Shared decision making for men facing prostate cancer treatment: a systematic review of randomized controlled trials

Figures & data

Figure 1 Process of identification and selection of studies.

Abbreviations: GDL, guidelines; SR, systematic reviews; SDM, shared decision-making.

Table 1 Characteristics of included studies

Author, year, country	Health care context, setting and facilities, n	Target population	Patients with chosen treatment^† (%)	Intervention(s) & randomized patients, N	Comparator(s) & randomized patients, N	Age: mean (SD) & target (range), years	Race or ethnicity, %			Married, %	Education	Employed, %	HCP
							White	Black	Hispanic
Mishel et al, 2009^Citation24 USA	Multidisciplinary (hospital and specialized) Cancer center, n=2 Community hospital, n=3 Veterans’ medical center, n=1	Men with biopsy-confirmed localized PC, no major cognitive impairment, ability to read, access to telephone, no prior cancer history, and a patient-designated PSP willing to participate in the study	NR	1) Treatment supplemented: Communication strategy DVD + Information Booklet + 4 Telephone calls by same nurse to patients and PSP; N=89 2) Treatment direct: Communication strategy DVD + Information Booklet + 4 Telephone calls by nurse; N=93	Handout on staying healthy during treatment; N=74	62.5 (7.4)	71.5	28.5	0	80.8	15.1 (SD 3.4) years of education	56.6	NR
Hack et al, 2007^Citation23 Canada	Specialized (Cancer) Tertiary oncology clinic treatment facilities, n=4 (in 3 cities)	Men with confirmed diagnosis of PC, presenting to a tertiary oncology clinic for their primary treatment consultation, without cognitive impairment disabling them from providing informed consent	Radical prostatectomy (10.7) Hormone therapy (18.0) Watchful waiting (43.9) No treatment (25.4) Other (2.0)	Audiotape: Audio recording of primary treatment consultation: 1) Audiotape given to men, N=120; and 2) Given choice to receive audiotape or not, N=94	No audiotape: 1) Consultation not audiotaped: no audio recording of primary treatment consultation, N=113; and 2) Not given audiotape: audio recording without giving audiotape, N=98	67.0 (8.0) (>18)	NR	NR	NR	84	43.5% with more than HS	NR	Radiation oncologists, n=15
Davison et al, 2007^Citation22 Canada	Hospital care General hospital, n=1	Men with biopsy-confirmed localized PC, aware of their diagnosis, who had an initial urologic treatment consultation, but not scheduled for definitive treatment within the following 4 weeks, and able to read and write English Men’s partners were included in the sessions if they accompanied the patient	Radical prostatectomy (76.5) External beam radiation (6.8) Brachytherapy (10.5) Watchful waiting (5.1) Complementary (0.3) Cryotherapy (0.3) Unknown/NR (0.3)	Generic information 24-min videotape with section on the identification of men’s preferences + Information printout individualized according to patient’s disease characteristics + Written information package with list of relevant info and help sources + Telephone calls by RN approx. 4 weeks after visits; N=162 Men encouraged to bring PSP and were included in the sessions if present	Generic information 24-min videotape + Written information package with list of relevant info and help sources; N=162 Men encouraged to bring PSP and were included in the sessions if present	62.4 (6.9)	NR	NR	NR	85.4	68.8% with more than HS	59.3	NR
Davison et al, 1997^Citation25 Canada	General medicine Community clinic with practicing urologists, n=1	Men newly diagnosed with PC (stage not specified), aware of their diagnosis, who had not have an initial treatment consultation, with no evidence of mental confusion, able to read, speak and write English	Pelvic lymph node dissection (NR) Radical prostatectomy (NR) Other (NR)	Written information package + Blank audiotape (optional) to record consultation + Interview with nurse with elements of patient empowerment to prepare men for consultation and to encourage participation in DM; N=30 Men encouraged to bring PSP to the treatment consultation	Written information package only; N=30	67.9 (7.1) (41–81)	NR	NR	NR	86.6	41.7% with at least HS Overall: 10.8 (SD 2.8) years of education	28.3	Urology physicians, n=2

Notes: ^†Hack, 2007: 449 patients received/selected treatment by the time of consultation; “Other” = transurethral resection of the prostate, orchiectomy. Davison, 2007: 294 patients. Davison, 1997: 75% of the men started/received treatment by the time of second interview.

