the development of a common diagnostic–therapeutic procedure to identify the indications for surgery and for the management of postsurgical follow-up [2]. The endocrinology team has proposed the introduction within the Hospital of a new procedure to continue to provide patients with all the therapeutic options available for the treatment of thyroid diseases. The Hospital considered a structured evaluation of the feasibility of providing the new service was needed, and this took into consideration the following issues: • evidence published in literature; • current organization of the diagnosis, treatment and management of benign thyroid diseases; • the constraints inherent to the system mainly due to issues concerning accreditation, tariffs of renumeration of services, the equipment required; • the potential demand for the new technique, and • the organizational and economic aspects of adopting the new LTA technique. On completion of the evaluation process, the decision was taken not to adopt the new procedure within the Hospital but that the endocrinology and diabetes unit would provide this type of service in agreement with another health care structure to use their equipment.
There are two types of thermal ablation: with radiofrequency or with a laser. Both types aim to induce a thermal necrosis of the thyroid tissue to reduce the volume. Radiofrequency is much more frequently used to treat some neoplastic pathologies concerning other organs, such as liver. However, it has been less used in the field of endocrinology. In which there are few reports in literature and information concerning patient follow-up is scarce. In this field, the use of LTA is more widespread. It was used for the first time in 2000 by an Italian group [3] and since then, other studies have been carried out. One randomized study (LTA versus medical therapy) showed encouraging results. In fact, the data demonstrate the efficacy of this technique in reducing nodule size by 50–70% with a related improvement in local compressive symptoms. Serious complications are rare. In a study of approximately 300 cases treated, only one case of reversible lesion of the laryngeal nerve was reported [4]. A recently published case report concerned a single case of tracheal laceration [9]. As far as longer term results after LTA are concerned, the longest follow-up is 3 years in a population of 122 patients [8]. Precisely because of the greater amount of scientific data acquired over the last few years, the recent 2010 guidelines drafted by the American Association of Clinical Endocrinologists, the Association of Endocrinologists (Associazione Medici Endocrinologi) and the European Thyroid Association have recognized LTA as a possible alternative treatment option to traditional surgery for benign nodules, and these recent guidelines confirm its efficacy and safety [6,13]. In particular, selection criteria have been codified for potential candidates for the procedure. Patients must present local compressive symptoms, aesthetic damage or have contraindications (or be at high risk) for traditional surgical techniques [6]. The same guidelines recommend that LTA should not be used as ‘routine’ treatment of thyroid nodules but that the technique should be kept in reserve for those cases for whom traditional surgery is not indicated [7]. An evaluation of published data confirms the safety of LTA with sufficient data in the literature for it to be developed as a miniinvasive procedure, even though it is still relatively new. However, there are still no long-term data available. Furthermore, given the need for careful patient selection, it can only be adopted in centres with highly skilled personnel with experience in the field and in a multidisciplinary context. In Italy, only a few centres satisfy this requirement and these are to be found in Turin, the region of Reggio Emilia, Rome, Naples, Pisa, Perugia and Genoa.
Methods
Current organization within the Hospital’s endocrinology department of the diagnosis, treatment and management of benign thyroid diseases
The hypothesis of providing a new procedure for patients with benign thyroid diseases was evaluated according to the approach indicated above.
Evidence published in literature A review of the selected literature showed that the use of percutaneous thermal ablation in the treatment of thyroid nodules is a relatively recent technique. It was introduced in 2000 to respond to the treatment needs of patients with solid benign thyroid nodules for whom conventional open surgery was not indicated or was considered at high risk [3–15]. 618
The endocrinology and diabetes outpatients’ clinic is the first step in patient care, and this is where patients are selected according to the different endocrinological diseases presented. When necessary, patients are sent through codified diagnostic procedures to second-level care. Altogether, thyroid diseases represent 80% of the patients who come to the clinic. The outpatients’ clinic can receive all patients, and therefore, this also includes those with the most frequent thyroid diseases, such as autoimmune hypothyroidism and benign nodules.
© 2014 John Wiley & Sons, Ltd.
M. Longo et al.
Treatment thyroid nodules hospital
Table 1 Patients examined in the outpatients’ clinic in the endocrinology department and diabetes unit: 2010–2012
Second-level care for thyroid disease, n Echo ultrasound, n Total number of other outpatient care
2010
2011
2012
1606 946 14 878
1760 874 15 052
1977 1705 14 780
Second-level care for thyroid disease is also available from other specialized clinics that deal with different patient groups. 1 A clinic specializing in malignant thyroid tumours: a diagnostic– therapeutic approach is agreed through close collaboration with the surgical team. 2 Autoimmune hyperthyroidism with thyroid ophthalmopathy: since January 2012 this has received recognition as a centre of excellence for this pathology working together with the medical teams of the ear, nose and throat and ophthalmopathy units. 3 Thyroid diseases in pregnancy. 4 Drug-derived thyroid disease. Echo ultrasound carried out by doctors in the endocrinology and diabetes unit completes the diagnostic procedures and is therefore strictly connected to clinical aspects of care. Ecography is available for both patients on the wards and outpatients. Ecography is used to carry out cutaneous alcoholization of cystic nodules. For this, patients are selected according to codified indications, and because the procedure can be performed without anaesthetic, it is carried out in the Day Hospital (DH) [16]. In the region of Lombardy, northern Italy, this is defined as a complex care need (CCN). On average, this procedure concerns two patients a week. Patients with non-cystic nodules are currently directed to other health care institutes for surgical treatment because the surgical unit within the Hospital gives priority only to malignant oncological pathologies. Table 1 shows data of patients examined in the outpatients’ clinic of the endocrinology and diabetes unit for the period 2010–2012.
