Systematic review

Shared decision-making for prostate cancer screening and treatment: a systematic review of randomised controlled trials

Nahara Anani Martínez-González, Andreas Plate, Oliver Senn, Stefan Markun, Thomas Rosemann, Stefan Neuner-Jehle

DOI: https://doi.org/10.4414/smw.2018.14584
Publication Date: 23.02.2018
Swiss Med Wkly. 2018;148:w14584

INTRODUCTION

Men facing prostate cancer screening and treatment need to make critical and highly preference-sensitive decisions that involve a variety of potential benefits and risks. Shared decision-making (SDM) is considered fundamental for “preference-sensitive” medical decisions and it is guideline-recommended. There is no single definition of SDM however. We systematically reviewed the extent of SDM implementation in interventions to facilitate SDM for prostate cancer screening and treatment.

METHODS

We searched Medline Ovid, Embase (Elsevier), CINHAL (EBSCOHost), The Cochrane Library (Wiley), PsychINFO (EBSCOHost), Scopus, clinicaltrials.gov, ISRCTN registry, the WHO search portal, ohri.ca, opengrey.eu, Google Scholar, and the reference lists of included studies, clinical guidelines and relevant reviews. We also contacted the authors of relevant abstracts without available full text. We included primary peer-reviewed and grey literature of randomised controlled trials (RCTs) reported in English, conducted in primary and specialised care, addressing interventions aiming to facilitate SDM for prostate cancer screening and treatment. Two reviewers independently selected studies, appraised interventions and assessed the extent of SDM implementation based on the key features of SDM, namely information exchange, deliberation and implementation. We considered bi-directional deliberation as a central and mandatory component of SDM. We performed a narrative synthesis.

RESULTS

Thirty-six RCTs including 19 196 randomised patients met the eligibility criteria; they were mainly conducted in North America (n = 28). The median year of publication was 2008 (1997–2015). Twenty-three RCTs addressed decision-making for screening, twelve for treatment and one for both screening and treatment for prostate cancer. Bi-directional interactions between healthcare providers and patients were verified in 31 RCTs, but only 14 fulfilled the three key SDM features, 14 had at least “deliberation”, one had “unclear deliberation” and two had no signs of deliberation.

CONCLUSIONS

There is significant variation in the extent of SDM implementation among studies addressing SDM for prostate cancer screening and treatment. Further evaluation of these results on patient outcomes, a standardised SDM definition and guidance for an effective implementation in several clinical settings are needed.

Keywords: systematic review, shared decision-making, prostate cancer, screening, treatment, randomised controlled trials

Introduction

Prostate cancer is one of the most serious public health concerns relating to men’s health worldwide. The World Health Organization (WHO) has declared prostate cancer to be the second most commonly diagnosed type of cancer in men, and the fifth leading cause of death due to cancer in men worldwide [1]. It accounts for 6.6% of the total deaths of men, and the burden is expected to increase to 1.7 million cases and 499 000 new deaths by 2030 globally [2].

Prostate cancer incidence varies widely in the world with higher rates (mostly) in high-income countries [1], mainly due to the widespread use of screening tests, which have improved early detection, but whose benefits and harms are controversial [3, 4]. There is no consensus on the general screening routine, including the age at which screening should be performed [59], and testing has led to false-positive results and over diagnosis [10]. Furthermore, patients often face more than one alternative treatment, which represent a variety of benefits and risks without convincing evidence indicating a best choice [11]. The survival benefit comes at the price of considerable morbidity, highly impaired quality of life, psychological distress and increased healthcare costs due to treatment [10, 12]. With these precedents, the individual patient’s situation becomes preference sensitive, requiring careful consideration and deliberation of many factors (e.g., diagnosis, prognosis, fears, values, beliefs, ethics, hopes and previous experience) that make decisions complex and highly preference sensitive.

Shared decision-making (SDM) is frequently advocated in clinical practice as the fundamental component of all patient-provider interactions in regards to medical decisions [13, 14] since it is based on the principles of patient-centred care [15, 16]. It is particularly recommended for “preference-sensitive medical decisions” [17] and considered essential for screening and treatment of prostate cancer [18, 19]. With this approach, the decision depends to a great extent on the patients’ informed preferences and on their value of risks, benefits and harms of options [17]. These attributes are often integrated and tailored to the patient’s circumstance by means of decision aids or other methods [2023] that facilitate SDM [16]. However, there is no single definition of SDM and no clear consensus about how to conduct SDM in routine medical practice. Ongoing debate also indicates that the goal of SDM is not yet clarified. Some view SDM as a partnership between patient and/or patient care-related parties (e.g., legal guardian, relatives) and healthcare providers to equally share decisions about healthcare choices [2427]. For others, SDM is a process to engage in decision-making [14, 28], or an approach to incorporate preference-sensitive elements that facilitate decision-making [17].

SDM appeals greatly to policy makers and healthcare providers because of its potential to reduce the overuse of options with unclear benefits [29] while enhancing the use of beneficial options [30] and reducing variations in practice [31]. We performed a systematic review to assess the extent of SDM implementation in studies of interventions aiming to facilitate SDM for men facing prostate cancer screening and/or treatment decisions.

Methods

We developed a protocol before starting the review following the principles for systematic reviews [32, 33], and we report the methods in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (see table S1 in appendix 1 for the PRISMA checklist) [34].

Inclusion and exclusion criteria

We focused on the extent to which the concept of SDM is implemented in clinical practice. We assessed the reported SDM interventions based on the SDM model (see section “Assessment of SDM implementation”). We broadly defined SDM interventions as the approaches, methods or tools designed to facilitate, foster, or improve patient-healthcare provider involvement in medical decision-making, based on Charles et al. [35]. We included peer-reviewed and grey literature of studies reported in English addressing (the effectiveness of) SDM interventions for men facing decisions about prostate cancer screening and/or treatment. Eligible studies were randomised controlled trials (RCTs), quasi-RCTs (method of allocation not strictly random), and cluster RCTs (1) comparing SDM interventions to one or more alternative interventions, and/or usual care, (2) directed at patients and/or their care-related parties and/or healthcare providers, and (3) conducted in primary or specialised healthcare including general practices, community clinics, ambulatory care, hospitals and private care services. Studies were included regardless of the length of follow-up, publication year and country of origin. We excluded studies conducted in non-clinical settings and community studies in which discussions were not intended or could not occur.

Search strategy and data sources

We designed and conducted a comprehensive search strategy in Medline Ovid, Embase (Elsevier), CINHAL (EBSCOHost), The Cochrane Library (Wiley), PsychINFO (EBSCOHost) and Scopus from their inception to March 2015. The search strategy was revised by an information specialist and, included terminology compatible with SDM (e.g., “patient participation” and “patient involvement”), “shared decision making” and “prostate cancer” (see table S2 in appendix 1). It was not restricted by publication date, language, country or outcomes, and included a study design filter for the identification of RCTs in humans [36]. We also searched for grey literature using individual clinical trial registers (clinicaltrials.gov and ISRCTN), the WHO search portal (http://apps.who.int/trialsearch), and the Ottawa Hospital Research Institute website (http://www.ohri.ca). The records were accessed between February and August 2016, and the trials registration number was additionally searched for by use of Medline and PubMed. We also used Google Scholar and the system for Information on Grey Literature in Europe (http://opengrey.eu/). We identified additional studies by screening the reference lists of included studies, relevant systematic reviews and clinical guidelines, and by contacting (June 2015 to January 2017) the authors of potentially eligible abstracts for which the full text could not be located.

