Single community research networks. The HARNET experience. Harrisburg Area Research Network.

Clinical research performed in family physicians' offices is critical for building an expanded knowledge base for modern health care. Practitioners do not usually have the time, funds, or research expertise to conduct clinical studies. Organized networks can accomplish this goal. Large-area networks, composed of many separate practice sites from a wide geographic area, are valuable sources of information for describing the natural history of disease. These observational studies usually consist of data collection during clinical practice. Experimental trials include evaluations of new protocols, diagnostic tests, or therapies, often in a randomized and blinded fashion. Because of the difficulties in adhering to a standardized protocol, experimental trials are rarely undertaken in the busy clinician's office. Similarly, it may be difficult to standardize these studies in large-area networks. Smaller networks, often in a single community, can feasibly perform more complex studies. Important strategies are required to avoid loss of interest, lack of continuity, and conflict of interest.

Follow-up Papanicolaou smear for cervical atypia: are we missing significant disease? A HARNET Study.

BACKGROUND: The presence of cervical atypia on the Papanicolaou (Pap) smear may be an indicator of significant cervical disease. Many investigators recommend that colposcopy be performed in these women. We wished to determine the prevalence of undetected cervical intraepithelial neoplasia (CIN) among women identified as having cervical atypia by cytologic testing in a primary care setting. METHODS: Pap smears were performed on all women (N = 7458) attending six family practice offices for a health maintenance examination from August 1989 through February 1991. Cytologic specimens were obtained using an endocervical Cytobrush and wooden spatula. Consenting subjects with cervical atypia underwent repeat Pap smear testing immediately before a colposcopic examination after a 4- to 6-month waiting period. RESULTS: One hundred fifty-nine women identified as having cervical atypia consented to having a colposcopic examination. Of these, 96 (60%) demonstrated abnormalities on biopsy, including 40 with condyloma, 41 with CIN I, and 15 with CIN II to III. The false-negative rate of the follow-up Pap smear for detecting these cases of condyloma and CIN was 57%. CONCLUSIONS: One third of the women with cervical atypia identified on an initial Pap smear in this primary care community setting had CIN after colposcopic biopsy. The single follow-up Pap smear obtained with the endocervical Cytobrush and wooden spatula failed to detect one half of the cases of biopsy-proven CIN. Further studies regarding the use of additional screening methods for follow-up are necessary.

Are Papanicolaou smears enough? Acetic acid washes of the cervix as adjunctive therapy: a HARNET study. Harrisburg Area Research Network.

BACKGROUND: The Papanicolaou smear has a false-negative rate ranging from 10% to 50%. Adjunctive screening methods for detecting cervical disease are thus of interest. We studied an adjunctive acetic acid wash of the cervix to detect additional cases of cervical disease not found by the Papanicolaou smear. METHODS: All women attending six family practice offices for health maintenance during the period August 1989 through April 1990 were examined (N = 2827). Papanicolaou smears were obtained using a Cytobrush and wooden spatula. Each subject's cervix was also visually examined 1 minute after application of 5% acetic acid. Women with abnormal Papanicolaou smear results or abnormal acetowhite areas on visual inspection of the cervix underwent colposcopy. RESULTS: Ninety-three cases of biopsy-proven condyloma or cervical intraepithelial neoplasia (CIN) were found on the basis of abnormal Papanicolaou smear results alone, 33 on the basis of abnormal acetic acid wash results alone, and 14 on the basis of abnormal results from both a Papanicolaou smear and an acetic acid wash. The prevalence of CIN was 3%. The overall positive predictive value for abnormal results obtained by acetic acid wash was .55 (95% CI = .43 to .63). CONCLUSIONS: Using a 1-minute 5% acetic acid wash improves the detection of cervical disease by 30%. Consideration should be given to augmenting the Papanicolaou smear with this safe, simple, and effective technique on premenopausal women during regular health maintenance examinations.