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1 Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Ireson J, Jones G, Winter MC, Radley SC, Hancock BW, Tidy JA. Systematic review of health-related quality of life and patient-reported outcome measures in gestational trophoblastic disease: a parallel synthesis approach. Lancet Oncol 2018; 19: e56 64.
2 Web Appendices Table I: Summary of PROMs used in included studies Study Purpose/aim of the study PROMs used Berkowitz et al. (1980) 1 Assess the psychological and social impact of GTN on patient s self image, Study specific marital relationship and future pregnancy plans Wenzel et al. (1992) 2 Further evaluate the presence, type, and magnitude of psychological, social POMS: Profile of Mood states and sexual stressors following GTD diagnosis and treatment. COPE: Ways of Coping Scale Dyadic Adjustment Scale Cervical Cancer Study Questionnaire Psychosocial Response to Illness Scale To describe the quality of life and long term psychosocial sequelae in women IES: Impact of Event Scale diagnosed with GTT SF 26 MHS: Short Form 36 mental health subscale MO SF 36 Medical Outcomes SF 36 QoL-CS: QoL Cancer Survivorship Scale ISEL: Interpersonal Support and Evaluation List SAQ: Sexual Activity Questionnaire + institutionally developed checklist Institutionally developed reproductive checklist FACIT-Sp: Functional Assessment of Chronic Illness Therapy Spiritual Well Being Scale Zhao et al. (2003) 4 Evaluate the QoL in Chinese cancer patients under chemotherapy and to explore the discrepancy between patients and nurses assessments of the EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 patients conditions Hengrasmee et al. Determine the prevalence of depression and associated risk factors among HSHR Health related self report; adapted from CES-D (2004) 5 gynecological patients in a tertiary hospital in Thailand Petersen et al. (2005) 6 To evaluate using validated questionnaires the impact of molar pregnancy on HADS: Hospital Anxiety and Depression scale quality of life, psychological symptoms, and sexual functioning SWLS- Satisfaction with Life Scale SHF-12 Sexual History Form Cagayan (2008) 7 Examined the impact of GTN therapy on women s sexuality Study specific Carter et al. (2009) 8 To empirically assess and describe the emotional, sexual, and physical impact CES-D Center for Epidemiologic Studies Depression Scale of cancer-related infertility on gynaecologic cancer survivors IES Impact of Event Scale FSFI: Female Sexual Function Index MSC: Menopausal Symptom Checklist Ferreira et al. (2009) 9 Assess QoL and psychological factors in patients with GTD, WHOQOL-BREF World Health Organisation Quality of Life BDI: Beck Depression Inventory STAI: State-Trait Anxiety Inventory Cagayan & Llarena Evaluate QoL of patient diagnosed with GTN in remission SF-12: Short Form-12 (2009) 10 Lok et al. (2011) 11 Investigate the psychologic consequences of weekly and monthly hcg measurements in patients with low risk GTD Study specific 1
3 Stafford & Judd (2011) 12 Stafford et al. (2011)13 Wilailak et al. (2011) 14 Leenharattanarak & Lertkhachonsuk (2014) 15 Di Mattei et al. (2015) 16 Di Mattei et al. (2016) 17 Report on the perceptions of causes and treatment of GTD and its impact on fertility and reproductive outcomes Investigation of the prevalence and nature of psychological, sexual and marital morbidity outcomes after GTD Compare quality of life of disease-free patients after therapy for gynecological malignancies at follow up in comparison with healthy check up patient Assess quality of life in women diagnosed with GTN and remission after treatment, and to determine factors that may affect QoL status To evaluate the psychological impact of GTD focusing on perceived fertility, depression and anxiety Evaluating how patients perceive their illness during the B-hCG follow up period after GTD diagnosis Study specific CES-D Center for Epidemiologic Studies Depression Scale HADS-A Hospital Anxiety and Depression scale IES-R Impact of Event Scale Revised FSFI Female Sexual Function Index Marital Satisfaction Scale MSS Study specific FACT-G Functional Assessment of Cancer Therapy - General FACT-G Functional Assessment of Cancer Therapy - General STAI-Y State-Trait anxiety inventory BDI-SF Beck Depression Scale-Short Form FPI Fertility problem inventory IPQ-R: Illness Perception Questionnaire Revised 2
