World Endometriosis Research Foundation Endometriosis Phenome and biobanking harmonization project: II. Clinical and covariate phenotype data collection in endometriosis research

Probably not a substantial claim: may not pass S3 (load-bearing).

The sections excluded from the minimum version focus on symptoms or characteristics pertaining across the life course.

“These sections focus on symptoms or characteristics pertaining across the life course.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The WERF EPHect global initiative has involved 34 clinical/academic centers and three industry collaborators (54 participants) from 16 countries on five continents.

“To date, the WERF EPHect global initiative has involved 34 clinical/academic centers and three industry collaborators (54 participants) from 16 countries on five continents.”

Classified as probably not a substantial claim.

EPHect agreed on two tiers for all data collection instruments as well as for biologic sample SOPs: standard recommended and minimum required.

“EPHect therefore agreed on two tiers for all data collection instruments as well as for biologic sample SOPs: standard recommended and minimum required.”

Classified as probably not a substantial claim.

The standard recommended (EPHect EPQ-S) and minimum required (EPHect EPQ-M) questionnaires contain questions on pelvic pain, subfertility and menstrual/reproductive history, hormone/medication use, medical history, and personal information.

“The standard recommended (EPHect EPQ-S) and minimum required (EPHect EPQ-M) questionnaires contain questions on pelvic pain, subfertility and menstrual/reproductive history, hormone/medication use, medical history, and personal information.”

Classified as probably not a substantial claim.

The EPQ captures the basic set of patient characteristics and exposures considered by the WERF EPHect Working Group to be most critical for the advancement of endometriosis research.

“The EPQ captures the basic set of patient characteristics and exposures considered by the WERF EPHect Working Group to be most critical for the advancement of endometriosis research”

Classified as probably not a substantial claim.

WERF EPHect provides evidence-based guidelines on detailed surgical, clinical, and epidemiologic phenotyping data to be collected from women with and without endometriosis to allow collaborative subphenotype discovery and validation analyses.

“WERF EPHect provides evidence-based guidelines on [1] detailed surgical, clinical, and epidemiologic phenotyping (phenome) data to be collected from women with and without endometriosis to allow collaborative subphenotype discovery and validation analyses”

Classified as probably not a substantial claim.

The EPHect Working Group agreed that pain intensity will be measured on an 11-point numerical rating scale anchored with 0 = no pain and 10 = worst imaginable pain.

“Using these guidelines, the EPHect Working Group agreed that pain intensity will be measured on an 11-point numerical rating scale (NRS) anchored with 0 = no pain and 10 = worst imaginable pain.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Pain affect is captured on the EPHect EPQ with the short form McGill Pain Questionnaire (SF-MPQ).

“Pain affect is captured on the EPHect EPQ with the short form McGill Pain Questionnaire (SF-MPQ).”

Classified as probably not a substantial claim.

The standard definition of infertility can be derived from data collected with the EPHect EPQ.

“and this definition can be derived from data collected with the EPHect EPQ.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The EPHect EPQ-S includes a table on lifetime menstrual cycle characteristics while not on hormone medication, across different age ranges, which is not included in the EPHect EPQ-M.

“The EPHect EPQ-S includes a table on lifetime menstrual cycle characteristics while not on hormone medication, across different age ranges, which is not included in the EPHect EPQ-M.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A detailed pregnancy history is captured in the EPHect EPQ, including age at the start of each pregnancy, type of fertility treatment used for each pregnancy, if applicable, and pregnancy outcome.

“A detailed pregnancy history is captured in the EPHect EPQ, including age at the start of each pregnancy, type of fertility treatment used for each pregnancy, if applicable, and pregnancy outcome.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The EPHect EPQ classifies menstrual flow as spotting, light, moderate, and heavy using a previously validated menstrual pictogram.

“Therefore, we have classified menstrual flow as spotting, light, moderate, and heavy using a previously validated menstrual pictogram (40).”

• cites [40] Wyatt, 2001, Determination of total menstrual blood loss, Fertil Steril sourceNot checked yet

  Not checked in the free run.

Classified as probably not a substantial claim.

Age at menarche and menstrual cycle characteristics in the last 3 months are captured in detail on the EPHect EPQ.

