Debate | Open | Open Peer Review | Published:
The role of national registries in improving patient safety for hip and knee replacements
BMC Musculoskeletal Disordersvolume 18, Article number: 414 (2017)
The serious adverse events associated with metal on metal hip replacements have highlighted the importance of improving methods for monitoring surgical implants.
The new European Union (EU) device regulation will enforce post-marketing surveillance based on registries among other surveillance tools. Europe has a common regulatory environment, a common market for medical devices, and extensive experience with joint replacement registries. In this context, we elaborate how joint replacement registries, while building on existing structure and data, can better ensure safety and balance risks and benefits.
Actions to improve registry-based implant surveillance include: enriching baseline and diversifying outcomes data collection; improving methodology to limit bias; speeding-up failure detection by active real-time monitoring; implementing risk-benefit analysis; coordinating collaboration between registries; and translating knowledge gained from the data into clinical decision-making and public health policy.
The changes proposed here will improve patient safety, enforce the application of the new legal EU requirements, augment evidence, improve clinical decision-making, facilitate value-based health-care delivery, and provide up-to-date guidance for public health.
The need to improve post-marketing surveillance of the safety of implants has been highlighted by serious complications, especially those with a delayed onset, as illustrated by pseudo-tumours developing in patients with metal-on-metal implants . In this piece we consider the future role of registries for joint replacement and what changes will be required to best inform decisions on the safety of both existing and novel hip and knee implants.
Hip and knee replacement incidence
Total hip and knee replacements are very common, and generally considered highly cost-effective orthopaedic procedures [2,3,4]. In 2005, about 745,000 hip (total and partial) and 430,000 knee replacements were performed in Europe according to the Organisation for Economic Co-Operation and Development (OECD). By 2012, these numbers increased by 10% and 30% respectively to about 820,000 hips and 560,000 knees implanted . Because of rising trends both in obesity prevalence and in life expectancy , together with a broadening of the indications for surgery, these numbers have been predicted to increase further [7, 8]. European hip and knee replacement incidence rates from the latest OECD report  are shown in Fig. 1a-b.
Joint replacement registries
Registries of joint replacements have since 1975 pioneered voluntary monitoring of real-world treatment on a national level with a focus on long-term surveillance of implant survival . For the majority of hip and knee replacements implant survival has been substantial and failure leading to revision surgery has remained an infrequent event. Other important potential adverse health consequences that have been evaluated include the short- and long-term risk of death and cancer [10,11,12]. The relatively low occurrence of complications on the one hand, and the very long-term follow-up required to characterise revision risk on the other hand, make registries well suited for long-term monitoring. Registries have focused on revision as the key outcome for several reasons: (1) it is the major indicator of an implant’s quality; (2) it constitutes a substantial burden to the patient and the society (costs); and (3) it is a “hard endpoint” (reproducible, comparable). A main issue with revision as the sole indicator of success or failure is that revisions can happen long after surgery  and as a consequence, not always directly inform the surgeon as to the quality of his/her implant choice. A surgeon’s perceived “performance” of an implant, which influences future implant choice, is likely to also depend on factors such as quality and length of the patient’s recovery, and the ease of surgery and postoperative period, neither of which registries currently capture. Another important issue with revision as the sole indicator is that not all failures are revised highlighting the importance of other measures of failure and success such as patient-reported outcomes (PROMs) and satisfaction [14, 15].
Implant vs. drug surveillance
Compared to drug safety monitoring, implant surveillance is characterised by several substantive differences: first, new implants do not need pivotal randomised clinical trials before they are licensed for use; second, the implanted material remains present for decades and so adverse consequences can arise in the longer term making their detection challenging [13, 16, 17]; third, the surgeon’s experience and learning curve based on the implants’ level of complexity are unique to device evaluation and important co-determinants of outcome ; fourth, implants frequently undergo incremental changes ; and fifth, a large number of different implants are available on the market for a limited number of clinical indications (ie several ‘in class’ marketed very closely in time compared to normally a single novel pharmaceutical) [19, 20].
