Evidence based practice and nursing research

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CULTIVATING QUALITY By Madeline Johnston, BSN, RN, OCN, and Morris A. Magnan, PhD, RN

Using a Fall Prevention Checklist to Reduce Hospital Falls: Results of a Quality Improvement Project

Two frequently missed fall prevention interventions were identified.

Preventing patient falls is one of the biggest chal-lenges facing health care workers today. The Agency for Healthcare Research and Quality (AHRQ) estimates that 700,000 to 1,000,000 falls occur annually in U.S. hospitals.1 The National Data- base of Nursing Quality Indicators (NDNQI) defines a fall as “an unplanned descent to the floor (or ex- tension of the floor, e.g., trash can or other equip- ment) with or without injury to the patient.”2 The NDNQI’s definition includes falls resulting from physiological and environmental factors as well as “assisted falls,” in which the patient falls in the pres- ence of any hospital staff member who attempts to lessen the fall’s impact. In September 2015, the Joint Commission issued a Sentinel Event Alert that stated: “Falls with serious injury are consistently among the Top 10 sentinel events” reported to its database of such events.3 (The Joint Commission defines a

sentinel event as “an unexpected occurrence involv- ing death or serious physical or psychological injury, or the risk thereof.”4) While reporting to the database is voluntary and the events reported reflect only a small proportion of actual events, the alert noted that 465 patient falls with injuries had been reported since 2009; the majority occurred in hospitals, and most troubling, approximately 63% of these resulted in death.

Commonly used fall prevention interventions in- clude fall risk assessments, fall risk alerts, environ- mental modification, use of assistive equipment, staff and patient safety education, medication manage- ment, staff assistance with transfers and toileting, hourly rounding, and bedside change-of-shift reports. Prevention interventions are presumed to be helpful but need to be used consistently. Erin Dupree, a for- mer chief medical officer and vice president of the

ABSTRACT Purpose: This quality improvement (QI) initiative aimed to promote patient safety by improving adherence to an existing hospital-approved fall prevention protocol. Specific aims of the initiative were to evaluate the impact of using a fall prevention checklist on (1) the implementation of a bundle of 14 specific interventions (the fall prevention protocol) and (2) the incidence of falls on participating units.

Methods: A QI team conducted a 26-day fall prevention initiative. Data were collected on day and night shifts for 13 days each. We evaluated the effect of using a new 14-item checklist based on the existing hospital- approved fall prevention protocol on the nursing staff’s adherence to each intervention and on the incidence of falls on the test unit. Oncoming staff used the checklist during change-of-shift handoffs to determine whether all prevention interventions were in place before accepting care of the patient. The incidence of falls was tracked daily.

Results: Thirty-seven nursing staff members (RNs and nursing assistants) participated in the pilot study and completed 90 fall prevention checklists. The most frequently missed intervention was setting the bed alarm, which was set incorrectly 19% of the time. There were no patient falls during the pilot study.

Conclusion: By evaluating staff use of the fall prevention checklist, the QI team identified frequently missed prevention interventions and areas for improvement in the hospital’s fall prevention protocol. A more comprehensive test of the fall prevention checklist’s impact on fall prevention is needed.

Keywords: checklist, fall prevention, falls, quality improvement

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Joint Commission Center for Transforming Health- care, has stated that standard fall prevention efforts are implemented inconsistently and should not be used in a “one-size-fits-all approach”; rather, she sug- gested that health care institutions should “discover what their issues are to target solutions to their unique needs.”5

The 2015 Sentinel Event Alert noted that the most common factors contributing to falls with injuries in- clude the following3:

• Inadequate assessment • Communication failures • Lack of adherence to protocols and safety prac-

tices • Inadequate staff orientation, supervision, staff-

ing levels or skill mix • Deficiencies in the physical environment • Lack of leadership

