Women's health

Adenomyosis

  • Development of disease-specific modules for adenomyosis

Contraception

  • PRO endpoint review in contraceptives
  • Manuscript publication on a monthly contraceptive device
  • Development of a PRO strategy in oral contraceptives and gynaecological therapies
  • Modification, development and validation of an existing tool in order to explore satisfaction and tolerability for an intrauterine device (IUD) versus oral contraceptives
  • Modification of the EVAPIL-R in order to explore tolerability for an intrauterine system (IUS) versus an implantable contraceptive
  • Linguistic validation of the EVAPIL-R questionnaire on tolerability of oral contraceptives
  • Expert panel meeting on an oral contraceptive

Endometriosis

  • Validation of ePRO endpoints and a regulatory dossier to support claims in endometriosis
  • Qualitative research in Europe and validation of ePRO endpoints to support product labelling claims in endometriosis
  • Development and validation of ePRO endpoints for use in endometriosis
  • Psychometric validation and communications for newly developed PROs in endometriosis
  • PRO instrument development in endometriosis
  • Manuscript on PRO development and validation in endometriosis
  • Endpoint validation and finalisation in endometriosis
  • Review of a revision of a psychometric validation report on endometriosis and in-person attendance at FDA meeting
  • Endometriosis symptom diary and impact scale communications strategy
  • Exploration of instrument scoring (following EMA CHMP advice), psychometric evaluation using data from clinical studies and development of instrument user manuals in endometriosis
  • Consultancy services for linguistic validation of an endometriosis symptom diary and endometriosis impact scale
  • Endpoint review and regulatory support regarding the suitability of the Biberoglu & Behrman Scale (B&B) and Endometriosis Health Profile-30 (EHP-30) for supporting US product labelling claims in endometriosis
  • FDA PRO dossier updates and the development of Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) user manuals
  • Review of a briefing book concerning a compound in development for the treatment of pain and other symptoms arising from endometriosis
  • Face and content validity of a new measure to assess symptoms associated with endometriosis
  • Development and face and content validation of a diary to assess symptoms associated with endometriosis
  • Development of disease-specific modules for endometriosis

Female sexuality and sexual desire

  • Focus study on the Female Sexual Desire Profile (FSDP) and Female Sexual Encounter Profile (FSEP)
  • Patient interviews and analysis/report on the FSDP and FSEP
  • Measurement of the impact of quality of life on female sexuality
  • Critical review of PROs in female sexual disorder
  • PRO endpoint review for a treatment for hypoactive sexual desire disorder (HSDD)
  • Validation of the Decreased Sexual Desire Screener (DSDS) in HSDD in Japan

Infertility

  • Development of a value dossier, health economic model and literature review in an infertility biosimilar to support pricing and reimbursement submissions in 15 EU countries
  • Workshop on the EU price strategy for a recombinant follicle stimulating hormone used for the treatment of infertility
  • Conference presentation of health economic data on infertility treatment
  • Pricing updates in Europe for a biosimilar hormone treatment for female infertility
  • Advisory board with two payers to appraise an infertility product for reimbursement

Menopause and hormone replacement therapy

  • Health economics on the menopause
  • Cost utility analysis of hormone replacement therapy (HRT)
  • Observational study of HRT
  • Cognitive debriefing of a women’s health screening tool
  • Consultancy on FDA documents on the menopause
  • Psychometric validation of the SAM/WSM using PNS validation study data
  • Literature review of HRT outcomes in the menopause
  • Development of a conceptual model for vasomotor symptoms in post-menopausal women
  • Trial of two drugs used to treat menopausal symptoms
  • Pilot testing of a paper hot flash diary and questionnaire on the menopause
  • Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms during the menopause
  • Development of a briefing document for measuring the impact of menopausal hot flushes
  • Development of a PRO for breast pain/pressure and vaginal bleeding/spotting for female patients on HRT
  • Manuscript reporting results of qualitative work to support development of a breast pain daily diary (BP-DD) and vaginal bleeding/spotting daily diary (VBS-DD)

Menstruation and dysmenorrhea

  • Provision of regulatory support for use of the Pictorial Blood Loss Assessment Chart (PBAC) in women’s health
  • Development of an ePRO for adult and adolescent dysmenorrhea
  • Regulatory consultation on dysmenorrhea assessments for an FDA type C meeting
  • Endpoint strategy in dysmenorrhea

Miscarriage

  • Meta-analysis of a treatment for recurrent miscarriage

Neural tube defects

  • Manuscripts, abstracts and posters on neural tube defects
  • Top-up literature review and communications on the burden of neural tube defects to patients, carers and society
  • Review on the burden of neural tube defects to healthcare systems, patients, care-givers and society
  • Content validation of a neurogenic detrusor overactivity (NDO) diary in paediatric spina bifida patients

Other women’s health experience

  • Visual aid and flyer for a drug in pelvic organ prolapse
  • Value demonstration and communication of UK burden of nausea and vomiting during pregnancy
  • Report on the humanistic burden and psychometric validation of the breast pain and vaginal bleeding e-diaries, the breast sensations and vaginal bleeding impact questionnaires and the treatment satisfaction questionnaire
  • FDA meeting on a functioning claim for cyclical mastalgia
  • Psychometric analysis of quality of life questionnaires in women’s health
  • Data entry and analysis of SMILE data received from a clinical trial in women’s health
  • Generation of utility measures in women’s health and rescoring of the Women’s Health Questionnaire (WHQ)
  • Patient preference and utility study for an injectable hormone treatment
  • EVAPIL-R communications and strategic advice regarding the modification of existing PRO measures in women’s health
  • Development of a PRO best practices document – interactions with international regulatory and HTA agencies in women’s health