International Urogynecology Journal

, Volume 22, Issue 8, pp 937–946

Goal attainment scaling in patients with lower urinary tract symptoms: development and pilot testing of the Self-Assessment Goal Achievement (SAGA) questionnaire

Authors

    • Loyola University Chicago
  • Vik Khullar
    • St. Mary’s Hospital
  • Elisabeth Piault
    • Mapi Values
  • Christopher J. Evans
    • Mapi Values
  • Tamara Bavendam
    • Pfizer Inc
  • James Beach
    • Beach Clinical Studies
  • Yating Yeh
    • Mapi Values
  • Zoe S. Kopp
    • Pfizer Inc
  • Con J. Kelleher
    • St. Thomas’ Hospital
  • Jeffrey Trocio
    • Pfizer Inc
Original Article

DOI: 10.1007/s00192-011-1382-7

Cite this article as:
Brubaker, L., Khullar, V., Piault, E. et al. Int Urogynecol J (2011) 22: 937. doi:10.1007/s00192-011-1382-7

Abstract

Introduction and hypothesis

The Self-Assessment Goal Achievement (SAGA) questionnaire was developed to identify treatment goals and assess goal-achievement in patients with lower urinary tract symptoms (LUTS).

Methods

This study consisted of (1) gathering information on goal setting/attainment concepts, (2) goal elicitation (n = 41 patients with LUTS), (3) cognitive debriefing of draft questionnaire (n = 11), and (4) pilot testing (n = 104).

Results

SAGA consists of baseline (goal-assessment; ranking) and follow-up (goal-achievement) modules. In addition to goals most frequently mentioned, patients can list up to five open goals. Goals most commonly reported as “very important” in pilot testing included reducing urgency (72%), incontinence (65%), and nocturia (64%). Treatment goals spontaneously reported as “very important” were reducing incontinence (45%), nocturia (40%), and frequency (26%).

Conclusions

SAGA may be used to identify treatment goals and assess goal-achievement in patients with LUTS in the clinic and for research (with additional validation). This information may promote patient–physician interaction and help patients establish realistic treatment goals, which may in turn improve treatment adherence and outcomes.

Keywords

AntimuscarinicBenign prostatic hyperplasiaBladder outlet obstructionGoal attainment scalingLower urinary tract symptomsOveractive bladder

Abbreviations

GAS

Goal attainment scaling

HRQL

Health-related quality of life

LUTS

Lower urinary tract symptoms

OAB

Overactive bladder

OAB-q

Overactive Bladder Questionnaire

OAB-S

Overactive Bladder Satisfaction

PPBC

Patient Perception of Bladder Condition

SAGA

Self-Assessment Goal Achievement

Introduction

Although physician-defined outcomes have been used by researchers studying treatments for lower urinary tract symptoms (LUTS), including overactive bladder (OAB) symptoms, patient-reported outcomes (PROs) are important for providing the patient’s perspective on their treatment aspirations for reducing symptoms, coping mechanisms, and treatment acceptability [1]. Some patients may begin therapy with unrealistic treatment expectations, which can lead to patient dissatisfaction or nonadherence [2, 3]. Patients with LUTS may also have insufficient knowledge of their condition and treatment options [4]; for example, they may view incontinence as an untreatable natural consequence of aging or childbirth [2].

Clinicians may lack knowledge of how a patient’s OAB symptoms affect their health-related quality of life (HRQL) because individual symptoms and the level of bother associated with them vary among patients with OAB [57]. Individualized, patient-centered treatment plans can help align the knowledge and expectations of the patient and healthcare provider by establishing a partnership that can facilitate development of realistic treatment expectations. This is particularly important with conditions such as lower urinary tract dysfunction where patients may be hesitant to communicate the true impact of their symptoms due to embarrassment, leading to misunderstandings between patient and physician about symptom severity and impact on HRQL [810]. For example, women seeking care for pelvic floor disorders vary in their preference for participating in treatment decisions and information sharing [11].