Abbreviations: DM, Decision Making; HCP, Health care Professional(s); HS, High School; NR, Not Reported; PC, Prostate Cancer; PSP, Primary Support Person (eg, wife).

Table 2 Methodological features of included studies

Author, year	Country & funding	Outcome definition	Participants criteria	Study size	Sample size calculation and power	Groups comparable at baseline	Adequate sequence generation	Adequate allocation concealment	Adequate blinding	Attrition (outcome), % (range)	Adequate follow-up	ITT data
Mishel et al, 2009^Citation24	USA, non-profit	Primary & Secondary	Inclusion: yes Exclusion: yes	N>200	nr	partially^†	Yes	Unclear	HCP: unclear Participants: unclear OA: unclear	Unclear	Yes	Unclear
Hack et al, 2007^Citation23	Canada, non-profit	Primary	Inclusion: yes Exclusion: nr	N>200	Yes	Yes	Yes	Yes	HCP: yes Participants: yes OA: nr	<20%	Yes	No
Davison et al, 2007^Citation22	Canada, non-profit	Primary	Inclusion: yes Exclusion: nr	N>200	Yes	Yes	Yes	Yes	HCP: unclear Participants: yes OA: no	<20% (9.26–9.57) or unclear	Yes	No
Davison et al, 1997^Citation25	Canada, non-profit	Primary	Inclusion: yes Exclusion: nr	N<200	nr	Yes	Yes	Unclear	HCP: no Participants: no OA: no	Unclear	Yes	Unclear

Notes: ^†Patients in the control group had higher level of education than patients in the treatment direct group.

Abbreviations: HCP, Health care Professionals; OA, Outcome Assessors; nr, not reported.

Table 3 Outcome effect estimates for SDM compared to usual care for decisions about prostate cancer treatment

