Strategies Used and Data Obtained During Treatment Fidelity Monitoring

Abstract

Background Treatment fidelity, also called intervention fidelity, is an important component of testing treatment efficacy. Although examples of strategies needed to address treatment fidelity have been provided in several published reports, data describing variations that might compromise efficacy testing have been omitted. Objectives To describe treatment fidelity monitoring strategies and data within the context of a nursing clinical trial. Method A three-group, randomized, controlled trial compared intervention (paced respiration) to attention control (fast, shallow breathing) to usual care for management of hot flashes and other menopausal symptoms. Data from both staff and participants were collected to assess treatment fidelity. Results Staff measures for treatment delivery indicated good adherence to protocols. Participant ratings of expectancy and credibility were not statistically different between intervention and attention control; however, the attention control was significantly more acceptable (p < .05). Intervention participant data indicated good treatment receipt and enactment with mean breath rates at each time point falling within the target range. Practice log data for both intervention and attention control indicated lower adherence of once daily, rather than twice-daily practice. Discussion Despite strengths in fidelity monitoring, some challenges were identified that have implications for other similar intervention studies.

Methods used to address fidelity of receipt in health intervention research: a citation analysis and systematic review

“…It was unclear who intervention deliverers were in 12 studies (21.8%) [26, 39, 46, 50, 51, 55, 59–64], but in studies where this information was identifiable, deliverers were most frequently nurses (10 studies, 18.2%) [33, 35–37, 40, 47, 52, 65–67]. With regards to level and mode of delivery, interventions were most frequently delivered at the individual (25 studies, 45.5%) [27–29, 33, 34, 40, 41, 45, 46, 48, 50–52, 54, 56, 60, 63, 65, 66, 68–73] and group level (19 studies, 35.1%) [26, 31, 32, 38, 39, 42, 43, 49, 53, 55, 58, 61, 62, 64, 67, 74–77]. Face to face was the most common (28 studies, 50.9%) mode of delivery [27, 29, 31, 32, 35–38, 41–45, 49, 50, 56, 58, 60–62, 66–68, 74–78].…”

“…An assessment of participants’ understanding was included in 20 (60.6%) studies [25, 29, 31, 33–37, 39, 45, 47, 48, 50, 57, 61, 65, 67, 73, 75, 78] and an assessment of participants’ performance of intervention-related skills in 14 (42.4%) studies [33–36, 45, 47, 48, 51, 54, 56, 57, 65, 75, 78]. With regards to strategies to enhance receipt, 4 (12.1%) studies reported using a strategy to enhance participants’ understanding [41, 48, 56, 57], 7 (21.1%) to enhance performance of intervention-related skills [39, 41, 44, 47, 48, 56, 57]. Four (12.1%) studies reported having considered multicultural factors in the design or delivery of the intervention [25, 29, 31, 64].…”

“…Given the focus of the forward citation search on the BCC framework, the two most common ways of assessing receipt in the 55 studies reviewed were measurements of understanding, included in 26 (47.3%) studies [25, 29–31, 33–37, 39, 40, 45, 47–50, 57, 60–62, 65, 67, 70, 73, 75, 78], and of performance of skills, included in 16 (29.1%) studies [33–36, 45, 47, 48, 51, 54, 56, 57, 65, 70, 71, 75, 78]. …”

Different interventions, same outcomes? Here are four good reasons

“…Treatment or intervention fidelity refers to the reliability and validity of the clinical interventions that are used 8. Treatment fidelity can be enhanced through provider training (eg, ensuring providers deliver treatment in a competent fashion), treatment delivery (eg, was the care consistently provided as intended), treatment receipt (eg, was the treatment understood by the patient) and treatment enactment (eg, did the recipients of the intervention use it as intended within their daily lives) 9.…”

Treatment Fidelity Over the Last Decade in Psychosocial Clinical Trials Outcome Studies: A Systematic Review

“…In contrast, competence measures assess the skills or accuracy with which the treatment is implemented [22,23]. Quantitative and qualitative research methods are pivotal tools for the investigation of these complex Treatment Fidelity phenomena [24][25][26][27]. Despite advances in the field of Treatment Fidelity, studies of treatment adherence and competence continue to reveal inconsistencies between treatment and outcome [28].…”