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Research Designs and Methodologies Related to Pharmacy Practice

The need for evidence to inform policy and practice in pharmacy is becoming increasingly important. In parallel, clinical pharmacy and practice research is evolving. Research evidence should be used to identify new areas for improved health service delivery and rigorously evaluate new services in pharmacy. The generation of such evidence through practice-based research should be predicated on appropriate use of robust and rigorous methodologies. In addition to the quantitative and qualitative approaches used in pharmacy practice research, mixed methods and other novel approaches are increasingly being applied in pharmacy practice research. Approaches such as discrete choice experiments, Delphi techniques, and simulated client technique are now commonly used in pharmacy practice research. Therefore, pharmacy practice researchers need to be competent in the selection, application, and interpretation of these methodological and analytical approaches. This chapter focuses on introducing traditional and novel study designs and methodologies that are particularly pertinent to contemporary clinical pharmacy and practice research. This chapter will introduce the fundamentals and structures of these methodologies, but more details regarding the different approaches may be found within the Encyclopedia.

Learning Objectives

• Discuss the value of pharmacy practice research to evidence-based practice and policy.
• Describe the classifications and types of study designs commonly used in pharmacy practice research.
• Discuss the concepts and structure of common study designs used in pharmacy practice research including experimental, quasi-experimental, observational, qualitative, and mixed method designs.
• Discuss the important considerations for conducting pharmacy practice research in terms of study design, data collection, data analyses, and ethical considerations.

Introduction to Research Methodologies Used in Pharmacy Practice

The mission of pharmacy profession and the role of pharmacists in healthcare have evolved toward patient-centered care in the last few decades. Pharmacists with their expertise in drug therapy and accessibility to the public have unprecedented opportunities to assume increasing responsibility for direct patient care ( Bond, 2006 ). New cognitive pharmaceutical services and new roles for pharmacists continue to emerge.

In the era of evidence-based practice and health services, it is not just adequate to propose those new pharmacy services or new roles without evidence of their benefit ( Awaisu and Alsalimy, 2015 , Bond, 2006 ). New pharmacy services and new roles must be proven to be feasible, acceptable, cost-effective, and increase health outcomes. Pharmacy practice research provides such evidence and can confirm the value of a new service, inform policy, and result in practice changes ( Bond, 2006 , Chen and Hughes, 2016 ). Research evidence should be used to identify new areas for improved health service delivery and rigorously evaluate new services. The research used to generate such evidence should be grounded in robust and rigorous methodologies ( Chen and Hughes, 2016 ). Traditionally, common quantitative and qualitative methods such as randomized controlled trials, cohort study, case control study, questionnaire-based surveys, and phenomenology using qualitative interviews have been used in pharmacy. However, in recent years, novel and more complex methods are being developed and utilized. Pharmacy practice researchers need to know how these old and new methodological approaches should be selected, applied, and interpreted in addressing research problems.

Various study designs, including, but not limited to experimental, quasi-experimental, observational, qualitative, and mixed method designs, have been used in pharmacy practice research. Furthermore, different classification systems (e.g., quantitative vs. qualitative, experimental vs. observational, descriptive vs. analytical study designs) have been used in the literature. The choice of a study design to answer a research question in pharmacy practice research is driven by several factors, including the type of the research question or the research hypothesis, expertise of the investigator, availability of data, and funding opportunities. Pharmacy practice researchers need to be competent in the selection, design, application, and interpretation of these methodological and analytical approaches. Today, many of the research methods used in pharmacy practice research have been adapted from fields such as sociology, anthropology, psychology, economics, and other disciplines. This paradigm shift has led to a greater emphasis on the appropriate choice of a specific research design or method to answer a specific research question ( Chen and Hughes, 2016 ). Consequently, pharmacy practice researchers should place an emphasis on the reliability of the methods selected, the correct interpretation of their findings, the testing of a specific hypothesis, and the internal validity of their data, among other considerations. Novice and early career researchers should be familiar and have sound foundation in a variety of methods applied in pharmacy practice research, which will be covered in this chapter and other chapters in this Encyclopedia. We do believe that more experienced researchers should focus on certain methods in order to advance research in our discipline.

Core Quantitative and Qualitative Approaches Used in Pharmacy Practice Research

Traditionally, core quantitative approaches used in pharmacy practice research include nonexperiments, quasi-experimental designs, and true experimental designs such as prospective randomized controlled intervention trials. Nonexperiments also include observational study designs that are often described as pharmacoepidemiologic study designs such as case–control study, cohort study, nested case–control study, and cross-sectional study ( Etminan, 2004 , Etminan and Samii, 2004 ). In recent years, conventional qualitative approaches and their philosophical paradigms are increasingly been used in pharmacy. These include the five qualitative approaches to inquiry: narrative research, phenomenology, grounded theory, ethnography, and case study. These qualitative methods are often difficult for pharmacy practice researchers to comprehend, and researchers tend to describe the methods of data collection such as individual interviews and focus group discussions as qualitative methods of inquiry. These data collection methods are briefly described later in this chapter, among others. Furthermore, there is an increasing importance on the appropriate selection and use of mixed method approach ( Hadi et al., 2013 ; Hadi and Closs, 2016a , Hadi and Closs, 2016b ), which are often designed and applied wrongly. Finally, it is worthwhile to be familiar with novel research methodologies such as discrete choice experiments, Delphi techniques, simulated client technique, and nominal group techniques, which fall between quantitative and qualitative approaches, often with no clear differentiation on where they belong. Although called “novel” in the context of this chapter, these methods are not new in other relevant disciplines, but new and not commonly used in pharmacy practice research.

Research Question and Selection of Study Design

Pharmacy practice researchers begin by conception of a research idea or identifying a research question and defining a hypothesis based on the question. The researcher then selects a study design that will be suitable to answer the research question. The study design should be appropriately selected prior to initiation of any research investigation. Selecting an inappropriate study design may potentially undermine the validity of a study in its entirety. Investigators are encouraged to critically think about the possible study designs to ensure that the research question is adequately addressed and should be able to adequately justify their choice. These study designs have been variously classified and one common classification system is quantitative vs. qualitative study designs. Study designs play a major role in determining the scientific value of research studies. Inappropriate choice of a study design is impossible to correct after completion of the study. Therefore, thorough planning is required to avoid unconvincing results and invalid conclusions. Good understanding of basic study design concepts will aid researchers in conducting robust and rigorous practice-based research. This chapter introduces the structure and the fundamentals of common study designs used in pharmacy practice research and discusses the important considerations for conducting pharmacy practice research in terms of study design, data collection, data analyses, and ethical considerations.

Classification of Research Methodologies Used in Pharmacy Practice

Various classifications for research designs and methods used in pharmacy practice have been used in the literature. The following are some of the approaches for the classification of research designs:

Case example: Investigators were looking for the association between acute myocardial infarction and smoking status, type of tobacco, amount of smoke, etc. ( Teo et al., 2006 ). Another example of a case–control study from published literature is the study investigating the association between the use of phenylpropanolamine and the risk of hemorrhagic stroke ( Kernan et al., 2000 ).

Case example: Investigators were interested to determine the long-term effectiveness of influenza vaccines in elderly people; they recruited cohorts of vaccinated and unvaccinated community-dwelling elderly ( Nichol et al., 2007 ).

Case example: A case report was written by a physician who contracted Severe Acute Respiratory Syndrome (SARS) during an outbreak in Hong Kong ( Wu and Sung, 2003 ). Another example is an ecological study examining diet and sunlight as risks for prostate cancer mortality ( Colli and Colli, 2006 ). Chim et al. conducted a large population-based survey in Australia to determine what community members think about the factors that do and should influence government spending on prescribed medicines ( Chim et al., 2017 ).

Case example: A group of investigators carried out a study to establish an association between the use of traditional eye medicines (TEM) and corneal ulcers. In this case, both case–control and cohort study designs are applicable. In an example of a case control study, Archibugi et al. aimed to investigate the association between aspirin and statin exclusive and combined and pancreatic ductal adenocarcinoma occurrence ( Archibugi et al., 2017 ). Another example of a cohort study is a study carried out by Wei et al. in which they investigated whether or not acid-suppression medicines increased the risk of bacterial gastroenteritis ( Wei et al., 2017 ).

Case examples: Investigators conducted a study about the newer versus older antihypertensive agents in African hypertensive patients (NOAAH) trial (nct01030458) to compare the efficacy of single-pill combinations of newer versus older antihypertensive agents (i.e., a single-pill combination of newer drugs, not involving a diuretic, with a combination of older drugs including a diuretic) ( Odili et al., 2012 ). In a crossover design, a group of investigators evaluated the effect of spironolactone on nonresolving central serous chorioretinopathy ( Bousquet et al., 2015 ).

Case examples: Prashanth et al. aimed to understand if (and how) a package of interventions targeting primary health centers and community participation platforms affect utilization and access to generic medicines for people with noncommunicable diseases using quasi-experimental design approach ( Prashanth et al., 2016 ).

c. Observational design—It involves only observation of natural phenomena and does not involve investigator intervention. Typically, this study design investigates associations and not causation. Examples include cohort study and case–control study. These studies can explore an association between a pharmacologic agent and a disease of interest. Case examples: Please see previous examples of these.

Case examples: Please see experimental studies, and case–control and cohort study designs.

Case examples: Investigators in Canada explored the lived experiences of youth who are prescribed antipsychotics by conducting interpretative phenomenology study ( Murphy et al., 2015 ).

