Impacts on Practice
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There is a lack of evidence on the role for the pharmacist in metabolic syndrome (MetS), the viable models of care and the beneficial population.
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The review suggests that pharmacists can effectively screen patients for MetS, and participate in the prevention and management amongst most at-risk populations and within different settings to enhance patient care.
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Further research is warranted to determine the readiness and acceptance for the pharmacist to intervene in MetS from the pharmacists, physicians and patient’s perspective.
Introduction
Aim of the review
Ethics approval
Method
Protocol development
Inclusion and exclusion criteria
Type of participants
Type of interventions
Type of comparator
Type of outcome
Types of studies to be included
Exclusion Criteria
Search strategy and data sources
Quality assessment and data extraction
Data synthesis
Results
The results of the search process
Quality assessment
Hammad et al. 2011 [38] | Plaster et al. 2012 [39] | Schneiderhan et al. 2014 [40] | Azevedo et al. 2017 [44] | |
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Random sequence generation (selection bias) | L | L | L | L |
Allocation concealment (selection bias) | L | L | L | L |
Blinding of participants and personnel (performance bias) | NA | NA | NA | NA |
Blinding of outcome assessment (detection bias) | L | L | L | L |
Incomplete outcome data (attrition bias) | L | L | L | L |
Selective outcome reporting? (reporting bias) | L | L | L | L |
Other bias | L | L | L | L |
The quality rating | Good | Good | Good | Good |
Schneiderhan et al. 2009 [41] | Olenak and Calpin 2010 [36] | Benavides et al. 2011 [42] | Via-Sosa et al. 2014 [37] | Kjeldsen et al. 2013 [43] | |
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Cross-sectional studies | |||||
1. Was the research question or objective in this paper clearly stated? | Y | Y | Y | Y | |
2. Was the study population clearly specified and defined? | N | Y | Y | Y | |
3. Was the participation rate of eligible persons at least 50%? | CD | CD | Y | CD | |
4. Were all the subjects selected or recruited from the same or similar populations (including the same time period)? Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants? | Y | Y | Y | Y | |
5. Was a sample size justification, power description, or variance and effect estimates provided? | N | N | N | Y | |
6. Were the outcome measures (dependent variables) clearly defined, valid, reliable, and implemented consistently across all study participants? | Y | Y | Y | Y | |
Before-and-after (pre-post) studies | |||||
1. Was the study question or objective clearly stated? | Y | ||||
2. Were eligibility/selection criteria for the study population prespecified and clearly described? | Y | ||||
3. Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest? | Y | ||||
4. Were all eligible participants that met the prespecified entry criteria enrolled? | CD | ||||
5. Was the sample size sufficiently large to provide confidence in the findings? | CD | ||||
6. Was the test/service/intervention clearly described and delivered consistently across the study population? | Y | ||||
7. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Y | ||||
8. Were the people assessing the outcomes blinded to the participants’ exposures/interventions? | N | ||||
9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis? | NA | ||||
10. Did the statistical methods examine changes in outcome measures from before to after the intervention? Were statistical tests done that provided P values for the pre-to-post changes? | Y | ||||
11. Were outcome measures of interest taken multiple times before the intervention and multiple times after the intervention (i.e., did they use an interrupted time-series design)? | N | ||||
12. If the intervention was conducted at a group level (e.g., a whole hospital, a community, etc.) did the statistical analysis take into account the use of individual-level data to determine effects at the group level? | N |
Data extraction
Author, year, country | Aim/objectives, as described by the author(s) | Study design | Results | Population | Main findings related to the reviews’ objectives | |||
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Description of pharmacist input | Impact of the identified input | Population who would benefit most from input | Facilitators and barriers to the effective implementation of MetS | |||||
