scholarly journals Fidelity is not easy! Challenges and guidelines for assessing fidelity in complex interventions

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Liane R. Ginsburg ◽  
Matthias Hoben ◽  
Adam Easterbrook ◽  
Ruth A. Anderson ◽  
Carole A. Estabrooks ◽  
...  

Abstract Background Fidelity in complex behavioural interventions is underexplored and few comprehensive or detailed fidelity studies report on specific procedures for monitoring fidelity. Using Bellg’s popular Treatment Fidelity model, this paper aims to increase understanding of how to practically and comprehensively assess fidelity in complex, group-level, interventions. Approach and lessons learned Drawing on our experience using a mixed methods approach to assess fidelity in the INFORM study (Improving Nursing home care through Feedback On perfoRMance data—INFORM), we report on challenges and adaptations experienced with our fidelity assessment approach and lessons learned. Six fidelity assessment challenges were identified: (1) the need to develop succinct tools to measure fidelity given tools tend to be intervention specific, (2) determining which components of fidelity (delivery, receipt, enactment) to emphasize, (3) unit of analysis considerations in group-level interventions, (4) missing data problems, (5) how to respond to and treat fidelity ‘failures’ and ‘deviations’ and lack of an overall fidelity assessment scheme, and (6) ensuring fidelity assessment doesn’t threaten internal validity. Recommendations and conclusions Six guidelines, primarily applicable to group-level studies of complex interventions, are described to help address conceptual, methodological, and practical challenges with fidelity assessment in pragmatic trials. The current study offers guidance to researchers regarding key practical, methodological, and conceptual challenges associated with assessing fidelity in pragmatic trials. Greater attention to fidelity assessment and publication of fidelity results through detailed studies such as this one is critical for improving the quality of fidelity studies and, ultimately, the utility of published trials. Trial registration ClinicalTrials.gov NCT02695836. Registered on February 24, 2016

2020 ◽  
Author(s):  
Emmanuel Kiiza Mwesiga ◽  
Noeline Nakasujja ◽  
Lawrence Nankaba ◽  
Juliet Nakku ◽  
Seggane Musisi

Introduction: Individual and group level interventions have the largest effect on outcomes in patients with the first episode of psychosis. The quality of these individual and group level interventions provided to first-episode psychosis patients in Uganda is unclear.Methods: The study was performed at Butabika National Psychiatric Teaching and referral hospital in Uganda. A retrospective chart review of recently discharged adult in-patients with the first episode of psychosis was first performed to determine the proportion of participants who received the different essential components for individual and group level interventions. From the different proportions, the quality of the services across the individual and group interventions was determined using the first-Episode Psychosis Services Fidelity Scale (FEPS-FS). The FEPS-FS assigns a grade of 1-5 on a Likert scale depending on the proportion of patients received the different components of the intervention. Results: The final sample included 156 first-episode psychosis patients. The median age was 27 years [IOR (24-36)] with 55% of participants of the female gender. 13 essential components across the individual and group interventions were assessed and their quality quantified. All 13 essential components had poor quality with the range of scores on the FEPS-FS of 1-3. Only one essential component assessed (use of single antipsychotics) had moderate quality.Discussion: Among current services at the National psychiatric hospital of Uganda, the essential for individual and group level interventions for psychotic disorders are of low quality. Further studies are required on how the quality of these interventions can be improved.


1999 ◽  
Vol 17 (11) ◽  
pp. 3603-3611 ◽  
Author(s):  
Dympna Waldron ◽  
Ciaran A. O'Boyle ◽  
Michael Kearney ◽  
Michael Moriarty ◽  
Desmond Carney

