Delphi questionnaire: Diagnostic criteria of Primary Dysmenorrhea

Menstrual complaints, such as primary dysmenorrhea, are common and can negatively impact daily activities and quality of life. The diagnostic criteria of primary dysmenorrhea are, however, not uniform. Various definitions of primary dysmenorrhea are used in literature and in clinical practice with regard to the timing of symptoms following menarche, duration of dysmenorrhea, associated symptoms and/or the necessity to exclude other diseases. To increase uniformity and optimize research in menstrual care, we want to reach consensus about the definition of primary dysmenorrhea and the diagnostic criteria.

What is a Delphi procedure

Previous studies have shown that an international, modified, digital Delphi procedure is a valid way to gain consensus. A Delphi study is a procedure where, in multiple rounds, international experts are asked to give their opinions. When a topic reaches consensus (defined as a Rate of Agreement of >70%), the topic is completed. When no consensus is reached, the topic will be readdressed in the next round, accompanied by anonymous comments from the experts. In a consensus statement, there is the risk of a disproportional influence of the consensus by certain experts based on personality, image or experience. Using a Delphi procedure, the aim is to get a more scientific rigorous result, with an equal influence on the consensus by each expert. Another benefit is the option to provide anonymous comments, which lowers the barrier of ventilating a possibly controversial opinion.

We started with a literature study evaluating all papers discussing primary dysmenorrhea. We then performed a focus group discussion with local experts to discuss any potential missed items. The collection of all questions is presented in this first round. Relevant background information from the literature study is added to the questions.

Which email address did you use to sign up for this Delphi?(Required)

NOMENCLATURE

The definition of “dysmenorrhea” in the diagnosis of primary dysmenorrhea varies in literature. In particular, the timing of the onset of dysmenorrhea in relation to blood loss is described differently. Orhan C. et al. (1) state that dysmenorrhea starts “just before and/or during” blood loss. It has also been stated in other articles that dysmenorrhea only starts ‘during’ blood loss (2, 3).

1. When should dysmenorrhea be present in relation to blood loss in the diagnosis of primary dysmenorrhea?(Required)

Dysmenorrhea is defined as pain caused by menstrual periods and is therefore always accompanied by blood loss.

Dysmenorrhea can be present already a (few) day(s) before blood loss.

Dysmenorrhea can be present a (few) day(s) before blood loss and during blood loss.

Other

Please explain your awnser:(Required)

Various definitions are used, both in literature and in clinical practice, for the term "primary" in the diagnosis of primary dysmenorrhea. “Primary” can refer to the absence of pathology (4-7). However, in clinical practice “primary” is also used to describe dysmenorrhea that occurs immediately after menarche.

2. What does, in your opinion, ”primary” in the diagnosis “primary dysmenorrhea” mean?(Required)

The absence of known pathology.

Dysmenorrhea that occurs directly, or shortly after, menarche.

Both the absence of pathology as well as dysmenorrhea that occurs directly, or shortly after, menarche.

Other

Please explain your answer:(Required)

In your opinion, “primary” in the diagnosis “primary dysmenorrhea” refers to dysmenorrhea that occurs directly, or shortly after, menarche.

Literature is not consistent in what “directly, or shortly” after menarche means. This varies between within six months after menarche (8) or up to three years after menarche (9). However, it is also suggested that the time between menarche and dysmenorrhea should not be part of the diagnostic criteria of primary dysmenorrhea (2, 10).

2.1. Should the time interval between menarche and the onset of dysmenorrhea be taken into account for the diagnosis of primary dysmenorrhea?(Required)

Yes

Please explain your answer:(Required)

2.1.2. What should be the time interval between menarche and the onset of dysmenorrhea for the diagnosis of primary dysmenorrhea?(Required)

Dysmenorrhea should be present directly from the onset of the first menses.

Dysmenorrhea should be present within a specified time interval after the first menarche.

Other

Please explain your answer:(Required)

2.1.3. What should be the time interval (in months or years) between menarche and the onset of primary dysmenorrhea?(Required)

Please explain your answer:(Required)

DIAGNOSIS OF EXLUCSION

Smith R. et al. (11) state that primary dysmenorrhea is a clinical diagnosis after exclusion and evaluation should include a detailed history and physical examination investigating signs and symptoms suggestive of pelvic pathology. Examples of pelvic pathology are pelvic inflammatory disease (PID), congenital uterine anomaly, endometriosis, adenomyosis, or uterine fibroids.