Much higher failure rates have been observed after metal-on-metal hip replacement as compared to other bearing surfaces [21, 22], and a substantial number of patients have already endured revision surgery. Another large group of so far unrevised patients is still at risk for local and/or systematic adverse effects of metal debris . Despite the existence of joint replacement registries the hazards of metal-on-metal hip replacement were not identified sufficiently early to protect public health. Major reasons for this included, among others , the prime focus on only one adverse outcome (revision), lack of “real-time” detection of adverse events, limited availability of comparative studies , no widely implemented guidance on what is considered acceptable safety and effectiveness, and sparse information on patient characteristics. It has been widely agreed [2, 19, 25,26,27] for some time [28,29,30] that the processes for post-marketing surveillance of joint replacements are insufficient. But the inadequate evaluation of the widely available metal-on-metal hip implants has revealed deficiencies in device safety that resulted in major public health concerns [31, 32] and finally prompted the European Union (EU) to revise device regulation.
New EU medical device regulation
The new EU medical device regulation adopted in April 5, 2017  and applicable for medical devices after a transition period of three years, includes measures to strengthen both pre- and post-marketing surveillance. Key elements are: “a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level; reinforcement of the criteria for designation and processes for oversight of Notified Bodies; improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification; the introduction of an “implant card” containing information about implanted medical devices for a patient; the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations; the strengthening of post-market surveillance requirements for manufacturers; improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance” . The new regulation will rely on registries for post-marketing surveillance among other surveillance tools [33, 35, 36]. Registry surveillance could start from “first-in-human experience onward” as recently suggested in a framework for evaluating and regulating medical device use .
Against this background, we believe that joint replacement registries, while building on existing structure and data, can better ensure safety and balance risks and benefits. We describe what changes registries need in terms of gathering data, linkage to other data sources, and approach to analysis, and we discuss the value of multiple registries working together.
Enriching data from registries, and improving analyses
Currently most registries provide detailed information on implants and surgery, but have little information on patient characteristics and outcomes other than implant revision. Registries must collect this additional information, which will then permit investigators (1) to analyse additional indicators of success and failure other than revision (e.g. PROMs) as well as surrogates of failure (e.g. early abnormal radiographic findings ), (2) to adjust for potential confounders when comparing treatments, (3) to evaluate causal mechanisms, and (4) to develop a personalised approach to treatment. Thus, registries should capture patient co-morbidities and health behaviours such as smoking and obesity, which could confound or modify the risks of adverse events . Although the most robust and complete data need to be gathered prospectively as part of the primary data collection of the joint registries, reduced data completeness and accuracy may jeopardize this goal. In practice there is currently greater reliance on linkage to secondary data sources to obtain additional data. Secondary sources include primary and secondary care data and data from registries such as for mortality, cancer or drugs. For example, researchers in the United Kingdom recently linked the National Joint Registry to the Clinical Practice Research Datalink to study safety issues related to the use of metal-on-metal implants , and also to the Hospital Episode Statistics (inpatient records) to compare uni-compartmental versus total knee replacement . In the latter case, the more detailed information about the patient’s characteristics at the time of surgery and about reoperations and readmissions - obtained from the inpatient records - increased the number of outcomes evaluated as well as the ability to adjust for differences between the two treatment groups. Another example is the linkage to databases that record medications (e.g. prolonged antibiotics or pain medication use), which has been shown to offer a useful surrogate measure for prosthesis infection  and revision . In addition, linking to a system designed for spontaneously reporting adverse events  may have the potential to improve the detection of failures. Finally, integrating health economics data within registries via primary data collection and/or linkage to secondary data may improve clinical and public health decision-making.
Improving data analysis requires speeding up failure detection and bias minimisation including, but not limited to, confounding by indication. First, stakeholders including manufacturers need to adopt strategies to improve post-authorisation safety surveillance, which are increasingly used to detect adverse events in vaccine and drug surveillance [45, 46] and have become routine when assessing drug post-marketing (EU Regulation No 1027/2012). Regulators should prioritise real-time monitoring of devices by analysing specific risks . Secondly, researchers, regulators and manufacturers should systematically use measures of benefit and risk [48, 49] including PROMs of pain, function and activity, health-related quality of life, satisfaction, and costs to compare devices from a societal and policy-makers’ perspective. Third, when possible randomized trials should be nested in registries. This has the potential to combine the advantages of both study designs and to facilitate the conduct of multi-centre trials with reduced duration and costs [50, 51]. Fourth, researchers should test and incorporate methods (e.g. propensity score methods, sequential cohort analyses among others) developed to reduce bias and confounding when evaluating drugs and vaccines in observational studies [52,53,54,55]. Fifth, there is a need to stratify the risk of implant failure and other adverse events by factors specific to patients, surgery, implant, and environment. This may allow stakeholders to target improvements to subgroups, and to inform case-mix adjustment models. Finally, methods for data analyses at an aggregate level should be applied to estimate the comparative effectiveness of multiple treatments .
