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Neurourology and Urodynamics 28:13–17 (2009) Goal Achievement Provides New Insights Into Interstitial Cystitis/Painful Bladder Syndrome Symptoms and Outcomes Christopher Payne* and Tina Allee Female Neurourology, Stanford School of Medicine, Stanford, CA Aims: Goal Assessment Scaling (GAS), wherein patients specify goals then evaluate treatments with regard to goal achievement, has proven utility in assessing treatment of complex conditions such as chronic pain, rheumatoid arthritis, and incontinence. We used surveys and focus groups to characterize the goals of patients with interstitial cystitis/painful bladder syndrome (IC/PBS) in order to create a pilot GAS. Methods: 37 patients with IC/PBS recorded and ranked their treatment goals which were pooled and analyzed for emergent domains and priority rankings. 15 patients participated in 3 separate focus groups. Focus group audiotapes were transcribed and reviewed to identify major themes and goals domains. Results: 140 separate goals were collected. Mean number of goals 4 2.73% had pain goals and 56% had frequency and/or nocturia goals. Focus groups revealed that urgency is a separate entity from pain or frequency and any of these may take priority. The groups defined urgency for IC/PBS patient as ‘‘the need to urinate due to an unpleasant sensation that prevents attention to any other task.’’ Additional goal domains of control, predictability, and information were explored. Unsatisfactory aspects of common urological surveys were discussed as well as positive and negative aspects of GAS. Conclusions: Patients have individualized treatment goals. GAS holds promise for addressing individuality in a standardized format. A new instrument developed from this work is being piloted in a multicenter RCT. We also suggest that questionnaires investigating urgency in IC/PBS clarify the definition in a way more applicable to the specific condition. Neurourol. Urodynam. 28:13–17, 2009. ß 2008 Wiley-Liss, Inc. Key words: LUTS; interstitial cystitis; painful bladder syndrome; female urology; IC; PBS; goals INTRODUCTION Female urology and urogynecology are surgical subspecial- ties focused on the correction of aberrant anatomy. It is logical and comforting to assume that anatomical correction will lead to symptom resolution, and by extension, greater patient satisfaction. However, this is not always the case. 1,2 Moreover, when faced with disorders that present as symptoms rather then signs, the clinician is dependent on patient reports to guide diagnosis and treatment. In clinical trials, where standardization is critical, the variability of symptoms and reporting styles moves from an occasional annoyance to a major obstacle. Lack of sensitive and consistent metrics can cripple the ability to detect clinically relevant change and therefore prevent formation of meaningful conclusions about treatment efficacy. To cope with this challenge, patient reported outcome measures (PROs) are being used more commonly in clinical trials. PROs are any instrument that allows patients to report their response directly. The vast majority of PROs are survey instruments with a set number of standardized questions. Validated PROs in urology such as the AUA symptom score and the Kings Health Questionnaire have widespread accep- tance. Though inarguably valuable, there are some important limitations to the data collected by standardized surveys. They may fail to address factors that are important to the individual sufferer while at the same time demanding focus on irrelevant symptoms. 3 Outcome reporting would be improved by a standardized method of evaluation that also accommodates individual experience. To this end, Goal Attainment Scaling, where the patient and/or provider set goals and then judge progress on the basis of goal attainment, may provide an answer. Goal Attainment Scaling was introduced in the 1960s by Kiresuk and Sherman for the evaluation of mental health programs and allows patient goals to be expressed in a systematic and measurable manner that is relevant and meaningful for each patient. 5 It has gained popularity in a vast array of medical settings including chronic pain, rheumatoid arthritis, cardiac and neurological rehabilitation, and management of geriatric care. In 2002 Hullfish et al. 1 applied goal theory to patients undergoing surgery for pelvic floor dysfunction. Subjects reported a mean of 3.6 goals with 75% of women meeting most of their goals 12 weeks after the intervention. The same researchers, with an expanded patient population, demon- strated that during long-term follow up, increased goal achievement related to lower scores on the Incontinence Impact Questionnaire (IIQ-7) and Urological Distress Inven- tory (UDI-6). 6 Brubaker et al. evaluated a similar cohort and found that while goal achievement was moderately related to satisfaction—objective cure was not. 2 In a later demonstration of reciprocity; reduced goal achievement was correlated with a decrease in satisfaction. 7 Urologic disorders erode QOL in multiple dimensions. Interstitial cystitis/painful bladder syndrome (IC/PBS) is notorious for its variable presentation, fluctuating course, and constellation of sensations that are difficult to articulate. In striving to improve the quality of RCTs, a flexible PRO that No conflict of interest reported by the author(s). Rodney Appell led the review process. *Correspondence to: Christopher Payne, Director, Female Urology and Neuro- urology, Associate Professor, 300 Pasteur Dr., Room A-260, Stanford, CA 94305- 5118. E-mail: [email protected] Received 25 February 2008; Accepted 28 April 2008 Published online 15 December 2008 in Wiley InterScience (www.interscience.wiley.com) DOI 10.1002/nau.20616 ß 2008 Wiley-Liss, Inc.

