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Available online at www.sciencedirect.com
ScienceDirect The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net
Review
The methodological quality of health economic evaluations for the management of hip fractures: A systematic review of the literature Sanjeeve Sabharwal a,*, Alexander Carter b, Lord Ara Darzi c, Peter Reilly a,c, Chinmay M. Gupte a,c a
Imperial College NHS Trust, UK Imperial College London, Institute of Global Health Innovation, UK c Imperial College London, UK b
article info
abstract
Article history:
Background and objectives: Approximately 76,000 people a year sustain a hip fracture in the
Received 31 July 2014
UK and the estimated cost to the NHS is £1.4 billion a year. Health economic evaluations
Received in revised form
(HEEs) are one of the methods employed by decision makers to deliver healthcare policy
30 September 2014
supported by clinical and economic evidence. The objective of this study was to (1) identify
Accepted 16 October 2014
and characterize HEEs for the management of patients with hip fractures, and (2) examine
Available online 15 December 2014
their methodological quality. Methods: A literature search was performed in MEDLINE, EMBASE and the NHS Economic
Keywords:
Evaluation Database. Studies that met the specified definition for a HEE and evaluated hip
Hip fracture
fracture management were included. Methodological quality was assessed using the
Health economic evaluation
Consensus on Health Economic Criteria (CHEC). Results: Twenty-seven publications met the inclusion criteria of this study and were included in our descriptive and methodological analysis. Domains of methodology that performed poorly included use of an appropriate time horizon (66.7% of studies), incremental analysis of costs and outcomes (63%), future discounting (44.4%), sensitivity analysis (40.7%), declaration of conflicts of interest (37%) and discussion of ethical considerations (29.6%). Conclusions: HEEs for patients with hip fractures are increasing in publication in recent years. Most of these studies fail to adopt a societal perspective and key aspects of their methodology are poor. The development of future HEEs in this field must adhere to established principles of methodology, so that better quality research can be used to inform health policy on the management of patients with a hip fracture. © 2014 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
* Corresponding author. Department of Surgery and Cancer, Imperial College London, 10th Floor QEQM Building, St Mary's Hospital, London W2 1NY, UK. Tel.: þ44 7939447204. E-mail address: [email protected] (S. Sabharwal). http://dx.doi.org/10.1016/j.surge.2014.10.005 1479-666X/© 2014 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
t h e s u r g e o n 1 3 ( 2 0 1 5 ) 1 7 0 e1 7 6
Introduction Advances in medical technology and an ageing population contribute to the widespread view that rising healthcare expenditure in the 21st century is inevitable.1,2 The 2007 global financial crisis and the economic downturn that followed has brought attention to the sustainability of existing healthcare systems.3 The National Audit Office in the United Kingdom (UK) has recommended that the National Health Service (NHS) achieve efficiency savings of up to £20 billion between 2011 and 2015.4 In the current fiscal climate, the importance of healthcare policy that is based on clinical and economic evidence is acute. Health economic evaluations (HEEs) are one the apparatuses that decision makers rely on to deliver evidence-based policy. An economic evaluation in healthcare can be defined as the comparative analysis of alternative courses of action in terms of both their costs and consequences.5 There are two distinguishing characteristics for any analysis to meet the defined criteria of a HEE. There must be a comparison of two or more alternatives and both the costs as well as the consequences of the alternatives must be examined.5 Although these evaluations are of great importance in healthcare policy, many have serious methodological flaws that weaken the validity of their conclusions.6 Recognition of this problem has led to the development of a number of guidelines that describe appropriate methodology in the development of HEEs.7 Approximately 76,000 people a year sustain a hip fracture in the UK and the estimated cost to the NHS is £1.4 billion a year.8 This represents a sizeable proportion of the total annual budget for musculoskeletal disease, which has been valued at £10 billion.9 The prevalence of this condition, and its associated mortality has contributed to a research drive that has identified aspects of care such as expediting time to surgery,10 the use of spinal anaesthesia11 and physician led management that improve survivorship.12 The importance of effective deployment of financial, technical and workforce resources to deliver evidence based approaches that improve clinical outcomes and provide value for money cannot be overstated in this field of medicine. The objective of this study was (1) to identify and characterize HEEs performed for management strategies in patients with hip fractures, and (2) to examine their methodological quality using established standards in health economics.
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combination with “hip”, “femoral neck” or “neck of femur”. The search was conducted for studies published between January 1990 and December 2013. The last date of the search was performed on the 20th of April 2014. A summary of the search strategy is show in Fig. 1.
Inclusion and exclusion criteria Only publications that described 2 or more alternatives, and included both costs as well as consequences, were included in the evaluation. Cost description, cost analysis and noncomparative cost-outcome studies do not meet the requirements of a full economic evaluation5 and were therefore excluded. The HEEs of interest in this study were those that focused on management strategies for patients with a hip fracture, therefore studies that described bone protection measures and hip fracture prevention were excluded.
Data extraction The following data was extracted using a standardized spreadsheet: study title, authorship, year of publication, country of origin, source of funding, type of health economic evaluation, level of evidence according to Oxford Centre for Evidence based Medicine,14 economic model perspective, use of age to define population of interest and study attributes related to the system used for methodological evaluation of quality (Table 1).
