Bristol Urological Institute, Southmead Hospital, Bristol, United Kingdom
Neurourology and Urodynamics 31:625–633 (2012)
Pelvic Physical Therapy Distance Journal Club: February 6, 2013
Prepared by Pamela Downey, PT, DPT, WCS, BCB-PMD & Kendra Boyce, SPT ’13
University of Miami School of Medicine, Department of Physical Therapy
Primary Aim: To develop and validate a urinary diary (UD) applicable to the adult population. Described here the first developmental stage of the UD, that of topic exploration (Phase 1a) and content validation (Phase 1b). Content validity is an assessment of whether the diary makes sense to those that are asked to complete it.
Background:
Although they are extensively used in clinical practice and research trials, a review of the literature identified limited UD development and validation. Only two studies investigated diary format and no studies specifically investigated diary content.
Methodology:
Topic Exploration (Phase 1a)
Patient opinion: Using a qualitative approach, a convenience sample of patients with LUTS were interviewed during their attendance at the urology outpatients’ clinic within the South West of England. Semistructured, open-ended interviews were conducted by the primary author in a private room to establish parameters for inclusion in a urinary diary.
Diary-naive patients, those who had not previously completed any form of UD and therefore with no preconceived ideas regarding the format and content of UDs, were selected in order to reduce social desirability bias. Interviews were audio-recorded, transcribed verbatim, and patients’ views were coded. After the first 17 patients had been interviewed the data was analyzed to ensure that patients had been sampled from the range of clinical conditions that would require patients to complete a urinary diary. To ensure all clinical conditions had been sampled the remaining 10 patients were purposively recruited during their clinic attendance, purely on the basis of their symptoms and probable clinical diagnosis. Additionally, some patients at these collection clinics produced their own UDs; these were analzyed for content as well.
Clinician opinion. Concurrently, UDs were collected from12 NHS departments within the South West of England to identify the different parameters being recorded. Fifteen departments in total were contacted and included urology, gynecology, and physiotherapy departments as well as secondary care and community-based continence advisors. This formed the list of possibilities included in a study-specific
questionnaire composed to collect clinical expert opinion. Using a modified-Delphi technique, a purposive sample of clinicians were either mailed or emailed this questionnaire and asked to rate parameters as essential, desirable, or not required, for inclusion in a UD.
Following topic exploration, four UDs were developed. These incorporated all the parameters deemed essential by patients and clinicians (time of void, volume of void, the amount, time and type of fluid intake, time of an incontinence episode, the amount of incontinence, time of pad change, recording of bladder sensation, and voiding symptoms), but differed in their format (portrait and landscape formats both with and without a printed 24 hr clock). The chosen diary duration reflected recommendations from previously published literature, as well as both the patient and clinician opinions.
Round 1: One hundred patients were requested to complete the draft 4-day diaries, comprising a different format for each day. The order of the four diaries was randomized for 100 patients. On day 5, patients were requested to complete a questionnaire regarding diary preference and suggestions for improvement.
Round 2: As no one preferred format emerged, and the response rate was lower than anticipated, this round was repeated in a further set of 100 patients.
Round 3: A second convenience sample of patients attending the urology outpatients’ clinic, were shown the two preferred diary formats that emerged from Rounds 1 and 2, and the diary instructions. (Patients were given adequate time to read both the instructions and the two diary formats, before being asked to express their opinions on the instructions and the diaries.
Round 4: Finally, in a further round of patient interviews (using the same questioning adopted in Round 3, the final draft diary was assessed to ensure that the wording and layout as depicted in Fig. 1 were both easily interpreted and useable.
Concurrently, patient-completed examples of the two patient-preferred diary formats from Rounds 1 and 2 were distributed to a group of clinical experts for review. A questionnaire requesting format preference and ease of interpretation of the two diaries was included.
Results
Topic Exploration (Phase 1a)
Patient opinion. Twenty-seven patients were interviewed (age range 28–89 years, mean 55.4 years), 10 male and 17 female,with a range of clinical conditions (Fig. 1).
