Table 1.
Characteristics of selected randomized controlled trials
| References/country | Design | Nature of population | Types of elective surgery | Age (mean±SD) | Sample size | Sex (female/male) | Interventions/mode of delivery | Comparisons (comparator) | Outcomes (measures) | Attrition rates (%) | ITT/MDM | Protocol/registration/grant |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allen et al. 50/USA | 2-arm RCT | Hip and knee osteoarthritis | Total hip or knee joint replacement | 61.8±11.7 | T: 155 I: 80 C: 75 |
94/61 | Video-based/self-guided | Active control (computer-based) | Decision conflict (DCS); Knowledge (K-DQI); Preparedness for decision-making; Outcome expectations | 5.8 | Y/N | N/N/N |
| Allen et al. 51/USA | 2-arm stepped-wedge RCT | Heart disease | Destination therapy LVAD placement | 63.4±9.9 | T: 248 I: 113 C: 135 |
39/209 | Video-based/clinician | Usual care | Invasive treatment choice; Decisional conflict (DCS); Decisional regret (DRS); General HRQoL (EQ VAS); Depression (PHQ-2); Perceived stress (PSS) | 33.5 | Y/Y | Y/Y/Y |
| Arterburn et al. 52/USA | 2-arm RCT | Obesity-related chronic health condition | Bariatric surgery | 50.5±9.9 | T: 152 I: 75 C: 77 |
111/41 | Video-based/self-guided | Usual care (booklet control) | Invasive treatment choice; Decisional conflict (DCS); Knowledge; Decision self-efficacy (DSES) | 4.6 | Y/N | N/N/Y |
| Auvinen et al. 53/Finland | 2-arm RCT | Prostate cancer | Radical prostatectomy/orchidectomy | 59.9±26.6 | T: 210 I: 104 C: 106 |
0/210 | Paper-based/clinician | Usual care (standardized treatment protocol) | Invasive treatment choice | 3.3 | Y/Y | N N/Y |
| Berry et al. 54/USA | 2-arm RCT | Prostate cancer | Prostatectomy | 57.4±13.5 | T: 392 I: 198 C: 194 |
0/392 | Computer-based/self-guided | Usual care (links+materials provided in clinic) | Decisional conflict (DCS) | 29.6 | N/Y | N/Y/Y |
| Bozic et al. 55/USA | 2-arm RCT | Osteoarthritis | Hip or knee replacement | 60±NR | T: 198 I: 95 C: 103 |
NR/NR | Video-based/self-guided | Usual care | Invasive treatment choice | 37.9 | N/N | N/Y/Y |
| Coylewright et al. 56/USA | 2-arm RCT | Heart disease | Percutaneous coronary intervention | 68.2±10.5 | T: 124 I: 65 C: 59 |
33/91 | Paper-based/clinician | Usual care | Decisional conflict (DCS) | 7.3 | Y/Y | N/Y/Y |
| De Achaval et al. 57/USA | 3-arm RCT | Knee osteoarthritis | Total knee arthroplasty | 62.8±9.0 | T: 208 I1: 70 I2: 69 C: 69 |
141/67 | Video-based/self-guided | Usual care (booklet control) | Decisional conflict (DCS); Satisfaction with decision-making (DCS) | 1.4 | N/N | N/N/Y |
| Deyo et al. 58/USA | 2-arm RCT | Lumbar spinal stenosis and herniated disk, or nonspecific back pain | Lumbar spine surgery | 52.4±16.5 | T: 393 I: 190 C: 203 |
188/205 | Video-based/self-guided | Usual care (booklet control) | Invasive treatment choice | 12.5 | Y/N | N/N/Y |
| Eden et al. 59/USA | 2-arm RCT | Pregnant women |
Cesarean section | 31.1±NR | T: 131 I: 66 C: 65 |