Health economic evaluation nomenclature There are various ways of classifying a HEE, however this study categorizes them into 4 groups that are commonly
Methods Review protocol This study was performed in accordance with the guidelines from the preferred reporting items for systematic reviews and meta-analyses (PRISMA).13
Information sources and search strategy A literature search was performed in MEDLINE, EMBASE and the NHS Economic Evaluation Database for English language studies that contained the words “cost” or “economic” in
Fig. 1 e Flow diagram showing systematic search strategy for study selection.
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Table 1 e Components of methodological quality of health economic evaluation (Evers et al., 2005). HEE component
Study no (%)
1. Is the study population clearly described? 2. Are competing alternatives clearly described? 3. Is a well-defined research question posed in answerable form? 4. Is the economic study design appropriate to the stated objective? 5. Is the chosen time horizon appropriate to include relevant costs and consequences? 6. Is the actual perspective chosen appropriate? 7. Are all important and relevant costs for each alternative identified? 8. Are all costs measured appropriately in physical units? 9. Are costs valued appropriately? 10. Are all important and relevant outcomes for each alternative identified? 11. Are all outcomes measured appropriately? 12. Are outcomes valued appropriately? 13. Is an incremental analysis of costs and outcomes of alternatives performed? 14. Are all future costs and outcomes discounted appropriately? 15. Are all important variables, whose values are uncertain, appropriately subjected to sensitivity analysis? 16. Do the conclusions follow from the data reported? 17. Does the study generalize the results to other settings and patient/client groups? 18. Does the article indicate that there is no potential conflict of interest of study researcher(s) and funder(s)? 19. Are ethical and distributional issues discussed appropriately?
described in health economic literature.15,16 A cost minimization analysis (CMA) is a HEE in which the outcomes of alternative interventions are known to be identical. The purpose of a CMA is to investigate the differences in costing between the treatment alternatives. A cost effectiveness analysis (CEA) compares the costs and benefits of two or more treatment alternatives. The benefit of interest relates to clinical outcomes such as life years gained. A cost utility analysis (CUA) compares costs with utilities. These are life years saved that are weighted for a valuation of life experienced during those years. These utilities are referred to as quality adjusted life years (QALYs). A cost benefit analysis (CBA) compares costs and outcome; however the latter are also valued in monetary terms derived from patient willingness to pay for treatment and estimates of future productivity. The viewpoint or perspective from which a HEE is adopted is one of the first steps in development and also one of the most controversial.17 A restrictive perspective is one in which only direct costs incurred by a third party payer, the NHS or the hospital are considered. A societal perspective includes indirect costs such as loss of earnings from sick leave and
Table 2 e Economic evaluation by topic. Topic Surgical procedure comparison Multi-disciplinary care pathway (including ortho-geriatric care) Post-operative rehabilitation pathway Care in a teaching hospital or high volume centre Anaesthetic care Diagnostic imaging Expediting time to surgery Thromboprophylaxis for hip fracture patients Management of psychological well-being Total
27 26 27 27 18 27 22 27 22 23 26 27 17 12 11 27 19 10 8
(100) (96.3) (100) (100) (66.7) (100) (81.5) (100) (81.5) (85.2) (96.3) (100) (63) (44.4) (40.7) (100) (70.4) (37) (29.6)
non-healthcare related expenditure incurred such as social services care. A societal perspective is often cited as the gold standard viewpoint from which a HEE should be conducted.5 Despite this, decision makers in healthcare may prefer a healthcare focused evaluation over one that is societal as they view the former to be more informative for managing their own resources.17
HEE quality assessment The criteria list from the Consensus on Health Economic Criteria (CHEC) was used for quality assessment of the HEEs included in this study.18 This criteria list was developed by 23 international experts who participated in a Delphi panel to achieve a generic set of items for quality assessment of economic evaluations. The CHEC is a 19-item checklist that provides a robust assessment of quality, and is used by the National Institute for Health Research (NIHR) in the development of their health technology assessments.19,20 It is also recommended by the Cochrane Collaboration for addressing risk of bias and performing critical appraisal of health economic evaluations.21
Statistical analysis Studies no (%) 9 (33.3) 6 (22.2) 4 (14.8) 2 (7.4) 2 1 1 1
(7.4) (3.7) (3.7) (3.7)
Descriptive statistics were produced and data were analysed in SPSS 20.0 (SPSS Inc, Chicago, IL). The distribution of the data were assessed with a KolmogoroveSmirnov test and found to be parametric. HEE characteristics were examined to determine whether they significantly affected quality scores using a one-way analysis of variance (ANOVA) test. A p-value < 0.05 was considered statistically significant.