Schneiderhan et al., 2009, Minnesota [41] | “To assess the usefulness of a metabolic risk screening program, including point-of-care (POC) glucose testing, to quantify baseline metabolic risk in outpatients receiving antipsychotics” | Retrospective cross-sectional | Of 92 patients screened 65 (71%) had one MetS parameter and 40 (43%) had 2. No significant difference reported between parameters irrespective of antipsychotic. No results presented for POC testing | Adult outpatients receiving antipsychotic medications | Piloted MetS risk screening clinic to identify rates of metabolic abnormalities Developed a MetS screening tool for patients treated with antipsychotic agents Communicated relevant information and recommendations to patients and patient’s psychiatrist | Earlier detection of Mets through pharmacist-led screening program (71% with at least 1 MetS parameter) Earlier intervention by providing proper education to the patients and relevant healthcare referral | Females receiving antipsychotics with a BMI > 30 kg/m2 of African American origin | Facilitators Being a part of and having a defined role in the multidisciplinary team Appropriate clinic set-up including facilities for referral, clinic logistics Availability of resources, such as POC devices. The latter is of particular importance when dealing with psychiatric patients Barriers Difficult behaviours of psychiatric patients |
Olenak and Calpin., 2010, Pennsylvania [36] | “To implement a comprehensive screening for MetS that could be duplicated in other community pharmacy settings, determine the prevalence of MetS in our local community, determine the 10-year risk of developing CHD in patients with MetS, and determine the effectiveness of an education provided by the pharmacist to encourage patients to make lifestyle changes” | Prospective cross-sectional study | Baseline screening indicated that 86 (36%) had MetS. Using Framingham risk assessment, 20 (8.3%) ware at high risk of CHD (≥ 20 10-year risk of CHD) 87% with MetS self-reported lifestyle changes following education provided by the pharmacist No further details were provided | 239 volunteers over 18 years of with no history of coronary heart disease (CHD) | Baseline screening for MetS and Framingham 10-year risk assessment Provision of educational lifestyle intervention at baseline for all patients Provision of screening results to the physician Assessing uptake of lifestyle modifications suggested by a non-validated questionnaire | Earlier detection of Mets through the pharmacist-led screening program Earlier intervention by providing education to the patients and relevant healthcare referral (58% discussed their results with a physician) | The prevalence of MetS was higher in older adults aged 49.9 ± 17 years and those with DM or pre-DM | Facilitators Community pharmacy setting placing the pharmacist in an excellent position to provide a screening service Effective communication with physicians Patient engagement and ownership of their health Availability of POC devices Effective advertising of screening service Barriers Financial costs of consumables |
Benavides et al., 2011, Cameron [42] | “To evaluate the role of a clinical pharmacist (CP) in screening children and adolescents for components of the MetS” | Prospective, cross-sectional study | Of the 25 participants who completed the study 1 (4%) had 3 parameters of MetS, 7 (28%) had two components, and 9 (36%) had only one Treatment recommendations were made for 17 (68%) participants and communicated to the paediatrician. All were non-pharmacological interventions | High-risk children aged 10-18 years old, of Mexican–American origin in a rural ambulatory health centre | Assessing the participants for each component of MetS Educating the participants about exercise Providing the paediatrician with screening results and management recommendations | Early detection of MetS and the components in a paediatric population (68% with at least 1 MetS parameter) Enhance the early management of MetS through the provision of treatment recommendation to the physicians Increase the patient’s knowledge and awareness of MetS Prevent the progression of the disease to overt HTN and DM Referrals to physician and dietitian for further assessment | Paediatric patients with components or risk factors of MetS like obesity, first-degree family history of DM or acanthosis nigricans | Facilitators Previous experience in pharmacist running of a screening clinic Effective collaboration with the physicians Barriers Financial costs of staff and consumables Rural areas and lack of access to healthcare provision Lack of consensus on MetS definition in children and adolescents |
