RAHM Foundation Retrospective Study By: Dr. Christina Rahm
Dr. Christina Rahm
Mother | Patented Scientist | Global Entrepreneur | Author | Manages 22 Companies | Works in 89 Countries
RAHM Foundation Retrospective Study
Retrospective Registry exposure for: Various Disease States
Protocol Number: RAHM 1002
Date September 26, 2013
Version 2
1. CONTACT LIST
1.1.RAHM Foundation
RAHM Foundation, LLC 209 10th Ave., South Suite 514
Nashville, TN 37203
615-712-9574
615-730-8475 Fax
RAHM Contact Person: Christina Cook, PhD RAHM Medical Director:Fernando Diaz, MD
Office: 248--‐312--‐8619 Email: [email protected]
1.2.Contract Research Organization
Datum Research, LLC
Risa Tyo
209 10th Ave., South Suite 514 Nashville, TN37203
214--‐729--‐7807
615--‐730--‐8475 fax
2. SUMMARY
Protocol Number: 0001
Version Number: 1
Welllness Registry for: Various disease states
Study Location: United States
Study Objectives Primary: To enhance the understanding of the
variability, progression and treatment of various disorders with the ultimategoal of better guiding and assessing nutritional supplements as a therapeuticintervention to support wellness and overall health metrics.. This will be done by benchmarking data and gap analysis
Study Design: Retrospective collection of data in participants and patients with various disorders.
Time Period November 1, 2021- November 1, 2022-2023
Study Population: Wellness as it pertains to participants and Patients with various disorders
3. INTRODUCTION
This is a retrospective data collection on treatment of various disorders. This registry will include a variety ofdifferent wellness products and nutritional supplements, along with traditional healthcare and wellness treatments. The registry will also collect any efficacy data and adverse events/complications that occur during or followingtreatment of these conditions. The data may be utilized to develop wellness strategic treatment pathways and/or benchmarking that will improve patient care. Ultimately, the goal of the registry is to enhance the understanding of nutritional and food supplements as it pertains to overall wellness and healthcare and as it pertains to the treatment in these disease states.
4. OBJECTIVES
4.1.Primary Objective
To collect data for the last 2 years on patients in a variety of specialties in order to benchmark data on outcomes, costs, processes. This benchmark data will be utilized to improve wellness care, decrease costs, and develop wellness treatment pathways. Data will be provided to each participating provider with recommendations for improvement.
5. STUDY DESIGN
The registry is an international, multi--‐center, retrospective collection for patients with a variety of disorders. Noexperimental intervention is involved. A core set of data will be collected if available. The data will be extracted from EMRs and/or patient charts into and entered into a centralized database. There will be various surveys added as needed so as to ask questions as it pertains to Quality of Life but this will be mandatory.
This database will be used to evaluate wellness nutiritonal supplements as it pertains to vaccines, viruses, illnesses, disease states, treatment utilization and outcomes, various treatments and outcomes, complicationsassociated with treatments and products, traditional medications, pain medication utilization and return to workand/or normal usual activities. This data will aid in the development of strategic treatment pathways andimproved patient care. Point of care in specialty areas will be collected. This will provide information on the entire spectrum of care.
6. STUDY POPULATION
6.1.Number of Subjects
Data will be collected in approximately 7 sites during the period between January 1, 2022 to January 1 2023/2024 Our goal is to amend this protocol in August, 2022 I order to collect follow-up data on each of these sites to compare to benchmark data.
6.2.Minimum Criteria for Enrollment
7.2.1 Inclusion criteria:
No specific inclusion criteria
7.2.2 Exclusion criteria:
No specific exclusion criteria
8 REGISTRY PROCEDURES
8.1 Data Collection
The purpose is to collect data on patients with a for variety of disorders. This includes point of care (primary care, internal medicine, pain management providers, etc. as well as a variety of specialty providers including neurosurgeons, orthopedic surgeons, oncologists, and dermatologists. The retrospective data collection willconsist of a core set of data as well as available. The registry will attempt to collect data prior tosurgery/treatment, during surgery, and various time points following surgery/treatment. The data willinclude, but is not limited to demographic data, past medical history, previous treatments, time off of work,type of surgery performed, products/implants used during surgery, treatments used for non-surgical conditions, anesthesia used during surgery, complications/adverse events following surgery and or treatment, outcome tools, imaging results, pain assessment, pain medication utilization, length of hospital stay, unplanned hospitaladmissions, revision surgery, adjacent level disease, patient return to work and patient return to normalactivity. The data collected will vary depending on disease state and treatment. This registry will also allow for comparisons on different treatments, procedures, etc. with a goal of developing the best pathways for a variety of different disease states.