Case examples: Shiyanbola et al. combined focus group discussion with a survey tool to investigate patients' perceived value and use of quality measures in evaluating and choosing community pharmacies ( Shiyanbola and Mort, 2015 ).

Below is a brief description of traditional and novel pharmacoepidemiologic study designs. Several examples of pharmacoepidemiologic study designs are provided above. Some descriptive studies including case reports, case series, and ecological studies will not be described in this chapter.

a. Case–control studies—In this design, patients (those who develop the disease or outcome of interest) are identified and control patients (those who do not develop the disease or outcome of interest) are sampled at random from the original cohort that gives rise to the cases ( Etminan and Samii, 2004 , Newman et al., 2013 ). The distribution of exposure to certain risk factors between the cases and the controls is then explored, and an odds ratio (OR) is calculated.
b. Cohort studies—This can be described as a study in which a group of exposed subjects and a group of unexposed subjects are followed over time and the incidence of the disease or outcome of interest in the exposed group is compared with that in the unexposed group ( Etminan and Samii, 2004 , Hulley et al., 2013 ).
c. Case-crossover studies—The case-crossover may be considered comparable to a crossover randomized controlled trial in which the patients act as their own control ( Etminan and Samii, 2004 ). Pattern of exposure among the cases is compared between event time and control time. The between-patient confounding that occurs in a classic case-control study is circumvented in this design. Tubiana et al. evaluated the role of antibiotic prophylaxis and assessed the relation between invasive dental procedures and oral streptococcal infective endocarditis, using a nationwide population-based cohort and a case-crossover study design ( Tubiana et al., 2017 ).
d. Case–time control studies—This design is an extension of the case-crossover design, but includes a control group ( Etminan and Samii, 2004 ). A group of researchers assessed medication-related hospitalization. They used the case–time control study design to investigate the associations between 12 high risk medication categories (e.g., antidiabetic agents, diuretics, benzodiazepine hypnotics) and unplanned hospitalizations ( Lin et al., 2017 ).
e. Nested case–control studies—In this design, a cohort of individuals is followed during certain time periods until a certain outcome is reached and the analysis is conducted as a case–control study in which cases are matched to only a sample of control subjects ( Etminan, 2004 ). de Jong et al. examined the association between interferon-β (IFN-β) and potential adverse events using population-based health administrative data in Canada ( De Jong et al., 2017 ).
f. Cross-sectional studies—In this type of study, the investigator measures the outcome of interest and the exposures among the study participants at the same time ( Hulley et al., 2013 , Setia, 2016b ). It provides a snapshot of a situation for a particular period.

Quantitative Research Designs in Pharmacy Practice

A wide range of quantitative methods are commonly applied in pharmacy practice research. These methods are widely used in published pharmacy practice literature to explore appropriateness of medicines use, appropriateness and quality of prescribing, and medication safety, through analyzing existing datasets, direct observation, or self-report ( Green and Norris, 2015 ). Pharmacy practice research questions also seek to determine the knowledge, behaviors, attitudes, and practices of pharmacists, other healthcare providers, patients, policy-makers, regulators, and the general public. Quantitative methods are also used in evaluating the effect of new pharmacy services and interventions to improve medicines use. These practice research projects provide valuable insights about how medicines are used, and how to maximize their benefits and minimize their harmful effects. In the context of this chapter, quantitative study designs will be broadly classified into three: (1) observational, (2) experimental and quasi experimental, and (3) other designs.

Observational Study Designs

Pharmacoepidemiology is a “relatively new science that explores drug efficacy or toxicity using large observational study designs” ( Etminan, 2004 , Etminan and Samii, 2004 ). These study designs explore drug use studies that usually cannot be answered using randomized controlled trials or other experimental designs. In several instances, experimental study designs may not be suitable or feasible; in such circumstances, observational study designs are applied ( Cummings et al., 2013 ). As the name implies, observational studies involve merely observing the subjects in a noncontrolled setting, without investigator intervention or manipulating other aspects of the study. Therefore, observational studies are nonexperimental. The observation of the variables of interest can be prospective, retrospective, or current depending on the type of the observational study.

In pharmacoepidemiology and other areas of pharmacy practice, researchers are often interested in measuring the relationships between exposure to a drug and its efficacy, toxicity, or other outcomes of interest using observational study designs. It is worthwhile to note that observational study designs investigate association, but, in most cases, not causation. Here, we provide descriptions of some commonly used study designs in pharmacoepidemiology and pharmacy practice research in general.

Case–Control Studies

Case–control study design is used to determine association between risk factors or exposures and outcomes. It is a useful design to study exposures in rare diseases or diseases that take long time to develop ( Newman et al., 2013 ). It investigates exposures in individuals with and those without the outcome of interest. Nevertheless, case–control studies can help to identify harmful or beneficial exposures. Furthermore, the outcome of interest can be undesirable (e.g., mortality) or desirable (e.g., microbiological cure). As the name suggests, in a case–control study design, there are two groups of subjects: (1) cases (individuals with the outcome of interest) and (2) controls (individuals without the outcome of interest) ( Newman et al., 2013 ). Cases are randomly selected based on prespecified eligibility criteria from a population of interest. Appropriate representative controls for the cases selected are then identified. The researchers then retrospectively investigate possible exposures to the risk factor. Fig. 1 represents a schematic diagram of a case–control study.

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Case–control study design.

Case–control studies are relatively inexpensive, less time-consuming to conduct, allow investigation of several possible exposures or associations, and are suitable for rare diseases. Selection of the control group is a critical component of case–control studies. Case–control studies have several drawbacks: confounding must be controlled, subject to recall, observation, and selection biases.

OR is the measure of association used for the analysis of case–control studies. This is defined as the odds of exposure to a factor in those with a condition or disease compared with those who do not have the condition or disease.

Cohort Studies

Similar to case–control studies, cohort studies determine an association between exposures/factors and development of an outcome of interest. As previously described, a cohort study is a study in which a group of exposed subjects and a group of unexposed subjects are followed over time to measure and compare the rate of a disease or an outcome of interest in both groups ( Etminan and Samii, 2004 , Hulley et al., 2013 ). A cohort study can be prospective (most common) or retrospective. While a case–control study begins with patients with and those without the outcome of interest (e.g., diseased and nondiseased patients), a cohort study begins with exposed and unexposed patients (e.g., patients with and those without certain risk factor) ( Hulley et al., 2013 , Setia, 2016a ). In a cohort study, both the exposed and the unexposed subjects are members of a larger cohort in which subjects may enter and exit the cohort at different periods in time ( Etminan and Samii, 2004 , Hulley et al., 2013 ).

Typically, a cohort study should have a defined time zero, which is defined as the time of entry into the cohort ( Etminan and Samii, 2004 ). The cohort (a group of exposed and unexposed subjects, who are free of the outcome at time zero) is followed for a certain period until the outcome of interest occurs. In addition, information or data related to all potential confounders or covariates should also be collected as failure to account for these can bias the results and over- or underestimates the risk estimate. There are two types of cohort studies: retrospective cohort and prospective cohort studies.

Retrospective cohort study, also known as historical cohort study, begins and ends in the present, while looking backward to collect information about exposure that occurred in the past ( Fig. 2 ). Historical cohort studies are relatively less time-consuming and less expensive than prospective cohort studies ( Etminan and Samii, 2004 , Hulley et al., 2013 , Setia, 2016a ). In addition, there is no loss to follow-up and researchers can investigate issues not amenable to intervention study designs. However, these studies are only as good as the data available, the investigator has limited control of confounding variables, and it is prone to recall bias.

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Retrospective (historical) cohort study design.

On the other hand, prospective cohort study, also known as longitudinal cohort study, begins in the present and progresses forward, collecting data from enrolled subjects whose outcomes fall in the future ( Etminan and Samii, 2004 , Hulley et al., 2013 , Setia, 2016a ) ( Fig. 3 ). Prospective cohort studies are easier to plan for data collection, have low recall bias, and the researcher has a better control of confounding factors. On the other hand, it is difficult to study rare conditions; they are more prone to selection bias, more time-consuming, expensive, and loss of subjects to follow-up is common.

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Prospective (longitudinal) cohort study design.

Relative risk (RR) is the measure of association used for the analysis of a cohort study. This is defined as the risk of an event or development of an event relative to exposure (i.e., the risk of subjects developing a condition when exposed to a risk factor compared with subjects who have not been exposed to the risk factor).

Case-Crossover Studies

This is a relatively new design in the field of epidemiology in which the patients act as their own controls ( Maclure, 1991 ). In this design, there is a case and a control element both of which come from the same subject. In other words, each case serves as its own control. It can be considered equivalent to a crossover RCT with a washout period ( Etminan and Samii, 2004 ). Pattern of exposure to the risk factor is compared between the event time and the control time ( Etminan and Samii, 2004 ). Case-crossover study design is useful to investigate triggers within an individual. For instance, it is applicable when studying a transient exposure or risk factor. However, determination of the period of the control and case components is a crucial and challenging aspect of a case-crossover study design. Since the patients serve as their own controls, the interindividual variability that is inherent in classic case–control studies is eliminated. This is important in studies involving progressive disease states in which disease severity may differ between patients such as multiple sclerosis. OR is estimated using techniques such as Mantel–Haenszel statistics and logistic regression.

