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| Name | Class |
|---|---|
| Live UTI Free | UNKNOWN |
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This study aims to develop and validate the first set of patient-reported outcome measures for recurrent urinary tract infection (UTI): the Recurrent UTI Symptom Scale and the Recurrent UTI Impact Questionnaire. These tools could be used in clinical practice, clinical trials and research to gather an insight into a patient's perspective of their recurrent UTI symptom severity and its impact on their life, as well as determining any possible improvement or other change in their condition due to interventions (e.g. antibiotic treatment).
Urinary tract infection (UTI) is a highly prevalent infection, most frequently affecting females. Recurrent UTI, a chronic condition defined as experiencing two or more UTIs in six months or three or more in twelve months, is associated with significant symptom burden and lowered quality of life. In addition to this personal impact, the effects span more widely to issues such as increased healthcare costs, work absenteeism, and antimicrobial resistance.
There are currently no validated patient-reported outcome measures to assess recurrent UTI symptoms and impact. These measures are much needed to encourage a more patient-centred approach to recurrent UTI treatment and care, which could be especially important given evidence that current routine testing approaches, and thus treatment approaches, are not sufficient alone.
This mixed-methods study aims to consult both clinicians and patients in order to develop and validate the first set of patient-reported outcome measures for recurrent UTI.
Outline:
Phase I: Concept elicitation Conduct a literature review and examine the findings of an international qualitative study exploring the experience of over 2,000 people living with recurrent UTI.
Phase II: Initial development and item generation Develop draft questionnaire items, instructions, and scale response options in line with current healthcare guidance and conclusions from Phase I.
Phase III: Modified Delphi method with 10-20 expert clinicians Screen the draft questionnaires by two rounds of a modified Delphi method, assessing item and instruction clarity and relevance for recurrent UTI.
Use qualitative comments and content validity indices to refine existing items, and remove or add new ones where appropriate.
Phase IV: Cognitive interviews with 25-30 patients Conduct one-to-one cognitive interviews using a think aloud and verbal probing procedure to verify the content validity and clarity of the new measures from the patient's perspective.
Summarise and analyse the interview transcripts using the Questionnaire Appraisal System and content analysis, used to refine the measures before Phase V.
Phase V: Two-part online pilot with 100+ patients Conduct a cross-sectional survey in which participants complete the new recurrent UTI measures and comparable existing standardised measures for each subscale (e.g. UTI Symptom Assessment). Participants will complete this twice, 24 hours apart.
Verify the psychometric properties of the new measures, including exploratory factor analysis, internal consistency, test-retest reliability, and criterion validity.
Optimise the measures for clinical and research purposes based on these analyses.
Please note: Phase III (with expert rUTI clinicians) and Phase IV (with rUTI patients) resulted in qualitative data, and as such the results are not reported in this record. For more information about the results from these phases, please see the references provided.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional Cross-sectional Patient Reported Outcome Measure Development | Other | Development of Patient Reported Outcome Measure |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Urinary Tract Infection Symptom Scale | RUTISS; Total minimum score = 0, total maximum score = 170. Newly designed instrument that can measure the patient experience of recurrent UTI symptoms and pain and/or discomfort; Urinary symptoms sub-scale minimum score = 0, maximum score = 70; urinary pain sub-scale minimum score = 0, maximum score = 100; higher scores indicate higher symptom severity | Baseline (Time 1) |
| Recurrent Urinary Tract Infection Symptom Scale | RUTISS; Total minimum score = 0, total maximum score = 170. Newly designed instrument that can measure the patient experience of recurrent UTI symptoms and pain and/or discomfort; Urinary symptoms sub-scale minimum score = 0, maximum score = 70; urinary pain sub-scale minimum score = 0, maximum score = 100; higher scores indicate higher symptom severity | Time 2 (24 hours after baseline) |
| Recurrent Urinary Tract Infection Impact Questionnaire | RUTIIQ; Total minimum score = 0, maximum score = 300. Higher scores indicate higher rUTI impact and psychosocial burden. Newly designed instrument that can measure the patient experience of recurrent UTI impact on personal wellbeing, social activities, work and daily activities, sexual activity, and satisfaction with UTI-related medical care; personal wellbeing sub-scale minimum score = 0; maximum score = 40; social wellbeing sub-scale minimum score = 0, maximum score = 50; work/activity interference sub-scale minimum score = 0, maximum score = 70; sexual wellbeing sub-scale minimum score = 0, maximum score = 40; patient satisfaction sub-scale minimum score = 0, maximum score = 100. The sexual wellbeing subscale is optional and therefore fewer participants than the total number provided data for analysis. | Baseline (Time 1) |
