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research-article2013

AOPXXX10.1177/1060028013501802The Annals of PharmacotherapySalgado et al

Review Article

Assessing the Implementability of Clinical Pharmacist Interventions in Patients With Chronic Kidney Disease: An Analysis of Systematic Reviews

Annals of Pharmacotherapy 47(11) 1498­–1506 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1060028013501802 aop.sagepub.com

Teresa M. Salgado, MSc1, Cassyano J. Correr, PhD2, Rebekah Moles, PhD3, Shalom I. Benrimoj, PhD4, and Fernando Fernandez-Llimos, MBA, PhD5

Abstract Background: Pharmacy practice studies have been criticized for presenting poor intervention description, which has serious implications when attempting to replicate interventions elsewhere. Evidence of improved outcomes for patients with chronic kidney disease (CKD) following pharmacist intervention exist in the literature, but similar concerns with intervention description have been raised. Objective: To assess the implementability of evidence-based clinical pharmacist interventions in patients with CKD, based on the information contained in the published manuscripts. Methods: PubMed was searched to retrieve systematic reviews addressing the role of pharmacists in patients with CKD. Primary studies describing clinical pharmacy services in CKD were subsequently extracted. To describe and characterize pharmacists’ interventions, the DEPICT (Descriptive Elements of Pharmacist Intervention Characterization Tool) was applied. Studies were independently classified as “implementable” or “nonimplementable” by 2 authors, based on whether they could be easily implemented into practice using the description provided in the article. Finally, implementable interventions were grouped in different areas. Results: Five reviews were retrieved, and 39 original studies were analyzed. Of these, 59.0% were classified as nonimplementable. Among implementable interventions, 6 evidence-based areas of pharmacist interventions were identified: anemia, renal osteodystrophy, and cardiovascular risk factors management, medication appropriateness evaluation and medication reconciliation, patient education and compliance, and cost containment. Conclusions: Information contained in most articles reporting pharmacist interventions in CKD is not sufficient to ensure the implementation of the service in clinical practice. Pharmacy practice research articles should be written with the aim of improving clinical practice and not just showing the results of pharmacists’ interventions. Keywords clinical pharmacy services, chronic kidney disease, evidence-based practice, pharmacist interventions Received July 23, 2013

Introduction Evidence from the literature demonstrates that pharmacists contribute to improved patient outcomes in several medical conditions.1-5 Specifically, 2 recent systematic reviews compiled evidence for the impact of pharmacist interventions in patients with chronic kidney disease (CKD).6,7 Nevertheless, these reviews concluded that few high-quality studies had been published, study designs lacked robustness, and articles contained poor intervention descriptions to enable other practitioners to implement these pharmacist services elsewhere.6,7 Implementation has been defined as “a specified set of activities designed to put into practice an activity or program of known dimensions.”8 A more precise description was articulated by Rabin et al,9 where he described it as the integration of evidence-based interventions within a setting.

Several examples in the medical literature reveal an inadequate translation of evidence into practice.10,11 Furthermore, pharmacy practice studies have been criticized for reporting 1

Research Institute for Medicines and Pharmaceutical Sciences (iMed. UL), University of Lisbon, Portugal 2 Departamento de Farmácia, Universidade Federal do Paraná, Brazil 3 University of Sydney, NSW, Australia 4 Graduate School of Health, University of Technology Sydney, Australia 5 Research Institute for Medicines and Pharmaceutical Sciences (iMed. UL), Department of Social Pharmacy, University of Lisbon, Portugal Corresponding Author: Fernando Fernandez-Llimos, MBA, PhD, Departamento de SócioFarmácia, Faculdade de Farmacia, Universidade de Lisboa, Av Prof Gama Pinto, 1649-003 Lisbon, Portugal. Email: [email protected]

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Salgado et al inconsistently or poorly described interventions,3,12,13 which might have implications for the reproducibility of studies14 and the establishment of relationships between interventions and outcomes.15 To address the issue of poor intervention description in pharmacy practice studies, a new validated tool was developed by Correr et al.16 DEPICT (Descriptive Elements of Pharmacist Intervention Characterization Tool) is an instrument to identify the components of pharmacist interventions performed as part of clinical pharmacy services. DEPICT allows a retrospective analysis of published studies, but it also serves as a guide for pharmacist intervention design and reporting.16 The aim of this study was to identify the interventions that form part of the evidence of clinical pharmacy services in patients with CKD that could be implemented in clinical practice based on the information contained in the published manuscripts.

