Pictorial Blood Loss Assessment Chart PBAC a measure

Pictorial Blood Loss Assessment Chart (PBAC): a measure to assess the effectiveness of endometrial ablation for HMB Author(s): LIanghe CHEN 1, Kendra, TANG 1, Menglan, ZHANG 1, Naveeshini, NAIR 1 Xinxin, HUANG 1 , Jingqiu, LI 1, Thiam Chye, TAN 2 Academic Affiliation: 1 Duke‐NUS, Graduate Medical School, Medical Student 2 Duke‐NUS, Graduate Medical School, Associate Professor

2 Outline 1. Introduction a. Definition of HMB b. Treatment options ‐ Endometrial ablation c. PBAC score 2. Materials and methods a. Inclusion Criteria b. Outcome Measures c. Statistical Analysis 3. Results 4. Discussion a. Applicability b. Current literature 5. Take-Home Message 6. References

3 Introduction: Heavy Menstrual Bleeding • HMB is cyclic (ovulatory), heavy bleeding • Definition: • Blood loss > 80 ml per menstruation, menstrual duration > 7 days. • Interferes with a woman’s physical, social, emotional and material quality of life • Can occur alone or in combination with other symptoms

4 Introduction: Treatment options Medical 1. Non-hormonal a. Tranexamic acid b. NSAIDs 1. Hormonal a. COC b. Progesterone‐only ○ Mirena, Depot, oral Surgical 1. Endometrial ablation a. 1 st generation (resectoscopic) b. 2 nd generation (non‐resectoscopic) i. Bipolar radiofrequency ii. Microwave iii. Hot liquid filled balloons iv. Cryoablation v. Circulating hot water (hydrothermal) 2. Hysterectomy *If HMB is secondary, treatment of primary etiology should be initiated first. (endocrinopathies, structural lesions)

5 Introduction: PBAC Score

6 Introduction: PBAC Score

7 Introduction: PBAC Score Total score = 258

8 Introduction: PBAC score • Most studies use score >150 to define HMB • PBAC score > 150 – Has significant prediction value for HMB (>80 ml) – M. S. Zakherah et al. 20111 Kappa value of 0. 593 (95% CI 0. 480– 0. 687) compared to alkaline hematin method (gold standard)

9 Journal Article

10 Study Design: Overview • Retrospective cohort study (n= 900 ) • Investigated if the PBAC score at 12 months after endometrial ablation is associated with patient satisfaction and reintervention rates

11 Study Design: Study population Selection pool • Database of raw individual patient data from 22 RCTs regarding endometrial ablation • Initially formed by Birmingham Clinical Trials unit • Updated by investigators to include trials up to Nov 2013 • Raw individual patient data from 9 trials eventually included – Sample size n = 900

12 Study Design: Study population Eligibility criteria Inclusion criteria 1. 2 nd‐Generation endometrial ablation 1. PBAC Scores a. Baseline b. Follow‐Up Exclusion criteria 1. 1 st‐Generation endometrial ablation

13 Study Design: Methods Data collection Start Endometrial ablation 1. Baseline PBAC score 12 months Outcome measures 1. PBAC score 2. Satisfaction (Yes/No) 3. Surgical reintervention (Yes/No) • Hysterectomy or re‐ablation

14 Study Design-Critique 1. Study population Strengths • Large sample size, n= 900 • Multinational • 2 nd gen: More clinically relevant

15 Study Design-Critique 1. Study population Weakness • Multiple confounding factors – Different ablation techniques – Inter‐indiv variability of clinicians carrying out technique

16 Study Design: Critique 2. Methods/outcome measures i. Follow‐up – Data from different follow‐up points were used (12 months vs 6 months) – 12 months an appropriate follow‐up time point? i. Surgical reintervention rates at 12 months not clearly defined – Decided at 12 month follow‐up OR – Done within first 12 months of treatment – Did not take into account medical reintervention – Could refine eligibility criteria

17 Study Design: Critique 2. Methods/outcome measures i. Follow‐up – Data from different follow‐up points were used (12 months vs 6 months) – 12 months an appropriate follow‐up time point? i. Surgical reintervention rates at 12 months not clearly defined – Decided at 12 month follow‐up OR – Done within first 12 months of treatment – Did not take into account medical reintervention – Could refine eligibility criteria

18 Study Design: Critique 2. Methods/outcome measures iii. Satisfaction – Different satisfaction scales used in different trials simplified to binary yes/no iii. PBAC score – No standardization of type of pads used across trials – Great inter‐indiv variability in assessing PBAC score

19 Study Design: Statistical analysis • Box and whisker plot • Logistic regression analysis • Receiver operating curve analysis

20 Results Box‐and‐whisker plot expressing the distribution of absolute PBAC scores at 12 months, in relation to re‐intervention and satisfaction.

21 Results -- ROC Curve AUC = 0. 93 Satisfaction AUC = 0. 93 Re-intervention Receiver Operating Characteristic curve with regard to satisfaction and re‐intervention at 12 months of follow‐up for possible PBAC cutoff points.

22 Results -- ROC Curve AUC = 0. 92 Satisfaction AUC = 0. 92 Re-intervention Receiver Operating Characteristic curve with regard to re‐intervention and satisfaction at 12 months of follow‐up for possible PBAC reduction (%) cutoff points.