Author, year	Outcome	Measurement method/tool	Measurement point	Intervention			Control			Effect estimate
BINARY DATA				SDM	Patients, n	Total patients, N	Usual Care	Patients, n	Total patients, N	RR (95% CI)
AFFECTIVE COGNITIVE OUTCOMES
Patient Satisfaction
Davison et al, 2007^Citation22	Satisfaction with treatment choice	10-item questionnaire based on 5-point Likert scale^†	4–10 weeks after visit - after men had made a treatment decision with/out their urologist	Generic information 24-min videotape with section on the identification of men’s preferences + Information printout individualized according to patient’s disease characteristics + Written information package with list of relevant info and help sources + Telephone calls by RN approx. 4 weeks after visits	141	149	Generic information 24-min videotape + Written information package with list of relevant info and help sources	135	145	1.02 (0.96 to 1.08)
Davison et al, 2007^Citation22	Satisfaction with level of involvement in decision making	5-item questionnaire based on 5-point Likert scale^‡	4–10 weeks after visit - after men had made a treatment decision with/out their urologist	Generic information 24-min videotape with section on the identification of men’s preferences + Information printout individualized according to patient’s disease characteristics + Written information package with list of relevant info and help sources + Telephone calls by RN approx. 4 weeks after visits	142	149	Generic information 24-min videotape + Written information package with list of relevant info and help sources	133	145	1.04 (0.98 to 1.10)
CONTINUOUS DATA				SDM	mean (SD)	Total patients, N	Usual Care	mean (SD)	Total patients, N	SMD (95% CI)
AFFECTIVE COGNITIVE OUTCOMES
Knowledge
Mishel et al, 2009^Citation24	PC knowledge	20-item questionnaire (true/false/do not know)^‡	4 weeks post-entry when treatment decision making meeting had occurred	1) Treatment supplemented: Communication strategy DVD + Information Booklet +4 Telephone calls by same nurse to patients and PSP	15.02 (3.00)	89	Handout on staying healthy during treatment	13.88 (3.83)	74	0.33 (0.02 to 0.64)
Mishel et al, 2009^Citation24	PC knowledge	20-item questionnaire (true/false/do not know)^§	3 months post-entry after patients had started their treatment	1) Treatment supplemented: Communication strategy DVD + Information Booklet +4 Telephone calls by same nurse to patients and PSP	15.21 (2.48)	89	Handout on staying healthy during treatment	14.51 (3.32)	74	0.24 (−0.07 to 0.55)
Mishel et al, 2009^Citation24	PC knowledge	20-item questionnaire (true/false/do not know)^§	4 weeks post-entry when treatment decision making meeting had occurred	2) Treatment direct: Communication strategy DVD + Information Booklet +4 Telephone calls by nurse	15.02 (3.00)	93	Handout on staying healthy during treatment	13.88 (3.83)	74	0.33 (0.03 to 0.64)
Mishel et al, 2009^Citation24	PC knowledge	20-item questionnaire (true/false/do not know)^§	3 months post-entry after patients had started their treatment	2) Treatment direct: Communication strategy DVD + Information + 4 Telephone calls by nurse	15.51 (2.36)	93	Handout on staying healthy during treatment	14.51 (3.32)	74	0.35 (0.04 to 0.66)
Mishel et al, 2009^Citation24	PC knowledge	20-item questionnaire (true/false/do not know)^§	4 weeks post-entry when treatment decision making meeting had occurred	1) +2)	15.02 (3.00)	182	Handout on staying healthy during treatment	13.88 (3.83)	74	0.35 (0.08 to 0.62)
Mishel et al, 2009^Citation24	PC knowledge	20-item questionnaire (true/false/do not know)^§	3 months post-entry after patients had started their treatment	1) +2)	15.36 (2.42)	182	Handout on staying healthy during treatment	14.51 (3.32)	74	0.31 (0.04 to 0.58)
Satisfaction with preparation for Decision Making
Davison et al, 2007^Citation22	satisfaction with preparation for treatment decision making with respect to information received	10-item questionnaire based on 5-point Likert scale^a	4–10 weeks after visit - after men had made a treatment decision with/out their Urologist	Generic information 24-min videotape with section on the identification of men’s preferences + Information printout individualized according to patient’s disease characteristics + Written information package with list of relevant info and help sources + Telephone calls by RN approx. 4 weeks after visits	2.8 (0.84)	149	Generic information 24-min videotape + Written information package with list of relevant info and help sources	2.67 (0.71)	145	0.17 (−0.06 to 0.4)
Perception of Being Informed
Hack et al, 2007^Citation23	perception of having been informed (total score)	9-item measure of patient satisfaction with communication with oncologist^¶	12 weeks post-consultation	Audiotape: audio recording of clinical encounter	21.83 (3.78)	214	Consultation not audiotaped	21.01 (4.31)	211	0.20 (0.01 to 0.39)
Hack et al, 2007^Citation23	perception of having been informed about treatment alternatives	9-item measure of patient satisfaction with communication with oncologist^¶	12 weeks post-consultation	Audiotape: audio recording of clinical encounter	4.73 (0.74)	214	Consultation not audiotaped	4.56 (1.03)	211	0.19 (−0.00 to 0.38)
