ABSTRACT

Objective:

To search, whether women would prefer a new method after they have been informed about automated breast ultrasound (US) examination, their perspective on technological developments and whether they make decisions based on their psychological and physical conditions.

Methods:

Between 17.02.2023-17.03.2023, 118 women have visited our clinic for breast examination and 91 of them filled the questionnaire-based survey and have been included into the study. Questions of the survey consisted of three parts. Questions related to hand-held breast US were: “Do you feel relaxed while chatting with the physician during the examination?”, “Do want to get information from the physician during or after the US examination?”, “Do the physician’s facial expressions have an effect on you?”. Questions related to automated US were: “Would you change your mind if there was pain while the procedure was applied and your breasts were compressed?”, “Would you think that this machine will give you more detailed information because it is a newer technology?”, “Does any machine need to be widely used to be reliable or does it need to be available in a low number of imaging clinics?”. Questions related to both methods were: “Does it make any difference to you whether the physician performs the procedure or not?”, “Do you have any tolerance level for the duration of the US examination?”, “Do you decide according to your own preference or the preference of the physician who referred you to have an US examination?”.

Results:

Mean age was 47.8 (22-74). Twelve out of 91 (13.1%) women had a history of breast cancer in their family. Seventy nine (86.8%) had a previous breast examination. Previous interventional procedures such as cyst aspiration or biopsy were applied for 5 (5.4%) women. When evaluating the questions about the physician as yes/no; the ratio of ‘yes’ answer was very high: Do want to get information from the physician during or after the US examination? (97.8% vs. 2.1%), Do you feel relaxed while chatting with the physician during the examination? (82.4% vs. 17.4%), Do the physician’s facial expressions have an effect on you? (83.5% vs. 16.4%), does it make any difference to you whether the physician performs the procedure or not (83.5% vs. 16.5%). When both examinations were evaluated jointly; the ratio of the women who do not care about the duration of the procedure was higher than the ratio of who care (85.7% vs. 14.2%), and who care about the decision of the physician who refers her was higher than her own choice (80.1% vs. 19.7%).

Conclusion:

Breast imaging is quite important and stressful for women. A significant number of the women care about obtaining information about the examination and being in direct contact with the physician as well as getting the results of the examination. However; although automated breast examination is a new technology and is not used very commonly in our country; it has been evaluated as testable for women.

INTRODUCTION

While technological developments are advancing rapidly in our age, new breast imaging techniques are being added day by day. The fact that breast cancer (BC) is the most common cancer in women and that early diagnosis reduces BC-related deaths and changes in the course of treatment play an important role in the rapid increase in developments.

In addition to mammography, ultrasonography (US) is used in BC screening. US can detect early stage, small invasive cancers that cannot be detected on mammography in women with dense breast parenchyma (1,2). However, the hand-held breast US (HHBUS) examination, which is used as a standard today, has some disadvantages. These disadvantages shown in some studies include dependence on the physician performing the procedure, its being time consuming for radiologists, high false-positive rates, and not being cost-effective (2-5). Due to these disadvantages, the use of automated three-dimensional breast US has been increasing in breast imaging clinics recently. Automated breast US (ABUS) allows the image to be stored digitally and is not user dependent and provides technical standardization (6-8).

The aim of this prospective study was to evaluate whether women would prefer a new method for breast US examination after being informed about ABUS examination, their distance from technological developments, and whether they decide according to their mental and physical conditions.

GİRİŞ

Çağımızda teknolojik gelişmeler hızla ilerlerken, meme görüntüleme tekniklerine de gün geçtikçe yenisi eklenmektedir. Meme kanserinin (MK) kadınlarda en sık görülen kanser olması ve erken teşhisin MK’ye bağlı ölümleri azaltması ve tedavinin seyrini değiştirmesi, gelişmelerin hızla artmasında önemli rol oynamaktadır.