Hospital falls have serious implications for both the patient and the institution. One study found an out-of-pocket cost of $1,363 with a total of $13 billion in Medicare expenditures.6 To ensure the best outcomes for the patient and prevent such extraneous costs, hospitals have implemented fall prevention pro- grams; the effectiveness of these programs is often de- termined by comparing the incidence of institutional falls with national benchmarks. In 2013, Bouldin and colleagues took on the challenge of trying to establish normative fall incidence rates for adults hospitalized on medical, surgical, and medical–surgical units in the United States.7 The authors’ analysis of NDNQI data from July 1, 2006, through September 30, 2008, showed that fall rates varied significantly according to the type of nursing unit. When calculated as the number of falls per 1,000 patient days, the authors found fall incidence rates to be highest on medical units (4.03), lower on medical–surgical units (3.62), and lowest on surgical units (2.76).7 According to Holley, oncology patients are most susceptible to falls because of their typically advanced age, im- paired physical function, sensory deficits, multiple medications, and deconditioning secondary to treat- ment.8

A sharp uptick in fall prevention initiatives began in 2009, probably as the result of the controversial decision of the Centers for Medicare and Medicaid Services to stop covering the extra costs associated with injuries caused by inpatient falls.9 Hospitals and other health care institutions launched extensive fall prevention programs and invested in new technolo- gies to prevent falls. For example, in our experience, bed alarm use has become much more common than it was a decade ago.

It’s important to note that, in fall prevention, no single intervention or technology is completely reli- able, and some commonly used prevention interven- tions are of questionable value. For example, recent research has raised questions about the reliance on bed alarms in preventing falls. Shorr and colleagues showed that bed alarm use does not affect fall rates.10 Moreover, the AHRQ and the Centers for Disease Control and Prevention do not include routine use of bed and chair alarms for fall prevention as a best practice recommendation (however, the Joint Com- mission does).1, 3, 11 Others have raised questions about the unintended consequences of immobility, as well as the decline in functional status and well-being that stems from the use of bed alarms.12 Nevertheless, many hospitals have endorsed the use of bed alarms for fall prevention despite the lack of evidence of their efficacy.

In our hospital, clinical staff members continually strive to reduce fall rates. In order to monitor fall trends, nursing leadership established a benchmark fall rate of 4 falls per 1,000 patient days based on ob- served historical trends. The annual fall rate decreased from 3.7 falls per 1,000 patient days in 2016 to 2.85 falls per 1,000 patient days in 2017, with nursing units frequently reporting fall rates of less than 4. As a result, the internal benchmark was reset from 4 per 1,000 patient days to a rate of 3, a rate that is well below other national prevalence data for medi- cal and medical–surgical units.7 Still, there is room for improvement. Ideally, clinical nurses and nursing leadership would like to classify falls as a “never event”—one that never occurs.

Fall prevention strategies in our hospital include • performing the Schmid fall risk assessment13 ev-

ery shift. • use of assistive equipment, such as a gait belt when

ambulating. • room signage and a fall risk light and sign visible

from the hallway. • fall risk wristbands. • nonskid footwear. • the call light placed within the patient’s reach. • personal items placed within the patient’s reach. • hourly rounding. • informing the patient of fall risk precautions and

expected adherence. • informing staff of patient fall risk status. • the bed alarm activated on zone 2.

The Stryker iBed used in our hospital allows nurses to select from three patient safety zone set- tings for fall prevention: zone 1 allows for the most patient movement before the alarm sounds, zone 2 allows for less movement, and zone 3 allows for the least amount of patient movement before triggering

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the alarm. Zone 2 is the standard setting for all pa- tients identified as a fall risk. The current standard of practice at our hospital is that bed alarms are to be used on all at-risk patients (those who have a Schmid score greater than or equal to 3) at all times.

The task of implementing fall prevention interven- tions is a complex one that involves many steps. Most tasks that humans perform daily require either sche- matic or attentional behavior.14 Attentional behav- ior, which depends on the critical thinking process, is very different from schematic behavior, in which a series of steps bundled together as a single task are performed, more or less automatically or “on auto- pilot.” Failing to think critically or engage actively in problem-solving can lead to mistakes in attentional

behavior. In contrast, the omission of a step in a series of steps occurs when there is a failure in schematic be- havior. The AHRQ refers to these errors of omission as “slips,”12 and they are more apt to occur as a result of distraction or a lack of concentration. Slips are not the result of a lack of knowledge but rather of the failure to use knowledge correctly and consistently.15 Others have suggested that slips can occur during execution of a well-established routine (reporting that the patient is a fall risk without reviewing actual pre- vention interventions, for example), as a result of dis- traction (when report is interrupted by a call light, for example), or as a result of absentmindedness (forget- ting to replace fall risk signage in the room of an at- risk patient, for example).16 Checklists map out the

