Final Research Plan

Falls Prevention in Community-Dwelling Older Adults: Interventions

October 22, 2015

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from August 6 until September 2, 2015 at 5:00 p.m., ET.

Note: The numbers in the figure correspond to the Key Questions.

Text Description.

The Figure is an analytic framework for the key questions of this report that depicts community-dwelling adults age 65 years or older (at average or high risk for falls) receiving falls prevention interventions and the impact of those interventions on falls, falls-related morbidity, and mortality. The figure also depicts the possibility of harms or adverse effects occurring as a result of falls prevention interventions.

  1. Is there direct evidence that primary care interventions to prevent falls in community-dwelling older adults at average or high risk for falls, used alone or in combination, reduce falls or falls-related injury, improve quality of life, reduce disability, or reduce mortality?
    1. How do included trials categorize participants as “high risk” for falls?
  2. What are the adverse effects associated with primary care interventions to prevent falls in community-dwelling older adults?

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the prognostic accuracy of falls risk assessment tools that are feasible for administration in primary care?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions (KQs).

  Included Excluded
Aim Trials with the primary or secondary aim of reducing falls or falls-related injuries Comparative effectiveness trials of fall interventions
Population Community-dwelling adults age ≥65 years (including those residing in independent living facilities). Includes older adults who are at average and high risk for falls; participants may be recruited from settings both within and outside of the community or primary care (e.g., community-dwelling adults recruited from emergency department visits for falls-related injuries).
  • Trials conducted exclusively in populations living in special settings outside of the community (e.g., hospitals, nursing or care homes, rehabilitation centers, or other long-term care facilities)
  • Trials conducted exclusively in special populations (e.g., adults with neurocognitive disorders, such as moderate to severe dementia or Parkinson’s disease; persons who are nonambulatory) in which interventions may be considered disease management
  • Trials conducted in adults age ≤65 years or with a mean study age of ≤65 years
Interventions KQ 1:
  • Interventions that are primary care feasible or referable
  • Studies with a minimum followup of 6 months

Categories of included interventions*:

  • Exercise (supervised or unsupervised, individual or group)
  • Medications (e.g., medical management, supplements [vitamin D, calcium])
  • Psychological (individual or group)
  • Environmental/assistive technology (e.g., home hazard assessment and modification)
  • Knowledge (e.g., educational materials)
  • Social environment (e.g., caregiver training)

Interventions may be delivered alone (single) or in combination (multifactorial, multiple). Multifactorial assessment and management is an included intervention.

KQs 1, 2:
  • Community interventions that are not generally accessible (e.g., senior residence program)
  • Social marketing (e.g., media campaign)
  • Policy (e.g., local and State public or health policy)
  • Institutional methods (e.g., use of restraints)
  • Surgery (e.g., cataract extraction, pacemaker placement, podiatry surgery)
  • Fluid or nutrition therapy
  • Management of urinary incontinence
  • Optical aids, hearing aids, and body-worn protective aids (e.g., hip protectors)
  • Interventions designed solely for persons with neurocognitive disorders
  • Interventions designed solely for persons who are nonambulatory
Comparators KQ 1: Placebo, minimal control (i.e., provision of education via written materials, video, lecture), usual care  
Outcomes KQ 1:
  • Falls
  • Mortality (all-cause and falls-related)
  • Falls-related morbidity, defined as:
    • Falls-related fracture injuries
    • Disability (activities of daily life and/or instrumental activities of daily life)
    • Quality of life (as measured on the 12-, 20-, or 36-item Short-form Health Survey; EuroQol; Sickness Impact Profile; Health Utilities Index; Dartmouth COOP Charts; Nottingham Health Profile)
    • Hospitalizations for falls-related injuries
    • Emergency department visits for falls-related injuries
    • Institutionalizations (e.g., transition from community dwelling to nursing or care homes, or other long-term care facilities)

KQ 2: Harm outcomes as reported in studies, including psychological outcomes

KQ 1:
  • Falls-related injuries other than fractures that do not lead to an emergency department visit or hospitalization
  • Quality of life measures not listed in the inclusion criteria
  • Disability measures other than activities of daily life and/or instrumental activities of daily life
  • Falls Efficacy Scale
  • Function measures (e.g., Performance-Oriented Mobility Assessment, Timed Get Up & Go Test, 6-meter timed walk, Functional Reach Test, and Berg Balance Scale)

KQ 2: Minor adverse events that are reported using nonvalidated, nongeneralizable measures

Study Designs KQ 1: Randomized, controlled trials

KQ 2 (vitamin D): Systematic evidence reviews; randomized, controlled trials identified from KQ 1

KQ 2 (all other interventions): Randomized, controlled trials identified from KQ 1

All KQs: Editorials, letters, nonsystematic reviews, opinions, comparative effectiveness trials

KQ 1: Clinical controlled trials, case-control studies, cohort studies

KQ 2: Convenience surveys, qualitative studies

Setting Interventions conducted in primary care or that are referable from primary care Interventions conducted in or recruited from settings that are not generalizable to primary care (e.g., worksites, university classrooms, institutional settings); in a population with pre-existing social ties (e.g., from the same worksite or church); in a setting with a population not comparable to a community-dwelling, primary care population (e.g., hospital, rehabilitation center, long-term care facility, emergency department); or in a setting where the intervention could not be reproduced in primary care or within a broader health system.
Country Countries categorized as “Very High” on the 2014 Human Development Index (as defined by the United Nations Development Programme) Countries not categorized as “Very High” on the 2014 Human Development Index
Language English only Non-English language publications
Quality Fair or good, according to design-specific criteria Poor, according to design-specific criteria

* Based on ProFaNE intervention descriptors (Lamb SE, Becker C, Gillespie LD, et al. Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions. Trials. 2011;12:125).

The draft Research Plan was posted for public comment on the USPSTF Web site from August 6 to September 2, 2015. Most comments were addressed through minor changes to the inclusion and exclusion criteria, clarifying which categories of interventions will be included and the types of community settings that are considered to be referable from primary care. Several comments asked about the definitions of “average risk” and “high risk.” Risk categorization will be determined based on the studies’ recruitment strategies, participants’ baseline characteristics, and analysis of fall rates in control groups. Several comments requested clarification on the type of providers for fall interventions. For the purposes of this review, primary care interventions may be provided by various types of providers, including, but not limited to, physicians, nurses, physical therapists, occupational therapists, and health educators. Several comments requested clarification on the definition of primary care. Consistent with other USPSTF systematic evidence reviews, this review will include interventions that are conducted in primary care, could feasibly be conducted in primary care, or are generally services to which primary care providers could refer their patients. In terms of included interventions, the USPSTF clarified that vision and hearing screening and treatment are not included in this review because they are evaluated in other USPSTF reviews. No major changes were made to the scope of the review or the approach to synthesizing the evidence.