Routine 18-Week Ultrasound Exam Without Informed Consent
Routine 18-week Ultrasound Exam (18wUSE): Accurately Average Fetuses Required
On the day of the routine 18-week ultrasound exam (18wUSE), NCFM eSnurra Group's eSnurra "method" (i.e., the plagiarized, misused Hutchon Method of PDEE) assumes all fetuses are:
However, Laila's combined, fully corroborating, factual LMPD/OTPD/SCID did not rely on her fetus/baby being"accurately average" in size, accurately average in growth velocity or accurately average in head shape. Ironically, Laila's midwife and doctor used Laila's factual LMPD to establish her pregnancy's GA in order to schedule Laila's routine 18wUSE, but directly after the scheduling of the ultrasound exam, Laila's combined, fully corroborating, factual LMPD/OTPD/SCID and all her other key pregnancy dates were summarily obviated from all medical evidence in accordance with Directorate of Health's knowledge-obviated, medically & ethically flawed 2014 Recommendation (i.e., national medical policy) with their exclusive implementation of NCFM eSnurra Group's "method" within a government-mandated protocol of evidence-obviated medicine, all without Laila's prior, informed, voluntary, explicit consent. All of Laila's factual, key pregnancy dates were obviated from all medical evidence and any and all consideration in the practice of evidence-based medicine.
Background: 18wUSE: Trojan Horse for Evidence-obviated Medicine
The Directorate of Health's 2014 Recommendation with their exclusive NCFM eSnurra implementation corrupted the routine 18wUSE in order to implement a government-mandated protocol of evidence-obviated medicine to ensure suboptimal, unilateral ultrasound-based estimates of EDD and, therefrom, calculations of GA using the equivalent of Naegele's rule, in reverse, for all pregnancies and abortions in Norway. Laila & Edward did not know, nor had they ever been informed, the 18wUSE was completely optional and voluntary. This was only learned via research efforts by Laila and Edward, as it was never disclosed. Also, Laila & Edward were never informed one of the primary purposes of the routine 18wUSE was to replace any first-trimester ultrasound-based GA & EDD values and to replace Laila's combined, fully corroborating, factual LMPD/OTPD/SCID-based GA & EDD values with a grossly inaccurate NCFM eSnurra BPD-based EDD and, therefrom, a calculated, grossly inaccurate GA using the equivalent of Naegele's rule, in reverse.
Following is some background on Directorate of Health's 2004 publication: "Guidelines for using ultrasound in pregnancy, Use of ultrasound in the general pregnancy care and in connection with fetal diagnosis" ("Veiledende retningslinjer for bruk av ultralyd i svangerskapet, Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.])
Directorate of Health's 2004 publication: "Guidelines for the use of ultrasound in pregnancy: Use of ultrasound in the general pregnancy care and in connection with obstetric diagnosis" ("Veiledende retningslinjer for bruk av ultralyd i svangerskapet: Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.]) states the routine 18-week ultrasound "is part of the general pregnancy check" and that"the woman shall have information on the purpose and content of the ultrasound examination." However, there is nothing in this document that states or implies the routine 18-week ultrasound exam is optional and voluntary; and, the only mention of consent is with respect to it being made clear that consent is not required (see excerpt below). Interestingly, the no consent required was "emphasized" in the very last sentence of the publication, the literal bottom line.
Interestingly, Directorate of Health's Website states that the midwife or doctor should "assess gestational age" at the 18wUSE which, of course, is very different than the assessment of term. In the excerpt below from Directorate of Health's Website there is no mention of either estimating or calculating term. This is decidedly strange, as it would appear Directorate of Health have switched from their 2014 Recommendation's policy of direct estimation of term via the exclusive use of NCFM eSnurra Group's "method" (i.e., the appropriated, plagiarized, misused Hutchon Method of PDEE) to a policy focused on gestational age via Naegele's rule, but in reverse. Or, possibly, this new focus on gestational age is the result of confusion within Directorate of Health. For contrast, compare the excerpt below with "1.2 Ultrasound Survey in General Pregnancy Care" above. Again, NCFM eSnurra's "method" estimates the number of days remaining to birth/delivery from the date of the routine 18wUSE, thereby directly estimating term (or EDD) and, therefrom calculating gestational age (indirectly) using the equivalent of Naegele's rule, but in reverse.
Informed Consent Reaffirmed by American College of Obstetricians and Gynecologists
The American College of Obstetricians and Gynecologists's Committee on Ethics reaffirmed Informed Consent: ACOG Committee Opinion Number 439.
Information & Informed Consent
Included below are excerpts from Directorate of Health's May 2005 National Academic Guidelines: Guidelines for Pregnancy Care, IS-1179 (Nasjonal faglig retningslinje for svangerskapsomsorgen). These excerpts demonstrate there has been much talk about ensuring a pregnant woman is provided with the information needed to make an informed decision or choice with respect to the routine 18-week ultrasound exam, but the fact is informed consent was neither requested by Laila's medical professionals nor was informed consent given by Laila. Moreover, informed consent is not possible without full disclosure of deceptively hidden conditions, implications, risks and consequences. Therefore, and with respect to informed consent, Directorate of Health talk-the-talk but they most definitely do not walk-the-walk.
First-trimester vs. Second-trimester Ultrasound
Moreover, Laila was not informed that since she had an ultrasound exam in her first trimester, that "there does not seem to be important differences between ultrasound in the first or second trimester with respect to term." Which means there was no medical need for NCFM eSnurra to replace GA & EDD values from her first-trimester ultrasound exam with the second-trimester GA & EDD values from the 18wUSE. That alone might have saved Laila from an unwanted, unnecessary Cesarean section surgery delivery, etc. Also, the BPD-based eSnurra EDD & GA from the first ultrasound exam on 10.08.2016 (or LMPD/OTPD/SCID-based GA = 13w+2) showed BPD-based eSnurra GA = 12w+3, lagging Laila's LMPD/OTPD/SCID-based GA by 0w+6 or 6 days and CRL-based eSnurra GA = 12w+0 , lagging Laila's LMPD/OTPD/SCID-based GA by 1w+2 or 9 days. Moreover, BPD-based eSnurra EDD = 20.02.2017 and CRL-based eSnurra EDD = 25.02.2017. So, if the BPD-based NCFM eSnurra EDD from Laila's first ultrasound exam had been used as Laila's "official" eSnurra EDD, the prediction error would have been (predicted (set to 0) - actual) = (02.20.2017 - 04.02.2017) = -16 days, or 2w+2. However, the first ultrasound exam NCFM eSnurra BPD-based EDD was only lagging Laila's LMPD/OTPD/SCID-based EDD of 14.02.2017 by 6 days, well under the umbrella of normal variance of Laila's LMPD/OTPD/SCID-based EDD. Consequently, if Laila's 18wUSE had not taken place, Laila's baby would have been routinely turned from breech to vertex before Laila went into labor. Also, and given that Laila had an NCFM eSnurra GA & EDD assigned to her pregnancy at her first ultrasound exam on 10.08.2016, this first NCFM eSnurra GA & EDD should never have been replaced with the eSnurra GA & EDD from her 18wUSE of 23.09.2016 when fetal metrics and their measurements presented greater random fetal growth velocity variances.
Laila & Edward were told the 18wUSE was important, necessary and part of regular pregnancy care. Laila & Edward were also informed that Trondheim had been notified to schedule Laila. Laila was never "offered" the 18wUSE as an optional, voluntary examination. On the contrary, she was informed the 18wUSE was important, necessary and that the scheduling of same had been ordered and that Trondheim (St. Olavs Hospital) would contact her with her appointment date. These were not words which communicated "completely optional" or "completely voluntary." In short, Laila was never informed the routine 18wUSE was optional and voluntary. Laila was never informed that with respect to her first-trimester ultrasound, "there does not seem to be important differences between ultrasound in the first or second trimester with respect to term." Laila was never informed of the true purpose of the routine 18wUSE relative to her first-trimester ultrasound exam and that the GA & EDD values of her first ultrasound exam and her own LMPD/OTPD/SCID-based GA & EDD values. Moreover, the NOKC report concludes the 18wUSE "...has a high uptake which indicates that women are in favor of it" is completely spurious. Also spurious in the same report was NOKC's statement: "Recent studies indicate that women are well informed about routine ultrasound in pregnancy, but there are challenges related to informing about nuchal translucency (NT) and serum markers." These statements are not only spurious, they are laughable, as there is no evidence to support these statements and conclusions, i.e., with the possible exception of "nuchal translucency (NT) and serum markers." Specifically, there is no evidence women are:
If Laila was representative of how the allegedly "optional" and "voluntary" status of the 18wUSE is communicated to women in Norway, and there is a plethora of evidence to support Laila was representative, then the "high uptake" stated in the NOKC report (first excerpt above) is supported by evidence that most women were not, and are not, "given both written and verbal information in advance about the purpose of the ultrasound examination." Consequently, Norway's women are not fully informed of the purpose, conditions, obligations, implications, risks and consequences of the routine 18wUSE before the scheduling and execution of same.