Maximising the value from multiple (national) registries
Europe has a common regulatory environment and a common market for medical devices. It also has extensive experience with joint replacement registries (e.g. Scandinavian countries, United Kingdom). Over the last 15 years registries have expanded to many other parts of Europe creating the opportunity to harmonise [57, 58] and extend data collection (e.g. International Society of Arthroplasty Registries (ISAR), Network of Orthopaedic Registries of Europe (NORE)) and to engage in multinational initiatives (Nordic Arthroplasty Register Association (NARA)) [59, 60]. These efforts constitute a basis for a coordinated European-wide evaluation of outcomes, which will provide:
Greater variation of implants, populations, and environment
The variety of implants used in Europe is large, and varies by country. For example 67% of the total hip replacements recorded in the Swedish Hip Arthroplasty Register are cemented compared to 36% in the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man and 15% in the Danish Hip Arthroplasty Registry according to the most recent annual report. This between-country variation constitutes a natural experiment , which enables one to compare devices under the condition of ‘quasi-randomisation’ assuming that the data are accurate, harmonised and sufficiently detailed to adjust for baseline imbalances. A multinational initiative would provide the coordination, infrastructure and methodology necessary to evaluate international differences, which would be difficult to achieve in a randomized trial. This between-registry evaluation has already successfully been established in the Scandinavian countries through the NARA collaboration [59, 61].
Higher volume and reduced time to discover poor implants
Combining the data from the existing registries will increase the numbers of an implant or surgical technique possible to evaluate within a fixed time span. This is critical for newly marketed prostheses, as they will be available only in small numbers in each registry. Pooling results would permit regulators to identify safety issues earlier and to decrease disability and costs associated with failures. Combining data will also allow testing the consistency of the findings by validating them in different populations and settings . Finally, an increased sample size will increase the precision of effect estimates and provide power for stratified analyses.
Translating knowledge gained from the data into public health policy and health care delivery [63, 64] will be as important as changing the EU device legislation and improving future orthopaedic surgeon education . Methods for stepwise introduction of new implants [65, 66] and new benchmark revision rates [67, 68] have also been proposed. Notwithstanding the challenges involved when using observational data for such evaluations, integrating quality and health outcomes from registries into health technology appraisals will undoubtedly improve them.
Richer sources of data, improved information technology and changing regulatory environment provide new opportunities to introduce safe orthopaedic implants, but numerous challenges remain. They relate to the use of observational data (especially issues with systematic error), to appropriate comparator identification and risk adjustment, to concerns with data quality, safety and privacy, and to issues of practicability, such as merging aggregate data from diverse sources, identifying signals and surrogates for clinically relevant adverse events, and measuring care processes. Finally, managing health policy and legal implications related to benchmarking and outlier identification as well as reconciling international and national priorities will be important.
The current infrastructure surrounding registries for joint replacement has improved but has not, as yet, solved all the problems with the safety of joint implants as demonstrated by metal-on-metal hip devices. Suggested actions to improve registry-based implant surveillance include enriching baseline and diversify outcomes data collection, improving methodology to limit bias, speeding-up failure detection by active real-time monitoring, implementing risk-benefit analysis, coordinating collaboration between registries, and translating knowledge gained from the data into clinical decision-making and public health policy. These changes will improve patient safety, enforce the application of the new legal EU requirements, augment evidence, improve clinical decision-making, facilitate value-based health-care delivery, and provide up-to-date guidance for public health.
Pandit H, Glyn-Jones S, McLardy-Smith P, Gundle R, Whitwell D, Gibbons CL, et al. Pseudotumours associated with metal-on-metal hip resurfacings. J Bone Joint Surg Br. 2008;90(7):847–51. doi: 10.1302/0301-620X.90B7.20213. Epub 2008/07/02. PubMed PMID: 18591590
Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, et al. Knee replacement. Lancet. 2012;379(9823):1331–40. 10.1016/S0140-6736(11)60752-6. PubMed PMID: 22398175
Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007;370(9597):1508–19. doi: S0140-6736(07) Epub 2007/10/30. PubMed PMID: 17964352
Daigle ME, Weinstein AM, Katz JN, Losina E. The cost-effectiveness of total joint arthroplasty: a systematic review of published literature. Best Pract Res Clin Rheumatol. 2012;26(5):649–58. doi: 10.1016/j.berh.2012.07.013. Epub 2012/12/12. PubMed PMID: 23218429; PubMed Central PMCID: PMC3879923
OECD/EuropeanUnion. Hip and knee replacement. Paris: OECD publishing; 2014.
Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006;54(1):226–9. doi: 10.1002/art.21562. PubMed PMID: 16385518
Pabinger C, Geissler A. Utilization rates of hip arthroplasty in OECD countries. Osteoarthr Cartil. 2014;22(6):734–41. doi: 10.1016/j.joca.2014.04.009. Epub 2014/05/02. PubMed PMID: 24780823
Pabinger C, Lothaller H, Geissler A. Utilization rates of knee-arthroplasty in OECD countries. Osteoarthr Cartil. 2015;23(10):1664–73. doi: 10.1016/j.joca.2015.05.008. Epub 2015/06/02. PubMed PMID: 26028142
Knutson K, Robertsson O. The Swedish knee Arthroplasty register (http://www.knee.se). Acta Orthop. 2010;81(1):5–7. doi: 10.3109/17453671003667267. PubMed PMID: 20170420; PubMed Central PMCID: PMC2856197
Hunt LP, Ben-Shlomo Y, Whitehouse MR, Porter ML, Blom AW. The main cause of death following primary Total hip and knee replacement for osteoarthritis: a cohort study of 26,766 deaths following 332,734 hip replacements and 29,802 deaths following 384,291 knee replacements. J Bone Joint Surg Am. 2017;99(7):565–75. doi: 10.2106/JBJS.16.00586. PubMed PMID: 28375889
Smith AJ, Dieppe P, Porter M, Blom AW. National Joint Registry of E, Wales. Risk of cancer in first seven years after metal-on-metal hip replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics. BMJ. 2012;344:e2383. doi: 10.1136/bmj.e2383. PubMed PMID: 22490979; PubMed Central PMCID: PMCPMC3318111
Onega T, Baron J, MacKenzie T. Cancer after total joint arthroplasty: a meta-analysis. Cancer Epidemiol Biomark Prev. 2006;15(8):1532–7. doi: 10.1158/1055-9965.EPI-06-0127. PubMed PMID: 16896045
Lubbeke A, Gonzalez A, Garavaglia G, Roussos C, Bonvin A, Stern R, et al. A comparative assessment of small-head metal-on-metal and ceramic-on-polyethylene total hip replacement. Bone Joint J. 2014;96-B(7):868–75. doi: 10.1302/0301-620X.96B7.32369. PubMed PMID: 24986938
Wylde V, Blom AW. The failure of survivorship. J Bone Joint Surg Br. 2011;93(5):569–70. doi:10.1302/0301-620X.93B5.26687. PubMed PMID: 21511918
Britton AR, Murray DW, Bulstrode CJ, McPherson K, Denham RA. Pain levels after total hip replacement: their use as endpoints for survival analysis. J Bone Joint Surg Br. 1997;79(1):93–8. PubMed PMID: 9020453
Gordon M, Rysinska A, Garland A, Rolfson O, Aspberg S, Eisler T, et al. Increased long-term cardiovascular risk after Total hip Arthroplasty: a Nationwide cohort study. Medicine (Baltimore). 2016;95(6):e2662. doi:10.1097/MD.0000000000002662. PubMed PMID: 26871792; PubMed Central PMCID: PMCPMC4753887
Robertsson O, Stefansdottir A, Lidgren L, Ranstam J. Increased long-term mortality in patients less than 55 years old who have undergone knee replacement for osteoarthritis: results from the Swedish knee Arthroplasty register. J Bone Joint Surg Br. 2007;89(5):599–603. doi:10.1302/0301-620X.89B5.18355. PubMed PMID: 17540743
Marinac-Dabic D, Normand SL, Sedrakyan A, Gross T. Epidemiologic studies of medical devices: Methodologic considerations for implantable devices. In: Strom BL, editor. Pharmacoepidemiology. 1st ed. Oxford: Wiley-Blackwell; 2012. p. 469–86.
