EAL

MNT: RDN in Medical Team (2015)

Citation:

Casey J, Li CH, Johnson V, Sluman C, McClelland P. Multidisciplinary approach for prescriptive management of mineral and bone metabolism in chronic kidney disease: Development of a dietetic led protocol. J Ren Care. 2006; 32 (4): 187-191.

PubMed ID: 17345976

Study Design:

Prospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To describe a prescriptive protocol developed for the management of mineral and bone metabolism abnormalities in chronic kidney disease (CKD) and evaluate the protocol for clinical effectiveness.

Inclusion Criteria:

CKD
Hemodialysis dialysis for at least 90 days.

Exclusion Criteria:

Hemodialysis dialysis for less than 90 days.

Description of Study Protocol:

Recruitment

Recruitment methods not reported.

Design

A multi-disciplinary working group developed a protocol for the management of bone metabolism disorders in the CKD population
The protocol was audited to evaluate its clinical effectiveness
Audits were conducted prior to the introduction of the protocol and 12 months after it was introduced.

Intervention

The aims of the protocol were to ensure:

A high standard of practice across the Hospital Trust
Satisfactory phosphate, corrected calcium and parathyroid (PTH) control for all CKD patients
The timely and appropriate initiation of phosphate binding agents
The timely and appropriate use of calcium-based phosphate binding agents
Appropriate use and dosing of vitamin D analogs
The development of “link nurses” to help implement and apply the protocol
A dietetic or pharmacy lead in the management of renal mineral and bone metabolism disorders in CKD patients.

The multi-disciplinary team that developed the protocol consisted of two renal dietitians, two renal pharmacists and a Nephrologist. The dietetic team assumed responsibility for maintaining and implementing the protocol and ensured that the protocol was disseminated to other members of the nephrology team via a series of presentations and education sessions.

Statistical Analysis

Not reported.

Data Collection Summary:

Timing of Measurements

At baseline (before the protocol was introduced) and 12 months after it was introduced.

Dependent Variables

Phosphate
Calcium
PTH.

Independent Variables

The protocol for managing bone metabolism abnormalities in CKD.

Description of Actual Data Sample:

Initial N: 98 (breakdown by sex not reported)
Attrition (final N): 88
Age: Not reported
Ethnicity: Not reported
Other relevant demographics: Not reported
Anthropometrics: Not reported
Location: United Kingdom.

Summary of Results:

Key Findings

Improvements in phosphate, calcium and PTH control were observed after introduction of protocol.

	Baseline Means	12 Months Means
Phosphate (mmol/L)	1.71	1.47
Calcium (mmol/L)	2.39	2.40
PTH (pmol/L)	59.7	34.8

Author Conclusion:

Dietitians have the knowledge, expertise and consistent presence in the dialysis unit to oversee the management of mineral and bone metabolism issues in CKD and are uniquely placed to complement the nephrology team
The development of the protocol provided an opportunity for the dietary team to extend their role within the nephrology service and to liase closely with pharmacy and medical colleagues. The adopted protocol is designed to prevent and treat mineral and bone metabolism disturbances early on and throughout all stages of CKD to improve renal patient's quality of life and longevity.

Funding Source:

University/Hospital:

University/Hospital: Arrowe Park Hospital

Reviewer Comments:

Characteristics of subjects not described (other than CKD)
Initial N=98; final N=88; cause of attrition is unclear
Statistical analysis not reported. Levels of significance not reported.
No discussion of findings or 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?		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?		No
	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%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	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?	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?	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?	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?	???
	6.6.	Were extra or unplanned treatments described?	???
	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?	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?	???
	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?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	No
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	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)?	No
	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?	No
	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?		No
	9.1.	Is there a discussion of findings?	No
	9.2.	Are biases and study limitations identified and discussed?	N/A
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