REP ORT USE OF ULTRASOUND IN ANTENATAL AND PRIMARY CARE assessment assessment HEALTH TECHNOLOGY ASSESSMENT UNIT MEDICAL DEVELOPMENT DIVISION health MINISTRY OF HEALTH MALAYSIA MOH/PAK/88.04(TR) i EXECUTIVE SUMMARY INTRODUCTION Ultrasound has been used for diagnostic purposes for more than 20 years in almost all branches of medicine. Ultrasonography has been widely accepted due to its clinical usefulness, convenience and non-invasiveness, as well as fetal biometry and detection of fetal anomalies. In addition, the newer ultrasound techniques like Doppler waveforms are used for fetal echography, uterine and fetal blood flow. The use of ultrasound as an effective diagnostic modality therefore continues to increase worldwide. Improvements in resolution and image quality, and in grey scale, have further enhanced its usefulness, while the advent of endo-vaginal and trans-rectal ultrasound examinations, allow direct access to anatomical structures without interference from overlying abdominal organs that occur in trans-abdominal ultrasound. OBJECTIVES To assess the safety, effectiveness, cost effectiveness of the use of ultrasound in antenatal care Deleted: cc and in primary care. Deleted: , which includes use of ultrasound RESULTS Deleted: use of ultrasound Safety Deleted: , subsequently to determine There is no scientific evidence on adverse effects of ultrasound, although there is some evidence ultrasound training for non-radiologist.¶ of a statistically significant association between ultrasound and left handedness among males baby. Effectiveness Use of ultrasound in antenatal care There is sufficient evidence that ultrasound is effective in dating pregnancy, assessing the viability of foetus, diagnosing twin pregnancy, diagnosing intrauterine growth retardation, diagnosis of placenta praevia, and detection of congenital abnormalities. There is also evidence of effectiveness of trans-vaginal ultrasound in detection of congenital abnormalities, retained products of conception, and predicting pre-term labour. There is sufficient evidence that routine ultrasound in antenatal care or ultrasound examination in low-risk population does not improve the outcome of pregnancy. Use of ultrasound in Gynaecology There is sufficient evidence that ultrasound is effective in detecting ectopic pregnancy, screening for ovarian cancer, and detecting uterine abnormalities. Use of Ultrasound in Surgery There is sufficient evidence that ultrasound is effective in diagnosing abdominal trauma, appendicitis, breast lesions, and gall bladder lesions like stones and tumours. Training There is sufficient evidence that the quality of ultrasound is determined by the level of training and experience of operators, and that appropriate training should be provided to those carrying out ultrasonography. ii Cost implications For antenatal screening, there is sufficient evidence that routine ultrasound screening for low-risk population is not cost-effective. Ethical implications There are ethical issues that need to be considered in providing ultrasonography services. Legal Aspects of Ultrasound There are legal issues to be considered in carrying out ultrasonography. RECOMMENDATIONS There is sufficient evidence to recommend that routine antenatal screening not be carried out in the low risk population. However, ultrasound screening should be carried out for high risk mothers. In addition, it should be used for diagnosis of various conditions in pregnancy or to rule out these conditions. Ultrasound is also recommended in secondary and tertiary care for diagnosis of gynaecological and surgical conditions. Training has to be provided for all those involved in providing ultrasonography services. Ethical and legal implications need to be considered. iii Expert Committee Dr J Ravindran Consultant Obstetric & Gynaecologist Seremban Hospital Dr Siti Fatimah Abbas Consultant Radiologist Malacca Hopsital Dr Gurdeep Singh Bedi Consultant Obstetric & Gynacologist Kajang Hospital Dr Huzaimi Yaakob Consultant Surgeon Malacca Hospital Dr Safiah Bahrin Assistant Director Family Health Development Division Ministry of Health Malaysia Dr Nordiana Hassan Assistant Director State Health Department Terengganu Dr Khairani Omar Family Medicine Specialist National University Malaysia Dr Zaiton Ahmad Family Medicine Specialist Sri Kembangan Health Clinic Dr Junaidah Sabirin Health Officer Kuala Langat District Health Officer Project Coordinators Dr Rusilawati Jaudin Principal Assistant Director Health Technology Assessment Unit Ministry of Health Malaysia iv Ms Bebi Kavundianan Nursing Officer Health Technology Assessment Unit Ministry of Health Malaysia Review and Updated by Ms Sin Lian Thye Nursing Officer Health Technology Assessment Unit Ministry of Health Malaysia Review