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Neurourology and Urodynamics 28:13–17 (2009)

Goal Achievement Provides New Insights Into InterstitialCystitis/Painful Bladder Syndrome Symptoms and Outcomes

Christopher Payne* and Tina AlleeFemale Neurourology, Stanford School of Medicine, Stanford, CA

Aims: Goal Assessment Scaling (GAS), wherein patients specify goals then evaluate treatments with regard to goalachievement, has proven utility in assessing treatment of complex conditions such as chronic pain, rheumatoidarthritis, and incontinence. We used surveys and focus groups to characterize the goals of patients with interstitialcystitis/painful bladder syndrome (IC/PBS) in order to create a pilot GAS. Methods: 37 patients with IC/PBSrecorded and ranked their treatment goals which were pooled and analyzed for emergent domains and priorityrankings. 15 patients participated in 3 separate focus groups. Focus group audiotapes were transcribed andreviewed to identify major themes and goals domains. Results: 140 separate goals were collected. Mean number ofgoals 4� 2.73% had pain goals and 56% had frequency and/or nocturia goals. Focus groups revealed that urgency isa separate entity from pain or frequency and any of these may take priority. The groups defined urgency for IC/PBSpatient as ‘‘the need to urinate due to an unpleasant sensation that prevents attention to any other task.’’Additional goal domains of control, predictability, and information were explored. Unsatisfactory aspects of commonurological surveys were discussed as well as positive and negative aspects of GAS. Conclusions: Patients haveindividualized treatment goals. GAS holds promise for addressing individuality in a standardized format. A newinstrument developed from this work is being piloted in a multicenter RCT. We also suggest that questionnairesinvestigating urgency in IC/PBS clarify the definition in a way more applicable to the specific condition. Neurourol.Urodynam. 28:13–17, 2009. � 2008 Wiley-Liss, Inc.

Key words: LUTS; interstitial cystitis; painful bladder syndrome; female urology; IC; PBS; goals

INTRODUCTION

Female urology and urogynecology are surgical subspecial-ties focused on the correction of aberrant anatomy. It is logicaland comforting to assume that anatomical correction will leadto symptom resolution, and by extension, greater patientsatisfaction. However, this is not always the case.1,2 Moreover,when faced with disorders that present as symptomsrather then signs, the clinician is dependent on patient reportsto guide diagnosis and treatment. In clinical trials, wherestandardization is critical, the variability of symptoms andreporting styles moves from an occasional annoyance to amajor obstacle. Lack of sensitive and consistent metrics cancripple the ability to detect clinically relevant change andtherefore prevent formation of meaningful conclusions abouttreatment efficacy.

To cope with this challenge, patient reported outcomemeasures (PROs) are being used more commonly in clinicaltrials. PROs are any instrument that allows patients to reporttheir response directly. The vast majority of PROs are surveyinstruments with a set number of standardized questions.Validated PROs in urology such as the AUA symptom scoreand the Kings Health Questionnaire have widespread accep-tance. Though inarguably valuable, there are some importantlimitations to the data collected by standardized surveys. Theymay fail to address factors that are important to the individualsufferer while at the same time demanding focus on irrelevantsymptoms.3 Outcome reporting would be improved by astandardized method of evaluation that also accommodatesindividual experience.