131/0 | Computer-based/self-guided | Usual care (brochure) | Invasive treatment choice; Decisional conflict (DCS) | 0 | Y/Y | N/Y/Y |
| Goel et al. 60/Canada | 2-arm cluster RCT | Breast cancer | Lumpectomy and mastectomy | 57.5±12.2 | T: 136 I: 86 C: 50 |
136/0 | Audio-based/self-guided | Usual care (pamphlet) | Decisional conflict (DCS); Satisfaction with decision-making (DCS); Knowledge (BCIT-R) | 21.3 | N/N | N/N/N |
| Gökce et al. 61/Turkey | 2-arm RCT | Renal stone | SWL and RIRS | 46.3±5.8 | T: 119 I: 60 C: 59 |
52/67 | Paper-based/self-guided | Usual care (standard information) | Invasive treatment choice; Decisional conflict (DCS) | 3.4 | N/N | N/N/N |
| Hawley et al. 62/USA | 2-arm RCT | Breast cancer | Mastectomy | 56.8±10.8 | T: 537 I: 267 C: 270 |
537/0 | Computer-based/self-guided | Active control (static version of icandecide) | Preparedness for decision-making; Decision quality (SDQ) | 7.6 | Y/Y | Y/Y/Y |
| Heller et al. 63/USA | 2-arm RCT | Breast cancer | Breast reconstruction | 47.0±9.4 | T: 133 I: 66 C: 67 |
133/0 | Computer-based/self-guided | Usual care (standard patient education) | Satisfaction with decision-making | 0 | N/N | N/N/N |
| Hutyra et al. 64/USA | 2-arm RCT | Anterior shoulder dislocations | Operative treatment | 23.6±5.3 | T: 199 I: 100 C: 99 |
45/154 | Computer-based/self-guided | Active control (text-based) | Invasive treatment choice; Decisional conflict (DCS) | 0.5 | N/N | N/N/Y |
| Ibrahim et al. 65/USA | 2-arm RCT | Knee osteoarthritis | Total knee replacement | 59.1±7.2 | T: 336 I: 168 C: 168 |
235/101 | Video-based/self-guided | Usual care (educational booklet) | Invasive treatment choice | 9.5 | Y/N | Y/Y/Y |
| Jayakumar et al. 66/USA | 2-arm RCT | Knee osteoarthritis | Total knee arthroplasty | 62.6±8.4 | T: 145 I: 76 C: 69 |
83/62 | Computer-based/clinician | Usual care (educational material) | Invasive treatment choice; Satisfaction with decision-making; Decision quality (K-DQI); Shared decision-making (CollaboRATE); Condition-specific HRQoL (KOOS JR) | 11 | N/N | Y/Y/Y |
| Jibaja-Weiss et al. 67/USA | 2-arm RCT | Breast cancer | Mastectomy | 51.0±10.9 | T: 100 I: 51 C: 49 |
100/0 | Computer-based/clinician | Usual care | Invasive treatment choice; Satisfaction with decision-making (SWDMP) | 24 | N/N | N/N/Y |
| Kearing et al. 68/USA | 2-arm RCT | Lumbar spinal stenosis | Operative treatment | 66.6±9.7 | T: 199 I: 98 C: 101 |
81/118 | Video-based/self-guided | Active control (video-based) | Invasive treatment choice | 15.6 | N/N | N/N/Y |
| Kennedy et al. 69/UK | 3-arm RCT | Menorrhagia | Hysterectomy | 40.3±7.0 | T: 894 I1: 296 I 2: 300 C: 298 |
894/0 | Video-based/self-guided | Usual care | Invasive treatment choice | 30.1 | N/Y | N/N/Y |
| Kleiss et al. 70/USA | 2-arm RCT | Upper-extremity conditions | Operative treatment | 55±14 | T: 147 I: 76 C: 71 |
98/49 | Computer-based/clinician | Usual care (no intervention) | Satisfaction with decision-making; Decisional regret (DRS); Physical Health (PROMIS PF) | 31.3 | N/N | N/Y/N |