Clinician opinion. Thirty clinical experts returned the questionnaire (response rate of 33.3%), from a variety of clinical specialties (Fig. 2). Clinicians identified frequency, volume voided, time of incontinence episode, amount of incontinence, and volume of fluid intake as parameters deemed essential for inclusion (Table II). Optimal diary duration was 3 days, preferably in a single sheet format.
Content Validation (Phase 1b)
In Round 1, 38 of 100 patients returned diaries with all four different diary formats (portrait and landscape, both with and without a specified 24-hr clock), and the day 5 questionnaire, completed. Patient demographics were 15 males, 16 females, 7 gender not specified, with an age range of 27–85 years (mean age 62.8 years).
The majority of patients reported time of void, volume of void, voiding symptoms, bladder sensation and the time, amount and type of fluid intake as essential for inclusion in the UD. Amount and time of incontinence episode, and time of pad change were overall rated as less important.
In Round 2, 24 males and 13 females (n=37) of 100 patients completed and returned diaries (again all four different diary formats and the day 5 questionnaire completed). Patient age ranged from 19 to 89 years, mean age 63.2 years.
Patient response to the inclusion of specified parameters was identical to that in Round 1. In both Rounds 1 and 2, patients preferred the portrait format diaries A and B (Table III)
In Round 3, 11 patients (4 males, 7 females, age 19–78 years, mean age 50.4 years) were interviewed until topic saturation was achieved. A number of common themes were expressed and therefore changed. The following word changes were made; ‘‘urinate’’ changed to ‘‘pass urine’’; ‘‘incontinence’’ to ‘‘leaks’’; ‘‘bathroom’’ to ‘‘toilet.’’ The title of the intake column was changed to simply ‘‘drinks’’ and the title of the output column to ‘‘urine output.’’ The coding systems were printed underneath the diary to allow easy reference.
Twenty-six of 58 clinicians returned a completed questionnaire regarding preference for either diary A or B, a response rate of 44.8% (Fig. 2). Sixty-nine percent (18/26) selected diary B (portrait with a printed 24-hr clock) as their preferred format.
In addition to urinary frequency and voided volume, the parameters deemed essential for inclusion in the diary were: amount and type of fluid intake and the time of incontinence episode. An equal number of clinicians rated the time of fluid intake as essential as they did desirable
In the fourth and final round, 9 patients (7 females, 2 males, mean age 57.3 years, age range 38–74 years) were interviewed. The draft UD was felt to be easy to understand and interpret by all nine patients. No changes were requested. The final draft UD can be seen in Appendix.
**The bladder sensation scale employed in this project was developed 4 years ago as part of a larger study, using exploratory patient, and clinician interviews. Therefore this stage of development did not require repetition during Phase 1a of the present study. This scale was tested for content validity in Phase 1b and some minor changes to the wording were made. The recording of bladder sensation was retained within the final draft due to the high level of patient acceptance and completion. As such the scale will undergo further validity, reliability and responsiveness testing to ensure full validation.
Conclusions
This study describes the first stage of development of a UD using exploratory studies incorporating both clinician and patient opinion as a baseline for gathering data, and with the resulting findings subject to content validation. To ensure that a fully validated UD is created, the draft diary will undergo further psychometric evaluation: construct validity (measurement validity), criterion validity (outcomes on one test correlate with a criterion test), reliability (consistency in which an instrument measures a variable), responsiveness in the next phase of development.
Interpretation:
Strengths:
• Modified Delphi method (4 rounds) to obtain a consensus of opinion in both patients and clinicians
• Qualitative approach using “naive patients” to elicit urinary diary parameters
• Adequate response rate for questionnaire return rate (35-40% deemed adequate)
• Different health profession specialties involved in Clinician review cohort
• Reliability and validation testing of a workhorse clinical instrument
Weaknesses:
• Regional to SW England
Questions for discussion:
• What would you like on the UD that is not represented?
• 4 days...how many are days are you requiring patients to fill one out?
• How do you use UD in your practice?
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