However, and on the face of it, the 18wUSE appeared to be a good opportunity to collect medical evidence of fetal health, position, development and potential anomalies. So, right as Laila & Edward were feeling positive about the 18wUSE, the insidious, systemic, institutionalized problem which had been intentionally and deceptively hidden emerged. The 18wUSE had been used as a Trojan horse for Directorate of Health's knowledge-obviated, medically & ethically flawed 2014 Recommendation with their exclusive implementation of NCFM eSnurra Group's "method" within a government-mandated protocol of evidence-obviated medicine. The purpose of which was, and is, to take total control of estimating EDD and, therefrom, calculating GA using the equivalent of Naegele's rule, in reverse, for Laila's pregnancy (and all pregnancies and abortions in Norway), despite the existence of contradicting medical evidence of known, proven efficacy which, for Laila, was her combined, fully corroborating, factual LMPD/OTPD/SCID. By having been deceived about the true intent, conditions, obligations, implications, risks and consequences of the routine 18wUSE, all of Laila's key, factual pregnancy dates (i.e., LMPD, OTPD, SCID, MPMD, PTPD, menstrual cycle/period regularity, etc.) were obviated from all medical evidence and from any and all consideration in medical thinking, medical decision-making and medical actions for the duration of her pregnancy, and beyond, all the way into Laila's baby's medical birth record at the Medical Birth Registry of Norway (MBRN). This is insidious, systemic, institutionalized problem is the direct result of Directorate of Health's knowledge-obviated, medically & ethically flawed 2014 Recommendation with their exclusive implementation of NCFM eSnurra Group's "method".
Become Informed: Then Just Say No! to Unnecessary Risks, Mistakes & Harms
If Norway's women want to reduce their risks of having an unnecessary, unwanted breech delivery or Cesarean section surgery delivery, or a baby with an unidentified, prolonged, undiagnosed, untreated FGR/malformation, or if Norway's women want to have their pregnancies tracked, managed and scheduled according to their factual, key pregnancy dates, such as a combined, fully corroborating, factual LMPD/OTPD/SCID-based GA & EDD, or just a factual OTPD-based GA & EDD, then Norway's women should just say no to the highly promoted, Trojan horse that is the routine 18wUSE which imposes, without a pregnant woman's prior, informed, voluntary, explicit consent, a government-mandated protocol of evidence-obviated medicine; a protocol proven to cause increased medical risks, critical medical mistakes and grievous medical harms (including perinatal death), unnecessarily, to some of Norway's women and their fetuses/babies. Laila wishes she had known the 18wUSE was optional and voluntary, and Laila wishes she had known of the undisclosed, deceptively hidden conditions, risks and consequences of the 18wUSE, because if Laila had been so informed, she would have just said no!
Norway's Health Personnel Act vs. Routine 18-week Ultrasound Exam
The routine 18-week ultrasound exam is marketed and heavily promoted by Directorate of Health and healthcare professionals employed by the government without full disclosure of all the hidden conditions, implications, risks and consequences to pregnant women. Moreover, Directorate of Health in conjunction with NCFM eSnurra Group do not comply with Norway's Health Personnel Act regarding the marketing of health and care services which, in this case, includes the routine 18-week ultrasound exam and the assignment of EDD & GA to pregnancies and abortions.
"Health Personnel Act & Marketing (e.g., ultrasound services)
Norway's Patient & User Rights Act & The Right to Participation and Information
Norway's Patient & User Rights Act & Consent to Health Care
Included below are Sections 4-1 & 4-2 of Chapter 4 of Norway's Patients' Rights Act [English] or Lov om pasient- og brukerrettigheter (pasient- og brukerrettighetsloven). These 2 Sections define patient consent. The Section headings for Sections 4.3 - 4.9 are also included for the purpose of demonstrating these Sections exist but do not apply to Laila's case. Interestingly, Section 4-1, para. 2, (below) empowers a patient to withdraw consent; however, in Laila's case, Laila never gave consent to the hidden, knowledge-obviated, medically & ethically flawed terms and conditions which comprise the routine 18-week ultrasound exam. Laila and Edward argued, vociferously, against using the erroneous, grossly inaccurate NCFM eSnurra BPD-based EDD & GA values instead of Laila's accurate, combined, fully corroborating, factual LMPD/OTPD/SCID-based EDD & GA for all medical thinking, medical decision-making and medical actions for Laila's pregnancy. Consequently, because Laila never gave consent, Section 4-1, para. 2 may not apply in Laila's case. However, Section 4-1, para. 1 most definitely does apply to Laila's case. Therefore, a discussion of legal theory and case law on this point would make for interesting reading and an even more interesting judicial decison.
Sweden, Autonomy Principle & Routine Ultrasound Examination During Pregnancy
The Principles of Biomedical Ethics by Beauchamp and Childress, first published in 1979, now in its 7th edition, presented 4 generally accepted medical ethical principles:
American College of Physicians Ethics Manual: Sixth Edition
Included below is an excerpt from the American College of Physicians Ethics Manual: Sixth Edition. The entirety of this manual is available via the links included below. It is interesting to note the ACP Ethics Manual has identifies the same 4 medical ethical principles above, it also contains 43 occurrences of the word "consent" and 16 occurrences of the 2-word sequence "informed consent."
Other Nordic Counties
An effort was made to determine if other Nordic countries had the same ethical issues as Norway with respect to securing valid, prior, informed, voluntary, explicit consent from pregnant women for the routine 18-week ultrasound exam. It was learned Sweden's Statens beredning för medicinsk och social utvärdering (SBU) (The state's preparation for medical and social evaluation), which appears to be the equivalent of Norway's National Knowledge Center for the Health Services (NOKC), authored the report "Rutinmässig ultraljudsundersökning under graviditet" ("Routine ultrasound examination during pregnancy") which confirmed women in Sweden had received inadequate information about the routine 18-week ultrasound exam and, therefore, women in Sweden were not able to provide valid, informed consent. The Swedish report, prepared by SBU, specifically cited the requirements of the medical ethical "autonomy principle" as problematic with respect to the routine 18-week ultrasound exam. And, the same is true for the women of Norway, as there is no evidence the "autonomy principal" or any other principle of medical ethics was applied in Laila's case,or the cases of other women in Norway.
On the day of the routine 18-week ultrasound exam (18wUSE), NCFM eSnurra Group's eSnurra "method" (i.e., the plagiarized, misused Hutchon Method of PDEE) assumes all fetuses are:
- accurately average in size for their gestational age,
- accurately average in growth velocity and
- accurately average in head shape, because NCFM eSnurra Group continues to promote and use the problematic, unreliable, 1-dimensional biparietal diameter (BPD) instead of the more robust 2-dimensional head circumference (HC) to estimate EDD and, therefrom, calculate GA, using the equivalent of Naegele's rule, in reverse
However, Laila's combined, fully corroborating, factual LMPD/OTPD/SCID did not rely on her fetus/baby being"accurately average" in size, accurately average in growth velocity or accurately average in head shape. Ironically, Laila's midwife and doctor used Laila's factual LMPD to establish her pregnancy's GA in order to schedule Laila's routine 18wUSE, but directly after the scheduling of the ultrasound exam, Laila's combined, fully corroborating, factual LMPD/OTPD/SCID and all her other key pregnancy dates were summarily obviated from all medical evidence in accordance with Directorate of Health's knowledge-obviated, medically & ethically flawed 2014 Recommendation (i.e., national medical policy) with their exclusive implementation of NCFM eSnurra Group's "method" within a government-mandated protocol of evidence-obviated medicine, all without Laila's prior, informed, voluntary, explicit consent. All of Laila's factual, key pregnancy dates were obviated from all medical evidence and any and all consideration in the practice of evidence-based medicine.
- "We have the impression that users of the Trondheim method [NCFM eSnurra] have been routinely using the 18-week routine measurements to calculate the pregnancy term and overrule any fetal age determination based on known time of ovulation, in-vitro fertilisation or first-trimester ultrasound." (Source: "Flawed recommendation issued by the Norwegian Directorate of Health concerning the determination of fetal age", Nr. 8, 5 mai 2015, Tidsskr Nor Legeforen, 2015; 135:7401, DOI: 10.4045/tidsskr.15.0093)
Background: 18wUSE: Trojan Horse for Evidence-obviated Medicine
The Directorate of Health's 2014 Recommendation with their exclusive NCFM eSnurra implementation corrupted the routine 18wUSE in order to implement a government-mandated protocol of evidence-obviated medicine to ensure suboptimal, unilateral ultrasound-based estimates of EDD and, therefrom, calculations of GA using the equivalent of Naegele's rule, in reverse, for all pregnancies and abortions in Norway. Laila & Edward did not know, nor had they ever been informed, the 18wUSE was completely optional and voluntary. This was only learned via research efforts by Laila and Edward, as it was never disclosed. Also, Laila & Edward were never informed one of the primary purposes of the routine 18wUSE was to replace any first-trimester ultrasound-based GA & EDD values and to replace Laila's combined, fully corroborating, factual LMPD/OTPD/SCID-based GA & EDD values with a grossly inaccurate NCFM eSnurra BPD-based EDD and, therefrom, a calculated, grossly inaccurate GA using the equivalent of Naegele's rule, in reverse.
Following is some background on Directorate of Health's 2004 publication: "Guidelines for using ultrasound in pregnancy, Use of ultrasound in the general pregnancy care and in connection with fetal diagnosis" ("Veiledende retningslinjer for bruk av ultralyd i svangerskapet, Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.])
