A critical assessment of screening methods for cervical neoplasia.

The objective of cervical cancer screening is to reduce cervical cancer incidence and mortality by detecting and treating precancerous lesions. Conventional cytology is the most widely used cervical cancer screening test. Although cytology has been effective in reducing the incidence of and mortality from cervical cancer in developed countries in both opportunistic and--more dramatically--organized national programs, it has been less successful and largely ineffective in reducing disease burden in low-resource settings where it has been implemented. Liquid-based cytology, testing for infection with oncogenic types of human papillomaviruses, visual inspection with 3-5% acetic acid, magnified visual inspection with acetic acid, and visual inspection with Lugol's iodine have been evaluated as alternative tests. Their test characteristics, and the applications and limitations in screening, are discussed with an emphasis on the work of the Alliance for Cervical Cancer Prevention over the past 5 years.

Advocating for cervical cancer prevention.

Cervical cancer is a significant health problem among women in developing countries. Contributing to the cervical cancer health burden in many countries is a lack of understanding and political will to address the problem. Broad-based advocacy efforts that draw on research and program findings from developing-country settings are key to gaining program and policy support, as are cost-effectiveness analyses based on these findings. The Alliance for Cervical Cancer Prevention (ACCP) has undertaken advocacy efforts at the international, regional, national, and local levels to raise awareness and understanding of the problem (and workable solutions), galvanize funders and governments to take action, and engage local stakeholders in ensuring program success. ACCP experience demonstrates the role that evidence-based advocacy efforts play in the ultimate success of cervical cancer prevention programs, particularly when new screening and treatment approaches-and, ultimately, radically new approaches such as a human papillomavirus vaccine-are available.

Training for Norplant implant removal: assessment of learning curves and competency.

OBJECTIVE: To determine the learning curves and rapidity with which clinicians become competent in implant removal using two Norplant removal techniques. METHODS: Twenty-four physicians, none of whom were experienced in the use of Norplant implants, were randomly assigned to learn either the "U" removal technique or the standard technique. The physicians in the two groups received identical training in all other respects. Each physician then performed ten supervised removals. Removal times, procedure problem rates, and the number of procedures performed by the clinicians before they were judged "competent" were assessed for both groups. RESULTS: Data from 240 removals were analyzed. Mean removal times were 38% faster in the "U" group than in the standard group. None of the "U" group procedures took longer than 20 minutes, compared with 11% of removals in the standard group (P < .001). The mean number of cases required before the provider consistently performed all steps adequately was significantly (P < .02) higher in the standard group (5.8 cases) than in the "U" group (3.9 cases). CONCLUSIONS: Using competency-based training methods, the "U" removal technique was learned easily by inexperienced clinicians. It appears to offer significant improvements in speed and achievement of proficiency over the standard technique recommended by the manufacturer. Large-scale programs should consider using competency-based training and the "U" technique as the removal method of choice when providing training in implant removal.

Risk factors as the basis for triage in low-resource cervical cancer screening programs.

OBJECTIVES: Several studies have shown impressive sensitivity and specificity of visual inspection using acetic acid wash (VIA) in detecting cervical dysplasia. This study examines how risk-factor based triage, using clinical history-taking to limit the testing to those at highest risk of disease, improves the clinical utility of VIA. METHODS: The study population included 2206 woman aged 25-56 from peri-urban primary care clinics in Zimbabwe. Three risk factors variables [age, lifetime number of sexual partners and history of a sexually transmitted infection (STI)] were selected as the basis for computer-simulated patient triage. Criteria for selecting risk factors were biological relevance, programmatic feasibility, historical evidence in the scientific literature as a risk factor for cervical cancer and a significant (P<0.05) predictor of dysplasia in this study population. Predictive values for VIA were calculated on subgroups of women with combinations of the three risk factors and then compared with the predictive value of VIA calculated on the full study population. RESULTS: The positive predictive value (PPV) among women with all three risk factors (30.2%) was 1.6 times higher than that of all study women and 4.5 times higher than women with none of the three risk factors (4.1%). Additionally, the PPV was slightly (30%) higher than that obtained from computer-simulated serial testing using VIA as the primary test followed by HPV testing (27.4%). CONCLUSION: Clinical history-taking could provide the basis for patient triage to increase the clinical utility of VIA. Such an approach could also serve to prioritize who gets tested first in low-resource countries with high disease prevalence that are struggling to strengthen national cervical cancer prevention programs.