PURPOSE: Despite the increasing importance of assessing quality of life (QoL) in patients with advanced cancer, relatively little is known about individual patient's perceptions of the issues contributing to their QoL. The Schedule for the Evaluation of Individual Quality of Life (SEIQoL) and the shorter SEIQoL–Direct Weighting (SEIQoL-DW) assess individualized QoL using a semistructured interview technique. Here we report findings from the first administration of the SEIQoL and SEIQoL-DW to patients with advanced incurable cancer. PATIENTS AND METHODS: QoL was assessed on a single occasion using the SEIQoL and SEIQoL-DW in 80 patients with advanced incurable cancer. RESULTS: All patients were able to complete the SEIQoL-DW, and 78% completed the SEIQoL. Of a possible score of 100, the median QoL global score was as follows: SEIQoL, 61 (range, 24 to 94); SEIQoL-DW, 60.5 (range, 6 to 95). Psychometric data for SEIQoL indicated very high levels of internal consistency (median r = .90) and internal validity (median R2 = 0.88). Patients' judgments of their QoL were unique to the individual. Family concerns were almost universally rated as more important than health, the difference being significant when measured using the SEIQoL-DW (P = .002). CONCLUSION: Patients with advanced incurable cancer were very good judges of their QoL, and many patients rated their QoL as good. Judgments were highly individual, with very high levels of consistency and validity. The primacy given to health in many QoL questionnaires may be questioned in this population. The implications of these findings are discussed with regard to clinical assessment and advance directives.


2003 ◽  
Vol 42 (02) ◽  
pp. 185-189 ◽  
Author(s):  
R. Haux ◽  
C. Kulikowski ◽  
A. Bohne ◽  
R. Brandner ◽  
B. Brigl ◽  
...  

Summary Objectives: The Yearbook of Medical Informatics is published annually by the International Medical Informatics Association (IMIA) and contains a selection of excellent papers on medical informatics research which have been recently published (www.yearbook.uni-hd.de). The 2003 Yearbook of Medical Informatics took as its theme the role of medical informatics for the quality of health care. In this paper, we will discuss challenges for health care, and the lessons learned from editing IMIA Yearbook 2003. Results and Conclusions: Modern information processing methodology and information and communication technology have strongly influenced our societies and health care. As a consequence of this, medical informatics as a discipline has taken a leading role in the further development of health care. This involves developing information systems that enhance opportunities for global access to health services and medical knowledge. Informatics methodology and technology will facilitate high quality of care in aging societies, and will decrease the possibilities of health care errors. It will also enable the dissemination of the latest medical and health information on the web to consumers and health care providers alike. The selected papers of the IMIA Yearbook 2003 present clear examples and future challenges, and they highlight how various sub-disciplines of medical informatics can contribute to this.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
S Villadsen ◽  
S Dias

Abstract For complex public health interventions to be effective their implementation needs to adapt to the situation of those implementing and those receiving the intervention. While context matter for intervention implementation and effect, we still insist on learning from cross-country comparison of implementation. Next methodological challenges include how to increase learning from implementation of complex public health interventions from various context. The interventions presented in this workshop all aims to improve quality of reproductive health care for immigrants, however with different focus: contraceptive care in Sweden, group based antenatal care in France, and management of pregnancy complications in Denmark. What does these interventions have in common and are there cross cutting themes that help us to identify the larger challenges of reproductive health care for immigrant women in Europe? Issues shared across the interventions relate to improved interactional dynamics between women and the health care system, and theory around a woman-centered approach and cultural competence of health care providers and systems might enlighten shared learnings across the different interventions and context. Could the mechanisms of change be understood using theoretical underpinnings that allow us to better generalize the finding across context? What adaption would for example be needed, if the Swedish contraceptive intervention should work in a different European setting? Should we distinguish between adaption of function and form, where the latter might be less important for intervention fidelity? These issues will shortly be introduced during this presentation using insights from the three intervention presentations and thereafter we will open up for discussion with the audience.


2021 ◽  
Vol 217 (2) ◽  
Author(s):  
Alexander G. Hayes ◽  
P. Corlies ◽  
C. Tate ◽  
M. Barrington ◽  
J. F. Bell ◽  
...  