| Korteland et al. 71/The Netherlands | 2-arm RCT | Heart disease | Prosthetic heart valve selection | 61.0±16.3 | T: 138 I: 67 C: 71 |
34/104 | Computer-based/self-guided | Usual care (standard preoperative care) | Decisional conflict (DCS); General Health (SF-36); Physical Health (SF-36); Mental Health (SF-36) | 11 | Y/Y | N/Y/Y |
| Kostick et al. 72/USA | 2-arm RCT | Heart disease | LVAD support | 59.8±12.1 | T: 98 I: 47 C: 51 |
23/75 | Paper-based/clinician | Usual care (standard care) | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making; Decisional regret (ORS); Preparedness for decision-making; Shared decision-making (CollaboRATE); General Health | 44.8 | Y/Y | N/Y/Y |
| Kuppermann et al. 73/USA | 2-arm RCT | Pregnant women |
Repeat cesarean section | 34.1±4.5 | T: 1485 I: 742 C: 743 |
1485/0 | Computer-based/clinician | Usual care | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making (SWD); Knowledge; Shared decision-making (SDM-Q-9); Decision self-efficacy (DSES) | 1.0 | N/Y | Y/N/Y |
| Lam et al. 74/Hong Kong | 2-arm RCT | Breast cancer | Mastectomy | 55.7±10.5 | T: 276 I: 138 C: 138 |
276/0 | Paper-based/self-guided | Usual care (standard information booklet) | Invasive treatment choice; Decisional conflict (DCS); Knowledge; Decisional regret (DRS); Outcome expectations; Mental health (CHQ); Anxiety (HADS); Depression (HADS) | 18.5 | Y/N | N/N/Y |
| Lamers et al. 75/The Netherlands | 2-arm RCT | Prostate cancer | Radical prostatectomy | 65.3±5.9 | T: 382 I: 273 C: 109 |
0/382 | Computer-based/self-guided | Usual care | Invasive treatment choice | 12.0 | N/N | Y/Y/Y |
| Luan et al. 76/USA | 2-arm RCT | Breast cancer | Breast reconstruction for mastectomy | 49.2±3.4 | T: 16 I: 8 C: 8 |
16/0 | Paper-based/self-guided | Usual care (standard preconsultation material) | Invasive treatment choice; Decisional conflict (DCS); Decisional regret (DRS); Condition-specific HRQoL (BREAST-Q) | 0 | N/N | N/N/N |
| Manne et al. 78/USA | 2-arm RCT | Breast cancer | Breast reconstruction for mastectomy | 50.2±10.6 | T: 55 I: 31 C: 24 |
55/0 | Computer-based/self-guided | Usual care (pamphlet) | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making; Knowledge; Anxiety (STAI) | 21.8 | Y/Y | N/N/Y |
| Manne et al. 77/USA | 2-arm RCT | Breast cancer | Contralateral prophylactic mastectomy | 46.5±8.4 | T: 93 I: 46 C: 47 |
93/0 | Computer-based/self-guided | Usual care | Invasive treatment choice; Satisfaction with decision-making; Knowledge; Preparedness for decision-making (OPDMS) | 10.8 | Y/Y | N/N/Y |
| Metcalfe et al. 79/Canada | 2-arm RCT | BRCA1/2 mutation | Prophylactic mastectomy/oophorectomy | 39.1±8.8 | T: 150 I: 76 C: 74 |
150/0 | Paper-based/self-guided | Usual care (standard genetic counseling) | Decisional conflict (DCS); Knowledge; Perceived stress (IES) | 7.0 | Y/Y | N/N/N |
| Montgomery et al. 80/UK | 3-arm RCT | Pregnant women | Cesarean section | 32.4±4.7 | T: 742 I1: 245 I 2: 250 C: 247 |
