ACOG 2009:6個問題之新版調查準確評量PMS對生活品質的影響


  May 6, 2009 (伊利諾州芝加哥) — 在新的調查中,6個問題的新版調查量表,可準確測量經前症候群(premenstrual syndrome,PMS)對婦女健康相關生活品質(HRQOL)的影響。
  
  Min Yang博士在美國婦產科學會(ACOG)第57屆年度科學會議中發表該項調查及其效果;Yang博士是進行本研究的羅德島林肯郡QualityMetric Inc公司的資深科學家。
  
  生育年齡的婦女有高達80%在月經來潮前幾天有生理不適症狀,經前異常包括經前症候群(PMS)以及經前障礙症(premenstrual dysphoric disorder,PMDD),這會影響婦女的心情、工作以及社交活動。問題是,該如何測量呢?
  
  根據Yang博士表示,現有的調查工具主要陳述出現經前症候群以及嚴重度;發展「經前症候群影響調查(Pre-Menstrual Symptoms Impact Survey,PMSIS)」用於評估特定症狀對於婦女HRQOL的影響。Yang博士描述此新方法的縱向確效。
  
  這項確效用於測量有無經前異常(不論是PMS或是PMDD)婦女使用PMSIS之一致性與檢測-再度檢測的可信度,以評估PMSIS對於有無經前異常婦女之區同與區別效度,以及評估PMSIS將婦女分為有無經前異常的準確度。
  
  使用Zoomerang這個線上調查工具蒐集資料。納入規範為18至45歲婦女、前三個月有規律月經週期、至少有一種2000年ACOG之PMS診斷規範的經前症候群。
  
  這項非隨機觀察研究在兩個不同時間點、間隔約四週,命名為時間1與時間2;時間1這組(n= 1100)平均年紀為30.4歲;377名(34.3%)婦女有PMS、164名(14.9%)診斷有PMDD;時間2這組(n= 770)的平均年紀是30.6歲;251名(32.6%)名婦女有PMS 、109名(14.2%)診斷有PMDD。
  
  Yang博士報告資料的統計效度,她發表每個時間點之PMSIS分數的平均值與標準差,以Cronbach's alpha值與平均時間內相關性測量PMSIS的內在一致性與信度。在未改變分組下,以各組參與者的反應跨時間組內相關顯示測驗-再測信度。使用PMSIS分數與標準變項之間的相關性PMSIS集中效度。使用時間1這組的標準變項PMSIS分數等級顯示已知群組區別效度。使用PMS組和PMDD組的整體曲線下面積描述PMSIS分類準確度。Yang博士也發表PMSIS作為時間1組之PMS預測因子的接受者操作特徵分析。
  
  Yang博士指出,研究限制為線上調查,使用診斷PMS與PMDD的回溯準則,使用經前症狀查檢表。
  
  Medscape Ob/Gyn & Women's Health 詢問Yang博士,PMSIS是否是唯一評估PMS對HRQOL影響的工具。Yang博士表示,就我們所知,是的。雖然有許多問卷探討經前症候群症狀和相關議題,例如經前症候群篩檢工具 [Premenstrual Symptoms Screening Tool]。不過,她指出,這些問卷很長。新版的方法很短、很容易使用。
  
  ACOG科學計畫委員會委員、Kurt L. Barnhart醫師向Medscape Ob/Gyn & Women's Health表示,著眼於PMS的工具多變,我們沒有太多相關經驗。Barnhart醫師是賓州大學婦女健康研究主任,擔任臨床與基礎研究報告小組共同主任。Barnhart醫師表示,所以重點在於,他們適當地以證據確認此工具的效果。
  
  被問到此新方法是否可以被廣泛使用時,Barnhart醫師表示,我希望它可以。一個調查方法應可更佳量化症狀,我們可以如何廣泛使用它們,不論是研究目的或臨床使用。
  
  本研究由Bayer HealthCare Pharmaceuticals藥廠支持。Yang 博士宣告沒有相關資金上的往來。
  
  美國婦產科學會(ACOG)第57屆年度科學會議:臨床與基礎研究報告。發表於2009年5月4日。
  

ACOG 2009: New 6-Question Survey Accurately Measures Effect of PMS on Quality of Life

By Richard Hyer
Medscape Medical News

May 6, 2009 (Chicago, Illinois) — A new 6-question survey instrument was shown to accurately measure the effect of premenstrual syndrome (PMS) on women's health-related quality of life (HRQOL) in a new survey.