| Recurrent Urinary Tract Infection Impact Questionnaire | RUTIIQ; Total minimum score = 0, maximum score = 300. Higher scores indicate higher rUTI impact and psychosocial burden. Newly designed instrument that can measure the patient experience of recurrent UTI impact on personal wellbeing, social activities, work and daily activities, sexual activity, and satisfaction with UTI-related medical care; personal wellbeing sub-scale minimum score = 0; maximum score = 40; social wellbeing sub-scale minimum score = 0, maximum score = 50; work/activity interference sub-scale minimum score = 0, maximum score = 70; sexual wellbeing sub-scale minimum score = 0, maximum score = 40; patient satisfaction sub-scale minimum score = 0, maximum score = 100. The sexual wellbeing subscale is optional and therefore fewer participants than the total number provided data for analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Tract Infection Symptom Assessment | (UTISA) 7 items assessing the severity of UTI symptoms in the past 24 hours; minimum total score = 0; maximum total score = 21. Higher scores indicate higher symptom severity and clinical cut-off for presence of a UTI = 3. | Baseline (Time 1) |
| Urinary Tract Infection Symptom Assessment |
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Inclusion Criteria:
Clinicians (Phase III only):
Patients (Phases IV and V):
Exclusion Criteria:
Patients:
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The target patient population consists of adults with a minimum of 2 UTIs in 6 months or a minimum of 3 UTIs in 12 months.
Phase III (with expert rUTI clinicians) and Phase IV (with rUTI patients) resulted in qualitative data, and as such the results are not reported in this record. For more information about the results from these phases, please see the references provided.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine A Finlay, PhD | University of Reading | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading | Reading | Berkshire | RG6 7BE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37025478 | Result | Newlands AF, Roberts L, Maxwell K, Kramer M, Price JL, Finlay KA. The Recurrent Urinary Tract Infection Symptom Scale: Development and validation of a patient-reported outcome measure. BJUI Compass. 2023 Jan 17;4(3):285-297. doi: 10.1002/bco2.222. eCollection 2023 May. | |
| 36740638 | Result | Newlands AF, Roberts L, Maxwell K, Kramer M, Price JL, Finlay KA. Development and psychometric validation of a patient-reported outcome measure of recurrent urinary tract infection impact: the Recurrent UTI Impact Questionnaire. Qual Life Res. 2023 Jun;32(6):1745-1758. doi: 10.1007/s11136-023-03348-7. Epub 2023 Feb 6. |
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Inclusion Criteria:
Clinicians:
Patients:
Exclusion Criteria (patients):
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot Participants | Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240). |
| FG001 | Expert Clinicians | Specialist doctors or nurses in urology or a closely related discipline, or general health doctors or nurses, with a minimum of 2 years of direct experience treating patients with recurrent UTI (N=15). This arm participated in a two-round Delphi consensus study to establish content validity of draft RUTISS and RUTIIQ items. The pre-specified quantitative outcome measures were not administered to this arm, as participants were clinicians rather than rUTI patients; data collected consisted of item-level consensus ratings and qualitative feedback only. |
| FG002 | Cognitive Interview Participants | Adult participants with a diagnosis of recurrent urinary tract infection (N=28). This arm participated in one-to-one cognitive think-aloud interviews evaluating the comprehension, relevance, and acceptability of draft RUTISS and RUTIIQ items. The pre-specified quantitative outcome measures were not administered as standardised scored assessments in this arm, as the PROMs were under development at this phase; data collected consisted of qualitative verbal probes and item-level feedback only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline demographic characteristics are reported for all three arms of the study. Arm 1 (Pilot Participants, N=240) comprised adults with recurrent UTI who completed the Phase V psychometric validation pilot and the full battery of pre-specified quantitative outcome measures. Arm 2 (Expert Clinicians, N=15) comprised specialist and general clinicians who participated in a two-round Delphi consensus study to establish content validity of draft RUTISS and RUTIIQ items. Arm 3 (Cognitive Intervie