Goal attainment scaling (GAS) was designed to facilitate the patient–provider interaction and put patient goals at the center of outcomes assessment [12]. The rating of GAS involves a multistep approach centered around the patient–physician interaction, which begins with the identification of those goals that are important yet might be unique for each patient. Patients indicate the importance of various treatment goals, and anticipated or expected outcome levels are then discussed with their health care provider [13]. This open dialogue provides an opportunity for eliminating unrealistic goals, addressing misinformation, and resetting patient expectations for treatment benefit. Finally, a time for the assessment of treatment goal attainment is determined [12].

GAS is used to assess treatment outcomes through goal achievement in numerous settings, especially those that require an individualized and multidimensional approach to treatment planning. Although goal setting has been used in several urogynecologic studies [1420], to date there are no self-completed instruments that would allow patients to proactively capture their treatment goals for discussion with the health care provider in routine clinical practice or research settings.

We conducted an institutional review board (IRB)-approved four-phase study to develop and pilot test a GAS for LUTS. The research phases were: (1) preparatory phase that generated preliminary information for assessing goal setting and attainment, (2) specific goal elicitation, (3) cognitive debriefing of a draft questionnaire, and (4) pilot testing of the questionnaire. The validation and reliability testing of the GAS will be reported elsewhere.

Methods

Preparatory phase

The preparatory phase included data from a goal achievement study conducted in women who had undergone pelvic reconstructive surgery at Loyola University Medical Center [2]. Following IRB approval, participants were asked through a paper survey about their goals before surgery and postoperative goal attainment and satisfaction. Review of the survey demonstrated patients’ difficulty formulating goals, and was therefore the basis for developing a preliminary list of most frequently reported symptom goals that would also be applicable to patients with LUTS. Using these data, we developed an initial draft of the SAGA questionnaire with a baseline module covering goal assessment and ranking and a follow-up module covering goal achievement.

Goal elicitation

Face-to-face, semistructured, qualitative interviews were conducted with 41 patients with LUTS to refine the spontaneously elicited goals reported by patients with LUTS and to better understand patients’ decision-making process when ranking goals, and how they determine goal achievement. The approach taken was consistent with FDA Guidance on the development of PRO measures [21]. Interview data were analyzed using the grounded theory tradition, according to published methods [2224], which seeks to produce rich descriptions and theoretical explanations of the phenomenon under investigation [25]. The draft measure developed above was used when necessary for probing purposes during these interviews. With this approach the concepts emerge from the data allowing the voice of the subject to be heard rather than apply a priori concepts or hypotheses [2224]. The goal elicitation phase resulted in a revised list of suggested common LUTS goals.

Cognitive debriefing

The cognitive debriefing phase consisted of face-to-face interviews with 11 patients to confirm the relevance of the goals included in the revised list and to confirm that the terminology used was appropriate. The content of the revised draft of the Self-Assessment Goal Achievement (SAGA) questionnaire underwent a detailed review by an expert panel before testing in a pilot study.

Pilot study

Pilot testing of the SAGA questionnaire was conducted at two sites in the United States: a specialist setting at Loyola University, Chicago, IL, and a general practitioner setting in Paradise Valley, AZ, following IRB approval. Patients were eligible for the pilot study if they were aged ≥ 18 years, had OAB for ≥ 3 months, and did not have a current urinary tract infection, known history of pelvic masses or bladder outlet obstruction, known history of uninvestigated hematuria, known complications from surgical procedures, current radiation treatment to pelvic organs or external genitalia for any reason, concomitant overt peripheral and central neurologic diseases, or significant hepatic or renal disease. Treatment received by patients was not specified as a requirement for inclusion in the pilot study; thus, patients had received a variety of treatments (e.g., biofeedback, medications, and surgery) with different levels of efficacy.