Adjunctive testing for cervical cancer in low resource settings with visual inspection, HPV, and the Pap smear.

OBJECTIVE: To test whether the performance of visual inspection using acetic acid (VIA) could be improved through adjunctive testing and to determine whether the combination of visual inspection of the cervix and HPV testing could prove useful for identifying those at highest risk of cervical precancer. METHODS: Between October 1995 and August 1997, 2199 women willing to be screened for cervical cancer in peri-urban clinics in Harare, Zimbabwe received VIA, Pap smear and HPV as screening tests. The presence or absence of (pre)cancer was confirmed via colposcopy with biopsy as indicated for >97% of all women. Computerized simulations of sequential testing scenarios provided estimates of the joint (net) test qualities of different paired combinations of the three tests and allowed for comparisons with the individual test qualities. RESULTS: Using HGSIL/CIN II-III as the reference threshold of disease, the net sensitivity and specificity of VIA and HPV when used sequentially were 63.6 and 81.9%, respectively, compared to 43.3 and 91%, respectively, when Pap smears were followed by HPV testing. VIA followed by the Pap smear yielded a net sensitivity of 37.5% and net specificity of 94.3%. CONCLUSIONS: For programs with limited resources but with the capacity for HPV testing, sequential testing involving the use of VIA followed by HPV could yield fewer false positives than the use of VIA alone at a cost of relatively few additional false negatives.

Problem visits to a family planning clinic.

In order to obtain information necessary for optimum delivery of services, data were collected on the nature of the services provided at a family planing clinic. Clinic visits were divided into initial, annual, routine, problem, supply, educational and unknown. An analysis of the "problem" visits was undertaken to assess various epidemiologic aspects of such visits and to identify areas of clinic efficiency that could be improved. Problem visits were defined as any visits for which the patient had a presenting complaint. Age, level of education, method of contraception and parity were statistically associated with problem visits. When compared to Pill users, diaphragm users, intrauterine device users and non-users had a higher-than-expected number of problem visits. Less educated women and teenagers had a lower-than-expected number of problem visits when compared to more educated and older women. Socioeconomic status and problem visits were not statistically associated. Problem visits required more time, utilized more medical services and resulted in more referrals to the gynecology clinic than did other visit types. As a result of this analysis, we have increased our educational efforts for patients at high risk of problem visits and have instituted a special problem-oriented family planning clinic in which a full complement of house staff and ancillary personnel are available. This arrangement makes the uncomplicated family planning clinic run more smoothly and efficiently and obviates the need for time-consuming and cost-ineffective referrals.

The American College of Nurse-Midwives' Domestic Violence Education Project: evaluation and results.

From October 1994 through September 1998, the American College of Nurse Midwives conducted a nationwide Domestic Violence Education Project. The project aimed to encourage universal screening for domestic violence among all women being seen for care. A four-pronged set of objectives was used, including policy, basic education, continuing education, and advocacy/activism. A description of the project and the results of the project evaluation, including replicable features, are presented. Process and outcome evaluations were performed using both quantitative and qualitative data. Surveys, interviews, and site visits formed the basis for the evaluation of the policy reform, education program, and advocacy components. Pretests and posttests of training participants formed the basis of the evaluation of the continuing education component. All project objectives were met. Policy reform occurred as expected. Changes were noted in education programs in both didactic content and clinical exposure. Changes in clinical behavior as assessed by the pretests and posttests look promising, although numbers of respondents at 12 and 24 months after training are small. Participants reported an increase in advocacy and activism. The Domestic Violence Education Project seems to be a successful and somewhat replicable model for changing attitudes about a health topic (among providers) with possible implications for clinical practice.

How research can affect policy and programme advocacy: example from a three-country study on abortion complications in sub-Saharan Africa.