Methods To identify relevant articles for this study, a 2-stage strategy was employed. In the first stage, we performed a PubMed search of systematic reviews published prior to 2012 that establish the evidence of the role of pharmacists in patients with CKD. The search strategy merged 3 components: (1) “pharmacist*” as text word, (2) “renal dialysis” or “renal insufficiency” as MeSH terms, and (3) the National Library of Medicine (NLM) search strategy used to create the systematic reviews subset on PubMed.17 Because this NLM strategy retrieves contributions other than systematic reviews and meta-analyses, the following inclusion criteria were applied by 2 independent authors to select reviews: (1) the term systematic review was identified either in the title or in the abstract or (2) the article fulfilled simultaneously items 4, 7, and 9 of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) checklist (explicit statement of questions being addressed, information sources description, and process for selecting studies, respectively).18 Articles written in a script with non-Roman alphabet were excluded. In a second stage of the data-gathering process, one of the authors assessed eligibility of all original studies included in each systematic review retrieved. The following exclusion criteria were applied: (1) conference abstracts; (2) interventions of other health care professionals in other patient groups; (3) interventions of other health care professionals in patients with CKD; (4) pharmacist interventions in other conditions; and (5) no pharmacist intervention. At this point, only studies describing pharmacist interventions in patients with CKD were included. The DEPICT was applied to studies describing pharmacist interventions in patients with CKD. The tool consists of 54 items, 53 of which are designed as dichotomous

variables (yes/no) and one as a discrete variable, grouped into 12 domains: contact with the patient, timing of the intervention setting of the intervention, target population, clinical data sources, assessment, pharmacist’s autonomy, pharmacist communication, support resources provided, education, counseling, follow-up, and other actions.16 The application of the instrument to each of the studies was performed by one of the authors (TMS) and double-checked by a second author (CJC) to ensure uniformity in analysis. Following the application of DEPICT, 2 authors (TMS and CJC) independently classified studies as “implementable” or “nonimplementable.” Where there were any divergences in the classification of the studies, a third author (FF-L) reconciled the discrepancies. We defined implementability to refer to a set of characteristics that predict the ease of implementation of a given pharmacist intervention based on the information provided in the article. The following criteria developed by the research team were used to assess implementability: 1. If studies describe the implementation of a protocol to improve patient outcomes, articles should contain detailed instructions on how to adjust therapy according to clinical biomarkers. 2. If studies assess pharmacotherapy appropriateness through a process similar to medication review, articles should present or reference the medication review process and the drug information sources used. Additionally, when the nomenclature “drugrelated problems” or “medication related problems” was employed by the authors, a reference or an explanation of the classification of these problems should appear. 3. If studies focus on patient education, articles should describe or present all educational materials used (if developed by the authors of the study) or reference any previously published materials. 4. If studies are intended to promote medication compliance, articles should have a description of the compliance enhancement strategy in sufficient detail, including the provision of multicompartment compliance aids or dose schedules or the use of a checklist to standardize information provided to patients. 5. If studies comprise complex clinical pharmacy services, articles were considered implementable if all the requisites for each type of intervention were fulfilled per the previous criteria. Studies were classified as nonimplementable if the interventions conducted appeared to depend solely on the knowledge and expertise of the pharmacist without providing enough information to transfer that knowledge. In studies assessing the impact of a new practice but containing a

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Systemac reviews idenficaon

Reviews idenfied through PubMed search (n=13) Reviews excluded: Language (n=1) Not a systemac review according to PRISMA criteria (n=7) Reviews used to extract studies (n=5)

Selecon of studies included in the systemac reviews

Gallagher et al. (n=9) 19

Idier et al. (n=35) 20

Manley et al. (n=7) 21

Records screened aer duplicates removed (n=87)

Full-text arcles assessed for eligibility (n=55)

Final studies included (n=39)

Salgado et al. (n=38) 6

Stemer et al. (n=21) 7

Records excluded: Conference Abstracts (n=4) Intervenons of other HCPs in other paent groups (n=3) Intervenons of other HCPs in CKD paents (n=24) Pharmacist intervenons in other condions (n=1)

Studies excluded: Intervenons of other HCPs in other paent groups (n=3) Intervenons of other HCPs in CKD paents (n=11) Pharmacist intervenons in other condions (n=1) No pharmacist intervenon (n=1)

Figure 1.  Flowchart illustrating the search strategy and results.