Patients completed the baseline module of the SAGA questionnaire prior to seeing their health provider, to whom they returned the questionnaire and discussed their responses during a regular visit. During a follow-up visit scheduled between 3 and 4 months later, patients then rated their goal achievement and discussed their treatment outcomes with a healthcare provider. In order to test for differences based on the order in which patients complete the suggested goal and open goal sections, we tested two SAGA formats. In the first format, given to 73% of participants, patients completed the suggested goal section before the section where they could enter up to five additional personal, open-ended goals. In the second format, the remaining 27% participants completed the open-ended goal section before the suggested goal section. Qualitative analysis was used to determine if there was any difference in the number of goals listed and ranking of goal importance between the two formats.

Results

Preparatory phase

The initial version of the SAGA questionnaire consisted of a mix of patient-initiated goals (i.e., goals that patients added to the questionnaire) and 12 suggested goals in six areas: symptoms (frequency, urgency, nocturia), physical impact (ability to go out and perform activities), emotional impact (worry about symptoms), adverse effects of treatment, desire for less medication, and better compliance.

Goal elicitation and cognitive debriefing

Forty-one patients (mean age [range], 63.6 [39–81] years; 54% women), participated in the goal elicitation and cognitive debriefing phases. The most common LUTS reported were nocturia (73%), frequency (71%), urgency (71%), dribbling (56%), and incontinence (53%) (Table 1). Clinical diagnoses included OAB (59%), urgency incontinence (15%), mixed incontinence (12%), pelvic organ prolapse (10%), stress incontinence (2%), and other LUTS (2%).
Table 1

Frequency of lower urinary tract symptoms reported in the goal elicitation phase

Symptom

Number (%) of patients

Nocturia

30 (73)

Frequency

29 (71)

Urgency

29 (71)

Dribbling

23 (56)

Incontinence

22 (54)

Stress incontinence

13 (32)

Hesitancy

11 (27)

Poor stream

9 (22)

Multiple peak flow

7 (17)

Straining

6 (15)

Pelvic pain

5 (12)

Pelvic organ prolapsed

4 (10)

The most common goals identified were symptom improvement goals, including decreasing frequency of urination (n = 17), relieving stress incontinence (n = 10), and reducing nocturia (n = 8) (Table 2). Patients also listed goals regarding decreasing the need for coping strategies (use of pads, n = 17; bathroom mapping, n = 10), reducing emotional impact (n = 14), improving medication efficacy (n = 13), and improving the ability to conduct daily activities (n = 12). Other reported goals included complete cure (n = 8), improved sexual functioning (n = 7), return to a feeling of normalcy (n = 5), and reduction in smell (n = 5). A representative sample of goals described by patients is listed in Table 2.
Table 2

Goals reported in the goal elicitation phase (N = 41)

Goal

No. (%) of patients

Sample of a representative patient quote of open goals

Coping strategy/pads

17 (41)

“And I do wear pads a lot of the time. A goal would be to be able to not wear a pad.”

Frequency—partial relief

17 (41)

Emotional well-being

14 (34)

“I just want to get this issue (urinary symptoms) off my back…stop worrying. Because I got enough to worry about”

Medication efficacy

13 (32)

“But I expect that—I hope that [the medication is] going to strengthen those muscles that in turn are affecting all of these other organs, to release some of that pressure.”

Role functioning (activities of daily living, social interaction, family interaction)

12 (29)

“If I’m shopping, I would like to be able to shop longer before I have to go find the restrooms…I’d like to be able to work longer and not have to stop and go to the bathroom so much.”

Coping strategy/bathroom map

10 (24)

“Yes, always on my mind where the next bathroom is…. A goal is not to have to worry where a bathroom is all the time.”

Stress incontinence—relief

10 (24)

“I don’t want to dread sneezing, I want to be mildly annoyed, but not dread it.”

Nocturia—relief

8 (20)

“Well in the case of getting up too frequently at night. it would be a matter of minimizing that activity”

Physical well-being

8 (20)

“Well, I have a goal of being able to go out for a long walk and not have to worry about going to the bathroom.”

