Questionnaire responses
| Survey questions and response options | No. (%) research nurse respondents* (n=560) | No. (%) data manager respondents* (n=41) | No. (%) trial manager respondents* (n=129) | No. (%) chief and principal investigator respondents* (n=37) |
|---|---|---|---|---|
| What assistance did you give to the trial participants during the completion of the questionnaire? (Last Trial) | ||||
| I read the questions out to the participants | 194 (36.9)† | – | – | – |
| I helped participants to understand the questions | 209 (39.7)† | – | – | – |
| The participants gave me the answers and I filled in the questionnaire | 121 (23.0)† | – | – | – |
| I gave no assistance, the participants filled in their questionnaires independently | 348 (66.2)† | – | – | – |
| If the participant had to complete the quality of life or other patient-reported outcome measure questionnaire in clinic, when did they do so? (Last Trial) | ||||
| Always before their consultant/doctor appointment | 92 (18.2) | – | – | – |
| Always after their consultant/doctor appointment | 47 (9.3) | – | – | – |
| Variable, sometimes before and sometimes after their consultant/doctor appointment | 242 (47.9) | – | – | – |
| Not applicable | 124 (24.6) | – | – | – |
| Which of the following did you do after trial participants had completed their PROM? (Last Trial) | ||||
| I sent the questionnaire to the data inputting centre without looking at it | 100 (19.6)† | – | – | – |
| I looked at the completed questionnaire to see if the participant had missed out any questions | 394 (77.3)† | – | – | – |
| If I discovered missing items, I prompted participants to complete them | 308 (60.4)† | – | – | – |
| I looked at the completed questionnaire to see if there were any scoring errors (eg, 2 options selected instead of 1, scoring the wrong way round, etc) | 141 (27.6)† | – | – | – |
| If I suspected a scoring error, I prompted participants to look again at some questions, to ensure they had understood them correctly | 137 (26.9)† | – | – | – |
| Checked for missing PROM data and followed up participant to rectify | 277 (49.9) | |||
| Checked for PROM scoring errors and followed up participant to rectify | 114 (21.2) | |||
| When the quality of life/patient-reported outcome questionnaire data were inputted, which of the following occurred? (Last Trial) | ||||
| The questionnaire was checked to see if the participant had completed all questions | – | 18 (72.0)† | – | – |
| If items were found to be missing, trial participants were followed up in some way (eg, by post, by phone or via their research nurse) in order to complete the questionnaire | – | 7 (28.0)† | – | – |
| The questionnaire was checked for scoring errors (eg, two answers given instead of one, or reversed scoring) | – | 19 (76.0)† | – | – |
| If scoring errors were detected, trial participants were followed up in some way (eg, by post, by phone or via their research nurse) in order to correct them | – | 4 (16.0)† | – | – |
| Checked for missing PROM data and followed up participant to rectify | – | 6 (15.4) | ||
| Checked for PROM scoring errors and followed up participant to rectify | – | 4 (9.8) | ||
| Were the staff involved in data collection given instructions on how to administer the quality of life/patient-reported outcome questionnaire? (Last Trial) | ||||
| Yes | – | – | 90 (70.9) | 29 (82.9) |
| No | – | – | 37 (29.1) | 6 (17.1) |
| What particular information on quality of life/patient-reported outcome measurement was given to the data collection staff in the last trial you were involved with? | ||||
| The purpose and/or importance of quality of life/patient-reported outcome data to the trial | – | – | 71 (86.6) | 27 (93.1) |
| Relevance and reasoning behind individual quality of life/patient-reported outcome questions | – | – | 43 (52.4) | 22 (75.9) |
| When to administer the questionnaire (time points) | – | – | 84 (100) | 29 (100) |
| When to administer the questionnaire during the clinic appointment (before/during/after the consultation) | – | – | 53 (67.9) | 22 (78.6) |
| How much assistance to give the participant during questionnaire completion | – | – | 52 (63.4) | 25 (86.2) |
| How to check for, and deal with, missing quality of life/patient-reported outcome data | – | – | 48 (58.5) | 24 (82.8) |