742/0 | Computer-based/self-guided | Usual care | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making (SDS); Knowledge; Anxiety (STAI) | 3.6 | Y/N | Y/Y/Y |
| Parkinson et al. 81/Australia | 2-arm RCT | Women with breast cancer or ductal carcinoma | Breast reconstruction following mastectomy | 51.9±9.5 | T: 222 I: 116 C: 106 |
222/0 | Computer-based/self-guided | Usual care (standard online information) | General HRQoL (QALYs) | 26.9 | Y/Y | N/Y/Y |
| Phelan et al. 82/USA | 2-arm RCT | Lumbar spinal stenosis | Lumbar spine surgery | 49.5±18.8 | T: 100 I: 47 C: 53 |
44/56 | Computer-based/self-guided | Usual care (booklet control) | Invasive treatment choice | 10 | Y/N | N/N/Y |
| Politi et al. 83/USA | 2-arm RCT | Breast cancer | Post-mastectomy breast reconstruction | 50.7±10.8 | T: 120 I: 60 C: 60 |
120/0 | Computer-based/self-guided | Enhanced usual care | Invasive treatment choice; Decisional conflict (SURE); Decision quality (DQI); Condition-specific HRQoL (BREAST-Q) | 0 | Y/Y | N/Y/Y |
| Rivero-Santana et al. 84/Spain | 2-arm RCT | Knee osteoarthritis | Total knee replacement | 66.8±8.4 | T: 193 I: 97 C: 96 |
139/54 | Computer-based/self-guided | Usual care | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making; Knowledge (K-DQI); Decisional regret (DRS) | 3.6 | N/N | N/Y/Y |
| Schwartz et al. 85/USA | 2-arm RCT | BRCA1/BRCA2 mutation carriers | Mastectomy | 43.9±10.9 | T: 214 I: 100 C: 114 |
214/0 | Computer-based/self-guided | Usual care (booklet control) | Invasive treatment choice | 12.1 | Y/N | N/N/Y |
| Sherman et al. 86/Australia | 2-arm RCT | Women with breast cancer or ductal carcinoma | Breast reconstruction following mastectomy | 51.9±9.5 | T: 222 I: 116 C: 106 |
222/0 | Computer-based/SELF-guided | Usual care (standard online information) | Decisional conflict (DCS); Satisfaction with decision-making; Decisional regret (DRS) | 26.9 | Y/N | N/Y/Y |
| Shorten et al. 87/Australia | 2-arm RCT | Pregnant Women |
Repeat cesarean section | 31.8±NR | T: 227 I: 115 C: 112 |
227/0 | Paper-based/self-guided | Usual care (routine pregnancy care) | Invasive treatment choice | 25.6 | N/N | N/N/Y |
| Shue et al. 88/USA | 2-arm RCT | Hip and knee osteoarthritis | Total hip or knee joint replacement | 61±11 | T: 147 I: 73 C: 74 |
78/69 | Video-based/self-guided | Active control (booklet-based) | Invasive treatment choice; Knowledge | 10.2 | N/N | N/N/Y |
| Stacey et al. 89/Canada | 2-arm RCT | Osteoarthritis | Total joint arthroplasty | 66.5±9.8 | T: 334 I: 167 C: 167 |
192/142 | Video-based/self-guided | Usual care (standard patient education) | Invasive treatment choice; Knowledge (K-DQI); Decision quality (K-DQI) | 37 | N/N | N/Y/Y |
| Stiggelbout et al. 90/The Netherlands | 2-arm RCT | Asymptomatic abdominal aneurysm | Elective aneurysm repair | 72.0±8.0 | T: 100 I: 49 C: 51 |
7/93 | Paper-based/clinician | Usual care (general brochure) | Invasive treatment choice | 11.5 | N/N | N/N/Y |
| Street et al. 91/USA | 2-arm RCT | Breast cancer | Mastectomy | 58.1±12.7 | T: 60 I: 30 C: 30 |