3. Which of the following conditions should be considered or excluded before diagnosing primary dysmenorrhea? Multiple answers are possible.(Required)

Sexually transmitted disease (STD) / Pelvic Inflammatory Disease (PID)

Congenital uterine anomaly

Endometriosis

Adenomyosis

Fibroids

All of the above

None of the above

Other

Please explain your answer:(Required)

Pelvic examination

Karout S et al. (12) describe that a pelvic examination to exclude pelvic pathology is part of the diagnostic process to diagnose primary dysmnorrhea. Some articles conclude that a pelvic examination is necessary to diagnose primary dysmenorrhea (13, 14). Others state that physical examination should only be performed when a patient does not respond to hormonal therapy or in case of an atypical medical history and/or presentation (11, 15-18).

4. Is it necessary to perform a pelvic examination before diagnosing primary dysmenorrhea?(Required)

Yes, performing a pelvic examination is necessary to diagnose primary dysmenorrhea.

Yes, performing a pelvic examination is necessary to diagnose primary dysmenorrhea, but can only be performed in sexually active patients.

No, performing a pelvic examination is not necessary to diagnose primary dysmenorrhea.

Other

Pelvic examination consists of: inspection of the external genital area, speculum examination and/or bimanual (vaginal) examination. The relevance of additional imaging (e.g. transvaginal ultrasound) will be discussed later.

Please explain your answer:(Required)

Further investigation

Literature is inconclusive with regards to when further investigation, aside from pelvic examination, should be performed before diagnosing primary dysmenorrhea. Some studies state that a transvaginal ultrasound should be performed only if pelvic disease is suspected (13, 15, 19). Some articles also report that an abdominal ultrasound or MRI could be performed if there is a suspicion of pelvic disease (19, 20). Others state that further investigation, for example a diagnostic laparoscopy, is necessary in absence of response to hormonal therapy (21).

5. Is further investigation necessary to diagnose primary dysmenorrhea?(Required)

Yes, further investigation is necessary to diagnose primary dysmenorrhea.

Yes, further investigation is necessary, but only when pelvic examination can not be performed.

Yes, further investigation is necessary, but only when pelvic examination is suggestive of underlying pathology.

No, further investigation is not necessary to diagnose primary dysmenorrhea.

Other

Further investigation consists of: Ultrasound, MRI and/or laparoscopy.

Please explain your answer:(Required)

In your opinion, further investigation is necessary to diagnose primary dysmenorrhea.

5.1. Which additional imaging technique(s) do you believe is necessary to diagnose primary dysmenorrhea? Multiple answers are possible.(Required)

Ultrasound (transvaginal, abdominal, perineal, transrectal) examination

Magnetic resonance imaging (MRI)

Diagnostic laparoscopy

Other

Please explain your answer:(Required)

Duration of dysmenorrhea

The duration of dysmenorrhea varies in literature. Ferries-Rowe E. et al. (20) state that dysmenorrhea seldomly lasts more than 72 hours. Orhan C. et al. (1) state that the dysmenorrhea lasts about 48–72 hours. Hu Z. et al. (22) say it lasts for 8-72 hours. Others do not incorporate the duration of dysmenorrhea in their definition (8, 23-25).

6. Do you think a minimal duration of dysmenorrhea should be part of the diagnostic criteria of primary dysmenorrhea?(Required)

Yes, a minimal duration of dysmenorrhea should be part of the diagnostic criteria of primary dysmenorrhea.

No, a minimal duration of dysmenorrhea should not be part of the diagnostic criteria of primary dysmenorrhea.

Please explain your answer:(Required)

In your opinion, a minimal duration of dysmenorrhea should be part of the diagnostic criteria of primary dysmenorrhea.

6.1. What should the minimal duration of dysmenorrhea be to diagnose primary dysmenorrhea?(Required)

Dysmenorrhea should be present at least 1 – 8 hours.

Dysmenorrhea should be present at least 8 – 72 hours.

Dysmenorrhea should be present at least 72 hours.

Other

Please explain your answer:(Required)

Severity of dysmenorrhea

In literature, some studies use an instrument to assess the severity of dysmenorrhea. Various instruments, with different cut-off values, have been described in literature to measure dysmenorrhea (26-28). The following questions will focus on whether and how to assess the severity of dysmenorrhea to diagnose primary dysmenorrhea.

7. Should the assessment of the severity of dysmenorrhea be part of the diagnostic criteria of primary dysmenorrhea?(Required)

Yes, the assessment of the severity of dysmenorrhea should be part of the diagnostic criteria of primary dysmenorrhea.

No, the assessment of the severity of dysmenorrhea should not be part of the diagnostic criteria of primary dysmenorrhea.

Please explain your answer:(Required)

In your opinion, the assessment of the severity of dysmenorrhea should be part of the diagnostic criteria of primary dysmenorrhea.

7.1 How would you assess the severity of dysmenorrhea to diagnose primary dysmenorrhea? Choose the most suitable option.(Required)

The severity should be assessed by the impact of dysmenorrhea on daily activities (for example school or work absenteeism).

