Javascript required
Skip to content Skip to sidebar Skip to footer
Home / Case Management+Best Practice+Registry+Peer Reviewed+Validity Instrument

Case Management+Best Practice+Registry+Peer Reviewed+Validity Instrument

  • Written report protocol
  • Open Admission
  • Published:

Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet exercise-based research network: study protocol

  • Donald I. Abrams2,
  • Rhonda Roberts3,
  • Kristen H. Griffinane,
  • Desiree Trebesch1,
  • Rowena J. Dolorthree,
  • Ruth Q. Wolever4,5,
  • 1000. Diane McKee6 &
  • Benjamin Kligler7

BMC Complementary and Culling Medicine book xvi, Article number:53 (2015) Cite this article

  • 1933 Accesses

  • 12 Citations

  • 2 Altmetric

  • Metrics details

Abstract

Background

Integrative medicine (IM) provides patient-centered care and addresses the full range of physical, emotional, mental, social, spiritual, and ecology influences that affect a person's wellness. IM is a "whole systems" approach that employs multiple modalities as opposed to an isolated complementary therapy. Thus, studying outcomes of IM is more challenging than evaluating an isolated intervention. Practice-based research networks (PBRNs) allow for clinicians/investigators at multiple diverse sites using common methodology to pool their data, increase participant sample size and increase generalizability of results. To conduct real-world, practice-based research, the Bravewell Collaborative founded BraveNet in 2007 as the first national integrative medicine PBRN.

Methods and design

Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) is a prospective, non-randomized, observational evaluation conducted at 14 clinical sites. Participants receive a non-standardized, personalized, multimodal IM approach for various medical conditions. Using the REDCap electronic platform, an anticipated x,000 report participants volition complete patient-reported issue measures including Patient Reported Outcomes Measurement Data System (PROMIS)-29, Perceived Stress Scale-4, and the Patient Activation Measure at baseline, 2, four, 6, 12, 18 and 24 months. Extractions from participants' electronic health records include IM services received, as well as ICD diagnostic codes, and CPT billing codes associated with each IM visit. Repeated-measures analyses will exist performed on data to appraise change from baseline through 24 months with planned subgroup analyses to include specific clinical population and specific IM intervention or combinations.

Discussion

Equally the PRIMIER registry grows, nosotros anticipate that our results would provide an indication of the promise of PBRN inquiry efforts in IM. Analyses will incorporate a large sample of participants and an expected 10-year observation period and will provide the ability to evaluate the effect of IM on outcomes for specific clinical populations and specific IM interventions or combinations. Every bit such, PRIMIER will serve every bit a national platform for future evaluations of IM all-time practices.

Trial registration

Clinical Trials.gov NCT01754038

Peer Review reports

Background

Integrative medicine (IM) provides patient-centered intendance and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences that impact a person's wellness [1]. Employing a personalized strategy that considers the patient'south unique atmospheric condition, needs, and circumstances, IM uses the virtually appropriate interventions from an array of scientific disciplines to heal illness and help people regain and maintain optimal health [1]. Because IM is a "whole systems" approach that employs multiple modalities in concert as opposed to an isolated complementary therapy, studying outcomes is more than challenging than evaluating an isolated pharmaceutical or botanical intervention [2].

"Patient-reported outcome" (PRO) measures are health data provided straight by patients, rather than outcomes that reflect the assessment of an investigator or clinician, as typically seen in clinical research. A PRO is an individual patient's self-reported assessment of their feelings or functions as they are dealing with diseases or conditions, and this assessment has important implications both in clinical practice and in enquiry. PRO information are especially important in evaluating the effectiveness of health care for chronic conditions, where a primary goal of treatment is to improve patients' part and to reduce symptoms associated with the condition [iii, 4]. Criticisms of the use of PROs in clinical research have been the broad range of instruments used, often to measure like outcomes, and the lack of standardization between result measures [4]. The recent development [5] of the NIH-funded Patient-Reported Outcomes Measurement Information System (PROMIS) suite of item banks and short forms for assessing health outcome domains related to quality of life and chronic conditions has been cited by researchers as a viable solution to these concerns [4, half dozen].

Unmarried-site studies in IM are generally too minor to identify differences in outcomes beyond sociodemographic or clinical subgroups. Multi-institutional scientific networks are able to recruit large numbers of participants for observational and interventional trials. Practice-based inquiry networks (PBRNs) allow for clinicians/investigators at multiple diverse sites using mutual methodology and a single analogous/data analysis center to pool their data likewise as increment generalizability of results. By collecting data in the context of patients receiving their clinical care, the results are more reflective of "existent world" outcomes. Given the growth of the number of clinics providing IM [7] and the resulting need for these clinics to behave real-world, practice-based inquiry, the Bravewell Collaborative founded BraveNet in 2007 equally the first national IM PBRN. BraveNet, a registered PBRN with the Agency for Healthcare Research and Quality (AHRQ), was established with the intent that information technology would provide data on IM'due south use, effectiveness, prophylactic, costs, and patient satisfaction. As of early 2015, BraveNet consists of 14 IM clinics that have robust patient populations too as stiff research capabilities.