AbstractThe NASA Perseverance rover Mast Camera Zoom (Mastcam-Z) system is a pair of zoomable, focusable, multi-spectral, and color charge-coupled device (CCD) cameras mounted on top of a 1.7 m Remote Sensing Mast, along with associated electronics and two calibration targets. The cameras contain identical optical assemblies that can range in focal length from 26 mm ($25.5^{\circ }\, \times 19.1^{\circ }\ \mathrm{FOV}$ 25.5 ∘ × 19.1 ∘ FOV ) to 110 mm ($6.2^{\circ } \, \times 4.2^{\circ }\ \mathrm{FOV}$ 6.2 ∘ × 4.2 ∘ FOV ) and will acquire data at pixel scales of 148-540 μm at a range of 2 m and 7.4-27 cm at 1 km. The cameras are mounted on the rover’s mast with a stereo baseline of $24.3\pm 0.1$ 24.3 ± 0.1  cm and a toe-in angle of $1.17\pm 0.03^{\circ }$ 1.17 ± 0.03 ∘ (per camera). Each camera uses a Kodak KAI-2020 CCD with $1600\times 1200$ 1600 × 1200 active pixels and an 8 position filter wheel that contains an IR-cutoff filter for color imaging through the detectors’ Bayer-pattern filters, a neutral density (ND) solar filter for imaging the sun, and 6 narrow-band geology filters (16 total filters). An associated Digital Electronics Assembly provides command data interfaces to the rover, 11-to-8 bit companding, and JPEG compression capabilities. Herein, we describe pre-flight calibration of the Mastcam-Z instrument and characterize its radiometric and geometric behavior. Between April 26$^{th}$ t h and May 9$^{th}$ t h , 2019, ∼45,000 images were acquired during stand-alone calibration at Malin Space Science Systems (MSSS) in San Diego, CA. Additional data were acquired during Assembly Test and Launch Operations (ATLO) at the Jet Propulsion Laboratory and Kennedy Space Center. Results of the radiometric calibration validate a 5% absolute radiometric accuracy when using camera state parameters investigated during testing. When observing using camera state parameters not interrogated during calibration (e.g., non-canonical zoom positions), we conservatively estimate the absolute uncertainty to be $<10\%$ < 10 % . Image quality, measured via the amplitude of the Modulation Transfer Function (MTF) at Nyquist sampling (0.35 line pairs per pixel), shows $\mathrm{MTF}_{\mathit{Nyquist}}=0.26-0.50$ MTF Nyquist = 0.26 − 0.50 across all zoom, focus, and filter positions, exceeding the $>0.2$ > 0.2 design requirement. We discuss lessons learned from calibration and suggest tactical strategies that will optimize the quality of science data acquired during operation at Mars. While most results matched expectations, some surprises were discovered, such as a strong wavelength and temperature dependence on the radiometric coefficients and a scene-dependent dynamic component to the zero-exposure bias frames. Calibration results and derived accuracies were validated using a Geoboard target consisting of well-characterized geologic samples.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
◽  

Abstract Patient information material (PIM) is omnipresent in healthcare. It is used to convey information or to familiarize potential end-users to offers of support. PIM recaps or elaborates on relevant information and offers recommendation for action. However, the quality of available PIM varies. When the formal and content-related quality of PIM is suboptimal, it not only fails to be effective but can also lead to uncertainty, misunderstandings, resistance or ignorance (e.g. of a support offer). Highly complex information requires much attention on the quality of the PIM, especially with respect to end-users (e.g. vulnerable groups). Excellent communication through the use of PIM is thus essential within complex interventions. Checklists, such as 'Discern' or 'PEMAT', as well as criteria catalogues or evidence-based patient information standards, may assist in the development, quality assessment and optimization of PIM. The inclusion of the end-users is recommended but for various reasons does not often take place. The innovative “integrated, cross-sectional Psycho-Oncology” (isPO) programme, offers needs-driven, professional support to all adult, newly diagnosed cancer patients early in their sickness trajectory. IsPO was developed in 2018. It was implemented and a formative evaluated in 2019. When developing this programme, different PIM were created top-down by the programme designers. During implementation, it became evident that these PIM materials required further improvement. A testing and optimization process started using the participatory health research (PHR) approach and was completed in a five-month period. A PIM-optimisation team was founded, which included the project partners involved in the network support, self-help organisations and the external evaluation institute. A practical instrument (PIM-checklist) for optimising the isPO-PIM was designed, piloted and used for testing by end-users, isPO service providers, and experts. Based on the recommendations in the checklist, the material was revised accordingly. Additionally, the PIM was completed with the design of two new components. Four optimisation rounds were conducted. The optimized PIM was tested on its comprehensibility (for end-users) and its usability (for service providers). During the presentations, the audience is invited to comment on critical questions that may appear during optimization (e.g. timing). Afterwards, there will be a skill building part with a focus on collaborative learning (45 minutes). First, we will focus on the requirements for a practical instrument that is handy for end-users, service providers and experts (mind mapping exercise). Finally, participants will be able to explore the following topics “World Café” discussion: (1) how to plan, conduct and communicate the development of optimization of PIM in a CI program, (2) what needs to be considered for the optimization (e.g. team composition, resources), and (3) how to continuously achieve end-userś participation. Key messages Excellent PIM are essential for a complex interventiońs success in practice and must include information and foster actionability. the iterative PIM design processes benefits from high user participation.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Louise C. Burgess ◽  
Thomas W. Wainwright ◽  
Khara A. James ◽  
Johan von Heideken ◽  
Maura D. Iversen

