Tedavi sadakati, bir deneysel araştırmadaki müdahalenin, araştırmanın başından sonuçlandırılmasına kadar planlandığı gibi uygulanmasını ifade etmektedir. Başka bir deyişle planlanan yönteme bağlılık ve sadık kalmayı içermektedir. Çalışma sonuçlarının müdahale veya tedavinin etkilerini doğru bir şekilde yansıtması için tedavi sadakati kritik bir öneme sahiptir. Tedavi sadakatinin üç boyutu (İçerik, Nicelik ve Süreç) ve dört bileşeni (Uyum, Dozaj, Maruziyet ve Kalite) bulunmaktadır. İçerik boyutu bileşeni “uyum” müdahale adımlarının planlandığı gibi uygulanma derecesini ifade etmektedir. Nicelik boyutunun iki ilişkili bileşeni vardır: Bunlardan ilki dozaj, diğeri maruziyet olarak belirtilmektedir. Dozaj, bir müdahalenin sunulduğu sıklık ve süredir. Maruziyet, bir alıcının müdahaleyi aldığı sıklık ve süredir. Süreç boyutunun bileşeni ise kalite olarak da adlandırılmakta ve müdahale adımlarının ne kadar iyi uygulandığını kastetmektedir. Bu dört bileşenin araştırmada değerlendirilmesi, elde edilen verilerin doğru bir şekilde yorumlanmasına ve araştırmanın tekrarlanabilirlik olasılığını artırılmasına katkı sağlayacaktır. Bu derleme uluslararası literatürde “treatment fidelity” olarak bilinen “tedavi sadakati” kavramını ulusal literatüre kazandırmak ve ülkemizdeki araştırmacıların deneysel çalışmalarda “tedavi sadakati”ni değerlendirmesini teşvik etmek amacıyla yazılmıştır.
Cook CE, O’Halloran B, Karas S, Klopper M, Young JL. Treatment fidelity in clinical trials. Arch Physiother. 2024;14(1):65-9. https://doi.org/10.33393/aop.2024.3128
Baker J, Stringer H, McKean C. Ensuring treatment fidelity in intervention studies: Developing a checklist and scoring system within a behaviour change paradigm. Int J Lang Commun Disord. 2024;59(1):379-95. https://doi.org/10.1111/1460-6984.12955
Clinical Research Education Library. Monitoring and reporting treatment fidelity. 2014. Erişim Adresi: https://academy.pubs.asha.org/2014/11/monitoring-and-reporting-treatment-fidelity/ Erişim Tarihi: 30/10/2024
An M, Dusing SC, Harbourne RT, Sheridan SM, Consortium SP. What really works in intervention? Using fidelity measures to support optimal outcomes. Phys Ther. 2020;100(5):757-65. https://doi.org/10.1093/ptj/pzaa006
Nezu AM, Nezu CM. Evidence-based outcome research: A practical guide to conducting randomized controlled trials for psychosocial interventions. Oxford University Press; 2007.
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: Conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65-76. https://doi.org/10.1007/s10488-010-0319-7
Ginsburg LR, Hoben M, Easterbrook A, Anderson RA, Estabrooks CA, Norton PG. Fidelity is not easy! Challenges and guidelines for assessing fidelity in complex interventions. Trials. 2021;22(1):372. https://doi.org/10.1186/s13063-021-05322-5
Ribeiro LP, Curiel-Montero F, Rodrigues-de-Souza DP, Camargo PR, Alburquerque-Sendín F. Assessment of description and implementation fidelity of clinical trials involving exercise-based treatment in individuals with rotator cuff tears: A scoping review. Brazilian J Phys Ther. 2024;101062. https://doi.org/10.1016/j.bjpt.2024.101062
Skinner BF. Science and human behavior. Simon and Schuster; 1965.