In this clarification of our report protocol, we describe the arroyo taken to carry a multi-site prospective observational cohort study of PROs in our network of IM clinics. The Patients Receiving Integrative Medicine Interventions Effectiveness Registry (PRIMIER) provides an opportunity to ameliorate understand which IM interventions patients are receiving, and how these interventions bear on both clinical measures and PROs, such every bit quality of life. Because randomized controlled trials can only examine ane or two specific interventions for a narrowly divers condition—and because IM often uses highly individualized combinations of interventions to treat multiple conditions simultaneously—the evidence base to support clinical decision making in IM is not progressing rapidly enough to accost the widespread use of this approach in our health care arrangement [8]. In that location have been a few attempts to deport randomized trials of IM interventions. However, these take been express past: pocket-size sample size and inadequate power [9]; generalizability and resource intensiveness [10]; and retention challenges potentially related to participant dissatisfaction with being randomized to the non-IM arm, also as express follow-upwards [11].

Methods

Overview

In 2013, BraveNet created and launched PRIMIER (Patients Receiving Integrative Medicine Interventions Effectiveness Registry), a multi-institutional project designed to uniformly collect PROs and extract electronic health record (EHR) data into a large national registry. The goal of PRIMIER is to provide a framework that can be used for prove-based practice, discernment of all-time practices of IM, and quality improvement. PRIMIER is listed in the Registry of Registries (RoPR ID: twoscore), which is maintained by AHRQ and ClinicalTrials.gov (NCT01754038). The intent is that PRIMIER will go on to expand over time, including more publicly-funded as well as private IM centers with e'er increasing information which could exist used for the mentioned objectives. Now, PRIMIER is 2 years into an anticipated 10-yr report timeframe. Active enrolling sites are expected to grow significantly beyond the nowadays 14 recruiting centers.

Research setting and eligibility criteria

As of June 30, 2015, the BraveNet PBRN includes the fourteen fellow member sites listed in Table 1 likewise every bit the BraveNet Data and Statistical Analogous Center. Most of our sites are specialty care, integrative medicine clinics, although an increasing number of member clinics have primary care capacities. The study is open to any patient age xviii or over who is seen by a provider for clinical purposes at whatsoever of the sites. Written report participants must be willing and able to provide informed consent, to participate, and to exist contacted in the future by report personnel. Patients who are involved simply in an education programme or ane-time activeness are excluded from participation.

Table ane BraveNet Fellow member Clinics (as of vi/xxx/2015)

Full size table

Ideals, consent and permissions

All participants will be asked to provide informed consent before initiation of whatsoever study-related procedures. The protocol was approved by the Institutional Review Board at each participating site including Beth State of israel Medical Centre Human Subjects Protection Office Institutional Review Lath; Boston University Medical Center Institutional Review Board; Colorado Multiple Institutional Review Board; Duke University Health Systems Institutional Review Board; Northwestern Academy Institutional Review Board; Schulman Associates Institutional Review Lath; Scripps Clinic Institutional Review Board; Thomas Jefferson University Division of Human Subjects Protection; University of California Los Angeles Institutional Review Board; University of California San Francisco Committee on Human Research; University of Maryland Institutional Review Lath; Academy of Maryland Institutional Review Lath and Vanderbilt University Human Enquiry Protection Plan. In addition, the Einstein Human Research Protection Program and Duke University Wellness Systems Institutional Review Board approved the report every bit the BraveNet Information and Statistical Coordinating Center. The study is registered in Clinical Trials.gov (NCT01754038).

Screening procedures and enrollment

Potential participants receive PRIMIER enrollment information either from clinic or research staff. Patients who decide to participate in PRIMIER log onto the PRIMIER website and electronically enroll directly into the registry. Online registrants are able to provide informed consent upon opening the showtime screen on their initial visit to the website. If they do not have computer admission or are uncomfortable with technology, patients may provide informed consent and complete the survey questionnaire by pen and paper. Following enrollment in PRIMIER, PRO measures are obtained at ii-month intervals for the kickoff vi months, then every vi months through the end of twelvemonth two. This information is combined with information extracted from the participants' EHR. Nosotros anticipate approximately 10,000 participants to be enrolled in PRIMIER.

Data drove

PRIMIER currently uses the Research Electronic Data Capture (REDCap) system as an online inquiry management tool to collect patient reported data. REDCap is a secure, web-based awarding designed exclusively to support data capture for research studies [12]. REDCap, which was initiated with funding from the National Institutes of Health, allows researchers to create study-specific websites for capturing participant data deeply through an intuitive interface for users to enter information and accept real fourth dimension validation rules (with automated data blazon and range checks) at the time of entry. REDCap further allows automated data export procedures for seamless data downloads to Excel, SPSS, SAS, and Stata. Adult by Vanderbilt University, REDCap currently supports 994 academic/non-profit consortium partners and over 100,000 research end-users (http://project-redcap.org). From Baronial 2013 to May 2015, PRIMIER patient surveys were collected using the Patient Reported Outcomes Measurement Data System (PROMIS) Cess Centre at Northwestern Academy. The database was inverse to REDCap in May 2015 to give the BraveNet coordinating center (Albert Einstein College of Medicine) the power to modify the survey and create one registry database instead of maintaining individual site databases as had been necessary with the Cess Centre platform.

Information collection schedule

With the exception of the tobacco and booze apply questionnaires and EHR data, all other data measures are collected seven times: at baseline and at two, four, six, 12, 18, and 24 months. Tobacco and alcohol utilise are asked at baseline, 12, and 24 months, and medical record data are pulled at baseline and every half dozen months. Run into Tabular array 2 for the schedule of information collection, and the following Demographics, Outcome Measures, and Utilization/Intervention Information sections for more particular.

