EAL

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: 18539688

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

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 Mean Change	Control group Mean change	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:

Novo Nordic, Aventis, Eli Llly, Merck Sharpe & Dohme, Pharma Vinci, Servier, and Nycomed

University/Hospital:

Odense University Hospital

Not-for-profit

Danish Osteoporosis Foundation; Augustinus Foundation; Frimondt-Heineke Foundation

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
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