FNOA: Assessment of Overweight/Obesity (2012)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  • To examine the role of modifiable predictors of functional decline among community-residing older women
  • To validate a clinical prediction tool for functional decline based on modifiable predictors.
Inclusion Criteria:
  • Women
  • Aged 65 years or older
  • Participants in the Study of Osteoporotic Fractures.
Exclusion Criteria:
  • African American women
  • Those unable to walk without the help of another person
  • Women with bilateral hip replacements.
Description of Study Protocol:

Recruitment

Participants were recruited from several sources. In two communities women were identified from membership lists for large health maintenance organizations. In one community they were identified from lists of residents that had been produced for the Hypertension Detection and Follow-up and the Systolic Hypertension in the Elderly Studies and from jury lists. In one community participants were identified from 1985 voter registration lists. In another, they were selected from county lists of holders of drivers' licenses and identification cards. Women received a letter and brochure inviting them to participate in the study.

Design

Prospective cohort study 

Blinding used

Not used

Intervention

Not applicable

Statistical Analysis

  • To create a simple tool that could be used by clinicians without much calculation, the authors dichotomized the continuous predictor variables
  • A prediction rule based on eight modifiable predictors classified women into three different risk groups for decline in basic activities
  • To generate a prediction rule score that would be practical in clinical settings, beta-coefficients were examined in each model, multiplied by a common factor, and rounded to the nearest integer
  • To estimate the maximum proportion of functional decline that could be attributed to modifiable predictors, models were constructed with the prediction tool variables in their original continuous state and were compared with those of the prediction tool
  • Sensitivity analysis was conducted because decisions regarding sample inclusion criteria, model selections, and predictor variable cutpoints may have influenced findings.

 

Data Collection Summary:

Timing of Measurements

  • Participants were recruited between September 1986 and October 1988. Visit 1 took place between 1986 and 1988, visit 2 between 1988 and 1990, and visit 4 between 1992 and 1994
  • At baseline and at two-year intervals, participants underwent evaluations that included performance tests and interviews to assess functional status. Potential predictors of functional status were measured at visit 1 or visit 2, and function was reassessed at visit 4.
  • Exercise level and and visual acuity were measured at visit 1; all other modifiable predictors were measured at visit 2.

 Dependent Variables

  • Functional decline as measured by ability to carry out 13 daily activities from the 1984 National Health Interview Survey Supplement on Aging 
  • Assessment of functional status was obtained by interviewing participants about their ability to carry out 13 daily activities from the National Health Interview Survey Supplement on Aging and a modified Health Assessment Questionnaire. Activities were classified as vigorous or base activities. Vigorous activities included doing household chores like vacuuming, dusting, etc, heavy housework like scrubbing floors or washing windows, shopping, climbing up 10 steps without resting, and walking two to three blocks on level ground. Base activities were things like getting in and out of bed, turning faucets of and off, getting in and out of a car, dressing yourself, washing and drying your body, bending down to pick clothes up off the floor, preparing your own meals, and lifting a full cup or glass to your mouth.

Independent Variables

  • Modifiable risk factors were those that a clinician seeing an older patient for the first time could act upon and reasonably expect to change over a four-year period. These modifiable predictors became candidates for the decision tool: Depression, high body mass (BMI), poor visual acuity, low bone mineral density (BMD), benzodiazepine use, weak grip, slow gait, low social functioning, and low exercise level.
  • Fixed predictors of functional decline included age, education, medical comorbidity, cognitive function, presence of spine fracture and smoking history
  • Benzodiazepine use (measurement was not described, but it is assumed to be based on self-report from interview/survey/questionnaire)
  • Depression as measured by the 15-item Geriatric Depression Scale using a cutpoint of 6 or greater
  • Low exercise level (measurement was not described but it is assumed to be based on self-report from interview/survey/questionnaire)
  • Social functioning (measurement was not described but it is assumed to be based on self-report from interview/ survey/questionnaire)
  • Body mass index as measured using standard techniques not described
  • Poor visual acuity as defined by binocular vision 20/40 or worse
  • Low bone mineral density as measured by dual-energy X-ray absorptiometry
  • Slow gait as measured by the time in seconds needed to walk six meters at a rapid pace
  • Weak grip as measured by a grip dynamometer in both hands Control Variables.

 

Description of Actual Data Sample:
  • Initial N: 6,632 women
  • Attrition (final N): All participants were accounted for; no attrition
  • Age: 65 years or older at baseline, with a mean age of 73±4.9 years
  • Ethnicity: Not specified except to note that African Americans were excluded
  • Other relevant demographics:
    • 39.2% of the sample had <12 years education
    • 40.3% had 12 years
    • 20.5% had >12 years education
  • Anthropometrics: Mean BMI of participants was 26.3±4.6. Of the sample of 6,632:
    • 12.1% reported having CAD (coronary artery disease)
    • 61.7% had arthritis
    • 3.5% had a previous stroke
    • 2.0 % had CHF (congestive heart failure)
  • Location: Participants were recruited from:
    • Portland, Oregon
    • Minneapolis, Minnesota
    • Baltimore, Maryland.