| What to do if participants write additional information on their questionnaires (or attach a letter) | – | – | 23 (28.0) | 12 (41.4) |
| Trial protocol and training questions | ||||
| The trial protocol included information about quality of life/patient-reported outcome measurement | 474 (92.2) | – | – | – |
| Reported PRO protocol content present and felt it was adequate for their needs | 415 (87.7) | – | – | – |
| I received trial training that included information on quality of life/patient-reported outcome measurement | 164 (32.7) | – | – | – |
| Reported receiving PRO training and felt it was adequate for their needs | 152 (94.4%) | – | – | – |
| The trial protocol included information about quality of life/patient-reported outcome data inputting | – | 13 (50.0) | – | – |
| Reported PRO protocol content present and felt it was adequate for their needs | – | 10 (76.9) | – | – |
| I received trial training which included information on quality of life/patient-reported outcome data inputting | – | 9 (39.1) | – | – |
| Reported receiving PRO training and felt it was adequate for their needs | – | 8 (88.9) | – | – |
| PRO assessment explanation questions | ||||
| It was explained to me why the quality of life/patient-reported outcome measure data were being collected in the trial | 314 (60.5) | – | – | – |
| I was confident I could explain to trial participants why the quality of life/patient-reported outcome measure data were being collected in the trial | 456 (87.7) | – | – | – |
| It was explained to me why each of the questions in the quality of life/patient-reported outcome measure were included, ie, how each was of relevance to the trial | 157 (30.3) | – | – | – |
| I was confident I could explain to trial participants why each of the questions in the quality of life/patient-reported outcome measure had been included, ie, how each was of relevance to the trial | 312 (59.9) | – | – | – |
| Please read the following statements. In each case, please indicate whether you ‘strongly agree’, ‘agree’, have ‘no opinion’, ‘disagree’ or ‘strongly disagree’ with the statement (Future Trials) | ||||
| There should be more protocol content and trial training covering quality of life/patient-reported outcome measurement, in trials employing such outcomes | SA 140 (27.9) A 283 (56.5) NO 57 (11.4) D 20 (4.0) SD 1 (0.2) | – | – | – |
| There should be more quality of life/patient-reported outcome measurement guidance contained within other trial documentation, such as site manuals or standard operating procedures, in trials employing such outcomes | SA 127 (25.4) A 302 (60.4) NO 52 (10.4) D 18 (3.6) SD 1 (0.2) | – | – | – |
| Please read the following statements. In each case, please indicate whether you ‘strongly agree’, ‘agree’, have ‘no opinion’, ‘disagree’ or ‘strongly disagree’ with the statement (Future Trials) | ||||
| There should be more protocol content and trial training for data managers/inputters, covering quality of life/patient-reported outcome measurement | – | SA 3 (10.7) A 17 (60.7) NO 2 (7.1) D 6 (21.4) SD 0 (0) | – | – |
| There should be site manuals or standard operating procedures available to data mangers/inputters that include information on quality of life/patient-reported outcome administration in the trial | – | SA 6 (21.4) A 18 (64.3) NO 3 (10.7) D 1 (3.6) SD 0 (0) | – | – |
| Please read the following statements. In each case, please indicate whether you ‘strongly agree’ (SA), ‘agree’ (A), have ‘no opinion’ (NO), ‘disagree’ (D) or ‘strongly disagree’ (SD) with the statement (Future Trials) | ||||
| Data collection staff in trials need more information on quality of life/patient-reported outcome measurement—in the trial protocol | – | – | SA 17 (14.8) A 33 (28.7) NO 23 (20.0) D 39 (33.9) SD 3 (2.6) | SA 6 (16.7) A 12 (33.3) NO 12 (33.3) D 5 (13.9) SD 1 (2.8) |
| Data collection staff in trials need more information on quality of life/patient-reported outcome measurement—in other trial documentation, such as SOPs | – | – | SA 17 (14.8) A 54 (47.0) NO 19 (16.5) D 22 (19.1) SD 3 (2.6) | SA 7 (19.4) A 16 (44.4) NO 8 (22.2) D 4 (11.1) SD 1 (2.8) |