Selection of studies

Two reviewers independently screened the titles and abstracts of all citations, and examined the full text of potentially eligible publications meeting the eligibility criteria. Studies reported in more than one publication were identified and treated as one unit. We resolved differences through consensus or by involving an arbitrator.

Data collection and synthesis

One reviewer extracted data using standardised data collection forms designed and developed a priori. A second reviewer independently verified data extractions, resolving differences by consensus or by involving an arbitrator. For each study, we extracted information on the bibliographic details of studies (design, country, time of study conduct, funding sources), characteristics of study populations and interventions, including the interventions’ attributes, and the elements and key features of SDM implementation. Data from a single study reported across various publications were extracted as one unit. We obtained full-text data from the authors of potentially eligible abstracts without available full text. In this review, we performed a narrative synthesis of the results, including a description of the reported SDM interventions and their implementation based on the SDM model. In a future report, we will include an analysis of the effectiveness of SDM interventions.

Assessment of the extent of SDM implementation

We evaluated the extent of SDM implementation in accordance with the essential characteristics of SDM proposed by Charles et al. [35] (see table S3 in appendix 1). Of the analytic stages of SDM, we considered deliberation to be central and mandatory, and that it must be bi-directional (i.e., active participation of both patient and healthcare provider) for SDM to occur. Provision of information only, such as use of decision aids, cannot replace this active and bi-directional participation, but such strategies in a “stand-alone” format can facilitate SDM or become a component of a multi-faceted intervention. To differentiate the variants (e.g., two-way from one-way) in decision-making, we assessed the intervention’s description and content, its delivery procedure and the mode of decisions to identify the elements aiming to facilitate decision-making. We evaluated whether:

  1. The intervention aimed to facilitate or foster shared decisions, for example by including elements of patient activation, encouragement to talk or discuss, etc.
  2. There was evidence of bi-directional interaction between patients and healthcare providers, such as planned (telephone or face-to-face) consultations.
  3. Implementation of decision-making was based on three key features of SDM [35], i.e., patient and healthcare provider:
  4. a. share/exchange information,
  5. b. deliberate, and
  6. c. make/implement a decision in consensus.

Ideally, this collection of behaviours occurs altogether within a clinical encounter [35]. We anticipated, however, that SDM definitions and goals would differ among studies resulting in heterogeneous decision-making behaviours in which SDM might not be achieved. We classified the interventions as SDM (all criteria met), partial SDM (at least deliberation met), unclear (unclear deliberation), and no SDM (unidirectional interaction) by coding 3a, 3b and 3c as one if the criteria was met, zero if the criteria was not met, or unclear (?) if criteria details were not reported or could not be verified. Table S4 (appendix 1) illustrates this system.

We considered the following criteria as components of SDM, since these were intended to encourage discussions between patient and healthcare provider or implied a bi-directional interaction between them: patient activation strategies such as provision of information, patient prompts, clinical encounters that occurred at or shortly before a healthcare appointment, coaching, interviews, or before filling out questionnaires.

Results

Identification of eligible studies

Our searches identified 15 398 records. After perusal of all titles and abstracts, we excluded 15 128 records. We examined in detail the full text of 270 potentially relevant articles. After excluding 220 articles, 36 RCTs reported in 50 publications met the inclusion criteria [3786]. Figure 1 shows the flow of study identification and selection. Characteristics of study, population and interventions of the 36 RCTs are summarised in supplementary table S5 (appendix 1)

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Figure 1
Identification and selection of studies.

Study and population characteristics

The 36 RCTs were published from 1997 to 2015, and 44.4% (n = 16) were published between 2010 and 2015; the median year of publication was 2008 (table 1). The vast majority (77.8%) of RCTs were conducted in North America (n = 28), and the remaining (22.2%) in Europe (n = 7) and Australia (n = 1). Thirty-five parallel RCTs included 18 484 randomised patients, and the cluster RCT randomised 712 patients with 120 physicians and 55 waiting areas. Twenty-three (63.9%) RCTs addressed decision-making for prostate cancer screening. Of those, only five (21.7%) defined screening as both testing for prostate-specific antigen (PSA) and a digital rectal examination (DRE); the other eighteen (78.3%) defined prostate cancer screening as testing for PSA only. Twelve (33.4%) RCTs addressed decision-making for prostate cancer treatment. Nine (75%) of those provided a range of treatment options of which surgery (n = 9) was the most commonly offered choice, followed by radiotherapy (external beam radiation; n = 7), watchful waiting (n = 6), brachytherapy (n = 6) and hormone therapy (n = 4). One RCT addressed decision-making for both screening and treatment of prostate cancer [86]. Thirty-two (88.9%) RCTs included patient-directed interventions, but four RCTs targeted both patients and their significant other (e.g., relatives, spouses) [83, 84], or patients and physicians [42, 45].

Table 1

Summary of the characteristics of 36 randomised controlled trials of decision-making interventions for prostate cancer.

Year of publication, mean (range)2008 (1997–2015)
Studies included
   35 parallel RCTs, randomised participants, n (range)18 484 (60–3327)
   1 cluster RCT, randomised participants, n (55 waiting areas)712 patients; 120 physicians
Country of studies
   North America
       USA22 (61%)
       Canada6 (17%)
   Europe
       United Kingdom3 (8%)
       The Netherlands, Finland, Spain, Greece4 (12%)
   Australia1 (3%)
Decision context
   Screening23 (64%)
       PSA only18 (50%)
       PSA and DRE5 (14%)
   Treatment*12 (33%)
       Radical surgery9 (100%)
       Radiotherapy7 (78%)
       Brachytherapy6 (67%)
       Watchful waiting6 (67%)
       Hormone therapy4 (44%)
       No treatment2 (22%)
       Other7 (78%)
    Screening and treatment: PSA only; surgery, radiotherapy, watchful waiting1 (3%)
Age of study participants, range (years)18–86
Number and specialty of participating healthcare providers, n (range)2–127
   Primary care providers: GPs or NPs14 (58%)
   Urology or oncology physicians10 (42%)
Intervention
   Target population 
       Patients32 (89%)
       Patients and partners or family members2 (6%)
       Patients and physicians2 (6%)
   Fostering of SDM 
       Intervention elements for fostering SDM35 (97%)
        Bi-directional interaction (physician ↔ patients) e.g., tied to consultations31 (86%)
   Key features of SDM 
       a) Information exchange (physician ↔ patients)28 (78%)
       b) Deliberation (physician ↔ patients)28 (78%)
       c) Implementation (physician ↔ patients)14 (39%)
Intervention classScreeningTreatmentScreening and treatment
1. SDM8 (35%)6 (50%) 
2. Partial SDM10 (43%)3 (25%)1 (100%)
3. Unclear2 (9%)1 (8%) 
4. No SDM3 (13%)2 (17%) 

DRE = digital rectal examination; GPs = general practitioners (faculty, general or internal medicine physicians); NPs = nurse practitioners; PSA = prostate-specific antigen; RCT = randomised controlled trial; SDM = shared decision-making. Data are presented as n (%) unless otherwise stated.
* Treatment options reported in nine of the twelve RCTs on treatment.
† Cryotherapy, pelvic lymph node dissection, transurethral resection, complementary, no preference, undecided, missing, “other”.
‡ Number of healthcare providers reported in eleven RCTs, and the specialty of healthcare providers was reported in 24 RCTs.
¶ SDM key features [a-b-c] coded as: 1 = criteria met, 0 = criteria not met, or ? = unclear (see table S4 in appendix 1).