MK taramasında mamografiye ilave olarak, ultrasonografi (US) kullanılmaktadır. US; meme parankimi yoğun kadınlarda, mamografide tespit edilemeyen, erken evre, küçük invaziv kanserleri tespit edebilir (1,2). Ancak günümüzde standart olarak kullanılan manuel US (HHBUS) incelemesinin bazı dezavantajları vardır. Bu dezavantajlar arasında; işlemi gerçekleştiren hekime bağlı olması, radyologlar için zaman alıcı olması, yanlış pozitiflik oranlarının yüksek olması ve bazı çalışmalarda maliyet etkin olmadığının gösterilmesi sayılabilir (2-5). Bu dezavantajlar nedeniyle, son zamanlarda meme görüntüleme kliniklerinde, otomatik üç boyutlu meme US kullanımı artmaktadır. Otomatik US (ABUS), görüntünün dijital olarak saklanabilmesine olanak sağladığı gibi; kullanıcıya bağımlı değildir ve teknik standardizasyonu sağlar (6-8).

Bu prospektif çalışmada amaç, kadınları ABUS tetkiki hakkında bilgilendirdikten sonra; yeni bir yöntemi tercih edip etmeyeceğini, kadınların teknolojik gelişmelere mesafesini, yapılacak meme US tetkiki için ruhsal ve fiziksel durumlara göre karar verip vermediğini değerlendirmekti.

METHODS

Between 17.02.2023 and 17.03.2023, 118 women who were admitted to our clinic for breast US examination were evaluated. Foreign nationals were not included in the study due to problems that might arise from incomplete communication and women with a history of BC and/or implants were not included in the study due to the lack of data on ABUS application.

An anonymous questionnaire was prepared by an experienced breast radiologist who had worked with several different ABUS devices. The forms were made available only in Turkish, printed on paper. All of the women who were admitted to our clinic were asked to fill out a questionnaire consisting of personal information (age, “do you have BC or does one of your relative have BC?”, “do you have any complaint about your breast?”, “has an interventional procedure been applied to the breast before?”) before the breast US examination and the data were recorded routinely. Information on personal characteristics used in the study was obtained from these forms. The questionnaire form prepared for this study was filled by the physician who would perform the HHBUS examination and who was also the investigator, after giving a brief verbal information about the ABUS. The physician also explained what the survey questions were about and informed that it would take approximately 7-8 minutes to answer. Women participated in the survey voluntarily and no coercion was applied to those who could not complete the survey.

It was stated that the questions of the questionnaire were aimed at the differences between the two methods, even if the ABUS device was used instead of the HHBUS device available in the clinic. Then, about the ABUS, it was told that the radiology technician would perform the imaging similar to mammography (but the evaluation would be done by the physician on the screen and the whole breast image might be saved), that the process might take longer than HHBUS, and that there might be pain because the breast would be compressed during the procedure, but the general procedure was found to be tolerable. It was told that these devices were not widely used and that they were available in a limited number of centers in Turkey.

The questions consisted of three groups: those related to HHBUS, those related to ABUS, and those that were related to both. The questions related to HHBUS were as follows: “Does the conversation with the doctor relax you?”, “Do you want to get information from the doctor during or after the US examination?”, and “Does the facial expression of the doctor affect you during the procedure?”. The questions related to ABUS were as follows: “Does compression of the breast and its being a painful procedure change your decision about the imaging method used?”, “Do you think that ABUS gives more detailed information because the device is a new technology?” and “Which is reassuring? Widely usage of a device or its use in a limited number of centers?” The questions regarding both procedures were as follows: “Does it make any difference to you if the doctor performs the procedure or not?”, “Do you have a tolerance level for the duration of the US examination?” (if possible, <10-15 minutes or I don’t care about the time) and “do you act according to the preference of the doctor who referred you or according to your own preference when having an imaging examination?”.

Descriptive statistics, numbers and percentage distributions were used for statistical analysis. İstanbul Medipol University Non-Interventional Clinical Research Ethics Committee approved the study (decision no: 178, date: 16.02.2023). Consent for the study was obtained from the patients.

Statistical Analysis

When the answers regarding HHBUS were evaluated as yes/no; the rate of patients who answered “yes” was found to be very high: “Do you want to get information from the doctor during or after the procedure?” (97.8% vs. 2.1%), “Does the conversation with the doctor relax you?” (82.4% vs. 17.4%), “Does the facial expression of the doctor affect you?” (83.5% vs. 16.4%) and “Does it make a difference for you if the doctor or technician does the extraction?” (83.5% vs. 16.5%).