Overall symptom relief (cure, stop symptom)

8 (20)

Control (overall)

7 (17)

“Well I expect it to do what the doctor said, which is improve my ability to control my bladder.”

Sexual functioning

7 (17)

Going out

6 (15)

“Sometimes when I go out dancing, I have to go a lot… but when I’m dancing around, feeling mildly uncomfortable is one thing, but thinking oh God, I got to go again soon, or if I jump too much who knows what’ll happen.”

Incontinence—relief

6 (15)

“The big one is not to be incontinent, and I do think that’s an achievable goal.”

No need for medication

6 (15)

“Ideally, I’d like to get off of or at least cut down on the medication if I can.”

Urge—relief

6 (15)

Coping strategy/clothes

5 (12)

Frequency—relief

5 (12)

“Well, at least make it three hours at least before I go. Man, it gets tiresome…. So I could go like to normal, so I don’t have to go every darn hour and a half, two hours.”

Normalcy

5 (12)

Smell

5 (12)

Urgency—partial relief

5 (12)

These data were used to revise the SAGA questionnaire so that the suggested goals were limited to symptom improvement. The highly individualized items regarding physical and emotional impact, coping, and other less common symptoms were removed from the suggested list due to a high degree of variability in patient responses; we formatted the questionnaire so that patients could add these individualized goals in the open-ended section.

The revised baseline version of SAGA consisted of five open-ended treatment goals where patients could record any individual goal and seven suggested goals related to symptoms: frequency (daytime and nighttime), sensation to use the bathroom, bladder voiding, starting or maintaining a urine stream, urine leakage, and urgency. Patients were also asked to rank their top five treatment goals and their criteria for treatment success. The follow-up module of the questionnaire contained the same seven suggested goals and five open-ended items as the baseline version, with a 5-point response continuum ranging from “did not achieve goal” to “greatly exceeded goal.” In addition, one global question on overall goal achievement was included.

Pilot study

The demographic characteristics of the 104 patients who participated in the pilot study are listed in Table 3. Among these patients, most (74%) rated their bladder condition as causing some moderate (32%), some severe (23%) or many severe (18%) problems on the Patient Perception of Bladder Condition (PPBC); the remaining patients (26%) rated their bladder condition as causing some minor (18%), very minor (7%), or no (1%) problems (based on number of nonmissing responses [n = 99]). Nearly half of the patients reported an urge to void between eight and 11 times a day and just over half reported an urge to go to the bathroom ≥ 3 times at night (Table 4).
Table 3

Demographic characteristics for patients enrolled in the pilot study (N = 104)

 

Illinois (n = 54)

Arizona (n = 50)

Overall (N = 104)

Age (years)

Mean (SD)

53.43 (13.04)

66.46 (11.53)

59.69 (13.92)

Median

52.50

68.00

61.50

Range

21–76

30–86

21–86

Missing/no responsea

0

0

0

Sex, n (%)

Female

46 (85)

24 (48)

70 (67)

Male

8 (15)

26 (52)

34 (33)

Missing/no responsea

0

0

0

Education, n (%)

Some high school

2 (4)

7 (14)

9 (9)

High school diploma/GED

6 (12)

20 (40)

26 (26)

Some years of college

6 (12)

13 (26)

19 (9)

Certificate program

6 (12)

2 (4)

8 (8)

College/university degree

12 (24)

6 (12)

18 (18)

Graduate or professional degree

11 (22)

2 (4)

13 (3)

Other

8 (16)

0

8 (8)

Missing/no responsea

3 (6)

0

3 (3)

Work Status, n (%)

Working full-time or part-time

21 (41)

16 (32)

37 (37)

Full-time or part-time homemaker

11 (22)

1 (2)

12 (12)

Unemployed

2 (4)

0

2 (2)

Student

1 (2)

0

1 (1)

Retired

12 (24)

27 (54)

39 (39)

Other

4 (8)

6 (12)

10 (10)

Missing/no responsea

3 (6)

0

3 (3)

