PREVENTIVE

MEDICINE

19, 630-641 (1990)

Improving Follow-up after an Abnormal Pap Smear: A Randomized Controlled Trial’ ELECTRAD. PASKETT,PH.D.,*,’ WILLIAM B. CARTER,PH.D.,+ AND

EMILY WHITE, PH.D.,? JOSEPH CHU, M.D., M.P.H.$

*Department of Public Health Sciences, Bowman Gray School of Medicine, 300 South Hawthorne Road, Winston-Salem, North Carolina 27103; fDepartment of Epidemiology, University of Washington and Cancer Prevention Research Program, Fred Hutchinson Cancer Research Center, Seattle, Washington; *Department of Health Services, School of Public Health Services and Community Medicine, University of Washington and Associate Director, Northwest Health Services Research and Development, Seattle VA Medical Center, Seattle, Washington; and BDepartment of Obstetrics and Gynecology and Department of Epidemiology, University of Washington, Seattle, Washington

Less than 60% of women diagnosed with cervical abnormalities on Pap smears return for proper surveillance and timely treatment. Previous tactics used to motivate these women to return have mainly relied on costly intensive recall efforts. Using a framework based on psychological value expectancy theory, a pamphlet was designed to motivate women with abnormal Pap smears to return for a repeat Pap smear. The effect of this pamphlet was tested in a randomized controlled trial. A total of 161 women with abnormal Pap smears were randomized and received either the pamphlet plus a notification letter or the letter only. The compliance rate was 64.2% in the intervention group and 51.3% in the comparison group (P = 0.10; two-tailed). In addition, subgroups of women who do not practice healthrelated behaviors were identified as groups where more intensive interventions may be needed. These results have implications for future strategies used to recall women with abnormal Pap smears. 6 1990 Academic PRSS, Inc.

INTRODUCTION Proper surveillance and timely treatment of cervical abnormalities has been found to reduce the incidence of invasive cancer of the cervix (l-3). Unfortunately, less than 60% of women diagnosed with cervical abnormalities on Pap smears return for this follow-up (4, 5). Previous studies attempting to increase compliance with recommendations to return for proper follow-up have mainly employed intensive reminder efforts, such as phone call reminders and home visits (6-9). These types of efforts, usually as part of a special cervical cancer screening program, have achieved compliance rates of 68 to 95%. Such costly efforts, though, may not be feasible in usual clinic settings. Furthermore, prior studies have not specifically utilized issues related to noncompliance with treatment recommendations, in part because little information has been available as to why women with abnormal Pap smears fail to obtain follow-up treatment. Noncompliance has been explored in other areas of health promotion using value’ A version of this paper was presented at the annual meeting of the American Society of Preventive Oncology in March 1990. * To whom reprint requests should be addressed. 630 0091-7435/90 $3.00 Copyright 0 1990 by Academic Press, Inc. All rights of reproduction in any form reserved

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expectancy theories and models, e.g., the health belief model and the hierarchical weighted utility model (10-20). Information gained from these models has been used to develop interventions aimed at increasing compliance. These interventions, mainly mailed reminders or educational motivators, have been successful in motivating compliance at relatively lower costs (21, 22). Using the framework of the hierarchical weighted utility model, key issues responsible for compliance with recommendations for a repeat Pap smear following an abnormal Pap smear have been identified from decision modeling of women’s beliefs (23). These salient issues include the value the women placed on their doctor’s opinion about getting a repeat Pap smear; the accuracy or seriousness of an abnormal result; the value of early detection and treatment; familiarity with the treatment procedure for an abnormal Pap smear; the time involved in getting a repeat Pap smear; femininity concerns due to treatment effects; worries about possible treatment effects; perceived risk of cervical cancer; and fears about cervical cancer. The goal of this study was to use a randomized controlled design to test the efficacy of an intervention to increase compliance with recommendations for surveillance, a repeat Pap smear, in women with abnormal Pap smears. The intervention consisted of an educational pamphlet with a prompt and addressed the salient issues described above. METHODS Description

