Weitzenkamp, D. A., Gerhart, K. A., Charlifue, S. W., Whiteneck, G. G., & Savic, G. (1997). Spouses of spinal cord injury survivors: The added impact of caregiving. Archives of Physical Medicine and Rehabilitation, 78(8), 822–827. https://doi.org/10.1016/S0003-9993(97)90194-5
Article CAS PubMed Google Scholar
Rees, J., O’boyle, C., & MacDonagh, R. (2001). Quality of life: Impact of chronic illness on the partner. Journal of the Royal Society of Medicine, 94(11), 563–566. https://doi.org/10.1177/014107680109401103
Article CAS PubMed PubMed Central Google Scholar
Pinto, R. A., Holanda, M. A., Medeiros, M. M., Mota, R. M., & Pereira, E. D. (2007). Assessment of the burden of caregiving for patients with chronic obstructive pulmonary disease. Respiratory Medicine, 101(11), 2402–2408. https://doi.org/10.1016/j.rmed.2007.06.001
das Medeiros, C., Ferraz, M. M., M. B., & Quaresma, M. R. (2000). The effect of rheumatoid arthritis on the quality of life of primary caregivers. The Journal of Rheumatology, 27(1), 76–83.
Rivera-Navarro, J., Benito-León, J., Oreja-Guevara, C., Pardo, J., Bowakim Dib, W.,Orts, E., … Caregiver Quality of Life in Multiple Sclerosis (CAREQOL-MS) Study Group.(2009). Burden and health-related quality of life of Spanish caregivers of persons with multiple sclerosis. Multiple Sclerosis Journal, 15(11), 1347–1355. doi:10.1177/1352458509345917.
Belasco, A. G., & Sesso, R. (2002). Burden and quality of life of caregivers for hemodialysis patients. American Journal of Kidney Diseases, 39(4), 805–812. https://doi.org/10.1053/ajkd.2002.32001
Malliori, M. M., Chioti, V., & Konstantopoulou, K. (2010). Extra care burden in comorbid mental–somatic illnesses. Current Opinion in Psychiatry, 23(4), 373–377. https://doi.org/10.1097/YCO.0b013e328338c1b2
Basra, M. K. A., & Finlay, A. Y. (2007). The family impact of skin diseases: The Greater patient concept. British Journal of Dermatology, 156(5), 929–937. https://doi.org/10.1111/j.1365-2133.2007.07794.x
Article CAS PubMed Google Scholar
Shah, R., Ali, F. M., Finlay, A. Y., & Salek, M. S. (2021). Family reported outcomes, an unmet need in the management of a patient’s disease: Appraisal of the literature. Health and Quality of life Outcomes, 19, 1–35. https://doi.org/10.1186/s12955-021-01819-4
Aoun, S. M., Grande, G., Howting, D., Deas, K., Toye, C., Troeung, L., … Ewing, G.(2015). The impact of the carer support needs assessment tool (CSNAT) in community palliative care using a stepped wedge cluster trial. PloS one, 10(4), e0123012. doi:10.1371/journal.pone.0123012.
Wood, R., Taylor-Stokes, G., Lees, M., & Chirita, O. (2017). Cost burden associated with advanced non-small cell lung Cancer (A-NSCLC): Impact of disease stage. Value in Health, 20(9), A427. https://doi.org/10.1016/j.jval.2017.08.170
Porter, M. E., & Lee, T. H. (2013). The strategy that will fix health care. Harv Bus Rev, 91(10), 50–70. https://hbr.org/2013/10/the-strategy-that-will-fix-health-care
Teisberg, E., Wallace, S., & O’Hara, S. (2020). Defining and implementing value-based health care: A strategic framework. Academic Medicine, 95(5), 682–685. https://doi.org/10.1097/ACM.0000000000003122
Lehtonen, L., Wild, C., Ricciardi, W., Barros, P. P., Brouwer, W., De Maeseneer, J.,… Siciliani, L. (2019). Defining Value in Value-Based Healthcare: Report of the Expert Panel on effective ways of investing in Health (EXPH). doi:10.2875/35471.