Results 1 (3.7) 27 (100)
Twenty-seven publications met the inclusion criteria of this study and were included in our descriptive and qualitative
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analysis. HEEs for patients with hip fractures compared alternative measures across a wide spectrum of fields, however the most common aspect of care related to comparison of surgical procedures which represented 9 of the 27 studies (Table 2). There was a clear trend that demonstrated an increased frequency of publication of HEEs over time (Table 3). Despite our search strategy examining publications from 1990 onwards, 48.2% of HEEs were published after 2010. There was a lack of uniform practice in defining population age within the inclusion criteria amongst the 27 papers (Table 4). Sixty three per cent of studies stated an age inclusion for patients, however there was observable heterogeneity amongst these values (range 50e80 years). There were 9 (33.3%) HEEs that had originated from the United States (US) and this represented the largest number from a single country. Eleven (40.7%) of studies did not disclose their source of funding. Sixteen (59.3%) of the studies used primary sources to determine costs and outcomes in their analysis. The vast majority of economic evaluations adopted a restrictive perspective (74.1%), and the largest proportion of HEEs that were performed were cost effectiveness analysis (48.1%). Details of these characteristics are demonstrated in Table 4.
Evaluation of economic evaluation methodology The CHEC questionnaire and methodological quality of the 27 HEEs is shown in Table 1. Aspects of methodology that were performed included: description of study population (100%), clarity in description of alternatives (96.3%), a well-defined research question (100%), appropriate study design (100%), description of study perspective (100%), appropriate units for cost measurement (100%), measurements of outcome (96.3%), outcomes valued appropriately (100%) and conclusions that reflected the study findings (100%). Domains of methodology which performed less impressively amongst the 27 studies included an appropriate time horizon (66.7%), incremental analysis of costs and outcomes (63%), future cost discounting (44.4%), sensitivity analysis (40.7%), declaration of conflicts of interest (37%) and discussion of ethical considerations (29.6%). An ANOVA test performed to compare the overall quality scores of the 27 studies amongst the countries of origin (p ¼ 0.69), the source of funding (p ¼ 0.16), the type of HEE (p ¼ 0.23) and the study perspective (p ¼ 0.14) found no significant differences.
Discussion This study has demonstrated that although the volume of HEEs for the management of patients with hip fractures is relatively small, there has been a considerable increase in publication of these studies in recent years. The majority of these studies adopt a restrictive perspective and therefore evidence on societal implications of care is lacking in the literature. Many studies fail to disclose how they are financed and government funded HEEs account for less than a quarter of the total number. Key aspects of methodology such as sensitivity analysis, appropriate discounting of future costs and outcomes, incremental analysis of treatment
Table 3 e Economic evaluation by year of publication. Year 1990e1995 1996e2000 2001e2005 2006e2010 2011e2013
Studies no (%) 1 (3.7) 1 (3.7) 3 (8.11) 9 (33.33) 13 (48.15)
alternatives, declaration of conflicts of interest and discussion of ethical considerations are often not performed. Increasing publication rates of orthopaedic HEEs has also been reported in other studies.22,23 It is likely that the burden of an ageing population, as well as increasing global attention towards the need for efficient healthcare management, have driven interest in this field in more recent years. Furthermore,
Table 4 e Other characteristics of health economic evaluations for the management of patients with hip fractures. Study no (%) Country of origin United States United Kingdom Canada Netherlands Sweden Norway Germany China Greece Israel Funding Not stated Industry, Government and Association Government Association/Charitable organisation Industry Data sources Primary Secondary (existing literature/national database) Combination of primary and secondary Perspective Restrictive Societal Level of evidence I II III IV Type of Health economic evaluation Cost minimisation Cost effectiveness Cost utility Cost benefit analysis Cost effectiveness and cost benefit HEE that specify age in their inclusion criteria Total number of studies Studies that specify age Mean age Median age Minimum age value Maximum age value
9 5 3 3 2 1 1 1 1 1
(33.3) (18.5) (8.1) (8.1) (7.4) (3.7) (3.7) (3.7) (3.7) (3.7)
11 (40.7) 6 (22.2) 6 (22.2) 3 (8.1) 1 (3.7) 16 (59.3) 5 (18.5) 6 (22.2) 20 (74.1) 7 (25.9) 6 (22.2) 2 (7.4) 15 (55.6) 4 (14.8) 2 (7.4) 13 (48.1) 10 (37) 1 (3.7) 1 (3.7) 27 17 (70%) >63.53 65 50 80
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in the UK, the introduction of data resources such as Hospital Episode Statistics (HES)24 and the National Hip Fracture Database (NFHD)8 have increased the availability of information that can be applied to economic evaluations in orthopaedic practice. Despite the rise in publication rates for HEEs for patients with hip fractures, key principles of development were found to be lacking and our results resonate with the findings of other researchers in this field. Brauer et al. performed a review of cost utility analyses in orthopaedic surgery that were published between 1976 and 2001. They identified a number of limitations in methodological quality which led them to question the ability of these studies to effectively guide health policy.25 A third of HEEs in this study failed to adopt an appropriate time horizon. The chosen time horizon in economic evaluations should be long enough to reflect important long-term differences in costs and consequences of alternative strategies.26 The standard we set for studies reporting a mortality benefit was a minimum time horizon of 1 year. Although 30day mortality is commonly cited in relation to hip fracture survivorship,8,10 a long-term outcome of treatment is preferable for the purpose of an economic evaluation26 and variability in mortality rates at 1 year is also widely reported in the literature.27,28 Incremental analysis of costs and consequences of alternatives was not described in a number of the studies. A number of HEEs that were self-described as cost effectiveness studies, reported on costs and consequences in a disaggregated way. Such studies are commonly termed costconsequence analysis.29 By separating cost and consequence from their incremental analysis, these studies transfer the burden of evaluating the difference in cost per unit of health outcome to the HEE user. Although some authors support the development of such studies,30 a key problem is that they rely on