Patients were mainly recruited from primary care clinics in 20 (55.6%) RCTs (table 2). In the other 16 (44.4%) RCTs, patients were recruited from hospital-based (n = 5) or cancer (n = 3) clinics, a specific population (n = 1), or from multidisciplinary (combining at least two; n = 7) settings. Thirty (83.4%) RCTs reported the targeted age of participants. In 27 RCTs (75%), the minimum and maximum targeted age of men was 40 and 86 years, respectively; one RCT (3%) targeted relatively young (younger than typically recommended) men who were at least 18 years old [82]; and two RCTs (5.6%) did not use age as an eligibility criterion for participants [68, 74]. Three RCTs were not tied to a consultation [38, 48, 57], but the type of participating healthcare providers was reported in 24 (66.7%) RCTs: 14 RCTs (38.8%) employed faculty, general or internal medicine physicians, and nurse practitioners; and 10 RCTs (27.8%) employed physician specialists (urology, oncology, and/or radiation oncology). Eleven (30.6%) RCTs reported the number of participating healthcare providers, which ranged from 2 [85] to 127 [54]. Seven RCTs (21.2%) reported the level of healthcare providers’ training or experience, which ranged from postgraduate practice to 40 years of experience, or board certified physicians. Thirty-four RCTs reported the funding sources; these were non-profit governmental and private institutions.

Table 2

Characteristics of 36 randomised controlled trials of decision-making interventions for prostate cancer.

First author, publication year [reference]CountryDecision contextSetting and facilities, nTarget population and patients’ target age (range), yearsIntervention group, randomised (n)Control group(s), randomised (n)Participating HCP and specialty, n
Screening
Lewis, 2015 [37]USAPSAPCs, 7
PC AGIMP, 1
Patients
50–75
n = 8311) n = 840
2) n = 828
3) n = 828
Mid-level healthcare provider, n = n.r.
Tomko, 2015 [3841] (Starosta, 2015; Tomko, 2015; Taylor, 2013)USADRE and PSAUH, 1
Hospital centre, 1
Medstar PP, 1
Patients
45–70
n = 6311) n = 630
2) n = 632
Not tied to a consultation - interviewers, n = n.r.
Wilkes, 2013 [42]*USAPSAAMC PC Net, 2
Staff model HMO, 2
MGPNet, 1
Patients and physicians
55–65
n = 19 waiting areas, 113 patients, 36 physicians1) n = 19 waiting areas, 246 patients, 41 physicians
2) n = 17 waiting areas, 353 patients, 43 physicians
Physicians in internal and family medicine (4-40 years’ experience since clinical training completed), n = 120
Williams, 2013 [43]USAPSAUMC, 1
UCaC, 1
Participants
40–70
n = 1381) n = 134
2) n = 137
3) n = 134
Urology physicians or oncologists, n = n.r.
Landrey, 2013 [44]USAPSAUH GIMPs, 2Patients
50–74
n = 1451) n = 158Internal medicine physicians, 44
Sheridan, 2012 [45]USAPSAAGP, 2
Community practice, 2
Patients (and physicians)
40–80
n = 601) n = 70Family physicians, 28
Lepore, 2012 [46]USAPSAIC beneficiaries healthcare workers' union, 1Patients
45–70
n = 2441) n = 246Primary care physician
Myers, 2011 [47]USAPSAPCs, 2Patients
50–69
n = 1561) n = 157Family physicians (board-certified practitioners), 22
Evans, 2010 [48]UK (South Wales)PSAGPs (from 9 local health board areas), 25Patients
50–75
n = 1291) n = 126
2) n = 127
3) n = 132
Not tied to a consultation
Stamatiou, 2008 [49]GRCPSAPC institutionsPatients
50–86
n = 5481) n = 587Physicians, n = n.r.
Frosch, 2008 [50]USAPSAPrev medicine clinic (KP), 1Patients
>50
n = 1551) n = 153
2) n = 152
3) n = 151
Physicians, n = n.r.
Volk, 2008 [51]USAPSAHGP (low HL site), 1
UGP (high HL site), 1
Patients
40–70 if AA or 50–70 if not AA
n = 2241) n = 226Physicians, n = n.r.
Krist, 2007 [52, 53] (Woolf, 2005)USAPSASuburban GP, 1Patients
50–70
n = 2261) n = 196
2) n = 75
Family physicians, 29 (13 faculty, 8 second-year residents, and 8 third-year residents)
Kripalani, 2007 [54]USADRE and PSATeaching hospital, 1Patients
45–70
n = 1011) n = 101
2) n = 101
Nurse practitioners, 5;
internal medicine physicians, 109
(post-graduate year 1, 2, or 3
under the supervision
of board-certified
internal medicine faculty);
faculty physicians, 13 (fully trained)
Partin, 2006 [55, 56] (Partin, 2004)USAPSAVA GIMP, 4Patients
≥50
n = 3841) n = 384
2) n = 384
General internal medicine physicians, n = n.r.
Watson, 2006 [57]UK (England and Wales)PSAGPs, 11Patients
40–75
n = 9801) n = 980Not tied to a consultation
Myers, 2005 [58]USADRE and PSACommunity-based PC, 3Patients
>40
n = 1211) n = 121Family physicians, 4; internal medicine physicians, 2; oncologist, 1
Gatellari, 2003 [59]AUSPSAUrban GPs, 13Patients
40–70
n = 1261) n = 122Family physicians, 13
Frosch, 2003 [60, 61] (Frosch, 2001)USAPSAPrev medicine clinic, 1Patients
>50
n = 1141) n = 112Physicians, n = n.r.
Volk, 2003 [62, 63] (Volk, 1999)USAPSAUGP, 1Patients
45–70
n = 801) n = 80Primary care provider, n = n.r.
Schapira, 2000 [64]USADRE and PSAVA outpatient clinic, 1Patients
50–80
n = 1221) n = 135Physician or research physicians (investigators), n = n.r.
Davison, 1999 [65]CANDRE and PSAFM teaching centre, 1Patients
50–79
n = 501) n = 50Family physicians (first and second year residents and academic staff), n = n.r.
Wolf, 1998 [66, 67] (Wolf, 1996)USAPSAUGPs, 4Patients
≥50
n = 1031) n = 102Primary care physicians, n = n.r.
Treatment
Chabrera, 2015 [68]SPNn.r.UH, 1Patients
>45
n = 731) n = 74Urology physicians, radiation oncology physicians, medical oncology physicians, n = n.r.
Oncology institutes, 2
Berry, 2013 [6971] (Berry, 2012; Bosco, 2012)USA1, 5, 6, 8, 13,14VA hospital, 3Patients
>40
n = 2661) n = 228Physician consultants (urology or oncology physician or other), n = n.r.
UCaC, 1
Ca institute, 2
Hacking, 2013 [72]UK (Scotland)1, 5, 6, 7, 8GH, 1Patients
Age, n.r.
n = 631) n = 60Urology physicians or oncologists, n = n.r.
van Tol-Geerdink, 2013 [73]NLD1, 5, 6, 11UMC, 1Patients
Age, n.r.
n = 1631) n = 77Urology physicians, n = n.r.
GHs, 2
Huang, 2014 [7476] (Auvinen, 2004; Auvinen, 2001)FIN1, 5, 7, 8UHs, 2Patients
All
n = 1041) n = 106Urology physicians (board-certified), 4
GHs, 2
Feldman-Stewart, 2012 [7779] (Feldman-Stewart, 2004; Feldman-Stewart, 2001)CAN1, 2, 5, 6, 10, 12, 14Ca clinic centres, 4Patients
>40
n = 811) n = 75Physicians, n = n.r.
Taylor, 2010 [80]USA1, 5, 6, 7, 8, 11UH, 1
Hospital centre, 1
Local PC support groups and newsletters
Patients
All
n = 66 (95 CD users)1) n = 66 (25 non-CD users)Urology physicians, radiation oncology physicians, medical oncology physicians, n = n.r.
Mishel, 2009 [81]USAn.r.Ca centre, 2
Community hospital, 3
VA medical centre, 1
Patients
Age, n.r.
n = 891) n = 93
2) n = 74
Physicians, n = n.r.
Hack, 2007 [82]CAN1, 4, 7, 8, 10Tertiary oncology clinic treatment facilities, 4Patients
>18
n = 2141) n = 211Fully trained radiation oncologists, n = 15
Davison, 2007 [83]CAN1, 2, 5, 6, 8, 9GH-based prostate education and research centre, 1Patients and partners
Age, n.r.
n = 1621) n = 162Urology physicians, n = n.r.
Feldman-Stewart, 2006 [84]CANn.r.Ambulatory Ca centres, 3Patients and family members
Age, n.r.
n = 1521) n = 156Physicians, n = n.r.
Davison, 1997 [85]CAN1, 3, 12Community clinic with practicing urologists, 1Patients
Age, n.r.
n = 301) n = 30Urology physicians, 2
Screening and treatment
Wilt, 2001 [86]USA1, 5, 8PCs at VA centre, 1Patients
≥50
n = 2751) n = 275Physicians, n = n.r.