The organizational and economic aspects of adopting the new LTA technique The Italian health service offers renumeration for services provided according to the context of care (ordinary admission, DH visit/day surgery, CCN, outpatients’ clinic). Tariffs are established according to the diagnosis-related group (DRG) classification while tariffs for CNN are established according to the pre-defined levels of complexity [16,17]. Up till now, only the region of Tuscany has given indications as to the correct level of care at which to provide these services and their related tariffs. In Tuscany, these services must be carried out in the DH as they are considered non-surgical procedures [18]. As for other similar health care, in the region of Lombardy, provision of new services for which tariffs are not codified, LTA must be carried out in the DH. This service is covered by DRG 301 (‘endocrine disease without complications’) and, therefore, carries a tariff of €1084.08 [17]. Over the next few months, completion of a long-term evaluation of similar services could lead to indications for LTA to be considered a CCN. This would mean that, according to the observation time to be guaranteed to the patient, LTA could be priced as CCN 11 or 12 at €249 or €219, respectively. © 2014 John Wiley & Sons, Ltd.
The requirements for accreditation established for the region of Lombardy state that the same structural, organizational and specific requirements are to be guaranteed regardless of whether the procedure is carried out in the DH or as an ordinary hospital admission. Therefore, LTA should be carried out in the DH of the endocrinology and diabetes unit. The LTA procedure requires that the following must be made available: • an echo ultrasound machine with probes suitable for examining the thyroid; • a 1064-mm Nd:YAG laser; • optical fibres to be used with small-calibre needles; • one nurse; • two doctors with the appropriate specialized clinical experience; • a room equipped for mini-invasive procedures; and • a bed in the DH. It should be remembered that this is an accredited area and is therefore exempt of the prerequisites for the management of urgent and emergency cases. The prevalence of both malignant and benign thyroid disease in Italy is 30–60%, according to the region and the level of iodine deficiency [1]. Around 20% of patients with goitre are candidates for surgery. Given the LTA selection criteria, the influx of patients to our specialist clinics, and the availability of personnel, approximately two patients a month could be considered for LTA. These candidates could be subdivided more or less into 50% being made up of patients who are at high risk with traditional surgery and 50% who could be subject to aesthetic damage caused by the nodule itself or by a post-thyroidectomy scar. Consideration should also be given to patient fears about surgery and the preference, therefore, for a non-invasive approach that does not require hospital admission. Patient selection criteria are [6]: • presence of a single nodule or a dominant nodule of large dimensions that causes deviation of the neck structure or a reduction in tracheal calibre; • elderly patients or those with worsening pathologies or at high surgical risk. Such patients, because of the deviation of the neck structure or the reduction in tracheal calibre, cannot undergo traditional surgical techniques; and • deviation of the neck structure or a reduction in tracheal calibre and the need to intervene to limit the aesthetic damage. Costs related to personnel and use of space and infrastructure have not been included in the economic analyses as the proposed introduction of LTA does not require new resources in terms either of personnel or new hospital areas. The economic analysis was carried out from a company’s perspective, that is, considering only the costs to the Hospital itself, not the costs to the patient (pharmaceutical products, transport, lost income from days off work etc.) The biggest cost was purchasing the equipment (echo ultrasound machine and laser) and these represent the fixed costs. The biggest variable costs were mainly for the disposable fibre needles since 1–4 are used during each intervention. In particular, the cost of the equipment and its use was subject to a detailed analysis. The procedure requires that at least the following equipment should be available: • the use of an echo ultrasound machine to visualize the nodules and to provide visual monitoring during the laser treatment, and • a Nd:YAG laser using 300 μm in diameter fibre optics introduced percutaneously with small-calibre needles. 619
Treatment thyroid nodules hospital
There is no need for an anaesthetic, and anaesthesia ventilators or hemodynamic monitoring systems are not therefore required. In order to carry out relative cost analyses, the following preliminary hypotheses were established: • 10 patients treated per month (in addition to the two patients from the Hospital’s own clinic, the procedure will be offered to an estimated eight patients per month from throughout the region of Lombardy and from the neighbouring regions), and • laser fibre (disposable, as indicated by the manufacturer). The reference economic values used were divided into fixed costs (the total annual sum of which is independent of the number of procedures carried out) and variable costs (that increase in proportion to an increase in the number of patients treated). Fixed costs: • cost of an echo ultrasound machine is €70 000 including Italian IVA, and • cost of the laser equipment, considered to be zero as the equipment is loaned free of charge, with full-risk maintenance cover, in exchange for the purchase of an agreed minimum quantity of disposable laser fibres. Variable costs: • cost of the kit (containing four fibres) €1400 including Italian IVA (price offered by a supplier to potential customers). Costs relating to the echo ultrasound machine will not actually be calculated as it is considered that current Hospital equipment will be used (or, alternatively, that the purchase of a new echo ultrasound machine will make the one currently in use available for other units within the Hospital that have so far not needed to purchase one for themselves). If this is not the case, or if this is not possible, the annual depreciation costs of the echo ultrasound machine should be added to the costs specified below (equal to one-fifth of the purchase price). This will be divided by the estimated number of procedures carried out annually (approximately 100). Therefore, €140 per procedure (equal to the value of the echo ultrasound machine/500) is to be added to the costs calculated below. This cost analysis therefore only considers the variable costs. However, this depends on the number of laser fibres used for each procedure and this in turn is related to the size of the nodules to be treated: 1 fibre used: cost of fibre is €350 per intervention; 2 fibres used: cost of fibres is €700 per procedure; 3 fibres used: cost of fibres is €1050 per intervention; and 4 fibres used: cost of fibres is €1400 per intervention. A review of the literature indicates that an average of two fibres are used for each intervention. Therefore, the cost per patient per intervention is €700 including Italian IVA. According to the hypothetical cost analysis used so far, this cost per patient can be considered the total treatment cost for the hospital [14]. According to these calculations, for this type of treatment, price coding for a DH tariff or for a CCN 11 or 12 would result in a reimbursement of €164 and €219 or €249, respectively. In fact, this is significantly lower than the costs sustained by the Hospital to provide the service, all the more so if it is remembered that other cost types (personnel, echo ultrasound machine, pharmaceutical products) were not taken into consideration or, according to our analysis, amounted to zero. From the regional health care system perspective, the introduction of LTA reduces the costs of benign thyroid nodules treatment; 620