Figure 1. Fall Prevention Checklist

Change of Shift Falls Safety Checklist

Staff member name:________________________ RN or Nurse Assistant (circle one)

Patient #1 Patient #2 Patient #3 Patient #4

Date:

Shift:

Room:

Pt. Initials:

YES NO YES NO YES NO YES NO

Fall Risk

Pt. Educated

Family Educated

RN Aware

Nurse Assistant Aware

Signage Posted in Room

Signage Posted in Hallway

Wristband

Bed in Low Position

Bed Alarm on Zone 2

Yellow Socks

Gait Belt

Call Light Within Reach

Personal Items Within Reach

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minimum steps necessary to consistently and correctly complete a task with many steps. Pilots and air traffic controllers, for instance, follow pre-takeoff checklists before every flight—not because they don’t know how to take off successfully, but to prevent any oversight that could lead to an error of omission. The use of checklists has the potential to reduce errors of omis- sion (slips) by standardizing the steps to be followed to prevent an adverse event, such as a fall.12, 17

Study purpose. In clinical rounds at our teaching hospital, clinical nurse specialists and nurse manag- ers noted that adherence to fall prevention standards was inconsistent. According to the Joint Commission, a “lack of adherence to protocols and safety practices” is one of the most commonly reported factors con- tributing to hospital falls.3 In response to this obser- vation, members of the quality improvement (QI) team discussed the use of a checklist and whether it might be an effective tool to reduce prevention in- tervention omissions and increase adherence to the hospital-approved fall prevention protocol. The overall purpose of this QI initiative was to promote patient safety by improving adherence to the proto- col. The specific aims of the initiative were to evalu- ate the effect of using a new 14-item checklist based on the existing hospital-approved fall prevention pro- tocol on (1) the nursing staff’s adherence to each in-

tervention in change-of-shift handoffs and (2) the incidence of falls on inpatient units. A secondary aim was to evaluate staff perceptions of the fall preven- tion checklist.

METHODS This QI initiative was conducted at a university- affiliated National Cancer Institute–designated com- prehensive cancer center located in the Midwest. The hospital’s 84 beds are dedicated solely to the care of oncology patients on six oncology specialty units. To achieve the specific aims of this initiative, one of us (MJ) convened a meeting of the QI team to plan the pilot study, design the intervention, create a falls pre- vention checklist, delineate procedures to be followed, provide staff education, and champion the pilot. The QI team comprised six nurses, including a clin ical nurse specialist, three staff nurses, a nurse educator (MJ), and a nurse consultant (MAM). All members of the team were well informed about fall-related policies and procedures.

Study intervention. We collaborated on writing a proposal that outlined the initiative. The nurse prac- tice council and nursing management, two groups that have shared responsibility for promoting and upholding the highest standards of nursing care in our institution, approved the proposal. The proposed intervention for this project was the use of a falls prevention checklist during change-of-shift hand- offs, thereby reassuring nursing staff that fall pre- vention interventions were implemented for at-risk patients before the offgoing staff transferred care of the patient to the oncoming staff.

One unit, a 19-bed bone marrow transplant unit, volunteered to be the test site for the pilot study. Data collection lasted for 26 days (from February 12, 2018, to March 9, 2018). With the approval of the nurse manager, the nursing staff collected data for 13 days on the day shift, followed by 13 days on the night shift (depending on schedules, these shifts could be eight or 12 hours). Data collection was staggered across the day and night shifts to stimulate greater staff participation. The QI team incentivized nursing staff to participate in the study by providing a pizza party for each shift at the end of the data collection period.

Members of the QI team oriented staff from all shifts (RNs and nursing assistants) to the pilot study. Staff members received all necessary documents dur- ing the orientation period, including the falls preven- tion checklist and a pilot evaluation form. Each staff member completed the checklist for four different pa- tients. To reduce bedside change-of-shift report time, staff members completed no more than two check- lists per shift. In bedside change-of-shift report, the

Protocol Criteria % Done % Not Done % Not Applicable

Fall risk 100 0 0

Patient educated 95 4 2

Family educated 89 2 9

RN aware 100 0 0

Nursing assistant aware 98 2 0

Signage posted in room 95 5 0

Signage posted in hallway 95 5 0

Wristband 96 4 0

Bed in low position 100 0 0

Bed alarm on Zone 2 81 19 0

Yellow socks 96 4 0

Gait belt 100 0 0

Call light within reach 100 0 0

Personal items within reach 100 0 0

Table 1. Implementation of Fall Prevention Interventions

Note: Percentages may not sum to 100% because of rounding.

