Promotion of Wellbeing in Women Athletes
Condition: Quality of Life
Study type: Observational

Summary: 
      The Female Athlete Triad is a medical condition often observed in physically active girls and
      women, and involves 3 components: (1) low energy availability with or without disordered
      eating, (2) menstrual dysfunction, and (3) low bone mineral density. An early intervention is
      essential to prevent its progression to serious endpoints including clinical eating
      disorders, amenorrhea, and osteoporosis that can affect the quality of life of these patients
      and even compromise the athletic performance.

      All patients, aged between 14 and 40 years, who met the inclusion and exclusion criteria,
      were prospectively enrolled in this observational study and were divided into two groups:
      Athletes agonists (Experimental Group or Group A) and women who do not perform agonistic
      sports (Control Group or Group B). In both groups of patients, the investigators administered
      two types of questionnaires: a standardized quality of Life questionnaire, validated in
      Italian (SF-12) and a screening questionnaire recommended by the Female Athlete Triad Expert
      Panel.
    

Detailed description: 
      From January 2016 to May 2016 the investigators considered eligible all consecutive women,
      aged between 14 and 40 years, who came to undergo routine physical examination.

      The institutional internal review board approved the study. Inclusion criteria were: I) age
      between 14 and 40 years; II) absence of malignancies; III) informed consent obtained from the
      patient; IV) no previous surgical, chemotherapic and/or radiotherapic treatments.

      the investigators excluded all patients who presented any conditions that could alter quality
      of life such as: I) recent traumas; II) recent surgeries; III) oncologic history; IV)
      uncontrolled systemic illnesses; V) severe or uncontrolled infection; VI) mental illness;
      VII) pregnancy.

      All patients who met the inclusion and exclusion criteria were prospectively enrolled in this
      observational study and were divided into two groups: Athletes agonists (Experimental Group
      or Group A) and women who do not perform any agonistic sports (Control Group or Group B).

      Were considered agonists athletes and enrolled in Group A all the patients who met the
      definition of competitive sports athletes adopted by the Italian Ministry of Health
      (Ministerial Decree, D.M. 18/02/1982 - Circular No. 7 of 01/31/1983): "form of sporting
      activity systematically and/or continually practiced, especially organized by the National
      Sports Federations, the Sporting Promotion bodies recognized both by CONI and the Ministry of
      Education with regard to the Youth Games at National level, to the achievement of a certain
      level of sportive performance". All other women were considered as not athletes and were
      included in the control group (Group B).

      To assess the sample size, in order to detect a difference of 3 points in
      SF12-questionnaires, were used the Cohen formulas, considering a power of 80% (two-tails; P =
      0.05 Long Rank Test): 100 patients were necessary for each group to detect a statistically
      significant difference.

      In all patients an accurate gynecological history was recorded with a special focus on
      menstrual irregularities, from the age of menarche to present. It was also investigated the
      presence of other gynecological symptoms that can affect athletic performance of the patient,
      such as pain during menstruation (dysmenorrhea) or other forms of pelvic pain.

      A registration of medication history was taken, including medications that can affect
      menstruation and /or bone mass density (BMD), as contraceptive pills or other contraceptive
      agents.

      Moreover all patients underwent the evaluation of every physical characteristics that could
      be suggestive of an eating disorders, such as low body mass index (BMI), weight loss,
      orthostatic hypotension, swelling of the parotid glands or presence of calluses on the
      proximal interphalangeal joints (also known as Mark Russell). Finally an accurate record of
      all the previous episodes of bone stress, injuries and fractures was recorded.

      In both groups of patients two types of questionnaires were administrated: a standardized
      quality of Life questionnaire, validated in Italian (SF-12) and a screening questionnaire
      (the same that the Female Athlete Triad Expert Panel recommends as a screening and an
      integral part of the athletes routine physical assessment) aimed to the identification of
      apparatus-specific dysfunctions (Female Athlete Triad). Even if this last questionnaire is
      still not validated in Italian, both questionnaires (SF-12 and screening) were administered
      in Italian.

      SF-12 questionnaire is considered a reliable measure of perceived health that describes the
      degree of general physical health status and mental health distress. It consists of 12 items,
      derived from the physical and mental domains. SF-12 was considered altered if the score was
      <40, either from the physical or mental functioning point of view, because means of 50 and
      standard deviations of 10 are usually achieved in the general population.

      The screening questionnaire was focused on those main risk factors that can lead to a
      decreased quality of life in women and to an early detection of a medical dysfunction related
      to the female triad. the investigators used two different cut-off to consider the
      questionnaire altered: 1) alteration of at least two items of the questionnaire; 2)
      alteration of at least two items of the questionnaire, where question 6,7 and 8 (all related
      to eating disorders) were considered as one.

      If either one of the two questionnaire resulted altered, or would arise any suspicion from
      the physical evaluation, the patient was sent to a more in-depth assessment in order to
      verify the presence of a clinical dysfunction.

      Finally all the data were recorded in a database. The incidence and prevalence of
      gynecological disorders were calculated.

      Spearman correlation test was used to assess if altered levels of quality of life
      corresponded to an alteration of the screening questionnaire and if an alteration of the
      screening questionnaire effectively corresponded, after a more in-depth clinical assessment,
      to a clinical dysfunction. Correlation coefficients whose magnitude were between 0.9 and 1.0
      indicated variables which could be considered very highly correlated. Correlation
      coefficients whose magnitude were between 0.7 and 0.9 indicated variables which could be
      considered highly correlated. Correlation coefficients whose magnitude were between 0.5 and
      0.7 indicated variables which could be considered moderately correlated. Correlation
      coefficients whose magnitude were between 0.3 and 0.5 indicated variables which had a low
      correlation. Correlation coefficients whose magnitude were <0.3 had little if any (linear)
      correlation.

      The sensitivity, specificity, positive (PPV) and negative (NPV) predictive values, and
      accuracy of the screening questionnaire in assessing the presence of a clinical dysfunction
      were calculated, using the physical examination as the 'gold standard'. The sensitivity,
      specificity, positive (PPV) and negative (NPV) predictive values, and accuracy of the
      screening questionnaire in assessing the presence of an alteration of quality of life were
      calculated, using SF-12 questionnaire as the 'gold standard'.

      All continuous data were expressed as mean and standard deviation. All the variables
      quantitative were compared using the Student's t test or the Mann-Whitney, depending on their
      distribution pattern. Qualitative variables were compared using the Chisquare or Fisher
      tests.

      For all statistical comparisons, statistical significance was set at P <0.05. Statistical
      analysis was performed using software Medcalc © statistical software ver. 12.4.0.0.
    

Intervention name(s): QoL questionnaire SF-12 and and a screening questionnaire
Intervention type(s): Other
Intervention description(s): patient were asked to fill questionnaires
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women aged between 14 and 40 years, who came to undergo routine physical examination.All
        patients who met the inclusion and exclusion criteria were prospectively enrolled in this
        observational study and were divided into two groups:Athletes agonists(Experimental
        Group)and women who do not perform any agonistic sports(Control Group). Were considered
        agonists athletes all the patients who met the definition of competitive sports athletes
        adopted by the Italian Ministry of Health:"form of sporting activity systematically and/or
        continually practiced, especially organized by the National Sports Federations with regard
        to the Youth Games at National level, to the achievement of a certain level of sportive
        performance".All other women were included in the control group.