When both processes were evaluated jointly, the rate of those who said “I don’t care about the time” in terms of tolerance level was found to be higher than those who said “I care” (85.7% vs. 14.2%). The rate of those who said “I care about the doctor’s preference” when choosing for the procedure was found to be higher than those who said “I act according to my own preferences” (80.1% vs. 19.7%).

YÖNTEMLER

17.02.2023-17.03.2023 tarihleri arasında, meme US tetkiki için kliniğimize başvuran 118 kadın değerlendirildi. Eksik iletişimden kaynaklanabilecek aksaklılar nedeniyle yabancı uyruklular ve ABUS uygulanması ile ilgili yeterli data olmaması nedeniyle silikonlu ve/veya MK öyküsü olan kadınlar çalışmaya dahil edilmedi.

Birkaç farklı otomatik meme US cihazı ile çalışmış ve bu konuda tecrübeli meme radyoloğu tarafından anonim bir anket formu hazırlandı. Formlar sadece Türkçe olarak, kağıda basılı halde hazır bulunduruldu. Kliniğimize gelen kadınların hepsi meme US tetkiki yapılmadan önce, kişisel bilgilerden oluşan soru formunu (yaş, “kendisinde ya da yakınlarında MK var mı?”, “meme ile ilgili bir şikayeti var mı?”, “Daha önceden memeye girişimsel bir işlem uygulandı mı?”, “Daha önce meme ile ilgili tetkik yapıldı mı?”) doldurmakta ve bilgiler rutin olarak kaydedilmektedir. Çalışmada kullanılan kişisel özelliklere yönelik bilgiler bu formlardan elde edildi. Bu çalışma için hazırlanmış anket formu ise HHBUS tetkikini uygulayacak ve aynı zamanda çalışmacı olan hekim tarafından, ABUS hakkında kısa bir sözel bilgi verildikten sonra dolduruldu. Hekim ayrıca, anket sorularının neyle ilgili olduğunu açıkladı ve cevaplamanın yaklaşık 7-8 dakika süreceği bilgisini verdi. Kadınlar ankete gönüllü olarak katıldı ve anketi tamamlayamayanlar için herhangi bir zorlama yapılmadı.

Anket sorularının, klinikte hazır bulunan HHBUS cihazı yerine ABUS cihazı kullanılıyor olsa, iki yöntem arasındaki farklara yönelik olduğu belirtildi. Daha sonra ABUS çekimi hakkında; çekimi mamografiye benzer şekilde radyoloji teknisyeninin yapacağı (fakat değerlendirmenin hekim tarafından ekran başında yapılacağı ve tüm meme görüntüsünün saklı kalabileceği), bu işlemin manuel US’ye göre daha uzun sürebileceği, işlem sırasında meme sıkıştırıldığı için ağrı olabileceği ancak işlemin genel olarak tolere edilebilir olduğu vurgulandı. Bu cihazların yaygın olarak kullanılmadığı, Türkiye’de birkaç merkezde bulunduğu belirtildi.

Sorular; HHBUS ile ilgili olanlar, ABUS ile ilgili olanlar ve her ikisini ilgilendirenler olmak üzere üç gruptan oluşmaktaydı. HHBUS ile ilgili olanlar: “İşlem sırasında hekimle sohbet etmek sizi rahatlatır mı?”, “US incelemesi sırasında ya da bitince hekimden bilgi almak ister misiniz?”, “İşlem sırasında hekimin yüz ifadesi sizi etkiler mi?”.

ABUS ile ilgili olanlar: “Memenin sıkıştırılması ve ağrılı bir işlem olması çekim için kararınızı değiştirir mi?”, “Cihaz yeni bir teknoloji olduğu için daha detaylı bilgi verdiğini düşünür müsünüz?”, “Bir cihazın güvenilir olması için yaygın olarak kullanılması mı, az merkezde bulunması mı güven vericidir?”. Her iki işlemle ilgili olanlar: “İşlemi hekimin yapması sizin için fark eder mi?”, “US tetkiki yapılırken süre ile ilgili bir tolerans seviyeniz var mı?” (mümkünse <10-15 dakika ya da süreyi önemsemem), “Görüntüleme tetkiki yaptırırken sizi yönlendiren hekimin tercihine göre mi, kendi tercihinize göre mi hareket edersiniz?” sorularından oluşmaktaydı.