OBJECTIVE: To provide a basis for continued policy dialogue and reform to address the problem of death due to abortion complications among the ECSA Health Community countries. The anticipated short-term outcome of this study was increased awareness among African health officials about the problem of incomplete abortion in SSA, especially CRHCS/ECSA countries. DESIGN: The study undertaken in 1993/1994, involved primary data collection of abortion-related morbidity and mortality statistics, the cost of treating patients with abortion complications and provider and abortion patient perspectives. Data were collected via one on one interviews and reviews of logbook data. A computerized literature review on abortion in the region covering the years 1980-1994 complemented the primary data collection. STUDY SETTING: Primary data collection was conducted in three countries (Zambia, Uganda and Malawi) at selected districts and tertiary care hospitals. SUBJECTS: Nurses and physicians providing care to women with complications of abortion in participating hospitals were interviewed as well as hospital administrators. Women receiving care in the selected hospitals during the data collection period also were interviewed. MAIN OUTCOME MEASURES: This analysis focused on cross-country comparisons of nurse and doctor attitudes and knowledge about abortion and family planning-related issues. INTERVENTIONS: At a 1994 CHRCS conference, Health Ministers from 12 Commonwealth countries reviewed and endorsed the results of this study. In a 1995 ECSA Director Joint Consultative Committee meeting, participants discussed the study findings and developed regional action plans which were subsequently endorsed by the Health Ministers' at their 1995 annual conference. RESULTS: Abortion complication patients in the three countries were on average 24-26 years old with two children. Patients experienced long hospital stays while receiving care for complications. The average monthly number of post-abortion patients was substantially higher in urban facilities as compared to mixed/rural ones. Opinions regarding factors that led to the abortion, access to abortion services and the legal provisions surrounding abortion were inconsistent between doctors and nurses. Patients were aware that complications of abortion were a major cause of maternal mortality. Overall, provider opinion about access to family planning (FP) information among abortion complication patients was also inconsistent between doctors and nurses but there was agreement on factors influencing use of FP. Opinions regarding access to FP services both before and after the abortion varied from easy to very difficult to obtain. CONCLUSIONS: These data represent the situation as it was in the region some years ago and the paper describes important implications of the findings for policy and programme development. This research provided some impetus for stakeholders in these countries to put safe abortion and management of abortion complications on their health agenda. Ensuring that research results will be shared with appropriate decision-makers is key to maximizing the extent to which research findings may affect policy and programme advocacy.

Safety, acceptability, and feasibility of a single-visit approach to cervical-cancer prevention in rural Thailand: a demonstration project.

BACKGROUND: To increase screening and treatment coverage, innovative approaches to cervical-cancer prevention are being investigated in rural Thailand. We assessed the value of a single-visit approach combining visual inspection of the cervix with acetic acid wash (VIA) and cryotherapy. METHODS: 12 trained nurses provided services in mobile (village health centre-based) and static (hospital-based) teams in four districts of Roi-et Province, Thailand. Over 7 months, 5999 women were tested by VIA. If they tested positive, after counselling about the benefits, potential risks, and probable side-effects they were offered cryotherapy. Data measuring safety, acceptability, feasibility, and effort to implement the programme were gathered. FINDINGS: The VIA test-positive rate was 13.3% (798/5999), and 98.5% (609/618) of those eligible accepted immediate treatment. Overall, 756 women received cryotherapy, 629 (83.2%) of whom returned for their first follow-up visit. No major complications were recorded, and 33 (4.4%) of those treated returned for a perceived problem. Only 17 (2.2%) of the treated women needed clinical management other than reassurance about side-effects. Both VIA and cryotherapy were highly acceptable to the patients (over 95% expressed satisfaction with their experience). At their 1-year visit, the squamocolumnar junction was visible to the nurses, and the VIA test-negative rate was 94.3%. INTERPRETATION: A single-visit approach with VIA and cryotherapy seems to be safe, acceptable, and feasible in rural Thailand, and is a potentially efficient method of cervical-cancer prevention in such settings.

Cervical cancer screening in developing countries.