The survey and its validation were described by coinvestigator Min Yang, MD, PhD, here at the American College of Obstetricians and Gynecologists (ACOG) 57th Annual Clinical Meeting. Dr. Yang is senior scientist at QualityMetric Inc in Lincoln, Rhode Island, where the study was conducted.

Up to 80% of women of reproductive age experience symptoms of physical discomfort prior to the first few days of their menstrual cycles. Premenstrual disorders can include both premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD), and can affect mood, work, and social activity. The question is: How can this be measured?

According to Dr. Yang, existing survey instruments principally document the presence and severity of premenstrual symptoms. The Pre-Menstrual Symptoms Impact Survey (PMSIS) was developed specifically to evaluate the impact of selective symptoms on women's HRQOL. Dr. Yang described the longitudinal validation of this new instrument.

The validation was designed to measure both the consistency and the test–retest reliability of the PMSIS among women with and without premenstrual disorders (either PMS or PMDD), to assess the convergent and discriminant validity of the PMSIS among women with and without premenstrual disorders, and to assess the accuracy with which the PMSIS can classify women into groups of those with and without premenstrual disorders.

Data were collected using Zoomerang, an online survey tool. Inclusion criteria limited the survey to women between 18 and 45 years who had experienced regular menstrual cycles for the previous 3 months and had at least 1 of the premenstrual symptoms listed in the 2000 ACOG diagnostic criteria for PMS.

This nonrandomized observational study was administered at 2 distinct time points approximately 4 weeks apart, referred to as time?1 and time?2. The time?1 group (n?= 1100) had a mean age of 30.4 years; 377 women (34.3%) were diagnosed with PMS and 164 women (14.9%) were diagnosed with PMDD. The time?2 group (n?= 770) had a mean age of 30.6 years; 251 women (32.6%) were diagnosed with PMS and 109 women (14.2%) were diagnosed with PMDD.

Dr. Yang described the statistical validation of data. She presented the mean and standard deviations for PMSIS scores at each time point and, as a measure of PMSIS internal consistency and reliability, presented Cronbach's alphas and average intertime correlations. Test–retest reliability was demonstrated with intraclass correlations between responses across time for participants with no change in group classification. PMSIS convergent validity was demonstrated by correlations between PMSIS scores and criterion variables. Known-groups discriminant validity was demonstrated with PMSIS scores across levels of criterion variables at time?1. PMSIS classification accuracy was described by overall area under the curve for PMS and PMDD groups. Dr. Yang also presented receiver operating characteristic analysis of PMSIS as a predictor of PMS for time?1.

Dr. Yang noted that the study was limited by its use of an online survey, by the use of retrospective criteria for the diagnosis of PMS and PMDD, and by the use of a symptom checklist for premenstrual symptom complaints.

Medscape Ob/Gyn & Women's Health asked Dr. Yang whether PMSIS is the only existing tool to assess the impact of PMS on HRQOL. "The short answer would be, to our knowledge, yes," Dr. Yang said. "But there are many questionnaires out there to measure premenstrual symptoms and issues, like [the Premenstrual Symptoms Screening Tool]." However, she noted that such questionnaires are usually long. This new instrument is short and easy to administer, she said.

"Tools that look at PMS are diverse, and we don't have a lot of clinical experience with them," Kurt L. Barnhart, MD, MSCE, a member ACOG's Committee on Scientific Program, told Medscape Ob/Gyn & Women's Health. Dr. Barnhart is director of women's health research at the University of Pennsylvania in Bryn Mawr, and served as codirector on the Papers on Clinical and Basic Investigation session. "So what's important about this is that they appropriately and in an evidence-based way validated the tools," said Dr. Barnhart.

When asked whether this survey instrument might find widespread use, Dr. Barnhart said: "I hope that it does. A survey instrument that can better quantitate the symptoms and how we might manage them would potentially have very widespread use, both for research purposes and for clinical practice."

The study was supported by Bayer HealthCare Pharmaceuticals. Dr. Yang has disclosed no relevant financial relationships.

American College of Obstetricians and Gynecologists (ACOG) 57th Annual Clinical Meeting: Papers on Current Clinical and Basic Investigation. Presented May 4, 2009.

    
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