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?:Problems implementing a potential cost-effective behavioural intervention in patients with hepatitis C
Beerthuizena, Eerena, Beukersa, de Knegtb, Busschbacha, Darlingtonc, de Manb, van �t Spijkera

aDepartment of Psychiatry, section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, the Netherlands
bDepartment of Gastroenterology and Hepatology, Erasmus MC, Rotterdam, the Netherlands
cSchool of Health Sciences, University of Southampton, Southampton, UK







Corresponding author:
Dr. Annemerle Beerthuizen
Erasmus MC
Department of Medical Psychology & Psychotherapy
Room Na 20-11
P.O. Box 2040
3000 CA Rotterdam
The Netherlands
Telephone: +31-10-7044234
Fax: +31-10-7044695
Email: a.beerthuizen@erasmusmc.nl
Quality of life of chronic hepatitis C patients is lower than the quality of life of healthy persons as well as lower than the quality of life of chronic hepatitis B patients ADDIN EN.CITE <EndNote><Cite><Author>Van der Plas</Author><Year>2003</Year><RecNum>689</RecNum><DisplayText>[1]</DisplayText><record><rec-number>689</rec-number><foreign-keys><key app="EN" db-id="59p0f92wpvd0sme0927pvxenve0ast2s0ead">689</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Van der Plas, S.  </author></authors></contributors><titles><title>Health related quality of life of chronic liver patients. A Dutch population-based study.</title><secondary-title>Proefschrift Erasmus University Rotterdam, the Netherlands. </secondary-title></titles><periodical><full-title>Proefschrift Erasmus University Rotterdam, the Netherlands.</full-title></periodical><dates><year>2003</year></dates><urls></urls></record></Cite></EndNote>[ HYPERLINK \l "_ENREF_1" \o "Van der Plas, 2003 #689" 1]. The quality of life could be improved by means of Problem Solving Therapy (PST)  ADDIN EN.CITE <EndNote><Cite><Author>Nezu</Author><Year>2003</Year><RecNum>1</RecNum><DisplayText>[2]</DisplayText><record><rec-number>1</rec-number><foreign-keys><key app="EN" db-id="ddd09evwprwddqepe515v9z7sees2dv925z2">1</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nezu, A. M.</author><author>Nezu, C. M.</author><author>Felgoise, S. H.</author><author>McClure, K. S.</author><author>Houts, P. S.</author></authors></contributors><auth-address>Department of Psychology, Drexel University, Philadelphia, Pennsylvania 19102-1192, USA. art.nezu@verizon.net</auth-address><titles><title>Project Genesis: assessing the efficacy of problem-solving therapy for distressed adult cancer patients</title><secondary-title>J Consult Clin Psychol</secondary-title></titles><periodical><full-title>J Consult Clin Psychol</full-title></periodical><pages>1036-48</pages><volume>71</volume><number>6</number><edition>2003/11/19</edition><keywords><keyword>Adaptation, Psychological</keyword><keyword>Adult</keyword><keyword>Caregivers/psychology</keyword><keyword>Cognitive Therapy/*methods</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Neoplasms/*psychology</keyword><keyword>Personality Assessment</keyword><keyword>*Problem Solving</keyword><keyword>*Sick Role</keyword><keyword>Social Support</keyword><keyword>Stress, Psychological/complications</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2003</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0022-006X (Print)&#xD;0022-006X (Linking)</isbn><accession-num>14622079</accession-num><urls><related-urls><url>http://www.ncbi.nlm.nih.gov/pubmed/14622079</url></related-urls></urls><electronic-resource-num>10.1037/0022-006X.71.6.1036&#xD;2003-09784-009 [pii]</electronic-resource-num><language>eng</language></record></Cite></EndNote>[ HYPERLINK \l "_ENREF_2" \o "Nezu, 2003 #1" 2], which is a cognitive behavioural approach aiming to improve coping strategies.
