MNT: RDN in Medical Team (2015)

Van den Berg J, Kalmijn S, Lindeman E, Veldink J, de Visser M, Van der Graaff M, Wokke J, Van den Berg L. Multidisciplinary ALS care improves quality of life in patients with ALS. Neurology, 2005; 65: 1,264-1,267. PubMed ID: 16247055
Study Design:
Cross-Sectional Study
D - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
To examine the effect of multi-disciplinary ALS care on the quality of life (QoL) of patients with ALS and their caregivers.
Inclusion Criteria:
Meeting the El Escorial diagnostic criteria for probable or definite ALS.
Exclusion Criteria:
Insufficient knowledge of the Dutch language or were suffering from cognitive disorders or other diseases that could affect the muscloskeletal system.
Description of Study Protocol:


Recruited from all regions of the Netherlands through the Dutch Neuromuscular Patients Association and two national referral centers for patients with motor neuron disease (University Medical Center at Utrecht and Academic Medical Center Amsterdam).


  • Cross-sectional study in which ALS patients and their caregivers were interviewed by an experienced research nurse who was blinded for type of care during home visits or at the outpatient clinic
  • Information was collected via the 36-item Short Form Health Survey (SF-36) and two visual analog scales (VAS)
  • Patients were grouped into receiving standard of care or multi-disciplinary care
  • Multi-disciplinary ALS Care Group criteria:
    1. An ALS team headed by a consultant in rehabilitation medicine and consisting of al least a physical therapist, occupational therapist, speech pathologist, dietitian and social worker
    2. Care was provided per the Dutch consensus protocol for rehabilitative management in ALS
    3. All members of the multi-disciplinary ALS team see at least six incident ALS patients per year.
  • General (standard of care) ALS Group criteria: Patients treated by a general practitioner, a physician in a nursing home or by a consultant in rehabilitation medicine who did not fulfill the multi-disciplinary ALS criteria.

Blinding Used 
Nurse researchers was blinded to the ALS patient grouping category.


Statistical Analysis

  • Conducted via SPSS v. 11.0.1
  • Chi-square or independent T-test to determine differences between standard of care and multi-disciplinary groups
  • Multi-variate linear regression alaysis to determine whether multi-disciplinary ALS care was associated with the SF-36, 2 VAS and the CSI for the caregiver.
Data Collection Summary:

Timing of Measurements

One-time assessment.

Dependent Variables

  • QoL: Validated Dutch version of the SF36; 36 items covering eight dimensions. Data was summarized to physical summary score and a mental summary score. Scale from zero (no life satisfaction or well-being)to 100 (best possible life satisfaction and well-being).
  • Loss of function: Measured with
    • Amyotrophic Lateral Sclerosis Severity Scale (ALS-SS): Rapid assessment of speech, swallowing, lower extremity and upper extremity abilities; scale from one (cannot do) to 10 (normal function)
    • Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS): Assesses function change in ALS; scale from zero (unable to attempt the task) to four (normal function).
  • Ability to cope: Measured with the Utrecht Coping List (UCL), a 47-item Dutch-validated questionnaire. Patients rated their coping behavior on a four-point scale over seven sub-scales: Active handling, palliative reaction, avoidance, seeking social support, passive reaction pattern, expression of emotions and reassuring thoughts.
  • Caregrive Strain Index (CSI): A 13-item questionnaire focused on sleep disturbance, physical strain and financial strain;  score ranges from zero (no) to one (yes)
  • Number of visits to professional caregivers (neurologist, consultant in rehabilitation medicine, physical therapist, occupational therapist, speech pathologist, dietitian and social worker)
  • Use of aids and appliances.

Independent Variables

Group (standard of care or multi-disciplinary care).

Control Variables

Controlled for sex, age, marital status, education, ALS type, ALS-FRS and coping style.

Description of Actual Data Sample:
  • Initial N: 208 ALS patients (63% men) and their caregivers: 133 in multi-disciplinary care; 75 in general care
  • Attrition (final N): 208 (0% attrition)
  • Age: Multi-disciplinary subjects, 58.2±10.3 years; general care subjects, 60.2±10.1 years
  • Ethnicity: Dutch.

Other Relevant Demographics

  • 74% with spinal ALS
  • 84% were married
  • 27% had a college degree
  • An approximately 26-point ALS Fucntional Rating Scale Score (not significant difference in demographics between groups).

Not described.


Summary of Results:

Key Findings

  • Percentage of patients with adequate aids and appliances was higher in the Multi-Disciplinary ALS Care Group
  • ALS multi-disciplinary care subjects showed improved QoL mental summary score and social functioning score.

Influence of Multi-Disciplinary vs. General ALS Care on Aids and Appliances

QoL Aid Multi-Disciplinary Care General Care P-Value
Swallowing aid 94.4% 66.7% 0.01
Communication aid 86.5% 72.2% 0.18
Ambulation aid 95.8% 92.3% 0.36
All aid 93.1% 81.3% 0.008

Adjusted Difference of QoL in Patients with Multi-Disciplinary vs. General ALS Care

  Outcome Adjusted Difference 95% CI P-Value
SF-36 Physical Functioning Physical summary scale -1.22 -4.2 to 1.7 0.42
Physical functioning -0.63 -8.6 to 7.4 0.88
Role functioning-physical -1.1 -11.5 to 9.3 0.83
General health perception 0.94 -5.2 to 7.0 0.76
Body pain -2.49 -10.9 to 5.9 0.56
SF-36 Mental Health Mental summary score 4.28 1.2 to 7.4 0.01
Vitality 4.02 02.2 to 10.3 0.21
Social functioning 15.0 6.8 to 23.3 <0.001
Role functional-emotional 5.1 -7.7 to 18.0 0.43
Mental health 4.5 -0.2 to 9.2 0.06
VAS subjective QoL 3.2 -3.4 to 9.8 0.34
VAS subjective health -0.53 -7.0 to 5.9 0.87

Other Findings

  • Number of visits per year to professional caregivers was similar between groups
  • Most non-professional caregivers were the spouses of the patients with ALS (90%); in 5% of the cases it was the daugher, in 3% neighbors and in 2% the father or mother of the patient.
Author Conclusion:
  • Patients with multi-disciplinary ALS care had better mental QoL than patients who were provided general care
  • A team of professionals coordinated by a physician and sufficient experience with this relatively rare, progressive disease is the most likely explanation for a better QoL in patients with multi-disciplinary ALS care.
Funding Source:
Other: Prinses Beatrix Fonds, Den Haag, ALS Stichting Fonds grant, and a Stichting Bijstand grant from Meander Medisch Centrum
Reviewer Comments:
The authors did not address study limitations.
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? No
  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) Yes
  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? Yes
  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? N/A
  4.1. Were follow-up methods described and the same for all groups? N/A
  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%.) N/A
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? N/A
  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? Yes
  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.) Yes
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? Yes
  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? N/A
  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? N/A
  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? 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? N/A
  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? Yes
  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)? Yes
  8.6. Was clinical significance as well as statistical significance reported? ???
  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? ???
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? No
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