the assumption that the HEE users are able to reliably analyse the results.29 The appropriate discounting of future costs and outcomes was another methodological component that most studies failed to perform. Health economists generally agree that costs and benefits have different weights over time. Costs should be discounted because of inflation and a preference to incur costs in the future rather than immediately.29,31 Discounting of health benefits is required because of “positive time preference” for health outcomes which is the belief that society tends to prefer earlier treatment benefits over those that occur later.32 In the UK the National Institute for Health and Clinical Excellence (NICE) recommends an annual discounting rate of 3.5%,33 however our research included studies from a number of countries and we therefore accepted annual discounting rates of between 3% and 5% based on commonly cited values in economic evaluation research.34 The characterization of uncertainty is a key element of economic analyis.35 Sensitivity analysis is the means of exploring the impact of uncertainty on the findings of a HEE and it is broadly accepted that a failure to perform this analysis demonstrates a lack of quality to the study.36 The absence of sensitivity analysis from economic evaluations across healthcare was reported almost 20 years ago,37 however given the multitude of guidelines that have subsequently emerged
and advise on performing this analysis, it is surprising that researchers still fail to perform it.7 The most concerning areas of methodological quality related to descriptions of conflicts of interest and discussions of ethical considerations of the studies. Addressing the latter domain, we found that 16 out of the 27 studies used primary data sources from clinical studies they performed to establish costs and outcomes. Nine of these studies failed to state whether ethical approval had been sought for their research. Key opinion leaders in orthopaedics have underlined the need for comprehensive ethical standards.38 Health economists as well as orthopaedic surgeons involved in the development of HEEs have a responsibility to adhere to these standards. Furthermore, measures must be taken to reduce the influence the pharmaceutical industry may seek over healthcare professionals by ensuring absolute transparency in research.39 Such transparency would include a clear description of conflicts of interest which is essential in research governance given that there is a known association between positive findings in medical research and industry sponsorship of studies.40,41 Although the effects of industry sponsorship on interventions such as patient rehabilitation pathways, expediting time to surgery and psychological wellbeing therapies are questionable, the evaluation of specific orthopaedic implants, anaesthethic drugs and thromboprophylaxis that involve industry funding could lead to sponsorship bias. Hip fracture economic evaluations shape policy that utilizes vast financial resources and therefore it is critical that this area of methodological quality is addressed for future research. As such, our finding that only 22% of the HEEs identified in this study were funded by government organizations is concerning. Some authors have suggested that government funding of economic evaluations in medicine is an effective way of dealing with perceptions of sponsorship bias.40 While increasing government funding of HEEs for hip fractures would address such bias, the current objective of policy makers to deliver high quality care and achieve efficiency savings4 may be more attainable if they increase financial support for research that evaluates which treatment alternatives are clinically and economically superior. It was not surprising to find that only a quarter of HEEs in our study adopted a societal perspective. Systematic reviews of HEEs across medicine report a preference in practice for adopting a restrictive perspective.42,43 In our analysis, studies in the US had a preference for adopting Medicare reimbursement rates and those published in the UK used the NHS best practice tariff. In both cases, this is likely to be owed to the convenience of using these data. The adoption of a healthcare system perspective for economic evaluations is useful for determining the allocation of resources available to that system; however, given the wider value of health and healthcare, a societal perspective, which incorporates indirect and non-health related costs, is commonly viewed to be the gold-standard method for conducting a HEE.5,17 This is particularly relevant for patients with hip fractures because a large proportion of them require long term care, and this increases estimates of societal costs of management considerably.44
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Limitations There are 5 main limitations to our study. Firstly, it is possible that the key words we adopted failed to identify all the relevant studies. Despite this, we used three large databases for our systematic review and we believe that the number of studies that may have been missed using our described search strategy is small. Secondly, we restricted our analysis to studies that described management of patients with a hip fracture and not those that reported on bone protection and other preventative measures. Although analysis of such studies would have been useful, our results provide orthopaedic surgeons, elderly care physicians and policy makers with important insight into the quantity and quality of currently available economic evaluations that examine treatment alternatives available for inpatient care. Thirdly, our assessment of methodological quality could have been more robust. When we assessed whether sensitivity analysis had been performed, we did not attempt to judge whether the right type of sensitivity analysis had been performed nor did we scrutinize whether appropriate data sources had been used for parameter estimation. Had this been done, it is possible that the quality the HEEs would have been even poorer. The fourth limitation relates to the use of only Englishlanguage studies within the search protocol. This restriction introduces language bias into the methodology of this systematic review. Finally, because of a small population size, statistical testing for a relationship between HEE characteristics and study quality is prone to type II error and therefore the absence of statistically significant relationships should be cautiously interpreted.
Conclusions HEEs for patients with hip fractures are increasing in publication, particularly in recent years. Most of these studies fail to adopt a societal perspective and key aspects of their methodology are poor. The development of future HEEs in this field should adhere to established principles of methodology, so that better quality research can be used to inform health policy on the management of patients with hip fractures.