Gresham FM, Gansle KA, Noell GH, Cohen S, Rosenblum S. Treatment integrity of school-based behavioral intervention studies: 1980–1990. School Psych Rev. 1993;22(2):254-72. https://doi.org/10.1080/02796015.1993.12085651
Feely M, Seay KD, Lanier P, Auslander W, Kohl PL. Measuring fidelity in research studies: A field guide to developing a comprehensive fidelity measurement system. Child Adolesc Soc Work J. 2018;35:139-52. https://doi.org/10.1007/s10560-017-0512-6
Sanetti LMH, Cook BG, Cook L. Treatment fidelity: What it is and why it matters. Learn Disabil Res Pract. 2021;36(1):5-11. https://doi.org/10.1111/ldrp.12238
Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011;71:S52-63. https://doi.org/10.1111/j.1752-7325.2011.00233.x
Resnick B, Bellg AJ, Borrelli B, De Francesco C, Breger R, Hecht J, et al. Examples of implementation and evaluation of treatment fidelity in the BCC studies: Where we are and where we need to go. Ann Behav Med. 2005;29(2):46-54. https://doi.org/10.1207/s15324796abm2902s_8
Dane AV, Schneider BH. Program integrity in primary and early secondary prevention: Are implementation effects out of control? Clin Psychol Rev. 1998;18(1):23-45. https://doi.org/10.1016/S0272-7358(97)00043-3
Gresham FM. Assessment of treatment integrity in school consultation and prereferral intervention. School Psych Rev. 1989;18(1):37-50. https://doi.org/10.1080/02796015.1989.12085399
Perepletchikova F, Kazdin AE. Treatment integrity and therapeutic change: Issues and research recommendations. Clin Psychol Sci Pract. 2005;12(4):365-83. https://doi.org/10.1093/clipsy.bpi045
Barber JP, Triffleman E, Marmar C. Considerations in treatment integrity: Implications and recommendations for PTSD research. J Trauma Stress. 2007;20(5):793-805. https://doi.org/10.1002/jts.20295
Hagermoser Sanetti LM, Fallon LM. Treatment integrity assessment: How estimates of adherence, quality, and exposure influence interpretation of implementation. J Educ Psychol Consult. 2011;21(3):209-32. https://doi.org/10.1080/10474412.2011.595163
Larios SE, Manuel JK, Newville H, Sorensen JL. Evidence-based treatment. In: Interventions for Addiction. Elsevier; 2013. p. 621-31.
Mowbray TC, Holter MC, Teague GB, Bybee D. Fidelity criteria: Development, measurement, and validation. Am J Eval. 2003;24(3):315-40. https://doi.org/10.1016/S1098-2140(03)00057-2
Cochrane WS, Laux JM. A survey investigating school psychologists’ measurement of treatment integrity in school-based interventions and their beliefs about its importance. Psychol Sch. 2008;45(6):499-507. https://doi.org/10.1002/pits.20319
Treatment fidelity refers to the implementation of an intervention in an experimental study as originally planned from the beginning to the conclusion of the research. In other words, it involves adherence to and consistency with the intended method. Treatment fidelity is critical to ensuring that study results accurately reflect the effects of the intervention or treatment. Treatment fidelity encompasses three dimensions (Content, Quantity, and Process) and four components (Adherence, Dosage, Exposure, and Quality). The content dimension component “compliance” refers to the degree to which the intervention steps are implemented as planned. The quantity dimension is associated with two components: dosage and exposure. Dosage refers to the frequency and duration of an intervention's delivery, while exposure indicates the frequency and duration with which a recipient engages with the intervention. The process dimension is represented by the component "quality," which refers to how well the intervention steps are implemented. Evaluating these four components in research contributes to the accurate interpretation of the data obtained and enhances the likelihood of the study's replicability. This review was written to introduce the concept of "treatment fidelity," known in international literature, into the national literature and to encourage researchers in our country to evaluate "treatment fidelity" in experimental studies.
Cook CE, O’Halloran B, Karas S, Klopper M, Young JL. Treatment fidelity in clinical trials. Arch Physiother. 2024;14(1):65-9. https://doi.org/10.33393/aop.2024.3128
Baker J, Stringer H, McKean C. Ensuring treatment fidelity in intervention studies: Developing a checklist and scoring system within a behaviour change paradigm. Int J Lang Commun Disord. 2024;59(1):379-95. https://doi.org/10.1111/1460-6984.12955
Clinical Research Education Library. Monitoring and reporting treatment fidelity. 2014. Erişim Adresi: https://academy.pubs.asha.org/2014/11/monitoring-and-reporting-treatment-fidelity/ Erişim Tarihi: 30/10/2024
An M, Dusing SC, Harbourne RT, Sheridan SM, Consortium SP. What really works in intervention? Using fidelity measures to support optimal outcomes. Phys Ther. 2020;100(5):757-65. https://doi.org/10.1093/ptj/pzaa006
Nezu AM, Nezu CM. Evidence-based outcome research: A practical guide to conducting randomized controlled trials for psychosocial interventions. Oxford University Press; 2007.