In developing countries, cervical cancer remains a clinical problem of public health proportions. Eighty percent of the approximately 400,000 new cases of cervical cancer each year occur in such settings. Primarily as a result of the introduction and success of screening programs, cervical cancer rates in developed countries have dropped remarkably. However, in most developing countries, screening programs are virtually nonexistent. Reasons for this relate primarily to lack of public awareness and the fact that screening via cytology is an untenable proposition for mass screening in such low-resource settings. Matching the resources available to provide cervical cancer screening in such settings requires alternative means of providing testing and treatment. Recent evidence indicates that, depending on local conditions and locally-made decisions, visual inspection of the cervix with acetic acid wash, coupled with a benign form of therapy, such as cryotherapy, could hold promise as a means of testing and treatment. By adapting resource-appropriate technologies and building local consensus regarding clinically driven public health approaches that are safe and feasible, the challenge of reducing the mortality from cervical cancer in developing countries can yet be met.

Complications of unsafe abortion in sub-Saharan Africa: a review.

The Commonwealth Regional Health Community Secretariat undertook a study in 1994 to document the magnitude of abortion complications in Commonwealth member countries. The results of the literature review component of that study, and research gaps identified as a result of the review, are presented in this article. The literature review findings indicate a significant public health problem in the region, as measured by a high proportion of incomplete abortion patients among all hospital gynaecology admissions. The most common complications of unsafe abortion seen at health facilities were haemorrhage and sepsis. Studies on the use of manual vacuum aspiration for treating abortion complications found shorter lengths of hospital stay (and thus, lower resource costs) and a reduced need for a repeat evacuation. Very few articles focused exclusively on the cost of treating abortion complications, but authors agreed that it consumes a disproportionate amount of hospital resources. Studies on the role of men in supporting a woman's decision to abort or use contraception were similarly lacking. Articles on contraceptive behaviour and abortion reported that almost all patients suffering from abortion complications had not used an effective, or any, method of contraception prior to becoming pregnant, especially among the adolescent population; studies on post-abortion contraception are virtually nonexistent. Almost all articles on the legal aspect of abortion recommended law reform to reflect a public health, rather than a criminal, orientation. Research needs that were identified include: community-based epidemiological studies; operations research on decentralization of post-abortion care and integration of treatment with post-abortion family planning services; studies on system-wide resource use for treatment of incomplete abortion; qualitative research on the role of males in the decision to terminate pregnancy and use contraception; clinical studies on pain control medications and procedures; and case studies on the provision of safe abortion services where legally allowed.

PIP: The Commonwealth Regional Health Community Secretariat conducted a study in 1994 to document the magnitude of abortion complications in Commonwealth member countries. The literature review component of the study identified a significant public health problem in the region, as measured by a high proportion of incomplete abortion patients among all hospital gynecology admissions. Hemorrhage and sepsis were the most common complications of unsafe abortion seen at health facilities. Studies on the use of manual vacuum aspiration for treating abortion complications found shorter lengths of hospital stay and a reduced need for a repeat evacuation. Few articles focused exclusively upon the cost of treating abortion complications, but authors agreed that it consumes a disproportionate amount of hospital resources. Studies on the role of men in supporting a woman's decision to abort or use contraception were similarly lacking. Articles on contraceptive behavior and abortion reported that almost all patients experiencing abortion complications had not used an effective, or any, method of contraception before becoming pregnant, especially among the adolescent population, while there were almost no studies on post-abortion contraception. Almost all articles on the legal aspect of abortion recommended law reform to reflect a public health, rather than a criminal, orientation. Research needs are presented.

Provider attitudes toward IUD provision in Zimbabwe: perception of HIV risk and training implications.

