Trial Outcomes & Findings for Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (NCT NCT02037438)

NCT ID: NCT02037438

Last Updated: 2019-03-04

Results Overview

Global rating of the provider from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS) compared between the two arms at end of study (12 months). The global rating instructions specify: "Using any number from 0 to 10, where 0 is the worst provider possible, and 10 is the best provider possible, what number would you use to rate this provider?"

Recruitment status

COMPLETED

Study phase

Target enrollment

1836 participants

Primary outcome timeframe

12 months

Results posted on

2019-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	CONV Arm Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center	PCCM ARM Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Overall Study STARTED	920	916
Overall Study COMPLETED	574	561
Overall Study NOT COMPLETED	346	355

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCCM ARM n=916 Participants Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.	Total n=1836 Participants Total of all reporting groups	CONV Arm n=920 Participants Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
Age, Continuous	49.1 years STANDARD_DEVIATION 14.98 • n=7 Participants	50.1 years STANDARD_DEVIATION 15.32 • n=5 Participants	51.1 years STANDARD_DEVIATION 15.60 • n=5 Participants
Sex: Female, Male Female	401 Participants n=7 Participants	797 Participants n=5 Participants	396 Participants n=5 Participants
Sex: Female, Male Male	515 Participants n=7 Participants	1039 Participants n=5 Participants	524 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	97 Participants n=7 Participants	186 Participants n=5 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	808 Participants n=7 Participants	1622 Participants n=5 Participants	814 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants n=7 Participants	28 Participants n=5 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=7 Participants	19 Participants n=5 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Asian	103 Participants n=7 Participants	249 Participants n=5 Participants	146 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	8 Participants n=7 Participants	16 Participants n=5 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=7 Participants	55 Participants n=5 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	677 Participants n=7 Participants	1284 Participants n=5 Participants	607 Participants n=5 Participants
Race (NIH/OMB) More than one race	88 Participants n=7 Participants	193 Participants n=5 Participants	105 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=7 Participants	20 Participants n=5 Participants	11 Participants n=5 Participants
Region of Enrollment United States	916 participants n=7 Participants	1836 participants n=5 Participants	920 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 546 CONV and 535 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Outcome measures

Outcome measures
Measure	CONV Arm n=546 Participants Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center	PCCM ARM n=535 Participants Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Global Rating After 12 Months	8.32 units on a scale Standard Deviation 1.973	8.45 units on a scale Standard Deviation 1.650

PRIMARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 540 CONV and 539 PCCM participant data were acceptable for statistical analysis for this outcome measure.

The vitality scale score of the Short Form-36 (SF-36) Version 2 Health Survey was compared at the end-of study (12 months) and was derived from the following four questions: "How much of the time during the past 4 weeks… Did you feel full of life?" "Did you have a lot of energy?" "Did you feel worn out?" "Did you feel tired?" The possible responses and point values were: all of the time (1), most of the time (2), some of the time (3), a little of the time (4), and none of the time (5). The scale is transformed to a 0-100 scale, with the lower the score indicating more disability.

Outcome measures

Outcome measures
Measure	CONV Arm n=540 Participants Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center	PCCM ARM n=539 Participants Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months	48.0 units on a scale Standard Deviation 10.84	47.1 units on a scale Standard Deviation 11.19

SECONDARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 530 CONV and 525 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Communication of provider as measured by the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS). This comprised "How Well Providers (or Doctors) Communicate with Patients" The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often did this provider explain things in a way that was easy to understand?" "In the last 12 months, how often did this provider listen carefully to you?" "In the last 12 months, how often did this provider show respect for what you had to say?" "In the last 12 months, how often did this provider spend enough time with you?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4).

Outcome measures

Outcome measures
Measure	CONV Arm n=530 Participants Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center	PCCM ARM n=525 Participants Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Provider Communication After 12 Months	3.59 units on a scale Standard Deviation 0.655	3.64 units on a scale Standard Deviation 0.551

SECONDARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 423 CONV and 426 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Helpfulness of Provider's Use of Computers During a Visit (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey \[CGCAHPS\]). This included composite measures of helpfulness of provider's use of computers during a visit. The ratings for the following two questions were averaged for each participant: "During your visits in the last 12 months, was this provider's use of a computer or handheld device helpful to you?" The point values for the responses were: yes, definitely (1), yes, somewhat (2), and no (3). "During your visits in the last 12 months, did this provider's use of a computer or handheld device make it harder or easier for you to talk with him or her?" The point values for the responses were: easier (1), not harder or easier (2), harder (3).