To this end, Goal Attainment Scaling, where the patientand/or provider set goals and then judge progress on the basisof goal attainment, may provide an answer. Goal AttainmentScaling was introduced in the 1960s by Kiresuk and Sherman

for the evaluation of mental health programs and allowspatient goals to be expressed in a systematic and measurablemanner that is relevant and meaningful for each patient.5 Ithas gained popularity in a vast array of medical settingsincluding chronic pain, rheumatoid arthritis, cardiac andneurological rehabilitation, and management of geriatric care.

In 2002 Hullfish et al.1 applied goal theory to patientsundergoing surgery for pelvic floor dysfunction. Subjectsreported a mean of 3.6 goals with 75% of women meetingmost of their goals 12 weeks after the intervention. The sameresearchers, with an expanded patient population, demon-strated that during long-term follow up, increased goalachievement related to lower scores on the IncontinenceImpact Questionnaire (IIQ-7) and Urological Distress Inven-tory (UDI-6).6 Brubaker et al. evaluated a similar cohort andfound that while goal achievement was moderately related tosatisfaction—objective cure was not.2 In a later demonstrationof reciprocity; reduced goal achievement was correlated witha decrease in satisfaction.7

Urologic disorders erode QOL in multiple dimensions.Interstitial cystitis/painful bladder syndrome (IC/PBS) isnotorious for its variable presentation, fluctuating course,and constellation of sensations that are difficult to articulate.In striving to improve the quality of RCTs, a flexible PRO that

No conflict of interest reported by the author(s).Rodney Appell led the review process.*Correspondence to: Christopher Payne, Director, Female Urology and Neuro-urology, Associate Professor, 300 Pasteur Dr., Room A-260, Stanford, CA 94305-5118. E-mail: [email protected] 25 February 2008; Accepted 28 April 2008Published online 15 December 2008 in Wiley InterScience(www.interscience.wiley.com)DOI 10.1002/nau.20616

� 2008 Wiley-Liss, Inc.

can capture subtle but significant improvements across thefull spectrum of patient experience would be highly desirable.We hypothesized that the currently available PROs fail tocapture the impact and effect of therapy in IC/PBS and thatGoal Assessment Surveys (GAS) could bridge this gap. We usedopen format questionnaires and focus groups to investigatethe vocabulary and spectrum of IC/PBS goals. This informationwas used to generate a menu of goals for utilization in a PROfor future RCTs.

MATERIALS AND METHODS

This project was approved by the Stanford UniversityInstitutional Review Board and all participants were providedwritten informed consent.

Goal Assessment Surveys: From June 2005 to October 2006,we recruited 37 patients with PBS as defined by the Interna-tional Continence Society from the Female Urology andNeuroUrology clinic at Stanford. No exclusionary attentionwas given to the patient’s current treatment protocol or lengthof treatment. As this was a pilot study of GAS, participantswere provided with goal identification forms modeled fromBrubaker’s work (see Appendix) and given minimal instruc-tions. They were simply asked to record and rank their goals. Ifthe participant asked questions about the type of responsedesired, they were told that interpretation of the instructionswas part of the study and encouraged to write whatever theythought was best. The one suggestion given to the participantswas to be as specific as possible. There was no time limit. Sinceour aim was to uncover the patients’ natural and spontaneousresponses, the questionnaires were accepted without review.We felt that the process of reworking goals with the patientwould confound our findings by shading the participant’sresponse with our intent.

Collected goals were pooled and analyzed by the authors foremergent domains and priority rankings. Special attentionwas paid to vocabulary and overlapping concepts. Goals thatcould be interpreted in multiple ways were selected for focusgroup discussion.