Table 2 Upshot Measures Utilized in PRIMIER

Full size table

Demographics

PRIMIER participants are asked to respond 19 items relating to basic demographics: age, race, ethnicity, sexual practice, education, marital, employment and insurance status, likelihood of insurance billing, household income, and self-reported height and weight. Lifestyle behaviors such as alcohol and tobacco use, nutrition and exercise habits, and utilise of opioid medication are also asked of all participants. These questions, shown in the Additional file 1, are not scored and will be treated categorically in data analyses.

Patient-reported consequence measures

PRIMIER uses the PROMIS-29 musical instrument as the core PRO mensurate forth with the Perceived Stress Scale-4 (PSS-4) [thirteen] and the Patient Activation Measure (PAM) [14].

Created with funding from the National Institutes of Health, the PROMIS suite of PRO instruments provides clinicians and researchers access to efficient, valid, and responsive self-reported measures of health, including symptoms, office, and well-being. The PROMIS-29 instrument includes 4-detail brusk forms covering seven singled-out domains including physical function, anxiety, depression, fatigue, pain intensity and pain interference, satisfaction with social office, as well every bit sleep disturbance. Questions are answered using standard one through five Likert scales. The PROMIS-29 has been validated as performing as well equally a multifariousness of legacy PRO measures [15], and the four-particular subscales for depression and anxiety have been found to have good internal reliability amid chronic pain patients [xvi]. A crosswalk has been adult and validated betwixt PROMIS Pain Interference and the Pain Interference subscale of the Brief Hurting Inventory [17], and between the PROMIS Fatigue brusk grade and the Modified Fatigue Touch on Calibration [eighteen]. PROMIS Low has also been cross-walked with several common depression measures (e.chiliad., Beck Depression Inventory-II and Heart for Epidemiologic Report-Low) [19]. In addition to the PROMIS-29, we include one PROMIS question to assess global quality of life.

The Perceived Stress Scale-4 (PSS-4) is a brief, validated, and widely used psychological instrument for assessing a participant'south perception of stress level. Based on an original 14-item scale [20], the PSS-4 consists of 4 questions to measure the degree to which participants perceive situations in their lives as stressful [13]. It includes questions related to perceived unpredictability, uncontrollability, and overload. This short version is recommended for a brief assessment when respondent time is limited. Participants choose responses ranging from never (0) to very oftentimes (4) with a total score ranging from 0 to sixteen. A recent study on the PSS-4 reconfirms its reliability [21].

The Patient Activation Measure (PAM) is a brief, validated instrument for gauging the knowledge, skills and confidence essential to managing one's ain health and healthcare [xiv]. The xiii-particular PAM cess (a short class of the original 22-item instrument) [22] divides participants into one of iv progressively higher activation levels. Each level addresses a broad assortment of cocky-care behaviors and offers insight into the characteristics that drive health activation [22]. Positive changes in activation have been associated with positive changes in a diverseness of self-management behaviors [23]. Comeback in patient activation has been shown to be strongly related to improvements in clinical outcomes such every bit decreased pain, increased utilization of prevention screenings, and a reduction in emergency room visits [23]. The four levels are defined as: Level 1 – Does non believe that he/she has an active or important role; Level 2 – Lacks confidence and knowledge to take activeness; Level iii – Beginning to have action; and Level 4 – Maintaining behavior over time. The PAM has been used in several studies of IM interventions [24–26].

Utilization/intervention information

In addition to providing PRO measures, participants written report the principal condition(south) or symptom(s) for which they are receiving treatment and the blazon of IM practitioner from whom they are receiving care based on questions from the National Health Interview Survey. At each data collection indicate, patients are asked to charge per unit or depict their change in symptoms, etc. since beginning care at the IM clinic [27]. Patients report whether they are experiencing chronic pain, defined as iv or greater on an 11-point visual analog scale. PRIMIER too collects information on what IM interventions patients have utilized in the past 6 months. Utilization of IM treatments is captured through two methods: 1) every bit reported past the study participants using patient visit questionnaires; and 2) as reported by the sites through an electronic or paper medical record extraction process. Each site abstracts the following data points from their participant's electronic medical and administrative records: dates of all appointments to the IM clinic, IM services received, diagnostic codes (International Classification of Diseases-nine: ICD-9) associated with each IM visit, and billing codes (Current Procedural Terminology: CPT) associated with each visit. These data are encrypted and sent electronically to the BraveNet information analogous centre. Additional data fields will be added from patient visits to whatsoever clinic (i.e., not limited to IM clinic visits) as relevant to specific studies of interest, for example, height, weight, pain, and lipid panels.

Information analyses

General statistical considerations

All subjects who complete baseline measurements, ≥1 follow-up visit at a BraveNet clinic, and who are followed for at least 6 months in the study volition exist included in statistical analyses. Counts and percentages will be reported on categorical variables whereas continuous variables volition be expressed as means and standard deviations (SDs) and/or medians (25thursday and 75th percentiles). The Wilcoxon rank-sum test or Chi-foursquare examination (Fisher's exact as advisable) will exist used to quantify comparisons as accounted necessary.

