Low back pain (LBP) is a major cause of disability worldwide [1], with almost 1 in 5 people reporting LBP at any one time [2]. People with LBP typically consult general practice, allied health, or community pharmacy for advice and management [3,4]. The role of community pharmacists has evolved from dispensing medication and providing medication advice, to include screening and management for a range of health conditions such as minor ailments and chronic health conditions [5-10]. In alignment with this expanding service model, there is interest for community pharmacy to play a greater role in the early management of back pain [11-13]. There are also potential economic benefits for using community pharmacy as an access point for a range of services, with lower patient and health system costs compared with other primary care models [13-15].

Current clinical practice guidelines for the management of LBP recommend first-line care that includes reassurance, advice to stay active and avoid bed rest, and discouraging diagnostic imaging such as plain radiographs unless serious pathology is suspected [3,16]. Despite these guideline recommendations, a substantial gap between evidence and practice still exists [17]. For example, Abdel Shaheed et al [18] reported that community pharmacists and their staff were able to deliver adequate advice on medication use for LBP, but their ability to provide advice on nonpharmacological management such as staying active, avoiding bed rest, and discouraging imaging was inconsistently delivered. The ability to identify presentations that required prompt medical review was also limited for some community pharmacists.

Clinical decision support systems (CDSSs) are targeted electronic systems that link evidence-based recommendations with the clinical presentation of the individual to improve clinical decision making and support patient engagement with health decisions [19-24]. Recently, CDSSs have been implemented for management of noncancer pain in the primary care setting [25-29], but these do not transfer to the pharmacy setting because of differences in professional training and consultation environment. Pharmacists already have access to CDSSs (eg, management of infection and deprescribing) [30,31], but none exist to support the community pharmacist–client consultation for LBP. Therefore, a CDSS for the early management of LBP in community pharmacy is warranted [32].

The main objective of this study was to develop a CDSS for pharmacists to guide first-line care of LBP in the community pharmacy setting using a mobile data collection system (Apple iPad, Apple Inc). We also sought to evaluate the pharmacist-reported usability and acceptance of the high-fidelity prototype to inform the next stage of CDSS development.

This study describes the iterative development of a CDSS for the management of pharmacy clients with LBP in community pharmacy. The CDSS was developed by a multidisciplinary team that included two pharmacy academics, a human-computer interaction expert, and four content experts in LBP [33]. Team members were consulted during each stage of development. The CDSS (high-fidelity prototype) was evaluated via a small-scale usability study [34]. The study was approved by University of Sydney Human Research Ethics Committee (2017/027).

Development of the CDSS was underpinned by the framework for user-centered design and evaluation of prototypes for clinical information systems (Figure 1) [35]. The framework describes the evolution of a CDSS based around low-cost usability testing methods before future evaluation with real clients in a clinical practice setting. During initial design of the CDSS, input was sought from a range of people involved with community pharmacy, including two pharmacy academic/educators, a community pharmacist, and an industry representative. This approach sought to uncover pharmacist training and procedural constraints that may impact pharmacist decision making for LBP [36], given that a pathway for the contemporary management of LBP specific to the community pharmacy setting does not exist.

Design goals were informed by Bates et al [37], Khorasani et al [38], and Zikos et al [39] who described features of a decision support system necessary to facilitate integration into clinical practice. The design goals of this CDSS were to (1) support pharmacists to offer simple, clear evidence-based advice to the pharmacy client who presents with LBP; (2) integrate with the pharmacist workflow (eg, consideration of medicines during decision making); (3) maximize time efficiency; and (4) provide a personalized report of recommendations for the pharmacy client.

The CDSS was designed in three components [22]: (1) knowledge base, (2) reasoning engine, and (3) interface (see Multimedia Appendix 1 for further explanation of design process). Briefly, the knowledge base included high level advice for the screening of serious pathology and early management of LBP [3,40-49]. The reasoning engine was coded from the knowledge base then refined using experts in LBP and community pharmacy to consider age, sex, results of screening questions, pain history, and up to three current medicines for LBP (Multimedia Appendix 2). Recommendations for the pharmacist are separated into key messaging for the pharmacy client, suggested medicine use, and referral options. The pharmacist progresses from a landing page (Figure 2), through to history, screening, and advice pages (Multimedia Appendix 3). Data input is via a touch interface (checkboxes, drop-down menus, and free-text input). The pharmacist can accept, modify, or reject advice generated by the CDSS. Finally, a custom letter for the pharmacy client is generated based on the pharmacist’s final recommendation (Multimedia Appendix 4).

The multidisciplinary team of experts were engaged at each stage of design, development, and internal testing. Decision trees were iteratively modified before coding decision logic and programming of the interface (Ionic Framework), then refined through multiple (>10) test cycles. Once the logic and interface were complete, each of the 408 unique decision combinations were checked for accuracy using the Web interface. Similarly, each of the clinical case vignettes (and CDSS-generated client handouts) were tested by the research team for language and accuracy before the interview phase.

After the completion of the internal testing, the next phase of usability was based on the recommendations of Yen and Bakken [34], where the community pharmacist interacted with the CDSS through a series of 5 case vignettes (system-user-task).

All pharmacists completed 5 case vignettes on the Apple iPad. Pharmacists were exposed to cases in the same order. The total time taken to role-play all 5 case vignettes (excluding discussion on decision logic or system improvements) ranged from 14 min 35 seconds (Pharmacist #1) to 28 min 4 seconds (Pharmacist #2). Case vignettes that included nonserious LBP required less time (Cases 1 and 2: mean 3 min 40 seconds per case, SD 1 min 8 seconds) than cases that raised suspicion of serious causes of LBP (Cases 3-5: mean 4 min 46 seconds per case, SD 1 min 23 seconds).