M. Longo et al.
in fact taking into account that for the region as a paying institution, the cost incurred for the provision of treatment is equal to the tariff established for the treatment itself and that currently the subjects not treated with LTA are undergoing to surgery classified in ordinary hospital admission for DRG 301 (tariff equal to 1084.08) the regional net saving per case treated amounts to €835.08 (1084.08-249).
Results This cost analysis shows that, strictly from an economic point of view, any provision of LTA treatment will result essentially as a loss on the Hospital’s balance sheet. Other medical and surgical services run at a loss in the Hospital, for example, diagnostic digestive endoscopy and robotic surgery. These calculations were made according to a company’s perspective that compared costs and revenues for the Hospital. The economic limitation of this perspective is that, in reality, unlike the evaluations carried out by the regional or national health care systems, it does not allow us to estimate the extent of the impact that the introduction of this technique would have on the overall budget. This is because it does not, for example, evaluate the savings that such a technique would make with respect to alternative therapeutic treatments (e.g. surgical removal of the nodule) that would undoubtedly cost more but with comparable clinical efficacy. Use of LTA within the Hospital would be integrated with and would complete a wide range of available diagnostic–therapeutic options. It would therefore probably be more useful to evaluate the economic sustainability and the impact of such a new option on the entire diagnostic–therapeutic course of the patient in the department of endocrinology and in the surgical department rather than look at the cost of each separate LTA intervention. It is possible to predict that, in the future, as has already been seen with other types of technologies, the price of the most expensive component of the procedure, that is, the laser fibre, could actually go down if the type of patients treated were to allow the number of fibres used for each intervention to be reduced. This could happen if fibres currently defined as disposable could eventually be re-used, for example, cleaving the ends of the fibres, already routine practice in other laser applications. Negotiating prices with sales representatives could also lower costs, as could greater competitiveness on the market, especially if suppliers of compatible products are identified. Evaluation of the surgical DRGs carried out in the Hospital by the team that carried out thyroid operations reported that, in 2012, only four patients undergoing surgery had a single thyroid nodule and the selection criteria for this procedure were not adopted. Therefore, it is not possible, as far as the Hospital is concerned, to hypothesize savings to the regional health authority for the use of a lower level of care even if the patients treated by this method could be subjects at higher risk of invasive surgery and could possibly require a bed in the intensive care unit. The adoption of such a new technique would undoubtedly raise the profile and enhance the reputation of the Hospital, even if this is difficult to express in economic terms.
Discussion Percutaneous thermal ablation represents a possible therapeutic option in selected candidates with benign thyroid nodules, and this
© 2014 John Wiley & Sons, Ltd.
M. Longo et al.
has now been confirmed by a consistent number of scientific publications. After carefully examining the evaluation made, the Hospital policy management has decided to extend the current agreement with a private authorized health care structure that already carried out LTA. The decision to come to an agreement with another structure already able to carry out this technique will allow the Hospital to strengthen its position as a centre of excellence in the field of thyroid diseases and to offer the whole range of health care options for this type of patient. This could attract those patients who satisfy the disease-defining criteria presented in the scientific literature. Using the new technique to treat these patients could result in cost savings for the entire regional health care system, widen the experience of the Hospital’s endocrinology team and offer the potential for the procedure also to be provided by operators on a freelance basis in addition to their normal hospital duties.
References 1. Yu, G. P., Li, J. C., Branovan, D., McCormick, S., Stimson, P. & Schantz, S. P. (2010) Thyroid cancer incidence and survival in the national cancer institute surveillance, epidemiology, and end results race/ethnicity groups. Thyroid, 20 (5), 465–473. 2. Fugazzola, L., Giarratana, L. & Beck Peccoz, P. (2013) Fondazione IRCCS Ca’ Granda OMP, Milan, Italy. [Documento del sistema qualità] P.04.180. 3. Pacella, C. M., Bizzarri, G., Spiezia, S., Bianchini, A., Guglielmi, R., Crescenzi, A., Pacella, S., Toscano, V. & Papin, E. (2000) Thyroid tissue: US-guided percutaneous interstitial laser ablation – a feasibility study. Radiology, 217, 673–677. 4. Spiezia, S., Vitale, G., Di Somma, C., Pio Assanti, A., Ciccarelli, A., Lombardi, G. & Colao, A. (2003) Ultrasound-guided laser thermal ablation in the treatment of autonomous hyperfunctioning thyroid nodules and compressive nontoxic nodular goiter. Thyroid, 13 (10), 941–947. 5. Papini, E., Guglielmi, R., Bizzarri, G., Graziano, F., Bianchini, A., Brufeni, C., Pacella, S., Valle, D. & Pacella, C. M. (2007) Treatment of benign cold thyroid nodules: a randomized clinical trial of percutaneous laser ablation versus levothyroxine therapy or follow-up. Thyroid, 17 (3), 229–235. 6. Valcavi, R., Riganti, F., Bertani, A., Formisano, D. & Pacella, C. M. (2010) Percutaneous laser ablation of cold benign thyroid nodules: a 3-year follow-up study in 122 patients. Thyroid, 20 (11), 1253–1261.