İstatistiksel amaçla, tanımlayıcı istatistikler, sayı ve yüzde dağılımları kullanıldı. İstanbul Medipol Üniversitesi Girişimsel Olmayan Klinik Araştırmalar Etik Kurulu çalışma için etik kurul onayı verdi (karar no: 178, tarih: 16.02.2023). Hastalardan çalışma için onam formu alındı.

İstatistiksel Analiz

HHBUS ile ilgili cevaplar evet/hayır olarak değerlendirildiğinde; evet cevabı verenlerin oranı çok yüksek bulunmuştur: İşlem sırasında ya da bitince hekimden bilgi almak ister misiniz? (%97,8 vs. %2,1), hekimle sohbet sizi rahatlatır mı? (%82,4 vs. %17,4), hekimin yüz ifadesi sizi etkiler mi? (%83,5 vs. %16,4), çekimi hekimin ya da teknisyenin yapması sizin için fark eder mi? (%83,5 vs. %16,5).

Her iki işlem ortak değerlendirildiğinde; süre ilgili tolerans seviyesi açısından süreyi önemsemem diyenlerin oranı, önemserim diyenlere göre yüksek bulunmuştur (%85,7 vs. %14,2). İşlem için tercih yaparken hekimin tercihini önemserim diyenlerin oranı, kendi tercihime göre hareket ederim diyenlere göre yüksek bulunmuştur (%80,1 vs. %19,7).

RESULTS

Of the women not included in the study, 5 had breast cancer, 12 were foreign nationals, and 8 had silicone. Two women over 75 years old, one was not included in the study because she was non-cooperative and the other thought she could not fill out the questionnaire. A total of 91 out of 118 women were included in the study.

When the sociodemographic characteristics of the women were evaluated, the mean age was 47.8 (22-74). Twelve (13.1%) women had a family history of breast cancer. The number of those who had breast imaging before was 79 (86.8%). Five (5.4%) women had previously undergone an interventional procedure as biopsy or cyst aspiration.

While only 3 (3.2%) out of 91 women were primary school graduates, 8 (8.7%) were high school graduates, 80 (87.9%) women were university graduates. While only 2 (2.1%) women lived in the small city, 89 (97.8%) women lived in İstanbul.

Seventy six out of 91 women, 76 women (83.5%) stated that they would prefer the doctor to perform the imaging, and 89 (97.8%) stated that they would like to get information about the procedure. While talking with the physician was comforting for 75 (82.4%) women, 76 (83.5%) women stated that the facial expression of the physician affected them.

Twenty-three women stated that they would not want a painful procedure, whether they previously had a mammogram or not. Of the women, 53 (58.2%) stated that ABUS would give better information because it was a new technology, while 61 (67%) stated that it was more reassuring to have the device in fewer centers.

While making a choice for the procedure, 73 (80.1%) women stated that they cared about the preference of the referring physician. The majority of them (61/91) stated that they only considered the preference of the physician. In terms of duration, there were 13 (14.2%) women who said that they would like the procedure to take a short time, while 78 (85.7%) women stated that they would not care about the duration (Tables 1, 2, 3).

DISCUSSION

Breast imaging is very important and also stressful for women (9,10). Anxiety levels are usually high during the procedure, but sometimes even days before the procedure. During HHBUS examination, women are curious about what the examining physician will say, and they may sometimes look into the eyes of the physician or carefully examine the physician’s facial expressions. Although there were not enough studies in the literature on this subject, it was shown in a study that while anxiety levels were high before breast US was performed, the level of anxiety decreased significantly when information about the procedure was given after the procedure (11).

