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APS Bulletin • Volume 19, Number 2, 2009
Innovations in Practice
Debra Gordon, MS RN, Department Editor
Registries for Acute Pain: Will They Advance Evidence-Based Practice?
Ruth Zaslansky, DSc, C. Richard Chapman, PhD, and Winfried Meissner, MD
Following surgery, as many as 80% of adult patients report pain, and it is mostly moderate to extremely severe (Apfelbaum, Chen, Mehta, & Gan, 2003). These figures have barely changed since the 1950s (Berry & Dahl, 2000) and come, mostly, from the United States, where about 73 million patients undergo surgery annually (Hutchison, 2007). In addition to causing needless patient suffering, unrelieved pain produces short- and long-term physiological and psychological adverse consequences. It degrades patient and family quality of life, increases healthcare utilization, and drives up associated costs. Bonica (1990) related the problem of insufficient pain management to “inadequate or improper application of available information or therapies.” At the root of the problem is pain professionals’ ongoing failure to generate, evaluate, and disseminate adequate evidence about postoperative pain management.
In the field of pain, as in many fields of medicine, randomized-controlled trials (RCTs) and meta-analysis of published RCTs comprise the gold standard for evaluating interventions in support of best practice. RCTs use select patient samples in order to test the impact of interventions under ideal conditions. But their findings do not generalize well to everyday practice where patients are heterogeneous, often elderly, and burdened with comorbidities (Liu et al., 2006; Parkin, 2006). Although the results from RCTs are valuable for regulatory authorities and for pharmaceutical research, their benefits are limited for clinicians making bedside decisions (McQuay & Moore, 2007) or for shaping best practice. Furthermore, RCTs are usually powered to test treatment effects, and sample sizes are typically too small to characterize the prevalence of the serious adverse events associated with these treatments (Liu et al.). Additionally, RCTs provide only a single snapshot of a situation because they do not update continuously. Clearly, the field of pain would benefit from an additional methodology that not only evaluates interventions, but also provides data that can facilitate best practice (Liu et al.).
Medical Registries
“A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves a predetermined scientific, clinical, or policy purpose(s).” The science of registries is in an active state of development (Gliklich & Dreyer, 2007, 1).
Medical registries have surprisingly deep historical roots. The ancient Egyptians categorized types of injury, treatments, and their outcomes. Florence Nightingale’s achievements in treating soldiers in the Crimean Wars derived from her use of statistics and not only her personal dedication to patients (Moore & Clark, 2008). Early registries in modern times have mostly targeted the epidemiology of a disease or assessed quality improvement in an institution. More recently, registries have developed in many fields of medicine, most notably in cancer (since the 1920s) and in trauma (since the 1960s). During the last 20 years the role of registries has evolved so that they now support planning and evaluating on regional, national, and international levels (Parkin, 2006). In some fields the term surveillance now modifies registry to denote that the program must not only collect data but also work actively to integrate the new evidence into public health programs (Parkin, 2008). The expanded role of registries today includes the following.
Quality Improvement
Registries provide audit and feedback to providers about their daily practice. Registry information has high exchangeability because it does not exclude difficult patients and can be used to identify regional, national, and international best practices (i.e., benchmarking) while allowing for individualized medical treatment. Registry information can help develop, assess, and refine treatment protocols and create teaching tools for providers and patients.
Research
A registry provides opportunities for investigators to plan, design, and conduct epidemiological and clinical research that contribute to scientific knowledge regarding prevention and management. A large and constantly growing database, comprised of data from multiple sites using a common formation of variables, permits powerful data analyses and modeling for prediction, hypothesis testing, and data mining. When a registry grows to a large size, it becomes possible to characterize otherwise elusive rare adverse effects. Different researchers can use the data repeatedly for varied purposes. Interfacing with other databases minimizes duplicate data collection. Registries permit, in principle, genetic profiling, study of gene by environment interactions, and evaluation of epigenetic influences.