Conflict of interests All authors have no conflicts of interest to declare.
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Review
The methodological quality of health economic evaluations for the management of hip fractures: A systematic review of the literature Sanjeeve Sabharwal a,*, Alexander Carter b, Lord Ara Darzi c, Peter Reilly a,c, Chinmay M. Gupte a,c a
Imperial College NHS Trust, UK Imperial College London, Institute of Global Health Innovation, UK c Imperial College London, UK b
article info
abstract
Article history:
Background and objectives: Approximately 76,000 people a year sustain a hip fracture in the
Received 31 July 2014
UK and the estimated cost to the NHS is £1.4 billion a year. Health economic evaluations
Received in revised form
(HEEs) are one of the methods employed by decision makers to deliver healthcare policy
30 September 2014
supported by clinical and economic evidence. The objective of this study was to (1) identify
Accepted 16 October 2014
and characterize HEEs for the management of patients with hip fractures, and (2) examine
Available online 15 December 2014
their methodological quality. Methods: A literature search was performed in MEDLINE, EMBASE and the NHS Economic
Keywords:
Evaluation Database. Studies that met the specified definition for a HEE and evaluated hip
Hip fracture
fracture management were included. Methodological quality was assessed using the
Health economic evaluation
Consensus on Health Economic Criteria (CHEC). Results: Twenty-seven publications met the inclusion criteria of this study and were included in our descriptive and methodological analysis. Domains of methodology that performed poorly included use of an appropriate time horizon (66.7% of studies), incremental analysis of costs and outcomes (63%), future discounting (44.4%), sensitivity analysis (40.7%), declaration of conflicts of interest (37%) and discussion of ethical considerations (29.6%). Conclusions: HEEs for patients with hip fractures are increasing in publication in recent years. Most of these studies fail to adopt a societal perspective and key aspects of their methodology are poor. The development of future HEEs in this field must adhere to established principles of methodology, so that better quality research can be used to inform health policy on the management of patients with a hip fracture. © 2014 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
* Corresponding author. Department of Surgery and Cancer, Imperial College London, 10th Floor QEQM Building, St Mary's Hospital, London W2 1NY, UK. Tel.: þ44 7939447204. E-mail address: [email protected] (S. Sabharwal). http://dx.doi.org/10.1016/j.surge.2014.10.005 1479-666X/© 2014 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
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Introduction Advances in medical technology and an ageing population contribute to the widespread view that rising healthcare expenditure in the 21st century is inevitable.1,2 The 2007 global financial crisis and the economic downturn that followed has brought attention to the sustainability of existing healthcare systems.3 The National Audit Office in the United Kingdom (UK) has recommended that the National Health Service (NHS) achieve efficiency savings of up to £20 billion between 2011 and 2015.4 In the current fiscal climate, the importance of healthcare policy that is based on clinical and economic evidence is acute. Health economic evaluations (HEEs) are one the apparatuses that decision makers rely on to deliver evidence-based policy. An economic evaluation in healthcare can be defined as the comparative analysis of alternative courses of action in terms of both their costs and consequences.5 There are two distinguishing characteristics for any analysis to meet the defined criteria of a HEE. There must be a comparison of two or more alternatives and both the costs as well as the consequences of the alternatives must be examined.5 Although these evaluations are of great importance in healthcare policy, many have serious methodological flaws that weaken the validity of their conclusions.6 Recognition of this problem has led to the development of a number of guidelines that describe appropriate methodology in the development of HEEs.7 Approximately 76,000 people a year sustain a hip fracture in the UK and the estimated cost to the NHS is £1.4 billion a year.8 This represents a sizeable proportion of the total annual budget for musculoskeletal disease, which has been valued at £10 billion.9 The prevalence of this condition, and its associated mortality has contributed to a research drive that has identified aspects of care such as expediting time to surgery,10 the use of spinal anaesthesia11 and physician led management that improve survivorship.12 The importance of effective deployment of financial, technical and workforce resources to deliver evidence based approaches that improve clinical outcomes and provide value for money cannot be overstated in this field of medicine. The objective of this study was (1) to identify and characterize HEEs performed for management strategies in patients with hip fractures, and (2) to examine their methodological quality using established standards in health economics.
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combination with “hip”, “femoral neck” or “neck of femur”. The search was conducted for studies published between January 1990 and December 2013. The last date of the search was performed on the 20th of April 2014. A summary of the search strategy is show in Fig. 1.
Inclusion and exclusion criteria Only publications that described 2 or more alternatives, and included both costs as well as consequences, were included in the evaluation. Cost description, cost analysis and noncomparative cost-outcome studies do not meet the requirements of a full economic evaluation5 and were therefore excluded. The HEEs of interest in this study were those that focused on management strategies for patients with a hip fracture, therefore studies that described bone protection measures and hip fracture prevention were excluded.
Data extraction The following data was extracted using a standardized spreadsheet: study title, authorship, year of publication, country of origin, source of funding, type of health economic evaluation, level of evidence according to Oxford Centre for Evidence based Medicine,14 economic model perspective, use of age to define population of interest and study attributes related to the system used for methodological evaluation of quality (Table 1).