Cross-Sectional Studies

Cross-sectional studies also known as prevalence studies identify the prevalence or characteristics of a condition in a group of individuals. This design provides a snapshot of the prevalence or the characteristics of the study subjects in a single time point. The study investigator measures the outcomes and the exposures in the study subjects simultaneously ( Etminan and Samii, 2004 , Hulley et al., 2013 , Setia, 2016b ). Hence, cross-sectional studies do not follow up patients to observe outcomes or exposures of interest. Data are often collected through surveys. Cross-sectional design cannot provide cause and effect relationships between certain exposures and outcomes of interest.

Experimental and Quasi-Experimental Study Designs

In a typical experimental study design, the investigator assigns subjects to the intervention and control/comparison groups in an effort to determine the effects of the intervention ( Cummings et al., 2013 ). Since the investigator has the opportunity to control various aspects of the experiment, this allows the researcher to determine the causal link between exposure to the intervention and outcome of interest. The researcher either randomly or conveniently assigns the subjects to an experimental group and a control group. When the investigator performs randomization, the study is considered a true experiment (see Fig. 4 ). On the other hand, if subjects are assigned into groups without randomization, the study is considered a quasi-experiment (refer to Fig. 5 ). As with experimental designs, quasi-experimental designs also attempt to demonstrate a causal link between the intervention and the outcome of interest. Due to the challenges of conducting a true experimental design, the quasi-experimental study designs have been consistently used in pharmacist intervention research.

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True experimental study design.

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Quasi experimental study design.

RCTs are considered the gold standard of experimental study designs in pharmacy practice and evidence-based research ( Cummings et al., 2013 ). The investigator randomly assigns a representative sample of the study population into an experimental group and a control group ( Fig. 4 ). Randomization in RCT is to minimize confounding and selection bias; it enables attainment of similar experimental and control groups, thereby isolating the effect of the intervention. The experimental group receives the treatment or intervention (e.g., a new drug or pharmaceutical care for treatment of a certain disease), while the control group receives a placebo treatment, no treatment, or usual care treatment depending on the objective of the study ( Cummings et al., 2013 ). These groups are then followed prospectively over time to observe the outcomes of interest that are hypothesized to be affected by the treatment or intervention. The result of the study is considered to have high internal validity if significant changes on the outcome variable occur in the experimental group, but not the control group. The investigator can infer that the treatment or intervention is the most probable cause of the changes observed in the intervention group. The unit of randomization in RCTs is usually the patient, but can sometimes be clusters to circumvent the drawbacks of contamination.

RCTs are very challenging to undertake and pharmacy practice researchers should ensure design of robust experiments, while considering all essential elements and adhering to best practices. For instance, to determine the impact of a cognitive pharmaceutical service, the selection of a representative sample of the population is a prime consideration in an RCT. Moreover, RCTs are expensive, labor-intensive, and highly prone to attrition bias or loss to follow-up.

In pharmacy practice research, it is often difficult to comply with the stringent requirements of true experimental designs such as RCTs, due to logistic reasons and/or ethical considerations ( Grady et al., 2013 , Krass, 2016 ). Whenever true experimental models are not feasible to be applied in pharmacy practice research, the researcher should endeavor to use a more robust quasi-experimental design. For instance, when randomization is not feasible, the researcher can choose from a range of quasi-experimental designs that are non-randomized and often noncontrolled ( Grady et al., 2013 , Krass, 2016 ). Quasi-experimental studies used in pharmacy literature may be classified into five major categories: (1) quasi-experimental design without control groups (i.e., one group pre–posttest design); (2) quasi-experimental design that use control groups with no pretest; (3) quasi-experimental design that use control groups and pretests (i.e., nonequivalent control group design with dependent pretests and posttests) (see Fig. 5 ); (4) interrupted time series and; (5) stepped wedge designs ( Brown and Lilford, 2006 , Grady et al., 2013 , Harris et al., 2006 ).

The one group pretest posttest design and the nonequivalent control group design ( Fig. 5 ) are the most commonly applied quasi-experimental designs in practice-based research literature. These designs have been commonly used to evaluate the effect of pharmacist interventions in medications management in general and specific disease states management. The lack of randomization and/or the lack of control group is a major weakness and a threat to internal validity in quasi-experimental designs ( Grady et al., 2013 ). The observed changes could be due to some effects other than the treatment.

Other Quantitative Study Designs

In addition to the common observational, experimental, and quasi-experimental designs described above, there are other designs that are used in pharmacy. These research methods include, but are not limited to, simulated client technique, discrete choice experiments, and Delphi techniques. These methods, which are considered relatively new to pharmacy, are now commonly used in pharmacy practice research. In this chapter, we briefly describe these methods and their application in pharmacy. However, a more detailed description of their components and the nitty gritty of their application in pharmacy practice are available elsewhere within this textbook.

Simulated Client Method

The use of simulated client or simulated patient (mystery shopper) method to assess practices or behaviors in pharmacy practice has received much attention in recent times ( Watson et al., 2004 , Watson et al., 2006 ). “A simulated patient is an individual who is trained to visit a pharmacy (or drug store) to enact a scenario that tests a specific behavior of the pharmacist or pharmacy staff” ( Watson et al., 2006 ). A review by Watson et al. demonstrated the versatility and applicability of this method to pharmacy practice research in both developing and developed countries ( Watson et al., 2006 ). The investigators also identified some important characteristics that should be taken into consideration in designing studies that use this technique.

This method can be used to assess wide range of cognitive pharmacy services including counseling and advice provision, treatment of minor ailments, provision of nonprescription medicines, and public health pharmacy, among other things. This method can be a robust and rigorous method of assessing pharmacy practice if used appropriately ( Watson et al., 2006 , Xu et al., 2012 ). More recent developments have documented that the simulated patient methods have been used to provide formative feedback in addition to assessing practice behavior of pharmacists and their staff ( Xu et al., 2012 ).

In a case example, a group of investigators evaluated Qatari pharmacists' prescribing, labeling, dispensing, and counseling practices in response to acute community-acquired gastroenteritis ( Ibrahim et al., 2016 ). In another example, the investigators documented the state of insomnia management at community pharmacies in Pakistan ( Hussain et al., 2013 ).

Discrete Choice Experiments

Evidence in healthcare suggests that understanding consumers' preferences can help policy-makers to design services to match their views and preferences ( Ryan, 2004 ). Traditionally, studies to understand patients' and consumers' preferences for pharmaceutical services used opinion or satisfaction survey instruments. Nevertheless, such satisfaction surveys lack the ability to identify the drivers of satisfaction or the relative importance of the different characteristics of the service ( Vass et al., 2016 ). Discrete choice experiments are a novel survey-based method in pharmacy that are predicated on economic theories that allow systematic quantification of preferences to help identify which attributes of a good or service consumers like, the relative value of each attribute, and the balance between the different attributes ( Naik Panvelkar et al., 2010 , Ryan, 2004 , Vass et al., 2016 ). In-depth description of this method and its essential elements are described in another chapter in the Encyclopedia.

Qualitative Research Designs in Pharmacy Practice

Qualitative research methodology is applied to investigate a problem that has unmeasurable variables, to get a comprehensive understanding of the topic, through discussing it with the involved individuals, and to recognize the natural context in which the investigated issue takes place ( Creswell, 2013 ). The use of qualitative research methodology is becoming increasingly common across diverse health-related disciplines, including pharmacy practice. This is because of its ability to describe social processes and behaviors associated with patients or healthcare professionals, which strengthen the research impact ( McLaughlin et al., 2016 ). Therefore, pharmacy researchers and practitioners need to be better oriented to qualitative research methods ( Behar-Horenstein et al., 2018 ).

In the following section, interpretative frameworks and philosophical orientations, methodologies, data collection and analysis methods, approaches to ensure rigor, and ethical considerations in qualitative research are briefly discussed ( Cohen et al., 2013 , Creswell, 2013 ).

Interpretative Framework and Philosophical Assumptions of Qualitative Research

Interpretative frameworks.

Interpretative frameworks are the conceptual structures for comprehension, which form researcher's reasoning and views of truth and knowledge ( Babbie, 2015 ). Different scholars have categorized qualitative research paradigms or interpretative frameworks differently. The following are examples of interpretative framework categories that are used in health science research based on the categorization of Creswell (2013) : (1) social constructivism (interpretivism) framework; (2) post-positivism framework; (3) transformative, feminist, critical frameworks and disabilities theories; (4) postmodern frameworks; (5) pragmatism frameworks.

Philosophical Assumptions

Philosophical assumptions are theories and perspectives about ontology, epistemology, axiology, and methodology, which underpin the interpretative frameworks selected by qualitative researchers ( Cohen et al., 2013 ). As with interpretative framework, there are numerous means to categorize the philosophical assumptions that are folded within interpretative framework. The following are explanations of philosophical assumptions based on the categorization of Creswell (2013) :

1. Ontological assumptions, which define the nature of reality
2. Epistemological assumptions, which clarify means for knowing reality
3. Axiological assumptions, which explain the role and influence of researcher values
4. Methodological assumptions, which identify approaches to inquiry

It is important that a qualitative researcher understands how interpretative frameworks (e.g., social constructivism, post-positivism, and pragmatic interpretative frameworks) are differentiated because of their underpinning philosophical assumptions (i.e., ontological, epistemological, axiological, and methodological assumptions).