Hammad et al., 2011, Jordan [38] | “To describe the clinical benefits of a physician-clinical pharmacist collaboration in achieving better glycemic control and better lipid and BP measurements in patients with metabolic syndrome as defined by NCEP/ATP III guidelines” | RCT non-blinded | Of the 199 participants, when comparing the control group to the intervention group, 22 (24.7%) versus 43 (39.1%), respectively (P = 0.032) were shifted from the MetS to none-MetS status. There was a significant reduction in TG, and BP in the intervention group compared to the control group. 308 pharmacist interventions were provided to patients and physicians | High-risk patients identified at family medicine outpatient clinics | Recruit the identified patients with suspected MetS Interview patient prior to the appointment with the physician Develop individualised care plans in collaboration with physicians Provide medication and lifestyle modification education with handouts Provide recommendations to start new treatment and laboratory monitoring Provide patient follow-up | Improve MetS status amongst the participants in the intervention group by 39.1% Improve the elements of MetS in the intervention group including TG reduced by 15 mg/dL more than in the control group (P = 0.029) Improve BP reduction was significantly higher in the intervention group (SBP 12.2 ± 20 mmHg and DBP 7.2 ± 12.6 mmHg (P = 0.049) Increase the patient’s knowledge and awareness of MetS | Patients with hypertension and high triglycerides | Facilitators Effective collaboration with the physicians in assessing and managing MetS Logistical issues associated with clinic site Engaging the patient and encouraging ownership and adherence Effective patient follow-up Barriers Lack of availability of resources including pharmacist time Lack of the formal integration of the MetS screening and management protocols within the health system |
Plaster et al., 2012, Brazil [39] | “To determine the impact of a pharmaceutical care program in a sample of public outpatients with MetS” | RCT non-blinded | 96 (80%) out of 120 participants had MetS. At baseline, drug-related problems (DRPs) were identified relating to efficiency, safety and necessity. At follow up, all were improved. Improvement in the intervention group was found in all the measured parameters after 6 months from baseline. This was statistically significant for almost all parameters | Diabetic patients with MetS identified at outpatient community health centres | Baseline assessment to obtain the demographical data and identify any DRP Provide pharmaceutical interventions targeting the proper medications use and lifestyle modifications Inform the physicians of the pharmacist interventions | A significant reduction in coronary heart disease (22 ± 2 to 14 ± 2%; P < 0.01). 83% resolution and 100% improvement of the DRPs and optimization of drug treatment Increase the medications adherence indicated indirectly by the improvement of the clinical outcomes Improve BP -13 ± 3 mmHg (P < 0.05) Increase weight reduction -2.6 ± 1 kg in the intervention group | Diabetic, hypertensive obese patients | Facilitators Effective collaboration with the physicians Being a part of the multidisciplinary team (MDT) and having a defined role Adequate financial resource Applying a pre-defined pharmaceutical framework (Dáder method) Barriers Limiting the community health centre pharmacist role to dispensing Lack of resource including staff and consumables |
Kjeldsen et al., 2013, Denmark [43] | “To evaluate the effect of outreach visit by clinical pharmacists to support the implementation of screening of MetS at a psychiatric ward” | Before-and-after study | Improvement in utilisation of MetS screening sheets by 45% (from 34 (36%) to 91 (81%), P < 0.001), Better documentation of screening values 24 (26%) to 91 (81%) (P < 0.001) and better identification of MetS (9.3 (10%) versus 50 (45%), P < 0.001) | 205 Patients over 18 years with schizophrenia or affective disorders, in a psychiatric ward for at least 10 days and on antipsychotics or mood-stabilizing medicines were included in the study (93 before the outreach visit and 112 after) | Auditing physician adherence to appropriate documentation Holding a weekly conference with the physicians and nurses to discuss the audit results Providing patient-specific recommendations | Successful