- "In January 2004, the Directorate of Health and Social Affairs was commissioned by the Ministry to develop draft guidelines for the use of ultrasound in general pregnancy care and in connection with obstetric diagnosis. The Ministry specifically asked that the guidelines clarify what ultrasound in pregnancy care should entail and what distinguishes this from ultrasound in fetal diagnostic purposes." (Source: "Veiledende retningslinjer for bruk av ultralyd i svangerskapet: Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" Sosial – og helsedirektoratet, IS-23/2004. [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.]) [Reference: Innst. S. nr. 250 (2003–2004) Innstilling til Stortinget fra finanskomiteen St.prp. nr. 63 (2003–2004), Innstilling fra finanskomiteen om tilleggsbevilgninger og omprioriteringer i statsbudsjettet medregnet folketrygden 2004. p. 131-133.
"The Ministry further pointed out that it was very important the academic communities in the country were included in the work on the guidelines. With this in mind, the Directorate established a working group to assist in drafting guidelines for the use of ultrasound: Professor Sturla Eik-Nes, National Center for Fetal Medicine, St. Olavs Hospital, Trondheim; Sectional Officer Guttorm Haugen, Women's Clinic, National Hospital, Oslo; Midwife Anne Kaasen, Department of Social Sciences, University of Bergen; Head of Department Jon Tuveng, Women's Child Department, Ringerike Hospital HF, Hønefoss; Secretariat: Anne Forus, Ingunn Myklebust and Sølvi Taraldsen, Department of Specialist Health Services, Directorate of Health and Social Affairs." (Source: ibid.)
"The Directorate submitted its proposal for guidelines to the Ministry in April 2004. The Ministry undertook only minor, outline changes in the draft and the guidelines were incorporated into the revised National Budget 2004. Based on Chapter 2790 Other matters - the Biotechnology Act - Ultrasound Guidelines for Revised National Budget 2004 3, the Social Committee presented the following proposals 4: - "The Parliament agrees with the guidelines for the use of ultrasound in pregnancy care, and indicates that the following are covered by the guidelines for ultrasound examinations in general pregnancy care:
- Routine examinations in weeks 17-19.
- Ultrasound examinations on medical indications.
- Ultrasound examinations beyond this are an option for women both before and after the routine pregnancy examination, but such examinations will not be justified by medical science and therefore are not eligible for reimbursement
- A majority of the Parliament agreed with the committee's recommendation. In Chapter 1 of this circular the Guidelines are reproduced the way they were laid down after treatment in the Parliament. Chapter 2 provides supplementary notes to individual points." (Source: ibid.)
Directorate of Health's 2004 publication: "Guidelines for the use of ultrasound in pregnancy: Use of ultrasound in the general pregnancy care and in connection with obstetric diagnosis" ("Veiledende retningslinjer for bruk av ultralyd i svangerskapet: Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.]) states the routine 18-week ultrasound "is part of the general pregnancy check" and that"the woman shall have information on the purpose and content of the ultrasound examination." However, there is nothing in this document that states or implies the routine 18-week ultrasound exam is optional and voluntary; and, the only mention of consent is with respect to it being made clear that consent is not required (see excerpt below). Interestingly, the no consent required was "emphasized" in the very last sentence of the publication, the literal bottom line.
- "2.3 Requirements for written consent in the field of fetal diagnostic examination
When using ultrasound examinations in connection with fetal diagnostics, section 4-3 of the Biotechnology Act stipulates that written consent shall be obtained from the person being examined:
"Before fetal diagnostics, cf. § 4-1, the person to be examined must give written consent".
It is emphasized that this does not apply to ultrasound examinations on medical indication or routine examination in weeks 17-19." (Source: ibid., p. 12.)
"2.3 Krav om skriftlig samtykke ved fosterdiagnostisk undersøkelse Når ultralydundersøkelser benyttes i forbindelse med fosterdiagnostikk følger det av bioteknologiloven § 4-3 at det skal innhentes skriftlig samtykke fra den som undersøkes:
”Før fosterdiagnostikk, jf. § 4-1 foretas, må den som skal undersøkes, gi skriftlig samtykke”.
Det presiseres at dette ikke gjelder for ultralydundersøkelser på medisinsk indikasjon eller rutineundersøkelsen i uke 17-19."
- 1.2 Ultrasound Survey in General Pregnancy Care
1.2.1 Guidelines
1. Routine Survey in Week 17-19 and Ultrasound Examinations on Medical indication are part of the general pregnancy check and is not considered as a fetus diagnosis.
2. The purpose of the routine survey in weeks 17-19 is to establish the term, the number of fetuses, placenta's location and to conduct an orientation study of the fetus's development and anatomy.
3. Before the ultrasound examination in weeks 17-19, the woman shall have information on the purpose and content of the ultrasound examination. (Source: "Veiledende retningslinjer for bruk av ultralyd i svangerskapet, Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" Sosial – og helsedirektoratet, IS-23/2004 [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.])
- "Dear Reader! This short version of the national clinical guideline for antenatal care has been produced for midwives, doctors and other health care personnel who are involved with antenatal care. The aim is that all health care personnel shall have knowledge about and a common understanding of what the services consist of. Antenatal care is a unique part of the health services. It includes all antenatal checkups, measures and referrals that are required during a normal pregnancy. ..... The Directorate for Health and Social Affairs looks forward to doctors, midwives and others who are directly involved with antenatal care implementing this clinical guideline in their practice." p. 3
- "Up to and including the 40th week of pregnancy, a basic programme of eight check-ups is recommended. This includes an ultrasound examination between the 17th and 19th weeks." p. 9
- "2.5 Ultrasound examination during pregnancy
It is recommended that pregnant women should be offered an ultrasound examination between the 17th and 19th weeks of pregnancy, in order to determine the expected date of delivery. [A]" p. 10
[A] Requires the support of evidence that is based on systematic review and meta-analysis of randomized controlled trials or at least one randomized controlled trial. (Evidence categories 1a and 1b)
Level 1 a: Evidence that is based on systematic review and meta-analysis of randomized controlled trials.
Level 1 b: Evidence that is based on at least one randomized controlled trial." - "The following things should be checked during the same examination: the number of fetuses, the position of the placenta and the anatomy of the fetus. [D]" p. 10
[D] Requires the support of expert committee reports or opinions and/or clinical experience of respected authorities. (Evidence category 4)
Level 4: Evidence obtained from expert committee reports or opinions, and/or clinical experience of respected authorities." - "Pregnant women should be given both written and verbal information in advance about the purpose of the ultrasound examination. They should also be informed that the examination is voluntary. √" p. 10
√ Recommendations for practice based on the clinical experience of the group that has developed the guideline." - "Routine ultrasound examination is the best method for determining the expected date of delivery. [B] p. 10
[B] Requires the support of evidence from at least one well-designed controlled study without randomization, or at least one other type of well-designed quasi-experimental study. (Evidence categories 2a and 2b)
Level 2 a: Evidence that is based on at least one well-designed controlled study without randomization.
Level 2 b: Evidence that is based on at least one other type of well-designed quasi-experimental study."
[Note: "It is concluded that ultrasound measurement of the biparietal diameter between 15 and 22 weeks of pregnancy is the best method for estimation of the day of delivery and should be used as a routine procedure." p. 178 (Source: A comparison between ultrasound and a reliable last menstrual period as predictors of the day of delivery in 15,000 examinations., Tunón K, Eik-Nes SH, Grøttum P., Ultrasound Obstet Gynecol. 1996 Sep;8(3):178-85.)] - "Guideline for the use of ultrasound during pregnancy.
Use of ultrasound in normal antenatal care and fetal diagnostics. IS 23/2004
Information about ultrasound during pregnancy. IS 1228B.
These brochures can be ordered from the Directorate for Health and Social Affairs, Norway.
The brochures are not available in English." p. 10
- Ultrasound examination in pregnancy
All pregnant women are offered an ultrasound examination in pregnancy week 17-19 to determine the term. At the same examination, midwife or doctor should look for the number of fetuses, placenta placement and an orientation of the fetus's anatomy. Routine ultrasound is the best method for determining the term. Midwife or doctor must inform in advance the purpose of the examination, both in writing and verbally, and that the examination is voluntary.
Ultralydundersøkelse i svangerskapet
Alle gravide får tilbud om ultralydundersøkelse i svangerskapsuke 17–19 for å bestemme termin. Ved den samme undersøkelsen skal jordmor eller lege se etter antall fostre, morkakens plassering og en orienterende undersøkelse av fosterets anatomi. Rutineultralyd er den beste metoden for terminbestemmelse. Jordmor eller lege skal på forhånd informere om hensikten med undersøkelsen både skriftlig og muntlig, samt om at undersøkelsen er frivillig.
(Source: Directorate of Health's Website: https://helsedirektoratet.no/folkehelse/graviditet-fodsel-og-barsel/graviditet-og-svangerskap/screening-og-rutineundersokelser-i-svangerskapet, "Sist faglig oppdatert: 25. januar 2018")
- There are several routine examinations during pregnancy. Midwife or general practitioner shall inform the background of the examinations. The information should be written and verbal.
(Det er flere rutineundersøkelser i løpet av svangerskapet. Jordmor eller allmennlege skal informere om bakgrunnen for undersøkelsene. Informasjonen bør være skriftlig og muntlig.) (Source: Directorate of Health's Website: https://helsedirektoratet.no/retningslinjer/nasjonal-faglig-retningslinje-for-svangerskapsomsorgen)
- "eSnurra as a method of calculating pregnancy length and term
The Directorate of Health recommends using one method, eSnurra, for the calculation of pregnancy length and term (letter of December 2014, PDF). eSnurra is the best research-based method, and the most precise tool for evaluation of the term and duration of pregnancy. When using eSnurra, overtime (294 days) will occur 11 days over the estimated term date.