Outcome measures

Outcome measures
Measure	CONV Arm n=423 Participants Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center	PCCM ARM n=426 Participants Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Health Information Technology Measure #1 After 12 Months	2.03 units on a scale Standard Deviation 0.378	2.06 units on a scale Standard Deviation 0.356

SECONDARY outcome

Timeframe: 12 months

Population: Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 268 CONV and 270 PCCM participant data were acceptable for statistical analysis for this outcome measure.

Helpfulness of Provider's Website in Giving Patient Information About Patient's Care and Tests (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey \[CGCAHPS\]). This included composite measures of helpfulness of provider's website in giving information about care and tests. The ratings for the following four questions were averaged for each participant: "In the last 12 months, how often was it easy to find these lab or other test results on the website?" "In the last 12 months, how often were these lab or other test results put on the website as soon as you needed them?" "In the last 12 months, how often were these lab or other test results presented in a way that was easy to understand?" "In the last 12 months, how often were the visit notes easy to understand?" The responses and point values were: never (1), sometimes (2), usually (3), and always (4).

Outcome measures

Outcome measures
Measure	CONV Arm n=268 Participants Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center	PCCM ARM n=270 Participants Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Change in CGCAHPS Health Information Technology Measure #3 After 12 Months	3.31 units on a scale Standard Deviation 0.787	3.30 units on a scale Standard Deviation 0.771

Adverse Events

CONV Arm

Serious events: 30 serious events

Other events: 0 other events

Deaths: 0 deaths

PCCM ARM

Serious events: 23 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Dr. Clete Kushida

Stanford University

Phone: 650-721-7560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CONV Arm n=158 participants at risk Conventional (CONV) care for the diagnosis and treatment of sleep disorders CONV care for the diagnosis and treatment of sleep disorders: The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center	PCCM ARM n=172 participants at risk Patient-Centered Outcomes and Coordinated Care Management (PCCM) for the diagnosis and treatment of sleep disorders PCCM for the diagnosis and treatment of sleep disorders: The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
Gastrointestinal disorders Emergency Department Visits	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Renal and urinary disorders Emergency Department Visits	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
General disorders Emergency Department Visits	0.00% 0/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Musculoskeletal and connective tissue disorders Emergency Department Visits	0.00% 0/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Nervous system disorders Emergency Department Visits	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Psychiatric disorders Emergency Department Visits	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Cardiac disorders Hospital Admissions	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Skin and subcutaneous tissue disorders Hospital Admissions	0.00% 0/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Gastrointestinal disorders Hospital Admissions	0.00% 0/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Respiratory, thoracic and mediastinal disorders Hospital Admissions	1.3% 2/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Nervous system disorders Hospital Admissions	1.3% 2/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Psychiatric disorders Hospital Admissions	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Cardiac disorders Surgeries/Procedures	1.9% 3/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	2.3% 4/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Endocrine disorders Surgeries/Procedures	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Gastrointestinal disorders Surgeries/Procedures	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	1.7% 3/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Renal and urinary disorders Surgeries/Procedures	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	1.2% 2/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Respiratory, thoracic and mediastinal disorders Surgeries/Procedures	2.5% 4/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
General disorders Surgeries/Procedures	0.00% 0/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	1.2% 2/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Musculoskeletal and connective tissue disorders Surgeries/Procedures	2.5% 4/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	2.3% 4/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Musculoskeletal and connective tissue disorders Accidents	1.3% 2/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Cardiac disorders Deaths	1.3% 2/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Endocrine disorders Deaths	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Respiratory, thoracic and mediastinal disorders Deaths	0.63% 1/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.00% 0/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.
Nervous system disorders Deaths	0.00% 0/158 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.	0.58% 1/172 • 1 year Only a subset of the total enrolled patients could be tracked for Serious Adverse Events. Other (Not Including Serious) Adverse Events were not recorded in the study. Serious Adverse Events were grouped into major organ system categories decided upon by the research team.