Patient centred care for the medical treatment of lower urinary tract symptoms in patients with benign prostatic obstruction: a key point to improve patients’ care – a systematic review

LUTS can be divided into storage, voiding and post-micturition symptoms [6]. LUTS are highly prevalent, cause bother and impact on QoL. LUTS are strongly associated with ageing processes; therefore associated costs and burden are likely to increase with future demographic changes. Most elderly men suffer at least of one LUTS. LUTS evolve dynamically: for some patients LUTS persist and progress over long time periods, and for others they remit [6]. Six pharmacological classes [alpha blockers (ABs), 5-alpha reductase inhibitors (5ARIs), phytotherapeutics, antimuscarinics (AMs), beta-3 agonists and phosphodiesterase type 5 inhibitors] are available alone or in combination for the treatment of male LUTS [7]. However, notwithstanding all these different therapeutic options, medical treatment of LUTS/BPO is far from the ideal situation and different unmet needs remain in this area [8, 9].

Despite most of the European countries adopt the same guidelines for the management of patients with LUTS/BPO, different prescription strategies exist between European countries [10]. The overall prescription index is three times more important in southern countries than in northern countries [10]. In addition, when three classes of medications are compared, alpha-blockers are continuously widely used, 5-ARI prescriptions are variable (highest in Poland and Italy), and the prescription of plants is strictly country dependent (significantly higher in France and Hungary) [10].

Fourcarde et al., in a cross-sectional observational study, described the profile and management of patients receiving medical therapy for BPH in primary care-centres in France [11]. Half of the BPO patients medically treated report unsatisfactory outcomes and only 60% of patients received a stable treatment without modifications over a year time [11, 12]. Moreover, only 17.3% of the patients start with combination treatment and curiously the most prescribed combination therapy was alpha blockers + plant extract (49.7%), non-considered as a recommended combination treatment in the current guidelines, highlighting that only a small number of physicians adhere to guidelines and algorithms [11, 12].

LUTS/BPO patients are managed by urologists and general practitioners (GPs) and some differences in drug prescription can be commonly observed. The BPH Registry and Patient Survey is a longitudinal, observational, disease registry cohort of patients enrolled from January 2004 to February 2005 in the United States [13]. It includes 402 urologist and primary care physician practices throughout the United States. Several differences in prescription patterns may be seen between urologist and GPs. GPs tend to prescribe more likely ABs (77,4% vs 58,4%) than 5ARIs (14% vs 6,3%), AB plus 5ARI combination therapy (22,7% vs 13,8%) or anticholinergic therapy (4,8% vs 2,5%) [26]. Nonetheless, the abovementioned results are confirmed by other experiences in European and Asian cohorts [14, 15]. Therefore this evidence emphasizes the low observance of international guidelines from Urologists and GPs, and prompts a better collaboration between GPs and Urologists.

Another important concern in the LUTS/BPO management is represented by the poor drug adherence. Adherence to medication is best defined by the extent to which patients take medications as prescribed by their health care providers [16]. Persistence is defined as the mean number of days that a patient remained on therapy. The non-adherence and the lack of persistence to a certain medication have been recognized as a public health problem [16]. The current guidelines offer multiple and different chronic drug regimens for the treatment of BPO/LUTS [17, 18]. However very little is known on the patient adherence to the LUTS/BPO medications. Wagg et al. investigated patterns of persistence with oral AMs drugs across different age groups in UK [19]. The mean persistence rate ranged between 77 and 157 days depending on AM type and age (older patients presented better persistence rates) [19]. The same issue has recently been addressed by Cindolo et al. in their study including 1,5 million patients under LUTS/BPO medications [20]. The number of patients who received prescriptions for at least 6 months was 97,407, decreasing to 61,298 (63%) at 10 months and 28,273 (29%) at 12 months (26%). The proportion of patients who continued the drugs up to 10 months was 70, 59, and 34% respectively for AB, 5ARI, and combination therapy, respectively [20]. These results confirmed by similar experiences [21] showed as medical treatment of LUTS/BPO is far from the ideal treatment and that several factors could influence the long-term efficacy in relation to the poor drug adherence and persistence observed in real life studies.

Several factors as race, insurance coverage, information technology, type of medication and prescription burden can influence drug adherence in LUTS/BPO patients, however recent evidence support that drug adherence is mostly influenced by patient’s perception of discomfort and inconvenience and patient’s expectations [19, 21].

Therefore, the clinicians should not limit their attention to the correct diagnosis and treatment of the disease (LUTS/BPO); they are required to provide a comprehensive assessment of the patient’s illness experience. Nevertheless a thorough exploration of the illness experience requires insight, tools, and practice. One helpful acronym, that could summarize the issues to be considered in a patient centered approach, is FIFE: Feelings, Ideas, Function, and Expectations [22].

The term “patient-centred” has been first used in a paper by Enid Balint in 1969 to indicate that the ‘whole person’ has to be considered in the clinical consultations [33]. Medical world showed a delayed reaction to this term and concept but in the last 20 years, there was progressively widespread acceptance that a ‘patient-centred’ approach may be beneficial [1, 2], although, as Stewart wrote: “Patient-centredness… may be most commonly understood for what it is not – technology-centred, doctor-centred, hospital-centred, disease-centred” [34]. Probably the rapid diffusion of a patient-centred model in several fields of medicine in the last decade has been linked to the crisis of the “Evidence-Based Medicine” model. As highlighted even by some members of the Centre for Evidence-Based Medicine of University of Oxford, evidence based medicine has not resolved all the problems it set out to address, which have become subtler and harder to detect [35]. In fact, patients often report that many of their informational and emotional needs remain unmet during encounters with their physicians and all this results in low levels of patient recall, a poor understanding of treatment recommendations, and a reduced adherence to those recommendations [35]. Therefore as suggested by the members of the Centre for EBM of University of Oxford, an exceeding of the standard EBM is needed, the research agenda should become broader and more interdisciplinary, embracing the experience of illness, the psychology of evidence interpretation, the negotiation and sharing of evidence by clinicians and patients [35]. Following these suggestions some authors have begun to explore the advantages of a patient centred approach in some chronic diseases, as hypertension, diabetes and arthritis [1, 2]. These studies showed that patients usually preferred patient centred care, and those who received it report enhanced health outcomes [1, 2]. In particular patient-centred encounters resulted in: better patient satisfaction, greater patient adherence to plans made, higher physician satisfaction, and fewer malpractice complaints [36].