It is reassuring for women to be in direct contact with the physician and to receive information about their breasts during or after the procedure in countries where the physician performs the US procedure, as in our country (6,12). In this study, 83.5% (76/91) of the women stated that they would prefer the doctor to perform the imaging, and 97.8% (89/91) of them would like to get information about the procedure. Conversation with the physician was found to be relaxing for 82.4% (75/91) of the women. One of the important results of this study was that the facial expression of the physician affected 83.5% (76/91) of the women. When the answers about HHBUS were evaluated, the rate of those who gave ‘Yes’ answer was very high.

The use of ABUS for both screening and diagnostic purposes is increasing (13-15). A method must be accepted by the female population, especially when it will be used for screening purposes (12). There are few studies evaluating the perspective of the procedure and the tolerance of the patients after having the ABUS procedure (6,12,16,17). The most important disadvantage of ABUS is the feeling of discomfort due to pressure and pain. However, it was shown to be less painful in one study compared to mammography (18). Considering all these studies, the procedure was generally found to be tolerable. In this study, it was told to the patients that the procedure could be painful and could take a long time, but it was emphasized that it was tolerable in these respects. In terms of breast compression and a painful procedure, 23 women (25.2%) stated that they would not want a painful procedure, whether they previously had a mammogram or not. Although the ability to save the whole breast image is an important advantage of ABUS, it may be viewed with suspicion in women because it is a new technology. However, it was seen in this study that more than half of the women (53/91) with a rate of 58.2% stated that ABUS would give better information because it was a new technology and that they would prefer a new technology instead of the traditional method and would like to try it. It was emphasized that while the widespread use of a device was not important for most women in terms of trust, it was more important to trust the center where the device was located and the physician who referred them. In such a situation, having the device in fewer centers was more reassuring for 67% (61/91) of women.

Patients are admitted to imaging clinics, usually by referral from different clinics. And if they trust the referring physician, they also trust the center where they will undergo the imaging. It was also seen in this study that while making a choice for the procedure, 80.1% (73/91) of the women stated that they cared about the preference of the physician who referred them. The majority of them (67%) stated that they only considered the preference of the physician. In terms of the duration of the procedure, the rate of those who said "I don't care about the duration" was very high (85.7% vs. 14.2%).

Study Limitations

Some of the limitations of this study could be listed as follows: The number of participants was relatively small and the questionnaire was administered in the light of the verbal information given, taking into account the advantages and disadvantages of the ABUS device, which was not routinely used in daily practice. However, the aim of the study was to assess how well the device would be accepted before placing it in the clinic. On the other hand, the reason why a new technology was viewed so positively might be that while patients were informed that the ABUS device was a new technology, they were not informed about the results in breast cancer detection.

TARTIŞMA

Meme görüntülemesi kadınlar için oldukça önemli ve bir o kadar da streslidir (9,10). Anksiyete düzeyleri, genellikle işlem sırasında yüksek olmakla birlikte, bazen işlemden günler önce bile yükselebilir. Kadınlar, HHBUS incelemesi sırasında, incelemeyi yapan hekimin söyleyeceklerini merak eder ve bazen hekimin gözlerinin içine bakabilir ya da hekimin mimiklerini ve yüz ifadesini dikkatle inceleyebilirler. Literatürde bu konuda yeterli çalışma bulunmamakla birlikte; bir çalışmada gösterilmiştir ki meme US yapılmadan önce anksiyete seviyeleri yüksekken, işlem bittikten sonra işlemle ilgili bilgi verildiğinde anksiyete düzeyi önemli ölçüde azalmaktadır (11).

Ülkemizdeki gibi, US işlemini hekimin gerçekleştirdiği ülkelerde, hekimle direkt iletişim halinde olmak ve işlem sırasında veya sonrasında memeleri ile ilgili bilgi almak, kadınlar açısından güven vericidir (6,12). Bu çalışmada da görüldü ki kadınların %83,5 (76/91) oranında büyük bir bölümü, çekimi hekimin yapmasını tercih edeceğini ve %97,8 (89/91) oranında bir bölümü ise işlem ile bilgi almak isteyeceğini belirtti. Hekim ile sohbetin, kadınların %82,4’ü (75/91) için rahatlatıcı olduğu görüldü. Bu çalışmanın önemli sonuçlarından biri de hekimin yüz ifadesinin, %83,5 (76/91) oranında kadını etkilemesiydi. HHBUS ile ilgili cevaplar evet/hayır olarak değerlendirildiğinde; “evet” cevabı verenlerin oranı belirgin olarak yüksekti.