CAN = Canada; NLD = The Netherlands; SPN = Spain; FIN = Finland; GRC = Greece. LPC = localised prostate cancer; DRE = digital rectal examination; PSA = prostate-specific antigen; AA = African American; n.r. = not reported; CD = CD-ROM-based decision aid.
Settings: VA = Veterans’ affair; PC = primary care clinics/practices; GIMP = general internal medicine practice; AGIMP = academic general internal medicine practice; UH = university hospital; MGP = medical group practice; PP = physician partners; HMO = health maintenance organisations; AMC = academic medical centre; Net = networks; UMC = university medical centre; UCaC = university cancer centre; AGP = academic general practice; GH = general hospital; FMC = family medicine centre/clinic; IC = insurance company; GPs = general/family medicine practices/clinics; Prev = preventive; KP = Kaiser Permanente; UGP = university-affiliated general practice; HGP = hospital-based general practice; HL = health literacy.
Treatment options: 1 = radical surgery (prostatectomy or “surgery”), 2 = cryotherapy (cryosurgery or cryoablation), 3 = lymphadenectomy (lymph node dissection), 4 = transurethral resection of the prostate, 5 = radiotherapy, 6 = brachytherapy (combination of radiotherapy and surgery), 7 = hormone therapy (e.g., orchidectomy, LHRH agonist treatment, antiandrogen or oestrogen), 8 = watchful waiting or active monitoring, 9 = complementary, 10 = no treatment, 11 = no treatment, preference, 12 = other (type not stated), 13 = undecided, 14 = missing.
* Cluster RCT.
† RCTs for which no specific target age was used as eligibility criterion.
‡ RCTs for which age was not used as eligibility criterion.

Attributes of decision-making interventions

The interventions varied widely in their delivery mode, form, and content (table 3). SDM was considered within the context of primary care in 55.5% (n = 20) of the RCTs, multidisciplinary healthcare in 19.4% (n = 7), hospital care in 14.0% (n = 5), specialised care in 8.3% (n = 3), and from a population perspective in 2.8% (n = 1). The interventions were delivered on-site (n = 14), home (n = 9), on-site or home (n = 9), home or on-site combined with other settings (n = 3), and face-to-face or by telephone (n = 1). Most interventions (n = 28) were delivered before consultations, interviews or questionnaires, and a few were delivered during (n = 6) or after (n = 2) consultations or questionnaires. The interventions were self-administered in 20 (55.6%) RCTs, exclusively delivered by clinicians or research staff in 10 (27.8%) RCTs, and either delivered by research staff or clinicians guided patients in 6 (16.7%) RCTs.

Table 3

Characteristics of decision-making interventions for prostate cancer screening and treatment.

