Developing an initial set of quality indicators for chiropractic care: a scoping review.

BACKGROUND: Quality indicators are standardized, evidence-based measures of health care quality. Currently, there is no basic set of quality indicators for chiropractic care published in peer-reviewed literature. The goal of this research is to develop a preliminary set of quality indicators, measurable with administrative data. METHODS: We conducted a scoping review searching PubMed/MEDLINE, CINAHL, and Index to Chiropractic Literature databases. Eligible articles were published after 2011, in English, developing/reporting best practices and clinical guidelines specifically developed for, or directly applicable to, chiropractic care. Eligible non-peer-reviewed sources such as quality measures published by the Centers for Medicare and Medicaid Services and the Royal College of Chiropractors quality standards were also included. Following a stepwise eligibility determination process, data abstraction identified specific statements from included sources that can conceivably be measured with administrative data. Once identified, statements were transformed into potential indicators by: 1) Generating a brief title and description; 2) Documenting a source; 3) Developing a metric; and 4) Assigning a Donabedian category (structure, process, outcome). Draft indicators then traversed a 5-step assessment: 1) Describes a narrowly defined structure, process, or outcome; 2) Quantitative data can conceivably be available; 3) Performance is achievable; 4) Metric is relevant; 5) Data are obtainable within reasonable time limits. Indicators meeting all criteria were included in the final set. RESULTS: Literature searching revealed 2562 articles. After removing duplicates and conducting eligibility determination, 18 remained. Most were clinical guidelines (n = 10) and best practice recommendations (n = 6), with 1 consensus and 1 clinical standards development study. Data abstraction and transformation produced 204 draft quality indicators. Of those, 57 did not meet 1 or more assessment criteria. After removing duplicates, 70 distinct indicators remained. Most indicators matched the Donabedian category of process (n = 35), with 31 structure and 4 outcome indicators. No sources were identified to support indicator development from patient perspectives. CONCLUSIONS: This article proposes a preliminary set of 70 quality indicators for chiropractic care, theoretically measurable with administrative data and largely obtained from electronic health records. Future research should assess feasibility, achieve stakeholder consensus, develop additional indicators including those considering patient perspectives, and study relationships with clinical outcomes. TRIAL REGISTRATION: Open Science Framework, https://osf.io/t7kgm.

Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.

Introduction: Pragmatic clinical trials (PCTs) can overcome implementation challenges for bringing evidence-based therapies to people living with pain and co-occurring conditions, providing actionable information for patients, providers, health systems, and policy makers. All studies, including those conducted within health systems that have a history of advancing equitable care, should make efforts to address justice and equity. Methods: Drawing from collective experience within pragmatic pain clinical trials networks, and synthesizing relevant literature, our multidisciplinary working group examined challenges related to integrating justice and equity into pragmatic pain management research conducted in large, integrated health systems. Our analysis draws from military and veteran health system contexts but offers strategies to consider throughout the lifecycle of pragmatic research more widely. Results: We found that PCTs present a unique opportunity to address major influences on health inequities by occupying a space between research, healthcare delivery, and the complexities of everyday life. We highlight key challenges that require attention to support complementary advancement of justice and equity via pragmatic research, offering several strategies that can be pursued. Conclusions: Efforts are needed to engage diverse stakeholders broadly and creatively in PCTs, such as through dedicated health equity working groups and other collaborative relationships with stakeholders, to support robust and inclusive approaches to research design and implementation across study settings. These considerations, while essential to pain management research, offer important opportunities toward achieving more equitable healthcare and health systems to benefit people living with pain and co-occurring conditions.

Assessment of chiropractic care on strength, balance, and endurance in active-duty U.S. military personnel with low back pain: a protocol for a randomized controlled trial.

BACKGROUND: Low back pain (LBP) is a common cause of disability among U.S. military personnel. Approximately 20% of all diagnoses resulting in disability discharges are linked to back-related conditions. Because LBP can negatively influence trunk muscle strength, balance, and endurance, the military readiness of active-duty military personnel with LBP is potentially compromised. Chiropractic care may facilitate the strengthening of trunk muscles, the alteration of sensory and motor signaling, and a reduction in pain sensitivity, which may contribute to improving strength, balance, and endurance for individuals with LBP. This trial will assess the effects of chiropractic care on strength, balance, and endurance for active-duty military personnel with LBP. METHODS/DESIGN: This randomized controlled trial will allocate 110 active-duty military service members aged 18-40 with non-surgical acute, subacute, or chronic LBP with pain severity of ≥2/10 within the past 24 h. All study procedures are conducted at a single military treatment facility within the continental United States. Participants are recruited through recruitment materials approved by the institutional review board, such as posters and flyers, as well as through provider referrals. Group assignment occurs through computer-generated random allocation to either the study intervention (chiropractic care) or the control group (waiting list) for a 4-week period. Chiropractic care consists primarily of spinal manipulation at a frequency and duration determined by a chiropractic practitioner. Strength, balance, and endurance outcomes are obtained at baseline and after 4 weeks. The primary outcome is a change between baseline and 4 weeks of peak isometric strength, which is measured by pulling on a bimanual handle in a semi-squat position. Secondary outcomes include balance time during a single-leg standing test and trunk muscle endurance with the Biering-Sorensen test. Patient-reported outcomes include pain severity, disability measured with the Roland Morris Disability Questionnaire, symptom bothersomeness, PROMIS-29, Fear Avoidance Beliefs Questionnaire, expectations of care, physical activity, and global improvement. DISCUSSION: This trial may help inform further research on biological mechanisms related to manual therapies employed by chiropractic practitioners. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02670148 Registered on 1 February 2016.

Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone. METHODS/DESIGN: This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation. DISCUSSION: Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability. TRIAL REGISTRATION: The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.