© 2014 John Wiley & Sons, Ltd.
Treatment thyroid nodules hospital
7. Gharib, H., Papini, E., Paschke, R., Duick, D. S., Valcavi, R., Hegedüs, L., Vitti, P. & for the AACE/AME/ETA Task Force on Thyroid Nodules (2010) Medical guidelines for clinical practice for the diagnosis and management of thyroid nodules. Endocrinology Practice Journal, 16 (1 Suppl.), 1–43. 8. Baek, J. H., Lee, J. H., Valcavi, R., Pacella, C. M., Rhim, H. & Na, D. G. (2011) Thermal ablation for benign thyroid nodules: radiofrequency and laser. Korean Journal of Radiology, 12 (5), 525–540. 9. Papini, E., Guglielmi, R., Gharib, H., et al. (2011) Ultrasound-guided laser ablation of incidental papillary thyroid microcarcinoma: a potential therapeutic approach in patients at surgical risk. Thyroid, 21 (8), 917–920. 10. Di Rienzo, G., Surrente, C., Lopez, C. & Quercia, R. (2012) Tracheal laceration after laser ablation of nodular goitre. Interactive Cardiovascular and Thoracic Surgery, 14 (1), 115–116. 11. Na, D. G., Lee, J. H., Jung, S. L., et al. (2012) Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations. Korean Journal of Radiology, 13 (2), 117–125. 12. Piana, S., Riganti, F., Froio, E., Andrioli, M., Pacella, C. M. & Valcavi, R. (2012) Pathological findings of thyroid nodules after percutaneous laser ablation: a series of 22 cases with cyto-histological correlation. Endocrine Pathology Journal, 23 (2), 94–100. 13. Gambelunghe, G., Fede, R., Bini, V., Monacelli, M., Avenia, N., D’Ajello, M., Colella, R., Nasini, G. & De Feo, P. (2013) Ultrasoundguided interstitial laser ablation for thyroid nodules is effective only at high total amounts of energy: results from a three-year pilot study. Surgical Innovation, 20 (4), 345–350. 14. Cesareo, R., Pasqualini, V. & Cianni, R. (2012) La radiofrequenza nell’ablazione dei noduli tiroidei: efficacia e limiti. AME FLASH, 9, 1–4. 15. Faggiano, A., Ramundo, V., Assanti, A. P., et al. (2012) Thyroid nodules treated with percutaneous radiofrequency thermal ablation: a comparative study. The Journal of Clinical Endocrinology and Metabolism, 97 (12), 4439–4445. 16. Region of Lombardy. Deliberation of the Regional Council no. 937 of 1/12/2010. [Determinazioni in ordine alla gestione del servizio socio sanitario regionale per l’esercizio 2011.]. 17. Region of Lombardy. Deliberation of the Regional Council no. 1479 of 30/3/2011. [Determinazione in ordine alla gestione del servizio socio sanitario regionale per l’esercizio 2011 – 11 provvedimento di aggiornamento in ambito sanitario.]. 18. Region of Tuscany. Deliberation of the Regional Council no. 321 of 27/4/2009. [Progetti di ricerca industriale e sviluppo sperimentale. Progetti strategici. Direttive di attuazione della procedura negoziale.].
621
Journal of Evaluation in Clinical Practice ISSN 1365-2753
Feasibility study for the introduction of a new treatment method for benign thyroid nodules in a teaching and research hospital Marcella Longo MD,1 Ing Paolo Cassoli Eng,2 Laura Fugazzola MD,3 Guia Vannucchi MD,3 Monica Lanzoni PhD4 and Silvana Castaldi MD5 1
Medical Doctor, Health Management Board, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy Clinical Engineer, Department of Clinical Engineering, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy 3 Medical Doctor, Endocrine Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico – Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy 4 Biostatistician, Quality Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy 5 Head of the Unit, Medical Doctor, Quality Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico – Department of Biomedical Sciences for Health, University of Milan, Milan, Italy 2
Keywords feasibility, new treatment, thyroid disease Correspondence Dr Silvana Castaldi Department of Biomedical Sciences for Health University of Milan via Pascal 36 Milano 20133 Italy E-mail: [email protected] Accepted for publication: 17 April 2014 doi:10.1111/jep.12177
Abstract Rationale, aims and objectives Numerous scientific publications have confirmed that percutaneous laser thermal ablation (LTA) represents a possible therapeutic option in selected patients with benign thyroid nodules. A study was carried out to evaluate the feasibility of adopting the LTA technique to treat benign thyroid nodules in a teaching and research hospital in northern Italy. Methods A cost analysis from a company’s perspective determined the impact of adoption of the new technique on the overall Hospital budget, considering currently available equipment, infrastructure and personnel, equipment costs and treatment tariffs. Results The cost analysis shows that, strictly from an economic point of view, any provision of the LTA technique will result as a loss on the Hospital’s balance sheet. However, it does not estimate the extent of the impact on the overall budget because it did not evaluate the savings that such a technique would make with respect to alternative therapeutic treatments. Therefore, the Hospital policy management decided to extend the current agreement with a private authorized health care structure that already carries out LTA. Also, although difficult to express in economic terms, this new technique would undoubtedly raise the profile and enhance the reputation of the Hospital. Conclusions Using the new technique in these patients could cut costs for the entire regional health care system, widen the experience of the Hospital’s endocrinology team and offer the potential for the procedure also to be provided by operators on a freelance basis within the Hospital.