Approaches to Inquiry (Methodology)

It is important that qualitative researchers understand the differences between the characteristics of the five qualitative approaches to inquiry, in order to select an approach to inquiry and attain methodological congruence ( Creswell, 2013 ). The five approaches to qualitative research inquiry are:

a. Narrative research: Describes participants' written and spoken stories about their experiences with a phenomenon being investigated, while considering the chronological connection of the phenomenon's series of events ( Anderson and Kirkpatrick, 2016 , Creswell, 2013 , Czarniawska, 2004 ).
b. Phenomenological research: Describes the essence of participants' common experiences of a phenomenon, so that the description is a general essence rather than an individual experience ( Creswell, 2013 , Giorgi, 1997 , Moustakas, 1994 ).
c. Grounded theory research: Aims to generate a theory grounded in participants' data that conceptually explain a social phenomenon, which could involve social processes, or actions or interactions ( Creswell, 2013 , Strauss and Corbin, 1990 , Woods et al., 2016 ).
d. Ethnographic research: Involves describing the shared patterns of values, behaviors, and beliefs of culture-sharing participants ( Creswell, 2013 , Harris, 1968 , Rosenfeld et al., 2017 ).
e. Case study research: Provides an in-depth examination of a real-life contemporary phenomenon that researchers cannot change over time, to illustrate the significance of another general topic ( Baker, 2011 , Creswell, 2013 , de León-Castañeda et al., 2018 , Mukhalalati, 2016 , Yin, 2014 ).

Data Collection and Analysis Methods in Qualitative Research

Data collection tools in qualitative research can be categorized into the following fundamental categories ( Creswell, 2013 ):

a. Observation
b. Documents
c. Individual semi-structured interviews
d. Focus groups (FGs)
e. Audio-visual materials
f. Emails chat rooms, weblogs, social media, and instant messaging.
a. Topic guides: Topic guides guide the discussions in focus groups and individual interviews, and contain open-ended questions and probes, to enable the researcher to understand the complete picture, based on participant views and experiences. They are developed based on the literature review, aim and objectives, research questions, and propositions ( Kleiber, 2004 ).
b. Audio recording of FGs and interviews: Audio recording of discussions that take place in interviews and FGs is essential for managing and analyzing data, and for increasing the accuracy of data collection and analysis, and ultimately enhancing the dependability and credibility of the research ( Rosenthal, 2016 , Tuckett, 2005 ).
c. Transcription of FGs and interviews recording: Verbatim transcription refers to the word-for-word conversion of oral words from an audio-recorded format into a scripted text format. Transcribing data is considered as the first data reduction step because it generates texts that can be examined and rechecked ( Miles et al., 2014 , Grossoehme, 2014 ).

Data analysis comprises several fundamental steps, including reading the transcribed text, arranging data, coding data deductively based on prefigured themes or inductively to produce emergent themes, and then summarizing the codes into themes, and finally presenting the analyzed data as results ( Cohen et al., 2013 , Crabtree and Miller, 1999 , Pope et al., 2000 ).

The most commonly used data analysis methods in health science research are:

Thematic analysis is characterized by identifying, analyzing, and reporting themes that are available in the data ( Braun and Clarke, 2006 , Castleberry and Nolen, 2018 ).

Content analysis comprises systematic coding followed by quantification of the analyzed data in a logical and unbiased way ( Berelson, 1952 , Vaismoradi et al., 2013 ).

Discourse analysis emphasizes the core format and the structure of texts to examine the assumptions and concealed aspirations behind discourses ( Brown and Yule, 1983 , Gee, 2004 ).

Quality Perspectives in Qualitative Research

Qualitative research validation involves ensuring the rigor of the utilized data collection, management, and analysis methods, by utilizing approaches to ensure the quality. In pharmacy practice research, Hadi and Closs, 2016a , Hadi and Closs, 2016b argued that quality in qualitative research topic has not been discussed widely in the literature, and therefore Hadi and Closs, 2016a , Hadi and Closs, 2016b suggested using several trustworthiness criteria to ensure the rigor of qualitative study. The trustworthiness criteria for ensuring quality in qualitative research ( Lincoln and Guba, 1985 ) are:

This criterion aims to ensure that the results are true and increases the possibility that the conclusions are credible ( Cohen and Crabtree, 2008 ).

This criterion aims to indicate that the research results are repeatable and consistent, in order to support the conclusions of the research ( Cohen and Crabtree, 2008 ).

This criterion aims to confirm the neutrality in interpretation by ensuring that the perspectives of participants, not the bias of researchers, influence the results ( Krefting, 1991 ).

This criterion involves identifying the contexts to which the study results can be generalized, and indicating if the study conclusions can be applied in similar setting ( Yin, 2014 ).

Reflexivity implies revealing and evaluating the effect and biases that researchers can possibly bring to research process, by explaining the researcher's opinion, feelings, and experience with the phenomenon in question, and explaining the influence of this experience on research methods, findings, and write-ups ( Creswell, 2013 , Krefting, 1991 , Lincoln and Guba, 1985 ).

Ethical Considerations

Obtaining an ethical approval from the Institutional Review Board (IRB) is required before conducting the qualitative research ( Creswell, 2013 ). The key ethical issues that need to be considered are:

Informed consent refers to the decision taken by a competent individual to voluntarily participate in a research, after adequately understanding the research. Participant information leaflet is usually distributed to participants before they consent to participate in the research to clarify them the voluntary nature of research participation, the aim and objectives of the research, the rights of the respondents and the potential risks and harms, the data collection, management and storage conditions, and the right of participants to withdraw from the research ( Jefford and Moore, 2008 ).

The anonymity is usually ensured by not disclosing names of participants and by utilizing a code system to identify them during data collection, management, analysis, and in the writing up of the research. The confidentiality of participants and data is ensured by using a code system to identify participants, and by storing all data in a locked cabinet and a password-protected computer for a specified period of time ( Creswell, 2013 ).

Power imbalance is caused by the fact that participants have the experience about the investigated phenomenon, and researchers need to obtain information about these experiences. The power imbalance is usually associated with interaction between the researcher and participants during recruitment stage, and during data collection, analysis, interpretation, and validation stages. Hence, researchers should take suitable measures at each stage to decrease the influence of possible power imbalance, and should enhance trust with participants ( Karnieli-Miller et al., 2009 , Yardley, 2000 ).

Mixed Methods in Pharmacy Practice Research

Research studies in pharmacy practice usually utilize single-method research designs. However, often these report numerous limitations and may not adequately answer the research question. Therefore, the combination of more than one research method to answer certain research questions has become increasingly common in pharmacy practice research ( Ryan et al., 2015 ). Mixed methods research design is now a popular and widely used research paradigm in pharmacy practice research fields ( Hadi et al., 2013 , Hadi et al., 2014 ; Hadi and Closs, 2016a , Hadi and Closs, 2016b , Ryan et al., 2015 ). Mixed methods research allows the expansion of the scope of research to offset the weaknesses of using either quantitative or qualitative approach alone ( Creswell et al., 2004 , Hadi et al., 2013 ; Hadi and Closs, 2016a , Hadi and Closs, 2016b , Pluye and Hong, 2014 ). Typically, qualitative and quantitative data are collected concurrently or sequentially in order to increase the validity and the comprehensiveness of the study findings ( Creswell et al., 2004 , Hadi et al., 2013 ; Hadi and Closs, 2016a , Hadi and Closs, 2016b , Pluye and Hong, 2014 , Ryan et al., 2015 ). The mixed method approach provides an expanded understanding of phenomenon under investigation through the comparison between qualitative and quantitative data ( Hadi et al., 2013 ; Hadi and Closs, 2016a , Hadi and Closs, 2016b , Pluye and Hong, 2014 ).

This section provides an overview and application of mixed method research in pharmacy practice. However, considerations in selecting, designing, and analyzing mixed methods research studies as well as the various typologies of mixed methods research are discussed elsewhere. Johnson et al. (2007) proposed the following definition for mixed methods research: “The type of research in which a researcher or team of researchers combines elements of qualitative and quantitative research approaches (e.g., use of qualitative and quantitative viewpoints, data collection, analysis, inference techniques) for the broad purpose of breadth and depth of understanding and corroboration.”

Mixed methods design allows the viewpoints of participants to be reflected, enables methodological flexibility, and promotes multidisciplinary teamwork ( Ryan et al., 2015 ). Furthermore, the approach allows a more holistic understanding of the research question. However, its major limitations include: need for wide range of research expertise across the research team members, highly labor-intensive, and the complexity of data integration.

Scholars believe that it is challenging to provide researchers with a step-by-step guide on how to undertake a mixed methods study and that this is driven by the specific research question ( Ryan et al., 2015 ). Nevertheless, the investigator should precisely determine the type of qualitative and quantitative methods to be employed, the order of data collection to be undertaken, the data collection instruments to be used, and the method of data analysis ( Ryan et al., 2015 ). This approach encompasses a synthesis of findings from both quantitative and qualitative components, which is achieved through integration of the findings from each approach ( Hadi et al., 2013 ; Hadi and Closs, 2016a , Hadi and Closs, 2016b , Pluye and Hong, 2014 ).

Different models or typologies for mixed methods research have been described in the literature. The most common typologies used in pharmacy practice and health services research include: concurrent or convergent parallel design, exploratory sequential design, explanatory sequential design, and the embedded design ( Hadi et al., 2013 , Pluye and Hong, 2014 ). Scholars believe that there are several factors to consider when selecting the typology or model of mixed methods research to use. These factors include: the order of qualitative and quantitative data collection (concurrent vs. sequential); priority of data (i.e., which type of data has priority between quantitative and qualitative data); purpose of integration of the data (e.g., triangulation); and number of data strands ( Hadi et al., 2013 , Pluye and Hong, 2014 ). In mixed methods research, integration of qualitative and quantitative findings is critical, and this research approach does not simply involve the collection of these data ( Ryan et al., 2015 ).