Even if a patient-centred care has been interpreted and enacted differently among the different studies [37], it is possible to recognize two different dimensions of the concept. The first dimension means that in a patient-centred consultation the physician has to explore both the patients’ disease and four dimensions of the illness experience including: their feelings about being ill, their ideas about what is wrong with them, the impact of the problem on their daily functioning, and their expectations of what should be done [38]; the second dimension means that a patient-centred consultation has to encourage a more sharing, participative, and equal approach with the patient [38, 39]. The two dimensions are not mutually exclusive and affect the consultation and its outcomes. Therefore, the term “patient-centred” includes the patient perspective, and the psychosocial context along with shared understanding, power, and responsibility [40, 41]. In a recent consensus statement developed by representatives from medical education and professional organizations, seven essential communication tasks were identified: 1) build the doctor–patient relationship; 2) open the discussion; 3) gather information; 4) understand the patient’s perspective; 5) share information; 6) reach agreement on problems and plans; and 7) provide closure [17]. These tasks should be adopted in medical education, providing a template for the assessment of the various elements of patient-centred approach. Moreover the awareness of suboptimal health literacy and the importance of cultural competence in communication are imperative for effective patient communication and have been identified as key contributors to patient safety by the Joint Commission [18]. To reach significant enhancements of all these physicians’ communication skills, an effort by National Health Institutions is awaited, likely requiring changes in instruction at both the undergraduate and graduate levels of training [40]. Furthermore the challenge of assessing communication skills should not be underestimated [42]. This assessment should use well-established instruments for measurement of physicians’ communication skills in patient encounters [42].

In conclusion the patient-centred model has come a long way since the pioneering work of Enid Balint was published [33]. The scope of communication skills, important for successful clinical encounters, has been broadened and better defined. Moreover it has been successfully demonstrated that a patient-centred approach is positively associated with better health outcomes for patients in some fields of medicine [1, 2]. However, the potential of this method have not yet been explored in full, whereas in many areas of medicine, such as urology, the experiences with this approach although promising are still very rare. Further studies with this model are waited to confirm the positive outcomes of these preliminary findings.

A patient centered approach seems an innovative option to overcome the current limitations in the pharmacological treatment of LUTS/BPO patients, improving outcomes and drug adherence. As suggested in the last paragraph of the EAU guidelines on non-neurogenic LUTS, a patient centred care should be preferred and treatment should follow patients’ preferences and expectations in terms of efficacy, morbidity, speed of onset and disease progression [43]. Similarly the first paragraph of the NICE guidelines about the treatment of LUTS highlights a better communication between physicians and patients is mandatory, possibly using different communication skills and instruments in relation to patients’ education and needs [44]. Unfortunately, despite all these considerations, in the field of urology the use of this approach is still very limited. In particular, a total of seven survey studies, widely mentioned in the previous paragraph, have assessed LUTS/BPO treatment preference [11, 12]. Of these, two studies evaluated preferences in patients [11, 12], three studies examined preferences in physicians [13‐15] and two studies investigated preferences in both patients and physicians [23, 24]. However, to our knowledge only two studies specifically addressed the impact of a shared-decision making approach for LUTS/BPO treatment outcomes [45, 46]. A preliminary RCT was performed in UK in the early 2000s to evaluate whether a decision aid on benign prostatic enlargement influenced patient decision-making, health outcomes, and resource use [45]. This study involved 33 GPs and 99 BPO patients, the decision aid consisted in interactive multimedia programme with booklet and printed summary [45]. Information included probabilities of the risks and benefits of each treatment, estimated on the basis of information on age, severity of symptoms, and general health entered by the patient at the beginning of the session. The final outcomes were promising, in fact the decision aid was highly acceptable to both the patients and their GPs; the decisional conflict was reduced in the intervention group and patients who accessed to the decision aid reported a more active part in the decision making process and were less anxious than control patients [45]. The study failed to reduce the rate of BPH surgical procedure, however the small sample size and the short follow up (9 months) may explain this inconclusive resul [45]. In the second study, including 678 patients with symptomatic BPH from eight Canadian centers, Piercy et al. examined the impact of a shared decision-making program (SDP) on perceived knowledge and treatment preference [46]. The SDP required by this study protocol, was rudimentary, consisting simply in viewing an educational programme designed to inform LUTS/BPO patients about their condition and treatment options [46]. SDP showed only a minor impact in changing the preferences of those subjects who had expressed an initial preference (89.7 and 89.4% of patients preferring surgical and non-surgical therapy respectively, maintaining their preferences after viewing the programme), although it helped almost half of those initially undecided in forming a preference, reducing the percentage of doubtful patients to 14.8% [46].

Figure 2 shows a possible suggestion of a patient centred approach in LUTS/BPH patients. Evidence based medicine includes etiology, diagnosis, current medications and guidelines/algorithms which should be integrated with patient illness, social context and partner. All the actors of a clinical consultation (GPs, urologist and patients) should participate together and actively communicate to achieve an integrated evidence based/patient centered approach. The disease and the patient are to be treated as a whole.