Focus group discussions: During the period of June 2006 toSeptember 2006, a convenience sample of fifteen patientswith IC/PBS from the Stanford Female Urology and Neuro-Urology clinic participated in three separate focus groups.Effort was made to include newly diagnosed and chronicsufferers within a wide severity range. Duration of each groupwas 60–90 min. Participation in the GAS questionnaireportion of the study was not a prerequisite for focus groupinclusion. Focus group conversations were lead by TA.Participants were encouraged to use specific personal exam-ples to the extent that they felt comfortable and to discuss‘‘treatment’’ or ‘‘therapy’’ as a general term to avoid shiftingfocus to a specific treatment. The format was minimallystructured but comprehensive in that the discussion points inevery group included:

1. Whether the current survey instruments and physicianencounters captured an accurate picture of disease stateand treatment progress.

2. Whether the recording and evaluation of goals wouldenhance communication.

3. Past goals, current goals, or anticipated future goals.4. What the wording in particular goals means. Urgency,

frequency, and control were specifically addressed.5. Why and how the goals discussed are separate or connected.

Using the information from the questionnaires and firsttwo focus groups, a comprehensive list of goals was compiledand presented to the last focus group for feedback. The focusgroup audiotapes were transcribed verbatim and reviewed bythe authors to identify major themes and the evolution ofconsensus.

RESULTS

Goal Assessment Survey

Demographics: Demographic information on the 37 res-ponders is presented in Table I. The range of scores for ICSI andICPI was 3–20 and 0–16, respectively. Our study populationwas more heavily weighted with ulcerative IC patients (30%)and patients with severe subjective disease (50% withICSI > 10) than might be expected in a typical communitysample.

One hundred forty separate goals were collected. The meannumber of goals per patient was 4 � 2 with a range of 0–9.There was a weak inverse correlation between goals listed andICSI score (Pearson product ¼�0.25).

Goal domains. The goals grouped into domains of Pain,Frequency and Nocturia, Life Style (subdomains of Sex, Food,Exercise, Work, Travel, and Pregnancy), Medication, GeneralDisease Goals, Education/Personal Understanding of Disease,Urination mechanics, Generalized Somatic Symptoms/Fatigue,Urge, Incontinence, Volume, and Seemingly Unrelated BodySymptoms.

The number of patients reporting goals in a domain and theraw number of goals per domain are presented in Table II.Sample goals are provided for illustration, the complete listingis available upon request. Pain was reported by the highestpercentage of patients (73%). Frequency and/or Nocturiawere the next most commonly reported (56%). Ten of the37 participants listed both pain and frequency goals. Of the10 patients listing both pain and frequency goals, 4 of themassigned their frequency goal a higher priority then their paingoal. Lifestyle goals as a group were the next most commongoals reported. Within the lifestyle domain, generalizedlifestyle goals, sexual goals, and goals related to diet toppedthe list (Table III).

Focus Groups

Demographics. Focus groups had 5, 6, and 4 participants,respectively. The first and third groups had 1 male each, allother participants were female. Average age was 47.2 �13 years. The mean ICSI and ICPI scores were 11.9 � 4.4 and10.8 � 3.9, respectively. Three participants had IC with ulcers,while the remaining 12 had non-ulcerative IC or PBS. Elevenparticipants (73%) were Caucasian, 2 participants (13%) wereIndian, 1 patient (7%) was African American, and 1 patient (7%)was Asian.

Current communication. The focus groups felt that thecurrent symptom reporting tools are not adequate. The majordeficits include inability to report details or subtle change and

Neurourology and Urodynamics DOI 10.1002/nau

TABLE I. Demographic Information for Written QuestionnaireParticipants

Gender Women; 35 (95%) Men; 2 (5%)

Subtype Ulcer; 11 (30%) Nonulcer; 26 (70%)

Severity ICSI ICPI

Mean � SD 12 � 5 10 � 5

Score over 10 20 (54%) 19 (51%)

14 Payne and Allee

the undue influence of immediate symptom severity onthe day of clinic visit:

Despite frustration with current assessment tools, thefocus group members were sympathetic to the difficultytracking patients’ response. The subjects instinctively ap-preciated the challenge of objectively tracking a diseasethat is characterized by a fluctuating course, especiallygiven that the various symptoms interact with eachother. This presents major barriers to full expression ofdisease status. Nevertheless, consideration of the patient’sperspective was felt to be critical to understanding anindividual’s disease state and worthy of continued efforts.