4 Table II: Summary of psychometric properties of validated PROMs in GTD Study Instrument Items Areas Psychometric Properties Leenharattanarak & FACT G Functional 27 Physical well being, social/family well being, emotional well being, and functional well being R + V Lertkhachonsuk (2014) 15 Wilailak et al. (2011) 14 Assessment of Cancer Therapy General FACIT-SP Functional 12 Sense of meaning, harmony, peacefulness, sense of strength and comfort R + V Assessment of Chronic Illness- Spiritual Well Being Ferreira et al. (2009) 9 WHOQOL World Health 26 Physical health, psychologic health, social relationships and environment R + V Organisation Quality of Life MO SF-36 Medical Outcomes 36 Physical functioning, role limitations, bodily pain, social functioning, general mental health, vitality R + V Short Form 36 and general health perceptions Wenzel et al. (1992) 2 Profile of Mood states 65 Mood states of tension, anger, fatigue, depression, confusion and vigor. V Wenzel et al. (1992) 2 Dyadic adjustment scale 32 Dyadic cohesion, dyadic satisfaction, dyadic consensus and affectional expression R + V Carter et al. (2009) 8 IES Impact of Event Scale QoL-CS QoL Cancer Survivorship Scale ISEL Interpersonal Support Evaluation List SAQ Sexual Activity Questionnaire 15 Cancer specific distress, Avoidance and intrusion subscales R 46 Four QoL domains: physical, psychological, social and spiritual well-being R + V 40 Social support R + V 23 Desire, frequency, satisfaction, dryness of vagina and penetration R + V COPE Ways of Coping Scale 24 Adaptive subscale - Active coping, emotional support, positive reframing, planning, humor, acceptance, religion, Maladaptive subscale - venting, distraction, denial, substance abuse, behavioural disengagement Di Mattei et al. (2015) 16 Ferreira et al. (2009) 9 BDI Beck Depression Inventory STAI State-Trait Anxiety Inventory 21 Cognitive-affective and somatic symptoms of depression R + V Di Mattei et al. (2015) 16 Ferreira et al. (2009) 9 20 State subscale -measures anxiety related to a particular situation or time period Trait subscale-relatively stable anxiety Di Mattei et al. (2015) 16 FPI Fertility Problem Inventory 46 Perceived infertility related stress, five domains social concern, sexual concern, relationship concern, need for parenthood and rejection of childfree lifestyle. Global stress = summing the scores across all five domains Carter et al. (2009) 8 Carter et al. (2009) 8 CES-D Centre for Epidemiological Studies Depression Scale FSFI Female Sexual Functioning Index 20 Symptoms of depression R + V 19 Sexual desire, arousal, lubrication, orgasm, pain and satisfaction R + V V R + V R + V 3
5 Carter et al. (2009) 8 Di Mattei et al. (2016) 17 Petersen et al. (2005) 6 Petersen et al. (2005) 6 Petersen et al. (2005) 6 Zhao et al. (2003) 4 Menopausal Symptom Checklist Illness Perception Questionnaire HADS-A Hospital Anxiety and Depression SWLS Satisfaction with Life Scales MSS Marital Satisfaction scale SHF-12 Sexual History Form 12 EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 36 Impact of menopausal symptoms 14; 38; 18 Identity scale the no of symptoms & perceived relation to illness. Opinions of illness scale duration, consequences, control, understanding Causes scale explanations patients use stress or worry, hereditary causes, chance or bad luck 7 Anxiety subscale R + V + SC Depression subscale 5 General life satisfaction, subjective well-being R + V 14 Homogamy, general satisfaction, interpersonal interaction R + V 12 Frequency, desire, arousal, orgasm, pain, sexual satisfaction for men and women R + V 30 Functional subscales- physical, role, cognitive, emotional, and social. Symptom subscale fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance and diarrhoea, perceived financial impact R + V R + V + SC R= evidence of reliability; V=evidence of validity; SC= evidence of sensitivity to change. 4