This study was conducted to assess providers' attitudes toward the provision of long-term methods of contraception, in particular the IUD, and provider concerns about human immunodeficiency virus (HIV) in the context of family planning (FP) services. The data were collected using self-administered structured questionnaires. Between 65% and 80% of the public and private providers thought that the IUD is a good contraceptive method for Zimbabwean women. In addition, the majority of these two provider groups felt that neither the IUD nor tubal sterilization (TL) posed much risk of HIV infection to the client. A significant number of providers (especially the public nurses), however, thought that the provision of TL put the provider at high risk of HIV infection and a significant proportion of public nurses were also concerned about provider risk associated with providing IUD and injectables. To address such concerns, future training interventions should emphasize appropriate infection prevention practices associated with surgical FP method provision. Nurses, in particular, should be informed about the magnitude of risk associated with FP service provision and ways to protect themselves. Logistic activities also need to be strengthened so that legitimate concerns among providers regarding lack of adequate infection prevention supplies (e.g. gloves) in the field can be addressed.

Institutionalizing fertility management/human sexuality training in Colombian nursing schools.

While there is no universally applied definition of the terms, 'institutionalization', 'capacity', 'capability' and 'commitment' have been suggested as subindicators of a self-sustained program. This paper describes efforts to measure these terms in the context of a fertility management/human sexuality (FM/HS) education program for student nurses in Colombia. Interviews with 19 school deans formed the basis of measuring progress towards institutionalization. All the deans supported the idea of having FM/HS instruction, although resource commitment to effectively carry out the instruction varied. Focus groups with professors from participating schools provided insights into the effect of the project on both the students and course teachers. Professors found that students who had taken the course were more effective FM/HS counselors in later practical courses. Responses from interviews with a random sample of students who had or had not attended the course were compared to assess the effect of the course on the nursing students. Although attitudes between the two groups did not differ significantly, knowledge levels about FM/HS were significantly higher among nursing students who had attended the course. In general, the results indicate that the participatory educational approach used in teaching the FM/HS topics was effective in sensitizing both students and teachers to this subject area.

Usefulness of a clinical scoring system to anticipate difficulty of Norplant removal.

OBJECTIVES: Removal of contraceptive implants (e.g. Norplant) is an issue affecting its worldwide acceptability. Reports of difficult, painful removals have resulted in lawsuits and reduced demand. To improve quality of care, we developed a scoring system to anticipate difficult removals. We report on the usefulness of such a system and present client perspectives about the removal experience. METHODS: A 9-point scoring system based on the visibility, arrangement, and position (VAP) of Norplant capsules was used to assess the anticipated difficulty of removal in 53 consecutive patients. The VAP score was then correlated with removal time and related parameters. RESULTS: Mean removal time was 14.74 min (range 4.75-47). In 20% of patients, the VAP score indicated a potentially difficult removal and the VAP score correlated significantly with removal time (r = 0.3, p = 0.05). Patients expected removal to be moderately difficult (mean visual analog score 4.7 out of a possible 10), but after removal they rated the actual removal experience as relatively easy (mean score 2.6/10). Before the removal, only 48% of patients said they would recommend Norplant to a friend but after removal, 70% said they would do so. CONCLUSIONS: A scoring system such as the VAP score can help identify potentially difficult removals so that an experienced remover can be present at the time of removal or an appropriate referral made. However, the VAP score cannot predict variables such as the density of the subcutaneous fibrous tissue "envelope". Although patient anxiety concerning removal may be high, the presence of a competent remover and an easy removal experience reduces this anxiety and encourages patients to be more positive about this method. The value of having properly trained, competent personnel available to perform removals cannot be over-emphasized.

Materials, methods and results of the Norplant training program.

Norplant subdermal implants for contraception were introduced into UK clinical practice in October 1993. Use of Norplant requires providers to learn additional skills. A training program designed to give providers to opportunity to obtain these skills was designed and implemented through the co-operation of Hoechst Roussel, JHPIEGO and members of the UK medical profession. Uptake of training for Norplant provision has been widespread and Norplant has been established as a realistic contraceptive choice for women in the UK. Introduction of Norplant in the UK has raised many issues that go beyond clinical considerations.

Impact of an integrated adolescent reproductive health program in Brazil.