Kynaston-Pearson F, Ashmore AM, Malak TT, Rombach I, Taylor A, Beard D, et al. Primary hip replacement prostheses and their evidence base: systematic review of literature. BMJ. 2013;347:f6956. doi:10.1136/bmj.f6956. PubMed PMID: 24355538; PubMed Central PMCID: PMC3898711
Marcus HJ, Payne CJ, Hughes-Hallett A, Marcus AP, Yang GZ, Darzi A, et al. Regulatory approval of new medical devices: cross sectional study. BMJ. 2016;353:i2587. doi:10.1136/bmj.i2587. Epub 2016/05/22 PubMed PMID: 27207165; PubMed Central PMCID: PMC4875244
Smith AJ, Dieppe P, Howard PW, Blom AW. National joint registry for E, Wales. Failure rates of metal-on-metal hip resurfacings: analysis of data from the National Joint Registry for England and Wales. Lancet. 2012;380(9855):1759–66. doi:10.1016/S0140-6736(12)60989-1. PubMed PMID: 23036895
Smith AJ, Dieppe P, Vernon K, Porter M, Blom AW. National Joint Registry of E, et al. failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales. Lancet. 2012;379(9822):1199–204. doi:10.1016/S0140-6736(12)60353-5. PubMed PMID: 22417410
Cohen D. All patients with metal-on-metal hip implants should undergo tests, says MHRA. BMJ. 2017;358:j3246. doi:10.1136/bmj.j3246. PubMed PMID: 28676483
Sedrakyan A, Normand SL, Dabic S, Jacobs S, Graves S, Marinac-Dabic D. Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence. BMJ. 2011;343:d7434. doi:10.1136/bmj.d7434. Epub 2011/12/01. PubMed PMID: 22127517; PubMed Central PMCID: PMC3226583
Horton R. Offline: the scandal of device regulation in the UK. Lancet. 2012;379(9812):204.
McCulloch P, Barkun J, Sedrakyan A, Collaboration I. Implantable device regulation in Europe. Lancet. 2012;380(9843):729. doi:10.1016/S0140-6736(12)61405-6. PubMed PMID: 22920749
Malchau H, Graves SE, Porter M, Harris WH, Troelsen A. The next critical role of orthopedic registries. Acta Orthop. 2015;86(1):3–4. doi:10.3109/17453674.2014.1002184. PubMed PMID: 25583041
Huiskes R. Failed innovation in total hip replacement. Diagnosis and proposals for a cure. Acta Orthop Scand. 1993;64(6):699–716. PubMed PMID: 8291421
Sochart DH, Long AJ, Porter ML. Joint responsibility: the need for a national arthroplasty register. BMJ. 1996;313(7049):66–7. PubMed PMID: 8688749; PubMed Central PMCID: PMC2351469
Malchau H. Introducing new technology: a stepwise algorithm. Spine. 2000;25(3):285. PubMed PMID: 10703097
Rising JP, Reynolds IS, Sedrakyan A. Delays and difficulties in assessing metal-on-metal hip implants. N Engl J Med. 2012;367(1):e1. doi:10.1056/NEJMp1206794. Epub 2012/06/22. PubMed PMID: 22716934
Sedrakyan A. Metal-on-metal failures--in science, regulation, and policy. Lancet. 2012;379(9822):1174–6. doi:10.1016/S0140-6736(12)60372-9. Epub 2012/03/16. PubMed PMID: 22417409
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, EUR-Lex 32017RO745 (2017). http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1499958093461&uri=CELEX:32017R0745. Accessed 12 July 2017.
Commission E. Revisions of medical device directives. 2017. https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en. Accessed 20 June 2017.
Labek G, Schoffl H, Meglic M. New medical device regulations ahead - what does that mean for arthroplasty registers? Acta Orthop. 2015;86(1):5–6. doi:10.3109/17453674.2014.1002185. PubMed PMID: 25583172; PubMed Central PMCID: PMC4366659
Sorenson C, Drummond M, et al. Milbank Q. 2014;92(1):114–50. doi:10.1111/1468-0009.12043. PubMed PMID: 24597558; PubMed Central PMCID: PMCPMC3955380
Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ. 2016;353:i2372. doi:10.1136/bmj.i2372. Epub 2016/06/11. PubMed PMID: 27283585
Pluot E, Davis ET, Revell M, Davies AM, James SL. Hip arthroplasty. Part 2: normal and abnormal radiographic findings. Clin Radiol 2009;64(10):961-71. doi:10.1016/j.crad.2009.05.002. PubMed PMID: 19748001.