First author, publication year [reference]Healthcare contextStrategyFormat and delivery modeDelivery time and locationHealth literacy or numeracyIntervention and randomised patients, nComparator(s) and randomised patients, n
Screening
Lewis, 2015 [37]General medicineSingle vs multifaceted• DVD and/or letter in paper format
• Self-administered
• Before consultation
• On-site clinic or home
Unclear/n.r.DVD DESI; n = 8311) Invitation to participate in SMA appointment with provider and other patients; n = 840
2) PSA DVD DESI + SMA; n = 828
3) No additional intervention material; n = 828
Tomko, 2015 [3841] (Starosta, 2015; Tomko, 2015; Taylor, 2013)Multidisciplinary (hospital and specialised)Single• Web-based and print-based
• Self-administered
• Before telephone interview (1 mo) (not tied to consultation)
• Home
YesWeb-based DA; n = 6311) Print-based DA; n = 630
2) UC; n = 632
Wilkes, 2013 [42]General medicineMultifaceted• Interactive web-based
• Self-administered
• Patient: 60 min before consultation; physician: before patient visits
• Intervention delivery location: n.r.; control: on-site clinic
n.r.Web-based physician education + web-based patient activation + access to CDC brochure; n = 19 waiting areas, 113 patients, 36 physicians1) Web-based physician education + access to CDC brochure; n = 19 waiting areas, 246 patients, 41 physicians
2) UC practice: CDC educational brochures; n = 17 waiting areas, 353 patients, 43 physicians
Williams, 2013 [43]Multidisciplinary (hospital and specialised)Single• Print-based
• Self-administered
• Before screening exam
• on-site clinic or home
YesDA-Home CDC-adapted booklet; n = 1381) Fact sheet DA-Clinic NCI booklet; n = 134
2) UC at home; n = 137
3) UC at clinic; n = 134
Landrey, 2013 [44]General medicineSingle• Print-based flyer
• Self-administered
• 1 week before annual health maintenance visit
• Home
YesFlyer with patient encouragement to talk with providers; n = 1451) UC with no flyer; n = 158
Sheridan, 2012 [45]General medicineMultifaceted vs single• Video, coaching sessions and counselling and print-based brochure
• Physicians or self-administered
• 1 hour before consultation
• On-site clinic (private room)
Unclear/n.r.Video-based DA + coaching session + supplemental brochure; n = 601) Educational video on highway safety; n = 70
Lepore, 2012 [46]Population-basedMultifaceted• Print-based and telephone
• Interventionists (graduate students with training in public health and health education) and trained graduate-level health educators
• Health insurance or at consultation
• Home
YesTelephone tailored education sessions + low literacy educational pamphlet; n = 2441) Attention control: telephone tailored education sessions (fruit and vegetable consumption) + educational pamphlet; n = 246
Myers, 2011 [47]General medicineMultifaceted• Face-to-face counselling sessions
• Physicians
• At consultation visit for non-acute care
• On-site clinic
Unclear/n.r.Enhanced intervention: structured decision counselling session + generic note in medical chart to prompt discussions with physician + informational brochure; n = 1561) SC: practice quality assessment survey + generic note in medical chart to prompt discussions + informational brochure; n = 157
Evans, 2010 [48]General medicineSingle• Web-based and text (from web)
• Self-administered
• Not tied to consultation (men identified from patients' registry), but delivered before patients' filling out questionnaire
• Home or other settings
Unclear/n.r.Web-based DA Prosdex interactive program; n = 1291) Paper-based DA Prosdex; n = 126
2) Control questionnaire; n = 127
3) Control no questionnaire (received nothing); n = 132
Stamatiou, 2008 [49]Multidisciplinary (hospital and specialised)Single vs multifaceted• Print-based illustrated leaflet
• Self-administered
• During pre-test interview and before consultation
• On-site clinic or home
YesPre-test interview with physician + illustrated educational leaflet; n = 5481) UC: pre-test interview with physician and physician's advice; n = 587
Frosch, 2008 [50]General medicineMultifaceted vs single• Internet-based
• Self-administered
• 2–3 weeks before health appraisal consultation
• Anywhere (internet): home or work
Unclear/n.r.Web-based traditional DA; n = 1551) Web-based CDTM; n = 153
2) Web-based TDA + web-based CDTM (n = 152); n = 152
3) Web links to screening sites from ACS and CDC; n = 151
Volk, 2008 [51]General medicineSingle• Video (interactive edutainment), audio booklet
• For subjects at the low-literacy site: RA read material
• For subjects at the high-literacy sites: self-administered
• RA were available to assist men with using the aids
• Before consultation
• On-site clinic
YesEdutainment: interactive and entertainment multimedia DA with medical information combined with storyline; n = 2241) Audio booklet without interactivity and entertainment factors; n = 226
Krist, 2007 [52, 53] (Woolf, 2005)General medicineSingle• Internet link to web-based or paper-based
• Self-administered
• Within 2 weeks of consultation
• Home
Unclear/n.r.Web-based DA; n = 2261) Pamphlet (paper version of web-based) DA; n = 196
2) UC with no pre-visit educational material; n = 75
Kripalani, 2007 [54]HospitalSingle• Print-based pamphlets in high detail or low detail
• Self-administered
• Before consultation
• On-site clinic (waiting room)
YesHigh-detail patient educational pamphlet to promote SDM; n = 1011) Low-detail “Talk to your doctor” Cue handout; n = 101
2) Attention control: pictured traditional food pyramid; n = 101
Partin, 2006 [55, 56] (Partin, 2004)General medicineSingle• Video or print-based pamphlet
• Self-administered
• Within 2 weeks before consultation
• Home
YesVideo “The PSA Decision: What YOU Need to Know” by the FIMDM; n = 3841) Pamphlet developed for study; n = 384
2) UC and whatever decision-making support provided in routine appointments; n = 384
Watson, 2006 [57]General medicineMultifaceted vs single• Print-based
• Self-administered
• Not tied to consultation, but delivered at same time as questionnaire
• Home
YesBrief patient DA leaflet + questionnaire; n = 9801) Control questionnaire only; n = 980
Myers, 2005 [58]General medicineMultifaceted vs single• Print-based booklet and face-to-face educational sessions
• Self-administered or trained health educator
• Before consultation
• On-site clinic or home
YesEnhanced intervention: informational booklet + decision education session by telephone; n = 1211) SC: informational booklet; n = 121
Gatellari, 2003 [59]General medicineSingle• Print-based booklet and pamphlet
• Self-administered
• Before consultation
• On-site clinic
YesEvidence-based booklet; n = 1261) Pamphlet by the Australian government; n = 122
Frosch, 2003 [60, 61] (Frosch, 2001)General medicineSingle• Videotape DA and web-version of videotape DA
• Self-administered
• Before (30 min or until time/date of) health appraisal consultation
• On-site clinic (videotape) or anywhere (web-based)
Unclear/n.r.Web-based DA; n = 1141) Video DA; n = 112
Volk, 2003 [62, 63] (Volk, 1999)General medicineMultifaceted (video and brochure)• Video or print-based (brochure)
• Self-administered
• Before consultation
• on-site clinic (video) or home (brochure)
YesEducational video by the FIMDM + accompanying brochure; n = 801) No intervention before visit + brochure after 2 week follow-up assessment; n = 80
Schapira, 2000 [64]General medicineMultifaceted vs single• Print-based pamphlet
• Self-administered and RA present and available to answer questions
• 2 weeks before consultation
• On site clinic
YesPamphlet DA about prostate cancer screening and treatment + educational information included in comparator pamphlet; n = 1221) Basic information pamphlet; n = 135
Davison, 1999 [65]General medicineMultifaceted vs single• Verbal and written (information)
• Physician (intervention) or investigator (control)
• Before periodic health examination
• On-site clinic
Unclear/n.r.Verbal and written information with encouragement to discuss with physician and to participate decision-making; n = 501) Attention control: discussion about general issues; n = 50
Wolf, 1998 [66, 67] (Wolf, 1996)General medicineSingle• Written (information)
• RA (read aloud the interventions)
• Before consultation
• On-site clinic
YesScripted overview of PSA screening; n = 1031) Brief control message about PSA availability; n = 102
Treatment
Chabrera, 2015 [68]Multidisciplinary (hospital and specialised)Single• Print-based booklet
• Self-administered
• After first consultation
• Take-home with on-site explanation (by physicians and nurses)
Unclear/n.r.Printed booklet DA with information, values clarification exercise and interview preparation material for consultation; n = 731) Standard information; n = 74
Berry, 2013 [6971] (Berry, 2012; Bosco, 2012)Multidisciplinary (hospital and specialised)Single• Computer (touch-screen in clinic or computer at home), text, print-based, video
• Self-administered
• Before consultation
• On-site clinic or home
YesTailored internet aid; n = 2661) Website links to established information about prostate cancer; n = 228
Hacking, 2013 [72]HospitalSingle• Face-to-face communication-interaction
• RA
• Before consultation
• Face-to-face meeting or telephone
YesCoaching DA: preparing for tailored personal consultation plan; n = 631) UC pathway with discussion of treatment options with specialists; n = 60
van Tol-Geerdink, 2013 [73]HospitalSingle• Face-to-face semi-structured interview and written information
• Researcher
• Before second consultation (when participants elaborated on treatment choice with urologist)
• On-site clinic or home
YesSemi-structured interview consultation DA to provide information + discussion of treatment choice with specialists; n = 1631) UC with discussion of treatment options with specialists; n = 77
Huang, 2014 [7476] (Auvinen, 2004; Auvinen, 2001)HospitalMultifaceted vs single• Verbal and written (structured information)
• Physicians in both groups
• During consultation
• On-site clinic
Unclear/n.r.Enhanced participation: patient-defined role in decision-making actively emphasised and discussions with urologist + structured information on treatment options; n = 1041) SC protocols; n = 106
Feldman-Stewart, 2012 [7779] (Feldman-Stewart, 2004; Feldman-Stewart, 2001)Specialised (cancer)Multifaceted vs single• Computer program and interview
• Self-administered and interview by RA (available to answer questions about using DA computer program)
• Between initial (doctor presents the treatment options) and second (~1 week later when treatment decision is made) consultation
• On-site clinic
Unclear/n.r.Computer DA interview with well-structured information and Value Clarification Exercises; n = 811) Computer DA interview with well-structured information and general questions; n = 75
Taylor, 2010 [80]Multidisciplinary (hospital and population-based)Multifaceted• CD-ROM and interactive tools
• Self-administered (home) or research staff (at study research offices)
• After first (baseline) telephone interview (material mailed sixteen days (median) after biopsy) but before (1 mo) follow-up telephone interview
• On-site study office or home
n.r.Information CD + interactive decision tools; n = 661) Information CD; n = 66
Mishel, 2009 [81]Multidisciplinary (hospital and specialised)Multifaceted vs single• Video DVD, booklet and telephone calls
• Self-administered and telephone calls by nurse (trained in the study intervention)
• 10 days to 2 weeks before consultation
• Home
YesTS: DVD + booklet + 4 telephone calls to patients and primary support person; n = 891) TD: DVD + booklet + 4 telephone calls to patients only; n = 93
2) UC: handout on staying healthy during treatment; n = 74
Hack, 2007 [82]Specialised (cancer)Single• Audiotape recording
• Clinical research nurse
• During consultation (recording of clinical encounter)
• on-site clinic
Unclear/n.r.Audiotape: audio recording of clinical encounter; n = 2141) Consultation not audiotaped; n = 211
Davison, 2007 [83]Hospital careMultifaceted• Written information
• Videotape, telephone,
research nurse
• Within 10 days of being referred and before consultation
• On-site (patient-education) centre
Unclear/n.r.Individualised information printout based on preferences and disease + written information package + telephone call weeks later + encouragement to bring significant others to appointment; n = 1621) Generic information videotape + written information package + telephone call four weeks later + encouragement to bring significant others to appointment; n = 162
Feldman-Stewart, 2006 [84]Specialised (Cancer)Single• Print-based booklet
• Self-administered
• Before and after the evaluation questionnaires; after first consultation (consent), but before (reading the intervention) the AFTER questionnaire
• Home
YesCCE information booklet; n = 1521) Standard information booklet developed by AstraZeneca routinely provided to patients; n = 156
Davison, 1997 [85]General medicineMultifaceted (verbal and written)• Booklet, written and verbal
• Research staff and nurse gave interviews in preparation for consultation and helped patients in the intervention group
• Before treatment consultation
• On-site clinic
Unclear/n.r.Empowerment intervention - interview preparing for consultation; n = 301) Written information package; n = 30
Screening and treatment
Wilt, 2001 [86]General medicineSingle• Print-based pamphlet
• Self-administered
• 7–10 days before consultation
• Home
YesQuestion and answer printed sheets; n = 2751) UC alone; n = 275