An impact evaluation of an integrated school- and health-clinic-based adolescent reproductive health initiative was undertaken by the State Secretariats of Health and Education in Bahia, Brazil during 1997-99. The project was initiated in response to continued high pregnancy rates among adolescents and growing numbers of new HIV infections among young adults. It sought to promote responsible sexual and health-seeking behaviors among public secondary-school students, including the use of public health clinics. The study design included a matched control group used to measure project impact. The findings indicate that the project was successful in increasing the flow of sexual and reproductive health information to secondary-school students and that it had an impact on adolescents' intentions to use public health clinics in the future. No effects on sexual or contraceptive-use behaviors or on use of public clinics were observed, however. Client exit-interview data from a subset of project clinics indicate that adolescents who use clinic-based services are overwhelmingly female and considerably older on average and much more likely ever to have been pregnant than are adolescents in the target population for the project.

HPV-based cervical cancer screening in a population at high risk for HIV infection.

We determined the utility of an assay for 13 cancer-associated HPV types in primary cervical cancer screening of Zimbabwe women at high risk of HIV infection. HIV antibody status was determined by ELISA of oral mucosal specimens, and HPV DNA in the genital tract was identified by hybridization of cervical scrapes with probe B of Hybrid Capture II. Among the 466 women investigated, the prevalence of HPV, low-grade squamous intraepithelial lesions (LGSIL) and high-grade SIL (HGSIL) were 47.2%, 13.9% and 12%. Fifty-three and one-half percent of the women were HIV-seropositive. As compared with HIV-seronegative women, HIV-infected women had a greater than 2-fold HPV prevalence (64.3% vs. 27.6%), a greater than 7-fold amount of HPV DNA (RLU of 82.6 vs. 10.7) in HPV(+) women assessed as normal on the reference standard, and a nearly 3-fold greater HGSIL prevalence (17.3% vs. 5.9%). The strong link between HGSIL and HPV DNA positivity was seen in both HIV-infected and HIV-seronegative women. The amount of HPV DNA increased with disease severity in both HIV-seronegative and HIV-infected women. The sensitivity and specificity of the HPV test for HGSIL were, respectively, 90.7% (95% confidence limit 77.9-97.4%) and 41.3% (34.5-48.3%) in HIV-infected women and 61.5% (31.6-86.1%) and 74.5% (68.0-80.3%), respectively, in HIV(-) women. The usefulness of the HPV test as a screening test for cervical cancer in areas of high HPV prevalence will depend upon local health resource availability, disease priorities and policies regarding clinical case management.

Evaluation of a human papillomavirus assay in cervical screening in Zimbabwe.

OBJECTIVE: To determine the utility of an assay for high risk genital human papillomavirus (HPV) in cervical screening in Zimbabwe, Africa. DESIGN: Cross-sectional study. SETTING: Harare, Zimbabwe. POPULATION: Zimbabwe women (n = 2,140), 25 to 55 years old, recruited in clinics in Chitungwiza and Greater Harare. METHODS: Genital specimens were assessed for HPV, using the HPV DNA test Hybrid Capture II (probe B). Further assessment of the women was conducted using colposcopy and biopsy as indicated. High grade squamous intraepithelial lesions were diagnosed in 215 women. Colposcopy and/or biopsy showed low grade lesions in 346 women. RESULTS: The overall prevalences were: 42 x 7% for HPV, 10% for high grade squamous intraepithelial lesions and 16% for low grade lesions. Prevalence for HPV decreased significantly with increase in age (P for trend < 0 x 0001) and increased significantly with increasing disease severity, from 35% in normal women, to 53% in women with low grade lesions and 81% in women with high grade lesions (P for trend < 0 x 001). In specimens positive for HPV, the amount was 14-fold higher in women with high grade lesions compared with normal women. In screening for high grade lesions the assay for HPV had a sensitivity of 81% (CI 75%-86%); sensitivity for low grade lesions was 64% (CI 60%-68%). Specificity was 62% (CI 59%-64%) for high grade lesions and 65% (CI 62%-67%) for low grade lesions. The positive predictive value was 19% (CI 17%-22%) for high grade lesions and 39% (CI 36%-42%) for low grade lesions. CONCLUSION: For high grade squamous intraepithelial lesions the sensitivity of the Hybrid Capture II HPV DNA test was high, but the specificity was relatively low. The test may therefore be most useful in conjunction with other screening tests.