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Participants | Adult participants with a diagnosis of recurrent urinary tract infection who completed the Phase V psychometric validation pilot. This arm completed the full battery of pre-specified quantitative outcome measures (RUTISS, RUTIIQ, UTISA, NPRS, PHQ-9, GAD-7, UCLA Loneliness Scale, WPAI, FSDS, and Satisfaction with Treatment) at baseline and at 24-hour follow-up. Demographic data (age, sex, race/ethnicity) were collected via self-report at baseline. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent Urinary Tract Infection Symptom Scale | RUTISS; Total minimum score = 0, total maximum score = 170. Newly designed instrument that can measure the patient experience of recurrent UTI symptoms and pain and/or discomfort; Urinary symptoms sub-scale minimum score = 0, maximum score = 70; urinary pain sub-scale minimum score = 0, maximum score = 100; higher scores indicate higher symptom severity | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment, as their study procedures did not include administration of the PROM as a quantitative instrument, instead focusing on qualitative assessment of PROMs in development. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. This is because no intervention was applied and the study simply observed characteristics of symptoms and quality of life when experiencing recurrent urinary tract infection. No intervention was administered. Patient participants were encouraged to seek support from a medical and/or mental health professional to discuss their symptoms and any concerns with physical and/or mental health.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. This is because no intervention was applied and the study simply observed characteristics of symptoms and quality of life when experiencing recurrent urinary tract infection. No intervention was administered. Patient participants were encouraged to seek support from a medical and/or mental health professional to discuss their symptoms and any concerns with physical and/or mental health.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Participants | Adults with a diagnosis of recurrent urinary tract infection (N=240). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Katherine Finlay, Associate Professor | University of Reading | 0118 987 5123 | katherine.finlay@reading.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 31, 2021 | May 3, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 31, 2021 | May 3, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 26, 2021 | Aug 24, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D017060 | Patient Satisfaction |
| D059350 | Chronic Pain |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Time 2 (24 hours after baseline) |
(UTISA) 7 items assessing the severity of UTI symptoms in the past 24 hours; minimum total score = 0; maximum total score = 21. Higher scores indicate higher symptom severity and clinical cut-off for presence of a UTI = 3. |
| Time 2 (24 hours after baseline) |
| Numerical Pain Rating Scale | Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours | Baseline (Time 1) |
| Numerical Pain Rating Scale | Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours | Time 2 (24 hours after baseline) |
| Depression | Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels. | Baseline (Time 1) |
| Depression | Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels. | Time 2 (24 hours after baseline) |
| Anxiety | Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity. | Baseline (Time 1) |
| Anxiety | Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity. | Time 2 (24 hours after baseline) |
| Loneliness | UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation. | Baseline (Time 1) |
| Loneliness | UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation. | Time 2 (24 hours after baseline) |
| Work Productivity and Impairment Questionnaire | Measure assessing specific health problems impairing work capacity. Work impairment sub-scale minimum score = 0; maximum work impairment = 100; activity impairment minimum total score = 0, maximum activity impairment = 100. Higher scores indicate greater impairment due to health problems. The 'work impairment' subscale is only applicable to participants who report to be currently in work. | Baseline (Time 1) |
| Work Productivity and Impairment Questionnaire | Measure assessing specific health problems impairing work capacity. Work impairment sub-scale minimum score = 0; maximum work impairment = 100; activity impairment minimum total score = 0, maximum activity impairment = 100. Higher scores indicate greater impairment due to health problems. The 'work impairment' subscale is only applicable to participants who report to be currently in work. | Time 2 (24 hours after baseline) |
| Sexual Distress | Female Sexual Distress Scale for assessing feelings of sexual distress. Minimum total score = 0, maximum total score = 52. Higher scores indicate greater sexual distress. Scores greater than 10 may indicate atypical/abnormal sexual distress. This scale is optional and therefore fewer participants than the total number provided data for analysis. | Baseline (Time 1) |
| Sexual Distress | Female Sexual Distress Scale for assessing feelings of sexual distress. Minimum total score = 0, maximum total score = 52. Higher scores indicate greater sexual distress. Scores greater than 10 may indicate atypical/abnormal sexual distress. This scale is optional and therefore fewer participants than the total number provided data for analysis. | Time 2 (24 hours after baseline) |
| Satisfaction With Treatment | Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. The score represents the sum of seven different patient satisfaction domain scores (see more here: https://www.rand.org/content/dam/rand/www/external/health/surveys\_tools/psq/psq18\_scoring.pdf). Higher scores indicate greater satisfaction with medical care. Minimum score = 1; maximum score = 35. | Baseline (Time 1) |
