Journal Club: June 2021

JPAG Article, June 2019:Dowlut-McElroy T, et al. Treatment of Prepubertal Labial Adhesions: A Randomized Controlled Trial.

  1. This study is a randomized control trial. Do you think this was a well-designed study? What are the study design types of randomized controlled trials?   

  2. The authors report that the relatively small sample size likely contributed to the lack of statistical significance between the 2 treatment groups (estrogen vs emollient).  What 4 components are necessary to calculate sample size for trials with dichotomous outcomes (i.e. complete resolution of labial adhesion or not)?  Did the authors provide all the necessary assumptions for readers to replicate their sample size calculation? Go to https://clincalc.com/stats/samplesize.aspx (or another sample size calculator). Based on the info they provided did they have enough patients in each group?  

  3. Although the results were not statistically significant, the estrogen intervention group was 2X as successful as the Cetaphil group (36% vs. 19%) with respect to complete resolution.  Though not statistically significant likely due to low sample size, would you consider the results to be clinically significant?  How, if at all, would you incorporate these findings into your clinical practice?  How would you use their results in a future study?

  4. The authors created a composite score to determine adhesion severity. What do you think about the variables included in this score? How do you interpret the significance of this score?  

  5. The authors identify a significant limitation in their study, ie: adherence to treatment was collected only by patient report and treatment was not observed.  The authors state that the overall lower complete resolution rates of labial adhesions in this study might be a function of lack of adherence.  Do you agree?  Would there any way to mitigate this limitation as consistent observed therapy would be challenging to achieve?

Answer Key

 

Journal Club: October 2020

Creation of a Composite Score to Predict Adnexal Torsion in Children and Adolescents

Beth I. Schwartz MD, Jill S. Huppert MD, MPH, Chen Chen PhD, Bin Huang PhD, Jennifer L. Reed MD,MS

https://www.jpagonline.org/article/S1083-3188(17)30310-8/pdf

 

Questions:

  1. The authors state in the Materials and Methods that at the institution of study, ultrasound protocol includes evaluation of Doppler flow of the adnexa, but that this is not always performed at outside institutions. What is the protocol for imaging at your institution and is Doppler always performed?

  2. Classification and regression tree (CART) decision method analysis was used to determine appropriate cut off points for risk ratios. Describe why this predictive analytic test was used to determine cut off points for this study. Evaluate Table 1 and Table 2 and explain the CART decision tree results for adnexal volume and adnexal ratio for both premenarchal and menarchal subjects.

  3. Why was a receiver operating characteristic (ROC) curve analysis used in this study? Evaluate Figure 2 and explain the x and y axis of the figure. What does an area under the curve result of 0.9488 signify?

  4. What are limitations in diagnosing adnexal torsion? Consider reviewing ACOG Committee Opinion 783: Adnexal Torsion in Adolescents. How does this study strive to overcome barriers to diagnosis in comparison to past studies on adnexal torsion?

  5. What were the main independent predictors of adnexal torsion? What was not found to be an accurate predictor of torsion in this study? Will this change your clinical approach to these patients in the future?

  6. In the Discussion the authors state that the scoring system has been incorporated into clinical practice and give an explanation of parameters. Do you agree with the use of this scoring tool in clinical practice?

Journal Club: September 2020


Age of Menarche in a Longitudinal US Cohort

Frank M. Biro MD, Ashley Pajak MS, Mary S. Wolff PhD, Susan M. Pinney PhD, Gayle C. Windham PhD, Maida P. Galvaz MD MPH, Louise C. Greenspan MD, Larry H. Kushi ScD, Susan L. Teitelbaum PhD
J Pediatr Adolesc Gynecol 2018; 31(4): 339-345

https://www.jpagonline.org/article/S1083-3188(18)30212-2/fulltext

1. How might the results of the Breast Cancer and the Environment Research Program changes recommendations for adult cancer surveillance? What findings of the study suggest a potential change in the breast cancer susceptibility window?