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: Conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65-76. https://doi.org/10.1007/s10488-010-0319-7
Ginsburg LR, Hoben M, Easterbrook A, Anderson RA, Estabrooks CA, Norton PG. Fidelity is not easy! Challenges and guidelines for assessing fidelity in complex interventions. Trials. 2021;22(1):372. https://doi.org/10.1186/s13063-021-05322-5
Ribeiro LP, Curiel-Montero F, Rodrigues-de-Souza DP, Camargo PR, Alburquerque-Sendín F. Assessment of description and implementation fidelity of clinical trials involving exercise-based treatment in individuals with rotator cuff tears: A scoping review. Brazilian J Phys Ther. 2024;101062. https://doi.org/10.1016/j.bjpt.2024.101062
Skinner BF. Science and human behavior. Simon and Schuster; 1965.
Gresham FM, Gansle KA, Noell GH, Cohen S, Rosenblum S. Treatment integrity of school-based behavioral intervention studies: 1980–1990. School Psych Rev. 1993;22(2):254-72. https://doi.org/10.1080/02796015.1993.12085651
Feely M, Seay KD, Lanier P, Auslander W, Kohl PL. Measuring fidelity in research studies: A field guide to developing a comprehensive fidelity measurement system. Child Adolesc Soc Work J. 2018;35:139-52. https://doi.org/10.1007/s10560-017-0512-6
Sanetti LMH, Cook BG, Cook L. Treatment fidelity: What it is and why it matters. Learn Disabil Res Pract. 2021;36(1):5-11. https://doi.org/10.1111/ldrp.12238
Borrelli B. The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. J Public Health Dent. 2011;71:S52-63. https://doi.org/10.1111/j.1752-7325.2011.00233.x
Resnick B, Bellg AJ, Borrelli B, De Francesco C, Breger R, Hecht J, et al. Examples of implementation and evaluation of treatment fidelity in the BCC studies: Where we are and where we need to go. Ann Behav Med. 2005;29(2):46-54. https://doi.org/10.1207/s15324796abm2902s_8
Dane AV, Schneider BH. Program integrity in primary and early secondary prevention: Are implementation effects out of control? Clin Psychol Rev. 1998;18(1):23-45. https://doi.org/10.1016/S0272-7358(97)00043-3
Gresham FM. Assessment of treatment integrity in school consultation and prereferral intervention. School Psych Rev. 1989;18(1):37-50. https://doi.org/10.1080/02796015.1989.12085399
Perepletchikova F, Kazdin AE. Treatment integrity and therapeutic change: Issues and research recommendations. Clin Psychol Sci Pract. 2005;12(4):365-83. https://doi.org/10.1093/clipsy.bpi045
Barber JP, Triffleman E, Marmar C. Considerations in treatment integrity: Implications and recommendations for PTSD research. J Trauma Stress. 2007;20(5):793-805. https://doi.org/10.1002/jts.20295
Hagermoser Sanetti LM, Fallon LM. Treatment integrity assessment: How estimates of adherence, quality, and exposure influence interpretation of implementation. J Educ Psychol Consult. 2011;21(3):209-32. https://doi.org/10.1080/10474412.2011.595163
Larios SE, Manuel JK, Newville H, Sorensen JL. Evidence-based treatment. In: Interventions for Addiction. Elsevier; 2013. p. 621-31.
Mowbray TC, Holter MC, Teague GB, Bybee D. Fidelity criteria: Development, measurement, and validation. Am J Eval. 2003;24(3):315-40. https://doi.org/10.1016/S1098-2140(03)00057-2
Cochrane WS, Laux JM. A survey investigating school psychologists’ measurement of treatment integrity in school-based interventions and their beliefs about its importance. Psychol Sch. 2008;45(6):499-507. https://doi.org/10.1002/pits.20319