Economics
Registries can provide a platform for estimating costs of services and can facilitate rational allocation of resources. This allows effective forecasting for service demands at hospital, national, and international levels. The National Trauma Data Bank (2007) uses hospital length of stay to assess costs but this is a proxy variable confounded by issues such as institutional discharge practices (Moore & Clark, 2008). Another approach is to use registry-derived data to carry out direct-cost-effectiveness analysis by quantifying each component involved in the treatment such as manpower, equipment, and treatments provided (McKenna et al., 2009). Developing methodology for carrying out cost analysis remains an important area for future research (Gabbe, Williamson, Cameron, & Dowrick, 2005).
Information Consolidation
Technological and Internet advances now make the consolidation of hospitalbased registries into regional, national, and international databases possible (Moore & Clark, 2008). They also enhance communication between national and international medical and research centers. Some registries now collect data without paper records using key entry in order to sustain a continuous bidirectional stream of information between a single site and multiple local and international sites over the Internet (Melloh et al., 2008).
The Impact of Registries
Assessing whether registry data has an impact on the healthcare patients receive is not straightforward. Indirect evidence of the value comes from studies looking at clinical outcomes data in the form of a decrease in trauma mortality following the introduction of trauma systems that include a registry (Moore & Clark, 2008). These results gain support from similar findings in various countries (e.g., United States [Mullins et al., 1994], Australia [Brennan et al., 2002], and Israel [Peleg et al., 2004]). On the other hand, Jamtvedt, Young, Kristoffersen, Thomson O’Brien, and Oxman (2006) carried out a systematic Cochrane review, assessing the effect of audit and feedback on the performance of healthcare professionals (i.e., looking at process data). They found that, when effective, the impact of audit and feedback was generally small to moderate. The effectiveness increased when the baseline adherence to the recommended practice was low and the feedback was delivered more intensively (e.g., verbally given to individual recipients). The Cochrane review does not support mandatory or unevaluated use of audit and feedback as an intervention to change practice.
Challenges Facing Medical Registries
Starting and sustaining a medical registry can be a formidable task. Administrators of contemporary medical data registries, such as cancer and trauma, face cost and data challenges. Pain registries will surely encounter many of the same barriers as they develop.
Costs
Lack of financial support can present a major hurdle in the creation and upkeep of medical registries. Insufficient funding and low levels of participation can threaten the quality and integrity of the data and, consequently, the registry. Thus, obtaining secure funding from government, private foundations, or other sources remains one of the critical operational imperatives of every registry.
Data
Given the expanding role of registries, there is a growing demand for an increase in the number and types of variables. Yet, there is a clash between the aim to obtain more data and the information it will yield versus the need to minimize or streamline data cores, which eases the load of obtaining the data and so promotes integrity of the database. In addition, hospital-based registries often differ markedly from one another in structure and content. This makes comparisons across registries difficult and challenges registry administrators working at the national or international level to create standard data dictionaries that ensure consistency across registries. A third concern is that although registry administrators need to develop mechanisms for collecting data, they also need mechanisms for data analysis and evidence dissemination to the various end users so that the database will be fully exploited.
Informed Consent and Protection of Privacy
Potential conflict exists between creating large representative, de-identified electronic databases and current health information privacy standards, namely the Health Insurance Portability and Accountability Act (HIPAA). This conflict needs to be resolved to maintain public support for studies that use medical record data (Parkin, 2006). Some institutions and professional societies have found ways to allow access to researchers while still protecting confidentiality (Moore & Clark, 2008).
Pain Databases and Registries
In the field of pain, recording data over time and analyzing chronological records is a relatively new methodology for evaluating evidence. Two terms, registry and database, are common in the literature. A number of subspecialties are in the process of developing registries or databases for assessing postoperative, neuropathic, and other types of chronic pain conditions. Here we limit the discussion to projects in the incipient field of postoperative pain. As terminology varies across projects, we employ the terminology that the founders use to describe their work.