2. What strategies did the authors use to overcome recall bias in this study?

3. Longitudinal studies, particularly when conducted prospectively, have numerous advantages and disadvantages. Discuss the benefits and drawbacks of performing longitudinal research, including the specific biases that may arise.

4. Table 4 includes several historical studies on breast development, menarche, and imputed tempo. Study designs for these investigations were either cross-sectional or longitudinal. Discuss the differences between these two study designs. In addition, this study was a longitudinal observational study, however longitudinal research can also be repeated cross-sectional studies. Describe the differences between these methodologies. What methodology would you argue is superior for the objectives of this study?

5. There are a number of covariates that can impact the onset of menarche. As a clinician who cares for young patients entering puberty, what covariates might you expect?

6. The data is stratified by race, location and BMI%. What interactions could be present between these variables? What secondary analysis could you consider performing to evaluate for these?

7. A 7 year old patient presents to your clinic with her parents. Her mother’s family has a strong history of breast cancer and she has read this study. She knows there is a drug available which will “pause puberty.” She wants to start this medication for her child as she and her sisters and mother all had menarche at 9 and she wants to limit this one risk factor for her daughter. How would you counsel her?

8. Based on the results of this study, what advice would you give to the parents of a pre-pubertal girl with T2 breast development, regarding the timing of menarrche?



Journal Club: April 2020

 

Article: Evaluation and Management of Primary Ovarian Insufficiency in Adolescents and Young Adults

Rula V. Jang MD, Nana Ama Ofei-Tenkorang BS, Mekibib Altaye PhD, Catherine M. Gordon MD, MSc. J Pediatr Adolesc Gynecol 2018;31:13-18.

https://www.jpagonline.org/article/S1083-3188(17)30314-5/pdf 

 

Questions:

 

1.Discuss the evaluation for Primary Ovarian Insufficiency (POI) that you perform at your institution. Review the American College of Obstetricians and Gynecologists’ Committee Opinion No. 605 (see Obstet Gynecol 2014;123:193-7),or whichever POI guideline you utilize in your field of practice. Do you follow the recommendations included in the guideline at your institution?

  2. Only 48% of patients met strict inclusion criteria for POI. Discuss how the inclusion and exclusion criteria influenced the makeup of the final sample. Discuss how this can affect the sensitivity and specificity of applying their recommendations to your practice. What do you think about the inclusion of Turner Syndrome but exclusion of other DSD? Discuss how these factors that may influence standardizing the evaluation for POI. 

 3.The demographic characteristics of patients with POI included diverse Tanner staging and menarchal status. Discuss the symptoms and signs that would prompt you to a more rapid evaluation for POI.

 4. The authors defined low bone mineral density on the basis of the 2013 International Society for Clinical Densitometry. Define Z-scores and T-scores, and discuss how the use of different scores, or using the classification of ‘osteopenia’ and ‘osteoporosis,’ might impact the evaluation and management of adolescents with POI.

 5. This study was a retrospective review of patients at a large tertiary care center. What are the implications of doing this study in a tertiary center? Discuss how care for POI might be different in a rural environment, including the pros and cons of burden on the patient, system, and access to subspecialty services.  

 6.The article discusses the major emotional effect of a POI diagnosis, and yet so few women were provided a psychosocial referral. Discuss how to improve the emotional support for adolescents with POI. What system-based and clinic-based changes would you make?

 7. There are different ways to present descriptive statistics of continuous numerical data (e.g. means, medians, standard deviations, 95% confidence intervals and ranges). Discuss the factors that should be considered when selecting the best method to represent a particular data set. Discuss how the utilization of one method may bias the interpretation of data. The authors chose to represent their data utilizing means and standard deviations. Do you agree with this choice, why or why not?

 

Additional references:

1. Gordon CM, Kanaoka T, Nelson LM. Update on primary ovarian insufficiency in adolescents. Curr Opin Pediatr. 2015;26(4):511-519.

 2. Covington SN, Hillard PJ, Sterling EW, Nelson LM. A Family Systems Approach to Primary Ovarian Insufficiency. J Pediatr Adolesc Gynecol. 2011;24:137-141.

 3. Tips and Tools for Talking POI