Using goals. When presented with GAS as a treatmentmetric patients responded favorably. They liked the ability tocustomize GAS to the impact of disease on their life. Concernsabout GAS centered on methods of goal collection, types ofgoals they would be expected to report, and the ways theirgoals would be quantified.

Goal domains. Participants felt that urologist would benefitfrom better understanding of goal domains since the subjectiveexperience of IC/PBS is not fully understood by non-sufferers.Patients agreed that Urgency, Frequency, and Pain are thecardinal symptoms of IC/PBS and that they are separate but notindependent goal domains.

Urgency. Participants asserted that urgency goals can bedifferentiated from frequency or pain goals. While pain,pressure, and burning are utilized as descriptors, it is theoverwhelming nature of urge that is the delineating factorin all cases. Through extensive discussion each groupindependently reached consensus on a definition of urgencyas ‘‘the need to urinate due to an unpleasant sensation thatprevents attention to any other task.’’ Although fear of leakingand pain were components of individual experience, the

presence or absence of these symptoms did not uniquelycharacterize urgency. In IC/PBS, It is the fact that urgencycommands attention and dictates actions that defined it as aseparate and important symptom.

Frequency. The discussion of frequency goals centeredaround activity disruption—especially with respect toemployment. In addition to time lost by frequent bathroombreaks, frequency undermines medical privacy since groupdisruption either forces public disclosure of their illness ornecessitates construction of elaborate cover stories to explainactivities.

Pain. While pain control is viewed as a straightforward goalby urologists, the pain goals associated with IC/PBS arecomplex and difficult to communicate. Although pain is aprominent symptom for many patients, some would notendorse personal pain goals. Rationales for this included (1)resignation that pain was refractory to treatment, (2) reasoningthat pain is bearable and thus not justifying treatment, or (3)refusal to use pain medications secondary to side effects.

Predictability. The ability to predict symptom severity(crucial to planning activities of daily living) was emphasizedas a predominant goal with profound effect on quality of life.Ideally, predictability would be an independent goal but isdifficult to express directly. However, lifestyle goals could beused as a proxy because the planning and execution of manylifestyle activities relies on the ability of the patient to predicttheir capabilities.

Control. Control did not appear in any of the GAS butwas brought up extensively during each of the focus groups.Patients agreed ‘‘control’’ was a separate goal domainthen ‘‘decreasing symptoms’’ since control is the ability to makedecisions about behaviors that cause symptom exacerbation. Aswith predictability, the evaluation of control goals independent

Neurourology and Urodynamics DOI 10.1002/nau

TABLE II. The Number of Participants Reporting Goals Within Each Domain and Total Number of Goals per Domain (Participants were not Limited to oneGoal per Domain). Selected Examples of Goals are also Provided

DomainsPatients with goals

within domain% Respondents withgoals in this domain

Raw number ofgoals reported

% Raw totalgoals

Pain 27 73% 31 22%

‘‘Pain minimized to tolerable level’’ ‘‘I’d like to be without pain and pressure in my bladder’’ ‘‘To be physically comfortable most of the time’’

Frequency and nocturia 22 56% 26 19%

‘‘To be able to go more then 2 hours without urinating’’ ‘‘To sleep 6 hr uninterrupted by the need to urinate’’

Life style 14 38% 31 22%

Generalized (n ¼ 7): ‘‘Be able to more reliable in making plans and following through’’ Sex (n ¼ 7): ‘‘I wish I could have intercourse and not pay the price of

having worse pain afterwards’’ Food (n ¼ 6): ‘‘To be able to eat the foods I love and miss because of having IC’’ Exercise (n ¼ 4):‘‘To be able to walk or work

out one hour without taking a bathroom break’’ Work (n ¼ 3): ‘‘To be able to work 6 hr per day at my old job’’ Travel (n ¼ 2): ‘‘To be able to travel and not

have to stop at every bathroom along the way’’ Pregnancy (n ¼ 1): ‘‘To be able to have a normal pregnancy in a few years’’