Data collection will include but is not limited to:(if available):
· DEMOGRAPHICS
o DATE OF BIRTH
o GENDER
o RACE
o HEIGHT
o WEIGHT
o INSURANCE STATUS
o TIME OFF WORK PRIOR TO SURGERY/TREATMENT (months)
o REASON FOR TIME OFF WORK
o TYPE OF WORK
· PRESURGERY/PRETREATMENT
o PAST MEDICAL HISTORY
o PAST TREATMENTS
o PAST SURGERIES AND DATE
o MEDICATIONS
o DIAGNOSIS AND/OR ICD-9 CODE
o IMAGING (TYPE, DATE, RESULTS)
o PAIN INTENSITY OR VAS SCORE
o OUTCOME TOOLS AND QUALITY OF LIFE
· POINT OF CARE
o REFERRAL TO WHAT SPECIALTY
o REFERRAL FROM WHAT SPECIALTY
o TREATMENTS PROVIDED PRIOR TO REFERRAL
o DIAGNOSIS AT REFERRAL
· SURGERY (IF APPLICABLE)
o DATE SURGERY PERFORMED:
o LOCATION OF SURGERY (INPATIENT OR OUTPATIENT)
o PRIMARY SURGERY OR REVISION SURGERY
o TYPE OF SURGERY PERFORMED
o AREA OF SURGERY PROCEDURE (i.e. levels fused)
o PRODUCT/IMPLANT USED AND MANUFACTURER USED
o BIOLOGIC USED AND MANUFACTURER
o GRAFTING USED AND MANUFACTURER
o ASA CLASSIFICATION
o ANESTHSIA USED
o LENGTH OF SURGERY
· MEDICATION(S) PRESCRIBED
o DOSE
o LENGTH OF TREATMENT
· POST SURGERY (if applicable)
o LENGTH OF HOSPITAL STAY
o DATE OF DISCHARGE
o ESTIMATED BLOOD LOSS
o COMPLICATIONS
o ADVERSE EVENTS
o DISCHARGE HOME OR REHABILITATION
o MEDICATIONS AT DISCHARGE
o TREATMENTS PRESCRIBED AT DISCHARGE
· FOLLOW UP VISITS
o DATE OF VISIT
o TYPE OF IMAGING AND RESULTS
o PAIN INTENSITY OR VAS SCALE
o CURRENT SYMPTOMS
o PAIN MEDICATIONS
o TREATMENTS (i.e. physical therapy)
o COMPLICATIONS
o ADVERSE EVENTS
o OUTCOME TOOLS
o BACK TO WORK
o REVISION SURGERY AND REASON
o HOSPITAL READMISSION AND REASON
o UNPLANNED ER VISIT
9 STATISTICAL CONSIDERATIONS
9.1 Analysis Population
The registry aims to enhance understanding of the variability, progression, and treatment pathways for a variety of disorders, with the ultimate goals of better guiding and assessing therapeutic intervention andproviding recommendations on patient care to the medical community.
12.2 Analysis Parameters Include but not limited to:
12.2.1 Predictor Variables
? Patient age, gender, occupation
? Medical history
? Type of surgery
? Type of treatment
? Type of product/implant
? Type of anesthesia
? BMI and other risk factors
12.2.2 Short Term Outcome Measures
? Length of hospital stay
? Post-operative complications (e.g., adverse events and re--‐ operation)
? Post-treatment complications
? Imaging Results
? Return to work
? Return to normal/usual activities
? Unplanned hospital/ER visits
? Pain medication utilization
12.2.3 Disease Specific Patient Reported Outcome Measures
? Quality of Life
? Disability outcomes from various outcome tool measurements
? Pain intensity
? Wound care
? Scar care
12.3 Statistical Methods
Prior to analysis, data in the operational database will be transferred to statistical analysis software foranalysis. The following is an overview of the analysis process. Methods for specific analyses will be described in more detail in the statistical analysis plan pending a diagnostic evaluation of the data.
12.3.1 Description of Baseline Characteristics
Descriptive statistics will be used to characterize the patient population, using the predictorvariables described above. For categorical variables, proportions and frequency counts will be calculated. Continuous variables will be summarized using means and standard deviations ormedians and interquartile ranges, as appropriate. Categorical variables will be presented asproportions. In addition, minimum, maximum, and range will be reported for both types ofvariables. Missing, extreme, and variable distributions will be explored. Group comparisons ofcategorical variables will be made using Pearson’s chi--‐square (χ2) tests and continuous variablesusing t--‐tests.
12.3.2 Description of Outcomes
Annual rates of the following outcomes (using Kaplan--‐Meier methods to account for loss tofollow--‐up) will be calculated if appropriate:
? Proportion of patients who experience an unplanned hospital/ER admission.
? Proportion of patients who return to work.
? Proportion of patients who return to normal/usual activities.
? Proportion of patients who experience post-operative complications.
? Proportion of patient who experience post-treatment complications
? Proportion of patients who experience an abnormal length of
hospital stay.
Distributions of the following will be calculated at monthly/yearly intervals following treatment if appropriate:
? Outcome tool score
? Pain intensity score
? Change from preceding outcome score.