Abbreviations: PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-analyses; CKD, chronic kidney disease; HCPs, health care professionals.

description of the usual practice of the pharmacists, implementability was only assessed for the interventions included in the new practice. Both implementable and nonimplementable studies were subsequently grouped into areas of intervention within CKD according to the intervention target outcomes and outcomes reported in the article.

Results Characterization of Studies The first stage of the analysis (identification of systematic reviews) retrieved 13 records, of which 5 were included after application of the exclusion criteria.6,7,19-21 The interrater agreement at this stage yielded a Cohen’s κ of 0.824, which denotes an “almost perfect” agreement.22 In the

second stage, the pool of articles of interest was extracted from the 5 systematic reviews included after deleting duplicates and applying exclusion criteria. A total of 39 articles were included in the final analysis23-61 (Figure 1). The 39 studies included were published between 1983 and 2009. The studies were conducted in the United States (n = 26), New Zealand (n = 2), India (n = 2), Canada, China, Colombia, France, Japan, Malaysia, Spain, Taiwan, and the United Kingdom (1 study each). Per the design of studies, 30 (77%) were uncontrolled, and 9 (23%) were controlled. The retrospective application of DEPICT revealed that studies reporting pharmacist interventions in patients with CKD were mostly conducted in the ambulatory (82.1%) or hospital (17.9%) settings through face-to-face contacts with patients (74.4%). Pharmacists assessed predominantly the process of medication use (92.3%), health outcomes (71.8%), and costs of treatment (33.3%). The intervention

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Salgado et al additionally included the provision of patient education and counseling in 51.3% of the studies. To support their interventions, pharmacists used the patient’s medical record as the principal clinical data source (92.3%), but patient interviews were also conducted (46.2%). In 20.5% of the studies, the pharmacist had autonomy to change, suspend, or start a new medicine as well as to order laboratory tests on the basis of protocols previously developed in collaboration with the renal care team. Online appendix 1 presents all the results from the application of DEPICT to the studies analyzed. Of the 39 studies, 16 (41.0%) were considered implementable23-38 and 23 (59.0%) nonimplementable,39-61 with a Cohen’s κ of interrater agreement of 0.726 (substantial agreement).22

Implementable Pharmacist Interventions In all, 6 evidence-based areas of implementable pharmacist interventions were identified: anemia management, renal osteodystrophy management, cardiovascular risk factors management, medication appropriateness evaluation and reconciliation, patient education and compliance, and cost containment. Below is a description of the potential portfolio of services ready for implementation based on the information contained in the articles. Anemia management.  Four studies described anemia management by pharmacists in patients undergoing hemodialysis, and all these articles contained sufficient information to put the intervention into practice.28,29,31,34 All these studies presented the anemia-managing protocol created by the multidisciplinary team to grant autonomy to the pharmacist to initiate, change, or withdraw erythropoiesis-stimulating agents and iron doses as a function of specified target levels of hemoglobin, hematocrit, ferritin, and transferrin saturation. The pharmacist could also order monthly laboratory tests to guide dose adjustments. Overall, the results showed a nonsignificant increase in mean hematocrit,29 hemoglobin,34 transferrin saturation,29,34 ferritin,34 and percentage of patients with an initial hemoglobin greater than 11 g/dL34 and a decrease in the percentage of patients with hematocrit lower than 31%.28 Renal osteodystrophy management. Two implementable studies were also found for the area of renal osteodystrophy.26,37 Both studies presented the phosphate management protocols developed by the dialysis center multidisciplinary team to allow pharmacists to autonomously adjust the doses of phosphate binders and vitamin D analogs. The protocol also informed the most adequate type of phosphate binder (calcium or non–calcium containing) to be used in each situation. Monthly routine laboratory tests were requested by the pharmacist, and these included the following: serum

