Guidelines on the Management of Complications related to Female Genital Mutilation Scoping Survey Instructions The following is a list of 33 potential questions which could guide the evidence retrieval to formulate the recommendations included in the guideline. These questions were developed using the PICO question format a formula for developing answerable, researchable questions. This makes the process of finding and evaluating evidence much more straightforward. A well-built PICO question should include four parts, the patient problem or population (P), intervention (I), comparison (C) and outcomes (O). From these potential questions, we will include up to 10 final questions for the evidence retrieval. In order to identify the questions to be included, please read through each question, including the outcomes, and rate the importance of the entire contents of the question on a 9-point scale ranging from 9 (critical) to 1 ( ), as shown below: 7 9 critical and should definitely be included in the guidelines 4 6 but critical 1 3 and should be included in the guidelines By virtue of participating in this consultation you agree that your responses will be compiled and tallied. All responses will be analysed as a group and will be identified by individual. If you have any comments about a question or its selected outcomes, or you consider other outcomes should be included, please add them in the comments box included in each question. The survey should take approximately 15 minutes of your time. 1. Download and save the attached PDF file on to your computer; 2. Open the PDF file from your computer and respond to the questions; 3. Save your responses, and attach the file in your reply e-mail to rhr_monitoring_eval@who.int (no printing, or scanning is required). If you have any questions regarding this survey, please contact Dr Karin Stein at rhr_monitoring_eval@who.int Many thanks for your time and participation in our survey. 1
Guidelines on the Management of Complications related to Female Genital Mutilation Scoping Survey Question 1 De-infibulation For the guideline this question is: 1 De-infibulation In women and girls living with FGM type III, does de-infibulation compared to no treatment result in: Outcomes: Increased patient satisfaction Decreased genital infections Decreased acute dyspareunia Decreased chronic vulvar/clitoral pain Improved obstetric outcomes (detailed list of outcomes in Area 4) - Bleeding (intra-operative and post-operative) - Wound infection - Pain Question 2 Procedure: Surgical technique For the guideline this question is: For women and girls living with FGM type III who require de-infibulation, does surgical technique 1 e.g. laser de-infibulation compared to other surgical techniques e.g. cutting diathermy de-infibulation OR scissor deinfibulation result in: Outcomes: Increased patient satisfaction Improved wound healing Adverse effects (rate of): - Bleeding (intra-operative and post-operative) - Wound infection - Pain but critical but critical 2
Question 3 Procedure: Suturing technique For the guideline this question is: For women and girls living with FGM type III who require de-infibulation, does the use of interrupted sutures compared to the use of continued sutures result in: Outcomes: Increased patient satisfaction Improved wound healing - Bleeding (intra-operative and post-operative) - Wound infection - Pain but critical Question 4 Procedure: Anaesthesia for women undergoing de-infibulation For the guideline this question is: 1 De-infibulation For women and girls living with FGM type III who will undergo de-infibulation, does local anaesthesia with Lidocaine compared to regional anaesthesia OR general anaesthesia OR monitored anaesthesia care (MAC) result in: Outcomes: Increased patient satisfaction Decreased level of pain during surgical procedure - Anaesthetic adverse events but critical Question 5 Procedure: Analgesia for women who have undergone de-infibulation For the guideline this question is: For women and girls who have undergone de-infibulation, does the post-operative administration of oral analgesic 1 compared to the post-operative administration of oral analgesic 2 result in: Outcomes: Increased patient satisfaction Decreased level of pain after surgical procedure - Medication adverse side effects (e.g. gastrointestinal intolerance; hypersensitivity) but critical 3
Question 6 Post-operative care: Prevention of labial fusion For the guideline this question is: In women and girls living with FGM type III who have undergone de-infibulation, does self-detachment of the edges of de-infibulated labia 3-4 times per day as compared to any self-applied post-operative care performed by women as usual result in: Outcomes: Reduction of post-operative spontaneous labial fusion - Bleeding (post-operative) - Wound infection - Pain but critical Question 7 Post-operative care: Pain during micturition after de-infibulation For the guideline this question is: 1 De-infibulation For women and girls living with FGM type III who have undergone de-infibulation, does urinating under a stream of running water/in a sitz bath during the first 7 days post-operation compared to standard cleaning and drying result in: Outcomes: Decreased burning/pain during micturition in the immediate post-operative period - Bleeding (post-operative) - Wound infection - Pain but critical Question 8 Post-operative care: Wound healing For the guideline this question is: In women and girls living with FGM type III who have undergone de-infibulation, does the use of post-operative topical estrogen cream 0.06% for 21 days compared to treatment as usual result in: Outcomes: Improved wound healing - Bleeding (post-operative) - Wound infection - Pain but critical 4