Medication 9 24% 10 7%

‘‘When experiencing bladder pain, I would like to be able to take a pain reliever that does not make me tired or irritable’’ ‘‘Take medication that decreases the

symptoms consistently’’

General disease goals 10 27% 7 5%

‘‘Improving overall symptoms for the long-term remission’’

Education/personal understanding of disease 4 11% 11 8%

‘‘Identification of the cause of the symptoms‘‘ ‘‘Understanding the various options for treatment’’

Misc urination mechanics 6 16% 6 4%

‘‘Gain ability to urinate spontaneously without need to pump muscles or use catheter’’

Generalized somatic symptoms/fatigue 5 14% 5 4%

‘‘I’d like to have more energy and not fall asleep at the drop of a hat’’

Urge 4 11% 4 3%

‘‘Having more notice before urgency to urinate sets in’’

Incontinence 4 11% 4 3%

‘‘To not have to wear protective underwear’’

Volume 3 8% 3 2%

‘‘More volume at a time, more then 200 cm3’’

Seemingly unrelated body symptoms 2 5% 2 1%

‘‘Better balance’’

New Insights Into IC/PBS 15

from symptoms goals is difficult. Therefore, attainment of lifestylegoals would be the closest measure.

Lifestyle. The lifestyle goals discussed paralleled thosecollected in questionnaire form. Diet, travel, and sexualrelations were recurrent themes. Some patients expressedreservations that despite their personal importance, urologistswould not value lifestyle goals. The cardinal symptoms of pain,frequency and urgency severely interfere with lifestyle goalsbut it is difficult to articulate their interactions directly. Given

this obstacle, lifestyle goals would be good proxy measure forsymptom improvement, predictability, and control. Cautionshould be used however in explaining lifestyle gains solelyon the basis of symptomatic improvement since improvededucation, patient adaptation, and coping strategies can allowlifestyle goals to be reached as well.

Information goals. There were two broad categories ofinformational goals. The first referred to gaining informationfor symptom management. This type of information goal

Neurourology and Urodynamics DOI 10.1002/nau

TABLE III. Selected Exemplifying Quotes from Focus Group Discussions

Issue Example quote

Current symptom reporting tools Pain. They will ask about pain. You know. How much pain you’re having with it. And how frequently do I urinate? Is it

disturbing my night’s rest? Duh! But nobody’s asking about anything beyond that

I think there are certain things that, certain ways people could respond to the treatment that have value that would

not be noticed, simply because patients do not talk about the details of how they respond to things

Yesterday was a horrendous day. Tomorrow might be even worse, but today we’re sitting here. It looks fine (today). So

that’s what is getting recorded

I know that every doctor I’ve ever seen has made a big deal about saying, ‘‘Well, your bladder can hold 650 cm3 under

anesthesia.’’ I’m like, ‘‘Well, great. But I don’t walk around under anesthesia’’

Urgency When the urgency hits, it’s pain. It’s not fear of peeing.

You lose control of yourself . . . It means that your social, physical ability to just be human and normal. All the

boundaries have been broken. It’s like bladder is out of control and has taken over my life and my body

And it’s nothing you can argue with or—I don’t know how to describe it. It will ruin your life. It will ruin your ability to

think no matter how smart you are. It will—you won’t care about anything . . . it will start stripping away your

personality, things that you valued. I mean, some of these people are parents, like I am, and if I see, you know,

urgency gets out of control, you will stop doing things for your kids. You will retreat into this little core where, as

you get better, maybe you start putting yourself back together, but don’t underestimate urgency

As a teacher I can particularly address [this] because I can live with discomfort in the classroom but I can’t live with

urgency in the classroom. I can’t just run out of the room to go whenever I want to and leave 30 kids unsupervised

Frequency Frequency interrupts your life so much. You know, whereas the pain, okay—You can bear it. Yeah, but the frequency,

I mean, you’ve got to plan out where’s the bathroom

You don’t want to share it. I mean, you know, everybody’s got a cover story. My cover story was I have a back problem.