Introduction The choice whether to allocate the limited resources available to the health care system to provide alternative treatment approaches is becoming increasingly difficult given the current world economic crisis. What happens in the system as a whole is also reflected in the choices concerning the allocation of resources and management made by individual providers of health care. These find themselves in a situation in which they must guarantee quality of care but have less and less funds available to do so. Therefore, they have to evaluate alternative and efficient methods of providing
care, above all when they have to deal with pathologies that have a low prevalence or that are extremely costly to treat. In recent years, in Italy and indeed worldwide, the number of cases of benign and malignant thyroid disease has increased by up to 5% each year. The causes of this increase can be attributed to higher average life expectancy, to improved diagnostic procedures and, as far as malignant disease is concerned, to the greater impact of risk factors such as the increase in environmental radioactivity [1]. Over the last few years, for some thyroid diseases (e.g. benign nodules), alongside the medical or surgical options, non-invasive conservative treatments have also been developed. These include
Journal of Evaluation in Clinical Practice 20 (2014) 617–621 © 2014 John Wiley & Sons, Ltd.
617
Treatment thyroid nodules hospital
M. Longo et al.
cutaneous alcoholization for cystic nodules and this has been carried out at the ‘Fondazione Ca’ Granda Ospedale Maggiore Policlinico’ (the Hospital), Milan, Italy, for around 10 years. More recently, a new minimally invasive technique has been developed: percutaneous laser thermal ablation (LTA). This is indicated for the treatment of benign non-cystic thyroid nodules. This new method is suitable for those patients considered at high risk for conventional surgical techniques, those who have multiple co-pathologies or who are elderly. LTA is already in routine use both in Italy and in other countries. The Hospital is a research hospital in the centre of Milan, northern Italy. It has just over 700 beds and three accident and emergency units (adult, paediatric and obstetric). It is a reference centre for 262 rare diseases. It also offers a degree course in medicine and surgery, various medical and surgical postgraduate schools and five degree courses for health care workers. The endocrinology and diabetes unit of the Hospital is considered a centre of excellence, in particular, in the medical and surgical treatment of malignant thyroid diseases. This quality profile has been achieved over the years thanks to the multidisciplinary collaboration with the surgical team. This has resulted in the development of a common diagnostic–therapeutic procedure to identify the indications for surgery and for the management of postsurgical follow-up [2]. The endocrinology team has proposed the introduction within the Hospital of a new procedure to continue to provide patients with all the therapeutic options available for the treatment of thyroid diseases. The Hospital considered a structured evaluation of the feasibility of providing the new service was needed, and this took into consideration the following issues: • evidence published in literature; • current organization of the diagnosis, treatment and management of benign thyroid diseases; • the constraints inherent to the system mainly due to issues concerning accreditation, tariffs of renumeration of services, the equipment required; • the potential demand for the new technique, and • the organizational and economic aspects of adopting the new LTA technique. On completion of the evaluation process, the decision was taken not to adopt the new procedure within the Hospital but that the endocrinology and diabetes unit would provide this type of service in agreement with another health care structure to use their equipment.
There are two types of thermal ablation: with radiofrequency or with a laser. Both types aim to induce a thermal necrosis of the thyroid tissue to reduce the volume. Radiofrequency is much more frequently used to treat some neoplastic pathologies concerning other organs, such as liver. However, it has been less used in the field of endocrinology. In which there are few reports in literature and information concerning patient follow-up is scarce. In this field, the use of LTA is more widespread. It was used for the first time in 2000 by an Italian group [3] and since then, other studies have been carried out. One randomized study (LTA versus medical therapy) showed encouraging results. In fact, the data demonstrate the efficacy of this technique in reducing nodule size by 50–70% with a related improvement in local compressive symptoms. Serious complications are rare. In a study of approximately 300 cases treated, only one case of reversible lesion of the laryngeal nerve was reported [4]. A recently published case report concerned a single case of tracheal laceration [9]. As far as longer term results after LTA are concerned, the longest follow-up is 3 years in a population of 122 patients [8]. Precisely because of the greater amount of scientific data acquired over the last few years, the recent 2010 guidelines drafted by the American Association of Clinical Endocrinologists, the Association of Endocrinologists (Associazione Medici Endocrinologi) and the European Thyroid Association have recognized LTA as a possible alternative treatment option to traditional surgery for benign nodules, and these recent guidelines confirm its efficacy and safety [6,13]. In particular, selection criteria have been codified for potential candidates for the procedure. Patients must present local compressive symptoms, aesthetic damage or have contraindications (or be at high risk) for traditional surgical techniques [6]. The same guidelines recommend that LTA should not be used as ‘routine’ treatment of thyroid nodules but that the technique should be kept in reserve for those cases for whom traditional surgery is not indicated [7]. An evaluation of published data confirms the safety of LTA with sufficient data in the literature for it to be developed as a miniinvasive procedure, even though it is still relatively new. However, there are still no long-term data available. Furthermore, given the need for careful patient selection, it can only be adopted in centres with highly skilled personnel with experience in the field and in a multidisciplinary context. In Italy, only a few centres satisfy this requirement and these are to be found in Turin, the region of Reggio Emilia, Rome, Naples, Pisa, Perugia and Genoa.
Methods
Current organization within the Hospital’s endocrinology department of the diagnosis, treatment and management of benign thyroid diseases
The hypothesis of providing a new procedure for patients with benign thyroid diseases was evaluated according to the approach indicated above.