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oncoming staff member checked off each step on the falls prevention checklist to indicate whether the pre- vention intervention was or was not in place for pa- tients known to be at risk for falls (the checklist was completed only for these at-risk patients; we did not track whether the checklist was completed more than once for any particular at-risk patient). Oncoming staff could then verify with offgoing staff the preven- tion interventions that were and weren’t in place. If an intervention was missing, the omission would be corrected before offgoing staff transferred care to oncoming staff. All 37 nursing staff members who received the falls prevention education participated in the pilot study. The nurse manager or her designee monitored the incidence of falls on the unit on a daily basis during the course of the study.

Measures. The QI team developed a 14-item fall prevention checklist based on the existing hospital- approved fall prevention protocol to evaluate the im- plementation of fall prevention interventions. The checklist itemized every component of the hospi- tal’s fall prevention protocol: fall risk status, patient and family awareness of risk, staff awareness of risk, proper signage (for example, “Call, don’t fall” and/or “STOP, patient is a fall risk”), fall risk wristband, bed in low position, bed alarm activated to zone 2, yellow nonskid footwear, a gait belt in every room, and the call light and personal items within the patient’s reach. The prevention checklist required yes-or-no responses

to indicate whether each intervention had or hadn’t been implemented. The QI team, all of whom were familiar with the hospital’s fall prevention protocol, independently affirmed face and content validity of the checklist. The nurse educator designed a checklist tool that allowed for data collection on four different pa- tients using a single sheet of paper (see Figure 1). In addition, the evaluation date, shift handoff time, pa- tient’s room number, and patient’s initials were re- corded during each handoff report.

To determine the incidence of falls, the number of falls occurring on the test unit were tracked daily dur- ing the study and compared with the previous three months. Finally, the secondary aim of determining staff perceptions of the falls prevention checklist and its use was achieved by having all participants com- plete a brief, nine-item questionnaire. Data for this QI initiative were entered into an Excel spreadsheet and analyzed using Excel descriptive statistics to ob- tain the percentages of yes-and-no responses reported for each item on the checklist.

RESULTS Thirty-seven staff members participated in the pilot study and completed 90 fall prevention checklists. The error most frequently observed was an incorrect set- ting on the bed alarm. Among the 90 checklists com- pleted, 19% (n = 17) recorded that bed alarms were not set on zone 2 (see Table 1). Another commonly

0

1

2

3

4

5

6

7

8

9

Nov. 2017 Dec. 2017 Jan. 2018 Feb. 2018 Mar. 2018

Months

Benchmark Falls

F a lls

/1 ,0

0 0

P a ti e n

t D

ay s

Fall rate/1,000 patient days

3.89 5.67 7.69 2.37 2.50

Pilot period Feb. 12–Mar. 9

Figure 2. Rate of Falls on the Pilot Unit

Note: The hospital falls benchmark was reset from 4 per 1,000 patient days in 2017 to 3 per 1,000 patient days in January 2018.

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observed error was missing signage. There were no falls during the pilot study period (February 12, 2018, to March 9, 2018), and therefore a sharp decline in the fall rate occurred during February and March of 2018 compared with the previous three months (see Figure 2).

Checklist evaluation. The QI team distributed a questionnaire to nursing staff members, asking them to evaluate the usefulness and convenience of the fall prevention checklist. We were particularly interested in knowing whether the checklist was cumbersome or easy to use, added too much time to shift handoff report, and was perceived to be of value as an aid in the prevention of falls. Fourteen of 37 participants completed checklist evaluations. All 14 respondents agreed that the checklist was easy to use and added value to the effort to reduce falls. However, there was disagreement about who should be using the form, nurses or nursing assistants. The majority (78%, n = 11) believed it should be used by both nurses and nursing assistants as part of change-of- shift handoffs (see Table 2).

