Our search protocol yielded a total of 1229 articles including 1205 from database search and 24 via other methods, 328 of which were duplicates. A total of 901 titles and abstracts were screened, from which 805 were excluded and 96 were for full-text review for eligibility. A final count of 9 articles met all criteria. A PRISMA 2020 flow diagram illustrating the process of selecting articles is shown in Figure 1.
Characteristics of the included studies
Of the 9 studies identified and met the criteria, 6 studies were conducted in Canada [26, 28, 30-33], one in Australia [29], Belgium [27] and the US [34] each respectively.
Study design consisted of one phase 2 randomised control trial [26], three ‘before and after’ observational studies [27, 31, 33], one prospective cohort study [29], one retrospective observational study [28], one retrospective cohort study [34], and two surveys (clinicians [30] and patients [32]). Study data are summarised in Supplementary Table 2.
i-PARIHS framework analysis
Table 1 summarised findings using the iPARIHS framework that consists 4 constructs.
Table 1 Summary of the key findings using the i-PARIHS framework
Innovation
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Context
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Recipients
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Facilitator / Facilitation
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Source of innovation
Starting point: evidence-based national guidelines and recommendations are viewed as robust. Clinical practice indicates poor compliance and insufficient bone care health for ADT users [26-34]
Theories: a pathway framework for pathway development, implementation and evaluation [27], a health belief model to support education impact on up taking bone health care guidance [26,31,33]
Experiences: from evidence in women with osteoporosis [20]
Literatures: SR point-of-care reminders increased adherence to clinical recommendations [31]
Strategies
Using an existing bone health care programme to proactively screen and treat patients
Proactively target men with PCa receiving long-term ADT within an existing generic osteoporosis prevention programme [34].
Re-designing care pathways (4 studies)
MDT (8 disciplines) was created for pathway development, implementation and evaluation according to a seven-phase pathway framework [27]. The MDT analysed daily practices, deficits in the care process (e.g. lack of time and resource) and transferrable components of pathways. In addition to bone health, the pathway also assessed cardiometabolic side effects and provided advice for exercises, nutrition and psychoeducation [27].
Referred patients to a dedicated men’s health clinic where metabolic and bone side effects were assessed and managed [29].
Assessed in an osteoporosis clinic by one doctor who specialised in male osteoporosis with experience in ADT treatment [28].
Provided point-of-care multiple intervention strategy [31]: for HCP to order BMD and provide bone health counselling; for patients, provide educational booklet
Knowledge transfer, developed new education resources for patients [26, 31, 33]
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At organizational level, either within a hospital or a community health care provider, driven for change by the gap between guidelines and poor practice
Recently published guidelines [30]
High research activities within unit, indicating a high level of support for change [26,28,30,31,33]
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Urologists and oncologist reported lack of time, supporting structure were the most significant barriers [30]. Also lack of training in assessing fracture risk assessment, and confidence in providing advice to patients regarding bone health self-management [30].
Challenges in team working, family physicians reported a low satisfaction rate with the new care pathway [26].
Patients lack basic information about ADT induced bone complications [32]
Gather feedback from stakeholders including patients and health care practitioners on intervention materials and workflow to fine tune the implementation approach [31]
Explore patients’ barriers and facilitators of lifestyle change in adopting health bone behaviour [32].
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Lack of detailed information about facilitators and facilitation process, and lack of details in evaluation and adaption
in most of the studies.
Based on the Awareness-to-Adherence mode of behaviour change [31].
Promote awareness and agreement: gather feedback from stakeholders (HCPs and patients), presentation to the site teams at weekly rounds
Following initial implementation (3 months), facilitate adoption and adherence: audit and feedback, reminders were integrated into routine clinical care team meetings, developed information posters as reminder [31]
Increase staff capacity to shortened referral waiting time in at the start of a new osteoporosis clinic [28]
Active screening and treatment protocols are easily implemented in an established healthy bone programme using automated systems and a comprehensive electronic medical record [34].
Lack of long-term strategies for sustainable services.
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The innovation construct
Innovation is the process of applying explicit knowledge into practice to generate change and improvement [23].
Source of innovation (underlying knowledge)
All studies were based on published recommendations to reduce osteoporosis and fracture risk for PCa-ADT users. A health belief model was used by a Canadian research team to support the importance of patient education in delivering care [26, 31,33]. They also adopted their intervention approach using strategies for women with osteoporosis [26], and findings from a previous systematic review of point-of-care reminders to increase adherence of recommendations [33]. A pathway framework was applied when a new pathway was developed by a Belgium team in referring patients for the comprehensive management of ADT-related complications [27].
Types of innovation
Using an existing bone health care programme to proactively screen and treat patients
A study in the US proactively identified PCa-ADT patients within an existing osteoporosis prevention programme for members of a healthcare community. Using the electronic medical record system and cancer registry, the authors found screening and treatment protocols were easily implemented. The study reported 70% reduction in hip fractures and an increased uptake of bone protective medicine (from 3.2% to 29.2%) [34].
Re-designing care pathways incorporating existing services
New pathways or clinics were developed in three studies, all at a tertiary hospital level [27-30]. In a before-after study by a Belgium team, a multidisciplinary team consisting of radiation oncologist, urologist, psychologist, dietician, oncology nurse, physical therapist, social worker and pathway facilitator, was created for pathway development, implementation and evaluation according to a seven-phase pathway framework [27]. The multidisciplinary team analysed daily practices, deficits in the care process and potential transferrable components of pathways. In addition to bone health, the pathway also assessed cardiometabolic side effects and provided advice for exercises, nutrition and psychoeducation to patients. BMD screening increased from 10% to 58% after the pathway implementation [27].