(eSnurra om metode for beregning av svangerskapslengde og termin
Helsedirektoratet anbefaler å bruke én metode, eSnurra, for beregning av svangerskapslengde og termin (brev av desember 2014, PDF). eSnurra er den beste forskningsbaserte metoden, og det mest presise av verktøy for vurdering av termin og svangerskapslengde. Ved bruk av eSnurra vil overtid (294 dager) inntreffe 11 dager over beregnet termindato.)
The use of one method nationally ensures abortion-seeking women similarity under the law (avoiding geographical variations), will give a similar assessment of prematurity and unambiguous assessment of overtime pregnancies.
(Bruk av én metode nasjonalt sikrer abortsøkende kvinner likhet for loven (unngår geografiske variasjoner), vil gi lik vurdering av prematuritet og entydig vurdering av overtidige svangerskap.)
eSnurra as a national tool is readily available as a plastic wheel, mobile and tablet app and an open available web version (esnurra.no).
(eSnurra som nasjonalt verktøy er lett tilgjengelig som et plasthjul, app for mobil og nettbrett og en åpen tilgjengelig webversjon (esnurra.no). )
After making traditional ultrasound measurements of the head and thighbone, the data can be used in all modern ultrasound machines."
(Etter å ha gjort tradisjonelle ultralydmålinger av hode og lårbein, kan dataene brukes i alle moderne ultralydmaskiner.)
(Source: Directorate of Health's website: https://helsedirektoratet.no/folkehelse/graviditet-fodsel-og-barsel/graviditet-og-svangerskap/overtidige-svangerskap ; Sist faglig oppdatert: 25. januar 2018 [accessed 10.03.2018])
Interestingly, Directorate of Health's Website states that the midwife or doctor should "assess gestational age" at the 18wUSE which, of course, is very different than the assessment of term. In the excerpt below from Directorate of Health's Website there is no mention of either estimating or calculating term. This is decidedly strange, as it would appear Directorate of Health have switched from their 2014 Recommendation's policy of direct estimation of term via the exclusive use of NCFM eSnurra Group's "method" (i.e., the appropriated, plagiarized, misused Hutchon Method of PDEE) to a policy focused on gestational age via Naegele's rule, but in reverse. Or, possibly, this new focus on gestational age is the result of confusion within Directorate of Health. For contrast, compare the excerpt below with "1.2 Ultrasound Survey in General Pregnancy Care" above. Again, NCFM eSnurra's "method" estimates the number of days remaining to birth/delivery from the date of the routine 18wUSE, thereby directly estimating term (or EDD) and, therefrom calculating gestational age (indirectly) using the equivalent of Naegele's rule, but in reverse.
- "Routine ultrasound in pregnancy week 17-19 (second control)
At the ultrasound examination, midwife or doctor should:
- assess gestational age
- identify number of fetuses
- identify location of placenta
- identify structural anomalies."
("Rutineultralyd i svangerskapsuke 17–19 (andre kontroll)
Ved ultralydundersøkelsen skal jordmor eller lege:
- vurdere gestasjonsalder
- identifisere flerlinger
- identifisere morkakens beliggenhet
- identifisere strukturelle anomalier.")
(Source: Directorate of Health's website: https://helsedirektoratet.no/folkehelse/graviditet-fodsel-og-barsel/graviditet-og-svangerskap/overtidige-svangerskap; Sist faglig oppdatert: 25. januar 2018 [accessed 10.03.2018])
- 1.2 Ultrasound Survey in General Pregnancy Care
1.2.1 Guidelines
"2. The purpose of the routine survey in weeks 17-19 is to establish the term, the number of fetuses, placenta's location and to conduct an orientation study of the fetus's development and anatomy.
(2. Formålet med rutineundersøkelsen i uke 17–19 er å bestemme termin, antall fostre, placentas beliggenhet og å gjøre en orienterende undersøkelse av fosterets utvikling og anatomi.) (Source: "Veiledende retningslinjer for bruk av ultralyd i svangerskapet, Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" Sosial – og helsedirektoratet, IS-23/2004. [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.])
Informed Consent Reaffirmed by American College of Obstetricians and Gynecologists
The American College of Obstetricians and Gynecologists's Committee on Ethics reaffirmed Informed Consent: ACOG Committee Opinion Number 439.
- "ABSTRACT: Obtaining informed consent for medical treatment, for participation in medical research, and for participation in teaching exercises involving students and residents is an ethical requirement that is partially reflected in legal doctrines and requirements. As an ethical doctrine, informed consent is a process of communication whereby a patient is enabled to make an informed and voluntary decision about accepting or declining medical care. In this Committee Opinion, the American College of Obstetricians and Gynecologists' Committee on Ethics describes the history, ethical basis, and purpose of informed consent and identifies special ethical questions pertinent to the practice of obstetrics and gynecology. Two major elements in the ethical concept of informed consent, comprehension (or understanding) and free consent, are reviewed. Limits to informed consent are addressed."(Source: Informed Consent: ACOG Committee Opinion Number 439, August 2009, Reaffirmed 2015, Committee on Ethics. The American College of Obstetricians and Gynecologists, Women's Health Care Physicians)
Information & Informed Consent
Included below are excerpts from Directorate of Health's May 2005 National Academic Guidelines: Guidelines for Pregnancy Care, IS-1179 (Nasjonal faglig retningslinje for svangerskapsomsorgen). These excerpts demonstrate there has been much talk about ensuring a pregnant woman is provided with the information needed to make an informed decision or choice with respect to the routine 18-week ultrasound exam, but the fact is informed consent was neither requested by Laila's medical professionals nor was informed consent given by Laila. Moreover, informed consent is not possible without full disclosure of deceptively hidden conditions, implications, risks and consequences. Therefore, and with respect to informed consent, Directorate of Health talk-the-talk but they most definitely do not walk-the-walk.
- "3.1 A Special Challenge
Pregnancy checks are not fundamentally different from other primary health care consultations. But the controls - especially the first meeting - have some characteristics that are challenging for midwives or physicians: You should provide a lot of information, so that the woman can make a variety of informed decisions about tests and examinations."
("3.1 En særlig utfordring
Svangerskapskontrollene er ikke prinsipielt forskjellig fra andre konsultasjoner i primærhelsetjenesten. Men kontrollene - særlig det første møtet - har noen særpreg som er utfordrende for jordmor eller lege: Du skal gi en masse informasjon, blant annet slik at kvinnen kan treffe en rekke informerte beslutninger om prøver og undersøkelser.") (Source: "Nasjonale Faglige retningslinjer: Retningslinjer for svangerskapsomsorgen IS-1179" Sosial- og helsedirektoratet, May 2005. ISBN 82-8081-067-6. [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.]) - "3.4 Practical tips - keywords: respect, routines and flexibility
Select which written information material you want to use. There are pros and cons with all material. The material must be offered, not rubbed on the woman. You should not inform her to death. Organize the material so that the review naturally leads to a conversation about the key topics from the woman's point of view, and the informed choices the woman will take for example HIV tests, ultrasound or fetus diagnostics."
(3.4 Praktiske tips – stikkord: respekt, rutiner og fleksibilitet
Velg ut hvilket skriftlig informasjonsmateriale du vil bruke. Det er fordeler og ulemper
med alt materiale. Materialet skal tilbys, ikke dyttes på kvinnen. Du skal ikke informere henne i hjel. Organiser materialet slik at gjennomgangen naturlig leder opp til en samtale om de sentrale temaene ut fra kvinnens ståsted, og de informerte valgene kvinnen skal ta om for eksempel HIV-test, ultralydundersøkelse eller fosterdiagnostikk.) (Source: ibid., p. 14) - "7 User-oriented care and informed choices or decisions
7.1 Information on routine surveys
In each routine examination, midwife or doctor should inform the woman of the purpose of the test and give her a clear notice that she is entitled to either accept or decline the test. Women should receive written and oral information, in line with WHO recommendations."
("7 Brukerorientert omsorg og informerte valg eller beslutninger
7.1 Informasjon om rutineundersøkelser
Ved hver rutineundersøkelse bør jordmor eller lege informere kvinnen om hensikten med testen og gi henne klar beskjed om at hun har rett til enten å akseptere eller avslå testen. Kvinner bør få skriftlig og muntlig informasjon, i tråd med WHOs anbefalinger.") (Source: ibid., p. 28) - Informed decision
"An informed decision can be defined as the individual's thoughtful choice based on relevant information about the pros and cons of current treatment options (46). Doctors and midwives in pregnancy care should bring the best available research-based knowledge to the users (47).
"A priority goal of pregnancy care is to enable the woman to make informed decisions about all aspects of care, such as where to check, who will do them, what routine surveys she is offered and where she wants to give birth. In order to do this, the woman must receive information so that she can discuss the possibilities with the person (s) performing the pregnancy checks."
("Informert beslutning
En informert beslutning kan defineres som individets gjennomtenkte valg, basert på relevant informasjon om fordeler og ulemper ved aktuelle behandlingsalternativer (46). Leger og jordmødre i svangerskapsomsorgen bør bringe den beste, tilgjengelige forskningsbaserte kunnskapen videre til brukerne (47).