DISCUSSION The pilot helped identify two common errors re- lated to implementation of the institution’s fall pre- vention protocol. First, the nursing staff was not activating zone 2 of the bed alarm 19% of the time, or nearly one time in five. This was the most com- monly missed intervention. Nursing staff also re- ported that, when they believed the bed alarm was set on zone 2, the alarm sounded at inappropriate times (when patients raised an arm off the bed to change the television channel, for example). Upon investigation, we determined that these occurrences

were the result of incorrect bed programming: in fact, the alarm wasn’t set to zone 2. Although any oversight is potentially detrimental, the incorrect use of the bed alarm is especially worrisome. Most of the fall prevention interventions are used when the nursing staff is present; the patient wears nonskid socks and a gait belt when ambulating with a staff member, for example. The bed alarm, however, is used to alert staff when the patient is alone and at- tempting to get out of bed without assistance. Staff members were taught how to recalibrate the bed cor- rectly when all the items the patient was likely to have on the bed were in fact on the bed, such as more than one pillow, more than one blanket, a cell phone, a tablet, and so on. Recalibrating the bed resulted in a more accurate alarm response to patient movement and a decrease in inappropriate bed alarms.

The second most commonly missed prevention in- tervention was fall risk signage. When nursing staff feel pressured to prepare a patient’s room for admission, posting the appropriate signage can be missed—not because staff don’t know how to do it, but because they are working “on autopilot.” While our analy- sis identified the absence of fall risk signage as a fre- quent omission in the safety protocol, the checklist itself acted as a reminder to replace the signage as necessary.

No falls occurred during the pilot period. Also, a sharp decline in the falls incidence rate was noted for February and March of 2018 compared with the three previous months. Since the pilot spanned a portion of both February and March, it is reasonable to assume the pilot contributed to these low monthly fall rates. Whether the decrease in the fall rates can be attributed to the use of the falls prevention checklist is difficult to say with certainty. It could be that the checklist func- tioned as intended and served as a reminder to apply all fall prevention interventions, thereby prompting the staff to correct errors of omission. It could be, for ex- ample, that using the checklist heightened staff aware- ness of fall risks, and as a result, handoff reports about fall risks were more complete. Although the pilot pe- riod was short, the absence of falls during this period and the apparent impact on unit level fall rates over time are notable.

In retrospect, persuading staff to buy into the project was perhaps the most challenging aspect of this initiative. Two areas of resistance were noted. First, some staff members resisted participating be- cause they could not understand or accept that they could commit errors when implementing the fall prevention protocol, as it was “something we do all the time.” Staff were reeducated on the concept of schematic behavior and its relationship to errors of omission. Once this concept was better understood,

Category % Yes % No

Checklist is easy to use 100 0

Good safety check 100 0

Should be used by everyone 78 22

Should include more than one patient per checklist 66 33

Should be used at each handoff 58 42

Should be used for every patient 58 42

Took too much time 33 67

RN to RN only 25 75

Nurse assistant to nurse assistant only 25 75

Table 2. Staff Evaluation of the Fall Prevention Checklist

Note: Percentages may not sum to 100% because of rounding.

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Madeline Johnston is a nurse educator in patient care services, and Morris A. Magnan is a clinical nurse specialist in the nurs- ing department, both at the Barbara Ann Karmanos Cancer Insti- tute in Detroit. Contact author: Madeline Johnston, johnstom@ karmanos.org. The authors have disclosed no potential conflicts of interest, financial or otherwise.

REFERENCES 1. Ganz DA, et al. Preventing falls in hospitals: a toolkit for im-

proving quality of care. Rockville, MD: Agency for Healthcare Research and Quality; 2013 Jan. AHRQ Publication No. 13- 0015-EF. https://www.ahrq.gov/sites/default/files/publications/ files/fallpxtoolkit.pdf.

2. American Nurses Association, National Center for Nurs- ing Quality. Guidelines for data collection on the American Nurses Association’s National Quality Forum endorsed mea- sures. Kansas City, KS: University of Kansas School of Nursing; 2010 May. National Database of Nursing Quality Indicators (NDNQI).

3. Joint Commission. Preventing falls and fall-related injuries in health care facilities. Sentinel Event Alert 2015(55):1-5.

4. Joint Commission. Sentinel events (SE). Oak Brook Terrace, IL; 2012 Feb 24. Comprehensive accreditation manual; https://www.jointcommission.org/assets/1/6/CAMH_2012_ Update2_24_SE.pdf.