23 Critique - Results • Logistic regression – Was performed to predict the probability of satisfaction and re ‐intervention at the 12‐month follow‐up using PBAC score – Appropriate for dichotomous Variable (Yes/No) – However adjustment of logistic regression gave unreliable results. – Author didn’t provide explanation – How reliable the PBAC score can be as an evaluation tool? • Eight different second-generation ablation techniques were used in the nine different trials

24 Critique - Results • Satisfaction -- a subjective parameter Busfield 2005 phone interview asking about satisfaction (excluded) Brun 2006 To evaluate the satisfaction rate at each consultation: excellent, good, moderate, bad Hawe 2003 procedural satisfaction: very satisfied, dissatisfied, very dissatisfied Penninx 2010 satisfaction about treatment result: completely satisfied, doubtful and not‐satisfied Bongers 2004 satisfaction with treatment results, completely satisfied, doubtful satisfied or not satisfied

25 Critique - Results • Satisfaction -- a subjective parameter – Lack of follow up on reasons for satisfaction / dissatisfaction Due to continued HMB? Post ‐procedure complication e. g. infection? – Certain studies use other evaluation tool to evaluate treatment outcome e. g. quality of life questionnaire – Hawe 2003: Patient satisfaction results at 12 months are more biased than those seen at 6 months due to a reduction in responses from women who had repeat surgery. – Is amenorrhea a satisfying outcome?

26 Discussion • Percentages of PBAC score is significantly associated with satisfaction and re‐intervention rates. • PBAC demonstrated to have high accuracy for both treatment outcomes. • Proposal to use the PBAC in research as a primary endpoint in studies on HMB, and in clinical practice as a measure to assess the effectiveness of treatment.

27 Critique Discussion • Accurate application of PBAC requires specific instructions and accuracy is highest when a medical professional reviews the documentation with the patient. • The interindividual variation was high, and the intraindividual variation was low. (Hald et al) • Authors were unable to compare the PBAC results with the actual volume of blood loss – Objective assessments such as Hb levels could be used

28 Critique Discussion NICE guidelines 2007 -updated 2016 Assessing HMB

29 Comparison with Previous Trials 1. Although PBAC has been used before in evaluating and comparing different treatment options for heavy menstrual bleeding, PBAC has not been evaluated before as an evaluation tool. 2. Similar to this study, improvement in blood loss is the most commonly used criteria in evaluating treatment outcome after second generation endometrial ablation. 3. Other factors including quality of life, satisfaction, and reintervention have also been used to evaluate treatment outcome.

30 Take Home Message PBAC score is a potential universal evaluation tool for assessing treatment outcome of HMB by second generation endometrial ablation, but its validity remains to be studied.

31 References 1. 2. 3. 4. 5. 6. 7. 8. Zakherah MS, Sayed GH, El‐Nashar SA, Shaaban MM. Pictorial blood loss assessment chart in the evaluation of heavy menstrual bleeding: Diagnostic accuracy compared to alkaline hematin. Gynecol Obstet Invest 2011; 71: 281– 4. Coulter A, Kelland J, Peto V, et al. Treating menorrhagia in primary care: An overview of drug trials and a survey of prescribing practice. International Journal of Technology Assessment in Health Care 1995; 11(3): 456– 71. Lethaby A, Farquhar C, Cooke I. Antifibrinolytics for heavy menstrual bleeding. (Cochrane Review). In: Cochrane Database of Systematic Reviews, Issue 4, 2004. Oxford: Update Software. Wellington K, Wagstaff AJ. Tranexamic acid: a review of its use in the management of menorrhagia. Drugs 2003; 63(13): 1417– 33 Lethaby A, Augood C, Duckitt K. Non‐steroidal anti‐inflammatory drugs for heavy menstrual bleeding. (Cochrane Review). In: Cochrane Database of Systematic Reviews, Issue 3, 2004. Oxford: Update Software. Fraser IS, Mc. Carron G. Randomized trial of 2 hormonal and 2 prostaglandin‐inhibiting agents in women with a complaint of menorrhagia. Australian and New Zealand Journal of Obstetrics and Gynaecology 1991; 31(1): 66– 70. Nelson AL, Sampson‐Landers C, Parke S, Jensen J. Efficacy of estradiol valerate/dienogest OC: results of 3 large studies in North America and Europe. Abstract plus poster presentation at 57 th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists; May 2‐ 6, 2009; Chicago, IL, USA. Irvine GA, Campbell‐Brown MB, Lumsden MA, et al. Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia. British Journal of Obstetrics and Gynaecology 1998; 105(6): 592– 8.

32 References 8. Cooper et al (2003) “Five year follow up of women randomized to medical management or trans cervical resection of the myometrium for heavy menstrual loss: clinical and quality of life outcomes” Br J Obs and Gyn, 108(12), pp 1222‐ 1228 9. Assessment of Periodic Blood Loss: Interindividual and Intraindividual Variations of Pictorial Blood Loss Assessment Chart Registrations Hald, Kirsten et al. Journal of Minimally Invasive Gynecology , Volume 21 , Issue 4 , 662 ‐ 668

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