Living Situation, n (%)

Alone

10 (20)

12 (24)

22 (22)

With a significant other/spouse

14 (27)

25 (50)

39 (39)

With children

7 (14)

6 (12)

13 (13)

With a significant other/spouse and children

13 (25)

4 (8)

17 (17)

With relative (other than significant other and children)

4 (8)

1 (2)

5 (5)

With friends

1 (2)

0

1 (1)

With others (other than family and friends)

1 (2)

0

1 (1)

Other

1 (2)

2 (4)

3 (3)

Missing or no responsea

3 (6)

0

3 (3)

Treatment for Urinary Symptoms, n (%)*

None

16 (31)

14 (28)

30 (30)

Decrease or increase drinking habits

16 (31)

6 (2)

22 (22)

Use of absorbent underclothing

19 (37)

6 (12)

25 (25)

Physical therapy, bladder retraining

16 (31)

7 (14)

23 (23)

Biofeedback; use of a urination chart

3 (6)

3 (6)

6 (6)

Implant injection

0

2 (4)

2 (2)

Surgical treatment

6 (12)

6 (12)

12 (12)

Treatment with medicines

22 (43)

26 (52)

48 (48)

SD standard deviation

aPercentages of missing/no response are based on the overall number of patients

*Percentages are based on the number of nonmissing responses

Table 4

Urinary symptoms reported on the SAGA questionnaire during the pilot study (N = 104)a

Item

n

Missing/no responseb

Number of episodes, n (%)

<3

4–5

6–7

8–9

10–11

12–13

14–15

>15

1a. Number of times you have the urge to go to the bathroom during a day

101

3 (3)

1 (1)

11 (11)

16 (16)

22 (22)

25 (25)

13 (13)

6 (6)

7 (7)

1b. (If treated) Number of times you expect to have the urge to go to the bathroom during a day

101

3 (3)

1 (1)

10 (10)

40 (40)

25 (25)

18 (18)

5 (5)

1 (1)

1 (1)

   

0

1

2

3

4

5

6

>6

2a. Number of times you have the urge to go to the bathroom during a night

101

3 (3)

4 (4)

16 (16)

21 (21)

34 (34)

16 (16)

5 (5)

5 (5)

0

2b. (If treated) Number of times you expect to have the urge to go to the bathroom during a night

101

3 (3)

49 (49)

39 (39)

12 (12)

1 (1)

0

0

0

0

   

0

1

2

3

4

5

6

>6

3a. Number of times you have some leaking on your way to the bathroom during a day

101

3 (3)

24 (24)

15 (15)

16 (16)

10 (10)

8 (8)

10 (10)

3 (3)

15 (15)

3b. (If treated) Number of times you expect to have some leaking on your way to the bathroom during a day

98

6 (6)

84 (86)

4 (4)

7 (7)

1 (1)

2 (2)

0

0

0

   

0

1

2

3

4

5

6

>6

4a. Number of times you have some leaking on your way to the bathroom during a night

101

3 (3)

39 (39)

16 (6)

21 (21)

15 (15)

6 (6)

2 (2)

2 (2)

0

4b. (If treated) Number of times you expect to have some leaking on your way to the bathroom during a night

98

6 (6)

93 (95)

5 (5)

0

0

0

0

0

0

aPercentages are based on the number of nonmissing responses

bPercentages of missing/no response are based on the overall number of patients

The open goals most commonly identified by patients were nocturia (58%), incontinence (50%), frequency (38%), general activities of daily living (34%), urge (28%), weak stream (18%), pad usage (15%), and empty bladder (14%) (Table 5). The open goals most commonly rated as “very important” among the entire population were incontinence (45%), nocturia (40%), frequency (26%), general activities of daily living (25%), urge (21%), and pad usage (12%) (Table 5). The open goals most commonly rated as “very important” among only those patients who identified the goal were incontinence (90%), urge (76%), pad usage (75%), general activities of daily living (74%), nocturia (70%), traveling (70%), and frequency (69%).
Table 5