Et prioritert mål ved svangerskapsomsorgen er å gjøre kvinnen i stand til å ta informerte beslutninger om alle aspekter ved omsorgen, eksempelvis hvor kontrollene skal foregå, hvem som skal foreta dem, hvilke rutineundersøkelser hun får tilbud om, og hvor hun ønsker å føde. For å kunne gjøre dette, må kvinnen få informasjon, slik at hun kan diskutere mulighetene med den eller de som foretar svangerskapskontrollene.") (Source: ibid., p. 46) - "Issue and Assessment
Although you know more about routine examinations in pregnancy than about other aspects of treatment during pregnancy, more research is needed to find out how to best help pregnant women to make informed decisions about routine surveys. In addition, although information is likely to be a necessary factor for making an informed decision, 48 Information Guidelines for Pregnancy Care 2005 alone are not enough. Other factors also affect. The user survey from TNS Gallup showed that written information distributed in pregnancy is read by the respondents (18): "98% of prospective mothers read about pregnancy either in brochures, online or in books. It is especially the brochures you get on the controls that are read and these are also read by all social groups.""
("Problemstilling og vurdering
Selv om man vet mer om rutineundersøkelser i svangerskapet enn om andre aspekter ved behandling under svangerskapet, trengs det mer forskning for å finne ut hvordan man best kan hjelpe gravide til å ta informerte beslutninger om rutineundersøkelser. I tillegg er det slik at selv om informasjon sannsynligvis er en nødvendig faktor for å ta en informert beslutning, er 48 Faglige retningslinjer for svangerskapsomsorgen 2005 informasjon alene ikke nok. Andre faktorer påvirker også. Brukerundersøkelsen fra TNS Gallup viste at skriftlig informasjon som deles ut i svangerskapet blir lest av respondentene (18): ”98 % av de blivende mødre leser om svangerskapet enten i brosjyrer, på Internett eller i bøker. Det er særlig brosjyrene man får på kontrollene som blir lest, og disse leses også av alle sosiale grupper"” (Source: ibid., p. 49) - "Need for Further Research
There is a need to investigate methods of disseminating knowledge and identifying how health professionals can effectively support pregnant women to make informed decisions about studies offered during pregnancy."
("Behov for videre forskning
Det er behov for å undersøke metoder for å formidle kunnskap og identifisere hvordan helsepersonell effektivt kan støtte gravide til å ta informerte beslutninger om undersøkelser som tilbys i svangerskapet.") (Source: ibid., p. 49) - "Issue and assessment
Is it appropriate to use a standardized pregnancy journal as a health card for pregnant women? Should pregnant women take care of the journal herself?
"The findings from surveys and randomized controlled studies confirm that it is appropriate to have a standardized pregnancy journal that the woman herself handles during pregnancy (72-74) [Knowledge Base Level 1b]. Research supports current practice in Norway. Because the woman herself "owns" the health card, the midwife and doctor can promote user involvement and informed decisions by appropriate use of the health card: In an active collaboration with the pregnant woman, so that she understands what is noted in the appointments."
("Problemstilling og vurdering
Er det hensiktsmessig med en standardisert svangerskapsjournal som helsekort for gravide? Bør gravide ta hånd om journalen sin selv?
Funnene fra spørreundersøkelser og randomiserte, kontrollerte studier bekrefter at det er hensiktsmessig å ha standardisert svangerskapsjournal som kvinnen selv tar hånd om i svangerskapet (72-74) [Kunnskapsgrunnlag nivå 1b]. Forskningen støtter gjeldende praksis i Norge. Fordi kvinnen selv ”eier” helsekortet, kan jordmor og lege fremme brukermedvirkning og informerte beslutninger ved en hensiktsmessig bruk av helsekortet: I et aktivt samarbeid med den gravide, slik at hun er inneforstått med det som noteres i forbindelse med kontrollene.") (Source: Ibid., p. 57). - "Ultrasound examination in pregnancy
The purpose of the ultrasound study is to detect the number of fetuses, determine the age of the fetus, locate the placenta and an orientation of the anatomy of the fetus (86; 87). Doctors and midwives should emphasize information so that the woman can make an informed decision in advance if she wishes the examination." |8.5 ("Ultralydundersøkelse i svangerskapet
Hensikten med ultralydundersøkelsen er å påvise antall fostre, fastslå fosterets alder, lokalisere placenta og en orienterende undersøkelse av fosterets anatomi (86;87). Leger og jordmødre bør legge vekt på å informere, slik at kvinnen kan treffe en informert beslutning på forhånd om hun ønsker undersøkelsen." )(Source: Ibid., p. 60)
First-trimester vs. Second-trimester Ultrasound
Moreover, Laila was not informed that since she had an ultrasound exam in her first trimester, that "there does not seem to be important differences between ultrasound in the first or second trimester with respect to term." Which means there was no medical need for NCFM eSnurra to replace GA & EDD values from her first-trimester ultrasound exam with the second-trimester GA & EDD values from the 18wUSE. That alone might have saved Laila from an unwanted, unnecessary Cesarean section surgery delivery, etc. Also, the BPD-based eSnurra EDD & GA from the first ultrasound exam on 10.08.2016 (or LMPD/OTPD/SCID-based GA = 13w+2) showed BPD-based eSnurra GA = 12w+3, lagging Laila's LMPD/OTPD/SCID-based GA by 0w+6 or 6 days and CRL-based eSnurra GA = 12w+0 , lagging Laila's LMPD/OTPD/SCID-based GA by 1w+2 or 9 days. Moreover, BPD-based eSnurra EDD = 20.02.2017 and CRL-based eSnurra EDD = 25.02.2017. So, if the BPD-based NCFM eSnurra EDD from Laila's first ultrasound exam had been used as Laila's "official" eSnurra EDD, the prediction error would have been (predicted (set to 0) - actual) = (02.20.2017 - 04.02.2017) = -16 days, or 2w+2. However, the first ultrasound exam NCFM eSnurra BPD-based EDD was only lagging Laila's LMPD/OTPD/SCID-based EDD of 14.02.2017 by 6 days, well under the umbrella of normal variance of Laila's LMPD/OTPD/SCID-based EDD. Consequently, if Laila's 18wUSE had not taken place, Laila's baby would have been routinely turned from breech to vertex before Laila went into labor. Also, and given that Laila had an NCFM eSnurra GA & EDD assigned to her pregnancy at her first ultrasound exam on 10.08.2016, this first NCFM eSnurra GA & EDD should never have been replaced with the eSnurra GA & EDD from her 18wUSE of 23.09.2016 when fetal metrics and their measurements presented greater random fetal growth velocity variances.
- "When ultrasound is used to date pregnancy, the date should be determined at the time of the firsts scan with acceptable measurements. That date should then be used throughout pregnancy, and should not be adjusted on the basis of subsequent ultrasound measurements." (Source: "New charts for ultrasound dating of pregnancy" D.G. Altman and L.S. Chitty. Ultrasound in Obstetrics & Gynecoloogy 10 (1997) 174-191, p. 188)
- "Based on our review of the included literature, there does not seem to be important differences between ultrasound in the first or second trimester with respect to term estimation." (Source: NOKC: Routine ultrasound in pregnancy, Report of the Knowledge Centre No. 11-2008, Systematic knowledge summary, Rapport: ISBN 978-82-8121-203-9 ISSN 1890-1298, p. 10.)
- "There do not seem to be any clinically important differences in the effect of offering routine ultrasound screening in the first or second trimester on gestational age." (Source: NOKC: Routine ultrasound in pregnancy, Report of the Knowledge Centre No. 11-2008, Systematic knowledge summary, Rapport: ISBN 978-82-8121-203-9 ISSN 1890-1298, p. 15.)
- "Handling of ultrasounds before routine examination
Use of ultrasound for age determination has error margins caused by biological and measurement variability. The variation (95% confidence interval) is lower in the first trimester (± 3.5 days) 14-17 increases to ± 5.7 days in other trimester 18, 19. The precision of age determination decreases with increasing gestational age, the influence of biological variation increases and touches of pregnancy pathology 20, 21 will be possible. The same applies to the ability to predict term. While approximately 85% of women give birth within 14 days around the estimated term on the basis of the 2nd trimester ultrasound 13, the figure 93% for 1st trimester ultrasound 22." (Source: Ultralydundersøkelser i den alminnelige svangerskapsomsorgen (Ultrasonography in the general antenatal care), Jørg Kessler, Ganesh Acharya, Guttorm Haugen, Harm-Gerd Blaas, Norsk gynekologisk forening, Veileder i fødselshjelp, 2014) - The U.K's National Institute for Health and Care Excellence (NICE) "Antenatal care for uncomplicated pregnancies," Clinical guideline [CG62] recommends "an early ultrasound scan between 10 weeks 0 days and 13 weeks 6 days to determine gestational age and to detect multiple pregnancies."