Hack et al, 2007^Citation23	perception of having been informed about side effects of treatment	9-item measure of patient satisfaction with communication with oncologist^¶	12 weeks post-consultation	Audiotape: audio recording of clinical encounter	4.63 (0.87)	214	Consultation not audiotaped	4.37 (1.17)	211	0.25 (0.06 to 0.44)
Mood State/Disturbance
Mishel et al, 2009^Citation24	mood disturbance caused by the personal situation, the disease itself or treatment	35-item POMS-SF scale	4 weeks post-entry when treatment decision making meeting had occurred	1) Treatment supplemented: Communication strategy DVD + Information Booklet +4 Telephone calls by same nurse to patients and PSP	33.11 (23.29)	89	Handout on staying healthy during treatment	37.04 (24.64)	74	−0.17 (−0.48 to 0.14)
Mishel et al, 2009^Citation24	mood disturbance caused by the personal situation, the disease itself or treatment	35-item POMS-SF scale	3 months post-entry after patients had started their treatment	1) Treatment supplemented: Communication strategy DVD + Information Booklet +4 Telephone calls by same nurse to patients and PSP	30.00 (20.4)	89	Handout on staying healthy during treatment	32.85 (24.98)	74	−0.13 (−0.44 to 0.18)
Mishel et al, 2009^Citation24	mood disturbance caused by the personal situation, the disease itself or treatment	35-item POMS-SF scale	4 weeks post-entry when treatment decision making meeting had occurred	2) Treatment direct: Communication strategy DVD + Information Booklet +4 Telephone calls by nurse	33.11 (23.29)	93	Handout on staying healthy during treatment	37.04 (24.64)	74	−0.17 (−0.47 to 0.14)
Mishel et al, 2009^Citation24	mood disturbance caused by the personal situation, the disease itself or treatment	35-item POMS-SF scale	3 months post-entry after patients had started their treatment	2) Treatment direct: Communication strategy DVD + Information Booklet +4 Telephone calls by nurse	30.44 (22.06)	93	Handout on staying healthy during treatment	32.85 (24.98)	74	−0.11 (−0.41 to 0.20)
Decisional Conflict
Davison et al, 2007^Citation22	decisional conflict	10-item low-literacy scale^††	4–10 weeks after visit - after men had made a treatment decision with/out their Urologist	Generic information 24-min videotape with section on the identification of men’s preferences + Information printout individualized according to patient’s disease characteristics + Written information package with list of relevant info and help sources + Telephone calls by RN approx. 4 weeks after visits	1.61 (0.33)	148	Generic information 24-min videotape + Written information package with list of relevant info and help sources	1.62 (0.23)	145	−0.04 (−0.26 to 0.19)
Decisional Regret
Mishel et al, 2009^Citation24	decisional regret	3-item subscale of the QoL scale^‡‡	3 months post-entry after patients had started their treatment	1) Treatment supplemented: Communication strategy DVD + Information Booklet +4 Telephone calls by same nurse to patients and PSP	3.93 (1.82)	89	Handout on staying healthy during treatment	4.17 (1.96)	74	−0.13 (−0.44 to 0.18)
Mishel et al, 2009^Citation24	decisional regret	3-item subscale of the QoL scale^‡‡	3 months post-entry after patients had started their treatment	2) Treatment direct: Communication strategy DVD + Information Booklet +4 Telephone calls by nurse	3.83 (1.44)	93	Handout on staying healthy during treatment	4.17 (1.96)	74	−0.2 (−0.51 to 0.11)
Mishel et al, 2009^Citation24	decisional regret	3-item subscale of the QoL scale^‡‡	3 months post-entry after patients had started their treatment	1) +2)	3.88 (1.64)	182	Handout on staying healthy during treatment	4.17 (1.96)	74	−0.17 (−0.44 to 0.1)
HEALTH OUTCOMES
Quality of Life
Mishel et al, 2009^Citation24	men’s perceptions of their overall QoL	10-item VAS^§§	4 weeks post-entry when treatment decision making meeting had occurred	1) Treatment supplemented: Communication strategy DVD + Information Booklet +4 Telephone calls by same nurse to patients and PSP	7.61 (1.79)	89	Handout on staying healthy during treatment	7.33 (2.23)	74	0.50 (0.18 to 0.81)
Mishel et al, 2009^Citation24	men’s perceptions of their overall QoL	10-item VAS^§§	3 months post-entry after patients had started their treatment	1) Treatment supplemented: Communication strategy DVD + Information Booklet +4 Telephone calls by same nurse to patients and PSP	7.57 (1.73)	89	Handout on staying healthy during treatment	7.72 (1.72)	74	0.00 (−0.31 to 0.31)
Mishel et al, 2009^Citation24	men’s perceptions of their overall QoL	10-item VAS^§§	4 weeks post-entry when treatment decision making meeting had occurred	2) Treatment direct: Communication strategy DVD + Information Booklet +4 Telephone calls by nurse	7.61 (1.79)	93	Handout on staying healthy during treatment	7.33 (2.23)	74	0.50 (0.19 to 0.81)
Mishel et al, 2009^Citation24	men’s perceptions of their overall QoL	10-item VAS^§§	3 months post-entry after patients had started their treatment	2) Treatment direct: Communication strategy DVD + Information Booklet +4 Telephone calls by nurse	7.76 (1.56)	93	Handout on staying healthy during treatment	7.72 (1.72)	74	−0.15 (−0.45 to 0.16)