European Union (2001). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use. https://www.legislation.gov.uk/eudr/2001/83/contents#
European Union (2007). Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02007R1394-20190726
Iglesias-López, C., Agustí, A., Obach, M., & Vallano, A. (2019). Regulatory framework for advanced therapy medicinal products in Europe and United States. Frontiers in Pharmacology, 10, 471441. https://doi.org/10.3389/fphar.2019.00921
Goula, A., Gkioka, V., Michalopoulos, E., Katsimpoulas, M., Noutsias, M., Sarri, E.F., … Kostakis, A. (2020). Advanced therapy medicinal products challenges and perspectives in regenerative medicine. Journal of Clinical Medicine Research, 12(12), 780. doi:10.14740/jocmr3964.
Magrelli, F. M., Merra, A., & Pellegrini, G. (2020). Surgery versus ATMPs: An example from ophthalmology. Frontiers in Bioengineering and Biotechnology, 8, 440. https://doi.org/10.3389/fbioe.2020.00440
Article PubMed PubMed Central Google Scholar
Hanna, E., Toumi, M., Dussart, C., Borissov, B., Dabbous, O., Badora, K., & Auquier, P. (2018). Funding breakthrough therapies: A systematic review and recommendation. Health Policy, 122(3), 217–229. https://doi.org/10.1016/j.healthpol.2017.11.012
Article CAS PubMed Google Scholar
Angelis, A., Lange, A., & Kanavos, P. (2018). Using health technology assessment to assess the value of new medicines: Results of a systematic review and expert consultation across eight European countries. The European Journal of Health Economics, 19, 123–152. https://doi.org/10.1007/s10198-017-0871-0
Gonçalves, E. (2020). Advanced therapy medicinal products: Value judgement and ethical evaluation in health technology assessment. The European Journal of Health Economics, 21(3), 311–320. https://doi.org/10.1007/s10198-019-01147-x
Article PubMed PubMed Central Google Scholar
Gonçalves, E. (2022). Value-based pricing for advanced therapy medicinal products: Emerging affordability solutions. The European Journal of Health Economics, 23(2), 155–163. https://doi.org/10.1007/s10198-021-01276-2
Jones, G. (2018). Raising the profile of pilot and feasibility studies in relation to the development, evaluation and implementation of patient-reported outcome measures. Pilot and Feasibility Studies, 4, 1–4. https://doi.org/10.1186/s40814-017-0151-x
Golics, C. J., Basra, M. K. A., Finlay, A. Y., & Salek, S. (2014). The development and validation of the family reported Outcome measure (FROM-16)© to assess the impact of disease on the partner or family member. Quality of Life Research, 23, 317–326. https://doi.org/10.1007/s11136-013-0457-y
Shah, R., Finlay, A. Y., Salek, M. S., Allen, H., Nixon, S. J., Nixon, M., … Ingram,J. R. (2024). Responsiveness and minimal important change of the Family Reported Outcome Measure (FROM-16). Journal of Patient-Reported Outcomes, 8(1), 38. doi.org/10.1186/s41687-024-00703-1.
Shah, R., Finlay, A. Y., Salek, S. M., Nixon, S. J., Otwombe, K., Ali, F. M., & Ingram, J. R. (2023). Meaning of Family reported Outcome measure (FROM-16) severity score bands: A cross-sectional online study in the UK. British Medical Journal Open, 13(3), e066168. https://doi.org/10.1136/bmjopen-2022-066168
Shah, R., Salek, M. S., Finlay, A. Y., Kay, R., Nixon, S. J., Otwombe, K., … Ingram,J. R. (2024). Mapping of family reported outcome measure (FROM-16) scores to EQ-5D:algorithm to calculate utility values. Quality of Life Research, 33(4), 1107–1119. doi: 10.1007/s11136-023-03590-z.