phosphate, serum calcium, and intact parathyroid hormone levels. Significant improvements were seen in serum phosphate levels and the calcium-phosphate product.37 There was an overall decrease in the number of patients with secondary hyperparathyroidism, and there were a significantly smaller number of patients with moderate to severe hyperparathyroidism.26 Cardiovascular risk factors management. Two other implementable studies were found in this area.30,33 One of these studies described a multidisciplinary program for achieving lipid goals in patients undergoing hemodialysis.30 The study presented the protocol developed for lipid management through which the pharmacist received permission to prescribe statins and make dosage adjustments. In addition, pharmacists ordered lipid profile laboratory tests such as total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglyceride levels. Pharmacist interventions resulted in significant improvements in total cholesterol, LDL cholesterol, and the percentage of patients reaching target LDL. Another study described the integration of the pharmacist within a diabetes specialists team caring for patients with type 2 diabetes with some degree of nephropathy.33 The pharmacist evaluated the patients’ medication compliance based on their self-report and reinforced the importance of medication compliance. Pharmacists also made recommendations to physicians regarding dosage regimens to maximize adherence, either verbally or via documentation in medical records. Significant improvements in total and LDL cholesterol and systolic and diastolic blood pressure were attained. Medication appropriateness evaluation and reconciliation. Three studies evaluating medication appropriateness24,32,38 and one describing medication reconciliation36 were considered implementable. One study classified patients as having renal insufficiency or renal failure on the basis of a definition contained in a reference book cited in the article.24 Subsequently, the authors provided a list of drugs primarily eliminated by the kidneys, on which the pharmacist had to focus when assessing pharmacotherapy appropriateness, and referenced the drug information sources used to assess doses appropriate to renal function. Finally, the authors provided the template of the form used to document the pharmacist evaluation.24 A second study assessed the rate of inappropriate dosing in hospitalized patients with CKD.38 Pharmacists’ recommendations were based on the information contained in a handbook prepared for the study, which compiled information from 5 different drug information sources specified in the article. The authors also created a standardized form for data collection, and even though it was not presented in the article, all the information contained in this form was described.38 In both

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studies, several dose adjustments were performed after the pharmacist recommendations,24,38 and both adverse drug events and clinicians’ noncompliance with dosing guidelines decreased.38 A third study detailed and cited the method of medication follow-up involving 9 activities to improve medication appropriateness in renal transplant patients.32 The study describing the impact of medication reconciliation in patients undergoing hemodialysis at the time of patient transfer from an in-center to a satellite dialysis unit explained how the pharmacist gathered a comprehensive medication history and ensured that all transfer orders were consistent with what the patient was actually taking. In the report, the authors clearly articulated different sources of information used by pharmacists to confirm the actual medication being taken by patients. The results revealed that almost 80% of the patients had at least 1 unintended medication discrepancy.36 Patient education and compliance.  Two implementable studies were identified in this area.23,35 A study described a 9-stage self-administration medication program for postrenal transplant patients. An in-depth description of the educational program was provided as well as all the written materials handed out to patients and the assessment questionnaire. The results illustrated a significant improvement in patient medication knowledge and retention of information over a 1-month period.23 Another study explained how pharmacists used the instructions provided by the manufacturer to provide information and training on erythropoietin injection devices as well as medical and therapeutic information regarding renal insufficiency and anemia.35 The training program resulted in improvement in patient knowledge after 3 months, the attainment of the hemoglobin target during the second month of treatment, and in 80% of patients having a mean level of 90% compliance in medication taking.35 Cost containment.  Considerable cost savings were generated after the implementation of the previously mentioned anemia-managing protocols through the promotion of a more rational use of epoetin.28,31,34 Another implementable study in the anemia area described the endorsement of a protocol by the pharmacy department, which promoted the intravenousto-subcutaneous switch and reduced the mean weekly dose of erythropoietin.25 This resulted in a decrease in expenditure of US$172 220 over 4 years, without affecting hematological parameters.25 Two other studies explained how the preparation of individual doses of epoetin alfa28 and intravenous calcitriol26 by the pharmacy department could result in significant cost savings when compared with the in-ward preparation from single-dose vials by nurses. Cost avoidance in these 2 studies were estimated as US$1 018 638 in 4 years28 and US$43 986 over a year,26 respectively.

One of the previously mentioned studies in which pharmacists assessed the rate of inappropriate dosing38 generated a drug cost avoidance of US$2250 in 4 months. Another study reported that pharmacists could assist patients entering a medication assistance program to obtain immunosuppressants from the pharmaceutical manufacturers and contribute to a yearly cost avoidance of US$124 793.27