Lubbeke A, Rothman KJ, Garavaglia G, Barea C, Christofilopoulos P, Stern R, et al. Strong association between smoking and the risk of revision in a cohort study of patients with metal-on-metal total hip arthroplasty. J Orthop Res. 2014;32(6):762–8. doi:10.1002/jor.22603. Epub 2014/03/13. PubMed PMID: 24615914
Lalmohamed A, MacGregor AJ, de Vries F, Leufkens HG, van Staa TP. Patterns of risk of cancer in patients with metal-on-metal hip replacements versus other bearing surface types: a record linkage study between a prospective joint registry and general practice electronic health records in England. PLoS One. 2013;8(7):e65891. doi:10.1371/journal.pone.0065891. PubMed PMID: 23861740; PubMed Central PMCID: PMCPMC3701644
Liddle AD, Judge A, Pandit H, Murray DW. Adverse outcomes after total and unicompartmental knee replacement in 101,330 matched patients: a study of data from the National Joint Registry for England and Wales. Lancet. 2014;384(9952):1437–45. doi:10.1016/S0140-6736(14)60419-0. PubMed PMID: 25012116
Lindgren V, Gordon M, Wretenberg P, Karrholm J, Garellick G. Deep infection after total hip replacement: a method for national incidence surveillance. Infect Control Hosp Epidemiol 2014;35(12):1491-1496. doi:10.1086/678600. PubMed PMID: 25419771.
Inacio MC, Pratt NL, Roughead EE, Graves SE. Using medications for prediction of revision after Total joint Arthroplasty. J Arthroplast. 2015. doi:10.1016/j.arth.2015.06.009. PubMed PMID: 26190569
Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, et al. Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15(20):1-234, iii-iv. doi:10.3310/hta15200. PubMed PMID: 21545758
Brown JS, Kulldorff M, Chan KA, Davis RL, Graham D, Pettus PT, et al. Early detection of adverse drug events within population-based health networks: application of sequential testing methods. Pharmacoepidemiol Drug Saf. 2007;16(12):1275–84. doi:10.1002/pds.1509. Epub 2007/10/24. PubMed PMID: 17955500
Oliveira JL, Lopes P, Nunes T, Campos D, Boyer S, Ahlberg E, et al. The EU-ADR web platform: delivering advanced pharmacovigilance tools. Pharmacoepidemiol Drug Saf. 2013;22(5):459–67. doi:10.1002/pds.3375. PubMed PMID: 23208789
Lieu TA, Kulldorff M, Davis RL, Lewis EM, Weintraub E, Yih K, et al. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care. 2007;45(10 Supl 2):S89–95. doi:10.1097/MLR.0b013e3180616c0a. PubMed PMID: 17909389
Thokala P, Duenas A. Multiple criteria decision analysis for health technology assessment. Value Health. 2012;15(8):1172–81. doi:10.1016/j.jval.2012.06.015. PubMed PMID: 23244821
Rolka H, Walker DW, English R, Katzoff MJ, Scogin G, Neuhaus E, et al. Analytical challenges for emerging public health surveillance. MMWR Surveill Summ. 2012;61(Suppl):35–40. PubMed PMID: 22832996
Lauer MS, D'Agostino RB, Sr. The randomized registry trial--the next disruptive technology in clinical research? N Engl J Med 2013;369(17):1579-81. doi:10.1056/NEJMp1310102. PubMed PMID: 23991657.
Ioannidis JP, Adami HO. Nested randomized trials in large cohorts and biobanks: studying the health effects of lifestyle factors. Epidemiology. 2008;19(1):75–82. doi:10.1097/EDE.0b013e31815be01c. PubMed PMID: 18090999
Craig P, Cooper C, Gunnell D, Haw S, Lawson K, Macintyre S, et al. Using natural experiments to evaluate population health interventions: new Medical Research Council guidance. J Epidemiol Community Health. 2012;66(12):1182–6. doi:10.1136/jech-2011-200375 Epub 2012/05/12 Epub 2012/05/12. PubMed PMID: 22577181; PubMed Central PMCID: PMC3796763
Rubin DB. Estimating causal effects from large data sets using propensity scores. Ann Intern Med. 1997;127(8 Pt 2):757–63. Epub 1998/02/12. PubMed PMID: 9382394
Rassen JA, Solomon DH, Glynn RJ, Schneeweiss S. Simultaneously assessing intended and unintended treatment effects of multiple treatment options: a pragmatic "matrix design". Pharmacoepidemiol Drug Saf. 2011;20(7):675–83. doi:10.1002/pds.2121. Epub 2011/06/01. PubMed PMID: 21626604
MacKinnon D. An introduction to statistical mediation analysis. New York: Lawrence Erlbaum Associates; 2008.