Single-Center Databases Assessing Acute Pain Service Patients
Acute Pain Service (APS) teams in many hospitals have created singlecenter, computerized databases. They use the information to document their activities over time as well as to assess the effectiveness and safety of treatments they provide (Cheung et al., 2008; Esteve Pérez et al., 2008; Goldstein, van den Kerkhof, Sherlock, Sherlock, & Harper, 2001; Pöpping et al., 2008; Rawal & Berggren, 1994; Shir, Shavelzon, Rosen, & Cotev, 1997). Follow up of patients treated by the APS is well suited for database development with standard methodology because the number of variables assessed for each patient is relatively small and well defined (at least per institution), and the team assessing patients is small. Institutions that have created their own APS database have tended to depend upon local initiatives to develop appropriate software programs.
Multi-Institutional Databases for Follow Up of Postoperative Pain
Concern about the meager published information for assessing performance and optimizing postoperative pain management led Liu and colleagues (2006) to propose that the American Society of Regional Anaesthesia develop an Acute Postoperative Pain (AcutePOP) database. The goal of this project is to create a national Internet-based, HIPAA-compliant database for tracking APS patients. Participation will be open to all individuals and institutions in the United States. Currently the group is working on issues such as consensus on the data elements and developing software for the project.
Thomas Volk, at the Department of Anesthesiology and Surgical Intensive Care at the Charité Medical Center in Berlin, Germany, initiated a specialized registry for data about complications associated with regional anesthesia, the Network for the Safety of Regional Anesthesia. Centered on neurologic and infectious complications, this registry attempts to prospectively define clear numerators and denominators for complications, to identify risk factors for developing complications, and to provide a framework for a benchmarking system. The project operates under the sponsorship and direction of the German Society of Anesthesiology, the Professional Association of German Anaesthetists, and the German Research Foundation (German Society of Anaesthesiology & Professional Association of German Anaesthetists, 2008).
Existing registries designed for other purposes are proving useful for investigating pain-related issues. For example, Wu and colleagues (2006) used a Medicare-claims registry to examine whether the type of intervention— epidural versus systemic analgesic medications—can influence mortality after a high-risk procedure, such as a colectomy. According to the authors, an RCT with standard-hypothesis testing would not have been feasible for this rare endpoint, as adequate power would require 24,000 high-risk patients and 1.2 million low-risk patients. Instead, the authors performed a cohort study from the Medicare-claims registry, which contains relevant data from millions of patients. They analyzed data from 12,817 Medicare beneficiaries who underwent elective partial excision of the colon from 1997 to 2001. The researchers decided on inclusion and exclusion criteria and randomly selected 5% of patients from the database, thereby forming a nationally representative sample of Medicare beneficiaries. Using multivariate regression, they assessed and compared the odds ratios for death 7 and 30 days post-procedure. Epidural analgesia was associated with significantly lower odds of death at both time points.
European and Other International Pain Registry Development
Three acute pain registry projects, Quality Improvement in Postoperative Pain Management (QUIPS), International Pain Registry (IPR), and Pain-Out, are similar in that they are Web-based projects for follow up of outcomes and processes of postoperative-pain patients, continuously do not restrict data accrual to APS patients, and the same nucleus of people run them. The proof-of-concept work for these projects began with postoperative patients. However, ultimately this approach will apply to any hospitalized patient in pain, adult or child, whether in oncology, general medical wards, or the emergency department, and will also apply to other related fields of medicine. Currently, the projects stand apart because they involve different medical centers. QUIPS operates in Germany, PainOut focuses on Europe, and IPR is international. The latter two are still in development. Ultimately, we expect the three projects will merge into a single project that will open the consolidated registry to institutions worldwide under supervision of a scientific society.