RA = Research Assistant; n.r. = not reported. DESI = DEcision Support Intervention; SMA = shared medical appointment; NCI = National Cancer Institute; CDC = Centers for Disease Control and Prevention; ACS = American Cancer Society; TDA = traditional DA; CDTM = Chronic Disease Trajectory Model; FIMDM = Foundation for Informed Medical Decision Making; TD = treatment direct; TS = treatment supplemented; CCE = Cancer Care and Epidemiology Unit from Cancer Research Institute; UC = usual care; SC = standard care intervention.

A multifaceted strategy was used in nearly half (47.2%) of the studies. Most interventions included material in paper-based (n = 25) format although some included web-based (n = 4), paper- and web-based (n = 2), or other format (e.g., interview, audiotape recording; n = 5). Healthcare literacy levels were considered in the development or pilot testing of the interventions in 19 RCTs (52.8%). Of these, one RCT exclusively developed separate interventions for low and high health literacy [51]; in two RCTs interventions were designed for low health-literacy populations [46, 54]; one RCT considered the target population with a literacy expert [58]; and one RCT used tailored literacy with a decision navigator [72].

Elements and key features of SDM interventions

Twenty-five RCTs (70%) intended to assess SDM to some degree (table 4). This intention was not clearly stated in the other 11 RCTs (30%), although the interventions included elements to facilitate or foster SDM in all but one study. “Informed decision-making” was the most frequently (n = 21) used term, whereas only 9 (25%) RCTs used the term SDM. The studies also referred to other terms and measurements relevant to SDM including “weighing up benefits and harms”, “risks”, “pros and cons of options”, “patients’ values”, “preferences”, “promotion of engagement”, “discussions of choices”, “activation” or “participation in decision-making appointments”, “decision role” (e.g., active, passive), “patient autonomy”, “patient centredness”, “knowledge and beliefs”, and “decisional conflict”. The interventions varied widely in the operational framework underlying their development, with the Ottawa Decision Support Framework (n = 5) being the most common among the 23 RCTs that reported using a framework. Other frameworks included the health belief model theory (n = 2), the US Preventive Services Task Force (n = 2), the Patient Centred (n = 2), and another twelve (n = 12) approaches.

Table 4

Elements and key features of decision-making interventions for prostate cancer screening and treatment.