Summary and Take-Home Messages

• In the era of evidence-based practice, it is not sufficient to propose new pharmacy services or roles without evidence of their benefit.
• New pharmacy services and new roles must be proven to be feasible, acceptable, beneficial, and cost-effective.
• Practice-based research provides such evidence and can inform policy, confirm the value of the new service, and change practice.
• Various study designs, including, but not limited to experimental, quasi-experimental, observational, qualitative, and mixed-methods designs, have been used in pharmacy practice research.
• Pharmacy practice researchers need to be competent in the selection, design, application, and interpretation of these methodological and analytical approaches.
• The choice of any study design in pharmacy practice research is driven by the expertise of the investigator, type of research question or hypothesis, data availability, time orientation, ethical issues, and availability of funding.

There is a great demand for innovation and quality in pharmacy practice. These can be achieved partly through robust and well-designed pharmacy practice research. Pharmacy students, practitioners, educators, and policy-makers are exposed to a variety of research designs and methods. We need to have the best evidence (e.g., in policy, regulation, practice) for making decisions about the optimal research design that ensures delivering an ultimate pharmacy practice and a quality patient care.

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Pharmacy Practice Research Case Studies

Department of Pharmacy
Pharmaceutical Policy and Practice Research Centre
School of Applied Sciences

Research output : Book/Report › Book › peer-review

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Pharmacy practices Social Sciences 100%
pharmacist Social Sciences 62%
health coverage Social Sciences 24%
pharmaceutical Social Sciences 17%
sustainable development Social Sciences 15%
research method Social Sciences 14%
Healthcare Social Sciences 14%
UNO Social Sciences 14%

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Research output per year

Pharmacy practice and continuing professional development in low and middle income countries (LMICs)

Research output : Chapter in Book/Report/Conference proceeding › Chapter › peer-review

Professional Practice 100%
Pharmacy 82%
Noncommunicable Diseases 56%

Pharmacy Practice Research Case Studies. / Babar, Zaheer-Ud-Din (Editor).

T1 - Pharmacy Practice Research Case Studies

A2 - Babar, Zaheer-Ud-Din

PY - 2021/2/19

Y1 - 2021/2/19

N2 - Pharmacy Practice Research Case Studies provides examples and details regarding how pharmacy practice research has transformed over the past decade and how this is impacting overall health. This book presents several methodologies and techniques used in current pharmacy practice. According to the United Nations Sustainable Development Goals, countries around the world are aiming to achieve Universal Health Coverage. In this context, pharmacists are a vital part of the healthcare teams and the book portrays the research methods used in conducting pharmacy practice and medicines use research. The professional role of pharmacists has evolved tremendously over the past few decades across the globe and the pace of change has been interestingly phenomenal in varying aspects. The book provides a great resource for pharmacists, pharmaceutical scientists, policymakers, and researchers to understand the dimensions of practice, education, research, and policy concerning pharmacy, and it provides the synthesis of the development so far, pointing to the needs and demands of the future.

AB - Pharmacy Practice Research Case Studies provides examples and details regarding how pharmacy practice research has transformed over the past decade and how this is impacting overall health. This book presents several methodologies and techniques used in current pharmacy practice. According to the United Nations Sustainable Development Goals, countries around the world are aiming to achieve Universal Health Coverage. In this context, pharmacists are a vital part of the healthcare teams and the book portrays the research methods used in conducting pharmacy practice and medicines use research. The professional role of pharmacists has evolved tremendously over the past few decades across the globe and the pace of change has been interestingly phenomenal in varying aspects. The book provides a great resource for pharmacists, pharmaceutical scientists, policymakers, and researchers to understand the dimensions of practice, education, research, and policy concerning pharmacy, and it provides the synthesis of the development so far, pointing to the needs and demands of the future.

KW - Pharmacy Practice Research

KW - case studies

UR - https://www.elsevier.com/books/pharmacy-practice-research-case-studies/babar/978-0-12-819378-5

U2 - 10.1016/C2019-0-00011-8

DO - 10.1016/C2019-0-00011-8

SN - 9780128193785

BT - Pharmacy Practice Research Case Studies

PB - Elsevier Inc.

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Student Handbook for Pharmacy Practice Research: A Companion Book to Conduct Practice-Based Research in Pharmacy

Chapter Eight: Case Reports and Case Series in Pharmacy

Katie E. Barber; Jamie L. Wagner

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Introduction, case reports and case series.

COMMON RESEARCH QUESTIONS IN CASE REPORTS AND CASE SERIES
PRACTICAL AND TECHNICAL CONSIDERATIONS FOR CASE REPORTS AND CASE SERIES
EXPERTISE NEEDED FOR CONDUCTING CASE REPORTS AND CASE SERIES
EXEMPLARS OF LEARNER-INVOLVED PUBLISHED CASE REPORTS OR CASE SERIES
DISSEMINATION CONSIDERATIONS AND FRAMEWORKS
SUMMARY AND CONCLUSIONS
KEY POINTS AND ADVICE
CHAPTER REVIEW QUESTIONS
ONLINE RESOURCES
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Supplementary Content

Define case reports and case series in pharmacy settings

Discuss various sources for case reports and case series in pharmacy settings

Identity common research questions in case reports and case series

Understand the practical and technical considerations for case reports and case series

Discuss the strategies for harnessing the expertise needed for conducting case reports and case series

Describe an example of learner-involved case reports or case series project

Understand the dissemination framework for case reports and case series

Case reports, case series

Case reports and case series are used primarily to convey unique or interesting clinical scenarios that help the medical community identify new diseases, recognize rare disease manifestations, utilize new diagnostic approaches, discover the pathophysiology of a disease process, detect new side effects of medications, or prescribe alternative therapeutic treatments. 1 These studies can help identify observations that would normally be missed or overlooked in larger clinical trials. The Food and Drug Administration encourages reporting of these observations to aid in documenting post-marketing experiences using the FDA MedWatch Portal. 2 Therefore, case reports and case series should be educational and provide useful, practical, and easy-to-follow instructions for others to accurately identify the scenario described.

The use of case reports and case studies in pharmacy literature is abundant. A simple search in Pubmed/MEDLINE with the terms “case report” or “case series” and “pharmacy” returns over 150,000 articles published in peer-reviewed journals. Unfortunately, case reports and case series are not always highly valued based on their low level in the research design hierarchy. 3,4 However, Murad et al. described an adapted hierarchy that suggests the divide between study design types is not as strict and can vary based on the information and bias contained within the report. 4 This chapter will provide a guide to understanding common research questions in case reports and case series within pharmacy practice, sources for case reports and case series, practical and technical considerations, expertise needed, and examples of learner-led reports.

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Open access
Published: 23 August 2021

The impact of clinical pharmacist services on patient health outcomes in Pakistan: a systematic review

Ali Ahmed 1 ,
Muhammad Saqlain 2 ,
Maria Tanveer 2 ,
Ali Qais Blebil 1 ,
Juman Abdulelah Dujaili 1 &
Syed Shahzad Hasan 3

BMC Health Services Research volume 21 , Article number: 859 ( 2021 ) Cite this article

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The pharmacist’s role shifts from dispensing to bedside care, resulting in better patient health outcomes. Pharmacists in developed countries ensure rational drug use, improve clinical outcomes, and promote health status by working as part of a multidisciplinary team of healthcare professionals. However, clinical pharmacist services on healthcare utilization in low-and middle-income countries (LMICs) like Pakistan are unclear. As a result, we aim to systematically review pharmacists’ clinical roles in improving Pakistani patients’ therapeutic, safety, humanistic, and economic outcomes.

We searched PubMed, Scopus, EMBASE, CINAHL, and Cochrane Library for relevant articles published from inception to 28th February 2021. All authors were involved in the screening and selection of studies. Original studies investigating the therapeutic, humanistic, safety, and economic impact of clinical pharmacists in Pakistani patients (hospitalised or outpatients) were selected. Two reviewers independently assessed the risk of bias in studies, and discrepancies were resolved through mutual consensus. All of the included studies were descriptively synthesised, and PRISMA reporting guidelines were followed.

The literature search found 751 articles from which nine studies were included; seven were randomized controlled trials (RCTs), and two were observational studies. Three RCTs included were having a low risk of bias (ROB), two RCTs were having an unclear ROB, while two RCTs were having a high ROB. The nature of clinical pharmacist interventions included one or more components such as disease-related education, lifestyle changes, medication adherence counselling, medication therapy management, and discussions with physicians about prescription modification if necessary. Clinical pharmacist interventions reduce medication-related errors, improve therapeutic outcomes such as blood pressure, glycemic control, lipid control, CD4 T lymphocytes, and renal functions, and improve humanistic outcomes such as patient knowledge, adherence, and health-related quality of life. However, no study reported the economic outcomes of interventions.

Conclusions

The findings of the studies included in this systematic review suggest that clinical pharmacists play important roles in improving patients’ health outcomes in Pakistan; however, it should be noted that the majority of the studies have a high risk of bias, and more research with appropriate study designs is needed.