Health economic evaluation nomenclature There are various ways of classifying a HEE, however this study categorizes them into 4 groups that are commonly
Methods Review protocol This study was performed in accordance with the guidelines from the preferred reporting items for systematic reviews and meta-analyses (PRISMA).13
Information sources and search strategy A literature search was performed in MEDLINE, EMBASE and the NHS Economic Evaluation Database for English language studies that contained the words “cost” or “economic” in
Fig. 1 e Flow diagram showing systematic search strategy for study selection.
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Table 1 e Components of methodological quality of health economic evaluation (Evers et al., 2005). HEE component
Study no (%)
1. Is the study population clearly described? 2. Are competing alternatives clearly described? 3. Is a well-defined research question posed in answerable form? 4. Is the economic study design appropriate to the stated objective? 5. Is the chosen time horizon appropriate to include relevant costs and consequences? 6. Is the actual perspective chosen appropriate? 7. Are all important and relevant costs for each alternative identified? 8. Are all costs measured appropriately in physical units? 9. Are costs valued appropriately? 10. Are all important and relevant outcomes for each alternative identified? 11. Are all outcomes measured appropriately? 12. Are outcomes valued appropriately? 13. Is an incremental analysis of costs and outcomes of alternatives performed? 14. Are all future costs and outcomes discounted appropriately? 15. Are all important variables, whose values are uncertain, appropriately subjected to sensitivity analysis? 16. Do the conclusions follow from the data reported? 17. Does the study generalize the results to other settings and patient/client groups? 18. Does the article indicate that there is no potential conflict of interest of study researcher(s) and funder(s)? 19. Are ethical and distributional issues discussed appropriately?
described in health economic literature.15,16 A cost minimization analysis (CMA) is a HEE in which the outcomes of alternative interventions are known to be identical. The purpose of a CMA is to investigate the differences in costing between the treatment alternatives. A cost effectiveness analysis (CEA) compares the costs and benefits of two or more treatment alternatives. The benefit of interest relates to clinical outcomes such as life years gained. A cost utility analysis (CUA) compares costs with utilities. These are life years saved that are weighted for a valuation of life experienced during those years. These utilities are referred to as quality adjusted life years (QALYs). A cost benefit analysis (CBA) compares costs and outcome; however the latter are also valued in monetary terms derived from patient willingness to pay for treatment and estimates of future productivity. The viewpoint or perspective from which a HEE is adopted is one of the first steps in development and also one of the most controversial.17 A restrictive perspective is one in which only direct costs incurred by a third party payer, the NHS or the hospital are considered. A societal perspective includes indirect costs such as loss of earnings from sick leave and
Table 2 e Economic evaluation by topic. Topic Surgical procedure comparison Multi-disciplinary care pathway (including ortho-geriatric care) Post-operative rehabilitation pathway Care in a teaching hospital or high volume centre Anaesthetic care Diagnostic imaging Expediting time to surgery Thromboprophylaxis for hip fracture patients Management of psychological well-being Total
27 26 27 27 18 27 22 27 22 23 26 27 17 12 11 27 19 10 8
(100) (96.3) (100) (100) (66.7) (100) (81.5) (100) (81.5) (85.2) (96.3) (100) (63) (44.4) (40.7) (100) (70.4) (37) (29.6)
non-healthcare related expenditure incurred such as social services care. A societal perspective is often cited as the gold standard viewpoint from which a HEE should be conducted.5 Despite this, decision makers in healthcare may prefer a healthcare focused evaluation over one that is societal as they view the former to be more informative for managing their own resources.17
HEE quality assessment The criteria list from the Consensus on Health Economic Criteria (CHEC) was used for quality assessment of the HEEs included in this study.18 This criteria list was developed by 23 international experts who participated in a Delphi panel to achieve a generic set of items for quality assessment of economic evaluations. The CHEC is a 19-item checklist that provides a robust assessment of quality, and is used by the National Institute for Health Research (NIHR) in the development of their health technology assessments.19,20 It is also recommended by the Cochrane Collaboration for addressing risk of bias and performing critical appraisal of health economic evaluations.21
Statistical analysis Studies no (%) 9 (33.3) 6 (22.2) 4 (14.8) 2 (7.4) 2 1 1 1
(7.4) (3.7) (3.7) (3.7)
Descriptive statistics were produced and data were analysed in SPSS 20.0 (SPSS Inc, Chicago, IL). The distribution of the data were assessed with a KolmogoroveSmirnov test and found to be parametric. HEE characteristics were examined to determine whether they significantly affected quality scores using a one-way analysis of variance (ANOVA) test. A p-value < 0.05 was considered statistically significant.
Results 1 (3.7) 27 (100)
Twenty-seven publications met the inclusion criteria of this study and were included in our descriptive and qualitative
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analysis. HEEs for patients with hip fractures compared alternative measures across a wide spectrum of fields, however the most common aspect of care related to comparison of surgical procedures which represented 9 of the 27 studies (Table 2). There was a clear trend that demonstrated an increased frequency of publication of HEEs over time (Table 3). Despite our search strategy examining publications from 1990 onwards, 48.2% of HEEs were published after 2010. There was a lack of uniform practice in defining population age within the inclusion criteria amongst the 27 papers (Table 4). Sixty three per cent of studies stated an age inclusion for patients, however there was observable heterogeneity amongst these values (range 50e80 years). There were 9 (33.3%) HEEs that had originated from the United States (US) and this represented the largest number from a single country. Eleven (40.7%) of studies did not disclose their source of funding. Sixteen (59.3%) of the studies used primary sources to determine costs and outcomes in their analysis. The vast majority of economic evaluations adopted a restrictive perspective (74.1%), and the largest proportion of HEEs that were performed were cost effectiveness analysis (48.1%). Details of these characteristics are demonstrated in Table 4.