Evidence published in literature A review of the selected literature showed that the use of percutaneous thermal ablation in the treatment of thyroid nodules is a relatively recent technique. It was introduced in 2000 to respond to the treatment needs of patients with solid benign thyroid nodules for whom conventional open surgery was not indicated or was considered at high risk [3–15]. 618
The endocrinology and diabetes outpatients’ clinic is the first step in patient care, and this is where patients are selected according to the different endocrinological diseases presented. When necessary, patients are sent through codified diagnostic procedures to second-level care. Altogether, thyroid diseases represent 80% of the patients who come to the clinic. The outpatients’ clinic can receive all patients, and therefore, this also includes those with the most frequent thyroid diseases, such as autoimmune hypothyroidism and benign nodules.
© 2014 John Wiley & Sons, Ltd.
M. Longo et al.
Treatment thyroid nodules hospital
Table 1 Patients examined in the outpatients’ clinic in the endocrinology department and diabetes unit: 2010–2012
Second-level care for thyroid disease, n Echo ultrasound, n Total number of other outpatient care
2010
2011
2012
1606 946 14 878
1760 874 15 052
1977 1705 14 780
Second-level care for thyroid disease is also available from other specialized clinics that deal with different patient groups. 1 A clinic specializing in malignant thyroid tumours: a diagnostic– therapeutic approach is agreed through close collaboration with the surgical team. 2 Autoimmune hyperthyroidism with thyroid ophthalmopathy: since January 2012 this has received recognition as a centre of excellence for this pathology working together with the medical teams of the ear, nose and throat and ophthalmopathy units. 3 Thyroid diseases in pregnancy. 4 Drug-derived thyroid disease. Echo ultrasound carried out by doctors in the endocrinology and diabetes unit completes the diagnostic procedures and is therefore strictly connected to clinical aspects of care. Ecography is available for both patients on the wards and outpatients. Ecography is used to carry out cutaneous alcoholization of cystic nodules. For this, patients are selected according to codified indications, and because the procedure can be performed without anaesthetic, it is carried out in the Day Hospital (DH) [16]. In the region of Lombardy, northern Italy, this is defined as a complex care need (CCN). On average, this procedure concerns two patients a week. Patients with non-cystic nodules are currently directed to other health care institutes for surgical treatment because the surgical unit within the Hospital gives priority only to malignant oncological pathologies. Table 1 shows data of patients examined in the outpatients’ clinic of the endocrinology and diabetes unit for the period 2010–2012.
The organizational and economic aspects of adopting the new LTA technique The Italian health service offers renumeration for services provided according to the context of care (ordinary admission, DH visit/day surgery, CCN, outpatients’ clinic). Tariffs are established according to the diagnosis-related group (DRG) classification while tariffs for CNN are established according to the pre-defined levels of complexity [16,17]. Up till now, only the region of Tuscany has given indications as to the correct level of care at which to provide these services and their related tariffs. In Tuscany, these services must be carried out in the DH as they are considered non-surgical procedures [18]. As for other similar health care, in the region of Lombardy, provision of new services for which tariffs are not codified, LTA must be carried out in the DH. This service is covered by DRG 301 (‘endocrine disease without complications’) and, therefore, carries a tariff of €1084.08 [17]. Over the next few months, completion of a long-term evaluation of similar services could lead to indications for LTA to be considered a CCN. This would mean that, according to the observation time to be guaranteed to the patient, LTA could be priced as CCN 11 or 12 at €249 or €219, respectively. © 2014 John Wiley & Sons, Ltd.
The requirements for accreditation established for the region of Lombardy state that the same structural, organizational and specific requirements are to be guaranteed regardless of whether the procedure is carried out in the DH or as an ordinary hospital admission. Therefore, LTA should be carried out in the DH of the endocrinology and diabetes unit. The LTA procedure requires that the following must be made available: • an echo ultrasound machine with probes suitable for examining the thyroid; • a 1064-mm Nd:YAG laser; • optical fibres to be used with small-calibre needles; • one nurse; • two doctors with the appropriate specialized clinical experience; • a room equipped for mini-invasive procedures; and • a bed in the DH. It should be remembered that this is an accredited area and is therefore exempt of the prerequisites for the management of urgent and emergency cases. The prevalence of both malignant and benign thyroid disease in Italy is 30–60%, according to the region and the level of iodine deficiency [1]. Around 20% of patients with goitre are candidates for surgery. Given the LTA selection criteria, the influx of patients to our specialist clinics, and the availability of personnel, approximately two patients a month could be considered for LTA. These candidates could be subdivided more or less into 50% being made up of patients who are at high risk with traditional surgery and 50% who could be subject to aesthetic damage caused by the nodule itself or by a post-thyroidectomy scar. Consideration should also be given to patient fears about surgery and the preference, therefore, for a non-invasive approach that does not require hospital admission. Patient selection criteria are [6]: • presence of a single nodule or a dominant nodule of large dimensions that causes deviation of the neck structure or a reduction in tracheal calibre; • elderly patients or those with worsening pathologies or at high surgical risk. Such patients, because of the deviation of the neck structure or the reduction in tracheal calibre, cannot undergo traditional surgical techniques; and • deviation of the neck structure or a reduction in tracheal calibre and the need to intervene to limit the aesthetic damage. Costs related to personnel and use of space and infrastructure have not been included in the economic analyses as the proposed introduction of LTA does not require new resources in terms either of personnel or new hospital areas. The economic analysis was carried out from a company’s perspective, that is, considering only the costs to the Hospital itself, not the costs to the patient (pharmaceutical products, transport, lost income from days off work etc.) The biggest cost was purchasing the equipment (echo ultrasound machine and laser) and these represent the fixed costs. The biggest variable costs were mainly for the disposable fibre needles since 1–4 are used during each intervention. In particular, the cost of the equipment and its use was subject to a detailed analysis. The procedure requires that at least the following equipment should be available: • the use of an echo ultrasound machine to visualize the nodules and to provide visual monitoring during the laser treatment, and • a Nd:YAG laser using 300 μm in diameter fibre optics introduced percutaneously with small-calibre needles. 619