First author, publication year
[reference]
Healthcare contextOperational frameworkElements for fostering SDMKey features of SDM implementation
Study aim to assess SDMIntervention fostering SDMbi-directional interactiona. Information exchange (physician ↔ patients)b. Deliberation (physician ↔ patients)c. Implementation (physician ↔ patients)Class, [a-b-c]
Screening
Lewis, 2015 [37]General medicineUnclear/n.r.YesYesYesYesYesUnclear2, [1-1-?]
Tomko, 2015 [3841]
(Starosta, 2015; Tomko, 2015; Taylor, 2013)
Multidisciplinary (hospital and specialised)YesNoYesUnclearUnclearUnclearUnclear3, [?-?-?]
Wilkes, 2013 [42]General medicineUnclear/n.r.YesYesYesYesYesYes1, [1-1-1]
Williams, 2013 [43]Multidisciplinary (hospital and specialised)Unclear/n.r.NoYesYesYesYesNo2, [1-1-0]
Landrey, 2013 [44]General medicineYesYesYesYesYesYesYes1, [1-1-1]
Sheridan, 2012 [45]General medicineYesYesYesYesYesYesYes1, [1-1-1]
Lepore, 2012 [46]Population-basedYesYesYesYesYesYesUnclear2, [1-1-?]
Myers, 2011 [47]General medicineYesYesYesYesYesYesYes1, [1-1-1]
Evans, 2010 [48]General medicineYesNoYesNoNoNoNo4, [0-0-0]
Stamatiou, 2008 [49]Multidisciplinary (hospital and specialised)YesYesYesYesYesYesUnclear2, [1-1-?]
Frosch, 2008 [50]General medicineUnclear/n.r.NoYesYesYesYesUnclear2, [1-1-?]
Volk, 2008 [51]General medicineYesNoYesYesYesYesUnclear2, [1-1-?]
Krist, 2007 [52, 53]
(Woolf, 2005)
General medicineYesYesYesYesYesYesYes1, [1-1-1]
Kripalani, 2007 [54]HospitalUnclear/n.r.YesYesYesYesYesUnclear2, [1-1-?]
Partin, 2006 [55, 56]
(Partin, 2004)
General medicineYesYesYesYesYesYesNo2, [1-1-0]
Watson, 2006 [57]General medicineYesNoYesNoNoNoNo4, [0-0-0]
Myers, 2005 [58]General medicineYesYesYesYesYesYesYes1, [1-1-1]
Gatellari, 2003 [59]General medicineUnclear/n.r.YesYesYesYesYesYes1, [1-1-1]
Frosch, 2003 [60, 61]
(Frosch, 2001)
General medicineUnclear/n.r.YesYesYesYesYesNo2, [1-1-0]
Volk, 2003 [62, 63]
(Volk, 1999)
General medicineYesYesYesYesYesYesNo2, [1-1-0]
Schapira, 2000 [64]General medicineYesYesYesYesUnclearUnclearUnclear3, [?-?-?]
Davison, 1999 [65]General medicineUnclear/n.r.YesYesYesYesYesYes1, [1-1-1]
Wolf, 1998 [66, 67]
(Wolf, 1996)
General medicineYesNoNoYesNoNoNo4, [0-0-0]
Treatment
Chabrera, 2015 [68]Multidisciplinary (hospital and specialised)YesNoYesUnclearUnclearUnclearUnclear3, [?-?-?]
Berry, 2013 [6971]
(Berry, 2012; Bosco, 2012)
Multidisciplinary (hospital and specialised)YesNoYesYesYesYesNo2, [1-1-0]
Hacking, 2013 [72]HospitalYesYesYesYesYesYesUnclear2, [1-1-?]
van Tol-Geerdink, 2013 [73]HospitalYesNoYesYesYesYesUnclear2, [1-1-?]
Huang, 2014 [7476]
(Auvinen, 2004; Auvinen, 2001)
HospitalUnclear/n.r.YesYesYesYesYesYes1, [1-1-1]
Feldman-Stewart, 2012 [7779]
(Feldman-Stewart, 2004; Feldman-Stewart, 2001)
Specialised (cancer)YesYesYesYesYesYesYes1, [1-1-1]
Taylor, 2010 [80]Multidisciplinary (hospital and population-based)Unclear/n.r.NoYesNoNoNoNo4, [0-0-0]
Mishel, 2009 [81]Multidisciplinary (hospital and specialised)YesYesYesYesYesYesYes1, [1-1-1]
Hack, 2007 [82]Specialised (cancer)Unclear/n.r.YesYesYesYesYesYes1, [1-1-1]
Davison, 2007 [83]Hospital careYesYesYesYesYesYesYes1, [1-1-1]
Feldman-Stewart, 2006 [84]Specialised (cancer)Unclear/n.r.YesYesYesNoNoNo4, [0-0-0]
Davison, 1997 [85]General medicineYesYesYesYesYesYesYes1, [1-1-1]
Screening and treatment
Wilt, 2001 [86]General medicineUnclear/n.r.YesYesYesYesYesUnclear2, [1-1-?]

n.r. = not reported. General medicine = general, internal, family and/or community practice clinics, preventive medicine, Veterans’ affair or primary practice clinics. Class: 1 = SDM, 2 = partial SDM, 3 = unclear deliberation, 4 = no SDM: no deliberation. Each SDM key feature [a-b-c] was coded as 1 = criteria met, 0 = criteria not met, or unclear (?) = judgement could not be made owing to unclear or lack of reporting (see table S4 in appendix 1).

The extent of SDM implementation varied widely among studies (tables 2 and 4). Overall, 31 (86.1%) RCTs were verified as showing bi-directional interactions between patient and healthcare provider. Of these, 28 (77.8%) RCTs showed bi-directional interactions for information exchange and deliberation, but only 14 (50%) were verified as having built consensus for decisions about screening or treatment options. Of the 31 (86.1%) RCTs in which decision-making involved at least two parties, 45.2% (screening, n = 8; treatment, n = 6) fulfilled the three key SDM features: nine considered SDM within the context of primary care and five within the context of hospital and/or specialised care. Another 45.2% (screening, n = 10; treatment, n = 3; screening and treatment, n = 1) met the criteria for partial SDM (verified deliberation); 3.2% (treatment, n = 1) had all key SDM features difficult to verify (unclear deliberation), and 6.4% (screening, n = 1; treatment, n = 1) had the characteristics of no SDM. The other five (13.9%) of the 36 included RCTs, showed unclear deliberation (screening, n = 1; treatment, n = 1) or no SDM (screening, n = 2; treatment, n = 1).

Discussion

In this systematic review, we identified 36 RCTs of interventions aiming to facilitate SDM for screening and treatment of prostate cancer in a variety of settings and populations. The majority of RCTs were from North America, mainly the USA (n = 22). Most of the participating men were 40 to 86 years old and more than half (55.6%) were recruited from primary care. There was a wide variation in the minimum age (range: 40–55) at which men were targeted to be screened for prostate cancer with starting cut-off ages at 40, 45, 50, 55 years, and 18 years in one study. Primary care physicians or nurse practitioners participated in at least a third of the studies, whereas specialised physicians participated in less than a third of the studies. Most studies addressed decision-making for prostate cancer screening, with PSA being the most (78.3%) frequently used method of diagnosis. The interventions differed widely in delivery mode, format and content.