Future data assay

In observational studies similar PRIMIER, at that place is no treatment randomization. Therefore, to minimize the furnishings of potential stable moderators (e.m., sex), channeling bias, and/or time- varying confounders, a Marginal Structural Model (MSM) arroyo will be utilized to analyze the concluding PRIMIER database. An MSM analysis is a weighted repeated measures approach using IM modality as a fourth dimension-varying covariate besides every bit accounting for baseline characteristics. Weights produce a pseudo-population with a residue in both time-invariant and time-varying covariates, allowing for causal treatment comparisons using standard repeated measures models. The weighting will also be adjusted to account for missing data, providing validity nether missing at random or missing completely at random. In order to incorporate adjustment for patients with missing visits, the same weight approach is used. Withal, instead of using a flag to designate IM modality, a flag denoting whether the patient remained in the study is used. The final weight for each patient's observation is computed by multiplying the IM modality selection weights and the censoring weights. In that location are four major components which need to be computed/assessed to perform a MSM analysis: 1) weight estimates for each subject visit adjusting for IM modality, 2) weight estimates for each subject visit adjusting for study discontinuation, 3) an a priori chosen vector of fourth dimension-independent variables, such as baseline characteristics, iv) an a priori chosen IM modality or set up of IM modalities which will be assigned as the "handling of interest" and tracked throughout time. Adjusted mean outcomes by written report time besides as resulting F-test p-values will exist reported past issue measure out.

As our sample size increases and the proportion of those completing long term follow-up assessments grows, we will exist able to evaluate the impact of IM on hurting scores in subgroups including but not express to: sexual practice, BMI < thirty vs BMI ≥ 30, and <40 on the PROMIS Depression Subscale vs ≥forty on PROMIS Depression Subscale. The potential of the varying impacts of IM on subgroups volition exist assessed by including interaction terms, i.eastward., subgroup by IM, in the MSM model. In the instance that the interaction terms are statistically significant, separate MSM analyses will be performed inside each subgroup. Also, the weight estimates for each subject area visit will be computed adjusting for dose of modality or modalities of interest (e.thou., acupuncture or IM physician visit) instead of IM modality in the MSM analysis. Accounting for modality dosing by visit over the course of the written report may potentially create more robust weight estimates for each subject by providing more information than just a binary response variable.

Sensitivity analysis to appraise the impact of memory rate will be performed on pre-specified subgroups of subjects who completed:

  • 75 % of surveys over the study period

  • fifty % of surveys over the written report period

  • 25 % of surveys over the study flow

All analyses volition be conducted using SAS (Cary, NC).

Discussion

The BraveNet PBRN has the potential to provide valuable information regarding the benefits of IM in real globe settings. The PRIMIER projection is already demonstrating changes in PRO measures in participants receiving intendance at our collaborating clinical sites. At this early on stage, the initial PRIMIER cohort contributing a full 6 months of information is non large enough to accurately appraise which interventions or which combination of interventions take had the greatest effect on PAM scores, depression and stress scores, or other PROs. Nor is there still the ability to discern which IM interventions are most constructive at improving symptoms in specific clinical populations receiving intendance at the BraveNet clinics. However, as participation and the retention charge per unit increase, nosotros will be able to refine our analysis and further examine which modalities or combinations thereof are about effective. For example, we will be able to address the question of which IM approaches are near effective in treating pain, which is past far the near common reason that patients seek care at our clinics [28–30]. Moreover, what is the optimal dosing of acupuncture for specific cancer conditions or does elevated depressive symptomology influence the effectiveness of heed/trunk interventions in patients with concrete ailments? As the PRIMIER database grows and with increased demographic multifariousness provided by boosted time to come sites, BraveNet is well-poised to address some of the important questions that remain unanswered in the field.

The goal of PRIMIER is to create a registry of sufficient size and then that we can explore subsequent hypotheses. For example, nosotros may hypothesize that pain patients who receive acupuncture weekly for eight weeks would have significantly improved outcomes on the PROMIS-29 measures at 12 months than pain patients who receive acupuncture less frequently than weekly. Another example of a hypothesis to exist tested would compare the cohort of patients with baseline elevated depressive symptomology (<forty on the PROMIS Depression Subscale) vs non-depressive symptomology (>xl on PROMIS Depression) on Patient Activation Measure at 12 months.

From our prior mapping study of IM in the United States [31], and from a BraveNet Registry report [28–30], we learned that IM heart leaders beyond the country perceived that their interventions were well-nigh useful in patients with complaints of chronic pain, depression, and stress. In a different study of patients with a primary complaint of chronic pain seen at the BraveNet sites, nosotros previously reported that an IM arroyo to hurting not only decreased pain, but depressive symptomology and stress as well [29]. Both of these studies were limited by virtue of either one-time only assessment [28–30] or small sample size [29]. From a more mature PRIMIER dataset, we should be able to define which particular treatment modalities offer the greatest reduction in hurting, as well every bit changes on measures of depressive symptomology and stress equally examples.

The PRIMIER projection offers a unique opportunity to assess the effectiveness of IM clinic intervention in a wide variety of clinical weather. As the dataset grows and the duration of follow-upward increases, we wait to be able to derive preliminary information to develop specific research proposals to address the difficult- to-treat conditions for which patients seek our care.

