Final Research Plan
Final Research Plan for Falls Prevention in Community-Dwelling Older Adults: Interventions
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.
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.
Key Questions to Be Systematically Reviewed
- 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?
- How do included trials categorize participants as “high risk” for falls?
- What are the adverse effects associated with primary care interventions to prevent falls in community-dwelling older adults?
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).
|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).||
Categories of included interventions*:
Interventions may be delivered alone (single) or in combination (multifactorial, multiple). Multifactorial assessment and management is an included intervention.
|KQs 1, 2:
|Comparators||KQ 1: Placebo, minimal control (i.e., provision of education via written materials, video, lecture), usual care|
KQ 2: Harm outcomes as reported in studies, including psychological outcomes
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).
Response to Public Comment
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.
Internet Citation: Final Research Plan: Falls Prevention in Community-Dwelling Older Adults: Interventions. U.S. Preventive Services Task Force. October 2015.