Question 9 Counselling for de-infibulation For the guideline this question is: 1 De-infibulation For women and girls living with FGM type III, does the inclusion of the male partner during counselling for de-infibulation compared to the non-inclusion of the male partner result in: Outcomes: Increased patient satisfaction (post-procedure) Increased acceptance of procedure Decreased rate of re-infibulation requests (e.g. after delivery) - Marital disharmony (marital satisfaction scale) - Loss of patient follow-up but critical Question 10 Acute infection For the guideline this question is: For women and girls that seek medical care within the first 7 days after being subjected to FGM, does the provision of prophylactic broad spectrum antibiotics compared to no prophylaxis reduce the incidence of: Outcomes: Local infection; cellulitis; abscess Sepsis Hospitalization rate Local vulvar fibrosis (as a result of infection) but critical 2 Infectious complications - Side effects of antibiotics (fungal infection, diarrhoea, other) - Anaphylaxis - Allergy Question 11 Route of administration of antibiotics in case of vulvar abscess/local infection For the guideline this question is: In women and girls that present with local wound infection/vulvar abscess after being subjected to FGM, does the oral administration of broad spectrum antibiotics (e.g. 3rd generation Cephalosporins) compared to intravenous administration of broad spectrum antibiotics result in: Outcomes: Increased infection resolution (defined as 24 hours of absence of fever) Decreased hospitalization rate Decreased local vulvar fibrosis (as a result of infection) - Side effects of antibiotics (fungal infection, diarrhoea, other) - Anaphylaxis - Allergy but critical 5
Question 12 Recurrent urinary tract infections (UTIs) For the guideline this question is: 2 For women and girls living with FGM type III who present with recurrent urinary tract infections (UTIs), does de-infibulation compared to the provision of standard UTI antibiotic treatment result in: Outcomes: Reduction of chronic urinary tract infections - Side effects of antibiotics (fungal infection, diarrhoea, other) - Anaphylaxis - Allergy but critical Question 13 Recurrent vaginitis For the guideline this question is: Infectious complications For women and girls living with FGM type III who present with recurrent vaginitis (e.g. bacterial vaginosis; candidiasis), does de-infibulation compared to the provision of standard vaginitis antibiotic/antimicotic treatment result in: Outcomes: Reduction of recurrent vaginitis - Side effects of antibiotics (fungal infection, diarrhoea, other) - Anaphylaxis - Allergy but critical 6
Question 14 FGM types I, II and IV: Surgical excision of scar tissue For the guideline this question is: 3 Vulvar pain/ clitoral pain For women and girls living with FGM types I, II and IV that present with vulvar pain/clitoral pain, does the surgical excision of scar tissue/surgical excision of scar tissue + clitoral reconstruction compared to psychotherapy alone OR no treatment result in: Outcomes: Relief of pain symptoms (numerical pain scale) Increased patient satisfaction Improved FSFI score* - Worsening of pre-operative complaints - Bleeding (intra-operative and post-operative) - Wound infection - Haematoma - Post procedure pain *Female Sexual Function Index (FSFI): is a 19 item self-report measure of sexual function (including sexual desire, arousal, orgasm, pain, and satisfaction). The questionnaire has been validated and translated for use in different populations including women with a history of FGM. but critical Question 15 FGM type III: De-infibulation For the guideline this question is: In women and girls living with FGM type III that present with chronic vulvar pain, does de-infibulation plus psychotherapy compared to de-infibulation alone OR psychotherapy alone result in: Outcomes: Relief of pain symptoms (numerical pain scale) Increased patient satisfaction Improved FSFI score but critical - Worsening of pre-operative complaints - Bleeding (intra-operative and post-operative) - Wound infection - Haematoma - Post procedure pain 7
Question 16 FGM types I, II and IV: Use of topical Lidocaine gel For the guideline this question is: 3 Vulvar pain/ clitoral pain In women and girls living with FGM types I, II and IV that present with chronic vulvar pain/clitoral pain, does the use of local topical Lidocaine gel compared to oral pain medications OR no treatment result in: Outcomes: Relief of pain symptoms (numerical pain scale) Increased patient satisfaction Improved FSFI score - Worsening of pre-treatment complaints - Drug reaction but critical 8