Treatment thyroid nodules hospital
There is no need for an anaesthetic, and anaesthesia ventilators or hemodynamic monitoring systems are not therefore required. In order to carry out relative cost analyses, the following preliminary hypotheses were established: • 10 patients treated per month (in addition to the two patients from the Hospital’s own clinic, the procedure will be offered to an estimated eight patients per month from throughout the region of Lombardy and from the neighbouring regions), and • laser fibre (disposable, as indicated by the manufacturer). The reference economic values used were divided into fixed costs (the total annual sum of which is independent of the number of procedures carried out) and variable costs (that increase in proportion to an increase in the number of patients treated). Fixed costs: • cost of an echo ultrasound machine is €70 000 including Italian IVA, and • cost of the laser equipment, considered to be zero as the equipment is loaned free of charge, with full-risk maintenance cover, in exchange for the purchase of an agreed minimum quantity of disposable laser fibres. Variable costs: • cost of the kit (containing four fibres) €1400 including Italian IVA (price offered by a supplier to potential customers). Costs relating to the echo ultrasound machine will not actually be calculated as it is considered that current Hospital equipment will be used (or, alternatively, that the purchase of a new echo ultrasound machine will make the one currently in use available for other units within the Hospital that have so far not needed to purchase one for themselves). If this is not the case, or if this is not possible, the annual depreciation costs of the echo ultrasound machine should be added to the costs specified below (equal to one-fifth of the purchase price). This will be divided by the estimated number of procedures carried out annually (approximately 100). Therefore, €140 per procedure (equal to the value of the echo ultrasound machine/500) is to be added to the costs calculated below. This cost analysis therefore only considers the variable costs. However, this depends on the number of laser fibres used for each procedure and this in turn is related to the size of the nodules to be treated: 1 fibre used: cost of fibre is €350 per intervention; 2 fibres used: cost of fibres is €700 per procedure; 3 fibres used: cost of fibres is €1050 per intervention; and 4 fibres used: cost of fibres is €1400 per intervention. A review of the literature indicates that an average of two fibres are used for each intervention. Therefore, the cost per patient per intervention is €700 including Italian IVA. According to the hypothetical cost analysis used so far, this cost per patient can be considered the total treatment cost for the hospital [14]. According to these calculations, for this type of treatment, price coding for a DH tariff or for a CCN 11 or 12 would result in a reimbursement of €164 and €219 or €249, respectively. In fact, this is significantly lower than the costs sustained by the Hospital to provide the service, all the more so if it is remembered that other cost types (personnel, echo ultrasound machine, pharmaceutical products) were not taken into consideration or, according to our analysis, amounted to zero. From the regional health care system perspective, the introduction of LTA reduces the costs of benign thyroid nodules treatment; 620
M. Longo et al.
in fact taking into account that for the region as a paying institution, the cost incurred for the provision of treatment is equal to the tariff established for the treatment itself and that currently the subjects not treated with LTA are undergoing to surgery classified in ordinary hospital admission for DRG 301 (tariff equal to 1084.08) the regional net saving per case treated amounts to €835.08 (1084.08-249).
Results This cost analysis shows that, strictly from an economic point of view, any provision of LTA treatment will result essentially as a loss on the Hospital’s balance sheet. Other medical and surgical services run at a loss in the Hospital, for example, diagnostic digestive endoscopy and robotic surgery. These calculations were made according to a company’s perspective that compared costs and revenues for the Hospital. The economic limitation of this perspective is that, in reality, unlike the evaluations carried out by the regional or national health care systems, it does not allow us to estimate the extent of the impact that the introduction of this technique would have on the overall budget. This is because it does not, for example, evaluate the savings that such a technique would make with respect to alternative therapeutic treatments (e.g. surgical removal of the nodule) that would undoubtedly cost more but with comparable clinical efficacy. Use of LTA within the Hospital would be integrated with and would complete a wide range of available diagnostic–therapeutic options. It would therefore probably be more useful to evaluate the economic sustainability and the impact of such a new option on the entire diagnostic–therapeutic course of the patient in the department of endocrinology and in the surgical department rather than look at the cost of each separate LTA intervention. It is possible to predict that, in the future, as has already been seen with other types of technologies, the price of the most expensive component of the procedure, that is, the laser fibre, could actually go down if the type of patients treated were to allow the number of fibres used for each intervention to be reduced. This could happen if fibres currently defined as disposable could eventually be re-used, for example, cleaving the ends of the fibres, already routine practice in other laser applications. Negotiating prices with sales representatives could also lower costs, as could greater competitiveness on the market, especially if suppliers of compatible products are identified. Evaluation of the surgical DRGs carried out in the Hospital by the team that carried out thyroid operations reported that, in 2012, only four patients undergoing surgery had a single thyroid nodule and the selection criteria for this procedure were not adopted. Therefore, it is not possible, as far as the Hospital is concerned, to hypothesize savings to the regional health authority for the use of a lower level of care even if the patients treated by this method could be subjects at higher risk of invasive surgery and could possibly require a bed in the intensive care unit. The adoption of such a new technique would undoubtedly raise the profile and enhance the reputation of the Hospital, even if this is difficult to express in economic terms.
Discussion Percutaneous thermal ablation represents a possible therapeutic option in selected candidates with benign thyroid nodules, and this
© 2014 John Wiley & Sons, Ltd.