| Satisfaction With Treatment | Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. The score represents the sum of seven different patient satisfaction domain scores (see more here: https://www.rand.org/content/dam/rand/www/external/health/surveys\_tools/psq/psq18\_scoring.pdf). Higher scores indicate greater satisfaction with medical care. Minimum score = 1; maximum score = 35. | Time 2 (24 hours after baseline) |
| completed follow-up significantly outside the 24-hour testing window |
|
| BG001 | Expert Clinicians | Specialist doctors or nurses in urology or a closely related discipline, or general health doctors or nurses, with a minimum of 2 years of direct experience treating patients with recurrent UTI. This arm participated in a two-round Delphi consensus study to establish content validity of draft RUTISS and RUTIIQ items. Demographic data collected at enrolment are reported below. Pre-specified quantitative outcome measures were not administered to this arm, as participants were clinicians rather than rUTI patients. |
| BG002 | Cognitive Interview Participants | Adult participants with a diagnosis of recurrent urinary tract infection who participated in one-to-one cognitive think-aloud interviews evaluating the comprehension, relevance, and acceptability of draft RUTISS and RUTIIQ items. Demographic data collected at enrolment are reported below. The pre-specified quantitative outcome measures were not administered as scored assessments in this arm, as the PROMs were under development at this phase; data collected from this arm consisted of qualitative item-level feedback only. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240). |
|
|
| Primary | Recurrent Urinary Tract Infection Symptom Scale | RUTISS; Total minimum score = 0, total maximum score = 170. Newly designed instrument that can measure the patient experience of recurrent UTI symptoms and pain and/or discomfort; Urinary symptoms sub-scale minimum score = 0, maximum score = 70; urinary pain sub-scale minimum score = 0, maximum score = 100; higher scores indicate higher symptom severity | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment, as their study procedures did not include administration of the PROM as a quantitative instrument, instead focusing on qualitative assessment of PROMs in development. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
|
|
|
| Primary | Recurrent Urinary Tract Infection Impact Questionnaire | RUTIIQ; Total minimum score = 0, maximum score = 300. Higher scores indicate higher rUTI impact and psychosocial burden. Newly designed instrument that can measure the patient experience of recurrent UTI impact on personal wellbeing, social activities, work and daily activities, sexual activity, and satisfaction with UTI-related medical care; personal wellbeing sub-scale minimum score = 0; maximum score = 40; social wellbeing sub-scale minimum score = 0, maximum score = 50; work/activity interference sub-scale minimum score = 0, maximum score = 70; sexual wellbeing sub-scale minimum score = 0, maximum score = 40; patient satisfaction sub-scale minimum score = 0, maximum score = 100. The sexual wellbeing subscale is optional and therefore fewer participants than the total number provided data for analysis. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment; their procedures focused on qualitative assessment of PROMs in development rather than quantitative administration. Summary statistics are therefore not available for Arms 2 and 3. The sexual wellbeing subscale is optional; fewer participants provided data. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
|
|
|
| Primary | Recurrent Urinary Tract Infection Impact Questionnaire | RUTIIQ; Total minimum score = 0, maximum score = 300. Higher scores indicate higher rUTI impact and psychosocial burden. Newly designed instrument that can measure the patient experience of recurrent UTI impact on personal wellbeing, social activities, work and daily activities, sexual activity, and satisfaction with UTI-related medical care; personal wellbeing sub-scale minimum score = 0; maximum score = 40; social wellbeing sub-scale minimum score = 0, maximum score = 50; work/activity interference sub-scale minimum score = 0, maximum score = 70; sexual wellbeing sub-scale minimum score = 0, maximum score = 40; patient satisfaction sub-scale minimum score = 0, maximum score = 100. The sexual wellbeing subscale is optional and therefore fewer participants than the total number provided data for analysis. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment; their procedures focused on qualitative assessment of PROMs in development rather than quantitative administration. Summary statistics are therefore not available for Arms 2 and 3. The sexual wellbeing subscale is optional; fewer participants provided data. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| Secondary | Urinary Tract Infection Symptom Assessment | (UTISA) 7 items assessing the severity of UTI symptoms in the past 24 hours; minimum total score = 0; maximum total score = 21. Higher scores indicate higher symptom severity and clinical cut-off for presence of a UTI = 3. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
|
|