Question 17 Timing of de-infibulation For the guideline this question is: In pregnant women and girls living with FGM type III, does de-infibulation during pregnancy compared to intra-partum de-infibulation result in: but critical 4 Obstetric care of women with history of FGM Outcomes: Maternal Decreased perineal lacerations during delivery Decreased duration of labour Decreased Infectious complications rate Decreased haemorrhagic events Decreased need for blood transfusion Change in mode of delivery (vaginal/c-section) Decreased rate of episiotomy Decreased level of pain during delivery Decreased rate of maternal death Improvement of maternal experience of delivery Neonatal Decreased neonatal morbidity (e.g. asphyxia, infections, birth trauma) Decreased admission to neonatal intensive care Decreased need for neonatal resuscitation Decreased rate of stillbirth or neonatal death Question 18 Post-partum Care For the guideline this question is: In women and girls living with any type of FGM, does the practice of Kegel Exercises* during the postpartum period compared to post-partum care as usual result in: Outcomes: Decreased rate of post-partum urinary incontinence Decreased requests for re-infibulation (for FGM type III) Better self-knowledge of genitalia but critical *Kegel exercises are pelvic floor exercises that consist on repeatedly contracting and relaxing the muscles that form part of the pelvic floor. 9
Question 19 Clitoral reconstruction For the guideline this question is: For women living with any kind of FGM, does clitoral reconstruction + sexual counseling compared to clitoral reconstruction alone OR sexual counseling alone OR no treatment, result in: Outcomes: Improvement of post-operative FSFI score Improvement of patient satisfaction Decreased medico-legal complaints but critical 5 - Worsening of pre-operative complaints (e.g. hyperesthesia of the clitoris; dyspareunia) - Bleeding (intra-operative and post-operative) - Fever (wound infection) - Haematoma - Post-procedure pain Question 20 Clitoral reconstruction: Multidisciplinary information about surgical outcomes For the guideline this question is: Surgical procedures In women living with any type of FGM that request clitoral reconstruction, does the provision of multidisciplinary information (including information about surgical outcomes, sexual counseling, presentation of alternative treatment) compared to no multidisciplinary information result in: Outcomes: Change in rate of surgical procedure Improvement of post-operative FSFI score Improvement of patient satisfaction Decreased medico-legal complaints - Worsening of pre-operative complaints (e.g. hyperesthesia of the clitoris; dyspareunia) - Bleeding (intra-operative and post-operative) - Fever (wound infection) - Haematoma - Post-procedure pain but critical 10
Question 21 Supportive psychotherapy alongside clitoral reconstruction (traumatic life events) For the guideline this question is: 5 In women living with any type of FGM that request clitoral reconstruction, does the screening for traumatic life events other than FGM alongside psychological treatment compared to clitoral reconstruction alone result in: Outcomes: Change in rate of surgical procedure Improvement of post-operative FSFI score Improvement of patient satisfaction Change in rate of identified traumatic events other than FGM Change in post-operative pain scale - Worsening of pre-operative complaints (e.g. hyperesthesia of the clitoris; dyspareunia) - Loss of follow up but critical Surgical procedures Question 22 Supportive psychotherapy alongside any FGM-related surgical procedure For the guideline this question is: For women and girls who undergo Surgical procedures to correct complications of FGM, does supportive psychotherapy alongside the surgical procedure compared to no psychotherapy result in: but critical Outcomes: Reduced duration of the post operative recovery period Reduced need for post-operative analgesia Improved return to full functioning and participation in society - Stigma of having a mental illness and/or seeing a mental health professional 11
Question 23 Symptomatic keloids For the guideline this question is: 6 Long-term consequences In women and girls living with any type of FGM that have undergone keloid excision surgery in the vulvar area, does the post-operative use of infiltrated corticosteroids* as compared to post-operative use of silicon pads** result in: Outcomes: Decreased rate of keloid relapse - Worsening of pre-operative complaints (e.g. hyperesthesia of the clitoris; dyspareunia) - Bleeding (intra-operative and post-operative) - Fever (wound infection) - Haematoma - Post-procedure pain *1 per week x 2-5 times + 1 per month 3-6 times ** 18 hours per day for 3 months but critical 12
Question 24 Depression and/or anxiety disorders: Cognitive Behavior Therapy For the guideline this question is: For women and girls living with FGM diagnosed with depression and/or anxiety disorders in relation to FGM, does Cognitive Behavior Therapy (CBT) compared to no CBT result in: Outcomes: Reduction of symptom severity post-intervention and at follow up Improved functioning in society post-intervention and at follow up Presence of mental disorder post-intervention and at follow up but critical - Stigma of having a mental illness and/or seeing a mental health professional - Non efficacy of treatment - Worsening of symptoms - Dependence on therapist - Increase in suicidality Question 25 Depression and/or anxiety disorders: Pharmacological treatment For the guideline this question is: 7 Mental health For women and girls living with FGM, does psychotherapy (e.g. cognitive behavioral therapy; dialectical behavioral therapy; interpersonal therapy) compared to pharmacological treatment result in: Outcomes: Reduction of symptom severity