Given the rapid increase in the number of clinical settings offer IM services, the public is continuing to seek out these therapies to augment and integrate with conventional medical practices. While randomized controlled trials assess the efficacy of specific interventions for specific patient populations in "controlled settings", observational studies evaluate the effectiveness of treatments in the existent world of clinical do. The highly individualized nature of IM interventions also tin make the randomized controlled trials model problematic, since treatments often evolve over fourth dimension as a function of a given individual's response to handling. Although there is now a growing trunk of randomized controlled trial research on the efficacy of integrative medicine approaches for a variety of conditions [32–38], in many means this trunk of enquiry does non accurately describe the real world do of IM considering of the controlled nature of the clinical trial paradigm. In contrast, observational research designs, despite some inherent limitations, present a promising choice. Bell et al. advise that observational designs are appropriate for studying complex interventions, despite the absence of randomization [2].

Treatment approaches consisting of multiple modalities or components present unique challenges. In their 2014 protocol of an IM principal care trial, Herman and colleagues provide a useful overview of how truly integrative approaches to care (every bit opposed to unmarried-modality offerings) can exist described as complex interventions [39, xl]. These complex interventions present challenges of "unpacking", due to the wide range of potential handling combinations and patient diagnoses [39]. Currently, we do not know what the makeup of the population for PRIMIER will exist (i.eastward., what weather and comorbidities patients will have and what combinations of therapies they might receive). For case, as in the Registry written report [28], nosotros may see a higher proportion of patients with hurting as compared with other symptoms. Considering our initial goal is to establish a registry from which to carry subsequent enquiry, a key feature of the projection is that we are non driving the interventions or the population characteristics; rather, that makeup is clinically driven. Therefore, our work is subject to some limitations, from the standpoint of conventional wellness outcomes research.

Authors of other multimodal studies have cited limitations such as the disability to make up one's mind the relative efficacy of components in a multifaceted study or intervention, [11, 39] noting that the virtually benign elements of a intervention may vary from patient to patient depending on individual needs and personal characteristics [41]. Bong argues that treatments that combine modalities (conventional and/or complementary) should be studied in combination as well [ii]. Herman notes that larger effect sizes may exist achieved in more controlled settings [39]; however, this is a tradeoff for studying a heterogeneous patient population receiving individualized, sometimes complex care. Maiers et al. admit the limited generalizability of an integrative care plan for low back pain, while also pointing out how the adaptability of integrative care models can make them more generalizable in some respects [10]. While information from individual PRIMIER sites may be similarly limited in their generalizability, the inclusion of sites and patient populations from around the country will provide a larger and more than diverse sample than comparable studies to date.

Although we recognize the importance of including economic analyses in studies of IM, not all of the medical costs for enrolled patients' care will be bachelor to the extracts from our electronic health record (e.g., if a patient received care at an emergency department outside the study site health organization). Every endeavor will exist made to conduct appropriate health economic analyses with PRIMIER, but this is an important limitation. Any other limitations in our analyses volition be discussed in futurity reporting of the report results. Withal, observational research using PROs will uniquely enable us to describe the results of this blazon of individualized and dynamic intendance [42].

The exploration of IM in real-earth settings is consistent with the strategic programme of the National Institutes of Health, National Middle for Complementary and Integrative Wellness (formerly the National Heart for Complementary and Alternative Medicine). Specifically, past seeking to "increase agreement of 'real world' patterns and outcomes of [complementary and culling medicine] apply and its integration into health intendance and health promotion", [43] PRIMIER will serve as a national platform for hereafter evaluations of IM best practices. In providing the ways to begin determining these best practices, the BraveNet PBRN volition be able to define the most effective IM interventions in a timely fashion, making valuable information readily bachelor that will help guide patients, providers, and payors to improve health and well-being for all.

Abbreviations

AHRQ:

Agency for Healthcare Research and Quality

CPT:

Current Procedural Terminology

EHR:

electronic health record

ICD-ix:

International Classification of Diseases-nine

IM:

integrative medicine

MSM:

Marginal Structural Model

PAM:

Patient Activation Measure out

PBRNs:

practise-based inquiry networks

PRIMIER:

Patients Receiving Integrative Medicine Effectiveness Registry

PRO:

patient-reported issue

PROMIS:

Patient Reported Outcomes Measurement Information System

PSS-four:

Perceived Stress Scale-4 item version

REDCap:

Enquiry Electronic Data Capture

References

  1. Kligler B, Maizes V, Schachter Southward, Park CM, Gaudet T, Benn R, et al. Core competencies in integrative medicine for medical school curricula: a proposal. Acad Med. 2004;79(6):521–31.

    Article  PubMed  Google Scholar

  2. Bong IR, Caspi O, Schwartz GE, Grant KL, Gaudet TW, Rychener D, et al. Integrative medicine and systemic outcomes research: issues in the emergence of a new model for primary wellness intendance. Arch Intern Med. 2002;162(ii):133–twoscore.

    Article  PubMed  Google Scholar

  3. Lohr K, Zebrack B. Using patient-reported outcomes in clinical practice: challenges and opportunities. Qual Life Res. 2009;xviii(1):99–107.

    Article  PubMed  Google Scholar

  4. Glasgow RE, Kaplan RM, Ockene JK, Fisher EB, Emmons KM. Patient-reported measures of psychosocial issues and wellness behavior should be added to electronic health records. Wellness Aff. 2012;31(three):497–504.

    Commodity  Google Scholar

  5. Cella D, Riley West, Rock A, Rothrock Northward, Reeve B, Yount Due south, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of developed self-reported wellness event particular banks: 2005-2008. J Clin Epidemiol. 2010;63(11):1179–94.