6 References 1. Berkowitz RS, Marean AR, Hamilton N, Bernstein M, Engle Jr RP, Sandman G, Goldstein DP. Psychological and Social Impact of Gestational Trophoblastic Neoplasia. The Journal of Reproductive Medicine, July; 25(1): Wenzel L, Berkowitz R, Robinson S, Bernstein M, Goldstein, D. The psychological, social, and sexual consequences of gestational trophoblastic disease. Gynecologic Oncology, (1): Wenzel L, Berkowitz RS, Newlands E, Hancock B, Goldstein DP, Seckl MJ, Habbal R, Bernstein M, Kluhsman B, Kulchak-Rahm A, Strickland S. Quality of life after gestational trophoblastic disease. The Journal of Reproductive Medicine, (5), pp Zhao H, Kanda K, Liu SJ, Mao XY. Evaluation of quality of life in Chinese patients with gynaecological cancer: assessments by patients and nurses. International journal of nursing practice Feb 1; 9(1): Hengrasmee P, Padungsutt P, Boriboonhirunsarn D. Depression among gynecologic cancer patients at Siriraj Hospital: prevalence and associated factors. Journal of the Medical Association of Thailand Oct; 87:S Petersen RW, Ung K, Holland C, Quinlivan JA. The impact of molar pregnancy on psychological symptomatology, sexual function, and quality of life. Gynecologic Oncology May 31; 97(2): Cagayan MS. Sexual dysfunction as a complication of treatment of gestational trophoblastic neoplasia. The Journal of Reproductive Medicine Aug; 53(8): Carter J, Chi DS, Brown CL, Abu-Rustum NR, Sonoda Y, Aghajanian C, Levine DA, Baser RE, Raviv L, Barakat RR. Cancer-related infertility in survivorship. International Journal of Gynecological Cancer Jan 1; 20(1): Ferreira EG, Maestá I, Michelin OC, de Paula, RC, Consonni M, and Rudge, MV. Assessment of quality of life and psychologic aspects in patients with gestational trophoblastic disease. The Journal of Reproductive Medicine Oct; 54(4): Cagayan MS, Llarena RT. Quality of life of gestational trophoblastic neoplasia survivors: a study of patients at the Philippine General Hospital trophoblastic disease section. The Journal of Reproductive Medicine Dec; 55(7-8): Lok CA, Donker M, Calff MM, Massuger LF, Ansink AC. Psychologic impact of follow-up after low-risk gestational trophoblastic disease. The Journal of Reproductive Medicine Dec; 56(1-2): Stafford L, Judd F. What do women with gestational trophoblastic disease understand about the condition? International Journal of Gynecological Cancer Jan 1; 21(1):
7 13. Stafford L, McNally OM, Gibson P, Judd F. Long-term psychological morbidity, sexual functioning, and relationship outcomes in women with gestational trophoblastic disease. International Journal of Gynecological Cancer Oct 1; 21(7): Wilailak S, Lertkhachonsuk AA, Lohacharoenvanich N, Luengsukcharoen SC, Jirajaras M, Likitanasombat P, Sirilerttrakul S. Quality of life in gynecologic cancer survivors compared to healthy check-up women. Journal of Gynecologic Oncology Jun 30; 22(2): Leenharattanarak P, Lertkhachonsuk R. Quality of life in gestational trophoblastic neoplasia patients after treatment in Thailand. Asian Pacific Journal of Cancer Prevention. 2014; 15(24): Di Mattei VE, Carnelli L, Bernardi M, Bagliacca EP, Zucchi P, Lavezzari L, Giorgione V, Ambrosi A, Mangili G, Candiani M, Sarno L. An investigative study into psychological and fertility sequelae of gestational trophoblastic disease: the impact on patients perceived fertility, anxiety and depression. PloS one Jun 1; 10(6): e Di Mattei VE, Carnelli L, Mazzetti M, Bernardi M, Di Pierro R, Bergamini A, Mangili G, Candiani M, Sarno L. Mental representations of illness in patients with gestational trophoblastic disease: how do patients perceive their condition?. PloS one Apr 21;11(4):e
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