Peer Review reports

Since 1990, with pharmaceutical care introduction, pharmacists’ careers have evolved from single dispensary positions to patient-oriented health care [ 1 , 2 ]. In developed countries, pharmacists are sufficiently trained to play a vital role in pharmaceutical care [ 3 , 4 ]. However, in developing countries, pharmacists’ roles are gradually shifting toward ward rounds with other health professionals to monitor the patient’s progress, drug-related issues and communicate a medication therapy management plan [ 5 , 6 , 7 ]. Meanwhile, they continue to be primarily responsible for manufacturing, distributing, and dispensing medicines [ 3 , 8 ]. Clinical pharmacists can offer patients a wide range of services, including prescription drugs and health-related services [ 9 , 10 ]. They can assist physicians in prescribing drugs rationally, ensuring that patients understand the dosage regimen and method of administration, and improving patient adherence [ 11 ]. Moreover, pharmacists play an important role in public health promotion at community pharmacy settings, such as tobacco and alcohol control, nutrition and a healthy lifestyle, routine immunisation, infection prevention and treatment, and the management of mental health and other chronic disease care [ 12 , 13 , 14 ].

According to the World Health Organization’s (WHO) data repository on the Pakistan health force, the pharmacist ratio per 10,000 population in 2019 was 1.545 [ 15 ]. Currently, over 3000 pharmacists in Pakistan receive Doctor of Pharmacy (Pharm D) degrees each year from 21 public and 25 private universities [ 16 ]. Moreover, as of 2019, the number of community pharmacies in Pakistan has increased to more than 40,000 [ 17 ]. To improve the regulation of medicines across the country, the Federal Government of Pakistan has established a regulatory body, the drug regulatory authority of Pakistan (DRAP) Act 2012 [ 18 , 19 ]. Under the Act, regulations range from existing basic services (i.e., dispensing, procurement, storage, distribution of therapeutic products and counselling) to enhanced medicine services (pharmaceutical care, pharmacovigilance, pharmacoepidemiology, pharmacoeconomic and services offered at drug information and poison centres) at all levels such as pharmacy, clinical, hospital, and community levels [ 19 , 20 ]. In 2014, to strengthen pharmacists’ expertise in clinical roles, the higher education commission (HEC) introduces the Department of Pharmacy Practice in Pakistan’s private and public sector universities [ 21 ]. As a result, studies in Pakistan have begun to highlight potential clinical pharmacy progress, including further bedside activities, patient consultation, and therapy optimization in chronic conditions such as diabetes and hypertension [ 22 , 23 , 24 , 25 ].

Published literature reviews of clinical pharmacist interventions in the United States (US) and Western countries reported that different health care settings and disease management could benefit from clinical pharmacist care [ 26 , 27 , 28 , 29 , 30 ]. In 2013, Pande et al. carried out a systematic review of the impact of pharmacist interventions on patient outcomes, health service utilization, and costs in low-and middle-income countries (LMICs) [ 31 ]. The findings revealed that pharmacist services improve treatment outcomes such as hyperglycemia and systolic blood pressure (SBP), diastolic blood pressure (DBP), cholesterol control, and the quality of life of people living with chronic diseases such as asthma, diabetes, and hypertension [ 31 ]. However, the authors could not retrieve cost-related data, and the results were inconsistent because each study measured different outcomes with different clinical conditions using other measurement methods, necessitating careful interpretation. The review included all studies from middle-income countries such as southeast Asia, Africa, and Eastern Europe. As a result, the findings may not apply to countries with varying healthcare systems, such as Pakistan, an LMIC in southern Asia [ 18 ]. The utilization of clinical pharmacist services in Pakistan is not well established [ 32 ]. There may be a lack of awareness about the additional benefits of clinical pharmacist services and their potential implications in the Pakistani context, which could assist policymakers and stakeholders in using these services. Therefore, this systematic review aims to synthesize the therapeutic, safety, humanistic, and economic impact of clinical pharmacist interventions in Pakistani patients compared to standard treatments without the involvement of pharmacists in direct patient care.

Scope of review: eligibility criteria

This systematic review was conducted following the Cochrane Handbook for Systematic Reviews of the Intervention Guidelines [ 33 ], and the reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement [ 34 ]. Studies were included if they were 1) randomized controlled trials (RCTs), non-RCTs (observational studies) such as pre-post without control group, follow up; 2) involved pharmacist intervention either alone or in a multidisciplinary team 3); measuring any health outcome (humanistic, safety, economic and therapeutic effects); 4) conducted among outpatients or inpatients in the hospital or community pharmacy settings; 5) had a control or comparison group (with healthcare professionals other than a pharmacist); 6) published in a peer-reviewed journal in English language and available in full-text.

Information sources

We used a population, intervention, comparator, and outcome (PICO) search strategy in PubMed, Scopus, OVIDEmbase, CINAHL Plus, and Cochrane Libraries to find relevant records. The initial search was undertaken on 14th February 2021, with follow-up searches conducted on 28th February 2021.

Database searching

From the database’s inception to 28th February 2021, a literature search was conducted using various search term combinations. The search terms used were (Pharmacist OR Pharmacy OR “Clinical Pharmacy” OR PharmD OR “Pharmacist-led”) AND (Adherence OR “Health outcomes” OR “Medication management” OR “Patient outcomes” OR outcome OR “Quality of life” OR “clinical outcome” OR Pharmacovigilance OR Economics OR “drug interactions” AND “drug safety”) AND (Pakistan OR Pakistani). Due to each database’s technical differences and limitations, the search mechanism in each database has been subsequently adapted and slightly modified ( Supplementary file ). Case reports, expert opinions, systematic reviews, letters to editors, comments, correspondences, news articles, qualitative studies, non-English studies, and conference abstracts were excluded if full articles were not available.

Data screening and extraction

The author AA conducted the searches in relevent databases and were later independently reviewed by MS, MT, JD, AB, and SSH. All eligible studies were imported into the Endnote Version.X9.3.3 software (San Francisco, Clarivate Analytics) [ 35 ]. In the Endnote software, subgroups were created for each database. Endnote software was used to remove duplicates. The titles and abstracts were independently screened for inclusion in the full paper by all authors. AA performed a full paper screening using a preliminary screening form, and all authors independently reviewed it. The final inclusion of articles was based on mutual consensus. After selecting the eligible studies, the AA extracted the data independently using a standardized Cochrane data extraction form [ 36 ]. The extracted data were checked for accuracy and consistency by the second author (MS). Article details (objective, year of publication, and first authors), study design, country of study, sample size, and study characteristics (age, follow-up duration, pharmacist intervention, intervention strategy, control group, intervention group, type of outcome measure, all health outcomes) were extracted.

Risk of Bias

Two reviewers (AA and MS) independently assessed the quality of RCTs using the Cochrane Risk of Bias Tool (ROB.2) [ 37 ]. Disagreements were resolved through mutual agreement. In non-RCTs, a Risk of Bias in non-Randomized Intervention Studies (ROBINS-I) tool was used for quality evaluation [ 38 ]. These studies have been assessed as being of low risk (if no bias), unclear risk (if any doubts affect results), and high risk (if bias has affected the results severely).

Data synthesis

The findings of selected studies were qualitatively synthesized rather than combined for meta-analysis due to the authors’ high risk of bias judgments. This decision was made because the clinical and methodological approaches used in the studies differed. Using the extracted data, text summaries and summary tables were created.

Study selection

The search strategy identified original research studies on the effect of clinical pharmacists’ interventions on therapeutic, safety, humanistic and cost-effective consequences of pharmacist intervention compared to usual care without pharmacist involvement in direct patient care in the Pakistani setting. Database searches yielded 751 papers. The use of EndNote software for de-duplication resulted in 707 papers being considered for preliminary screening by all authors for titles and abstracts. 45 papers were found to be eligible and underwent full paper screening. The bibliographies of the full-length articles were also reviewed, but no additional papers were discovered. Finally, nine studies were included in the qualitative synthesis. The search and screening processes are presented in a flowchart using a PRISMA diagram (Fig. 1 ) [ 34 ].

PRISMA flow diagram of included studies

Study characteristics

All of the studies were conducted between 2013 and 2020 and involved a total of 2931 patients. In eight studies, outpatients were enrolled [ 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 ], while inpatients were included in one study [ 47 ]. Patients with diabetes, hypertension, tuberculosis, chronic kidney disease (CKD), human immunodeficiency virus and hepatitis C infection were included in the studies. Of the nine studies, seven were randomized clinical trials (RCTs) [ 39 , 40 , 41 , 42 , 43 , 44 , 45 ], and two were observational studies (non-RCTs) [ 46 , 47 ]. Therapeutic outcomes were studied in seven studies [ 39 , 41 , 42 , 43 , 44 , 45 , 46 ], eight studies reported humanistic outcomes [ 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 ], and two studies discussed safety outcomes [ 43 , 47 ]. None of the studies reported economic results. Pharmacist interventions were delivered (for example, at outpatient departments or inpatient departments), frequency of intervention range from 2 to 6 times during follow up (range 2 to 10 months), length of pharmacist intervention sessions (First session range 15 to 60 min, follow up sessions range from 10 to 45 min) reported in the studies.

Three RCTs included were having a low ROB [ 41 , 43 , 44 ], two RCTs were having an unclear ROB [ 39 , 42 ], while two RCTs were having a high ROB [ 40 , 45 ]. As part of the intervention, pharmacists were directly or indirectly involved in selecting participants and assessing outcomes in the majority of the RCTs in this review [ 39 , 40 , 41 , 42 , 43 , 45 ]. Other common causes of bias included participant randomization issues, missing information of follow-up lengths, and handling missing data. Except for one study [ 41 ], none of the others provided pharmacists with training to help them deliver interventions. Both observational studies had a high ROB [ 46 , 47 ]. Khan et al. failed to provide specific information about participants and the criteria used to purposefully sample participants, which introduces bias [ 47 ]. Khokhar et al. did not explain how outcome measurements were calculated or handled missing data [ 46 ]. Figures 2 , 3 , 4 and 5 show the review authors’ assessments of each risk of bias item for each included study, as well as the percentages of bias across all included studies for RCTs and non-RCTs separately.