    PubMed Primal  Article  PubMed  Google Scholar

  6. Ahmed Due south, Berzon R, Revicki D, Lenderking W, Moinpour C, Basch E, et al. The use of patient-reported outcomes (PRO) within comparative effectiveness research: implications for clinical practice and wellness care policy. Med Care. 2012;50(12):1060–70.

    Article  PubMed  Google Scholar

  7. Ananth South. 2010 Complementary and culling medicine survey of hospitals: Summary of results. In.: Samueli Institute; 2011.

  8. Verhoef Yard, Lewith Thousand, Ritenbaugh C, Boon H, Fleishman S, Leis A. Complementary and culling medicine whole systems research: beyond identification of inadequacies of the RCT. Complement Ther Med. 2005;13(iii):206–12.

    Commodity  PubMed  Google Scholar

  9. Sundberg T, Petzold M, Wändell P, Rydén A, Falkenberg T. Exploring integrative medicine for back and neck hurting - a businesslike randomised clinical pilot trial. BMC Complement Altern Med. 2009;9:33.

    PubMed Primal  Article  PubMed  Google Scholar

  10. Maiers MJ, Westrom KK, Legendre CG, Bronfort G. Integrative care for the management of depression back hurting: employ of a clinical intendance pathway. BMC Health Serv Res. 2010;x:298.

    PubMed Central  Commodity  PubMed  Google Scholar

  11. Edelman D, Oddone EZ, Liebowitz RS, Yancy Jr WS, Olsen MK, Jeffreys Every bit, et al. A multidimensional integrative medicine intervention to better cardiovascular chance. J Gen Intern Med. 2006;21(seven):728–34.

    PubMed Cardinal  Article  PubMed  Google Scholar

  12. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic information capture (REDCap)--a metadata-driven methodology and workflow procedure for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.

    PubMed Central  Article  PubMed  Google Scholar

  13. Cohen S, Williamson G. Perceived stress in a probability sample of the Us. In: Spacapan Due south, Oskamp Due south, editors. The Social Psychology of Wellness. Newbury Park: Sage; 1988. p. 31–67.

    Google Scholar

  14. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a curt form of the patient activation measure. Health Serv Res. 2005;forty(6 Pt ane):1918–30.

    PubMed Primal  Article  PubMed  Google Scholar

  15. Hinchcliff M, Beaumont JL, Thavarajah G, Varga J, Chung A, Podlusky S, et al. Validity of 2 new patient-reported outcome measures in systemic sclerosis: Patient-Reported Outcomes Measurement Information System 29-item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea brusk form. Arthritis Care Res. 2011;63(11):1620–8.

    Article  Google Scholar

  16. Kroenke K, Yu Z, Wu J, Kean J, Monahan PO. Operating characteristics of PROMIS iv-particular low and anxiety scales in principal care patients with chronic hurting. Pain Med. 2014;15(11):1892–901.

    Commodity  PubMed  Google Scholar

  17. Askew R, Kim J, Chung H, Cook One thousand, Johnson K, Amtmann D. Development of a crosswalk for pain interference measured by the BPI and PROMIS pain interference brusque form. Qual Life Res. 2013; Mar 29. [Epub ahead of impress].

  18. Noonan VK, Cook KF, Bamer AM, Choi SW, Kim J, Amtmann D. Measuring fatigue in persons with multiple sclerosis: creating a crosswalk between the Modified Fatigue Impact Scale and the PROMIS Fatigue Brusk Form. Qual Life Res. 2012;21(7):1123–33.

    Article  PubMed  Google Scholar

  19. Choi SW, Schalet B, Melt KF, Cella D. Establishing a common metric for depressive symptoms: linking the BDI-Two, CES-D, and PHQ-nine to PROMIS low. Psychol Assess. 2014;26(2):513–27.

    Article  PubMed  Google Scholar

  20. Cohen S, Kamarck T, Mermelstein R. A global measure out of perceived stress. J Health Soc Behav. 1983;24(4):385–96.

    Article  CAS  PubMed  Google Scholar

  21. Warttig SL, Forshaw MJ, South J, White AK. New, normative, English-sample data for the Curt Form Perceived Stress Scale (PSS-4). J Health Psychol. 2013;18(12):1617–28.

    Article  PubMed  Google Scholar

  22. Hibbard J, Stockard J, Mahoney E, Tusler M. Evolution of the Patient Activation Mensurate (PAM): conceptualizing and measuring activation in patients and consumers. Wellness Serv Res. 2004;39(4 Pt 1):1005–26.

    PubMed Central  Article  PubMed  Google Scholar

  23. Hibbard J, Mahoney E, Stock R, Tusler M. Do increases in patient activation outcome in improved self-management behaviors? Wellness Serv Res. 2007;42(4):1443–63.

    PubMed Central  Article  PubMed  Google Scholar

  24. Wolever RQ, Webber DM, Meunier JP, Greeson JM, Lausier ER, Gaudet TW. Modifiable affliction risk, readiness to modify, and psychosocial operation improve with integrative medicine immersion model. Altern Ther Wellness Med. 2011;17(four):38–47.

    PubMed Fundamental  PubMed  Google Scholar

  25. Wolever RQ, Dreusicke M, Fikkan J, Hawkins TV, Yeung S, Wakefield J, et al. Integrative wellness coaching for patients with type ii diabetes: a randomized clinical trial. Diabetes Educ. 2010;36(four):629–39.