“Age at menarche and menstrual cycle characteristics in the last 3 months are captured in detail on the questionnaire”

Classified as probably not a substantial claim.

Subfertility is assessed in the EPHect EPQ by the longest time (>6 months) a study participant has tried to become pregnant without success and any tests she might have had to find the cause of the sub-fertility.

“Subfertility is assessed in the EPHect EPQ by the longest time (>6 months) a study participant has tried to become pregnant without success and any tests she might have had to find the cause of the sub-fertility.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Additional details for live births include whether the pregnancy was a multiple gestation, the type of delivery, and pregnancy complications.

“Additional details for live births include whether the pregnancy was a multiple gestation, the type of delivery, and pregnancy complications.”

Classified as probably not a substantial claim.

To capture bowel symptoms that are common in women with endometriosis, questions from the Rome III criteria irritable bowel syndrome module are included.

“To capture bowel symptoms that are common in women with endometriosis, we have included questions from the Rome III criteria irritable bowel syndrome module (58).”

• cites [58] Drossman, 2006, Rome III: New standard for functional gastrointestinal disorders, J Gastrointestin Liver DisNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

A diagnostic history for endometriosis is canvassed in detail, including age at first symptoms, age and method of diagnoses, and any prior surgical treatments.

“A diagnostic history for endometriosis is canvassed in detail, including age at first symptoms, age and method of diagnoses, and any prior surgical treatments.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A family history of endometriosis or of chronic pelvic pain is also obtained.

“A family history of endometriosis or of chronic pelvic pain is also obtained”

Classified as probably not a substantial claim. May combine two claims.

Any occurrence of a structural problem/birth defect of the uterus, cervix, or vagina is ascertained and whether it was surgically repaired.

“Any occurrence of a structural problem/birth defect of the uterus, cervix, or vagina is also ascertained and whether it was surgically repaired”

Classified as probably not a substantial claim.

Women are asked about recent bowel and urinary symptoms.

“Additionally, women are asked about recent bowel and urinary symptoms.”

Probably not a substantial claim: may not pass S3 (load-bearing).

During Workshop II, a consensus was obtained on the final content and format of the questionnaire.

“During Workshop II, the questionnaire was presented to participants together with a summary of reviews obtained through e-mail consultation, and a consensus was obtained on the final content and format of the questionnaire”

May combine two claims.

There are a variety of different mechanisms by which pain could be generated in endometriosis, potentially producing discrete pain phenotypes, even though current understanding of these mechanisms is still fragmented.

“As with many other disorders that involve visceral pain, it has become apparent that there are a variety of different mechanisms by which pain could be generated in endometriosis (Fig. 2) (20), potentially producing discrete “pain phenotypes,” even though our current understanding of these mechanisms is still fragmented.”

• cites [20] Stratton, 2011, Chronic pelvic pain and endometriosis: translational evidence of the relationship and implications, Hum Reprod Update sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Both psychological and cognitive factors can modulate-in either a facilitatory or inhibitory manner-the pain experience, and they may also need to be considered.

“Furthermore, both psychological and cognitive factors can modulate–in either a facilitatory or inhibitory manner–the pain experience, and they may also need to be considered (Fig. 3) (21).”

• cites [21] Tracey, 2007, The cerebral signature for pain perception and its modulation, Neuron sourceNot checked yet

  Not checked in the free run.

May combine two claims.

Given variation in quality and complexity of data collected across disparate centers, data pooling may not always be feasible, which can impede scientific progress.

“Given the variation in quality and complexity of the data collected across disparate centers, data pooling may not always be feasible, which can impede scientific progress.”

May combine two claims.

Collaboration and pooling of individual participant data across research centers can enable much larger sample sizes, can afford subgroup analyses, and is more effective than meta-analyses.

“Collaboration and pooling of individual participant data across research centers can enable much larger sample sizes, can afford subgroup analyses, and is more effective than meta-analyses (3).”

• cites [3] Thompson, 2009, Thinking big: large-scale collaborative research in observational epidemiology, Eur J Epidemiol sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

It is plausible that pain phenotypes may be characterized by different biomarker profiles or may be responsive to specific treatments only, and therefore a failure to correctly characterize the pain symptoms may obscure a significant result in such studies.

