MNT: RDN in Medical Team (2015)
Citation:
Nielsen D, Ryg J, Nissen N, Nielsen W, Knold B, Brixen K. Multidisciplinary patient education in groups increases knowledge on osteoporosis: A randomized controlled trial. Scand J Public Health. 2008; 36(4): 346-352.
PubMed ID: 18539688Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:

Research Purpose:
To evaluate if multi-disciplinary education of patients with osteoporosis increases knowledge of osteoporosis.
Inclusion Criteria:
Diagnosed with osteoporosis.
Exclusion Criteria:
- Unable to participate in mild physical exercise
- Suffering from specific conditions (cancer, psychiatric disease or cognitive disturbances).
Description of Study Protocol:
Design
Randomized controlled trial:
- Control group: One-hour physician visit with 15-minute follow-up
- School group: Group-based education with multi-disciplinary team along with one-hour physician visit and 15-minute follow-up.
Intervention
- School group participated in the educational program in classes of eight to 12 patients; divided into three sessions a day for four weeks (12 hours of education total). The program was conducted by a multi-disciplinary team (physician, dietitian, physiotherapist and nurse). Topics included how osteoporosis develops, medical work-up, diet, prevention of falls, fractures and pain, pharmacological treatment and instructions on physical exercise. Each group discussed how to live with osteoporosis. The school group was also offered participation in a reinforcement program using a computerized telephone call from a private company (contact one time per month to address intensity of pain, QoL and physical activity).
- Both control and school groups were seen in an outpatient clinic (one hour) with a physician and had a follow-up consultation (15 minutes) after three months. Control group participants with previous vertebral or hip fractures were offered instructions in an exercise program by physiotherapist.
Statistical Analysis
- Mann-Whitney and chi-square tests for differences between group in demographic
- Wilcoxon's T-test to assess changes in osteoporosis knowledge scores pre-test and post-test
- Spearman's correlation test to evaluate associations among variables
- Significance established as P<0.05.
Data Collection Summary:
Timing of Measurements
Baseline and three-month post-test.
Dependent Variables
- Patients' knowledge of osteoporosis score: Using validated PAVIOS questionnaire (Patienters Viden om Osteoporose). Validation of questionnaire was described [initially 100 questions were designed by healthcare team and reduced to 27 multiple choice questions (possible score range zero to 27 points)]. The questionnaire covered topics such as risk factors, symptoms, DEXA and treatment options.
- Time sent reading about osteoporosis categories:
- A: Less than one hour per month
- B: One to three hours per month
- C: More than three hours per month.
- Demographic variables (sex, education, age, professional relationship to healthcare)
Independent Variables
- Time
- Group.
Description of Actual Data Sample:
- Initial N: N=300 (89% female, evenly distributed between groups); N=150 randomized to each group (N=522 screened; N=222 excluded or unwilling)
- Attrition (final N): N=272 (N=128 control; N=144 school group); 10% attrition
- Age: Median age 63.5 years
- Ethnicity: Danish
- Other relevant demographics: No differences between groups, each having knowledge scores median of 22 points; in education; or time per month spent reading about health issues
- Location: Denmark.
Summary of Results:
Key Findings
Variables |
School Group |
Control group |
Statistical Significance of Group Difference |
PAVIOS score |
+3 points |
0 points |
P<0.001 |
Other Findings
- At baseline:
- Level of education was positively correlated with knowledge score (Rho=0.44; P<0.001)
- Time spent reading about health was positively correlated with participant's knowledge of osteoporosis (Rho = 0.22; P<0.001)
- Females had higher knowledge scores than men (22 patients vs. 19 patients) (P<0.01)
- Age was inversely correlated with knowledge score (Rho=-0.20; P=0.001) and inversely associated with education (Rho=-0.19; P<0.01).
- At study end: School group had an inverse relationship between education level and change in knowledge score (Rho=-0.25; P<0.01).
Author Conclusion:
A multi-disciplinary group-based education program for patients with osteoporosis can increase patients' knowledge of the disease.
Funding Source:
Industry: |
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University/Hospital: | Odense University Hospital | |
Not-for-profit |
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Reviewer Comments:
- Author defined limitations:
- Unknown impact for long-term or if there was improved QoL
- Did not assess where information came from (i.e., general physician, Osteoporosis Foundation, or local fitness center)
- Participants in the control group with vertebral or hip fractures were offered exercise classes by physiotherapist (four one-hour sessions)
- Higher dropout rate in control group.
- Did not address baseline level or change in physical activity.
Quality Criteria Checklist: Primary Research
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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) | Yes | |
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) | Yes | |
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? | Yes | |
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? | Yes | |
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? | Yes | |
3. | Were study groups comparable? | Yes | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | No | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | Yes | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | Yes | |
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? | Yes | |
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? | No | |
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? | N/A | |
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? | Yes | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | Yes | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | Yes | |
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? | Yes | |
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? | Yes | |
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? | Yes | |
7.5. | Was the measurement of effect at an appropriate level of precision? | Yes | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
7.7. | Were the measurements conducted consistently across groups? | Yes | |
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)? | No | |
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 | |