Evaluation of economic evaluation methodology The CHEC questionnaire and methodological quality of the 27 HEEs is shown in Table 1. Aspects of methodology that were performed included: description of study population (100%), clarity in description of alternatives (96.3%), a well-defined research question (100%), appropriate study design (100%), description of study perspective (100%), appropriate units for cost measurement (100%), measurements of outcome (96.3%), outcomes valued appropriately (100%) and conclusions that reflected the study findings (100%). Domains of methodology which performed less impressively amongst the 27 studies included an appropriate time horizon (66.7%), incremental analysis of costs and outcomes (63%), future cost discounting (44.4%), sensitivity analysis (40.7%), declaration of conflicts of interest (37%) and discussion of ethical considerations (29.6%). An ANOVA test performed to compare the overall quality scores of the 27 studies amongst the countries of origin (p ¼ 0.69), the source of funding (p ¼ 0.16), the type of HEE (p ¼ 0.23) and the study perspective (p ¼ 0.14) found no significant differences.
Discussion This study has demonstrated that although the volume of HEEs for the management of patients with hip fractures is relatively small, there has been a considerable increase in publication of these studies in recent years. The majority of these studies adopt a restrictive perspective and therefore evidence on societal implications of care is lacking in the literature. Many studies fail to disclose how they are financed and government funded HEEs account for less than a quarter of the total number. Key aspects of methodology such as sensitivity analysis, appropriate discounting of future costs and outcomes, incremental analysis of treatment
Table 3 e Economic evaluation by year of publication. Year 1990e1995 1996e2000 2001e2005 2006e2010 2011e2013
Studies no (%) 1 (3.7) 1 (3.7) 3 (8.11) 9 (33.33) 13 (48.15)
alternatives, declaration of conflicts of interest and discussion of ethical considerations are often not performed. Increasing publication rates of orthopaedic HEEs has also been reported in other studies.22,23 It is likely that the burden of an ageing population, as well as increasing global attention towards the need for efficient healthcare management, have driven interest in this field in more recent years. Furthermore,
Table 4 e Other characteristics of health economic evaluations for the management of patients with hip fractures. Study no (%) Country of origin United States United Kingdom Canada Netherlands Sweden Norway Germany China Greece Israel Funding Not stated Industry, Government and Association Government Association/Charitable organisation Industry Data sources Primary Secondary (existing literature/national database) Combination of primary and secondary Perspective Restrictive Societal Level of evidence I II III IV Type of Health economic evaluation Cost minimisation Cost effectiveness Cost utility Cost benefit analysis Cost effectiveness and cost benefit HEE that specify age in their inclusion criteria Total number of studies Studies that specify age Mean age Median age Minimum age value Maximum age value
9 5 3 3 2 1 1 1 1 1
(33.3) (18.5) (8.1) (8.1) (7.4) (3.7) (3.7) (3.7) (3.7) (3.7)
11 (40.7) 6 (22.2) 6 (22.2) 3 (8.1) 1 (3.7) 16 (59.3) 5 (18.5) 6 (22.2) 20 (74.1) 7 (25.9) 6 (22.2) 2 (7.4) 15 (55.6) 4 (14.8) 2 (7.4) 13 (48.1) 10 (37) 1 (3.7) 1 (3.7) 27 17 (70%) >63.53 65 50 80
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in the UK, the introduction of data resources such as Hospital Episode Statistics (HES)24 and the National Hip Fracture Database (NFHD)8 have increased the availability of information that can be applied to economic evaluations in orthopaedic practice. Despite the rise in publication rates for HEEs for patients with hip fractures, key principles of development were found to be lacking and our results resonate with the findings of other researchers in this field. Brauer et al. performed a review of cost utility analyses in orthopaedic surgery that were published between 1976 and 2001. They identified a number of limitations in methodological quality which led them to question the ability of these studies to effectively guide health policy.25 A third of HEEs in this study failed to adopt an appropriate time horizon. The chosen time horizon in economic evaluations should be long enough to reflect important long-term differences in costs and consequences of alternative strategies.26 The standard we set for studies reporting a mortality benefit was a minimum time horizon of 1 year. Although 30day mortality is commonly cited in relation to hip fracture survivorship,8,10 a long-term outcome of treatment is preferable for the purpose of an economic evaluation26 and variability in mortality rates at 1 year is also widely reported in the literature.27,28 Incremental analysis of costs and consequences of alternatives was not described in a number of the studies. A number of HEEs that were self-described as cost effectiveness studies, reported on costs and consequences in a disaggregated way. Such studies are commonly termed costconsequence analysis.29 By separating cost and consequence from their incremental analysis, these studies transfer the burden of evaluating the difference in cost per unit of health outcome to the HEE user. Although some authors support the development of such studies,30 a key problem is that they rely on the assumption that the HEE users are able to reliably analyse the results.29 The appropriate discounting of future costs and outcomes was another methodological component that most studies failed to perform. Health economists generally agree that costs and benefits have different weights over time. Costs should be discounted because of inflation and a preference to incur costs in the future rather than immediately.29,31 Discounting of health benefits is required because of “positive time preference” for health outcomes which is the belief that society tends to prefer earlier treatment benefits over those that occur later.32 In the UK the National Institute for Health and Clinical Excellence (NICE) recommends an annual discounting rate of 3.5%,33 however our research included studies from a number of countries and we therefore accepted annual discounting rates of between 3% and 5% based on commonly cited values in economic evaluation research.34 The characterization of uncertainty is a key element of economic analyis.35 Sensitivity analysis is the means of exploring the impact of uncertainty on the findings of a HEE and it is broadly accepted that a failure to perform this analysis demonstrates a lack of quality to the study.36 The absence of sensitivity analysis from economic evaluations across healthcare was reported almost 20 years ago,37 however given the multitude of guidelines that have subsequently emerged
