The annual National Health Service (NHS) England spend on medication was £15.5 billion in 2015 and the volume of medication prescribed in by NHS England rises every year [1-3]. The World Health Organization (WHO) reported that the average medication adherence in patients with long-term conditions in developed countries is approximately 50% [4]. According to the WHO, there is a need to acquire more data related to medication adherence from all age band subgroups [4]. It is estimated that, in the UK, more than a third of patients with at least one long-term illness do not adhere to their medication regime [5]. Medication nonadherence is associated with higher number of hospitalizations, adverse drug reactions, nursing home admissions, and an increase in health care and social costs [6].

A number of systems are currently employed to use information and communication technologies (ICT) to store, manage, and employ health and medical information. The use of ICT for NHS health care policy was made clear in the 2002 report, Securing Our Future Health: Taking a Long-Term View [7], even though patients’ electronic access to their health records had already been planned in The NHS Plan 2000 [8]. Following that, the NHS developed the Summary Care Record and HealthSpace programs to explore the development and application of shared electronic health records (EHRs) and personal health records (PHRs) [9]. The NHS Future Forum highlights the importance of patient access to their online GP health records to assist in the development of a self-care and self-management culture [10].

NHS policy documents and frameworks such as the Personalised Health and Care 2020 (P2020) report [11] and the Five Year Forward View [12] specify that the NHS needs to harness the power of technology. The aim is to enable patients to make correct choices and to support clinicians by providing access to all necessary data and assisting the clinicians to make the most of technology available and these data. The P2020 claims that unless the gap between care and technology closes, patients may experience “unnecessary levels of preventable ill health” [11]. It also provides evidence of the growing demand for technology in England, as evidenced by the fact that 59% of all UK citizens have a smartphone. It also compares the health care sector to other safety-critical industries and it argues that digital tools and technologies, such as mobile apps, improve self-management of patients’ health [11].

There are four main terms in general use for structured health care information systems, namely electronic medical records (EMRs), electronic patient records (EPRs), EHRs, and PHRs [13]. Although there have been attempts to differentiate the definitions of EMR, EPR, and EHR [14-16], in practice, these terms lack precision and are often used interchangeably [13]. We have adopted the term “EHR” in this protocol. The definition of a generic EHR is “a repository of information regarding the health status of a subject of care, in computer processable form” [13,17].

There are multiple definitions of a PHR. Generally, the term “PHR” emerged from “EHR” and can be defined as “health records related to patient care that are controlled by the patient” [18]. Although there are paper based PHRs, in this protocol we refer to PHRs that are electronic and accessible via mobile devices [18].

Based on the PHR definitions provided by Cruickshank [9], Paton [19], Rohers [18], and Archer [20], we identified the common denominators and the following PHR definition is used throughout this protocol and the systematic literature review:

This definition is agnostic to the type of PHR, which can be defined as tethered [16,20,22] or standalone [18,20]. A tethered (tied) PHR includes features that are not patient-controlled; thus, it can be connected to the data source, including the cloud and institutional EHRs [16,18,20]. Untethered or standalone PHRs’ main feature is that the patient-user is the only one permitted to enter, maintain, and self-manage data related to their own health conditions [20,23]. Based on the above definition, this review will also include studies that use copies of personal health data on storage devices, such as smart cards and USB sticks. Figure 1 illustrates how the EHR and PHR differ for health care and medical records.

PHRs are typically important for patients that are suffering from chronic conditions, whom gain the most value from the PHR and have a higher adoption rate for PHR use [20,24-26]. Some PHR characteristics, as derived by the literature [20,24-26], are summarized in Table 1.

The adoption of PHRs is global, for example, PHRs are expected to be adopted by 75% of patients in the USA by 2020 [27]. In Australia, a national tethered PHR system has been launched [28] and in Canada and Denmark there are health centers which offer PHRs to their patients [9]. Furthermore, the NHS England is working toward a greater adoption of PHRs [11,12,29]. There is a growing focus on the adoption of PHRs worldwide because, in addition to geographically targeting the major economies such as the USA and UK, studies have also been conducted in middle- and low-income countries to evaluate, improve, and quantify the benefits of PHR use in global health [9,30-35].