PST has proven to be effective in different patient groups, e.g. depressed patients or patients with cancer  ADDIN EN.CITE <EndNote><Cite><Author>Malouff</Author><Year>2007</Year><RecNum>3</RecNum><DisplayText>[3]</DisplayText><record><rec-number>3</rec-number><foreign-keys><key app="EN" db-id="ddd09evwprwddqepe515v9z7sees2dv925z2">3</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Malouff, J. M.</author><author>Thorsteinsson, E. B.</author><author>Schutte, N. S.</author></authors></contributors><auth-address>School of Psychology, University of New England, Armidale, NSW, 2351, Australia. jmalouff@une.edu.au</auth-address><titles><title>The efficacy of problem solving therapy in reducing mental and physical health problems: a meta-analysis</title><secondary-title>Clin Psychol Rev</secondary-title></titles><periodical><full-title>Clin Psychol Rev</full-title></periodical><pages>46-57</pages><volume>27</volume><number>1</number><edition>2006/02/17</edition><keywords><keyword>Adult</keyword><keyword>Depressive Disorder/psychology/therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Mental Disorders/psychology/*therapy</keyword><keyword>Practice (Psychology)</keyword><keyword>*Problem Solving</keyword><keyword>Psychotherapy/*methods</keyword><keyword>Randomized Controlled Trials as Topic</keyword><keyword>Somatoform Disorders/psychology/*therapy</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2007</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0272-7358 (Print)&#xD;0272-7358 (Linking)</isbn><accession-num>16480801</accession-num><urls><related-urls><url>http://www.ncbi.nlm.nih.gov/pubmed/16480801</url></related-urls></urls><electronic-resource-num>S0272-7358(05)00168-6 [pii]&#xD;10.1016/j.cpr.2005.12.005</electronic-resource-num><language>eng</language></record></Cite></EndNote>[ HYPERLINK \l "_ENREF_3" \o "Malouff, 2007 #3" 3]. PST is provided as a group intervention consisting of seven sessions (two hours each) during which a group of on average seven patients are taught skills to address problems in a systematic way. By improving problem solving skills in patients with a chronic disease who experience high levels of stress, PST should decrease the amount of stress and depressive feelings. To investigate the effect of PST in chronic hepatitis C patients, we set up a multicentre randomized controlled trial. Fourteen hospitals from different regions in the Netherlands were invited to participate in this study, six of them agreed to do so. Patients were originally invited to participate by specialized nurses or their treating physician. When inclusion rates appeared to be lower than expected, we tried to increase these rates by involving patient advocate groups, placing advertisements and writing letters directly to registered patients of the out-patient clinic of the participating hospitals. To disseminate knowledge on PST, staff members of the different hospitals were trained by an experienced psychologist, who is an expert on PST, to carry out the intervention in their own hospital. Despite the efforts to include patients, only 37 patients (17 PST; 20 controls) were included from 2007 till 2010 and only three patients finished the training. Based on these results, we draw the following conclusions concerning PST and multicentre trials in hepatitis C patients. First, to ensure compliance, adequate selection of patients is required to detect whether there is sufficient need for PST. With hindsight, it is easy to conclude that we also included patients who were not in need of PST; if the experienced burden of disease is limited, there is little reason to adhere to an intensive intervention. Second, adherence of patients should be a main task of the trainer. Treatment adherence should not primarily be an issue for the patient, but mainly concern the therapist. Increasing adherence can be achieved by being more outreaching as a trainer or shifting responsibility for adherence from patient to trainer, like in multisystemic therapy for delinquent youth  ADDIN EN.CITE <EndNote><Cite><Author>Henggeler</Author><Year>2009</Year><RecNum>690</RecNum><DisplayText>[4]</DisplayText><record><rec-number>690</rec-number><foreign-keys><key app="EN" db-id="59p0f92wpvd0sme0927pvxenve0ast2s0ead">690</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Henggeler, S.W. </author><author>Schoenwald, S.K. </author><author>Borduin, C.M. </author><author>Rowland, M.D. </author><author>Cunningham, P.B. </author></authors></contributors><titles><title>Multisystemic Therapy for Antisocial Behavior in Children and Adolescents (Second edition)</title></titles><dates><year>2009</year></dates><pub-location>New York</pub-location><publisher>The Guildford Press</publisher><urls></urls></record></Cite></EndNote>[ HYPERLINK \l "_ENREF_4" \o "Henggeler, 2009 #690" 4]. Third, symptoms of the disease should be taken into account, as these symptoms are also related to adherence. For instance, travelling to the hospital on seven occasions is not appropriate for a patient with fatigue. This problem could be solved by offering  a partly home-based or internet-based version of PST. Finally, to guarantee continuity of the training, at least two employees per participating hospital should be trained in PST in order to replace each other in case of absence.   
