Greek - language Clinical Guidelines and Consent Forms in Obstetrics and Gynecology developed by the HSOG

Vrachnis Nikolaos1, Loufopoulos Aristotelis2, Tarlatzis Vasileios3

12nd Department of Obstetrics and Gynecology, Aretaieio hospital, University of Athens Medical School, Athens, Greece

2 2nd Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Medical School, Hippokrateio hospital,
Thessaloniki, Greece

31st Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Medical School, Papageorgiou hospital,
Thessaloniki, Greece

Correspondence: Vrachnis Nikolaos, 2nd Department of Obstetrics and Gynecology, University of Athens, Medical School, Aretaieio hospital, 76 Vasilissis Sofias Avenue, GR-11528, Athens, Greece

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The Hellenic Society of Obstetrics and Gynecology (HSOG) has published, with a great sense of responsibility and pride, the first set of Guidelines and Consent Forms in Obstetrics and Gynecology in the Greek language. With evidence - based medicine nowadays becoming increasingly important, this was an imperative and, as a consequence, our Society resolved to ensure that these Guidelines would form an invaluable support and reference point for all Greek Obstetricians - Gynecologists in their daily clinical practice.

The pace of innovation in healthcare has never been greater, and with each passing day the number of studies being published is increasing. As a result, the need for meticulous scientific evaluation has become a prominent focus. Meanwhile, the constantly evolving research work going on in the field of Obstetrics and Gynecology requires constant renewal and often revision of formerly established views and practices, this also in the sense that it is today abandoning the tendency to dogmatism and experiential exercise that has long characterized our specialty. While continuing education in Obstetrics and Gynecology is then an ever - growing need, equally important is the adoption of Guidelines on key issues. These must be viewed as a highly constructive tool in the hands of all colleagues, both they and lifelong education ensuring the continuous upgrading of the quality of the health services while also contributing to savings for our National Health System.

The effort to set up Obstetrics and Gynecology Guidelines in Greece started in June 2013; this was a HSOG Board decision, in collaboration with government agencies and other Medical Societies, among them the Athens Medical Society, with the aim of improving the quality of medical services. To date, 25 Guidelines and 6 Consent Forms have been produced, endorsed and presented. A few of them are already referenced in international journals. Furthermore, a printed version was distributed to the Society’s members, while at the same time all guidelines are freely available on our website (www.hsog.gr). This gives the opportunity not only to Obstetricians and Gynecologists but also to all healthcare providers to have direct access to quality information in the Greek language.

Talking about guidelines, it is essential to clarify three different terms, namely recommendations, guidelines and protocols, which are very often confused. Recommendations are suggestions about what should be done about a specific condition, which, however, are usually not readily or widely adopted. Guidelines, on the other hand, are a number of recommendations for clinicians about the care of patients with a specific condition. They aim to help clinical doctors to make the right decision while not imposing a particular treatment. The third term is protocols, a Greek word, which refer to very strict rules that every doctor is obliged to follow. Regardless of their differences, all three are based on evidence, although they vary in their strength; they constitute the cornerstone of evidence - based medicine that does not derive from personal experience but from external evidence based on systematic research.

Medicine has been described as the art and science of disease prevention, diagnosis, treatment and health maintenance, while it has also been characterized as “an art of probability”. Similarly, evidence is defined as any reasonable grounds for believing that something is or is not true, that which tends to prove or disprove a premise. Evidence - based medicine was originally named “critical appraisal”, this defining the application of basic rules of evidence. It was in 1990 that the term “evidence - based medicine” was initially used, and it appeared as part of an informational document published in the American College of Physicians (ACP) Journal Club in 1991. Since then, many scientific organizations have both endorsed and substantially enhanced “evidence - based medicine”, among others Archie Cochrane who established the Cochrane collaboration in 1993.

 

Guidelines

Within the first trimester of 2015, the HSOG has issued 25 guidelines and 6 consent forms, with the same procedure being applied for each one. Firstly, there was a discussion conducted by the Board of the HSOG in order to define the topic to be developed. Topic selection was regarded as a very important step since the aim was to cover the most common conditions in Obstetrics and Gynecology. In addition, other guidelines were developed upon request by the Health Ministry or other government/public bodies. The team responsible for preparing each guideline produces a first version of the guideline to be elaborated, this version being based on the existing guidelines of international scientific societies, adjusted to the Greek clinical reality; further additions are based on a more recent bibliography search. The first version is discussed at the next Board meeting and is also revised by the HSOG’s Committee for National Guidelines Development, which is also approved by the National Pharmaceutical Organization. Subsequently, every guideline is posted on the Society’s website for public consultation for one month. The writing team responds to comments made and incorporates any approved comments in the developing guideline if they are supported by the literature, until eventually its final form is achieved. The coordination and supervision of this procedure is carried out by the scientific coordinator.