Discussion Our study sought to characterize clinical pharmacy services provided to patients with CKD and to assess their implementability in clinical practice. It was outside the scope of our work to analyze the quality of the design of the studies included. The aim of our investigation was to determine whether methods in studies included in systematic reviews providing evidence for a role for pharmacists in caring for patients with CKD could be implemented in another health care facility based only on the information described in the article. We chose to perform a “systematic review of systematic reviews” because this research strategy is recommended for topics on which a substantial amount of evidence exists even though this evidence is controversial.62 The retrospective application of DEPICT16 allowed discrimination of the intervention components performed as part of clinical pharmacy services. To ensure a robust analysis, the classification as implementable or nonimplementable studies was carried out independently by 2 researchers and resulted in substantial agreement. Of the 39 studies constituting the evidence in this area, nearly 60% were considered nonimplementable because the description of the pharmacist intervention provided in the article would not be sufficient to reproduce the intervention in clinical practice. Poor intervention description in pharmacy practice studies has long been recognized,14,15,63,64 and this has had serious implications when attempting to compile evidence of clinical pharmacy services in systematic reviews and meta-analyses.3,4,12,13,65-67 Our study demonstrated that DEPICT is a useful instrument to use in retrospective analyses of published studies. Furthermore, as advocated by the authors, it also appears to be a helpful guide to researchers to prompt them to articulate sufficient detail of pharmacist intervention components.16 However, this exhaustive description may be difficult for researchers to document because of word count limitations in many scientific journals. Nevertheless, most international journals nowadays offer the possibility of publishing online appendices.68 Therefore, the inclusion of all the information required to describe a clinical pharmacy service in-depth, such as therapeutic protocols, educational programs, or any other materials, should not be a major issue. Journal editors and peer reviewers play a key role in ensuring that only studies with an appropriate description of the pharmacist intervention are published. This would

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Salgado et al enable pharmacists around the world to implement innovative evidence-based practices within their own facilities. Several of the studies included in our work did not report changes in patient health outcomes as a result of the pharmacist intervention but only reported changes in intermediate process measures.24,32,36,39-43,46-48,50,56,60 Most of these studies were also classified as nonimplementable39-43,46-48,50,56,60 because all of them described pharmacist-led medication reviews without describing the method of medication review or the drug information sources used. Previous authors have highlighted the need for an evidence-based practice when conducting medication reviews.69 Lack of definition of the method of medication review can lead to misinterpretation when comparing results from different studies. This was evident when 2 different teams who apparently described the same service—medication review—achieved discrepant results in terms of outcomes.70-73 Some of the studies describing patient education programs lacked information regarding the educational program structure and content, materials provided to patients, and drug information sources used to structure patient counseling.44,54,59 Patient education strategies must be reported with an in-depth description of the entire educational program and materials to ensure reproducibility and sustainability of the service.74 On the other hand, we identified implementable studies23-38 in several areas of pharmacist interventions in patients with CKD. These studies provided protocols26,28-31,34,37 and educational materials23,35 and reported the information sources used to assess medication appropriateness.24,32,38 These detailed descriptions allow the implementation of these services in future studies without the need to contact the authors. In addition, using the information contained in these articles would be sufficient to create an intervention manual for clinical pharmacists working with patients with CKD. As practical implications of our study, we highlight the need for clear and thorough reporting of pharmacist interventions, providing a description of all the materials and procedures constituting the structure and process elements of the service. Research should be oriented toward the improvement of the clinical practice and not just on increasing the number of articles showing the results of pharmacists’ interventions in patient outcomes. An article that demonstrates the benefit of a given pharmacist intervention should also provide the complete details to allow the implementation of that intervention. A limitation of our study is the small number of studies analyzed. However, we gathered all the evidence available in systematic reviews of pharmacists’ interventions in the area of CKD.

Conclusions The literature provides evidence for a role for pharmacists in caring for patients with CKD. However, nearly 60% of the

studies were considered nonimplementable because the information available was not sufficient to ensure the replication of the intervention in clinical practice. Among studies considered implementable, 6 evidence-based areas of pharmacist interventions were identified in patients with CKD: anemia management, renal osteodystrophy management, cardiovascular risk factors management, medication appropriateness evaluation and reconciliation, patient education and compliance, and cost containment. Pharmacy practice research should be conducted and reported with the aim of improving the clinical practice, and journal editors and peer reviewers play a key role in ensuring the implementability of the interventions reported in published manuscripts. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Fundaçao para a Ciencia e a Tecnologia (Foundation for Science and Technology), Ministry of Education and Science, Portugal, Doctoral Grant Reference Number SFRH/BD/43999/2008.

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Assessing the implementability of clinical pharmacist interventions in patients with chronic kidney disease: an analysis of systematic reviews.

Pharmacy practice studies have been criticized for presenting poor intervention description, which has serious implications when attempting to replica...
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