“It is plausible that these phenotypes may be characterized by different biomarker profiles or may be responsive to specific treatments only, and therefore a failure to correctly characterize the pain symptoms may obscure a significant result in such studies.”

Classified as probably not a substantial claim. May combine two claims.

All participants in the consultation were asked to decide which information in the EPHect EPQ should be collected as a minimum (EPQ-M) requirement and which would be recommended as standard (EPQ-S), and a consensus on this division was achieved during Workshop II.

“All participants in the consultation were asked to decide which information in the EPHect EPQ should be collected as a minimum (EPQ-M) requirement and which would be recommended as standard (EPQ-S), and a consensus on this division was achieved during Workshop II.”

Classified as probably not a substantial claim. May combine two claims.

The SF-MPQ-2 uses ratings on an 11-point scale, similar to measures of pain intensity, and has seven additional questions that allow calculation of four separate domains (continuous pain, intermittent pain, neuropathic pain, and affective) and a total score, as opposed to the original SF-MPQ which only calculates two domains (sensory and affective) and a total score.

“we strongly recommend as standard the use of the most recent SF-MPQ-2, as ratings are given on an 11-point scale, similar to the measures of pain intensity, and seven additional questions allow for the calculation of four separate domains (continuous pain, intermittent pain, neuropathic pain, and affective) and a total score”

• cites [23] Dworkin, 2009, Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2), Pain sourceNot checked yet

  Not checked in the free run.

Classified as probably not a substantial claim.

Recommendations have been published for standard endometriosis-associated pain data collection techniques.

“Recommendations have been published for standard endometriosis–associated pain data collection techniques (22).”

• cites [22] Vincent, 2010, Pain scoring in endometriosis: entry criteria and outcome measures for clinical trials: report from the Art and Science of Endometriosis meeting, Fertil Steril sourceNot checked yet

  Not checked in the free run.

May combine two claims.

The relationship between endometriosis and pain symptoms is complex, with little correlation between the extent of disease seen at laparoscopy and the severity of pain experienced by the patient.

“However, the relationship between endometriosis and pain symptoms is complex, with little correlation between the extent of disease seen at laparoscopy and the severity of pain experienced by the patient (18, 19).”

• cites [18] Chapron, 2003, Deep infiltrating endometriosis: relation between severity of dysmenorrhoea and extent of disease, Hum Reprod sourceNot checked yet

  Not checked in the free run.

• cites [19] Vercellini, 2007, Association between endometriosis stage, lesion type, patient characteristics and severity of pelvic pain symptoms: a multivariate analysis of over 1000 patients, Hum Reprod sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

The EPQ is also relevant to other female conditions with similar risk factors and/or symptomatology.

“but is also relevant to other female conditions with similar risk factors and/or symptomatology.”

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

Standardization and harmonization of phenotypic data and biologic sample collection methods are crucial to allow meaningful comparison between different patient populations and ethnic groups in endometriosis research, and will aid scientific inquiry into etiology and pathogenesis.

“Moreover, standardization and harmonization of phenotypic data and biologic sample collection methods are crucial to allow meaningful comparison between different patient populations and (ethnic) groups in endometriosis research, and will aid the scientific inquiry into the etiology and pathogenesis of the disease.”

• AssumptionRests on an assumption: Endometriosis is heterogeneous with respect to its natural history, disease burden, extent of inflammation, state of progression, and phenotypic presentation of lesions and symptoms.
• AssumptionRests on an assumption: Important nonsurgical aspects characterize patient subpopulations, including symptomatology and nonsymptomatic phenotypes such as anthropometric characteristics, ethnicity, and reproductive and demographic factors.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Most questions were piloted by patients and volunteers in the centers contributing the questions, and all questions were reviewed by the workshop participants for face validity.

“In addition, most questions were piloted by patients and volunteers in the centers contributing the questions, and all questions were reviewed by the workshop participants for face validity.”

Classified as probably not a substantial claim. May combine two claims.

Pain catastrophizing is considered a trait measure and thus should not be influenced by the preceding questions.