Very convenient - you know, ‘‘Oh, God. My back’s killing me. I’ve got to take a break.’’ I just can’t, you know [say],

‘‘Can you give me five minutes?’’

Pain I realized after I’d been [ . . . ] seeing a doctor for well over a year that I was under reporting my pain. Because I was

like—well—that’s pressure. Well, yeah, but it’s pressure that keeps me from doing anything . . . somebody else

might call it pain

I’m not at a zero pain level. I’m at about a three or a four all the time. And I would like to be better but I’m content to be

there. So my goal is to wait for a new treatment or, you know, some day a cure I hope

Predictability If you ask me next Tuesday at 10:00 in the morning what can I do at 10:00 in the morning next Tuesday, I don’t have

the foggiest idea what I can do. 10:00 five days in a row or to 30 days in a row, at some point the whole thing’s

gonna fall apart . . . if you know (in advance) you’re gonna drop below this (symptom) threshold, it’s invaluable to

you

Control Just knowing that I can control my pain. Meaning that watching . . . my fluid intake with caffeine. You know, that is

the biggest thing for me. And if I know that I’m gonna have my two lattes, okay, then I just know today’s gonna be a

burning day. You know, I have control

Lifestyle These are not things my doctor is interested in.

And I think a survey along these lines [would be helpful]. How does this affect your work? How does this affect your

relationships? If you’re married, how does it affect your marriage? If you’re not married, how does it affect your

dating life? How on earth would you tell somebody about this when you start dating him? Oh, by the way, sex may

be a big problem. How does it affect your friendships? How does it affect your participation in church? How does it

affect going to a party? How does it change your dynamics at a party? How does it change what you wear? How far

you drive? All of that gets affected

For an IC patient, what they have to work with is terms of frequency, urgency, and pain . . . [ ] . . . in other words, if they

walk in, and they don’t get any relief, you can write off all those [lifestyle] activities

[GAS] would give you what capabilities that individual had . . . [ ] . . . it will show up when somebody has to travel

because they have a frequency problem. And when you travel, you need to find a restroom

Information Goals If I have one sort of a pain, then yes, I’m taking this [Viocoden]. But [sometimes] I don’t want to take Vicodin because

I’m supposed to take care of two kids. So I don’t want to be sleeping when they come home and I need to be doing

things. So it’s very specific about what I’m trying to address even on hourly basis during the day and what

medication I take to do that . . . [ ] . . . It’s like I’m deciding that on my own versus my doctors or anybody helping me,

but it’s good enough. I can at least manage that. You know, I mean - and I think a lot of us would like to at least be

getting specifics about each medication and see what this does versus what [that] does and how it would help you

in the long run

I want to know how I got this. I would say that that would be a goal of mine to figure out what, for me personally, you

know, did I have a lack of vitamin B and my adrenal glands weren’t working right or was I just over acidic for years

and years and years and then it built up or, I mean that’s a goal of mine to figure (the cause) out

I think that if we knew then I could comfortably say, ‘‘Okay, I’ll have a child and my child will know don’t take this

kind of medication or don’t ever quit this kind of medication.’’ Then I would feel more comfortable having a child

16 Payne and Allee

relates to control, predictability, and lifestyle goals. The othertype of informational goals refers to understanding of IC/PBSetiology and is irrespective of symptoms improvement.Patients want to know why they got the disease and if thereis a genetic or environmental link. The intrinsic value lies in theability to create a meaningful illness narrative and adjustfamily planning.

Preliminary GAS menu. The third focus group was asked toevaluate a standardized menu of goals for use with GAS. Thegroup felt that the initial menu was complete and reflectedthe spectrum of experience. Since lifestyle was identifiedrepeatedly as the best proxy measure of improvement, thesegoals were originally listed before other symptoms. Howeverthe group objected to the listing of lifestyle goals before thosedealing with cardinal symptoms because it was felt thatimprovement of the cardinal symptoms were the primaryconcern and the achievement of lifestyle goals were proxymeasures.