Notes: ^†Scale: 0= not at all, 5= a great deal; items scored and scores converted to 0–100; higher scores = higher levels of satisfaction. ^‡Scores: 1= strongly disagree, 5= strongly agree; higher scores = higher levels of satisfaction. ^§PC knowledge based on uncertainty management measures. Score based on the sum of the number of correct items. ^¶Highest possible satisfaction = score 9. ^††Scores: yes =1.5, no =4.5, unsure =3; range of scores: 15–45; higher scores = higher levels of decision conflict. ^‡‡Scores: higher = greater use of problem solving. ^§§Indexed subjects’ perceptions of their overall QoL. Scores: 1–10 for how positive men felt about their QoL; higher scores = greater QoL.

Abbreviations: SDM, Shared Decision Making; QoL, Quality of Life; POMS-SF, Profile Of Mood States-Short Form; VAS, Visual Analogue Scale; PSP, Primary Supporting Person (eg, wife); RN, Research Nurse; n, number of patients with outcome; N, total number of patients in a group; RR, Relative Risk; SMD, Standard Mean Difference; CI, Confidence Intervals.

Figure 2 Outcomes reported in the included studies.

Notes: Green = quantitative data; Yellow = qualitative data; Red = no outcome data.

Abbreviation: DM, Decision-Making. 

Table S1 PRISMA checklist for the reporting of the systematic review

Section/topic	#	Checklist item	Reported on page #
TITLE
Title	1	Identify the report as a systematic review, meta-analysis, or both.	1
ABSTRACT
Structured summary	2	Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.	1
INTRODUCTION
Rationale	3	Describe the rationale for the review in the context of what is already known.	1-2
Objectives	4	Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).	2
METHODS
Protocol and registration	5	Indicate if a review protocol exists, if and where it can be accessed (eg, Web address), and, if available, provide registration information including registration number.	2
Eligibility criteria	6	Specify study characteristics (eg, PICOS, length of follow-up) and report characteristics (eg, years considered, language, publication status) used as criteria for eligibility, giving rationale.	2
Information sources	7	Describe all information sources (eg, databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.	2
Search	8	Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.	Table S2
Study selection	9	State the process for selecting studies (ie, screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).	2
Data collection process	10	Describe method of data extraction from reports (eg, piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.	2
Data items	11	List and define all variables for which data were sought (eg, PICOS, funding sources) and any assumptions and simplifications made.	2
Risk of bias in individual studies	12	Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.	2
Summary measures	13	State the principal summary measures (eg, risk ratio, difference in means).	2
Synthesis of results	14	Describe the methods of handling data and combining results of studies, if done, including measures of consistency (eg, I^2) for each meta-analysis.	2
Risk of bias across studies	15	Specify any assessment of risk of bias that may affect the cumulative evidence (eg, publication bias, selective reporting within studies).	2
Additional analyses	16	Describe methods of additional analyses (eg, sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.	2
RESULTS
Study selection	17	Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.	3, Figure 1
Characteristics	18	For each study, present characteristics for which data were extracted (eg, study size, PICOS, follow-up period) and provide the citations.	3-4, Table 1
Risk of bias within studies	19	Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12).	4, Table 2
Results of individual studies	20	For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot.	4, 9, Figure 2, Table 3
Synthesis of results	21	Present results of each meta-analysis done, including confidence intervals and measures of consistency.	NA
Risk of bias across studies	22	Present results of any assessment of risk of bias across studies (see Item 15).	Table 2
Additional analysis	23	Give results of additional analyses, if done (eg, sensitivity or subgroup analyses, meta-regression [see Item 16]).	NA
DISCUSSION
Summary of evidence	24	Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (eg, health care providers, users, and policy makers).	9, 16
Limitations	25	Discuss limitations at study and outcome level (eg, risk of bias), and at review-level (eg, incomplete retrieval of identified research, reporting bias).	17
Conclusions	26	Provide a general interpretation of the results in the context of other evidence, and implications for future research.	17
FUNDING
Funding	27	Describe sources of funding for the systematic review and other support (eg, supply of data); role of funders for the systematic review.	No external funding