M. Longo et al.
has now been confirmed by a consistent number of scientific publications. After carefully examining the evaluation made, the Hospital policy management has decided to extend the current agreement with a private authorized health care structure that already carried out LTA. The decision to come to an agreement with another structure already able to carry out this technique will allow the Hospital to strengthen its position as a centre of excellence in the field of thyroid diseases and to offer the whole range of health care options for this type of patient. This could attract those patients who satisfy the disease-defining criteria presented in the scientific literature. Using the new technique to treat these patients could result in cost savings for the entire regional health care system, widen the experience of the Hospital’s endocrinology team and offer the potential for the procedure also to be provided by operators on a freelance basis in addition to their normal hospital duties.
References 1. Yu, G. P., Li, J. C., Branovan, D., McCormick, S., Stimson, P. & Schantz, S. P. (2010) Thyroid cancer incidence and survival in the national cancer institute surveillance, epidemiology, and end results race/ethnicity groups. Thyroid, 20 (5), 465–473. 2. Fugazzola, L., Giarratana, L. & Beck Peccoz, P. (2013) Fondazione IRCCS Ca’ Granda OMP, Milan, Italy. [Documento del sistema qualità] P.04.180. 3. Pacella, C. M., Bizzarri, G., Spiezia, S., Bianchini, A., Guglielmi, R., Crescenzi, A., Pacella, S., Toscano, V. & Papin, E. (2000) Thyroid tissue: US-guided percutaneous interstitial laser ablation – a feasibility study. Radiology, 217, 673–677. 4. Spiezia, S., Vitale, G., Di Somma, C., Pio Assanti, A., Ciccarelli, A., Lombardi, G. & Colao, A. (2003) Ultrasound-guided laser thermal ablation in the treatment of autonomous hyperfunctioning thyroid nodules and compressive nontoxic nodular goiter. Thyroid, 13 (10), 941–947. 5. Papini, E., Guglielmi, R., Bizzarri, G., Graziano, F., Bianchini, A., Brufeni, C., Pacella, S., Valle, D. & Pacella, C. M. (2007) Treatment of benign cold thyroid nodules: a randomized clinical trial of percutaneous laser ablation versus levothyroxine therapy or follow-up. Thyroid, 17 (3), 229–235. 6. Valcavi, R., Riganti, F., Bertani, A., Formisano, D. & Pacella, C. M. (2010) Percutaneous laser ablation of cold benign thyroid nodules: a 3-year follow-up study in 122 patients. Thyroid, 20 (11), 1253–1261.
© 2014 John Wiley & Sons, Ltd.
Treatment thyroid nodules hospital
7. Gharib, H., Papini, E., Paschke, R., Duick, D. S., Valcavi, R., Hegedüs, L., Vitti, P. & for the AACE/AME/ETA Task Force on Thyroid Nodules (2010) Medical guidelines for clinical practice for the diagnosis and management of thyroid nodules. Endocrinology Practice Journal, 16 (1 Suppl.), 1–43. 8. Baek, J. H., Lee, J. H., Valcavi, R., Pacella, C. M., Rhim, H. & Na, D. G. (2011) Thermal ablation for benign thyroid nodules: radiofrequency and laser. Korean Journal of Radiology, 12 (5), 525–540. 9. Papini, E., Guglielmi, R., Gharib, H., et al. (2011) Ultrasound-guided laser ablation of incidental papillary thyroid microcarcinoma: a potential therapeutic approach in patients at surgical risk. Thyroid, 21 (8), 917–920. 10. Di Rienzo, G., Surrente, C., Lopez, C. & Quercia, R. (2012) Tracheal laceration after laser ablation of nodular goitre. Interactive Cardiovascular and Thoracic Surgery, 14 (1), 115–116. 11. Na, D. G., Lee, J. H., Jung, S. L., et al. (2012) Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations. Korean Journal of Radiology, 13 (2), 117–125. 12. Piana, S., Riganti, F., Froio, E., Andrioli, M., Pacella, C. M. & Valcavi, R. (2012) Pathological findings of thyroid nodules after percutaneous laser ablation: a series of 22 cases with cyto-histological correlation. Endocrine Pathology Journal, 23 (2), 94–100. 13. Gambelunghe, G., Fede, R., Bini, V., Monacelli, M., Avenia, N., D’Ajello, M., Colella, R., Nasini, G. & De Feo, P. (2013) Ultrasoundguided interstitial laser ablation for thyroid nodules is effective only at high total amounts of energy: results from a three-year pilot study. Surgical Innovation, 20 (4), 345–350. 14. Cesareo, R., Pasqualini, V. & Cianni, R. (2012) La radiofrequenza nell’ablazione dei noduli tiroidei: efficacia e limiti. AME FLASH, 9, 1–4. 15. Faggiano, A., Ramundo, V., Assanti, A. P., et al. (2012) Thyroid nodules treated with percutaneous radiofrequency thermal ablation: a comparative study. The Journal of Clinical Endocrinology and Metabolism, 97 (12), 4439–4445. 16. Region of Lombardy. Deliberation of the Regional Council no. 937 of 1/12/2010. [Determinazioni in ordine alla gestione del servizio socio sanitario regionale per l’esercizio 2011.]. 17. Region of Lombardy. Deliberation of the Regional Council no. 1479 of 30/3/2011. [Determinazione in ordine alla gestione del servizio socio sanitario regionale per l’esercizio 2011 – 11 provvedimento di aggiornamento in ambito sanitario.]. 18. Region of Tuscany. Deliberation of the Regional Council no. 321 of 27/4/2009. [Progetti di ricerca industriale e sviluppo sperimentale. Progetti strategici. Direttive di attuazione della procedura negoziale.].
621