    Article  CAS  PubMed  Google Scholar

  26. Saha S, Koley 1000, Mahoney ER, Hibbard J, Ghosh S, Nag 1000, et al. Patient activation measures in a government homeopathic infirmary in India. J Evid-Based Complement Alternative Med. 2014;19(4):253–9.

    Article  Google Scholar

  27. Barnes P, Bloom B, Nahin R. Complementary and alternative medicine utilize among adults and children: United States, 2007. In: National health statistics reports, vol. 12. Hyattsville: National Center for Health Statistics; 2008. p. 23.

    Google Scholar

  28. Wolever R, Abrams D, Kligler B, Dusek J, Roberts R, Frye J, et al. Patients seek integrative medicine for preventive arroyo to optimize health. Explore. 2012;8(six):348–52.

    Article  PubMed  Google Scholar

  29. Abrams D, Dolor R, Roberts R, Pechura C, Dusek J, Amoils South, et al. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013;xiii(1):146–54.

    PubMed Central  Article  PubMed  Google Scholar

  30. Dusek J, Abrams D. Longitudinal collection of patient-related outcomes in integrative medicine clinics: a pilot study from the BraveNet Practice Based Research Network. BMC Complement Altern Med. 2012;12 Suppl 1:O63.

    PubMed Key  Article  Google Scholar

  31. Horrigan B, Lewis Due south, Abrams D, Pechura C. Integrative medicine in America: How integrative medicine is existence practiced in clinical centers across the United States. Glob Adv Health Med. 2012;i(3):18–94.

    PubMed Central  Article  Google Scholar

  32. Furlan AD, Yazdi F, Tsertsvadze A, Gross A, Van Tulder Thousand, Santaguida L, et al. A systematic review and meta-analysis of efficacy, cost-effectiveness, and rubber of selected complementary and alternative medicine for neck and depression-back hurting. Evid Based Complement Alternat Med. 2012;2012:953139. doi: ten.1155/2012/953139. Epub 2011 November 24.

  33. Vickers AJ, Cronin AM, Maschino AC, Lewith Chiliad, MacPherson H, Foster NE, et al. Acupuncture for chronic pain: individual patient data meta-assay. Curvation Intern Med. 2012;172(nineteen):1444–53.

    PubMed Fundamental  Article  PubMed  Google Scholar

  34. Alraek T, Lee MS, Choi TY, Cao H, Liu J. Complementary and alternative medicine for patients with chronic fatigue syndrome: a systematic review. BMC Complement Altern Med. 2011;xi:87.

    PubMed Key  Article  PubMed  Google Scholar

  35. Finnegan-John J, Molassiotis A, Richardson A, Ream Due east. A systematic review of complementary and alternative medicine interventions for the management of cancer-related fatigue. Integrative Cancer Therapies. 2013;12(4):276–xc.

    Article  PubMed  Google Scholar

  36. Meeks TW, Wetherell JL, Irwin MR, Redwine LS, Jeste DV. Complementary and culling treatments for late-life depression, feet, and sleep disturbance: a review of randomized controlled trials. J Clin Psychiatry. 2007;68(10):1461–71.

    Article  CAS  PubMed  Google Scholar

  37. Lakhan SE, Vieira KF. Nutritional and herbal supplements for anxiety and feet-related disorders: systematic review. Nutr J. 2010;9:42.

    PubMed Cardinal  Article  PubMed  Google Scholar

  38. Freeman MP, Mischoulon D, Tedeschini E, Goodness T, Cohen LS, Fava Chiliad, et al. Complementary and alternative medicine for major depressive disorder: a meta-analysis of patient characteristics, placebo-response rates, and treatment outcomes relative to standard antidepressants. J Clin Psychiatry. 2010;71(6):682–8.

    Article  PubMed  Google Scholar

  39. Herman PM, Dodds SE, Logue Md, Abraham I, Rehfeld RA, Grizzle AJ, et al. IMPACT--Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model. BMC Complement Altern Med. 2014;xiv:132.

    PubMed Primal  Commodity  PubMed  Google Scholar

  40. Craig P, Dieppe P, Macintyre South, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Enquiry Council guidance. Int J Nurs Stud. 2013;50(5):587–92.

    Article  PubMed  Google Scholar

  41. Carlson LE, Speca Chiliad, Patel KD, Goodey East. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004;29(4):448–74.

    Article  CAS  PubMed  Google Scholar

  42. Westfall JM, Mold J, Fagnan Fifty. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007;297(4):403–6.

    Article  CAS  PubMed  Google Scholar

  43. Strategic Objective 3: Increment Agreement Of "Real Earth" Patterns and Outcomes of CAM Use and Its Integration into Health Care and Health Promotion [https://nccih.nih.gov/about/plans/2011/objective3.htm]. Accessed 4/15/15.