 

Summary of Results:

Key Findings

Five modifiable risk characteristics (slow gait, short-acting benzodiazepine use, depression, low exercise level, and BMI ≥29) are associated with functional decline in both vigorous and basic activities. Weak grip predicted functional decline in vigorous activities, whereas long-acting benzodiazepine use and poor visual acuity predicted functional decline in basic activities.

A prediction rule based on these eight modifiable predictors classified women in the derivation set into three risk groups for decline in vigorous activities (12%, 25%, and 39% risk) and two risk groups for decline in basic activities (2% and 10% risk). In the validation set, the probabilities of functional decline were nearly identical.

Significant Multivariable Predictors of Functional Decline in Vigorous Activities*

Risk Factor β OR 95% CI Points°
y Intercept -3.53       
Slow gait (lowest quintile)  0.57  1.76  1.44-2.16 
Short-acting benzodiazepine use  0.48  1.62  1.21-2.18 
Depression (6 or greater on 15-item GDS)  0.41  1.51  1.09-2.08 
Low exercise level  0.31  1.36  1.12-1.67 
BMI≥29  0.26  1.30  1.07-1.58 
Weak grip strength (lowest quintile)  0.19  1.21  0.99-1.49 

* Model adjusted for age, level of education, medical comorbidity, cognitive function, presence of spine fracture, smoking status, and enrollment site

OR=odds ratio   CI=confidence interval

°Calculated by multiplying β coefficients by 4 and rounding to the nearest integer. The point scheme for predicting functional decline is derived from summing the points from the six significant factors.

Significant Multivariable Predictors of Functional decline in Basic Activities

Risk Factor β OR 95% CI Points
y Intercept -1.66       
Slow gait (lowest quintile) 0.83  2.29  1.66-3.17 
Depression (6 or greater on the 15-item GDS) 0.62  1.87 1.17-2.98 
Long-acting benzodiazepine use 0.59  1.80 1.10-2.95 
Visual acuity worse than 20/40 0.51  1.66 1.09-2.55 
Short-acting benzodiazepine use 0.50  1.66  1.02-2.68 
Low exercise level (lowest quintile) 0.39  1.47  1.06-2.05 
BMI ≥29 0.32  1.37  0.98-1.93 

* Model adjusted for age, level of education, medical comorbidity, cognitive function, presence of spine fracture, smoking status, and enrollment site

OR=odds ratio   CI=confidence interval

°Calculated by multiplying β coefficients by 4 and rounding to the nearest integer. The point scheme for predicting functional decline is derived from summing the points from the six significant factors.

 Performance of the Prediction Rule for Functional Decline

Risk Group Points

Derivation Set
n/N (95% CI*)² RR 

Validation Set
n/N (95% CI*)² RR

Vigorous Activities

Low

Moderate

High

 

0-1

2-3

=4

 

391/3172(11.2-14.7)     1.0

249/1012(22.0-27.3)      2.0

92/238(32.5-44.9)          3.1

 

 220/1614(12.0-15.3)    1.0

126/474(22.6-30.6)        2.0

48/122(307-48.0)           2.9

Basic Activities

Low

High

 

0-1

=2

 

 74/3151 (1.8-2.9)          1.0

130/1271(8.6-11.9)       4.4

 

38/1602(1.6-3.1)          1.0

42/608(4.5-8.9)              2.9

 *95% confidence intervals of participants in risk group experiencing functional decline

 ²Chi-square trend, P<0.001

Author Conclusion:

The authors conclude that a substantial portion of the variation of functional decline can be attributed to risk factors amenable to intervention over the short term. In addition, using eight modifiable predictors that can be identified in a single office visit, clinicians can identify older women at risk for functional decline.

Funding Source:
Government: Public Health Service
University/Hospital: UCLA School of Medicine, USCF School of Medicine
Not-for-profit
Robert Wood Johnson Foundation
Other non-profit:
Reviewer Comments:
  • It is not clear to this reviewer how information on benzodiazepine use, social functioning, and low exercise level were obtained but it appears to be self-reported. Self-reporting may not be accurate and could have affected the outcome of the study.
  • The authors do not appear to have taken confounding factors such as use of medications (aside from benzodiazepines) into account
  • This age group is at risk for dementia, which could affect BMI, physical functioning (gait and exercise level), social functioning and depression. Presence or absence of dementia is not accounted for in this study.
  • It is not clear to this reviewer if changes in benzodiazepine use and/or dose were measured over time
  • Authors note a major limitation is lack of ethnic and gender diversity among participants; whether findings are generalizable to different populations is unknown 
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) N/A
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) N/A
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? ???
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? N/A
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? N/A
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) N/A
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? N/A
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? N/A
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? No
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? N/A
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? N/A
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? N/A
  6.6. Were extra or unplanned treatments described? N/A
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? ???
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? ???
  7.5. Was the measurement of effect at an appropriate level of precision? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? N/A
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? N/A
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes