Development of a clinical protocol for detection of cervical cancer precursor lesions

ABSTRACT Objective: to develop and validate the content of a clinical protocol aimed at prevention of cervical cancer in primary care. Method: technological research according to the steps: (1) submission of the project to the research ethics committee; (2) bibliographic survey; (3) elaboration of the clinical protocol; and (4) content validation. In the third step, the information was collected through bibliographic research and gynecology specialists were consulted. For the final step, four judges were selected to evaluate the clinical protocol according to AGREE 2. Domains that reached the minimum level of agreement of 75% in the scores were considered validated. Results: the scores obtained in each domain of the instrument were as follows: domain 1 (scope and purpose) = 87.5%; domain 2 (stakeholder involvement) = 83.3%; domain 3 (development rigor) = 79.7%; domain 4 (clarity of presentation) = 76.3%; domain 5 (applicability) = 78.1%; and domain 6 (editorial independence) = 85.4. Conclusion: the clinical protocol proved to be a validated material with scores above the minimum required. The protocol obtained positive recommendations with modifications and went through adjustments in order to make it more effective.


Introduction
It is estimated that the number of cases of cervical cancer worldwide reaches 527,600, and this disease is responsible for 265,000 deaths (1) .
In Brazil, data show that 15 This can directly interfere with mortality from cervical cancer, reducing the death rate by half (3)(4) .
Considering that screening actions are the main source of evidence for detection of cervical cancer precursor lesions, it is necessary to build a protocol to be followed by nursing professionals during gynecological consultations. This protocol will provide greater support to their practice and to contribute to the early detection of precursor lesions and consequent decrease of the incidence of cervical cancer, as well as promote a better quality of care to clients.
Nurses play a fundamental role in consolidating the adequate coverage of cervical cancer prevention.
They are among the professionals who are responsible for its realization and for encouraging the adherence of users to the follow-up and to appropriate periodicity of the examination. They also perform health promotion activities that aim to educate patients about the risk factors of the disease, as well as increase the number of adherents to regular visits to the Pap smear test (5)(6) .
In this way, the creation of protocols to direct the care practices and routine procedures of professionals in diverse services becomes fundamental for its organization and management. It is worth mentioning that all the actions advocated in this type of material are prepared by specialists in the area of action to which it is proposed and these are based on the best scientific evidence. When it comes to application in the health area, they are known as clinical protocols or clinical guidelines, for they are directed to the search for quality and promotion of the user's health, focused on preventive actions such as the Pap smear test (7) .
Because it is a type of technology, clinical guideline are recommended to be used in the screening of cervical cancer, providing greater appropriation of the health problem that is reported, allowing professionals to have technical and scientific support backing their actions, favoring greater self-confidence in their practices (7) .
In view of the above, the objective of this study was to develop and validate the content of a clinical guideline aimed at gynecological nursing consultation for prevention of cervical cancer in primary care.

Method
This is a research of technological development in health (8)  The step of preparation of the clinical guideline included the following phases: an integrative review (9)    guideline, selected by means of non-probabilistic sampling technique (12) . Invitations were sent to 04 gynecology specialists, from different professional categories, as recommended by AGREE II for a good evaluation of the clinical guideline. They were chosen according to pre-established criteria (13) .
After meeting the inclusion criteria, the specialists were invited to participate in the study through formal contact via invitation letter. At the same time, the evaluation questionnaire, instructions about the objectives of the study, and instructions for the adequate completion of the instrument were given to the specialists. After accepting to participate in the research, the informed consent term (ICF) was sent to professionals to register their consent.

Results
The evaluation of this clinical guideline was performed by four health professionals, who were named A1, A2, A3, A4. All of them work in the area of gynecology and/or development and evaluation of health technologies; there were 02 physicians and 02 nurses who work in the area of assistance and teaching.
The time elapsed after graduation ranged from 7 to 30 years; two of them had a specialist degree, one had completed the Post-doctorate, and one had a Master's degree.
The assessment of adequacy of the clinical guideline was carried out through the AGREE II domains, presented in Figure 3.
We found that the domain 1 (scope and purpose) obtained the highest score (87.5%). The domains 2 (stakeholder involvement) and 6 (editorial independence) also held scores above 80%.  should receive more emphasis in the protocol, which was accepted; the guideline describes the age of onset of the screening, as well as the justification for it.
In relation to the domain 2, the appraisers A2 and suggested that the ASC-US algorithm were revised, but did not specify which aspect needed revision. Regarding the age for onset of screening, duly justified throughout the text of the clinical guideline, the authors did not carry out the suggested change because it is only a textual presentation form, which actually facilitates the identification of the target audience of the guideline.
The expert A3 assigned 5 points to the item 16, justifying that the algorithm exposed on page 20 was ambiguous. The algorithm was revised. In the item 17, The evaluation of clinical guidelines by an interdisciplinary team is supported by the AGREE II, which has been used in other studies in order to achieve a positive and comprehensive evaluation (16)(17) .
Furthermore, a clinical guideline built by an interdisciplinary team to be used in a specific area of the health service becomes more objective, capable of directing the professionals towards effective clinical decision-making, and helps avoiding multiple clinical judgments about health problems (18)(19) .  (21) . Although the AGREE II does not establish a cut-off point for guideline quality, it is worth noting that this clinical guideline was evaluated by 16 judges and recommended by 12 of them (22) . AGREE II recommends the evaluation by 4 experts only, and the strategy used to calculate adequacy was designed for 4 evaluators. It is known that the greater the number of appraisers, the greater is the diversity of opinions and the greater the possibility of generating disagreement between them, which may explain the low adequacy indices found in the above mentioned diabetes protocol.
A suggestion of classifying the quality of clinical guidelines was adopted by the authors of a study carried out in Spain, which established the following classification for quality of clinical protocols: percentage of suitability less than or equal to 25% was considered very low; suitability equal to 50% was low; suitability between 50% and 75% was high; and suitability above 75% was very high (22) . This is in line with the present study, for it was established here that a clinical protocol should obtain a minimum of 75% adequacy in its domains to be considered of good quality.

Conclusion
The clinical guideline studied brings technological innovations regarding the screening of lesions that cause cervical cancer, such as digital cervicography and colposcopy. The study was evaluated according to the AGREE II and obtained scores consistent with a good quality guideline, which can be implemented in health services in order to improve gynecological health care.
Among the limitations of the study is the fact that the study was related to actions that occurred in a single research locus, which reduces its geographical coverage in relation to the target population and its power of inference to other primary health institutions.
The realization of a clinical study is recommended to analyze the impact and the implementation of cervical cancer screening tests within a set period of time to verify the cost-effectiveness of the use of this clinical guideline in order to investigate the viability of its implementation in the routine of health services, so that the guideline may be widely adopted in health units. The guideline will be updated periodically in order to preserve actions based on high levels of evidence and better recommendations. www.eerp.usp.br/rlae