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For Peer Review Only - Page 1 of 22 BMJ Open BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-014307 on 28 May 2017. Downloaded from Methods and Rationale of a Multi-Centre Cross Sectional Costing Study of Elective Percutaneous Coronary Intervention: A Study Design based on Malaysia, a Middle- income Country ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2016-014307 Article Type: Research Date Submitted by the Author: 16-Sep-2016 Complete List of Authors: Lee, Kun Yun; University of Malaya, Department of Social and Preventive Medicine Ong, Tiong Kiam; Sarawak General Hospital Heart Centre, Division of Cardiology Low, Ee Vien; Bahagian Perkhidmatan Farmasi Kementerian Kesihatan Malaysia Liau, Siow Yen; Queen Elizabeth 2 Hospital, Department of Pharmacy Anchah, Lawrence; Sarawak General Hospital Heart Centre, Department of Pharmacy Hamzah, Syuhada; Penang General Hospital , Administrative Office Mohd Ali, Rosli; National Heart Institute Liew, Huong Bang; Queen Elizabeth 2 Hospital, Division of Cardiology http://bmjopen.bmj.com/ Ismail, Omar; Penang General Hospital , Division of Cardiology Wan Ahmad, Wan Azman; University Malaya Medical Centre, Medicine Said, Mas Ayu; University of Malaya, Department of Social and Preventive Medicine Dahlui, Maznah; University of Malaya, Department of Social and Preventive Medicine <b>Primary Subject Health economics Heading</b>: on October 1, 2021 by guest. Protected copyright. Secondary Subject Heading: Cardiovascular medicine, Health services research, Public health Coronary heart disease < CARDIOLOGY, Coronary intervention < Keywords: CARDIOLOGY, STATISTICS & RESEARCH METHODS, Low- and middle- income countries, Costing approach For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 22 BMJ Open 1 BMJ Open: first published as 10.1136/bmjopen-2016-014307 on 28 May 2017. Downloaded from 2 3 TITLE 4 5 Methods and Rationale of a Multi-Centre Cross Sectional Costing Study of Elective Percutaneous 6 7 Coronary Intervention: A Study Design based on Malaysia, a Middle-income Country. 8 9 10 AUTHORS 11 12 Lee Kun Yun a *, Ong Tiong Kiam b, Low Ee Vien c, Liau Siow Yen d, Lawrence Anchah e, Syuhada 13 f g h i j 14 Hamzah , Liew Huong Bang , Rosli Mohd Ali , Omar Ismail , Wan Azman Wan Ahmad , Mas 15 Ayu Said a, Maznah Dahlui a 16 For peer review only 17 18 a Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 19 Malaysia. 20 21 b Division of Cardiology,, Sarawak General Hospital Heart Centre, Malaysia. 22 23 c 24 Pharmaceutical Services Division, Ministry of Health, Malaysia. 25 d 26 Department of Pharmacy, Queen Elizabeth 2 Hospital, Sabah, Malaysia. 27 28 e Department of Pharmacy, Sarawak General Hospital Heart Centre, Malaysia. 29 30 f Administrative Office, Penang General Hospital, Malaysia. 31 32 g Division of Cardiology, Queen Elizabeth 2 Hospital, Sabah, Malaysia. 33 http://bmjopen.bmj.com/ 34 h National Heart Institute, Kuala Lumpur, Malaysia 35 36 i 37 Division of Cardiology, Penang General Hospital, Penang, Malaysia. 38 j 39 Department of Medicine, Faculty of Medicine, Kuala Lumpur, Malaysia. 40 41 *Corresponding Author on October 1, 2021 by guest. Protected copyright. 42 43 44 Email address: [email protected] Telephone number: + 603-7967 4756 45 46 47 WORD COUNT 3975 48 49 50 KEYWORDS 51 52 Costing approach, research methods, coronary intervention, low- and middle-income countries 53 54 55 56 57 58 59 1 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 22 1 BMJ Open: first published as 10.1136/bmjopen-2016-014307 on 28 May 2017. Downloaded from 2 3 ABSTRACT 4 5 6 7 Objectives: 8 9 Limitations in the quality and access of cost data from low- and middle-income countries constrain 10 11 the implementation of economic evaluations. With the increasing prevalence of coronary artery 12 disease in Malaysia, local cost information are vital for cardiac service expansion. We aim to 13 14 describe a modified costing data collection method tailored to our country setting, and to present the 15 preliminary result. Percutaneous coronary intervention (PCI) was chosen for this purpose. 16 For peer review only 17 18 Design: 19 20 This is a cross-sectional costing study from the perspective of healthcare providers, using top-down 21 approach, from January-June 2014. Cost items under each unit of analysis involved in the provision 22 23 of PCI service were identified, valuated and calculated to produce unit cost estimates. 24 25 26 Setting: 27 28 Five public cardiac centres participated. All the centres provide full-fledged cardiology services. 29 30 They are also the tertiary referral centres of their respective regions. 31 32 Participants: 33 http://bmjopen.bmj.com/ 34 35 We included only patients who undergo PCI as an elective procedure. Patients with urgent/emergent 36 indication for PCI, or with shock and hemodynamic instability were excluded. 