and advise on performing this analysis, it is surprising that researchers still fail to perform it.7 The most concerning areas of methodological quality related to descriptions of conflicts of interest and discussions of ethical considerations of the studies. Addressing the latter domain, we found that 16 out of the 27 studies used primary data sources from clinical studies they performed to establish costs and outcomes. Nine of these studies failed to state whether ethical approval had been sought for their research. Key opinion leaders in orthopaedics have underlined the need for comprehensive ethical standards.38 Health economists as well as orthopaedic surgeons involved in the development of HEEs have a responsibility to adhere to these standards. Furthermore, measures must be taken to reduce the influence the pharmaceutical industry may seek over healthcare professionals by ensuring absolute transparency in research.39 Such transparency would include a clear description of conflicts of interest which is essential in research governance given that there is a known association between positive findings in medical research and industry sponsorship of studies.40,41 Although the effects of industry sponsorship on interventions such as patient rehabilitation pathways, expediting time to surgery and psychological wellbeing therapies are questionable, the evaluation of specific orthopaedic implants, anaesthethic drugs and thromboprophylaxis that involve industry funding could lead to sponsorship bias. Hip fracture economic evaluations shape policy that utilizes vast financial resources and therefore it is critical that this area of methodological quality is addressed for future research. As such, our finding that only 22% of the HEEs identified in this study were funded by government organizations is concerning. Some authors have suggested that government funding of economic evaluations in medicine is an effective way of dealing with perceptions of sponsorship bias.40 While increasing government funding of HEEs for hip fractures would address such bias, the current objective of policy makers to deliver high quality care and achieve efficiency savings4 may be more attainable if they increase financial support for research that evaluates which treatment alternatives are clinically and economically superior. It was not surprising to find that only a quarter of HEEs in our study adopted a societal perspective. Systematic reviews of HEEs across medicine report a preference in practice for adopting a restrictive perspective.42,43 In our analysis, studies in the US had a preference for adopting Medicare reimbursement rates and those published in the UK used the NHS best practice tariff. In both cases, this is likely to be owed to the convenience of using these data. The adoption of a healthcare system perspective for economic evaluations is useful for determining the allocation of resources available to that system; however, given the wider value of health and healthcare, a societal perspective, which incorporates indirect and non-health related costs, is commonly viewed to be the gold-standard method for conducting a HEE.5,17 This is particularly relevant for patients with hip fractures because a large proportion of them require long term care, and this increases estimates of societal costs of management considerably.44
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Limitations There are 5 main limitations to our study. Firstly, it is possible that the key words we adopted failed to identify all the relevant studies. Despite this, we used three large databases for our systematic review and we believe that the number of studies that may have been missed using our described search strategy is small. Secondly, we restricted our analysis to studies that described management of patients with a hip fracture and not those that reported on bone protection and other preventative measures. Although analysis of such studies would have been useful, our results provide orthopaedic surgeons, elderly care physicians and policy makers with important insight into the quantity and quality of currently available economic evaluations that examine treatment alternatives available for inpatient care. Thirdly, our assessment of methodological quality could have been more robust. When we assessed whether sensitivity analysis had been performed, we did not attempt to judge whether the right type of sensitivity analysis had been performed nor did we scrutinize whether appropriate data sources had been used for parameter estimation. Had this been done, it is possible that the quality the HEEs would have been even poorer. The fourth limitation relates to the use of only Englishlanguage studies within the search protocol. This restriction introduces language bias into the methodology of this systematic review. Finally, because of a small population size, statistical testing for a relationship between HEE characteristics and study quality is prone to type II error and therefore the absence of statistically significant relationships should be cautiously interpreted.
Conclusions HEEs for patients with hip fractures are increasing in publication, particularly in recent years. Most of these studies fail to adopt a societal perspective and key aspects of their methodology are poor. The development of future HEEs in this field should adhere to established principles of methodology, so that better quality research can be used to inform health policy on the management of patients with hip fractures.
Conflict of interests All authors have no conflicts of interest to declare.
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