DISCUSSION

Other investigators have explored the use of goals in thesurgical management of prolapse and incontinence, but upuntil this point there has been little exploration of goals inIC/PBS. In this study we hypothesized that the currentlyavailable PROs fail to identify the full impact of IC/PBS andits therapy in RCTs and that GAS could bridge this gap. Tobegin investigation we used an open ended questionnaire.The average number of goals per patient was 4 � 2. Goalsvaried greatly in wording and were specific to individualexperience. This is similar to previous findings that women’sgoals are personal and highly subjective.1 Yet despite thevariability, we identified several recurrent goal domainsincluding: Pain, Frequency and Nocturia, Life Style, Medica-tion, General Disease Goals, Education/Personal Understand-ing of Disease, Urination Mechanics, Generalized SomaticSymptoms/Fatigue, Urge, Incontinence, Volume, and Seem-ingly Unrelated Body Symptoms. Focus groups enhancedunderstanding of open ended questionnaire data. In the focusgroups the additional goals of control, predictability, andinformational goals emerged as being vitally importantalthough difficult to communicate. As such, lifestyle goalswere considered a suitable proxy.

Clinical experience would have lead us to believe that painis the most troubling symptom; however the data show thatover a third of the time frequency is a higher priority goal thenpain relief. Reasons for this include the life disrupting natureof frequency. Whereas pain can be endured privately, frequentrestroom breaks force this personal problem into the publicdomain.

Since urgency is a commonly used but rarely defined term,we felt it was important to explore its meaning as itrelates to IC/PBS. A consensus definition of urgency as ‘‘theneed to use the restroom due to an unpleasant sensation thatprevents attention to any other task’’ emerged. This is animportant finding since shared meaning is a prerequisite foruseful discussions of urge, especially in regard to symptomtracking.

The fundamental question of whether GAS adds value toRCTs should be central to future investigations. Previous workcorrelating goal attainment with satisfaction but not surgicalcure showed that objective measures may not be the bestmethod of evaluating urological interventions.6 However, noparadox exists with IC/PBS since there are no acceptedobjective measures. In the current state of the art, patientsatisfaction and preservation of QOL is the entire goal.

The data from this study suggest that GAS would provide auseful tool in RCTs of IC/PBS. However some issues should beconsidered. It is possible that patients’ intrinsic motivationwill influence goal achievement in a manner independentfrom the intervention itself. It was found that in pelvic surgerypatients, worse self described health status was associatedwith decreased goal achievement, while feeling prepared forsurgery was associated with increase goal achievement. Thissuggests that the realization of goals can be influenced bypatient dependent factors.2 However, in a well designed RCT,the control group would be balanced to prevent such factorsfrom skewing the conclusions.

Depending on the patient population and resourcesavailable, goal assessment methods may or may not utilizeprovider input for initial goal setting. The main purpose ofprovider input would be to challenge or modify unreasonablegoals since their inability to be satisfied would jeopardize thesensitivity of GAS. The provider facilitated ‘‘bargaining’’ oradjustment phase can be utilized to minimize this problem.Another option would be providing the patient with a menuof sample goals. A menu can help focus the patient’sexpectations and prevent the exclusion of goals by simpleomission. Since this method would be more easily stand-ardized then direct provider input, we decided to construct asample menu of goals for reference during the goal settingsession. This coupled with allowance for non listed goals whilerequiring the patient to write each goal in their own wordsshould allow for sufficient patient individualization whileproviding some grounding and structure. From the datacollected we created a standardized menu of goals for pilottesting of GAS in a current North American randomizedclinical trial. While our objective was to study to investigateGAS in RCTs, it has not escaped our notice that the use of GASin clinic work might prove useful as well.

REFERENCES

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Neurourology and Urodynamics DOI 10.1002/nau

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