of the Intervention

Pamphlet

A pamphlet was designed to include issues found to be associated with the decision to obtain a repeat Pap smear for a cervical abnormality (see Fig. 1). The process of identifying these issues using a hierarchical weighted utility model is described elsewhere (23). The issues were incorporated into the intervention pamphlet in a “quick quiz” format. The text consisted of actual wording used by the women who participated in the earlier study. The sample of women in the earlier study was from the same target population (clinic), but there was no overlap in the sample of women from the two studies. The pamphlet was also designed to have the following: (a) a catchy cover, so women would want to open it; (b) a pleasant color, appealing to women; (c) answers to the “quick quiz” from “your doctor”; (d) a prompt, in the form of a reminder sticker with the date that the repeat smear was due, designed to be removed from the pamphlet and stuck in a visible place; and (e) a size that a clinic could easily mail in their usual envelopes. Study Setting This study was conducted at the Women’s Care Center (WCC), the obstetric and gynecology clinic at the University of Washington Medical Center in Seattle. The WCC sees an average of 100 patients daily from all socioeconomic levels. The majority of the patients are self-referred (approximately 70%) and the remaining are referred from a variety of community sources. The clinic specializes in ob-

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stetric and gynecology services, but has numerous subspecialty programs, including in vitro fertilization, perinatology, gynecological oncology, prenatal genetic diagnosis, and counseling. There are approximately 210 Pap smears performed on gynecology patients at the WCC monthly, of which 16% are found to be abnormal (atypical or dysplasia). Based on estimates from the clinic Pap smear log obtained prior to the beginning of this study, the rate of compliance for repeat Pap smears following an abnormal smear in this population was 55%. Study Design Pap smears of women from the WCC from 15 June 1987 to 31 August 1988 were reviewed weekly. Women with an abnormal Pap smear (atypia or dysplasia) who were not pregnant, were not advised to have colposcopy, and resided in Washington state were eligible for the study. To ensure that we were not intervening with women who were already compliant with repeat Pap smear recommendations, women who had had a prior abnormal Pap smear within the last 6 months were excluded. Women with unsatisfactory smears were included if their initial notification letter was identical to the letter for women with atypia and dysplasia, i.e., they were not told that they had an unsatisfactory Pap smear, but were treated as if they had an atypical or dysplastic smear (N = 16). All eligible women (N = 170) were randomly assigned to an intervention or comparison group based on a randomization scheme involving their hospital identification number. Intervention women received the motivational pamphlet along with an initial notification letter and an explanation sheet about Pap smears from the clinic. This letter informed them of their abnormal Pap smear result and advised them to return for a repeat Pap smear within a specified time period. Women in the comparison group received only the clinic notification letter and explanation sheet. The clinic mailed these letters 2 to 4 weeks after the initial Pap smear was taken. All women were contacted by telephone and asked to complete a brief 5-min interview on beliefs regarding Pap smears and cervical cancer that were included in the pamphlet. The interview also collected demographic and prior medical information. To avoid possible contamination of the survey responses due to information from the pamphlet, attempts were made to interview the women before they received the notification letter. This meant that all women needed to be contacted within 2 days of the mailing of the letter. Women who refused (N = 13) or could not be reached before they received this initial notification letter (N = 34), were still included in the study. Certain information for these women was obtained from medical records, although attitudes about Pap smears and cervical cancer could not be ascertained. Ascertainment Compliance each woman’s was mentioned written on the

of Endpoints was defined as having obtained a repeat Pap smear by the date that physician had asked her to return for the repeat smear. This date in the notification letter, and for the intervention women, it was reminder sticker in the pamphlet. The return date varied from 6

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weeks to 9 months from this notification letter, depending on the woman’s history, the type of abnormality, and her physician’s method of handling abnormal Pap smears. The WCC sends a reminder letter to each woman with an abnormal smear after this date if she has not returned for a repeat Pap smear. For the purposes of this study, the operational definition of compliance was obtaining a repeat Pap smear by the date this reminder letter was mailed. Thus, each woman had ample time to comply within the recommended time period, and compliance status could be determined independent of the effect of the reminder letter. Ascertainment of compliance status was accomplished using several sources. The WCC Pap smear log was the primary source for women who returned to the WCC. If a woman’s repeat smear was not listed in the log, she was phoned and asked if and when she had obtained a repeat Pap smear. Eight percent of compliant women were compliant by self-report. If a woman could not be contacted by phone, a letter with a return postcard was mailed to her. If these methods failed, relatives listed in her medical chart were then contacted in an effort to locate the woman. Data Analysis