Patients were also referred to a new dedicated clinic, for example, a men’s health clinic by an Australia team where metabolic and bone complications were assessed and managed. Bone loss was prevented over 2 years [29]. A Canadian team referred patients to a bespoke osteoporosis clinic where they were seen by one doctor who specialised in ADT treatment-induced osteoporosis [28]. High quality of bone health care was achieved as defined by a valid fracture risk assessment tool used in all patients, and all patients with high fracture risk recommended bone protective medication [28].
Providing education resources coupled with BMD request
Studies from the Canadian group emphasized the impact of education on patient care [26,31,33]. They developed complex interventions that included patient education and measures for clinicians to request BMD tests. A customized written booklet on bone health was created and given to patient at the initiation of ADT or during ADT treatment [26, 31,33]. Patients also received counselling, either one face-to-face counselling with specialists [31,33], or from a bone health care coordinator over 3 months [26]. BMD ordering was part of a pre-populated ‘healthy bone prescription’ [31,33], or requested by a bone health care coordinator or the patient’s family physicians who were advised by hospital letters [26]. A significant increase in BMD requests was achieved in all 3 studies [23,31,33].
The context construct
There are different layers of context from immediate local setting (inner context) to the wider health system (outer context) [23].
All studies were driven by the gap between guidelines and poor real-world practice. For the internal context, all studies reported on drivers for change at the organizational level. A research group from the largest cancer centre in Canada conducted focused studies on the ADT-induced bone complications, indicating a high level of support and leadership within the unit [26,31,33]. No information of any external contextual factors was reported in any study, e.g. policy or economic drivers.
The recipients construct
Recipient encompasses the people who are affected by and influence implementation at both the individual and collective team level [23].
Skills, knowledge, and resources for clinicians
Urologists and oncologists who initiate ADT are the key recipients of the implementation providers. They reported lack of time, supporting structure and resources as major barriers [27,30]. Lack of training and confidence were also reported in a survey from Canadian radiation oncologists and urologists [30]. It was suggested that referring patients to primary care physicians or bone health specialists might be appropriate [24]. The research team subsequently conducted a randomized phase 2 clinical trial to assess 2 education-based interventions to improve bone health care. One strategy was to refer patients to their family physicians who were provided with a hospital letter. The letter contained specific advice and recommendations for BMD screening and bone health care, along with a pocket card for current recommendations and a copy of the patient booklet. The result showed that with the family physician’s input, BMD ordering was significantly increased compared with usual care (58% vs 36%, p=0.47).
Support and collaboration at multidisciplinary team level
The novel patient care pathways were predominantly multidisciplinary [26,27,30,31,34]. Perspectives from different specialists of the new services were usually not reported. In the above phase 2 clinical trial involving family physician, despite an improvement in bone health care, family physicians reported a very low satisfaction rate (26%), which was the only feasibility outcome that didn’t meet the target [26]. Problems included hospital letters that were neither timely, clearly written nor helpful. This indicates the challenges in communication and shared care between secondary and primary. The authors recommended eliciting feedback from family physicians before embarking on a larger trial [26].
Knowledge gap for patients as recipient
Patients as the service user fit into a wide range of stakeholders within the recipient construct, and their views should be consulted [23]. Only one study included patients’ feedback on design of intervention materials during implementation development, although no details were reported [31]. A survey with 175 PCa patients exploring their knowledge and healthy bone behaviour showed that most lacked basic information and awareness of ADT-induced bone complications despite their relatively high health motivation [32]. Providing information and education to patients resulted in an increase in BMD tests [26,31,33]. To assist patients adopting healthy bone behaviour, more than a brief single educational intervention was needed to be effective [33].
Facilitator and facilitation process
Facilitation activates implementation through assessing and responding to characteristics of the innovation and the recipients within their contextual setting. This requires a facilitator and a set of strategies and actions (the facilitation process) to enable implementation [23].
Poor reporting of facilitator roles and facilitation processes
There was a lack of detailed information about facilitators and the facilitation process in most of the studies. A bone health care co-ordinators and a central pathway facilitator were reported in 2 studies [26,27]. The care co-ordinator went through the educational material with the patient using principles of adult education and chronic disease self-management. They also followed up with the patient at least twice over 3 months to facilitate behavioural change and BMD ordering [26]. The pathway coordinator received referrals of patients from radiation oncologists and urologists. They discussed the pathway with the patients and provided follow up appointments for the screening assessments and preventative strategies [27]. However, there was no information regarding speciality background of the coordinators, i.e., whether the person was a nurse, administrator or doctor, and from which medical speciality. Referral rates to the novel service were either suboptimal (61%) [27] or not reported [28,29]. One study applied a theory-based implementation strategy to facilitate the intervention [31]. Based on the Awareness-to-Adherence mode of behaviour change, the authors applied multiple enabling and reinforcing interventions. Strategies included presentations to the site teams at weekly tumour rounds to promote awareness and agreement, and audit and information posters to facilitate adoption and adherence [31]. When a new pathway was developed to improve implementation of guidelines for the management of ADT induced complications, a protocol as well as an implementation plan was developed. However, there were no details about how it was implemented and facilitated [27].
Evaluation
Evaluation was often not included or reported. In a phase 2 clinical trial assessing an education-based intervention, the authors investigated feasibility of the study and found good recruitment (exceeded the target of 60%), retention (over 90%), patient satisfaction (over 90%) and outcome capture (over 90%, although satisfaction rate for family physician was low (26%) [26]. Evaluation was also included in the development of a new multidisciplinary pathway service using a seven-step pathway development framework [27]. However, no detailed information of evaluation was reported [27].
Most studies were performed in a tertiary hospital with data collected from 6 months to 5 years. Ongoing re-evaluation of the care pathway and strategies to ensure that the new service is sustainable are all required if implementation is to be applied to wider settings and longer term.