Our approach for assessing the implementation of SDM interventions was based on the criteria defined by Charles et al. [24, 35]. The model distinguishes the roles and responsibilities of the relationship between patient and healthcare provider for SDM compared with other models of decision-making. The essential characteristic of SDM is the bi-directional interaction between patient and healthcare provider which places SDM in the middle between a paternalistic and an informed-decision approach. Patients (and/or related parties) and healthcare providers need to actively adopt a set of behaviours in each of the analytic stages, namely information exchange, deliberation and decision implementation [35]. Our approach also supports deliberation as the key feature to accomplish SDM in routine practice, in keeping with Elwyn et al. [87].

We found that different strategies are used to encourage participation in decision-making, and interventions might be considered to facilitate SDM, although they might not be explicitly termed as such. Informed decision-making is the most frequently used term in the literature and it could be either a stand-alone strategy to facilitate SDM, or one component of multi-faceted interventions. SDM could also be measured as a process (e.g., recording consultations) or can be conceptualised as an outcome.

The quality of implementation of SDM interventions varied widely among studies. In most, the interventions were consistent in providing information, and the majority (n = 28) intended to involve deliberation to some degree. In fact, interventions were mostly delivered before consultations, interviews, evaluations or questionnaires as an attempt to empower patients. However, only 38.9% (n = 14) met the key criteria for SDM as proposed by Charles et al. [35]. Interestingly, half of the treatment studies, compared with nearly 35% of the screening studies, achieved the three key SDM features.

Given the prevalence of prostate cancer, that SDM is guideline recommended and viewed as the fundamental component of all interactions between patients and -healthcare providers, it is surprising to find only a small number of studies on the effects of SDM for prostate cancer, especially treatment. However, nearly half (44.5%) of the included studies were published from 2010 onwards, which might indicate a growing area of research. In addition, most (55.5%) studies considered decision-making within the context of primary care by general practitioners, and only a few evaluated decision-making in the context of specialised care by urologists or oncologists. Moreover, the study interventions were developed to target mostly patients (88.9%), rarely involving the patients’ significant others (e.g., family members, carers) despite recommendations that views and participation from others in decision-making may lead to more efficient and effective healthcare [29, 88].

Our review confirms an increase in the development of SDM interventions for prostate cancer. It also confirms the lack of both consensus on the definition of SDM and guidance for SDM implementation in routine practice. Makoul et al. [14] identified a range of 31 different SDM definitions and, as noted in our review, their recommendations for a single and more integrative concept of SDM are yet to be followed. Future research should consider that this variability might make comparison across studies difficult, and that consistent reporting of interventions and their components could allow better estimation of SDM implementation. Involving others (e.g., patients’ carers or relatives) in the process of decision-making might affect patient outcomes and should be considered in further research. Nevertheless, our results merit further evaluation of their impact on patient outcomes.

Strengths and limitations

To our knowledge, this is the first systematic review about SDM implementation for both screening and treatment for prostate cancer. As such, this review focused on assessing and describing the reported SDM interventions and their implementation in clinical practice based on the SDM model. Given the lack of a single SDM definition, we considered the diversity in the type of interventions that would be compatible with SDM. Various reviews have focused on decision aids. We used a broad definition of SDM interventions and did not limit our search strategy exclusively to the term “shared decision-making” or “decision aids”. We used a range of search terms relevant to decision-making, including SDM and decision aids. We applied broad inclusion criteria at the screening stage and full-text evaluation, and included studies regardless of whether a specific decision was promoted. Our review also covered international literature with no restriction to countries or type of healthcare provider. We included literature published in English only, and academic databases were searched up to March 2015. However, we made considerable efforts to identify all relevant studies by comprehensively searching both peer-reviewed and grey (accessed: February–August 2016) literature in twelve sources. We also contacted authors (2015–2017) of abstracts for which full texts were not available, increasing the chance of identifying more literature that is contemporary. Our work thus benefited from the response of authors, which led to the identification of more studies and thus more complete data were considered for eligibility. Moreover, our method for evaluating the implementation of SDM confirmed that research gaps in the conceptualisation of SDM continue despite previous recommendations [14]. We used the SDM model by Charles et al. [35] because it represents only one SDM concept, and it is the most prominent [14] approach to viewing SDM compared with other models of decision-making. Our review thus presents the elements and key features of SDM interventions and provides an overview of the extent of SDM implementation for prostate cancer.

Our review was limited by the quality of reporting of intervention details, which made the verification of SDM criteria difficult at times. Thus we cannot exclude the possibility that we underestimated SDM implementation. Many studies were published within the last decade, but the use of frameworks was lacking in nearly a third of them.

Conclusions

There is a significant variation in the components of SDM interventions for prostate cancer screening and treatment. Only 39% of the studies contained the SDM intervention components suggested in the SDM model, and interventions were implemented mostly within the context of primary care. These results merit further evaluation on patient outcomes. There might be strong ethical, medical and interpersonal reasons to recommend SDM. However, to date there seems to be uncertainty about the SDM concept, intervention content, and how to implement SDM in practice. A standardised SDM definition and guidance for SDM implementation in practice that is feasible for several clinical settings are needed.

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Appendix 1: Supplementary tables

The supplementary tables are available in a separate file for downloading at: https://smw.ch/en/article/doi/smw.2018.14584/

Table S1

PRISMA checklist.

Table S2

Search strategy for OVID Medline.

Table S3

Models of shared decision-making.

Table S4

Method for assessing the key features of SDM implementation.

Table S5

Characteristics of study, population and interventions of 36 randomised clinical trials in review.

Martínez-González Nahara Anani, Plate Andreas, Senn Oliver, Markun Stefan, Rosemann Thomas, Neuner-Jehle Stefan

Institute of Primary Care, University of Zurich and University Hospital of Zurich, Switzerland

NAMG wrote the manuscript. NAMG, OS and SNJ conceived and designed the review. NAMG designed the data extraction forms. NAMG, AP, SM, OS and SNJ tested the data extraction forms, screened and selected studies. NAMG and AP extracted and verified the data. NAMG, AP, SM, SNJ performed the studies assessment. NAMG performed the analyses. TR revised the manuscript and contributed to its improvement. All authors revised and contributed to improving the manuscript, and read and approved the final manuscript.

We are grateful to Martina Gosteli, librarian from the main library of the University of Zurich, for her assistance with the search strategies. We are also grateful to Donna L. Berry, Bettina Meiser, Michael A. Diefenbach, Glenn Salkeld, Alan L. Kaplan, Kathryn L. Taylor, Daniel D Matlock, Alexander H. Krist, Roshan Bastani, Andrew Stephenson and Alison Hermann for providing access to their publications and/or for providing additional information from the original studies.

No financial support and no other potential conflict of interest relevant to this article was reported.

Nahara Anani Martínez-González, RA, Institute of Primary Care, University Hospital Zurich, University of Zurich, Pestalozzistrasse 24, CH-8091 Zürich, Nahara.Martinez[at]usz.ch

systematic review, shared decision-making, prostate cancer, screening, treatment, randomised controlled trials