Sutton A, Ades AE, Cooper N, Abrams K. Use of indirect and mixed treatment comparisons for technology assessment. PharmacoEconomics. 2008;26(9):753–67. PubMed PMID: 18767896
Blomer W, Steinbruck A, Schroder C, Grothaus FJ, Melsheimer O, Mannel H, et al. A new universal, standardized implant database for product identification: a unique tool for arthroplasty registries. Arch Orthop Trauma Surg. 2015;135(7):919–26. doi:10.1007/s00402-015-2238-2. PubMed PMID: 25957983
Rolfson O, Bohm E, Franklin P, Lyman S, Denissen G, Dawson J, Dunn J, Chenok K, Dunbar M, Overgaard S, Garellick G, Lübbeke A. Patient-reported outcome measures working Group of the International Society of Arthroplasty registries. Patient-reported outcome measures in arthroplasty registries: report of the patient-reported outcome measures working Group of the International Society of Arthroplasty registries. Part II. Recommendations for selection, administration, and analysis. Acta Orthop. 2016. In press.
Havelin LI, Fenstad AM, Salomonsson R, Mehnert F, Furnes O, Overgaard S, et al. The Nordic Arthroplasty register association: a unique collaboration between 3 national hip arthroplasty registries with 280,201 THRs. Acta Orthop. 2009;80(4):393–401. doi:10.3109/17453670903039544. PubMed PMID: 19513887; PubMed Central PMCID: PMC2823198
Sedrakyan A, Paxton EW, Phillips C, Namba R, Funahashi T, Barber T, et al. The international consortium of Orthopaedic registries: overview and summary. J Bone Joint Surg Am. 2011;93(Suppl 3):1–12. doi:10.2106/JBJS.K.01125. Epub 2012/01/25. PubMed PMID: 22262417
Makela KT, Matilainen M, Pulkkinen P, Fenstad AM, Havelin LI, Engesaeter L, et al. Countrywise results of total hip replacement. An analysis of 438,733 hips based on the Nordic Arthroplasty register association database. Acta Orthop. 2014;85(2):107–16. doi:10.3109/17453674.2014.893498. PubMed PMID: 24650019; PubMed Central PMCID: PMC3967250
Hailer NP, Lazarinis S, Makela KT, Eskelinen A, Fenstad AM, Hallan G, et al. Hydroxyapatite coating does not improve uncemented stem survival after total hip arthroplasty! Acta Orthop. 2015;86(1):18–25. doi:10.3109/17453674.2014.957088. Epub 2014/09/02. PubMed PMID: 25175664; PubMed Central PMCID: PMC4366665
AbouZahr C, Adjei S, Kanchanachitra C. From data to policy: good practices and cautionary tales. Lancet. 2007;369(9566):1039–46. doi:10.1016/S0140-6736(07)60463-2. PubMed PMID: 17382830
Marshall DA, Burgos-Liz L, Pasupathy KS, Padula WV, IJzerman MJ, Wong PK, et al. Transforming healthcare delivery: integrating dynamic simulation Modelling and big data in health economics and outcomes research. PharmacoEconomics 2015. doi:10.1007/s40273-015-0330-7. Epub 2015/10/27. PubMed PMID: 26497003.
Malchau H, Bragdon CR, Muratoglu OK. The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplast. 2011;26(6):825–31. doi:10.1016/j.arth.2010.08.007. PubMed PMID: 20888183
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105–12. doi:10.1016/S0140-6736(09)61116-8. PubMed PMID: 19782876
Kandala NB, Connock M, Pulikottil-Jacob R, Sutcliffe P, Crowther MJ, Grove A, et al. Setting benchmark revision rates for total hip replacement: analysis of registry evidence. BMJ. 2015;350:h756. doi:10.1136/bmj.h756. PubMed PMID: 25752749
NICE. Total hip replacement and resurfacing arthroplasty for end-stage arthritis of the hip. NICE technology appraisal guidance [TA304] 2014 [cited 2016 21 March ]. Available from: https://www.nice.org.uk/guidance/ta304/chapter/1-Guidance.
There was no funding source involved.
Availability of data and materials
Ethics approval and consent to participate
Consent for publication
DP-A is a member of the Editorial Board of BMC Musculoskeletal Disorders. The other authors have no competing interests.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.