Seven attitudinal questions that used a 5-point response format (“strongly agree” to “strongly disagree”) were included in the questionnaire to assess attitudes about items identified as being relevant to the decision of whether to obtain a repeat Pap smear following an abnormal Pap smear. Examples of how these questions were presented are as follows: “Pap smears are valuable in diagnosing changes in a woman’s cervix” and “Pap smears are uncomfortable.” The scores from these seven items were summed for each woman to create a belief scale. Social class was computed using the Hollingshead two-factor scale (woman’s occupation and education) for women who were not married (24); for married women who did not work outside of the home, the two-factor scale was also used (husband’s occupation and woman’s education); a modification of the Hollingshead four-factor scale (average of the woman’s and husband’s occupations and woman’s education) was used for households with two working members (25). Standard statistical methods were employed for data analyses. t tests were used to assess any differences between groups for continuous variables and x2 tests (26) were used for categorical variables. Differences in rates were calculated using a test for difference in proportions (27). Mantel-Haenszel tests (28) and multiple logistic regression analyses (29) were used to assess relationships between the outcome, compliance, and the dependent variable, intervention or comparison group assignment, and other variables. In the logistic model, the odds of compliance, measured by the log odds (In@/ l-p), where p is the probability of compliance), is assumed to be a linear function of variables such as group assignment, education, history of abnormal Pap smears, or other variables. Estimates of the odds ratio (pill-pl)l(pO/l-p0) are obtained from the logistic models and describe the odds of compliance among those with a factor compared with those without a factor, after adjustment for other factors. Odds ratios presented in this study cannot be interpreted as relative risks since the probability of compliance is not small among the subjects in this

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study. Estimates of the parameters were unconditional likelihood estimates based on an independent binomial model (29). Interaction terms between factors in the models were also included to test whether the intervention had a different effect at different strata of the factor. RESULTS

Subject Characteristics A total of 170 women were randomized to the study conditions, 83 to the intervention group and 87 to the comparison group. Four of the women randomized to the comparison group were later excluded as 3 women never received the initial notification letter from the clinic and 1 woman was found to be ineligible because she lived out of state at the time of the initial Pap smear. Five women (3%), 3 in the intervention group and 2 in the comparison group, could not be located to ascertain compliance status. This resulted in a final sample of 161 women, 81 in the intervention group and 80 in the comparison group. Women in both groups were nearly identical across all demographic and medical history variables (Table 1). On average, women were 31 years of age, about half were currently married, they were predominantly white, and well-educated. The majority of the women were professionals or managers and most of the women were in the upper two social classes. Approximately 50% of the women had a child, regularly practiced BSE, and never smoked. Over 80% stated that they regularly wore seatbelts while riding in or driving a car. Table 2 presents the Pap smear screening characteristics of the women in this study. Again, women in both groups were nearly identical across all variables. Almost all of the women obtained Pap smears at least once a year and knew that routine Pap smears were recommended at least every 3 years. Most of the women were in the middle category of the belief scale. About 34% had had a prior abnormal Pap smear. Forty percent of the women were treated by a private physician. The majority of the women had an atypical Pap smear (88%), and the average time from first abnormal Pap smear to recommended repeat date was 12 weeks. Effect of the Intervention

on Compliance

Table 3 shows the compliance rates by group assignment. The compliance rate in the comparison group was 51.3%, while the compliance rate in the intervention group was 64.2%. This represents a difference of 12.9 percentage points (95% confidence interval: - 2.0%, 28.2%). The odds ratio for the comparison of the two rates is 1.71 (95% confidence interval: 0.91, 3.20). The two-sided P value for the between-group comparison was 0.10. Adjustment for variables listed in Tables 1 and 2 did not change the estimate of the odds ratio for group assignment; therefore, we concluded that there were no confounders present. The effect of the intervention appeared to be modified by three factors, although only one approached a significant modifying effect (Table 4). The first was the frequency of Pap smear screening. Among women who have regular Pap smears at least every year, the intervention appeared to have a moderate effect