“Although pain catastrophizing is considered a trait measure (25) and thus should not be influenced by the preceding questions”

• cites [25] Quartana, 2009, Pain catastrophizing: a critical review, Expert Rev Neurother sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

Collection of information on psychological state and health-related quality of life in a symptom-based questionnaire can be important as these factors may affect responses related to symptomatology and therefore may be important in patient (symptomatic) stratification.

“Collection of information on psychological state and health-related quality of life in a symptom-based questionnaire can be important as these factors may affect responses related to symptomatology and therefore may be important in patient (symptomatic) stratification.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The standard definition of infertility is 12 months of regular unprotected intercourse without achieving a clinical pregnancy.

“The standard definition of infertility is 12 months of regular unprotected intercourse without achieving a clinical pregnancy (45)”

• cites [45] Zegers-Hochschild, 2009, The International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) Revised Glossary on ART Terminology, 2009, Hum Reprod sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

Early life menstrual cycle characteristics and their change over time may be important in the etiology of endometriosis.

“because early life menstrual cycle characteristics and their change over time may be important in the etiology of endometriosis.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The FIGO classification for volume of menstrual flow is heavy (>80 mL), normal (5-80 mL), and light (<5 mL).

“The FIGO classification for volume of menstrual flow is heavy (>80 mL), normal (5–80 mL), and light (<5 mL)”

• cites [39] Fraser, 2011, The FIGO recommendations on terminologies and definitions for normal and abnormal uterine bleeding, Semin Reprod Med sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

The FIGO recommendation for defining normal menstruation and menstrual cycle characteristics includes four parameters: regularity of menses, frequency of menses, and duration and heaviness of menstrual flow.

“The International Federation of Gynecology and Obstetrics (FIGO) recommendation for defining normal menstruation and menstrual cycle characteristics includes four parameters: regularity of menses, frequency of menses, and duration and heaviness of menstrual flow (39).”

• cites [39] Fraser, 2011, The FIGO recommendations on terminologies and definitions for normal and abnormal uterine bleeding, Semin Reprod Med sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Subfertility and endometriosis may have a common origin, as suggested by evidence linking in-utero exposures with endometriosis.

“In fact, subfertility and endometriosis may have a common origin, as suggested by evidence linking in-utero exposures with endometriosis.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In prospective studies, increasing number of live births has been linearly associated with decreasing incidence of endometriosis.

“In prospective studies, increasing number of live births has been linearly associated with decreasing incidence of endometriosis (38).”

• cites [38] Missmer, 2004, Reproductive history and endometriosis among premenopausal women, Obstet Gynecol sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The Hospital Anxiety and Depression Scale (HADS) can be used as a combined measure to save time and/or space, but it has been argued that this is more useful as a measure of overall psychological distress than for accurately determining the degree of anxiety and depression.

“Alternatively, to save time and/or space, a combined measure such as the Hospital Anxiety and Depression Scale (HADS) (32) can be used, but it has been argued that this is more useful as a measure of overall psychological distress than for accurately determining the degree of anxiety and depression (33).”

• cites [32] Zigmond, 1983, The Hospital Anxiety and Depression Scale, Acta Psychiatr Scand sourceNot checked yet

  Not checked in the free run.

• cites [33] Cosco, 2012, Latent structure of the Hospital Anxiety and Depression Scale: a 10-year systematic review, J Psychosom Res sourceNot checked yet

  Not checked in the free run.

May combine two claims.

Validated depression and anxiety scales that can be helpful for patient stratification include the Beck Depression Inventory (BDI) and the State Trait Anxiety Inventory (STAI), both of which are also considered valid for healthy controls.

“Additionally, validated depression and anxiety scales that can be helpful for patient stratification include measures such as the Beck Depression Inventory (BDI) (30) and the State Trait Anxiety Inventory (STAI) (31), both of which are also considered valid for healthy controls.”

• cites [30] Beck, 1996, Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients, J Pers Assess sourceNot checked yet

  Not checked in the free run.

• cites [31] Spielberger, 1983Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S4 (based).

Menstrual cycle characteristics are likely to influence symptom reporting.

“[2] are likely to influence symptom reporting”

May combine two claims.