Across the 5 case vignettes, 70 recommendations were generated by the CDSS related to self-care advice, medicine advice, and referral advice. Pharmacists accepted 90% (18/20) of self-care recommendations, 100% (25/25) of medicines recommendations, and 88% (22/25) of referral recommendations. Of those accepted, pharmacists added to the advice for 8% (5/65) of the recommendations generated by the CDSS (eg, Figure 4).

A CDSS was developed to enhance pharmacist care of LBP, underpinned by clinical practice guidelines and informed by a multidisciplinary team of experts that included consultation with community pharmacy. Community pharmacists rated the overall usability of the high-fidelity protype as good to excellent [59], despite expression of some negative sentiment in relation to guidance in screening for serious causes of LBP and interface inconsistency. There was a high level of acceptance for the advice generated by the CDSS for self-care, medicines, and referral, with pharmacists augmenting advice for a minority (5/65) of recommendations.

Pharmacists reported a high level of usability based around simple use of language, logical workflow, brief consultation time, ability to customize advice, and convenience of a customized handout for the client. A number of usability issues were raised with regard to interface including page layout, text size, and button placement, which will be considered in the next phase of the CDSS refinement. The screening page (Figure 3) received the majority of negative comments and may reflect nonintuitive interaction with the layout of the screening page and/or lack of familiarity with the screening questions used to raise suspicion of serious causes of LBP. Although education for pharmacists in Australia contains topics on symptom recognition for differential diagnosis [62] and interprofessional referral [63], pharmacists expressed interest for more training on this topic, which is consistent with recommendations of Abdel Shaheed et al [64].

All pharmacists agreed that the information provided by the CDSS was applicable to the clinical scenarios presented and could potentially improve client-pharmacist encounters. One pharmacist disagreed with the messaging to avoid imaging and preferred to refer to medical care as a first option for nonserious LBP, but given the small sample, may not be representative of their peers. Pharmacists also commented that the CDSS helped them to ask more questions of the client with LBP and increased management options for LBP beyond their usual advice. However, it is unclear if the advice delivered by the CDSS in this setting would be superior to usual pharmacy care for LBP.

Pharmacists commented that they appreciated guidance provided by the CDSS in relation to management, particularly for options beyond medicines advice. This aligns with recommendations of Abdel Shaheed et al [65] and others [11] on the potential benefit of tools/guidelines to support pharmacists when managing clients with LBP. Pharmacists also reflected on the current general lack of guidance to manage pain within pharmacy compared with the promotion and availability of management tools for other health conditions [5,7,8,14,66]. This view is consistent with results from a recent study by Abdel Shaheed et al [65] who found that pharmacists were receptive to implementing a disease state management program for LBP. One area highlighted by pharmacists was the lack of operational knowledge in relation to screening clients for serious causes of LBP, which has been highlighted previously [18]. Abdel Shaheed et al also found that pharmacists had both the willingness and capacity to increase knowledge in this area [32,64]. One goal of a training module integrated into the next version of the CDSS would be to empower the pharmacist with the skillset to raise suspicion of potentially serious underlying pathology, then inform clients of options for prompt medical review [43,45].

The small sample size may not be adequate to capture the full range of pharmacists’ views or usability issues thus limiting the generalizability of the results [67], particularly with regard to the level of acceptance. However, the sample size was appropriate for this stage of CDSS development [34,51]. That is, it was sufficient to identify major usability issues (eg, when screening for risk of serious disease), that the CDSS interface could be navigated with minimal training, and that decisions generated were logical and easy for the pharmacist to apply (in a simulated scenario). The method used to assess usability (think aloud with active intervention) may have enhanced task performance through researcher-induced bias [68] but allowed greater insight into the sections of the CDSS that required further development [52]. Another source of bias that may have enhanced task performance was the nonrandomized order of cases (case complexity was greater later in interview). This stage of CDSS development was to finalize design elements in the community pharmacy setting before testing with real clients [34]. In its current design, the CDSS does not integrate with existing electronic record systems in pharmacy, which would be necessary before advanced testing and would increase the chance of adoption by pharmacists [69]. One approach would be integration with existing disease state management systems [70], which was also suggested by pharmacists during testing.

This CDSS is the first tool that the authors are aware of to assist community pharmacists in first-line care for people with LBP. Other electronic decision support systems have been targeted at the primary care setting for the management of LBP [25] and chronic pain [26,27]. This CDSS differs from existing systems in that it aims to empower the pharmacist to offer evidence-based first-line care beyond medicines advice, and stepped referral options to allied health, primary, or emergency care based on presentation or symptom progression. The opportunity to enhance the pharmacist-client interaction, identified as lacking in other systems [27,71], has been built into this CDSS by allowing the pharmacist to modify management advice then provide a customized handout for the client.

The next phase is to modify the CDSS with lessons learned from this usability study, then reevaluate during the next level of system development (integration with clients into the pharmacy setting) [34]. The CDSS will also be evaluated with respect to the credibility of advice and satisfaction with care from the perspective of clients with LBP. An education module on the evidence-based management of LBP could be delivered to pharmacists in conjunction with training for the CDSS, which would assist with knowledge of screening for pathology and give context to the guideline-based care options suggested by the CDSS. Future studies may establish if pharmacist training during the use of a CDSS within the clinical encounter improves both pharmacist and pharmacy client satisfaction with care.

Despite many years of clinical guidelines for the management of LBP, significant evidence-to-practice gaps remain. This CDSS has been designed to provide a unique opportunity for community pharmacists to provide simple evidence-based advice for clients who present with LBP. Importantly the CDSS offers key messages of reassurance, to remain active, to use medicines appropriately, and to avoid inappropriate imaging.