Ranking of open goal importance in the pilot study (N = 104)

Item

Number (%) of patientsa

Not very important goal (1)

(2)

(3)

(4)

Very important goal (5)

Total number of patients who identified goal

Symptom: nocturia

0

2 (2)

4 (4)

12 (12)

42 (40)

60 (58)

Symptom: incontinence

0

0

0

5 (5)

47 (45)

52 (50)

Symptom: frequency

0

0

1 (1)

11 (11)

27 (26)

39 (38)

Activity of daily living: general

0

2 (2)

3 (3)

4 (4)

26 (25)

35 (34)

Symptom: urge

0

1 (1)

0

6 (6)

22 (21)

29 (28)

Symptom: weak stream

1 (1)

1 (1)

3 (3)

4 (4)

10 (10)

19 (18)

Impacts: pads

0

0

1 (1)

3 (3)

12 (12)

16 (15)

Symptom: empty bladder

1 (1)

0

1 (1)

3 (3)

10 (10)

15 (14)

Symptom: pressure

0

0

0

2 (2)

10 (10)

12 (12)

Activity of daily living: traveling

0

1 (1)

0

2 (2)

7 (7)

10 (10)

Impacts: physical

0

0

2 (2)

1 (1)

5 (5)

8 (8)

Symptom: pain

0

0

2 (2)

1 (1)

3 (3)

6 (6)

Symptom: infection

0

0

0

0

4 (4)

4 (4)

Impacts: pharmacologic treatment

0

0

0

1 (1)

3 (3)

4 (4)

Symptom: dysuria

0

1 (1)

0

0

3 (3)

4 (4)

Impacts: successful treatment

0

0

0

0

3 (3)

3 (3)

Impacts: nonpharmacologic treatment

0

0

0

1 (1)

2 (2)

3 (3)

Symptom: Bowel

0

0

0

0

2 (2)

2 (2)

Impacts: Social

0

0

0

1 (1)

1 (1)

2 (2)

Impacts: clear diagnosis

0

0

0

0

2 (2)

2 (2)

Emotional impact: worry

0

0

0

0

2 (2)

2 (2)

Behavior: drinking

0

0

0

0

2 (2)

2 (2)

Symptom: pelvic floor prolapsed

0

0

0

0

1 (1)

1 (1)

Symptom: overall control

0

0

0

0

1 (1)

1 (1)

Activity of daily living: clothing

0

0

0

0

1 (1)

1 (1)

Impacts: Strategy for treatment

0

0

0

0

1 (1)

1 (1)

Emotional impact: embarrassing

0

0

0

0

1 (1)

1 (1)

Impacts: sleep

0

0

0

0

1 (1)

1 (1)

aPercentages are based on the number of nonmissing responses

The suggested goals most commonly rated as “very important” included reductions in the need to rush to the bathroom (72%), urine leakage (65%), nocturia (64%), and daytime frequency (62%) (Table 6). Goals considered not very important or not applicable included reductions in the difficulty maintaining a stream (40%); urine loss when coughing, laughing exercising, sneezing (31%); and difficulty in emptying the bladder (31%).
Table 6

Ranking of suggested goal importance in the pilot study (N = 104)

Item

N

Number (%) of patientsa

Missing/no responseb

Not very important goal (1)

(2)

(3)

(4)

Very important goal (5)

Not applicable

1. Reduce the number of times I go tothe bathroom throughout the day

103

1 (1)

5 (5)

5 (5)

12 (12)

17 (17)

64 (62)

0

2. Reduce the number of times I get up at night to go to the bathroom

103

1 (1)

7 (7)

9 (9)

10 (10)

10 (10)

66 (64)

1 (1)

3. Reduce the sensation of pressure in my lower abdomen

103

1 (1)

17 (17)

8 (8)

11 (11)

13 (13)

39 (38)

15 (15)

4. Reduce the sensation of pressure that prompts me to go to the bathroom

103

1 (1)