|
| Secondary | Urinary Tract Infection Symptom Assessment | (UTISA) 7 items assessing the severity of UTI symptoms in the past 24 hours; minimum total score = 0; maximum total score = 21. Higher scores indicate higher symptom severity and clinical cut-off for presence of a UTI = 3. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
|
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| Secondary | Numerical Pain Rating Scale | Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
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| Secondary | Numerical Pain Rating Scale | Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| Secondary | Depression | Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
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| Secondary | Depression | Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| Secondary | Anxiety | Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
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| Secondary | Anxiety | Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| Secondary | Loneliness | UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
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| Secondary | Loneliness | UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| Secondary | Work Productivity and Impairment Questionnaire | Measure assessing specific health problems impairing work capacity. Work impairment sub-scale minimum score = 0; maximum work impairment = 100; activity impairment minimum total score = 0, maximum activity impairment = 100. Higher scores indicate greater impairment due to health problems. The 'work impairment' subscale is only applicable to participants who report to be currently in work. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. Work impairment subscale applies only to those currently in work. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
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| Secondary | Work Productivity and Impairment Questionnaire | Measure assessing specific health problems impairing work capacity. Work impairment sub-scale minimum score = 0; maximum work impairment = 100; activity impairment minimum total score = 0, maximum activity impairment = 100. Higher scores indicate greater impairment due to health problems. The 'work impairment' subscale is only applicable to participants who report to be currently in work. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. Work impairment subscale applies only to those currently in work. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| Secondary | Sexual Distress | Female Sexual Distress Scale for assessing feelings of sexual distress. Minimum total score = 0, maximum total score = 52. Higher scores indicate greater sexual distress. Scores greater than 10 may indicate atypical/abnormal sexual distress. This scale is optional and therefore fewer participants than the total number provided data for analysis. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. This scale is optional; fewer participants provided data. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
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| Secondary | Sexual Distress | Female Sexual Distress Scale for assessing feelings of sexual distress. Minimum total score = 0, maximum total score = 52. Higher scores indicate greater sexual distress. Scores greater than 10 may indicate atypical/abnormal sexual distress. This scale is optional and therefore fewer participants than the total number provided data for analysis. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. This scale is optional; fewer participants provided data. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| Secondary | Satisfaction With Treatment | Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. The score represents the sum of seven different patient satisfaction domain scores (see more here: https://www.rand.org/content/dam/rand/www/external/health/surveys\_tools/psq/psq18\_scoring.pdf). Higher scores indicate greater satisfaction with medical care. Minimum score = 1; maximum score = 35. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Time 1) |
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| Secondary | Satisfaction With Treatment | Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. The score represents the sum of seven different patient satisfaction domain scores (see more here: https://www.rand.org/content/dam/rand/www/external/health/surveys\_tools/psq/psq18\_scoring.pdf). Higher scores indicate greater satisfaction with medical care. Minimum score = 1; maximum score = 35. | Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3. | Posted | Mean | Standard Deviation | score on a scale | Time 2 (24 hours after baseline) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000091662 | Genital Diseases |
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| Work and Activity Interference |
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| Sexual Wellbeing |
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| Patient Satisfaction |
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| Work and activity interference |
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| Sexual wellbeing |
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| Patient satisfaction |
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