Risk of bias summary: review authors’ judgements about each risk of bias item for included RCTs

Risk of bias graph: review authors’ judgements about each risk of bias item presented as percentages across all included RCTs

Risk of bias summary: review authors’ judgements about each risk of bias item for each included non-RCTs

Risk of bias graph: review authors’ judgements about each risk of bias item presented as percentages across all included non-RCTs

Nature of pharmacist interventions

Pharmacists provided a variety of interventions broadly classified into six categories 1) Provision of education regarding disease stages with booklets; 2) exploring adherence barriers and motivational interviewing to improve adherence; 3) lifestyle modification guidance; 4) pharmaceutical care consisting of pharmacovigilance, drug-drug interactions, drug-food interactions; 5) interacting with the physician to change the drug regimen 6) maintain patient follow up care.

Tables 1 and 2 summarised the study characteristics, patient outcomes, and the impact of pharmacist intervention on therapeutic, humanistic, and safety outcomes.

Impact of pharmacist interventions on therapeutic outcomes

Three studies reported clinical pharmacist interventions significantly reduced the SBP and DBP in hypertension patients [ 41 , 42 , 44 ]. Saleem et al. detected significant reduction in mean SBP (mean difference: IG = 8.4 vs CG = 0.2; p = 0.004) and DBP (mean difference: IG = 6.6 vs.CG = 0.4; p = 0.009) in intervention group compared to control group [ 41 ]. Amer et al. also reported that pharmacist-led intervention significantly improved hypertension as SBP (IG:131.81 vs. CG:137.91) and DBP (IG:83.75 vs. CG:87.77) was considerably lower in the intervention group compared to the control group ( p < 0.001) [ 42 ]. Similarly Javaid et al. reported that participants in intervention arm had better improvement in SBP (mean difference = IG: − 21.1 vs. CG: + 6.1; p < 0.001) and DBP (mean difference = IG: − 7 vs. CG: + 4; p < 0.001) than control arm [ 44 ].

Three studies on the impact of clinical pharmacist’s interventions in diabetes care were published, with findings ranging from positive to significant [ 39 , 44 , 46 ]. Samtia et al. reported that there was no statistical difference in mean fasting blood glucose (mean difference: -11.95; P = 0.116) and HbA1C level (mean difference: -0.43; P = 0.112) between the intervention group and control group at five months follow-up [ 39 ]. Kokhar et al. also reported similar findings as there was no significant change in fasting and random blood glucose level at baseline and follow-up [ 46 ]. On the contrary to these findings, Javaid et al. reported that at follow-up, participants in the intervention arm 10.9 ± 1.7 vs. 7.7 ± 0.9) had significantly better improvement in HbA1C level compared to the control arm (10.3 ± 1.3 vs. 9.7 ± 1.3) [ p < 0.001] [ 44 ].

Samtia et al. reported that pharmacist-led intervention had significantly reduced body mass index (BMI) (mean difference: − 1.87; p = 0.014) and waist circumference (mean difference: − 1.27; p = 0.002) of diabetic patients in the intervention group [ 39 ]. Chatha et al. reported that at the end of the follow-up period, the intervention group had statistically significant increases in CD4 lymphocytes cells compared to the usual care group ( p = 0.005) [ 45 ]. Similarly, Javaid et al. reported that for various process outcome measures, inter-group improvements were more significant in the intervention group at final follow up in comparison to the control group; SBP ( p < 0.0001), DBP ( p = 0.02), cholesterol ( p < 0.0001), triglycerides ( p < 0.0001), serum creatinine ( p < 0.001), estimated glomerular filtration (eGFR) ( p < 0.001).

Impact of pharmacist interventions on humanistic outcomes

Samtia et al. reported that the pharmacist intervention group had shown improved adherence ( p = 0.003), improved knowledge regarding sensory changes ( p < 0.001), self-monitoring of blood glucose level ( p = 0.001), and knowledge regarding exercise ( p < 0.001) compared to the control group [ 39 ]. Saleem et al. observed at follow-up there was a significant improvement in adherence (− 1.8 vs. 3.2; p < 0.001) and disease-related knowledge (7.5 vs. 10.2; p < 0.001) among participants who received pharmacist intervention [ 41 ]. Similar results were reported by Amer et al. that group that received the pharmacist intervention had improved adherence (IG: 5.89 vs. CG:3.89; p < 0.001) and disease-related knowledge score (IG: 18.18 vs. CG:13.31; p < 0.001) compared to patients in the control group [ 42 ]. Likewise, Ali et al. revealed that hepatitis C patients in the pharmaceutical care group had better (88.6%) adherence than patients in the usual care group (77.9%) (p < 0.001) [ 43 ]. Chatha et al. also observed that educational intervention significantly improved the medication adherence among HIV patients as a proportion of patients who never missed their medication was increased up to 36% in the intervention group compared to only a 3% change in the usual care group [ 45 ]. Kokhar et al. evaluated the medication adherence and knowledge scores among CKD patients. At follow-up, a significant improvement was observed in medication adherence ( p = 0.042) and knowledge scores ( p = 0.022) of participants in the intervention group compared to the control group [ 46 ]. Also, Kaukab et al. studied the impact of pharmacist education and socioeconomic support on the depression status among drug-resistant tuberculosis patients. At ten months follow-up, patients who received education and support had significant improvement in depression symptoms than the control group [ 31 ].

Amer et al. reported that after the pharmacist intervention, the participants had significantly improved health-related quality of life (HRQoL) score (IG: 0.73 vs. CG: 0.68; p < 0.001) and VAS score (IG: 69.43 vs. CG: 64.29; p < 0.001) compared to the control group [ 42 ]. Ali et al. reported that HRQoL was significantly improved in both the usual care and pharmaceutical care groups, but no statistically significant change was observed between them. While there was a significant difference in visual analog scale (VAS) score between both groups at follow-up as patients in the pharmaceutical care group had higher scores than the usual care group ( p < 0.001) [ 43 ]. Interestingly Saleem et al. reported that at follow up the quality of life was significantly reduced (42.2 vs. 39.6; p < 0.001) in the intervention group [ 41 ].

Impact of pharmacist interventions on safety outcomes

Pharmacists actively provided pharmaceutical care, identified drug-related issues, and reported them to physicians to change prescriptions [ 43 , 44 , 47 ]. For example, Khan et al. reported that clinical pharmacists investigated the 373 inpatients profiles and identified 147 drug-related problems (DRP), of which 41.5% ( n = 61) were related to adverse drug reactions. To solve these problems, 161 recommendations like the change of drug, dosage adjustments were made by a clinical pharmacist, of which 139 (86.33%) successfully solved the issues [ 47 ]. In addition, Ali et al. evaluated the frequency of adverse drug events and reported that fewer patients in the pharmaceutical care group (8.2%) had experienced adverse drug events than the usual care group (10.5%) [ 43 ].

To the best of the authors’ knowledge, this is the first systematic review to include widespread evidence of clinical pharmacists’ role in Southern Asia, particularly in an LMIC like Pakistan. This systematic review incorporates evidence from nine studies in which the primary intervention provided by clinical pharmacists was disease-specific education, followed by motivational interviewing of patients to improve treatment adherence and medication therapy management to improve patients’ health outcomes. All studies found that clinical pharmacist interventions improved therapeutic outcomes (SBP, DBP, HBAIc, Blood glucose, CD-4 T lymphocytes, serum creatinine levels, eGFR) and safety outcomes (drug-related problems like drug-drug interactions). Interventions also improved humanistic outcomes such as disease knowledge, treatment adherence, depression, and HRQoL in all studies except Saleem et al [ 41 ], where HRQoL of the intervention group was surprisingly got lower, maybe due to comorbidities or higher depression scores in chronic disease patients due to associated psychological distress [ 48 , 49 ]. In Pakistan, clinical pharmacy education is evolving, but it is still at its foundational level [ 32 ]. Despite widespread recognition of the need for advanced pharmacy education, clinical pharmacist capacity and experience are severely lacking in LMICs [ 50 ]. LMICs must develop a mandatory continuing professional development (CPD) model for clinical pharmacists to update, advance, and update their training and skills in this context [ 51 ]. Furthermore, CPD in LMICs should strengthen the pharmacy system and its role in improving clinical pharmacy practise [ 50 ]. The review findings may persuade policymakers in Pakistan that clinical pharmacists can improve patients’ health outcomes and healthcare systems. Furthermore, stakeholders can benefit from Babar’s ten recommendations for advancing pharmacy practise in Pakistan [ 8 ].