60/0 | Computer-based/self-guided | Usual care (Brochure) | Invasive treatment choice | 0 | N/N | N/N/Y |
| Trenaman et al. 93/Canada | 2-arm RCT | Osteoarthritis | Total joint replacement | 66.5±9.5 | T: 334 I: 167 C: 167 |
192/142 | Video-based/self-guided | Usual care (standard patient education) | General HRQoL (QALYs) | 37 | N/Y | N/Y/Y |
| Trenaman et al. 92/Canada | 2-arm RCT | Osteoarthritis | Total joint replacement | 66.6±9.8 | T: 324 I: 161 C: 163 |
185/139 | Video-based/self-guided | Usual care (standard patient education) | Invasive treatment choice | 37 | N/N | N/Y/Y |
| Tucholka et al. 94/USA | 2-arm RCT | Breast cancer | Mastectomy | 56.3±14.7 | T: 227 I: 116 C: 111 |
227/0 | Computer-based/self-guided | Usual care (standard website) | Knowledge (BCSDQI) | 7.0 | Y/N | N/Y/Y |
| van Roosmalen et al. 95/The Netherlands | 2-arm RCT | Deleterious BRCA1/2 mutation | Prophylactic mastectomy/oophorectomy | 43.6±10.8 | T: 368 I: 184 C: 184 |
368/0 | Video-based/self-guided | Usual care | Invasive treatment choice; Knowledge; General HRQoL; Anxiety (STAI); Depression (CES-D) | 3.3 (only those withdrew) | Y/Y | N/N/Y |
| van Roosmalen et al. 96/The Netherlands | 2-arm RCT | Deleterious BRCA1/2 mutation | Prophylactic mastectomy/oophorectomy | 39.5±10.0 | T: 88 I: 44 C: 44 |
88/0 | Computer-based/clinician | Usual care | Invasive treatment choice; General HRQoL; Anxiety (STAI); Depression (CES-D); Perceived stress (IES) | 1.1 | Y/Y | N/N/Y |
| van Tol-Geerdink et al. 97/The Netherlands | 2-arm RCT | Localized prostate cancer | Prostatectomy | 64±5.0 | T: 240 I: 163 C: 77 |
0/240 | Paper-based/clinician | Usual care | Invasive treatment choice | 0 | Y/N | N/Y/Y |
| Vandemheen et al. 98/Canada, Australia | 2-arm RCT | Cystic fibrosis | Lung transplantation | 30.4±8.9 | T: 149 I: 70 C: 79 |
68/81 | Computer-based/self-guided | Usual care | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making; Knowledge; Preparedness for decision-making; Outcome expectations | 16.1 | Y/N | N/Y/Y |
| Varelas et al. 99/USA | 2-arm RCT | Breast cancer | Breast reconstruction following mastectomy | 49.6±11.2 | T: 47 I: 25 C: 22 |
26/0 | Computer-based/self-guided | Usual care (consultation) | Decisional conflict (DCS); Condition-specific HRQoL (BREAST-Q); Anxiety (STAI) | 44.7 | N/N | N/N/N |
| Vina et al. 100/USA | 2-arm RCT | Osteoarthritis | Knee replacement | 61.6±8.0 | T: 493 I: 240 C: 253 |
251/242 | Video-based/self-guided | Usual care (booklet control) | Invasive treatment choice | 0.6 | N/Y | N/Y/Y |
| Vodermaier et al. 101/Germany | 2-arm RCT | Breast cancer | Mastectomy | 55.2±11.0 | T: 111 I: 55 C: 56 |
111/0 | Paper-based/clinician | Usual care (standard care) | Invasive treatment choice; Decisional conflict (DCS) | 7.9 | N/N | N/N/Y |
| Vuorma et al. 102/Finland | 2-arm RCT | Menorrhagia | Hysterectomy | 44.4±4.18 | T: 363 I: 184 C: 179 |
363/0 | Paper-based/self-guided | Usual care | Invasive treatment choice | 13.2 | Y/Y | N/N/Y |