"1.2.6 Gestational age assessment
1.2.6.1 Pregnant women should be offered an early ultrasound scan between 10 weeks 0 days and 13 weeks 6 days to determine gestational age and to detect multiple pregnancies. This will ensure consistency of gestational age assessment and reduce the incidence of induction of labour for prolonged pregnancy. [2008]
1.2.6.2 Crown–rump length measurement should be used to determine gestational age. If the crown–rump length is above 84 mm, the gestational age should be estimated using head circumference. [2008]" (Source: NICE "Antenatal care for uncomplicated pregnancies," Clinical guideline [CG62] Published date: March 2008 Last updated: January 2017, Chapter 1, 1.2.6 Gestational age assessment) - "Subsequent scans should not be used to recalculate a new estimated date of confinement if age has already been established by a high quality scan during earlier pregnancy. Subsequent measurements, optimally at least 2 weeks from a preceding scan, are usually reported as deviations from mean values with their expected ranges for a given age. This information can be expressed as Z scores, percentile reference ranges, or on a graph although the degree of deviation from normal at this early stage of pregnancy that would justify action (e.g. a follow -up scan to assess fetal growth or fetal chromosomal analysis) has not been firmly established." (Source: ISUOG Practice Guidelines for Performance of the Routine Mid-Trimester Fetal Ultrasound Scan, ISUOG Prenatal Ultrasound Screening Task Force June 2010, p.6-7)
- "Use of multiple biometric markers — The four standard biometric parameters used to estimate gestational age if the initial ultrasound examination is in the second trimester (14+0 to 27+6 weeks) or third trimester (28+0 weeks to delivery) are biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC), and femur length (FL) [66]. These measurements should never be used to change an EDD determined in the first trimester by CRL, since the latter is more accurate. Instead, they are used to determine whether fetal size is within the normal range or restricted, accelerated, or asymmetric based on the previously calculated EDD." (Source: "Expected day of delivery from ultrasound dating versus last menstrual period--obstetric outcome when dates mismatch" Thorsell M, Kaijser M, Almström H, Andolf E. BJOG. 2008 Apr;115(5):585-9. doi: 10.1111/j.1471-0528.2008.01678.x.)
Laila & Edward were told the 18wUSE was important, necessary and part of regular pregnancy care. Laila & Edward were also informed that Trondheim had been notified to schedule Laila. Laila was never "offered" the 18wUSE as an optional, voluntary examination. On the contrary, she was informed the 18wUSE was important, necessary and that the scheduling of same had been ordered and that Trondheim (St. Olavs Hospital) would contact her with her appointment date. These were not words which communicated "completely optional" or "completely voluntary." In short, Laila was never informed the routine 18wUSE was optional and voluntary. Laila was never informed that with respect to her first-trimester ultrasound, "there does not seem to be important differences between ultrasound in the first or second trimester with respect to term." Laila was never informed of the true purpose of the routine 18wUSE relative to her first-trimester ultrasound exam and that the GA & EDD values of her first ultrasound exam and her own LMPD/OTPD/SCID-based GA & EDD values. Moreover, the NOKC report concludes the 18wUSE "...has a high uptake which indicates that women are in favor of it" is completely spurious. Also spurious in the same report was NOKC's statement: "Recent studies indicate that women are well informed about routine ultrasound in pregnancy, but there are challenges related to informing about nuchal translucency (NT) and serum markers." These statements are not only spurious, they are laughable, as there is no evidence to support these statements and conclusions, i.e., with the possible exception of "nuchal translucency (NT) and serum markers." Specifically, there is no evidence women are:
- "given both written and verbal information in advance about the purpose of the ultrasound examination. They should also be informed that the examination is voluntary. "
- informed if an earlier ultrasound-based GA & EDD existed, it would be replaced with a less reliable and less accurate NCFM eSnurra GA & EDD at the 18wUSE when fetal metrics and their measurements present greater random fetal growth velocity variances and measurement errors and, consequently, the assignment of less accurate GA & EDD values to their pregnancy which would increases risks, unnecessarily
- informed the known risks and consequences such as NCFM eSnurra Group's "outliers (gross errors) and/or pathologies" that result in grossly inaccurate EDD predictions (i.e.,< -14 days or > 14 days ), with 12.8% of pregnancies erroneously classified as: 1) preterm (3.5%), 2) post-term (4.3%) and 3) 5% classified as < -14 days and > -24 days , as published in NCFM eSnurra Group's Gjessing et al. 2007, Figure 3, p. 23. [Note: Figure 3 terminology: "residual frequencies" is equivalent to "prediction error frequencies"]
- informed all factual key pregnancy dates (e.g., LMPD, OTPD, SCID etc.) including combinations, such as Laila's fully corroborating, factual LMPD/OTPD/SCID; a combination of dates of know, proven efficacy, would be summarily obviated from all medical evidence and excluded from any and all consideration in the practice of evidence-based medicine
- informed that for the duration of pregnancy all medical thinking, medical decision-making and medical actions must be based, exclusively, on the NCFM eSnurra assigned EDD & GA, even if overwhelming, fact-based evidence of known, proven efficacy, such as a combined, fully corroborating, factual LMPD/OTPD/SCID-based GA & EDD values were to prove NCFM eSnurra Group's eSnurra "method" had assigned grossly inaccurate EDD & GA values to her pregnancy
- informed a pregnant woman must surrender her common sense, critical thinking and educated understanding of human reproductive biology, gestational variances and gestational mathematics,
- informed a pregnant woman must accept being labeled as stupid or a liar or both for not conceding her factual, key pregnancy dates really took place 12 days later than she had meticulously recorded these event-dates in her pregnancy spreadsheet and smartphone,
- a pregnant woman cannot give prior, informed, voluntary, explicit consent nor make any informed choice if a pregnant woman is made to feel medically compromised or afraid for herself or for her fetus/baby by her medical professional(s), or if a pregnant woman is made to feel ignorant (not understanding) or stupid (not able to understand) by her medical professionals if she were to say no to the Trojan horse, routine 18-week ultrasound exam.
- "Ultrasound is offered to all pregnant women in weeks 17 to 19 of pregnancy and has a high uptake which indicates that women are in favour of it. Based on the literature included, it does not seem to be the case that screening programmes in the first or second trimester increase levels of anxiety or worries." (Source: NOKC: Routine ultrasound in pregnancy, Report of the Knowledge Centre No. 11-2008, Systematic knowledge summary, Rapport: ISBN 978-82-8121-203-9 ISSN 1890-1298, p. 11.)
- "The offer of routine ultrasound is based on womens’ choice." (Source: ibid, p. 11)
- "The ultrasound examination is offered to all pregnant women. It is voluntary if you want to be examined. The ultrasound examination is not a mandatory part of the routine antenatal care." ("Ultralydundersøkelsen er et tilbud til alle gravide. Det er frivillig om man vil la seg undersøke. Ultralydundersøkelsen er ikke en obligatorisk del av den rutinemessige svangerskapsomsorgen.") (Source: Norsk Helseinfrmatikk (NHI), Ultrasonography for pregnant women, Last Revised: 02/25/2014, Brochure prepared by the Norwegian Board of Health in collaboration with the Norwegian Gynecological Association and The Norwegian midwife association, https://nhi.no/familie/graviditet/svangerskap-og-fodsel/sykdommer/undersokelser/ultralydundersokelse-for-gravide-sh/)
If Laila was representative of how the allegedly "optional" and "voluntary" status of the 18wUSE is communicated to women in Norway, and there is a plethora of evidence to support Laila was representative, then the "high uptake" stated in the NOKC report (first excerpt above) is supported by evidence that most women were not, and are not, "given both written and verbal information in advance about the purpose of the ultrasound examination." Consequently, Norway's women are not fully informed of the purpose, conditions, obligations, implications, risks and consequences of the routine 18wUSE before the scheduling and execution of same.
However, and on the face of it, the 18wUSE appeared to be a good opportunity to collect medical evidence of fetal health, position, development and potential anomalies. So, right as Laila & Edward were feeling positive about the 18wUSE, the insidious, systemic, institutionalized problem which had been intentionally and deceptively hidden emerged. The 18wUSE had been used as a Trojan horse for Directorate of Health's knowledge-obviated, medically & ethically flawed 2014 Recommendation with their exclusive implementation of NCFM eSnurra Group's "method" within a government-mandated protocol of evidence-obviated medicine. The purpose of which was, and is, to take total control of estimating EDD and, therefrom, calculating GA using the equivalent of Naegele's rule, in reverse, for Laila's pregnancy (and all pregnancies and abortions in Norway), despite the existence of contradicting medical evidence of known, proven efficacy which, for Laila, was her combined, fully corroborating, factual LMPD/OTPD/SCID. By having been deceived about the true intent, conditions, obligations, implications, risks and consequences of the routine 18wUSE, all of Laila's key, factual pregnancy dates (i.e., LMPD, OTPD, SCID, MPMD, PTPD, menstrual cycle/period regularity, etc.) were obviated from all medical evidence and from any and all consideration in medical thinking, medical decision-making and medical actions for the duration of her pregnancy, and beyond, all the way into Laila's baby's medical birth record at the Medical Birth Registry of Norway (MBRN). This is insidious, systemic, institutionalized problem is the direct result of Directorate of Health's knowledge-obviated, medically & ethically flawed 2014 Recommendation with their exclusive implementation of NCFM eSnurra Group's "method".
Become Informed: Then Just Say No! to Unnecessary Risks, Mistakes & Harms
If Norway's women want to reduce their risks of having an unnecessary, unwanted breech delivery or Cesarean section surgery delivery, or a baby with an unidentified, prolonged, undiagnosed, untreated FGR/malformation, or if Norway's women want to have their pregnancies tracked, managed and scheduled according to their factual, key pregnancy dates, such as a combined, fully corroborating, factual LMPD/OTPD/SCID-based GA & EDD, or just a factual OTPD-based GA & EDD, then Norway's women should just say no to the highly promoted, Trojan horse that is the routine 18wUSE which imposes, without a pregnant woman's prior, informed, voluntary, explicit consent, a government-mandated protocol of evidence-obviated medicine; a protocol proven to cause increased medical risks, critical medical mistakes and grievous medical harms (including perinatal death), unnecessarily, to some of Norway's women and their fetuses/babies. Laila wishes she had known the 18wUSE was optional and voluntary, and Laila wishes she had known of the undisclosed, deceptively hidden conditions, risks and consequences of the 18wUSE, because if Laila had been so informed, she would have just said no!