post-intervention and at follow up Improved functioning in society post-intervention and at follow up Presence of mental disorder post-intervention and at follow up - Stigma of having a mental illness and/or seeing a mental health professional - Non efficacy of treatment - Worsening of symptoms but critical Question 26 Acute traumatic stress symptoms post FGM For the guideline this question is: For women and girls that present with acute traumatic stress symptoms in the first month after the performance of FGM, does cognitive psychotherapy compared to no treatment result in: Outcomes: Reduction of symptom severity post-intervention and at follow up Improved functioning in society post-intervention and at follow up Presence of mental disorder post-intervention and at follow up but critical - Stigma of having a mental illness and/or seeing a mental health professional - Non efficacy - Worsening of symptoms 13
Question 27 Sexual Counselling For the guideline this question is: In women living with any kind of FGM, does sexual counseling compared to no counseling result in: Outcomes: Improved FSFI score - Worsening of symptoms - Stigma - Marital disharmony (marital satisfaction scale) but critical Question 28 Male Sexual Health For the guideline this question is: 8 Sexual health For male partners of women living with FGM type III (infibulation), does de-infibulation (of infibulated female partner) result in: Outcomes: Improved Brief Male Sexual Functioning Inventory (BSFI)* Decrease of pain during sex in the male partner (numerical pain score) - Failure to produce expected outcomes (e.g. numerical pain score; BSFI score) - Worsening of symptoms - Stigma - Marital disharmony (marital satisfaction scale) *Brief Male Sexual Functioning Inventory (BSFI): is an 11-item report measure that covers 5 aspects of sexual functioning: sexual drive, erection, ejaculation, perception of problems with sexual function in each of these areas, and overall satisfaction. but critical Question 29 Dyspareunia For the guideline this question is: In women and girls living with FGM types I, II and IV* that present with superficial dyspareunia, does the use of water based lubricants during sexual intercourse compared to sexual education OR standard sexual practice result in: Outcomes: Improved FSFI score (includes questions about pain) - Worsening of symptoms - Stigma - Marital disharmony (marital satisfaction scale) but critical *Note: There is no scientific evidence that supports the use of lubricants in women with FGM type III that present with dyspareunia. 14
Question 30 Medical photography and pre-formatted diagrams For the guideline this question is: For pregnant women and girls living with FGM that seek pre-natal care, does the use of medical photography and/or pre-formatted diagrams (with patient consent) during the first antenatal care visit compared to standard reporting/registration result in: Outcomes: Improved patient satisfaction with antenatal care and/or delivery Improved healthcare provider s confidence in caring for women with FGM Increased rate of de-infibulation - Declining of medical examination - Loss of follow-up but critical Question 31 Health care provider s attitudes For the guideline this question is: 9 Health care services For health care providers caring for women and girls living with any type of FGM, does the provision of information on the consequences of FGM compared to no information result in: Outcomes: Improved patient satisfaction with care Improved healthcare provider s attitudes towards FGM (questionnaire) Improved rate of documentation Improved rate of correct diagnosis - Declining of medical examination - Loss of follow-up but critical Question 32 Interpreters For the guideline this question is: For women and girls living with FGM, does the use of certified interpreters compared to standard care with translation offered by a family member or a friend result in: Outcomes: Improved patient satisfaction with care Improved rate of documentation Improved rate of correct diagnosis Increased rate of de-infibulation but critical - Loss of follow-up 15
Question 33 Body image For the guideline this question is: 9 Health care services In women and girls living with FGM, does the provision of education and information* on anatomy/physiology offered by healthcare providers compared to standard gynaecological care result in: Outcomes: Improved Body Image Score Improved patient satisfaction with care Increased rate of de-infibulation Improved FSFI score Change in rate of clitoral reconstruction request - Declining of medical examination - Loss of follow-up *Information refers to explaining physiological changes (e.g. in micturition); cultural beliefs (e.g. non-infibulated genitalia are nor too wide or an uncut clitoris does grow); and education on anatomy (e.g. showing the clitoris under the scar). but critical If you consider any of the questions should be re-grouped into a single question and addressed in one broad systematic review, please list the question numbers here: If you are aware of unpublished studies which may be related to areas of recommendations for this guideline, please list the reference and contact persons here: Name Survey Respondents Characteristics (responding to the following questions is optional) Gender Female Male Country Workplace If other, please specify: Area of work If other, please specify: 16