Despite the low number of patients, we constructed a model to compare PST with a control group on both the costs and effects. Obviously, a conclusion on the effectiveness of PST within hepatitis C patients cannot be drawn due to the above mentioned implementation problems. However, the unit cost estimation of PST is less dependent on the number of included patients and showed interesting results: PST appeared to be cheap when implemented (� 176 per patient in 2012. Given this unit cost of PST, we computed which effect would be needed for PST to be cost-effective relative to the control group. We assume that the additional health care resource costs besides treatment are equal for both treatment arms. The effect needed is measured as Quality Adjusted Life Years (QALYs; range1 = full health, 0 = death), which is a generic measure that represents the improvement of both the health-related quality of life and quantity of life years gained [5]. The QALY measure is the most frequently used measure in cost effectiveness analyses  ADDIN EN.CITE <EndNote><Cite><Author>Drummond</Author><Year>2005</Year><RecNum>732</RecNum><DisplayText>[5, 6]</DisplayText><record><rec-number>732</rec-number><foreign-keys><key app="EN" db-id="59p0f92wpvd0sme0927pvxenve0ast2s0ead">732</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Drummond, M.F.</author><author>Sculpher, M. </author><author>Torrance, G.W. </author><author>O&apos;Brien, B. J. </author><author>Stoddart, G.L. </author></authors></contributors><titles><title>Methods for the economic evaluation of health care programmes (Third edition). </title></titles><dates><year>2005</year></dates><pub-location>Oxford</pub-location><publisher>Oxford University Press</publisher><urls></urls></record></Cite><Cite><Author>Briggs</Author><Year>2006</Year><RecNum>733</RecNum><record><rec-number>733</rec-number><foreign-keys><key app="EN" db-id="59p0f92wpvd0sme0927pvxenve0ast2s0ead">733</key></foreign-keys><ref-type name="Book">6</ref-type><contributors><authors><author>Briggs, A. </author><author>Claxton, K. </author><author>Sculpher, M. </author></authors></contributors><titles><title>Decision modeling for health economic evaluation. </title></titles><dates><year>2006</year></dates><pub-location>Oxford</pub-location><publisher>Oxford University Press</publisher><urls></urls></record></Cite></EndNote>[ HYPERLINK \l "_ENREF_5" \o "Drummond, 2005 #732" 5,  HYPERLINK \l "_ENREF_6" \o "Briggs, 2006 #733" 6]. If we assume society to be willing to pay � 15,000 per gained QALY, which is a relatively low threshold, PST is already cost-effective when the QALY of patients who received PST would increase with 0.012 points relative to the controls. The 0.012 QALY gain was estimated by dividing  � 176for PST by � 15,000 per QALY. Even when only a few patients would participate in a PST training (i.e. only four patients; unit cost of PST increases till � 306), an increase of 0.020 points on the QALY-scale relative to the controls leaves PST to be cost-effective. On the other hand, if the maximum amount of ten patients will take part in PST, the unit cost of PST is � 124, for which an increase of 0.008 QALY-points is sufficient. 
The experiences described can serve as a tool for future researchers interested in multicentre trials in hepatitis C patients. In addition, the low unit cost of PST is a favourable result for future trials concerning this intervention. 


Declaration of funding interests
This study was funded in part by Nuts Ohra, grant number: SNO-T-08-82; and in part by the Stomach-Liver-Bowel Foundation [Maag-Lever-Darm Stichting], grant number: WO-07-50. 






References
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$d�a$gdFd�$a$gd�A`$���0�^��`�0�a$gd�A`d�gdFd�d�gd�;��d�`��gd�;�=>>>>#>%>0>:>F>G>Z>�>�>�>�>�>�����޼ޮ��{jYG5#h�A`h�j6�OJQJ^JmH	sH	#h�A`h�6�OJQJ^JmH	sH	 h?*�hn�OJQJ^JmH	sH	 h�^5h��OJQJ^JmH	sH	 h�^5h��OJQJ^JmH	sH	 h�^5h�*(OJQJ^JmH	sH	 h�^5h�e�OJQJ^JmH	sH	h�^5OJQJ^JmH	sH	 h�A`h�i�OJQJ^JmH	sH	 h�A`hyR�OJQJ^JmH	sH	 h�A`h��OJQJ^JmH	sH	 h�A`h�^5OJQJ^JmH	sH	�>�>�>�>�>�>?0?I?L?b?e?g?h?i?j?k?u?v?w?��ͼ�����y�gU@)jh�A`h��OJQJU^JmH	sH	#h�A`h��5�OJQJ^JmH	sH	#h�A`h`�5�OJQJ^JmH	sH	h�A`hNlA6�OJQJ^JhNlA6�OJQJ^JhL=�6�OJQJ^Jh�A`hL=�6�OJQJ^J h�A`h�OJQJ^JmH	sH	 h�A`h!K�OJQJ^JmH	sH	 h�A`h�[�OJQJ^JmH	sH	 h�A`h�_OJQJ^JmH	sH	 h�A`h�OJQJ^JmH	sH	w?�?�?�Q�S��������������������������ʺʺʯڜ��}�}�}�}iVKGh|1'hFd�h|1'mH	sH	$hFd�h|1'CJOJQJaJmH	sH	'jh|1'CJOJQJUaJnHtHh$-jh$-U$h�A`h%:�CJOJQJ^JmH	sH	$h�A`h%:�CJOJQJaJmH	sH	h�A`mHnHsH	uh�A`h�A`5�mHnHsH	uh�A`h�A`mHnHsH	uU)jh�A`h��OJQJU^JmH	sH	 h�A`h��OJQJ^JmH	sH	1.	Van der Plas, S. (2003) Health related quality of life of chronic liver patients. A Dutch population-based study. Proefschrift Erasmus University Rotterdam, the Netherlands. .
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