The severity should be assessed by using the Numeric Rating Scale (NRS).(The scale varies from ‘0-10’, with ‘0’ no pain and ‘10’ being the worst pain imaginable (29))

The severity should be assessed by using the Visual Analogue Scale (VAS). (This scale is a 100mm long line, from 0 (no pain) to 100 (worst pain imaginable). Each patient ticks her pain level on the line and the distance from ‘no pain’ on the extreme left to mark is measured in millimeters yielding a pain score from 0 to 100 (29). This scale is also used with smileys.)

The severity should be assessed by using the Verbal Multidimensional Scoring System (VMSS).

Other

The VMSS grades pain, the effect on daily activities, systemic symptoms and analgesic requirements. There are 3 grades. Grade 0: Menstruation is not painful, daily activity is unaffected, no systemic symptoms and analgesics are not required. Grade 1: Menstruation pain is mild, but seldom inhibits daily activities. No systemic symptoms and analgesics are seldom required. Grade 2: Moderate pain, daily activities are affected, analgesics are required and provide relief so that absence from work or school is unusual. Grade 3: severe pain and activity clearly inhibited, poor effect of analgesics and systemic symptoms like headache, tiredness, nausea and vomiting are apparent. (27).

Please explain your answer:(Required)

You stated that you would assess the severity of dysmenorrhea by the impact of dysmenorrhea on daily activities.

7.2. In your opinion, what should the minimal impact of primary dysmenorrhea be on daily life activities to diagnose primary dysmenorrhea?(Required)

Please explain your awnser:(Required)

You stated that you would assess the severity of dysmenorrhea by using the Numeric Rating Scale (NRS). Different cut-off values of the NRS are being used to determine primary dysmenorrhea. Some articles classify NRS values into groups, others use a cut-off value of 5 and above for primary dysmenorrhea (28, 30, 31).

7.3. What should be the cut-off value of the NRS to diagnose primary dysmenorrhea?(Required)

Please explain your answer:(Required)

You stated that you would assess the severity of dysmenorrhea by using the Visual Analogue Scale (VAS). Different cut-off values of the VAS are being used to determine primary dysmenorrhea. Some articles classify VAS values into groups, others use a cut-off value of 50 cm and above for the definition of primary dysmenorrhea (28, 32, 33).

7.4. What should be the cut-off value of the VAS (in mm) to diagnose primary dysmenorrhea?(Required)

Please explain your answer:(Required)

You stated that you would assess the severity of dysmenorrhea by using the Verbal Multidimensional Scoring System (VMSS). Different cut-off values of the VMSS are being used to determine primary dysmenorrhea. Some articles use grade 1-3 to determine primary dysmenorrhea, others classify dysmenorrhea as grade 2 and above (27, 34).

7.5. What should be the cut-off value of the VMSS to diagnose primary dysmenorrhea?(Required)

Grade 1: Menstruation pain is mild, but seldom inhibits daily activities. No systemic symptoms and analgesics are seldom required.

Grade 2: Moderate pain, daily activities are affected, analgesics are required and provide relief so that absence from work or school is unusual.

Grade 3: severe pain and activity clearly inhibited, poor effect of analgesics and systemic symptoms like headache, tiredness, nausea and vomiting are apparent.

Please explain your answer:(Required)

You stated that you would assess the severity of dysmenorrhea by using a different tool than the options mentioned before.

7.6. What is the cut-off value of your classification system to diagnose primary dysmenorrhea?(Required)

Please explain your answer:(Required)

Additional symptoms

It is important to determine whether additional symptoms should be part of the diagnostic criteria of primary dysmenorrhea, for example gastrointestinal symptoms (nausea, vomiting, bloating), psychological symptoms (depression and anxiety) and systemic symptoms (fatigue and headache (12, 35).

Some studies report that additional symptoms are required to meet the criteria for primary dysmenorrhea (21, 35). However, Faramarzi M. et al. (9) do not include any additional symptoms in their definition of primary dysmenorrhea.

8. Should additional symptoms be present to diagnose primary dysmenorrhea?(Required)

Yes, additional symptoms should always be present to diagnose primary dysmenorrhea.

No, additional symptoms can be present, but it is not mandatory to diagnose primary dysmenorrhea.

Please explain your answer:(Required)

In your opinion, additional symptoms should be part of the diagnostic criteria of primary dysmenorrhea.

8.1. Which symptoms should be part of the diagnostic criteria of primary dysmenorrhea? Multiple answers are possible.(Required)

Please explain why you answered "other":(Required)

This was the questionnaire for the first round of the Delphi procedure. We would like to thank you for your participation. If you have any comments, please mention them below.

Comments:

The questionnaire for round 2 will follow via e-mail.

References

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