| Whelan et al. 103/Canada | 2-arm cluster RCT | Breast cancer | Mastecty/lumpectomy plus radiation | Median: 58.35 | T: 201 I: 94 C: 107 |
201/0 | Paper-based/clinician | Usual care | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making (DCS); Anxiety (STAI); Depression (CES-D) | 17.9 | Y/N | N/N/Y |
| Wilkens et al. 104/USA | 2-arm RCT | Osteoarthritis | Operative treatment | 63.5±1.4 | T: 90 I: 45 C: 45 |
65/25 | Computer-based/self-guided | Usual care | Invasive treatment choice; Decisional conflict (DCS); Satisfaction with decision-making; Decisional regret (DRS); Condition-specific HRQoL (QuickDASH); Depression (PHQ-2) | 7.8 | Y/Y | N/N/N |
| Wilkins et al. 105/USA | 2-arm RCT | Breast cancer | Mastectomy | 54.9±9.80 | T: 101 I: 52 C: 49 |
101/0 | Video-based/self-guided | Active control (written educational materials) | Invasive treatment choice; Satisfaction with decision-making; Knowledge; Decision self-efficacy (SECPMD); Anxiety (STAI) | NR | N/N | N/N/Y |
| Wong et al. 106/UK | 2-arm RCT | Pregnant women | Surgical termination of pregnancy | 25±NR | T: 328 I: 163 C: 165 |
328/0 | Paper-based/self-guided | Usual care (placebo leaflet) | Invasive treatment choice; Decisional conflict (DCS); Knowledge; Anxiety (STAI) | 14.0 | Y/N | N/N/N |
| Ye et al. 107/China | 2-arm RCT | Cataract | Cataract surgery | 64.3±0.3 | T: 773 I: 386 C: 387 |
556/217 | Paper-based/self-guided | Usual care (booklet control) | Invasive treatment choice; Decisional conflict (DCS); Decision quality | 3.4 | Y/Y | Y/Y/Y |
BCIT-R, Breast Cancer Information Test – Revised; BCSDQI, Breast Cancer Surgery Decision Quality Instrument; CES-D, Center for Epidemiologic Studies Depression Scale; CHQ, Chinese Health Questionnaire; DCS, Decision Conflict Scale; DRS, Decision Regret Scale; DSES, Decision Self-Efficacy Scale; HADS, Hospital Anxiety and Depression Scale; HRQoL, health-related quality of life; IES, Impact of Event Scale; ITT, Intention-to-treat; K-DQI, Knee Osteoarthritis Decision Quality Instrument; KOOS JR, Knee Injury and Osteoarthritis Outcome Score Joint Replacement; LVAD, left ventricular assist device; MDM, missing data management; N, no; NR, not recorded; OPDMS, Ottawa Preparation for Decision-Making Scale; ORS, Ottawa Regret Scale; PDSI, patient decision support intervention; PHQ, Patient Health Questionnaire; PROMIS PF, Patient-Reported Outcomes Measurement Information System Physical Function; PSS, Perceived Stress Scale; QALY, quality-adjusted life-year; QoL, quality of life; QuickDASH, Quick Disabilities of Arm, Shoulder, and Hand; RCT, randomized controlled trial; RIRS, retrograde intrarenal surgery; SDM-Q-9, Shared Decision-Making Questionnaire 9-item; SDQ, Subjective Decision Quality; SDS, Satisfaction with Decision Scale; SECPMD, Self-Efficacy to Communicate with Physician/Manage Disease; SF, Short-Form Health Survey; STAI, State-Trait Anxiety Inventory; SWD, Satisfaction with Decision Scale; SWDMP, Satisfaction with the Process of Making a Treatment Decision Scale; SWL, shock wave lithotripsy; Y, yes.