| Data collection staff in trials need more information on quality of life/patient-reported outcome measurement—delivered in the form of trial training | – | – | SA 24 (21.1) A 55 (48.2) NO 17 (14.9) D 17 (14.9) SD 1 (0.9) | SA 6 (16.7) A 14 (38.9) NO 72 (19.4) D 8 (22.2) SD 1 (2.8) |
| It is important to explain to data collection staff, the purpose and importance of quality of life/patient-reported outcome data to the trial | – | – | SA 41 (36.3) A 69 (61.1) NO 3 (2.7) D 0 (0) SD 0 (0) | SA 13 (33.3) A 20 (55.6) NO 2 (5.6) D 1 (2.8) SD 1 (2.8) |
| It is important to explain to data collection staff, the relevance and reasoning behind individual quality of life/patient-reported outcome questions | – | – | SA 30 (26.1) A 55 (47.8) NO 18 (15.7) D 12 (10.4) SD 0 (0) | SA 8 (22.2) A 22 (61.1) NO 4 (11.1) D 0 (0) SD 2 (5.6) |
| Thinking about the future. What particular quality of life/patient-reported outcome guidance should be included the trial protocol, what should be included in trial training, and what should be included in a standard operating procedure? (TP, trial protocol; TT, trial training; SOP, standard operating procedure) | ||||
| Purpose/importance of quality of life/patient-reported outcome data in trial | TP 389 (79.1) TT 344 (69.9) SOP 131 (26.6) | – | TP 77 (67.5) TT 89 (78.1) SOP 28 (24.6) | TP 27 (87.1) TT 23 (74.2) SOP 15 (48.4) |
| How to administer the questionnaire | TP 212 (43.1) TT 403 (81.9) SOP 275 (55.9) | – | TP 43 (38.1) TT 101 (89.4) SOP 73 (64.6) | TP 13 (40.6) TT 27 (84.4) SOP 23 (71.9) |
| How to input quality of life/patient-reported outcome data into the database‡ | – | TP 3 (11.1) TT 22 (81.5) SOP 18 (66.7) | – | – |
| When to administer the questionnaire | TP 359 (73.9) TT 328 (67.5) SOP 202 (41.6) | – | TP 88 (77.2) TT 95 (83.3) SOP 64 (56.1) | TP 23 (71.9) TT 28 (87.5) SOP 21 (65.6) |
| What to do if there are missing data or in the event of scoring errors (eg, two answers provided instead of one, or reversed scoring)‡ | – | TP 2 (7.3) TT 19 (67.3) SOP 28 (78.2) | – | – |
| What to do if participants write additional information on their questionnaires (or attach a letter) | TP 178 (36.3) TT 405 (82.5) SOP 232 (47.3) | TP 3 (10.7) TT 20 (71.4) SOP 28 (64.3) | TP 14 (12.7) TT 83 (75.5) SOP 78 (70.9) | TP 5 (15.6) TT 25 (78.1) SOP 22 (68.8) |
| Ethical issues associated with quality of life/patient-reported outcome use | TP 253 (52.5) TT 345 (71.6) SOP 180 (37.3) | – | TP 57 (56.4) TT 68 (67.3) SOP 36 (35.6) | TP 12 (40.0) TT 24 (80.0) SOP 16 (53.3) |
| How to deal with upset patients (communication/counselling skills) | TP 71 (15.2) TT 390 (83.7) SOP 204 (43.8) | – | TP 6 (6.0) TT 91 (91.0) SOP 50 (50.0) | TP 6 (18.8) TT 29 (90.6) SOP 17 (53.1) |
| Working with non-English language patients | TP 248 (51.8) TT 329 (68.7) SOP 284 (59.3) | – | TP 39 (38.2) TT 80 (78.4) SOP 66 (64.7) | TP 18 (58.1) TT 24 (77.4) SOP 20 (64.5) |
| How to support the participant to answer sensitive questions | TP 76 (15.9) TT 429 (89.7) SOP 180 (37.7) | – | TP 4 (3.7) TT 100 (92.6) SOP 45 (41.7) | TP 8 (27.6) TT 27 (93.1) SOP 19 (65.5) |
| How to collect quality of life/patient-reported outcome data without biasing the results | TP 190 (38.7) TT 412 (83.9) SOP 265 (54.0) | – | TP 32 (28.6) TT 98 (87.5) SOP 63 (56.3) | TP 9 (28.1) TT 29 (90.6) SOP 21 (65.1) |
| Collecting quality of life/patient-reported outcome data in different patient groups and/or settings | TP 145 (30.3) TT 381 (79.9) SOP 220 (46.0) | – | TP 24 (25.0) TT 75 (78.1) SOP 42 (43.8) | TP 12 (41.4) TT 23 (79.3) SOP 16 (55.2) |
| Relevance and reasoning behind individual quality of life/patient-reported outcome questions | TP 269 (55.1) TT 371 (76.0) SOP 94 (19.3) | – | TP 50 (54.3) TT 66 (71.7) SOP 17 (18.5) | TP 12 (42.9) TT 23 (82.1) SOP 10 (35.7) |
| How to deal with difficult situations. | TP 71 (15.2) TT 391 (83.7) SOP 94 (45.6) | – | TP 2 (2.0) TT 88 (88.9) SOP 41 (41.4) | TP 5 (16.7) TT 27 (90.0) SOP 22 (73.3) |
A, agree; D, disagree; N, no; NO, no opinion; SA, strongly agree; SD, strongly disagree; SOP, standard operating procedure; TP, trial protocol; TT, trial training; Y, yes.
*Columns may not add up to n due to missing values.
†Respondents were able to select multiple categories. Full survey data set available in online supplementary file 2.
‡Data manager respondents only.