The scope of this review is global and there are no geographical restrictions on this study. The use of PHRs not only varies between different groups of patients, but it also varies among studies [36]. Patients that have a long-term condition or an illness that requires recurrent care are more likely to use a PHR than patients who claim to be in good health [37]. The adoption of PHRs worldwide started around 2003 [9], so all the evidence is recent, and this remains an immature and rapidly developing field. Illustrating this, early in 2011 Google decided to terminate their PHR product (Google Health) due to its low impact and adoption rate [9,38].

NHS England engaged in a “landscape review” in 2015 to identify how local NHS organizations and commercial companies are using PHRs [39]. Most research and quality of life and care schemes that the NHS is currently referencing have been published after 2011 [11,36,40,41]. This context has informed our selection of a suitable date range for the literature searches.

There are many claimed benefits of PHRs, such as (1) the ability of PHRs to improve patient outcomes, (2) decrease in care costs, (3) to give patients the ability to self-manage their health, (4) an increase access to care especially in remote areas, (5) empowerment of patients, and (6) to improve medication adherence [18-20,24-26,36,42,43].

Medication adherence can be defined as “the extent to which a person’s behavior towards their medication intake, corresponds with agreed recommendations from a health care provider” [44]. Medication adherence is the preferred terminology, but some sources still use the word “compliance,” which many consider to be dated as it is a more restrictive term and less patient centered [45]. The ABC taxonomy [46] was selected as the conceptual framework for medication adherence in this study since it is well cited, it includes the time dimension, and it is considered more comprehensive than the WHO five interacting dimensions that affect adherence [44]. The ABC taxonomy states that there are three components to medication adherence: initiation (the time until the first dose has been taken), implementation (the extent to which a patient’s dosage consumption corresponds to the prescribed dose regimen) and discontinuation (stop taking the medication) [46]. Medication adherence and persistence are closely related and often persistence is incorporated in the notion of adherence [46,47]. Medication persistence can be defined as the extent to which patients adhere over time [45], in other words it is the time between the medication initiation until the medication discontinuation [46]. According to some authors, medication compliance and medication adherence are synonymous [46], with the latter not only to be introduced as a less aggressive term to describe the same phenomena but also to provide the patient with a sense of self-control and self-management of their treatment [48,49]. Concordance is another important term related to adherence to prescribed medication, which reflects the need to reach an agreement between a patient and the prescriber by which health beliefs are accounted for. A concordant consultation would be expected to lead to enhanced adherence to medication, as the prescribing process would involve the patient in the clinical decision making [48].

Some studies indicate that polypharmacy has a negative effect on medication adherence [44,50,51]. Polypharmacy is defined as the parallel use of multiple medications by one patient, for complex or multiple conditions [52-54]. Polypharmacy can signify “the prescribing of either many drugs (appropriately)” or “too many drugs (inappropriately)” [55]. Our focus extends to either use of polypharmacy, since the impact of PHRs on either polypharmacy or simple prescribing is unknown.

Medication adherence is a well-known challenge in health care [44,56-58], and is related to a large number of factors such as side effects [59], forgetfulness [57], or effective self-management and is affected by psychological factors and beliefs [60]. Although a number of strategies and interventions have been identified to assist patients’ medication adherence [58,61], they have had limited success.

NHS policy assumes that increasing the usage of health apps by citizens will reduce demand on health care services.

However, the quality of the literature about the use of health apps to improve patient outcomes is often questionable [62].

This protocol complies with the requirement of the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocol (PRISMA-P 2015) including the PICOS elements (participants, interventions, comparators, outcomes and study design) highlighted in Table 2 [63].

There is no requirement for ethical review since this study is secondary research. The final report of the systematic review in the form of a scientific paper will be published in a peer-reviewed journal. Findings may further be presented at conferences and be submitted to relevant NHS authorities. We also plan to include an updated version of this systematic review in the author’s thesis.

This research is limited to include only articles that have outcomes related to the effect of electronic PHRs in medication adherence, concordance, compliance, or persistence, rather than also including other outcomes such as quality of life. In this sense, the review will focus exclusively on articles that measure medication adherence as a primary or secondary outcome. This review is limited to obtain articles published either in ICT or health care and medical portals. This means that a lot of ICT related literature is unobtainable, since it in not included in the academic literature, but is commercial or governmental work. The aim of this review is to identify the essential design features of the PHR that assist adults with at least one long-term condition to adhere with their medication, without taking into consideration adolescents nor adults that are not considered chronically ill or terminally ill, have cancer, or are pregnant.