Norway's Health Personnel Act vs. Routine 18-week Ultrasound Exam
The routine 18-week ultrasound exam is marketed and heavily promoted by Directorate of Health and healthcare professionals employed by the government without full disclosure of all the hidden conditions, implications, risks and consequences to pregnant women. Moreover, Directorate of Health in conjunction with NCFM eSnurra Group do not comply with Norway's Health Personnel Act regarding the marketing of health and care services which, in this case, includes the routine 18-week ultrasound exam and the assignment of EDD & GA to pregnancies and abortions.
"Health Personnel Act & Marketing (e.g., ultrasound services)
- Health Personnel Act (English: Health Personnel Act)
Chapter 2. Requirements for health personnel profession
(Kapittel 2. Krav til helsepersonells yrkesutøvelse)
§ 13. Marketing
(§ 13.Markedsføring) Chapter 2, § 13, para 1
Marketing of health and care services shall be responsible, objective and factual.
(Markedsføring av helse- og omsorgstjenester skal være forsvarlig, nøktern og saklig.)
In the marketing of businesses providing health and care services, the first paragraph applies correspondingly.
(Ved markedsføring av virksomhet som yter helse- og omsorgstjenester, gjelder første ledd tilsvarende.)
The Ministry may by regulations lay down further provisions on the marketing of health and care services, and may, among other things, prohibit certain forms of marketing.
(Departementet kan i forskrift gi nærmere bestemmelser om markedsføring av helse- og omsorgstjenester, og kan herunder fastsette forbud mot visse former for markedsføring.)
0 Endret ved lov 22 juni 2012 nr. 46.
Norway's Patient & User Rights Act & The Right to Participation and Information
- Patient & User Rights Act (Official Norwegian Version)
Patient & User Rights Act (Unofficial English Version)
Chapter 3. The right to participation and information
§ 3-1. Patient and user's authority participation
Patient and user have the right to participate in the implementation of health and care services. This includes the patient's right to participate in choosing between available and appropriate examinations and treatment. The form of participation must be adapted to the individual's ability to provide and receive information.
The services must as far as possible be designed in collaboration with the patient and user. It should be emphasized what the patient and the user believes the design of services for health and care law §§ 3-2 first paragraph no. 6, 3-6 and 3-8. Children under 18 should be consulted when the child's development and maturity and the nature dictates.
If the patient is not competent to give consent, the patient's next of kin is entitled to participate together with the patient.
Want patient or user that other people should be present when health care is provided, this must generally be accommodated.
0 Amended by Law 24 June 2011 No.. 30 (ikr. January 1, 2012 acc. Res. 16 Dec 2011 No.. 1252 ). Amended by Law 16 June 2017 No.. 53 (ikr. January 1, 2018 acc. Res. 8 Dec 2017 No.. 1951).
§ 3.2. Patient and user's right to information
The patient should have the information necessary to gain insight into their health status and content of health care. Patients should also be informed about the possible risks and side effects.
Information should not be given against a patient's expressed will, unless it is necessary to prevent adverse effects of the health care, or it is determined in or pursuant to law.
Information may be omitted if it is urgently necessary to prevent danger to life or serious damage to the patient himself. Information can also be omitted if it is clearly inadvisable in the interests of persons close to the patient, providing such information.
If the patient or user to cause damage or serious complications, the patient or the user is informed. It shall also be informed of their right to seek compensation from the Norwegian Patient, to approach the patient and user ombudsman and the right to ask the supervisory authority for assessment of any breach of duty by patient and user Rights Act 1 § 4.7.
If the patient or user is injured or suffers severe complications and the outcome is unexpected in relation to the likely risk, the patient or user shall also be informed of the measures that the health and care service will take to prevent similar events from occurring again.
If, after the end of treatment, it is found that the patient may have suffered considerable damage as a result of the health care, the patient should if possible be informed.
Users should have the information necessary to get sufficient insight into service provision and in order to safeguard their rights.
0 Amended by laws 24 June 2011 No.. 30 (ikr. January 1, 2012 acc. Res. 16 Dec 2011 No.. 1252 ), June 7, 2013 No.. 29 (ikr. January 1, 2014 acc. Res. 6 Dec 2013 No.. 1398 ) . Amended by Act of 15 Dec 2017 no. 107 (ikr. From the King decides).
1 i.e., this Act.
§ 3.3. Information for the patient's next of kin
If the patient agrees or the situation so warrants, the patient's next of kin have information about the patient's health status and the health care provided.
Is the patient over 16 years and obviously can not protect their interests because of physical or mental disorders, dementia or mental retardation, both the patient and his or her next of kin is entitled to information under the provisions of § 3.2.
If a patient or user dies and the outcome is unexpected in relation to the foreseeable risk, the patient or the user's next of kin the right to information under § 2.3 subsections, as far as confidentiality is no obstacle to this.
0 Amended by laws 24 June 2011 No.. 30 (ikr. January 1, 2012 acc. Res. 16 Dec 2011 No.. 1252 ), June 7, 2013 No.. 29 (ikr. January 1, 2014 acc. Res. 6 Dec 2013 No.. 1398 ) . Amended by Law 16 June 2017 No.. 53 (ikr. January 1, 2018 acc. Res. 8 Dec 2017 No.. 1951 ). Amended by Act of 15 Dec 2017 no. 107 (ikr. From the King decides).
§ 3.4. Information when the patient is a minor
Is the patient under 16 years, both the patient and the parents or others with parental responsibility informed.
If the patient is between 12 and 16, information must not be given to parents or others with parental responsibility when the patient for reasons that should be respected, not wanting this.
Information needed to fulfill parental responsibility must nevertheless be given to parents or others with parental responsibility when the patient is under 18 years old.
If the child welfare service has taken care of children under 16 years after the Child Welfare Act § 4-8 or § 4-12, the first, second and third paragraphs accordingly for child welfare services.
0 Endres by Act 16 June 2017 no. 53 (ikr. January 1, 2018 acc. Res. 8 des 2017 no. 1951 )
§ 3-5. Information form
The information must be adapted to individual circumstances, such as age, maturity, experience and cultural and linguistic background. The information shall be provided in a considerate way.
The personnel shall, as far as possible ensure that the recipient has understood the nature and importance of the information.
Disclosure of the information provided shall be recorded in the patient's or user's journal.
0 Amended by Law 24 June 2011 No.. 30 (ikr. January 1, 2012 acc. Res. 16 Dec 2011 No.. 1252 ). Amended by Law 16 June 2017 No.. 53 (ikr. January 1, 2018 acc. Res. 8 Dec 2017 No.. 1951 ).
§ 3-6. The right to protection against the spread of information
Information on Medical and health conditions as well as other personal information shall be treated in accordance with applicable confidentiality provisions. The information must be treated with caution and respect for the integrity of the data subject.
The professional secrecy falls away to the extent that is entitled to confidentiality consents.
If health personnel disclose information that is subject to a statutory duty of disclosure, the information applies, as far as conditions dictate informed that the data is given and the information in question.
Norway's Patient & User Rights Act & Consent to Health Care
Included below are Sections 4-1 & 4-2 of Chapter 4 of Norway's Patients' Rights Act [English] or Lov om pasient- og brukerrettigheter (pasient- og brukerrettighetsloven). These 2 Sections define patient consent. The Section headings for Sections 4.3 - 4.9 are also included for the purpose of demonstrating these Sections exist but do not apply to Laila's case. Interestingly, Section 4-1, para. 2, (below) empowers a patient to withdraw consent; however, in Laila's case, Laila never gave consent to the hidden, knowledge-obviated, medically & ethically flawed terms and conditions which comprise the routine 18-week ultrasound exam. Laila and Edward argued, vociferously, against using the erroneous, grossly inaccurate NCFM eSnurra BPD-based EDD & GA values instead of Laila's accurate, combined, fully corroborating, factual LMPD/OTPD/SCID-based EDD & GA for all medical thinking, medical decision-making and medical actions for Laila's pregnancy. Consequently, because Laila never gave consent, Section 4-1, para. 2 may not apply in Laila's case. However, Section 4-1, para. 1 most definitely does apply to Laila's case. Therefore, a discussion of legal theory and case law on this point would make for interesting reading and an even more interesting judicial decison.
- Patient & User Rights Act (Official Norwegian Version)
Patient & User Rights Act (Unofficial English Version)
Chapter 4. Consent to health care
§ 4-1. General rule relating to consent
Health care may only be provided with the patient’s consent, unless legal authority exists or there are other valid legal grounds for providing health care without consent. In order for the consent to be valid, the patient must have received the necessary information concerning his health condition and the content of the health care.
The patient may withdraw his consent. If the patient withdraws consent, the health care provider shall give the necessary information regarding the consequences of not giving the health care.
Section 4-2. Requirements regarding the form of consent
Consent may be given explicitly or tacitly. Tacit consent is considered to have been given if it is probable, based on the patient’s conduct and all other circumstances, that he or she accepts the health care.
The Ministry may issue regulations regarding a requirement of written consent or other formal requirements in connection with certain types of health care.