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TABLE DEMOGRAPHIC

AND MEDICAL -

1

HISTORY CHARACTERISTICS BY GROUP ASSIGNMENT*

OF WOMEN

RANDOMIZED

Intervention Variable Demographic variables Age (YeW Marital status Single Married Divorced/separated/widowed Race White Black Other Education (years) Occupation Professional/managerial Sales/technical/service Clerical Laborer/unemployed/housewife Social class I (High) II III IV v (Low) Medical history variables Pregnancy history Ever given birth Average number of births Age at first birth (years) BSE practice Regular Irregular/never Smoking status Never Former Current Regular seatbelt use

Comparison

% or f (SD)

N

% or !i (SD)

N

31.1 (10.9)

81

31.5 (9.7)

80

35.8 50.6 13.6

29 41 11

41.8 45.6 12.7

33 36 10

80.2 12.3 7.4 13.5 (2.1)

65 10 6 70

81.3 10.0 8.8 13.7 (2.1)

65 8 7 64

38.3 18.3 18.3 25.0

23 11 11 15

33.8 20.0 15.4 30.8

22 13 10 20

32.8 21.9 23.4 6.3 15.6

21 14 15 4 10

25.0 20.3 28.1 14.1 12.5

16 13 18 9 8

68.8 1.9 (1.5) 23.5 (5.7)

55 55 51

64.6 1.8 (1.1) 23.0 (5.6)

41 51 48

57.1 42.9

36 27

55.2 44.8

32 26

50.0 24.4 25.6 87.1

39 19 20 54

47.9 27.4 24.7 82.1

35 20 18 46

-

-__

* Test of equality between groups: P > 0.05 for all variables.

(OR = 1.50); among women who obtain regular Pap smears less frequently, the intervention appeared to have no effect or an adverse effect (OR = 0.67). The effect of the intervention also differed by current smoking status. The intervention had the greatest effect among women who were former smokers (OR = 3.56), a moderate effect in women who never smoked (OR = 1.68), and no effect in women who were current smokers (OR = 1.05). Last, the effect of the intervention was modified by whether a women wore a seatbelt (x2 test for homogeneity of the odds ratios = 3.62, P = 0.06). Among women who always wore

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TABLE 2 PAPSMEARSCREENINGCHARACTERISTICSOFWOMENRANDOMIZEDBYGROUPASSIGNMENT* Intervention Variable

% orf(SD)

Frequency of regular Pap smear screening ?Once/year 0.05 for all variables. ** See Methods for a description of this variable.

a seatbelt, the intervention had a motivating effect (OR = 1.83); among women who did not wear a seatbelt, the intervention had the opposite effect (OR = 0.22). These results need to be interpreted cautiously as the sample size of this study was not adequate to test for the presence of effect modifiers. DISCUSSION

The goal of this study was to test the effectiveness of an intervention designed to increase compliance rates with recommendations for a repeat Pap smear in women with an abnormal Pap smear. The intervention, developed from the theoTABLE 3 EFFECTOFTHEINTERVENTIONONCOMPLIANCERATESFOROBTAININGAREPEATPAPSMEAR Group

N

Compliance rate

Intervention Comparison

81 80

64.2% 51.3%

* Two-tailed P value.

Measure

Estimate

Confidence interval

Difference Odds ratio

12.9% 1.71

(- 2.0%, 28.2%) (0.91, 3.20)

P

value

0.097* 0.097*

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TABLE EFFECT SMEAR

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OF THE INTERVENTION ON COMPLIANCE WITH RECOMMENDATIONS FOR A REPEAT PAP BY FREQUENCY OF PAP SMEAR SCREENING, SMOKING STATUS, AND SEATBELT USAGE

Stratum Frequency of regular Pap smear screening 2 l/year

Improving follow-up after an abnormal Pap smear: a randomized controlled trial.

Less than 60% of women diagnosed with cervical abnormalities on Pap smears return for proper surveillance and timely treatment. Previous tactics used ...
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