Golics, C. J., Basra, M. K. A., Salek, M. S., & Finlay, A. Y. (2013). The impact of patients’ chronic disease on family quality of life: An experience from 26 specialties. International Journal of General Medicine, 787–798. https://doi.org/10.2147/IJGM.S45156
Chantarasap, P., Johns, N. P., Pairojkul, S., Sookprasert, A., Wirasorn, K., Cheawchanwattana,A., … Subongkot, S. (2019). Validation of the Thai version of the family reported outcome measure (FROM-16)© to assess the impact of disease on the partner or family members of patients with cancer. Health and Quality of Life Outcomes, 17, 1–8. doi:10.1186/s12955-019-1091-3.
Elsner, S. A., Salek, S. S., Finlay, A. Y., Hagemeier, A., Bottomley, C. J., Katalinic, A., & Waldmann, A. (2021). Validation of the German version of the family reported outcome measure (FROM-16) to assess the impact of disease on the partner or family member. Health and Quality of Life Outcomes, 19, 1–14. https://doi.org/10.1007/s11136-013-0457-y
Oh, H. Y., & Shin, Y. S. (2021). Psychometric properties of the Korean family reported outcome measure for family members of patients with acquired brain injury. Journal of Neuroscience Nursing, 53(6), 256–261. https://doi.org/10.1097/JNN.0000000000000619
Wójcik, E., Reszke, R., Otlewska, A., Matusiak, Ł., FINLAY, A. Y., & SZEPIETOWSKI, J. C. (2020). Family reported Outcome Measure–16 (FROM-16): Creation, reliability and reproducibility of the Polish Language Version. Acta Dermato-Venereologica, 100(14). https://doi.org/10.2340/00015555-3583
Shah, R., Ali, F. M., Nixon, S. J., Ingram, J. R., Salek, S. M., & Finlay, A. Y. (2021). Measuring the impact of COVID-19 on the quality of life of the survivors, partners and family members: A cross-sectional international online survey. BMJ open, 11(5), e047680. https://doi.org/10.1136/bmjopen-2020-047680
Article PubMed PubMed Central Google Scholar
Brittain, E., Muirhead, N., Finlay, A. Y., & Vyas, J. (2021). Myalgic Encephalomyelitis/Chronic fatigue syndrome (ME/CFS): Major impact on lives of both patients and family members. Medicina, 57(1), 43. https://doi.org/10.3390/medicina57010043
Article PubMed PubMed Central Google Scholar
Raja, A., Wood, F., & Joshi, H. B. (2020). The impact of urinary stone disease and their treatment on patients’ quality of life: A qualitative study. Urolithiasis, 48, 227–234. https://doi.org/10.1007/s00240-019-01142-0
Davies, R., & Dart, J. (2005). The ‘most significant change’(MSC) technique. A Guide to its use, 10. https://doi.org/10.13140/RG.2.1.4305.3606
QSR International Pty Ltd (2020). NVivo (released in March 2020).
R Core Team. (2022). R: A language and environment for statistical computing. R Foundation for Statistical Computing.
Gamer, M., Lemon, J., Fellows, I., & Singh, P. (2019). irr: Various coefficients of interrater reliability and agreement. R package version 0.84. 1. Computer Software and Manual]. Retrieved from. https://cran.r-project.org/package=irr
Rizopoulos, D. (2007). Ltm: An R package for latent variable modeling and item response analysis. Journal of Statistical Software, 17, 1–25. https://doi.org/10.18637/jss.v017.i05
IBM Corp (2021). IBM SPSS Statistics for Windows, Version 28.0. Published online 2021.
Shah, R., Finlay, A. Y., Salek, S. M., Nixon, S. J., Otwombe, K., Ali, F. M., & Ingram, J. R. (2023). Meaning of Family reported Outcome measure (FROM-16) severity score bands: A cross-sectional online study in the UK. BMJ open, 13(3), e066168. https://doi.org/10.1136/bmjopen-2022-066168
Article PubMed PubMed Central Google Scholar
Chantarasap, P., Johns, N. P., Pairojkul, S., Sookprasert, A., Wirasorn, K., Cheawchanwattana,A., … Subongkot, S. (2019). Validation of the Thai version of the family reported outcome measure (FROM-16)© to assess the impact of disease on the partner or family members of patients with cancer. Health and Quality of Life Outcomes, 17, 1–8. doi.org/1
Comments (0)