Notes: Reproduced from: ¹ For more information, visit: www.prisma-statement.org.

Table S2 Search strategy for OVID Medline

Item	Searches
1	exp Decision Making/or Decision Making, Organizational/or Decision Trees/or Decision Making/or Decision Support Techniques/or Decision Support Systems, Clinical/or Decision Making, Computer-Assisted/or exp Computer-Assisted Instruction/or exp Patient Participation/or exp Professional-Patient Relations/or exp “Attitude of Health Personnel”/or Counseling/or exp Health Communication/
2	exp Informed Consent/
3	(choice behavior or decision making or shared decision making).mp,tw.
4	(informed adj3 (consent or choice* or decision*)).mp,tw.
5	((decision* or decid*) adj4 (support* or aid* or tool* or instrument* or technolog* or technique* or system* or program* or algorithm* or process* or method* or intervention* or material*)).mp,tw.
6	(decision adj3 (board* or guide* or counseling)).mp,tw.
7	(computer* adj4 decision making).mp.
8	(patient adj3 (participation or involvement or cent#d care)).mp,tw.
9	((risk communication or risk assessment or risk information) adj4 (tool* or method*)).mp,tw.
10	interact* health communication*.mp,tw.
11	(interact* adj (internet or online or graphic* or booklet*)).mp,tw.
12	(interact* adj4 tool*).mp,tw.
13	((interact* or evidence based) adj3 (risk information or risk communication or risk presentation or risk graphic*)).mp,tw.
14	adaptive conjoint analys#s.mp,tw.
15	or/1–14
16	(Prostat* adj3 (Neoplasm* or Cancer or tumo?r* or carcinoma)).mp,tw.
17	exp Prostatic Neoplasms/
18	16 or 17
19	15 and 18
20	(letter or letter$ or editorial or historical article or anecdote or commentary or note or case report$ or case study).pt,sh.
21	(animals not humans).sh.
22	20 or 21
23	19 not 22
24	exp Randomized Controlled Trial/or exp clinical trial/
25	randomized controlled trial.pt.
26	randomized controlled trial.sh.
27	controlled clinical trial.pt.
28	random allocation.sh.
29	double blind method.sh.
30	single blind method.sh.
31	or/24–30
32	31 not 22
33	exp clinical trial/or exp Clinical Trials as Topic/
34	clinical trial.pt.
35	((singl$ or doubl$ or trebl$ or trpl$) adj25 (blind$ or mask$)).ti,ab.
36	(clin$ adj25 trial$).ti,ab.
37	(random$ or placebo$).ti,ab.
38	(PLACEBO or RESEARCH DESIGN).sh.
39	or/33–38
40	39 not 22
41	40 not 32
42	exp EVALUATION STUDIES/
43	(comparative study or follow up studies or prospective studies).sh.
44	(control$ or prospectiv$ or volunteer$).ti,ab.
45	or/42–44
46	45 not 22
47	46 not (32 or 41)
48	23 and (32 or 41 or 47)

Notes: *Similar strategies were developed in EMBASE (Elsevier), CINHAL (EBSCOHost), The Cochrane Library (Wiley), PsychINFO (EBSCOHost), and Scopus.

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