J Manipulative Physiol Ther. 2010 (Jun); 42 (5): 327–334 ~ FULL TEXT
Carol P. Roth, RN, MPH, Ian D. Coulter, PhD, Lisa S. Kraus, MSPPM, Gery W. Ryan, PhD,
Gary Jacob, DC, LAc, MPH, Joyce S. Marks, BS, Eric L. Hurwitz, DC, PhD, Howard Vernon, DC, PhD,
Paul G. Shekelle, PhD, Patricia M. Herman, ND, PhD
University of California Los Angeles,
Southern California Health Sciences,
Santa Monica, California.
OBJECTIVES: The purpose of this paper is to describe the 4-step process (consent, selection, protection, and abstraction) of acquiring a large sample of chiropractic patient records from multiple practices and subsequent data abstraction.
METHODS: From April 2017 to December 2017, RAND acquired patient records from 99 chiropractic practices across the United States. The records included patients enrolled in a survey e-study (prospective sample) and a random sample of all clinic patients (retrospective sample) with chronic back or neck pain. Clinic staff were trained to collect the sample, scan, and transfer the records. We designed an online data collection tool for abstraction. Protocols were instituted to protect patient confidentiality. Doctors of chiropractic were selected and trained as abstractors, and a system was established to monitor data collection.
RESULTS: In compliance with data protection protocols, 3,603 patient records were scanned, including 1,475 in the prospective sample and 2,128 in the random sample. A total of 1,716 patients (prospective sample) consented to having their records scanned, but only 1,475 could be retrieved. Of records scanned, 19% were unusable owing to illegibility, no care during the period of interest, or poor scanning. The abstractor interrater reliability for appropriateness of care decisions was fair to moderate (κ .38-.48).
CONCLUSION: The acquisition, handling, and abstraction of a large sample of chiropractic records was a complex task with challenges that necessitated adapting planned approaches. Of the records abstracted, many revealed incomplete provider documentation regarding the details of and rationale for care. Better documentation and more standardized record keeping would facilitate future research using patient records.
KEYWORDS: Chiropractic; Complementary Therapies; Medical Records; Patient Generated Health Data
From the FULL TEXT Article:
The National Center for Complementary and Integrative Health funded RAND Corporation to advance the methodology of determining the appropriateness of care in complementary and integrative health. The treatments studied were chiropractic spinal manipulation and mobilization, and the target conditions were chronic low back pain (CLBP) and chronic cervical pain (CCP). To accomplish that, we needed to access patient files to be able to calculate a rate of appropriate care and to determine how much chronic back and neck pain is being treated in chiropractic offices. In addition to collecting data from the patient record, the overall project involved input from 2 expert panels and collection of data through a series of online patient surveys described elsewhere.  In this article, we review the process of acquiring and abstracting 2 samples of chiropractic patient records to evaluate appropriateness of mobilization and manipulation for CLBP and CCP. The data collection from patient records for this project, the challenges it presented, and how we addressed them are the focuses of this paper. Four major steps were involved in acquiring the patient record data: obtaining consent for record review, identification and transfer of the records, record protection, and record abstraction.
The collection of a large amount of patient data from records is challenging. Files can be in various forms (electronic and nonelectronic), the data can be entered in a variety of ways, some highly personalized, and relevant data may not be entered at all. Furthermore, the data collection must be done in a manner that ensures that data are acquired, handled, and abstracted in a fashion that is not only methodologically correct but also meets regulations and laws related to handling protected health information (PHI).
The tasks included selecting the most appropriate source of data, obtaining consent for chiropractic patient record review, obtaining records, maintaining patient confidentiality, creating a reliable and comprehensive patient record abstraction tool, selecting and training abstractors, and maintaining quality during data collection. The choices made are driven by the project’s needs but must take into consideration other factors, such as timeline, budget, and addressing unexpected issues that arise during implementation.
Patient records provide a readily available data source but are highly dependent on what is recorded in them. The medical record may be considered the gold standard of information about patient care owing to its comprehensiveness. However, other sources of data (eg, patient interviews, administrative documents) may be more feasible. Comparisons of administrative and medical record data have revealed that certain aspects of care (eg, surgery, radiation treatments) are reliably accessed from either source. [2, 3] But other data elements (eg, time of symptom onset, contraindications, patient refusals of offered care) are less likely found in the medical record. [4–6] Data such as current symptoms and counseling received may be better elicited from patient interviews.  The source of data used can also affect the results of quality-of-care measures. 
When the data source is the patient record, the complexity of data can be challenging for abstractors to interpret in a standardized manner. Therefore, a comprehensive abstraction guide is essential, including priorities of source for data elements, standardization of terminology, definitions for unstructured data elements, and a process for guideline revision during data collection. [9, 10] The utility of the abstraction tool used is maximized by logically organizing the content to be user friendly and approximate the organization of the medical record. However, even if content is organized in a logical order, patient records in the field may not reflect that order.11 Pilot testing of the tool during the design phase provides an opportunity to gauge ease of use and content adequacy. 
Clinical knowledge and experience are key to abstractors’ ability to interpret documentation in patient records and should guide abstractor selection. Selected abstractors must be trained to follow prescribed study protocols. Use of a standardized medical record for training is an additional tool for evaluating abstractors’ level of guideline adherence and abstracting accuracy. [12, 13] Selection of appropriate abstractors and provision of comprehensive training are vital for successful data collection.
