Fall Prevention 1 Mr. Samuels asks, “I have fallen several times before and even fractured my hip. How can I reduce the risk of falling again?” Adults 65 years or older who have previously fallen or suffered a hip fracture have a higher risk of falling again. Falls in older adults may be linked to injury or even fatality, but research suggests that the risk of falls may be reduced or even prevented. Doctors can assess a patient’s risk factors that may lead to a dangerous fall, such as level of physical activity and prior history of falls or previous hip fractures. From this assessment, patients with varying degrees of risk receive an individualized plan aimed to lower their susceptibility to falls. This may include a combination of different types of exercises such as balance, strength, endurance, and physical therapy, as well as vitamin D supplementation and home safety precautions. Exercise therapies may also provide overall health benefits, such as improved sleep, better cognition, and reduced depression. Although studies suggest exercise therapies and vitamin D supplementation may improve health and reduce the risk of falling, it is unknown which combination of treatments is most effective or which patients would benefit most. A comparison between the effectiveness of exercise therapies and other clinical treatments in older adults may help doctors recommend preventative measures and targeted treatment for patients who have a history or a high risk of falling. Fall Prevention 2 Topic Brief Based on PCORI Review Criteria: Disease Area Suggested Research Topic Elderly Health • Compare the effectiveness of primary prevention methods to prevent falls, such as exercise and balance training, versus clinical treatments in older adults at varying degrees of risk, including those patients post hip fracture and repair. • Assessing the potential of combining therapeutic agents to achieve additive or synergistic treatment benefits. • Improving adherence to clinical protocols by developing and testing less burdensome dosing regimens or routes of administration and exploring approaches that reduce drug side effects. • Using improved predictors of fracture risk that incorporate aspects of an individual's environment, lifestyle, and medical history to target multi-component prevention programs to high-risk individuals. • Investigating the effect of genetic variation on response to treatments. First-quartile recommendation from the Institute of Medicine’s (IOM’s) Initial National Priorities for Comparative Effectiveness Research, as well as a slight variation on a second-quartile recommendation:11 • Compare effectiveness of primary prevention methods, such as exercise and balance training, versus clinical treatments in preventing falls in older adults at varying degrees of risk. • Compare long-term effectiveness of weight-bearing exercise and bisphosphonates in preventing hip and vertebral fractures in older women with osteopenia and/or osteoporosis. Note: Conceptual VOI analysis(see Appendix) PCORI Criteria Brief Description RESEARCH STRATEGY: Background and Significance 2 1. Impact of the • Between 30 percent and 40 percent of community-dwelling persons 65 years or older fall at least once per year. 1 Fall Prevention 3 PCORI Criteria Brief Description RESEARCH STRATEGY: Background and Significance condition on the • Falls are the leading cause of fatal and nonfatal injuries among persons 65 years or older.3 health of individuals and populations • The estimated direct medical costs for fatal and nonfatal fall-related injuries among community-dwelling persons 65 years or older in 2000 was $19.2 billion, with one study estimating that this cost could reach $43.8 billion by 2020.4 Refers to the current impact of the condition on the health of individuals and populations. Is the condition or disease associated with a significant burden in the US population, in terms of prevalence, mortality, morbidity, individual suffering, or loss of productivity? A particular emphasis is on patients with chronic conditions, including those patients with multiple chronic conditions. Difference in • Falls among older adults are preventable. In 2006, the American Geriatrics Society and the British Geriatrics Benefits Society published an updated evidence-based practice guideline recommending that older adults at high risk for falls receive a multi-factorial fall-risk assessment and individualized, targeted interventions to address the risks and deficiencies identified in the assessment.5 • Physicians face significant barriers in intervening to prevent falls, including lack of awareness and appropriate knowledge, competing risks, and difficulty assessing risk.6 Reduction in • Despite the depth of research into interventions, additional research is needed to confirm the context in Uncertainty which multi-factorial assessment and intervention, home safety interventions, vitamin D supplementation, and other interventions are effective.7 2. Innovation and • A Cochrane review of 111 trials (55,303 participants) concluded that multi-component exercise, individually potential for prescribed multiple-component home-based exercise, and tai chi resulted in a reduced rate of falls, but it is improvement unclear which patients would benefit most.8 • Evidence underpinning the U.S. Preventive Services Task Force recommendations regarding fall prevention in older adults comes from time-limited, randomized, controlled trials involving heterogeneous populations that participated in different combinations of balance, strength, endurance, or general exercise programs in various settings under the supervision of diverse groups of experts (eg, physical therapists, nurses, and exercise physiologists).9 The trials provide general guidance but no details as to how to construct or conduct a clinical exercise program.10 Probability of • Given the limited amount of information on how to target either known fallers or those at high risk to fall, Implementation probability of implementation is likely for successfully proven treatment strategies in certain subgroups of older persons. Fall Prevention 4 PCORI Criteria Brief Description RESEARCH STRATEGY: Background and Significance Durability of • Durability of information is likely to be very unpredictable. The range of multi-component interventions is Information likely to be exponentially large with multiple variations of exercise therapies or teams for treatment planning. • With such a dramatic risk of hip fracture and disability from falls, strategies for fall prevention may have long-lasting effects on practice. Refers to the potential that the proposed research may lead to meaningful improvement in patient health, well-being, or quality of care. Is the research novel or innovative in its methods or approach, in the population being studied, or in the intervention being evaluated, in ways that make it likely to change practice? Does the research question address a critical gap in current knowledge as noted in systematic reviews, guidelines development efforts, or previous research prioritizations? Has it been identified as important by patient, caregiver, or clinician groups? Do wide variations in practice patterns suggest current clinical uncertainty? Do preliminary studies indicate potential for a sizeable benefit of the intervention relative to current practice? How likely is it that positive findings could be disseminated quickly to effect changes in current practice? • In contrast to the healthcare burden of hip fracture, repair, and surgical recovery, results that support exercise or physical therapy and vitamin D could largely impact health and costs of care. • Primary care physicians may be overburdened with the requirement to prescribe and oversee home-based therapies, 3. Impact on health although rehabilitation-oriented providers may be very interested and supportive of exercise or therapy-based interventions. care performance Refers to the potential that the proposed research could lead to improvements in the efficiency of care for individual patients or for a population of patients. Does the research promise potential improvements in convenience or elimination of wasted resources, while maintaining or improving patient outcomes? • Studies on exercise-based interventions have the potential to utilize a patient-centered approach for a range of benefits, including improved sleep, reduced depression, and better cognition, as well as improvement in overall function and certain 4. Patient chronic conditions, including heart failure, chronic obstructive pulmonary disease, and arthritis. centeredness Is the proposed research focused on questions and outcomes of specific interest to patients and their caregivers? Does the research address one or more of the key questions mentioned in PCORI’s definition of patient-centered outcomes research? Is the absence of Fall Prevention 5 PCORI Criteria Brief Description RESEARCH STRATEGY: Background and Significance any particularly important outcomes discussed? RESEARCH STRATEGY: Inclusiveness of Different Populations • Fall prevention spans many different risk factors for those age 65 years or older across all ranges of different populations. While individual studies may be condition- or combination-specific, many have the potential to be inclusive of different populations. 5. Inclusiveness of Does the proposed study include a diverse population with respect to age, gender, race, ethnicity, geography, or clinical status? different populations Alternatively, does it include a previously