The pain catastrophizing scale is valid and relevant for both patients and healthy controls, acceptable to patients/controls, and comprises only 13 questions.

“As the pain catastrophizing scale is valid and relevant for both patients and healthy controls (referring to any pain experienced rather than to pelvic pain specifically), acceptable to patients/controls, and comprises of only 13 questions”

• cites [25] Quartana, 2009, Pain catastrophizing: a critical review, Expert Rev Neurother sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S4 (based). May combine two claims.

Surgical history (the age at each surgery, the type of surgery, and its indication) can be etiologically related to pelvic pain symptoms and impact on symptom reporting.

“Surgical history (the age at each surgery, the type of surgery, and its indication) can be etiologically related to pelvic pain symptoms and impact on symptom reporting.”

Classified as probably not a substantial claim.

Bowel and urinary symptoms are important to capture for defining case subpopulations.

“and these are important to capture for defining case subpopulations.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Greater body size is associated with a decreased risk of endometriosis.

“Greater body size and adolescent weight have both been shown to be associated with a decreased risk of endometriosis (66, 70).”

• cites [66] Shah, 2013, Body size and endometriosis: results from 20 years of follow-up within the Nurses' Health Study II prospective cohort, Hum Reprod sourceNot checked yet

  Not checked in the free run.

• cites [70] Vitonis, 2010, A prospective study of body size during childhood and early adulthood and the incidence of endometriosis, Hum Reprod sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

Hair and eye color are associated with endometriosis.

“Two questions on hair and eye color, previously associated with endometriosis (71–75) and possibly useful in marking genetic subpopulations, are also included.”

• cites [71] Kvaskoff, 2009, Endometriosis risk in relation to naevi, freckles and skin sensitivity to sun exposure: the French E3N cohort, Int J Epidemiol sourceNot checked yet

  Not checked in the free run.

• cites [72] Missmer, 2006, Natural hair color and the incidence of endometriosis, Fertil Steril sourceNot checked yet

  Not checked in the free run.

• cites [73] Somigliana, 2010, ‘Here comes the sun’: pigmentary traits and sun habits in women with endometriosis, Hum Reprod sourceNot checked yet

  Not checked in the free run.

• cites [74] Woodworth, 1995, A prospective study on the association between red hair color and endometriosis in infertile patients, Fertil Steril sourceNot checked yet

  Not checked in the free run.

• cites [75] Wyshak, 2000, Red hair color, melanoma, and endometriosis: suggestive associations, Int J Dermatol sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Retrospective studies have suggested that women with endometriosis may have higher rates of maternal complications and fetal problems such as preeclampsia and miscarriage, though these associations need further study.

“Retrospective studies have suggested that women with endometriosis may have higher rates of maternal complications and fetal problems such as preeclampsia and miscarriage (46–50), though these associations need further study.”

• cites [46] Fernando, 2009, Preterm birth, ovarian endometriomata, and assisted reproduction technologies, Fertil Steril sourceNot checked yet

  Not checked in the free run.

• cites [47] Stephansson, 2009, Endometriosis, assisted reproduction technology, and risk of adverse pregnancy outcome, Hum Reprod sourceNot checked yet

  Not checked in the free run.

• cites [48] Tomassetti, 2006, Endometriosis, recurrent miscarriage and implantation failure: is there an immunological link?, Reprod Biomed Online sourceNot checked yet

  Not checked in the free run.

• cites [49] Vercellini, 2012, Pregnancy outcome in women with peritoneal, ovarian and rectovaginal endometriosis: a retrospective cohort study, Br J Obstet Gynaecol sourceNot checked yet

  Not checked in the free run.

• cites [50] Brosens, 2012, Risks of adverse pregnancy outcome in endometriosis, Fertil Steril sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

Experimental data suggest that anti-inflammatory drugs may affect the severity of endometriosis.

“Moreover, experimental data suggest that anti-inflammatory drugs may affect the severity of the disease (61, 62).”

• cites [61] Olivares, 2011, The inhibitory effect of celecoxib and rosiglitazone on experimental endometriosis, Fertil Steril sourceNot checked yet

  Not checked in the free run.