Medical record content may be structured and poses challenges to interpreting and collecting data in a uniform fashion across all abstractors. In addition to training, abstractors are monitored during data collection by assessing interrater reliability (IRR). [14, 15] Two abstractors abstract the same record to evaluate whether abstraction guidelines are implemented consistently and to identify problems for ongoing quality improvement.
In summary, patient records present 5 major challenges: first, getting consent; second, selecting the physical records themselves, which includes their format (eg electronic), their location, and their age; third, the content of the records, that is, what is and what is not included, and lack of standardized record keeping; fourth, protecting the data, that is, preserving confidentiality; and fifth, abstracting the data from the record, which includes developing a protocol, training abstractors, abstracting the data, and interpreting the data.
The following describes the choices we made for this study regarding the acquisition, housing, and protection of patient records; selection and training of abstractors; and data abstraction.
There is increasing interest in the traditional field of medicine in the integrated use of chiropractic care, particularly for low back and neck pain, and chiropractic care is also increasingly being included in research studies. [21–24] This interest may subject chiropractic records to increased scrutiny, and, as a result, chiropractic leaders have urged for more complete chiropractic documentation, including rationale for treatment modalities, procedures, and monitored patient outcomes. [25–28] Many of these documentation needs may be facilitated with the use of an EHR. However, an EHR requires significant provider buy-in, financial investment, and upkeep and requires intensive staff training and redevelopment of practice work flow for successful implementation. [29–31] Regardless of the form of record documentation, paper or electronic, a provider can maximize documentation by comprehensively describing the care provided, the rationale for that care, and the results of tracked patient outcomes. Better documentation would also facilitate internal practice audits for those clinics that may want to self-evaluate their care as a basis for quality improvement. For this research project, better record documentation and increased involvement of trained clinic staff would have potentially increased the quality of data collected and allow for a more valid generalization of the results. Three results from this type of study are of paramount importance to the profession:
(1) how much chronic back pain is being treated in chiropractic clinics,
(2) how appropriate is the treatment being rendered, and
(3) does appropriate care lead to better patient outcomes.
These outcomes cannot be determined without adequate record keeping.
This study used a convenience sample, thus persons who were available therefore may not be representative of all chiropractors treating patients with CLBP and CCP. However, this was a methods study, so the purpose was not to generalize to the total population being treated in chiropractic clinics. We did end up with a large patient sample from 6 regions across the United States, so it is likely we are capturing the variability in chiropractic care in the United States. Furthermore, the imperfections in some submitted patient records meant that we could not determine the actual care rendered and therefore could not judge its appropriateness or link it to patient outcomes.
Documentation in some records was missing essential treatment data or was only minimally documented. Also, record documentation may be partly determined by what care can be billed for reimbursement. If mobilization cannot be billed for, for example, it is less likely to be noted in the record even if it done in conjunction with manipulation. Also, clinics that do not bill insurance may be less incentivized to maintain more detailed documentation. All these factors affect what is recorded in the patient file and therefore determine the files’ usefulness in research.
The chiropractic record data collection for this project focused on evaluating the appropriateness of mobilization and manipulation for chronic low back pain (CLBP) and chronic cervical pain (CCP). Additional data were collected to summarize the duration of care, frequency of visits, and nature of treatments provided. For this study, the chiropractic record provided the most comprehensive data to assess appropriateness of chiropractic care. Records of care were successfully obtained from most study sites.
This paper set out to provide an overview of the 4–step process (consent, selection, protection, and abstraction) of acquiring a large sample of chiropractic patient records from multiple practices and subsequent data abstraction. As we noted, each step poses challenges, and in each step, we documented the solutions we implemented. For future research based on chiropractic clinics, it is clear that improved record keeping and easier access to files would greatly simplify the task of abstracting data from a patient file.
Use of an EHR may improve clinical content, but even paper-based records could benefit from improved and better use of templates to document patient history, examinations, treatment, and outcome measurements. Consistent documentation would ease ongoing research efforts and support providers in case of legal questions or a reimbursement audit. As chiropractic care becomes more accepted in medical settings that may require more provider collaboration, maintenance of complete treatment documentation will become even more important.
This study describes the selection, protection, and abstraction of chiropractic patient records for determining appropriateness of care.
This approach was successfully applied in a national study of chiropractic patients with chronic pain.
The findings will be of interest to researchers and clinicians in the complementary and integrative health professions who want to collect data about patient care and outcomes from patient records.
Funding Sources and Conflicts of Interest
This study was funded by the NIH’s National Center for Complementary and Integrative Health Grant No: 1U19AT007912-01. All authors report that they were funded by a grant from the National Center for Complementary and Integrative Health during the study. No conflicts of interest were reported for this study.
Concept development (provided idea for the research): I.D.C., E.L.H., H.V., P.G.S., P.M.H.
Design (planned the methods to generate the results): C.P.R., I.D.C., L.S.K., G.W.R., J.S.M., E.L.H., H.V., P.M.H.
Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): C.P.R., I.D.C.
Data collection/processing (responsible for experiments, patient management, organization, or reporting data): C.P.R., I.D.C., L.S.K., G.W.R., G.J., E.L.H., P.G.S.
Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): C.P.R., I.D.C., J.S.M.
Literature search (performed the literature search): C.P.R., I.D.C.
Writing (responsible for writing a substantive part of the manuscript): C.P.R., I.D.C., L.S.K., G.W.R., G.J., J.S.M., E.L.H., H.V., P.G.S., P.M.H.
Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): C.P.R., I.D.C., L.S.K., G.W.R., G.J., J.S.M., E.L.H., H.V., P.G.S., P.M.H.
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