Figure 1. QUIPS Pain Registry Screen shot taken from the QUIPS Web site, showing the Web-based outcomes page accessible to participating clinical sites. The graph (lower, right) shows benchmark information. On the X-axis, bars mark the levels of pain on weight bearing (mean, SD, significance of deviation from mean) for each of the participating sites. Data for own site is in red, whereas, that of the other clinics is in brown and is anonymous. Y-axis shows severity of pain (0–10 scale). Different outcome measures, surgical disciplines, and time spans can be selected (see upper, righthand side of the figure and left). The data is updated continuously. The outcome variables are obtained from the patient questionnaire, which is based on the Brief Pain Inventory (Cleeland, 1991). Figure 1 taken from Meissner, W., Mescha, S., Rothaug, J., Zwacka, S., Goettermann, A., Ulrich, K., et al. (2008). Quality improvement in postoperative pain management— Results from the QUIPS Project. Deutsches Äerzteblatt International, 105(50), 865–870. Permission required. |
QUIPS (Figure 1) began in 1998 in one center and today about 100 hospitals throughout Germany contribute data, with three to four hospitals joining the project every month. Today, the database includes records from more than 64,000 patients, and increases by more than 2,000 data sets per month. Participation from hospitals is voluntary. The third author initiated this project, and it now operates under the joint direction of the German Society of Anesthesiology and German Society of Surgeons (Meissner et al., 2008; www.quips-projekt.de). Local quality assessment and benchmarking is supported by immediate Web-based feedback to each of the participating sites. QUIPS also provides a platform for discussion and research.
The IPR receives support and guidance from an interdisciplinary working group of the International Association for the Study of Pain (IASP). IASP aims to promote better treatment of pain in the developed countries and developing regions. Suboptimal management of pain is a worldwide problem, but most of the information about the problem comes from developed nations. In addition, resources for changing practices are allocated within the developed world. As a result, IPR plans to involve developing countries in this effort, too.
During 2008, the IPR carried out a pilot project to demonstrate feasibility of collecting data about management of postoperative pain internationally, in 10 developed countries—the United States, Australia, the United Kingdom, Germany, Switzerland, Sweden, Italy, France, Spain, and Israel—and three developing countries—Romania, Kenya, and Palestine. Professor Arthur Lipman from the University of Utah, led the project in the United States. From April 2008 to October 2008, participating institutions collected data from 688 adult surgical patients. Each participating hospital site entered their anonymized data into a password-secured, Web-based server and could then obtain immediate feedback about their site compared to others. This pilot study demonstrated that it is feasible to collect, analyze, and provide feedback about management of pain internationally from countries with high and low healthcare resources. Further developments in the IPR will take place in close cooperation and in parallel to Pain-Out.
Pain-Out is a 4-year project that was launched in 10 European countries in January 2009 by the European Union’s 7th Framework Program to create a European internet-based Pain Registry (www.pain-out.eu). Data about costs related to treatment and quality of life will be collected in addition to data about outcomes and processes. The registry data will serve several purposes:
Summary
In fields such as cancer and trauma, registries are well-established, proven resources. Registry data serve many purposes including quality improvement, research and planning, and allocation of resources on regional, national, and international levels. Though difficult to assess, registry methodology appears to exert a positive influence on healthcare outcomes. This remains to be demonstrated definitively. In the field of postoperative acute pain, projects for collecting data over time are less established and may carry the label of either database or registry. Single-center databases on postoperative pain have existed since the 1990s, mainly for local quality assurance programs and for assessing interventions. Over the last 10 years, nascent national and international acute-pain databases and registries have emerged. We hope that as these grow to maturity, this methodology will prove to have a positive impact on management of postoperative pain and our knowledge of the field.
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Drs. Zaslansky and Meissner work in the department of anaesthesia and intensive care at Friedrich-Schiller-Universität Jena, in Jena, Germany. Dr. Chapman is professor and director of the Pain Research Center in the department of anesthesiology at the University of Utah in Salt Lake City, UT.