Download references

Acknowledgements

None of this would have been possible without the vision and generous support of the Bravewell Collaborative, which funded the creation of BraveNet and this study. The Bravewell Collaborative played no part in the blueprint and conduct of the study; collection, management, assay, and estimation of the data; preparation, review, or approving of the manuscript; and decision to submit the manuscript for publication. We are indebted to our participants for their invaluable contributions to this project. We are also grateful to our site collaborators who contributed enormously to the success of the PRIMIER: Alliance Institute for Integrative Medicine: Steve Amoils Doctor, Sandy Amoils Doc, Nancy Merrel, Alex Crumley; Boston Medical Center at Boston University: Robert Saper MD, Paula Gardiner Medico, Eric Roseen DC, Chelsey Lemaster; Center for Integrative Medicine at the University of Maryland School of Medicine: Brian Berman MD, William Rollow Physician, Chris D'Adamo PhD, Mary Bahr, Mei Zheng; Duke Integrative Medicine at Duke University: Adam Perlman Doctor, Elizabeth Matteson-Bechard, Teresa Keever; Integrative Medicine at the Academy of Colorado Denver: Lisa Corbin Physician, Jacinda Niklas Dr., Kayla Mieczkowski; Jefferson Myrna Brind Center for Integrative Medicine at Thomas Jefferson University: Andrew Newberg MD, Nancy Wintering MSW; Mt. Sinai Mount Sinai Beth Israel Medical Heart for Wellness and Healing: Woodson Merrell MD, Jenna Cantor, Elidania Perez; Osher Center for Integrative Medicine at Northwestern University; Melinda Ring MD, David Victorson PhD, Natalie Step; Osher Center for Integrative Medicine at the University of California- San Francisco: Margaret Chesney PhD, Kevin Barrows MD, Vierka Goldman; Osher Eye for Integrative Medicine at the Vanderbilt University: Roy Elam Doctor, Gurjeet Birdee Dr., Isabella Ahrens; Penny George Institute for Wellness and Healing: Courtney Baechler Md, Stephanie Wallerius; Scripps Center for Integrative Medicine: Chris Suhar Md, Eva Stuart, RN, Tiffany Bryant; Simms/Isle of man Health and Health Eye, Program in Integrative Medicine at Venice Family Clinic: Myles Spar Dr., Nancy Rodriguez, Ryan Woodson, Cristina Perez and the Academy of Pittsburgh Center for Integrative Medicine: Neil Ryan Doctor, Carol Greco PhD, Christine McFarland.

We also thank our colleagues at the U.s.a. Department of Veteran'due south Affairs Office of Patient-Centered Care and Cultural Transformation: Tracy Gaudet MD; US Section of Veteran'south Affairs Quality Enhancement Research Initiative: Barbara Bokour PhD, Rani Elway PhD, and Dorothy Plumb.

Special gratitude to Claudia Lechuga, Albert Einstein Higher of Medicine of Yeshiva University (electric current BraveNet Data and Statistical Coordinating Center) and to Ron Roddy, Knuckles Clinical Research Institute (prior BraveNet Data and Statistical Coordinating Eye), for successfully managing this multicenter project.

Author information

Affiliations

  1. Integrative Wellness Research Heart, Penny George Institute for Health and Healing, Allina Wellness, 2925 Chicago Avenue South, Mail Route 10039, Minneapolis, MN, 55407-1321, USA

    Jeffery A. Dusek, Kristen H. Griffin & Desiree Trebesch

  2. Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, U.s.a.

    Donald I. Abrams

  3. Duke Clinical Enquiry Institute, Duke University Medical Heart, Durham, NC, USA

    Rhonda Roberts & Rowena J. Dolor

  4. Duke Integrative Medicine, Duke University Medical Center, Durham, NC, USA

    Ruth Q. Wolever

  5. Section of Physical Medicine & Rehabilitation, Osher Heart for Integrative Medicine, Vanderbilt Schools of Medicine and Nursing, Nashville, TN, The states

    Ruth Q. Wolever

  6. Albert Einstein Higher of Medicine of Yeshiva Academy, New York, USA

    M. Diane McKee

  7. Department of Integrative Medicine, Mount Sinai Beth Israel Medical Heart, New York, NY, USA

    Benjamin Kligler

Corresponding writer

Correspondence to Jeffery A. Dusek.

Boosted information

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

JAD drafted the original report protocol/manuscript and led report coordination of the manuscript. RR conducted the data analysis and contributed to interpretation of the findings and writing of the manuscript. KHG, DT participated in a review of the literature and contributed to writing of the manuscript. RJD participated in the data analysis and interpretation of the findings. BK, RQW, MDM provided important intellectual insight and revisions to the manuscript. JAD, DIA conceived of the report and participated in its pattern and coordination and provided important intellectual insight and revision to the study protocol/manuscript. All authors read and approved the final manuscript.

Additional file

Rights and permissions

Open Access This article is distributed nether the terms of the Artistic Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/iv.0/), which permits unrestricted employ, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(due south) and the source, provide a link to the Artistic Commons license, and indicate if changes were fabricated. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/aught/1.0/) applies to the data made available in this article, unless otherwise stated.

Reprints and Permissions

Virtually this article

Verify currency and authenticity via CrossMark

Cite this commodity

Dusek, J.A., Abrams, D.I., Roberts, R. et al. Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based inquiry network: study protocol. BMC Complement Altern Med 16, 53 (2015). https://doi.org/10.1186/s12906-016-1025-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI : https://doi.org/10.1186/s12906-016-1025-0

Keywords

  • Integrative Medicine
  • Observational report
  • Practice-based enquiry
  • Depression
  • Stress
  • Patient activation
  • Complementary medicine
  • Study protocol

cockerillarpher.blogspot.com

Source: https://bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-016-1025-0