5. Commins J. Joint Commission issues Sentinel Event Alert on patient falls. Health Governance Report 2015;25(12).

6. Hoffman GJ, et al. The costs of fall-related injuries among older adults: annual per-faller, service component, and patient out-of-pocket costs. Health Serv Res 2017;52(5):1794-816.

7. Bouldin EL, et al. Falls among adult patients hospitalized in the United States: prevalence and trends. J Patient Saf 2013; 9(1):13-7.

8. Holley S. A look at the problem of falls among people with cancer. Clin J Oncol Nurs 2002;6(4):193-7.

9. Centers for Medicare and Medicaid Services. CMS proposes additions to list of hospital-acquired conditions for fiscal year 2009 [press release]. 2008 Apr 14. https://www.cms.gov/news room/fact-sheets/cms-proposes-additions-list-hospital-acquired- conditions-fiscal-year-2009.

10. Shorr RI, et al. Effects of an intervention to increase bed alarm use to prevent falls in hospitalized patients: a cluster randomized trial. Ann Intern Med 2012;157(10):692-9.

11. Centers for Disease Control and Prevention. Keep them STEADI: preventing older adult falls in hospital-based set- tings. 2016. https://www.cdc.gov/steadi/stories/hospital.html.

12. Growdon ME, et al. The tension between promoting mobility and preventing falls in the hospital. JAMA Intern Med 2017; 177(6):759-60.

13. Schmid NA. Reducing patient falls: a research-based com- prehensive fall prevention program. Mil Med 1990;155(5): 202-7.

14. Agency for Healthcare Research and Quality, Patient Safety Network (PSNet). Checklists. Rockville, MD; 2019 Jan. Pa- tient safety primers; https://psnet.ahrq.gov/primers/primer/ 14/checklists.

15. Heckhausen H, Beckmann J. Intentional action and action slips. Psychol Rev 1990;97(1):36-48.

16. Reason JT, Mycielska K. Absent-minded? The psychology of mental lapses and everyday errors. Upper Saddle River, NJ: Prentice-Hall; 1982.

17. Hales BM, Pronovost PJ. The checklist—a tool for error man- agement and performance improvement. J Crit Care 2006; 21(3):231-5.

staff willingness to participate improved. A second area of resistance concerned the adequacy of the checklist. Some staff members reported that their patients were more apt to fall as a result of the medi- cations they were receiving than the absence of a pre- scribed prevention intervention. These nurses agreed to support the pilot project, as planned, with the un- derstanding that the investigators would work with them to particularize the checklist to capture patient- specific concerns once the pilot study was completed. Results of the pilot study were reported to nursing management and the nurse practice council. Collab- oratively, these groups decided this pilot study should be extended to a 90-day initiative, include all nursing units, and use a revised checklist to capture patient- specific concerns.

Limitations. Given the small number of observa- tions and the short period of time dedicated to data collection, it’s impossible to draw conclusions about possible trends in the fall rate that might be attribut- able to use of the fall prevention checklist. In addi- tion, the low rate of return of the checklist evaluations raises questions about response bias. It could be that only staff members with a relatively favorable view of the checklist completed the evaluations.

Implications for practice. The process of preparing for and implementing this pilot study was enlighten- ing and raised questions about the adequacy of our institution’s fall prevention practices. For example, in light of the evidence that bed alarms do not prevent falls and may have unintended adverse consequences for patients, the hospital-mandated use of bed alarms for all at-risk patients at all times is now being chal- lenged.1, 10, 12 Anecdotally, nurses report that bed alarms have, on occasion, “saved the day” in preventing a fall. In view of this deeply held belief, it seems unlikely that nursing staff will abandon the use of bed alarms completely. However, a more moderate approach to the use of bed alarms with zone setting determined by nursing judgment and patient-specific factors would increase nursing autonomy and might benefit some patients by avoiding the unintended consequences of bed alarm–enforced immobility.

Another insight that came from this study was the observation that within our institution there seems to be a steadfast allegiance to the one-size-fits-all ap- proach to fall prevention. Nurses who participated in the checklist evaluation consistently reported that the reasons their patients fell could not be captured using a checklist of conventional precautions. Instead, they believed that patient-specific factors, such as medica- tions, needed to be reported in change-of-shift hand- offs. Going forward, we will modify the fall prevention checklist to allow for the reporting and documentation of such patient-specific contributing factors. ▼