implementation of a psychiatric hospital-based screening program indicated as follows: Increase utilization of the screening sheets by 45% Improve the quality of the screening by 55% Earlier detection of antipsychotic-induced MetS by 35% Earlier management of the identified MetS cases amongst hospitalized psychiatric patients | Adult hospitalised patients receiving antipsychotics or mood-stabilizers | Facilitators Availability of appropriate documentation with audit for compliance Effective collaboration with the MDT, with a defined role Barriers Difficult behaviours of the psychiatric patients Lack of proper communication and/or documentation with the general practitioners in the community health centres Unavailability of the IT software to facilitate documentation and communication |
Via-Sosa et al., 2014, Spain [37] | “The main aim of the study was to determine the prevalence of pre-MetS, the secondary aims were to study the presence of other cardiovascular risk factors and determine patients’ cardiovascular risk” | Cross-sectional, descriptive study | Among the 650 screened participants, 124 (21.9%) had pre-MetS. Of the study population; 319 (49.1%) were hypertensive, 262 (40.3%) had abdominal obesity, 179 (27.5%) had high FBG, 131 (20.1%) had high TG and 109 (16.8%) had low HDL-C. 27% had not been previously diagnosed with dyslipidemia or hypertension | 18-65 year old adults who visited 23 community pharmacies to check for MetS risk factors | Screen of participants for pre-MetS and cardiovascular risk factors including patient interviews and measurement of appropriate metabolic parameters | Earlier detection of MetS through pharmacist-led screening program (27% neve diagnosed with HTN or dyslipidemia) | Men Older adults (age > 53 years old) with BMI > 25 kg/m2 Sedentary lifestyle (less than 30 min regular activity 4 to 5 times per week) | Facilitators Community pharmacy setting placing the pharmacist in an excellent position to provide a screening service Available resource such as POC devices Barriers Lack of financial support including that for staff and consumables |
Schneiderhan et al., 2014, Minnesota [40] | ”To determine the percentage of subjects taking antipsychotic agents who meet the criteria for MetS at baseline using POC test results. Secondary objectives included the following (1) evaluate the effectiveness of the prevision by pharmacist comprehensive medication management services regarding their ability to reduce the mean difference in number of MetS risk parameters based on POC test resulted at 6 and 12 months and (2) evaluate the overall impact of psychiatric medication therapy on MetS” | RCT non-blinded | At baseline of 120 participants screened, 106 (88.3%) had dyslipidemia, 63 (52.5%) were hypertensive and 27 (22.5%) were diabetic. No significant difference in MetS parameters between groups at 6 months and 12 months. No significant difference reported between parameters irrespective of antipsychotic | Patients 18 years and over, taking antipsychotic medications recruited from three community mental health clinics who had never been reviewed by a pharmacist | Baseline assessment of MetS risk factors amongst patients receiving antipsychotic medications Assessment of the safety and effectiveness of the prescribed medications Follow up of patients at regular intervals Provision of the interpretation of POC test results, care plans, and recommendations to the physician | Earlier detection of MetS through pharmacist-led screening program allowing earlier management Potential decrease drug-induced MetS amongst psychiatric patients receive antipsychotics | Psychiatric patients who are receiving antipsychotics | Facilitators Availability of the POC devices particularly due to the challenging behaviour of psychiatric patients Being a part of the multidisciplinary team (MDT) with a defined role Barriers Challenging behaviours of psychiatric patients Lack of financial support including that for staff and consumables |