10 (10)

8 (8)

14 (14)

17 (17)

49 (48)

5 (5)

5. Reduce the difficulties I have completely emptying my bladder

102

2 (2)

15 (15)

4 (4)

15 (15)

15 (15)

37 (36)

16 (16)

6. Reduce the difficulty starting or maintaining a urinary stream

103

1 (1)

22 (22)

13 (13)

16 (16)

14 (14)

20 (19)

18 (18)

7. Reduce the urine loss when I cough, laugh, exercise, or sneeze

102

2 (2)

15 (15)

9 (9)

10 (10)

4 (4)

48 (47)

16 (16)

8. Reduce my urine leakage

103

1 (1)

8 (8)

5 (5)

8 (8)

5 (5)

67 (65)

10 (10)

9. Reduce the sudden need to rush to the bathroom

102

2 (2)

5 (5)

2 (2)

8 (8)

11 (11)

73 (72)

3 (3)

aPercentages are based on the number of nonmissing responses

bPercentages of missing/no response are based on the overall number of patients

Goal ranking and mean number of goals reported did not differ between the two SAGA formats tested in which patients completed the open goal section first followed by the suggested goal section (mean [SD] number of goals, 3.9 [1.5]) or the suggested goal section first followed by the open goal section (mean [SD] number of goals, 3.9 [1.5]).

After the pilot study was conducted, two changes were made to the SAGA questionnaire. “Reduce dribbling after urinating” was added as a new suggested goal, and the suggested goal “reduce my urine leakage” was split into two goals (“reduce my urine loss when I have a sudden need to rush to the bathroom” and “reduce my urine loss when I cough, laugh, exercise, or sneeze”).

Discussion

Patients with LUTS have many goals regarding treatment. Their principal treatment goals involve traditional symptom areas, such as frequency and urgency, for which assessment could be easily standardized; however, patients also expect treatment to affect their social, emotional and physical functioning. It is also clear that goals differ among patients, with some patients placing a greater emphasis on reducing the impact of LUTS on daily activities than on symptom relief.

Patient-completed measures using GAS differ from traditional PRO measures using severity or frequency rating scales such as the OAB-q [26], or OAB-S [27]. Both types of measure capture information that is relevant to patients with OAB, such as their symptoms or impact on their social, emotional and physical functioning. However, traditional measures are designed to produce results that can be generalized to an overall patient population; whereas the SAGA questionnaire provides the patient-centered approach that is required for the assessment of individual patients’ goals. This individualized approach to measurement augments information gained from other standardized outcome measures. With SAGA, outcome scales are tailored specifically to the individual; patients can select their own goals in the open-ended portion of the questionnaire and need rate only the symptoms or areas impacted that they feel are important.

Because we found early in the study that some patients had difficulty setting goals, we provided suggested goals common to LUTS treatment that patients could rank in the baseline module and rate their treatment success in the follow-up module. These suggested goals provided examples for the patients and allowed them to think about the impact of LUTS on their lives. This left intact the essential element of GAS, in which patients select and record their own individualized goals, but also allowed goal setting to proceed around a common set of complaints for patients who have difficulty completing a goal-setting exercise.

The role of patient expectations is central to GAS [12]. Under traditional PRO evaluations, expectations for treatment outcomes are largely ignored. With satisfaction assessments, the role is more explicit, but expectations data are usually only analyzed to determine how much of the change in satisfaction resulted from initial expectations of treatment benefit. In clinical practice, healthcare providers can use GAS to actively manage patient goals and expectations. If patients set unrealistic treatment goals that are unlikely to be achieved, then the healthcare provider needs to separate unrealistic goals from realistic ones and explain to patients what the treatment can actually achieve [12]. Additionally, healthcare providers can use GAS to tailor treatment plans to meet the needs of individual patients. Further, the goal-setting exercise creates a treatment path in patients’ minds, and they are able to monitor their progress in fulfilling their treatment objectives. Healthcare providers should assess goal achievement with patients during follow-up visits. The appropriate time for a follow-up visit may vary depending on a number of factors (e.g., patient’s goals, type of treatment). Although further studies would be required to support recommendations for how often patients should be asked about their goals, follow-up visits should be scheduled to allow sufficient time after treatment initiation for progress to occur, and also allow adjustments to unmet goals to be made in a timely manner.