ABUS’nin gerek tarama gerekse tanısal amaçla kullanımı giderek artmaktadır (13-15). Bir yöntemin özellikle tarama amacıyla kullanımında, kadın popülasyonu tarafından kabul görmesi gerekir (12). Hastaların, ABUS işlemini yaptırdıktan sonra işleme bakış açısını ve işlem ile ilgili toleransını değerlendiren az sayıda çalışma bulunmaktadır (6,12,16,17). ABUS’nin en önemli dezavantajı, baskı ve ağrıdan dolayı oluşan rahatsızlık hissidir. Yine de bir çalışmada mamografi ile karşılaştırıldığında daha az ağrılı olduğu gösterilmiştir (18). Tüm bu çalışmalara bakıldığında ise işlem genel olarak tolere edilebilir bulunmuştur. Bu çalışmada da işlemin ağrılı olabileceği ve uzun sürebileceği hastalara belirtilmiş ancak bu açılardan tolere edilebilir olduğu vurgulanmıştır. Memenin sıkıştırılması ve ağrılı bir işlem açısından bakıldığında; 23 kadın (%25,2) ister mamografi çektirmiş ister çektirmemiş olsun ağrılı bir işlem istemeyeceğini belirtti. Bütün meme görüntüsünün saklanabilmesi, ABUS’nin önemli bir avantajı olmasına rağmen, yeni bir teknoloji olduğu için kadınlarda kuşku ile karşılanabilir. Ancak bu çalışmada görüldü ki kadınların %58,2’lik bir oranla yarısından fazlası (53/91) yeni bir teknoloji olduğu için ABUS’nin daha iyi bilgi vereceğini, geleneksel yöntem yerine yeni bir teknolojiyi tercih edeceğini ve denemek isteyeceğini belirtti. Bir cihazın yaygın olarak kullanılması güven açısından, kadınların çoğu için önemli değilken; cihazın bulunduğu merkeze ve kendilerini yönlendiren hekime güvenmenin daha önemli olduğu vurgulandı. Böyle bir durumda, cihazın az merkezde bulunması, kadınların %67’si (61/91) açısından daha güven vericiydi.

Hastalar, radyoloji tetkiki yaptırmak için görüntüleme kliniklerine, genellikle farklı kliniklerden yönlendirme ile gelmektedir. Ve eğer kendilerini yönlendiren hekime güveniyorlarsa çekimi yaptıracakları yere de güven duymaktadırlar. Bu çalışmada da görüldü ki, işlem için tercih yaparken kadınların %80,1 (73/91) oranında büyük bir kısmı, kendilerini yönlendiren hekimin tercihini önemsediğini belirtti. Bunların çoğunluğu ise (%67) sadece hekimin tercihini dikkate aldığını ifade etti. Süre açısından bakıldığında “Süreyi önemsemem” diyenlerin oranı belirgin olarak yüksekti (%85,7 vs. %14,2).

Çalışmanın Kısıtlılıkları

Bu çalışmanın bazı sınırlılıkları şöyle sıralanabilir: Katılımcı sayısı nispeten azdı ve günlük pratikte rutin olarak kullanılmayan ABUS cihazının avantaj ve dezavantajları göz önünde tutularak verilen sözel bilgiler ışığında anket uygulanmış oldu. Ancak çalışmanın amacı, zaten cihazı kliniğe yerleştirmeden önce ne kadar kabul göreceğini değerlendirmekti. Öte yandan, yeni bir teknolojiye bu kadar olumlu bakılmasının sebebi, hastalara ABUS cihazının yeni bir teknoloji olduğu bilgisi verilirken MK tespitindeki sonuçlar açısından bilgi verilmemiş olması olabilir.

CONCLUSION

It may be helpful to survey patients before placing a new device in imaging clinics. Especially in terms of breast imaging, a significant portion of women care about getting information about the examination and being in direct contact with the physician as much as they care about the result of the examination.