• cites [62] Ozawa, 2006, A selective cyclooxygenase-2 inhibitor suppresses the growth of endometriosis xenografts via antiangiogenic activity in severe combined immunodeficiency mice, Fertil Steril sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

Alcohol use is associated with endometriosis in a prospective study.

“Smoking and alcohol use, which have been associated with endometriosis in a prospective study (76), are captured as former and current smoking and packs per day as well as current number of alcoholic drinks per week.”

• cites [76] Missmer, 2004, Incidence of laparoscopically confirmed endometriosis by demographic, anthropometric, and lifestyle factors, Am J Epidemiol sourceNot checked yet

  Not checked in the free run.

Classified as probably not a substantial claim. May combine two claims.

The questionnaire can be completed by any woman undergoing investigation for symptoms of endometriosis (whether she has the disease or not), or asymptomatic women, subject to signed written informed consent obtained from each patient and local ethics approval for the study according to ethical principles for clinical research summarized in the Declaration of Helsinki.

“The questionnaire can be completed by any woman undergoing investigation for symptoms of endometriosis (whether she has the disease or not), or asymptomatic women, subject to signed written informed consent obtained from each patient and local ethics approval for the study according to ethical principles for clinical research summarized in the Declaration of Helsinki.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Smoking is associated with endometriosis in a prospective study.

“Smoking and alcohol use, which have been associated with endometriosis in a prospective study (76), are captured as former and current smoking and packs per day as well as current number of alcoholic drinks per week.”

• cites [76] Missmer, 2004, Incidence of laparoscopically confirmed endometriosis by demographic, anthropometric, and lifestyle factors, Am J Epidemiol sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

Standardization of phenotypic data collection across studies of endometriosis will promote large-scale research using multiple data sets characterized using the same phenotypic definitions and will simplify interpretation of concordant or discordant results among data sets.

“This standardization will promote large-scale research using multiple data sets that are characterized using the same phenotypic definitions and will simplify interpretation of concordant or discordant results among data sets.”

Probably not a substantial claim: may not pass S2 (checkable).

If adopted by research centers across the globe, the EPHect EPQ will aid in the design and conduction of large, multicenter, geographically diverse studies with high reliability and validity.

“If adopted by research centers across the globe, the EPHect EPQ will aid in the design and conduction of large, multicenter, geographically diverse studies with high reliability and validity, conducted on behalf of the millions of girls and women struggling with endometriosis and its associated symptoms.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

These categories may not sufficiently capture all populations where this questionnaire will be used.

“However, we realize these categories may not sufficiently capture all populations where this questionnaire will be used.”

Classified as probably not a substantial claim.

The EPQ is not designed for use in clinical practice to inform immediate clinical decisions.

“The EPQ is not designed for use in clinical practice to inform immediate clinical decisions.”

• AssumptionRests on an assumption: None of the longstanding, validated component parts of the EPQ have been applied in an immediate point-of-care setting.

Probably not a substantial claim: may not pass S3 (load-bearing).

Race/ethnicity is assessed with categories previously used in a worldwide study.

“Race/ethnicity is assessed with categories previously used in a worldwide study (63).”

• cites [63] Nnoaham, 2011, Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries, Fertil Steril sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

The questionnaire was not designed to accommodate in-clinic completion and immediate review.

“However, the questionnaire was not designed to accommodate in-clinic completion and immediate review, as this is beyond the scope and inconsistent with the goals of EPHect.”

• AssumptionRests on an assumption: None of the longstanding, validated component parts of the EPQ have been applied in an immediate point-of-care setting.

Classified as probably not a substantial claim. May combine two claims.

The EPHect EPQ captures details on pain, menstrual and reproductive history, medical history, hormone use and infertility, and demographics and lifestyle characteristics and is sufficient to capture the minimum nonsurgical clinical phenome in endometriosis cases and controls.

“The EPHect EPQ captures details on pain, menstrual and reproductive history, medical history, hormone use and infertility, and demographics and lifestyle characteristics and is sufficient to capture the minimum nonsurgical clinical phenome in endometriosis cases and controls.”

• AssumptionRests on an assumption: The demographic data required for interpretation of any epidemiologic study result include age, race/ethnicity, major ancestry, and highest level of education attained.