Managing and setting realistic treatment expectations can be hypothesized to reduce patients’ likelihood of discontinuing treatment because they understand that some of their goals may never be achieved or only partially achieved, others may be obtained within the first weeks of treatment, and others may not be achievable for months. For example, if a patient understands that their goal of a cure is realistic, they may adhere to a treatment that alleviates symptoms with tolerable adverse effects. Treatment persistence is a major issue across chronic health conditions [28] and LUTS is no exception. In one study, conducted in a Medicaid population with OAB, only 32% of patients taking oxybutynin immediate release and 44% of those taking either oxybutynin extended release or tolterodine extended release remained adherent to treatment after 30 days [29]. Understanding patients’ treatment goals may help clinicians make more informed decisions regarding when to initiate, switch, or titrate treatment [3].

Although the SAGA questionnaire offers an individualized approach to measuring PROs, it may also prove useful in clinical trial settings. Careful consideration should be given to how the SAGA questionnaire is used in a clinical trial: patients who set unrealistic treatment goals will need to be asked to reset their goals to realistic levels following a discussion with their health care provider. Once realistic goals have been established then follow-up should occur on the new set of goals rather than on the initial set.

The use of the SAGA questionnaire in a clinical trial may appear to be counterintuitive because patients’ goals may differ both in terms of goal number and type. However, GAS scores can be combined by treatment group into a summary score using standardized z-based scoring. Other GAS measures have been found to be more responsive to change than the measures commonly used in evaluating effectiveness of specialized intervention [30], this may also be the case for SAGA as well.

Our study confirms the appropriateness of a GAS evaluation and the need for a specific LUTS assessment tool. Patients in our study reported numerous LUTS, and the symptoms reported represent areas they considered important in terms of treatment relief. Additionally, patient goals encompass coping strategies, emotional well-being, and role functioning. The use of a goal attainment scale will be particularly useful given the multidimensional nature of LUTS and their impact on HRQL, the need for patient behavior change, and given that current treatments may not offer the possibility of a cure.

Conclusion

Our study demonstrates that patients’ treatment goals for LUTS are subjective, numerous, and personal. Healthcare providers’ knowledge of patients’ treatment expectations may improve provider–patient interactions, treatment adherence, and treatment outcomes. Additional research is under way to determine the psychometric validity of the SAGA questionnaire in US and European patient populations based on follow-up data to this study, how goal achievement predicts satisfaction, and whether the process of goal setting and monitoring can improve treatment adherence and outcomes. Further studies could address the question of whether patients’ goals are associated with factors including clinical and/or demographic characteristics including, for example, age, gender, race, and socioeconomic status. Given that the SAGA questionnaire is suitable for computer-based administration, future studies might also explore the possibility that the resultant data could be incorporated into patients’ electronic records. The pragmatically designed SAGA questionnaire may improve provider–patient interaction and allow goal achievement to be assessed in research studies.

Acknowledgement

This study was initiated and sponsored by Pfizer Inc. Editorial support was provided by Simon J. Slater, PhD, at Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

Conflicts of interest

LB is a consultant and investigator for Pfizer Inc; EP, CJE, and YY are consultants for Pfizer; JB is a consultant and investigator for Pfizer Inc, and an investigator for Bristol-Myers Squibb, Astellas, LLC, Ingenix, and GlaxoSmithKline, plc; VK is a board member, consultant, investigator, and lecturer for Pfizer Inc, and a board member, consultant, and investigator for Astellas, and LLC; TB, ZSK, and JT are employees of Pfizer Inc.

Copyright information

© The International Urogynecological Association 2011