37 38 39 Primary and secondary outcome measures: 40 41 on October 1, 2021 by guest. Protected copyright. 42 The outcome measures of interest were the unit costs of admission to cardiac ward and cardiac 43 catheterization utilization, which made up the PCI hospitalization cost. 44 45 46 Results: 47 48 Preliminary results from a single centre showed the total hospitalization cost per patient for elective 49 50 PCI to be RM 14,309.01 (USD 3974.73). PCI consumables were the dominant cost item. 51 52 53 54 55 56 57 58 59 2 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 22 BMJ Open 1 BMJ Open: first published as 10.1136/bmjopen-2016-014307 on 28 May 2017. Downloaded from 2 3 4 Conclusions: 5 6 Comprehensive results from all centres enable comparison from the levels of cost items, unit costs to 7 8 total costs. Standardized costing approach in a multi-centre study generates important information on 9 10 cost variations between centres, thus providing valuable guidance for service planning. In the setting 11 of limited data availability like many LMIC, a modified costing method can be used for the purpose 12 13 of economic evaluations. 14 15 16 Registration: For peer review only 17 18 Malaysian MOH Medical Research and Ethics Committee (ID: NMRR-13-1403-18234 IIR) 19 20 21 22 ARTICLE SUMMARY 23 24 Strengths and limitations of this study 25 26 27 • Based on limitations in local settings, modified costing approach can be applied in LMIC to 28 29 enhance the uptake of economic evaluation for healthcare services. 30 • Cost estimates from standardized collection methods can lead to between-centre comparison 31 32 at multiple levels from individual cost items to overall hospitalization cost. 33 http://bmjopen.bmj.com/ 34 • The non-participation of private cardiac centres may limit the generalizability of the results. 35 36 37 INTRODUCTION 38 39 40 Economic evaluation is an important component of modern healthcare delivery. With the increasing on October 1, 2021 by guest. Protected copyright. 41 prevalence of diseases and advancement of medical technologies, healthcare costs continue to 42 43 escalate. In many developed countries, there are well-established guidelines for healthcare economic 44 45 evaluation.[1] Most of the guidelines available were established in the backdrop of an easy access to 46 high quality and freely available data, based on the setting in high-income countries. Therefore, 47 48 costing analysis of healthcare services are commonly applied to assess the impact of investments in 49 50 disease prevention and treatment, and to guide decision-making in future budget allocation and 51 service planning.[2] In contrast, the lack of infrastructure and financial support for evidentiary data 52 53 capture in low and middle-income countries (LMIC) results in a paucity of easily accessible and 54 reliable cost data. This becomes a huge challenge to the healthcare providers in these countries 55 56 towards the uptake of research and application of economic evaluation in their daily practice.[3-6] 57 58 59 3 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 22 1 BMJ Open: first published as 10.1136/bmjopen-2016-014307 on 28 May 2017. Downloaded from 2 3 4 As with many other LMIC, the total health expenditure in Malaysia has been steadily increasing 5 6 from 3.0% in 2000, 4.0% in 2013 to 4.2% of national gross domestic product in 2014[7]. Public and 7 private healthcare sector expenditures were almost equal at 52.3% and 47.4%.[7, 8] However, the 8 9 expenditure pattern is not a good reflection of the difference in utilization rate between the public 10 and private sectors. Public healthcare service in Malaysia recorded higher utilization because it is 11 12 provided free or at a highly subsidized rate. This was reflected in the number of admission that was 13 14 twice as higher to public hospitals compared to private hospitals.[9] 15 16 For peer review only 17 Among the various disease burdens in Malaysia, cardiovascular disease (CVD) is a leading cause of 18 19 morbidity and mortality. While the CVD mortality rate is declining in developed nations, the drastic 20 21 urbanization and lifestyle changes brought on by epidemiological transition has led to higher 22 prevalence of non-communicable diseases in LMIC, with CVD topping the list.[10] As a chronic 23 24 condition requiring frequent follow-ups and hospitalization, CVD places a huge economic burden on 25 the healthcare system. Hospitalizations and cost burden attributed to CVD have shown an increasing 26 27 trend in the European countries.[11-13] Malaysia is not spared of the same CVD epidemic. In 2013, 28 29 CVD accounted to 24.71% of total mortality in Malaysia and one of the top five causes of 30 hospitalization.[9] 31 32 33 http://bmjopen.bmj.com/ 34 CVD encompasses a range of medical conditions such as coronary artery disease (CAD), 35 cerebrovascular disease, peripheral artery disease, and heart failure.
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