Most guidelines are based on the respective guidelines of international scientific societies, which are subsequently adapted to Greek day - to - day practice and reality. Moreover, new evidence and study results are added in accordance with the recent literature. The last page of the guideline includes a statement on the level of evidence and the level of recommendation of the statements and studies included.

 

Consent Forms

As part of the day - to - day practice, a patient will give a written consent for a specific diagnostic or therapeutic procedure. Prior to a diagnostic test or an operation, a healthcare provider will ensure that the patient is fully informed and understands all the aspects of her condition, the prognosis and the possible consequences and risks. At the same time, all alternative options must be carefully presented and any uncertainties that the patient may mention should be discussed and clarified. Following this procedure, the healthcare provider will ask for the patient’s consent.

Talking to a patient requires special skills and preparation as well as a thorough knowledge of the issues covered. It is very important that any risk involved in the proposed procedure or any likelihood of complications be described in such a way that it is easily comprehensible to the patient.

A delicate issue is the fact that many women ask for the presence of trusted relatives or friends during consultation. This is acceptable, but there should also be an effort to meet the patient on her own, at least at some stage of the care pathway.

Another increasingly common problem in Greece is that many patients do not speak Greek as their first language. Using the patient’s relatives or friends as interpreters may be useful, but it is necessary to ensure that the patient receives an unbiased interpretation of the doctor’s information. Therefore, provision of an approved translation service and translated versions should be considered wherever possible.

For patients under 18 years old, consent can be obtained from a parent or those who exert parental responsibility. However, even in these cases, it is useful to involve children and young people in decisions.

Taking into consideration all these factors, HSOG has prepared and developed Consent Forms for the most common procedures in the daily practice of Obstetrics and Gynecology. Each Consent Form was discussed by the Society’s Board and was also validated by a Legal Adviser, specialized in medical law. This was followed by a post on the Society’s website (www.hsog.gr) for public consultation for one month prior to its publication in its final form. All the approved forms are freely available on the HSOG website and can easily be printed and used by the healthcare provider.

In conclusion, a healthcare provider needs to go through the medical guidelines of his or her profession and to decide whether or not to follow the recommendations of a guideline for an individual treatment. However, it should always be taken into consideration the experience, training, education and ability of each doctor, and the personal preferences and values of the patient. Moreover, the written consent form must provide the patient with all the necessary information, but should also provide legal cover to the doctor in the event of a possible future legal dispute.

In this context, we trust that the project of the developing group will be positively recognized, as it has been already been by the Greek Obstetrics and Gynecology community, and we invite the HSOG members to contribute to the enrichment of the existing guidelines and the production of new ones.

 

 

editorial 1.2015

 

Figure. HSOG has drawn up and published Clinical Guidelines and Consent Forms in Obstetrics and Gynecology in the Greek language. The first edition, published in May 2014, contained 17 Clinical Guidelines and 6 Consent Forms. The wide recognition accorded to these, not only by the Greek Obstetric and Gynecologic community but also by government bodies, courts and allied specialties and professionals, has led to its second edition, this containing 8 more Guidelines all analyzing common issues in day-to-day practice. The Clinical Guidelines published to date concern: Pelvic inflammatory disease (PID), Vaginitis, Prophylactic antibiotics in gynecological operations, Emergency contraception, Urinary tract infections, Pharmaceutical treatment of pain associated with endometriosis, Preterm rupture of membranes, Use of corticosteroids for reducing neonatal morbidity and mortality, Induction of labor, Prenatal diagnosis: follow-up of a low risk pregnancy, Preterm labor and tocolytics, Cesarean section, Primary and secondary prevention against cervical cancer, Osteoporosis, Climacteric, Menopause, Secondary prevention against breast cancer, Planned home birth, Shoulder dystocia, Cervical cerclage, Intrauterine death or stillbirth, Hemostatic agents in Obstetrics and Gynecology, Use of anti-adhesion agents in Obstetrics and Gynecology, Postpartum hemorrhage, Vaginal birth after cesarean section (VBAC). In addition, the 6 Consent Forms published to date are: Abdominal hysterectomy, Cesarean section, Surgical abortion, Abdominal myomectomy, Conization, Amniocentesis.