? Change from preceding Pain intensity score.
? Change from pre-surgery/pre-treatment outcome tool score.
? Change from pre-surgery/pre-treatment pain intensity score.
As with baseline characteristics, summary measures will be presented depending on the type of variable(continuous versus categorical), and type of distribution. Point estimates and 95 percent confidenceintervals will also be presented.
Gap analysis will also be done on financial data and processes, if available.
Analysis done will depend on data available from each provider.
10 CHANGES TO FINAL PROTOCOL
All protocol amendments must be submitted to the central IRB. Protocol modifications that impact subject safety,the scope of the investigation, or affect the scientific quality of the study must be approved by the central IRB beforeimplementation of such modifications to the conduct of the study. However, RAHM Foundation may, at any time,amend this protocol.
11 DATA HANDLING AND RECORD MANAGEMENT
11.1 Data Collection
11.1.1 Patient Confidentiality:
Information about study subjects will be kept confidential and managed according to the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations require that WIRB grant approval of an authorization to collect the Protected Health Information (PHI) without written consent from the participant for research purposes.
· Data Collection Methods
Ultimately data will be maintained in Datum Research, LLC database. On-line collection application forms are available for data entry into which study values are entered either by DC2 staff, by the site staff, or by database engineers loading data directly from electronic sources. Once we identify the source data per site, it’s method of storage will dictate collection methods ranging anywhere from electronic data pulls to manual entry from paper forms.
1. Electronic extraction from EMR systems.
2. Physical copy of paper records usually transmitted via Fax
3. Electronic copy of scanned paper records transmitted by email, FTP, or mobile storage devices like external hard drives, USB drives, CD, DVD…
4. On line data entry by site personnel
De-identify
The basics are to: collect retrospective health data from source records which are protected; de-identify data by removing all personally identifiable information from the collected data while maintaining a cross reference to the source for re-identification. There are three main ways that data may be collected:
1. When possible source date will be de-identified prior to sending to DATUM RESEARCH, LLC. Removal of names, addresses, and other unique numeric identifiers such as Social Security, Medicare, or Medicaid numbers.
2. Work with either health site personnel to enter the study data into the collection application remotely
3. Establish an independent third party organization (MTS) who can set up "data use agreement" or "restricted access agreement" with the collection site for a period of time to pull the required data from patient records and enter that information directly into the collection application.
Each patient will be given a unique identification code. This identification code will be tied to the sites main patient code, which the site will keep in a secure location. DATUM RESEARCH, LLC will destroy it’s correlation tool at the completion of the study in accordance with the DATUM RESEARCH, LLC documentation destruction policy.
Implementation specifications: re-identification. A covered entity may assign a code or other means of record identification to allow information de-identified under this section to be re-identified by the covered entity, provided that:
1. Derivation. The code or other means of record identification is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual; and
2. Security. The covered entity does not use or disclose the code or other means of record identification for any other purpose, and does not disclose the mechanism for re-identification
· Regulatory Binder
A regulatory binder will be maintained for this study at Datum Research, LLC. This will include items such as this protocol, the letter of approval from the IRB, the Waiver of Authorization form, and all other information pertinent to this study.
· Study Auditing
The investigator will permit study-related monitoring, audits, and inspections by the WIRB, the sponsor, and government regulatory bodies of all study related documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.).
Participation as an investigator in this study implies acceptance of potential inspection by government regulatory authorities.
12 PUBLICATION POLICY
Any investigator who wishes to develop a publication or presentation based on the results from this study mustobtain approval from RAHM FOUNDATION prior to submission. RAHM FOUNDATION will grant theinvestigator the freedom to publish any scientific or medical results deemed by the author to be of medical orscientific significance, provided that the information is scientifically sound, does not duplicate a previous or alreadyplanned publication, and is not being released prematurely.
DATUM RESEARCH, LLC/RAHM FOUNDATION reserves the right to review these documents for scientificintegrity, effect on clinical activities, and relevance to partnership agreements. RAHM FOUNDATION will notsuppress publications or presentations, but reserves the right to delay publications to avoid compromisingintellectual property. Additionally, RAHM FOUNDATION reserves the right to delay publications of sub--‐analysesuntil after the publication of the main study results.
All authors will be given full access to all relevant statistical tables, figures, protocols, and reports to support thedevelopment of publications and presentations. “Relevant” data is defined as data that are related to the scientificobjective(s) of the study, or which are necessary to fully understand the study results.
Authors who are not RAHM FOUNDATION employees must enter into a written publication agreement. Theagreement must contain provisions that comport with the publication policies of both authors and contributors.
RAHM FOUNDATION reserves the right to exclusively publish and/or present the study information inpeer--‐reviewed journals and/or at professional society meetings.
13 STUDY COMPLETION
The Central IRB must be notified of completion of this patient registry.