Azevedo et al. 2017, Brazil [44] | “To evaluate the effectiveness of home pharmaceutical interventions in Brazilian primary care patients with MetS” | RCT non-blinded | 63 patients with MetS were enrolled in the study. 64.5% (n = 49) of pharmacists’ interventions were educational and behavioural orientation. 26.3% (n = 20) involved physician requesting review, and 9.2% (n = 7) of the cases were referred to the physician for further assessment. After 6 months follow-up, the intervention group showed a significant reduction of BP by 8%, TG by 18.7%, DRPs by 59% and adherence increment by 18.2% | Adult patients aged 18 years and over diagnosed with MetS within 30 days | Baseline assessment of both groups Monthly follow-ups of the intervention group, including the following activities: Reviewing medications, identification of DRPs that might decrease the adherence and resolving them Provide education about administration and storage Diet and lifestyle recommendations Identify any unaddressed medical problem | Improve the management of MetS and the individual components (reduction of BP by 8%, TG by 18.7%) Foster medication adherence by 18.2% Decrease the DRPs by 59% | Older patients with MetS mean age 62 years particularly if (low income and low educational level) | Facilitators Collaboration with MDT Applying standardized care pharmaceutical care plan [61] The settings of home visits Barriers No identified barriers |
Ganzer, Nicole 2015, West Palm Beach [45] | To evaluate the number of pharmacologic pharmacist interventions, assess the number of nonpharmacologic interventions, and compare the patient load post expansion to the pilot implementation of the metabolic clinic. | Quality improvement project | The initial pilot clinic had 40 referrals, of them 25 were followed up. The new expanded clinic received 28 referrals with 17 followed up. Twenty-five pharmacological (initiate new medications or dose adjustment) and 33 nonpharmacological interventions (diet and exercise) were made. Three referrals to national weight loss program and 1 referral to smoking secession were offered by the pharmacists | Adults diagnosed with MetS and on a second generation antipsychotic | Baseline assessment s for MetS Ordering and monitoring lab investigations Made required medications adjustments to the doses of psychiatric medications and, diabetes, hypertension and dyslipidemia medications Educating participants about diet and healthy life style, and referred to the national program for weight loss Advising patients to stop smoking and referral to smoking secession clinic | Potential improvement in management of MetS in psychiatric patients on second generation antipsychotics | Adults on a secondary generation antipsychotic with average age 58 years, male gender, smokers and not formally active | Facilitators Appropriate clinic set-up including facilities for referral, clinic logistics Effective advertising of screening service via in-service presentation Authority of pharmacist to initiate medications and order labs Availability of appropriate documentation Effective follow-up Barriers Lack of adherence to the clinic follow-up Lack of awareness of this service in the community Difficult behavior of psychiatric patients |
Data synthesis
Review objective 1: Description of pharmacist input
Review objective 2: Impact of pharmacist role in MetS
Review objective 3: The beneficiary population
Review objective 4: Facilitators and barriers
Schneiderhan et al., 2009 [41] | Olenak and Calpin, 2010 [36] | Benavides et al., 2010 [42] | Hammad et al., 2011 [38] | Plaster et al., 2012 [39] | kjeldsen et al., 2013 [43] | Via-Sosa et al., 2014 [37] | Schneiderhanet al, 2014 [40] | Azevedo et al. 2017 [44] | Ganzer, Nicole 2015 [45] | Total | |
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Facilitators | |||||||||||
Collaboration with MDT with a defined role for each member | ✓ | ✓ | ✓ | ✓ | ✓ | 5 | |||||
Effective communication/documentation and referral to the MDT | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 8 | ||
Appropriate setting/easy accessibility | ✓ | ✓ | ✓ | ✓ | ✓ | 5 | |||||
Patient engagement in the therapeutic plan | ✓ | ✓ | 2 | ||||||||
Positive experience with pharmacist–led activity | ✓ | 1 | |||||||||
Pharmaceutical framework adaptation | ✓ | ✓ | 2 | ||||||||
Effective follow-up | ✓ | ✓ | ✓ | ✓ | 4 | ||||||
Effective funds including; POC, advertising | ✓ | ✓ | ✓ | ✓ | ✓ | 5 | |||||
Authority to prescribe medications and order lab parameters | ✓ | 1 | |||||||||
Barriers | |||||||||||
Difficult behaviour of psychiatric patients | ✓ | ✓ | ✓ | ✓ | 4 | ||||||
Lack of funding for consumables, staff and IT software | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | 7 | |||
Rural area and lack of healthcare access | ✓ | 1 | |||||||||
No consensus on the clear MetS definition for paediatrics | ✓ | 1 | |||||||||
Lack of formal integration of protocols in the healthcare system | ✓ | 1 | |||||||||
Restricting the pharmacist to dispensing | ✓ | 1 | |||||||||
Improper documentation and ineffective communication with physicians | ✓ | 1 |