and edited by Dr S Sivalal Head, Health Technology Assessment Unit Deputy Director Medical Development Division v TABLE OF CONTENTS EXECUTIVE SUMMARY i LIST OF EXPERT COMMITTEE iii TABLE OF CONTENTS iv 1. BACKGROUND 1 2. INTRODUCTION 1 2.1 Use of ultrasound in antenatal care 1 2.2 Use of Ultrasound in Gynaecological Care 2 2.3 Use of Ultrasound in Surgical Settings 2 3. OBJECTIVE 2 4. METHODOLOGY 2 5. TECHNICAL FEATURES 2 5.1 3D Ultrasound Imaging 3 5.2 Doppler Ultrasound 3 6. RESULTS AND DISCCUSION 3 6.1 Safety 3 6.2 Effectiveness 4 6.2.1 Use of ultrasound in antenatal care 4 Dating of pregnancy 4 Viability of foetus 4 Multiple pregnancies 4 Detection of intrauterine growth restriction 5 Location of placenta 5 Congenital abnormalities 6 Sensitivity and specificity of ultrasound screening 6 Use of ultrasound to detect major and minor 6 abnormalities Use of ultrasound in detection of cardiac anomalies 7 Use of ultrasound in detection of CNS abnormalities 7 Use of ultrasound in detection of Downs Syndrome 7 Use of ultrasound for detection of abdominal wall 7 defects Use of ultrasound for detection of other abnormalities 7 Use of trans-vaginal ultrasound in antenatal care 8 Use of trans-vaginal ultrasound in detection of 8 abnormalities Use of trans-vaginal ultrasound in detection of retained 8 products of conception Use of trans-vaginal ultrasound in improving perinatal 8 outcome Use of trans-vaginal ultrasound in prediction of 9 preterm delivery 6.2.2 Use of ultrasound in Gynaecology 10 Ectopic pregnancy 10 Ovarian cancer 12 Endometrial polyps 12 Uterine abnormalities 13 vi Adnexal massses 13 6.2.3. Use of Ultrasound in Surgery. 13 Use of Ultrasound In Abdominal Trauma 13 Use of Ultrasound in Appendicitis 15 Use of Ultrasound in Breast 16 Use of Ultrasound in Gall bladder 18 Use of Ultrasound in Thyroid 19 Use of Ultrasound in Urology 19 Use of Ultrasound in Orthopaedics 19 Use of Ultrasound in Congenital Hip Dysplasia 20 Use of Ultrasound in diagnosis of Intussusception 20 6.3. Training 20 6.4 Cost implications 21 6.4.1 Antenatal screening 21 6.4.2 Trauma 22 6.4.3 Acute abdomen 22 6.4.4 Congenital dislocation of hip 22 6.5 Ethical implications 23 6.5.1 Competence and Referral 23 6.5.2 Disclosure 23 6.5.3 Confidentiality 23 6.5.4 Routine Screening 23 6.6 Legal Aspects of Ultrasound 23 6.6.1 Source of Litigation 23 6.6.2 Safe practice 24 6.6.3 Departmental protocols 24 6.6.4 Interpretation of measurements 24 6.6.5 Suspected abnormalities 24 6.6.6 Diagnostic ultrasound 24 7. CONCLUSION 25 7.1 Safety 25 7.2 Effectiveness 25 7.2.1 Use of ultrasound in antenatal care 25 7.2.2 Use of ultrasound in Gynaecology 25 7.2.3 Use of Ultrasound in Surgery 25 7.3 Training 25 7.4. Cost implications 25 7.4 Ethical implications 25 7.5 Legal Aspects of Ultrasound 25 8. RECOMMENDATIONS 25 Evidence Table 26 Appendix 1 : Details of Literature Search 178 Appendix 2: Level of Evidence Scale 180 vii 1. BACKGROUND Deleted: and as an accepted diagnostic tool Ultrasound has been used for diagnostic purposes for more than 20 years in almost all branches Deleted: is of medicine. Ultrasonography has been widely accepted due to its clinical usefulness, Deleted: ance convenience and non-invasiveness, as well as fetal biometry and detection of fetal anomalies. In Deleted: nd addition, the newer ultrasound techniques like Doppler waveforms are used for fetal echography, Deleted: . W uterine and fetal blood flow (Reece at al, 1990). The use of ultrasound as an effective diagnostic Deleted: the modality therefore continues to increase worldwide. Improvements in resolution and image Deleted: s quality, and in grey scale, have further enhanced its usefulness, while the advent of endovaginal and transrectal ultrasound examinations; allow direct access to anatomical structures without Deleted: s interference from overlying abdominal organs that occur in trans-abdominal ultrasound. Deleted: s Deleted: have the In addition, the development of specialised applications like color flow monitoring has the Deleted: i potential to increase the diagnostic effectiveness of ultrasound. However, it has become evident Deleted: ity that there has been an associated trend toward the use of equipment or machines with greater Deleted: R power outputs. Modern ultrasound equipment is capable of emitting acoustic power at levels that Deleted: it are sufficient to produce measurable effects in biological tissue (Barnett et al, 1994). In recent Deleted: s years there have been serious concerns that diagnostic applications of ultrasound may produce Deleted: ly significant biological effects. The most sensitive target for ultrasound induced biological effects Deleted: sidered is the central nervous system of the developing embryo and foetus. As the bone develops so does the