The provision of simple education (about the disease, therapy, lifestyle, potential consequences of lack of adherence) was the most common intervention by the clinical pharmacist. Few studies evaluated complete pharmaceutical care follow-up, including optimizing medication therapy, monitoring disease progression, assessing adherence, identifying and resolving drug-related problems by communicating with physicians, and maintaining manual records for each patient [ 41 , 43 , 44 , 46 , 52 ]. This demonstrates that identifying drug-related problems (DRPs) through a pharmacist review can improve patient medication safety, as other studies have also shown [ 53 , 54 , 55 ]. Clinical Pharmacists are primarily concerned with DRPs. These issues must be identified and resolved to achieve their therapeutic goals and achieve the best possible outcomes from their drug therapy. Given the high number of DRPs reported by studies in Pakistan [ 56 , 57 , 58 , 59 , 60 , 61 ], clinical pharmacists in Pakistan have an excellent opportunity to resolve these issues and improve patients’ health outcomes. We found cross-sectional [ 62 , 63 ] and qualitative studies [ 64 , 65 ] from community pharmacy settings, but we couldn’t find any follow-up studies from community pharmacy settings, so we recommend further development of pharmacist activities at community pharmacies as these provide an alternative for the public to obtain medicines and access to basic, minor health-related services.

The studies included in this review ranged in quality, had methodological heterogeneity, versatility in outcome measurement, and reported on selected outcomes with varying pharmacist interventions. Regarding pre-training of clinical pharmacists about the intervention, only one study provided data [ 41 ]. Nonetheless, clinical pharmacists played an important role in identifying and addressing therapy-related issues in chronic diseases (diabetes, Hepatitis C, CKD, hypertension, tuberculosis, and HIV). These findings are comparable with the study conducted in a Jordanian upper-middle-income setting [ 3 ]. However, we could not find any research that evaluated the cost-effectiveness of pharmacist intervention. Similarly, a Cochrane review also reported limited evidence of the cost of pharmacist interventions in LMICs [ 31 ]. In terms of safety outcomes, the review found little evidence of clinical pharmacist intervention; similarly, less evidence of safety was generated and reported from the United States of America (USA) and European countries [ 13 , 27 , 66 , 67 ]. Involving the clinical pharmacist might come based on task shifting by the physicians towards clinical pharmacists to take the responsibility of therapeutic medication management, but still, it relies on the credibility, confidence, and trust, which may achieve with meeting therapy goals.

Implications for practice and research

Clinical pharmacist roles are emerging, and this review highlighted the impact of these services in the Pakistani context. However, acceptance of their clinical roles by other healthcare workers is sometimes challenging [ 20 , 32 ]. The barriers to engaging pharmacists in collaborative care could be overcome by building trust and demonstrating the value of pharmacists in health care teams and strategically engaging stakeholders, including legal departments, in the development of the collaborative practise process. Moreover, there should be multidisciplinary group discussions to advance clinical pharmacy services in Pakistan. Only Saleem et al. reported on the type of training given to pharmacists prior to implementing the research intervention [ 41 ]. Disease epidemiology, treatment, prevention, pharmacotherapy, strategies to overcome adherence barriers, the importance of treatment outcome, health education, effective communication skills, patient counselling techniques, and the importance of HRQoL assessment in treatment outcome assessment were all covered in the pharmacist training. Each year, many pharmacists are produced in Pakistan; however, the problem is with their clinical practise training [ 68 ]. Students in their final years have some fix visits to hospitals, but they are not given enough time or training during graduation to become experts in clinical settings. No professional body in Pakistan certifies pharmacist specialties, such as the board of pharmacy specialties (BPS) in America, which certifies pharmacists in specialised services [ 69 ]. As of August 2021, only twelve BPS certified pharmacists are working in different hospitals of Pakistan [ 70 ]. Government (Govt) of Pakistan should start initiatives like forming a council at a state level to begin clinical residency and certification programs to strengthen pharmacists to take better responsibility for patients’ pharmaceutical care. Moreover, govt should start continuous education programs like in the United Kingdom (UK) 30 h of ongoing professional development are necessary to complete per year [ 71 ].

Future research should focus on the safety and cost-effectiveness of clinical pharmacist interventions to further develop pharmacist roles. Adequately powered randomised studies with standardised outcome measurements, longer intervention duration, and equal baseline between groups will be required in the future. Research is also needed on pharmacist interventions’ time, frequency, and content to improve clinical outcomes [ 72 ]. Furthermore, this study concludes essential insight for future research focusing on a tailored intervention and the cost of delivering future cost-effective interventions. The result will be beneficial for the policymakers to choose pharmacist interventions based on the availability of their resources.

Strengths and limitations

We have previously seen clinical pharmacist reviews from developed or upper-middle-income countries, but there is no review from LMIC. This review focuses on an LMIC where the clinical pharmacy is still in its early stages of development. Evidence suggests that clinical pharmacists’ participation in the healthcare team improves patients’ health outcomes. Our findings support the provision of more clinical residency training to pharmacy graduates, who can play a more important role in improving patient health outcomes and cost savings for the health care system and society.

There are some limitations of this review. First, to avoid bias, only peer-reviewed published studies were included in this review; unpublished studies were not included. Second, we found one or a maximum of two studies for each outcome, so it was practically impossible to apply meta-analysis due to follow-up variation, high risk of bias, and intervention content differences. Third, there was variation in health outcome measurements as well as heterogeneity in pharmacist interventions. Fourth, only evidence from Pakistan was included; data from neighbouring countries were not included due to different healthcare systems. Despite limitations, this review can help to advance clinical pharmacy development in LMICs and thus improve patient outcomes.

The review underlined the role of the clinical pharmacist services in improving patient outcomes and medication therapy management. Clinical pharmacist interventions showed a positive impact on therapeutic, humanistic, and safety outcomes. However, much remains to be understood in cost, and long-term intervention impact. Future studies must be more rigorous in terms of evaluating multidimensional and long-term outcomes. Evidence of Costs-effectiveness must also be sought to allow informed decision-making and allocation of resources. The findings of this review will be of interest to policymakers, particularly in areas where new clinical pharmacy services are being developed.

Availability of data and materials

All data is presented within the manuscript.

Abbreviations

Drug Regulatory Authority of Pakistan

Higher Education Commission

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

Population, intervention, comparator, and outcome

Risk of Bias in non-Randomized Intervention Studies

Randomized clinical trials

Systolic blood pressure

Diastolic blood pressure

Health related quality of life

lower-middle-income countries

Continuing professional development

Drug-related problems

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Ahmed, A., Saqlain, M., Tanveer, M. et al. The impact of clinical pharmacist services on patient health outcomes in Pakistan: a systematic review. BMC Health Serv Res 21 , 859 (2021). https://doi.org/10.1186/s12913-021-06897-0

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In this chapter, we aim to document the research evidence of continuing education (CE) and continuing professional development (CPD) for pharmacists, including their impact, design and development process, delivery methods, gaps and challenges, pharmacists’ attitudes and motivators, utilization of technology, and accreditation. Despite the effectiveness of CE/CPD in improving pharmacists’ knowledge in the short term, their long-term effectiveness and the impact on pharmacists’ skills and practices, as well as patient outcomes, still need further investigation. Developing CPD programs consists of five stages through which combined competency-based, demand-side, and supply-side standards are utilized. The use of technology in distance learning for pharmacists proved to be useful and effective. However, the use and accessibility of the internet and technology and time limitations are among the challenges facing the successful delivery of CE/CPD. Gaps and challenges while developing and implementing CE/CPD programs were found to cause many issues in pharmacy practice and need to be considered. Improving pharmacists’ attitudes and engaging them in the development process were found to motivate them and increase their participation. Low-middle income countries (LMICs) are not yet implementing CPD programs efficiently, with a lack of accreditation and validation. Therefore, health policy makers in LMICs must consider imposing a compulsory CPD model, assessing pharmacists’ needs, and improving the quality of CPD programs that aim to improve patient-related outcomes.

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Doctoral School of Health Sciences, Faculty of Health Sciences, University of Pécs, Pécs, Hungary

School of Pharmacy, Faculty of Medicine and Health Sciences, An Najah National University, Nablus, Palestine

Department of Chemistry, Faculty of Science, Bethlehem University, Bethlehem, Palestine

Fouad Moghrabi

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Amer, F., Moghrabi, F. (2023). Continuous Education for Pharmacists: Documenting Research Evidence. In: Encyclopedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy. Springer, Cham. https://doi.org/10.1007/978-3-030-50247-8_137-1

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Research Designs and Methodologies Related to Pharmacy Practice

Learning Objectives

Introduction to Research Methodologies Used in Pharmacy Practice

Core Quantitative and Qualitative Approaches Used in Pharmacy Practice Research

Research Question and Selection of Study Design

Classification of Research Methodologies Used in Pharmacy Practice

Quantitative Research Designs in Pharmacy Practice

Observational Study Designs

Case–Control Studies

Cohort Studies

Case-Crossover Studies

Cross-Sectional Studies

Experimental and Quasi-Experimental Study Designs

Other Quantitative Study Designs

Simulated Client Method

Discrete Choice Experiments

Qualitative Research Designs in Pharmacy Practice

Interpretative Framework and Philosophical Assumptions of Qualitative Research

Philosophical Assumptions

Approaches to Inquiry (Methodology)

Data Collection and Analysis Methods in Qualitative Research

Quality Perspectives in Qualitative Research

Ethical Considerations

Mixed Methods in Pharmacy Practice Research

Summary and Take-Home Messages

Further Reading

Pharmacy Practice Research Case Studies

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Conclusions

Scope of review: eligibility criteria

Information sources

Database searching

Data screening and extraction

Data synthesis

Study selection

Study characteristics

Nature of pharmacist interventions

Impact of pharmacist interventions on therapeutic outcomes

Impact of pharmacist interventions on humanistic outcomes

Impact of pharmacist interventions on safety outcomes

Implications for practice and research

Strengths and limitations

Availability of data and materials

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