Section 4-3. Who has competence to give consent
Section 4-4. Consent on behalf of children
Section 4-5. Consent on behalf of young people who are not competent to give consent
Section 4-6. Consent on behalf of persons who are of full legal age and legal capacity and who are not competent to give consent
Section 4-7. Patients who have been declared legally incapacitated
Section 4-8. Patients who are not competent to give consent and who have no next of kin
Section 4-9. The patient’s right to refuse health care in special situations
(Source: The Act of 2 July 1999 No. 63 relating to Patients’ Rights (Patients’ Rights Act [English] or Lov om pasient- og brukerrettigheter)
Sweden, Autonomy Principle & Routine Ultrasound Examination During Pregnancy
The Principles of Biomedical Ethics by Beauchamp and Childress, first published in 1979, now in its 7th edition, presented 4 generally accepted medical ethical principles:
- respect for autonomy (i.e., respecting the decision-making capacities of autonomous persons)
- non-maleficence (avoiding the causation of harm)
- beneficence (providing benefits and balancing benefits, burdens, and risks),
- justice (fairness in the distribution of benefits and risks)
(Source: "Further Development of Beauchamp and Childress’ Theory Based on Empirical Ethics" Mette Ebbesen, Svend Andersen, and Birthe D. Pedersen. J Clinic Res Bioeth 2012, S:6e001. DOI: 10.4172/2155-9627.S6-e001)
American College of Physicians Ethics Manual: Sixth Edition
Included below is an excerpt from the American College of Physicians Ethics Manual: Sixth Edition. The entirety of this manual is available via the links included below. It is interesting to note the ACP Ethics Manual has identifies the same 4 medical ethical principles above, it also contains 43 occurrences of the word "consent" and 16 occurrences of the 2-word sequence "informed consent."
- "Medical and professional ethics often establish positive duties (that is, what one should do) to a greater extent than the law. Current understanding of medical ethics is based on the principles from which positive duties emerge (Table 1). These principles include beneficence (a duty to promote good and act in the best interest of the patient and the health of society) and nonmaleficence (the duty to do no harm to patients). Also included is respect for patient autonomy—the duty to protect and foster a patient's free, uncoerced choices (6). From the principle of respect for autonomy are derived the rules for truth-telling. The relative weight granted to these principles and the conflicts among them often account for the ethical dilemmas that physicians face. Physicians who will be challenged to resolve those dilemmas must have such virtues as compassion, courage, and patience.
In addition, considerations of justice must inform the physician's role as citizen and clinical decisions about resource allocation. The principle of distributive justice requires that we seek to equitably distribute the life-enhancing opportunities afforded by health care. How to accomplish this distribution is the focus of intense debate. More than ever, concerns about justice challenge the traditional role of physician as patient advocate." (Source: American College of Physicians Ethics Manual: Sixth Edition, ACP ETHICS MANUAL, 3 JANUARY 2012 (HTML version) or (PDF version). Lois Snyder, JD; for the American College of Physicians Ethics, Professionalism, and Human Rights Committee (*), Article, Author, and Disclosure Information)
Other Nordic Counties
An effort was made to determine if other Nordic countries had the same ethical issues as Norway with respect to securing valid, prior, informed, voluntary, explicit consent from pregnant women for the routine 18-week ultrasound exam. It was learned Sweden's Statens beredning för medicinsk och social utvärdering (SBU) (The state's preparation for medical and social evaluation), which appears to be the equivalent of Norway's National Knowledge Center for the Health Services (NOKC), authored the report "Rutinmässig ultraljudsundersökning under graviditet" ("Routine ultrasound examination during pregnancy") which confirmed women in Sweden had received inadequate information about the routine 18-week ultrasound exam and, therefore, women in Sweden were not able to provide valid, informed consent. The Swedish report, prepared by SBU, specifically cited the requirements of the medical ethical "autonomy principle" as problematic with respect to the routine 18-week ultrasound exam. And, the same is true for the women of Norway, as there is no evidence the "autonomy principal" or any other principle of medical ethics was applied in Laila's case,or the cases of other women in Norway.
- Ethical Aspects ( "Rutinmässig ultraljudsundersökning under graviditet", p. 229)
"Routine ultrasound examination during pregnancy can be discussed in accordance with the four ethical principles: goodness principle, suffering principle (no harm), justice principle and autonomy principle."
"The autonomy principle requires that all pregnant women be informed of the benefits and disadvantages of routine ultrasound examination and on the possibilities and limitations of the ultrasound examination. According to several Swedish studies, pregnant women indicate that they received inadequate information prior to the ultrasound examination, or that they experienced the ultrasound examination as a mandatory routine. This violates the principle of autonomy. In order to make a well-founded decision, to refrain or accept to undergo the examination, the woman must receive adequate information. If routine ultrasound examination is offered, one should comply with both the principles of beneficence and justice, ensuring that the routine ultrasound examinations maintain the same high quality throughout the country . This imposes training and organization requirements." (Source: "Rutinmässig ultraljudsundersökning under graviditet" ("Routine ultrasound examination during pregnancy") September 1998. p. 229. SBU – Statens beredning för utvärdering av medicinsk metodik. ISBN 91-87890-52-6)
Summary: Informed Consent & 18-week Ultrasound Exam (18wUSE)
The following list summarizes the key Directorate of Health publications, Norwegian laws and medical ethics principles regarding informed consent with respect to the hidden purpose, conditions, obligations, implications, risks and consequences which constitute the routine 18-week ultrasound exam.
The following list summarizes the key Directorate of Health publications, Norwegian laws and medical ethics principles regarding informed consent with respect to the hidden purpose, conditions, obligations, implications, risks and consequences which constitute the routine 18-week ultrasound exam.
- Marketing of health and care services shall be responsible, objective and factual. (Health Personnel Act, Chapter 2 § 13 ¶ 1)
- Before the ultrasound examination in weeks 17-19, the woman shall have information on the purpose and content of the ultrasound examination. (Source: "Veiledende retningslinjer for bruk av ultralyd i svangerskapet, Bruk av ultralyd i den alminnelige svangerskapsomsorgen og i forbindelse med fosterdiagnostikk" Sosial – og helsedirektoratet, IS-23/2004, p.12)
- It is emphasized that this [i.e., the person to be examined must give written consent] does not apply to ultrasound examinations on medical indication or routine examination in weeks 17-19." (Source: ibid., p. 12.)
- "1.1 Information about routine examinations At every routine examination, the midwife or doctor should inform the woman about the purpose of the test (tests and examinations) and clearly inform her that she has the right either to accept or to refuse the test. Women should be given written and verbal information, in line with the recommendations of WHO. [D]" (Source: Nasjonale faglige retningslinjer (National Academic Guidelines) A National Clinical Guideline for Antenatal Care. Short version - Recommendaitons IS-1339/E (English version), p. 8, Authors: Synne Holan, Mariann Mathiesen, Kirsten Petersen, 12/2005, ISBN-978-82-8081-078-1, Published by Directorate for Health and Social Affairs, Norway. [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.])
- "1.1 Informasjon om rutineundersøkelser Ved hver rutineundersøkelse bør jordmor eller lege informere kvinnen om hensikten med testen (prøver og undersøkelser) og gi henne klar beskjed om at hun har rett til enten å akseptere eller avslå testen. Kvinner bør få skriftlig og muntlig informasjon, i tråd med WHOs anbefalinger. D" (Source: Retningslinjer for svangerskapsomsorgen: Kortversjon - anbefalinger IS-1339 (Norwegian version), Forfattere: Synne Holan, Mariann Mathiesen, Kirsten Petersen, 12/2005, ISBN-978-82-8081-078-1, Published by Directorate for Health and Social Affairs, Norway. [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.])
- Pregnant women should be given both written and verbal information in advance about the purpose of the ultrasound examination. They should also be informed that the examination is voluntary. (Source: A National Clinical Guideline for Antenatal Care. Short version IS-1339/E, p. 10. 12/2005, ISBN-978-82-8081-078-1, Published by Directorate for Health and Social Affairs, Norway. [Update: Access to this document has been removed by Norwegian Directorate of Health; View/Download this document here.])
- The patient is entitled to participate in the implementation of health care. (Patient & User Rights Act § 3-1, ¶ 1)
- The patient has the right to participate in the choice of available and appropriate examination and treatment methods. (Patient & User Rights Act § 3-1, ¶ 1)
- The form of participation must be adapted to the individual's ability to provide and receive information. (Patient & User Rights Act § 3-1, ¶ 1) -The patient should have the information necessary to gain insight into their health status and content of health care. (Patient & User Rights Act § 3-2, ¶ 1)
- Patients should also be informed about the possible risks and side effects. (Patient & User Rights Act § 3-2, ¶ 1)
- Health care may only be provided with the patient’s consent, unless legal authority exists or there are other valid legal grounds for providing health care without consent. (Patient & User Rights Act § 4-1, ¶ 1)
- In order for the consent to be valid, the patient must have received the necessary information concerning his health condition and the content of the health care. (Patient & User Rights Act § 4-1, ¶ 1)
- The patient may withdraw his consent. (Patient & User Rights Act § 4-1, ¶ 2)
- If the patient or user is injured or suffers severe complications and the outcome is unexpected in relation to the likely risk, the patient or user shall also be informed of the measures that the health and care service will take to prevent similar events from occurring again. (Patient & User Rights Act § 3-2, ¶ 5)
- The autonomy principle (Principles of Biomedical Ethics by Beauchamp and Childress) requires all pregnant women be informed of the benefits and disadvantages of routine ultrasound examination and of the possibilities and limitations of the ultrasound examination. ("Rutinmässig ultraljudsundersökning under graviditet", p. 229)