Abstract Background Therapeutic exercise is recommended as a core treatment for hip osteoarthritis (HOA). Whilst it is widely accepted that exercise can improve pain and disability, optimal type and dose of exercise are yet to be agreed upon. This may, in part, be attributed to the wide variation and inadequate reporting of interventions within the literature. This study evaluates the quality of intervention reporting among trials of therapeutic exercise in HOA. Methods Randomised controlled trials (RCTs) were sourced in a systematic review, completed in August 2020. Two raters independently used the Template for Intervention Description and Replication (TIDieR) and Consensus on Exercise Reporting Template (CERT) to evaluate intervention reporting. Correlations between quality assessment scores and CERT and TIDieR scores evaluated the relationship between internal validity and external applicability. The year of publication was compared to the quality of reporting scores. Results Fourteen RCTs were included in the analysis. On average, studies were awarded 9.43 ± 1.95 out of 12 points for the TIDieR checklist (range 4–12) and 13.57 ± 4.01 out of 19 points for the CERT (range 5–19). Pearson’s correlation coefficient suggested that the quality of reporting had improved over time and that there was a fair, positive relationship between internal validity and external applicability. Discussion Whilst the quality of intervention reporting is improving, many RCTs of therapeutic exercise in HOA lack the detail necessary to allow accurate evaluation and replication. Researchers are encouraged to utilise the standardised reporting guidelines to increase the translation of effective interventions into clinical practice.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Julius Sama Dohbit ◽  
Namanou Ines Emma Woks ◽  
Carlin Héméry Koudjine ◽  
Willy Tafen ◽  
Pascal Foumane ◽  
...  

Abstract Background Safe childbirth remains a daunting challenge, particularly in low-middle income countries, where most pregnancy-related deaths occur. Cameroon’s maternal mortality rate, estimated at 529 per 100,000 live births in 2017, is significantly high. The WHO Safe Childbirth Checklist (SCC) was designed to improve the quality of care provided to pregnant women during childbirth. The SCC was implemented at the Yaoundé Gynaeco-Obstetric and Paediatric Hospital to improve the quality of care during childbirth. Methods This study was a retrospective study to determine the adoption rate of the SCC and its association with maternal (eclampsia, perineal tears, and postpartum haemorrhage) and neonatal (stillbirth, neonatal asphyxia and neonatal death) complications. Data were collected 6 months after the introduction of the SCC. Multivariate binary logistic regression was used to analyse the association between the use of the SCC and maternofoetal complications. Results Out of 1611 deliveries conducted, 1001 records were found, giving a retrieval rate of 62%. Twenty-five records were excluded. During the study period, the checklists were used in 828 of 976 clinical notes, with an adoption rate of 84.8% and a utilization rate of 93.9% at 6 months. Severe preeclampsia/eclampsia was associated with the non-use of the SCC (2.1 vs 5.4%, p = 0.041). Stillbirth, neonatal asphyxia, and neonatal death rates were not significantly different between the checklist and non-checklist groups. However, for all neonatal outcomes, the proportion of complications was lower when the checklist was used. Conclusion The use of the SCC was associated with significantly reduced pregnancy complications, especially for reducing the rates of severe pre-eclampsia/eclampsia. The use of the SCC increased to 93.9% of all deliveries within 6 months. We advocate for the use of the WHO Safe Childbirth Checklist in maternity units.


2021 ◽  
Vol 20 ◽  
pp. 160940692110167
Author(s):  
Snæfrídur Thóra Egilson ◽  
Linda B. Ólafsdóttir ◽  
Anna Sigrún Ingimarsdóttir ◽  
Freyja Haraldsdóttir ◽  
Ásta Jóhannsdóttir ◽  
...  

The LIFE-DCY research project has two aims. First, to evaluate disabled children’s quality of life (QoL) as reported by themselves and their parents, and second, to locate commonalities, differences, and conflicting issues in the processes that may influence disabled children’s life quality and participation. This paper describes the study design, methodology, and methods along with lessons learned. In addition various methodological and ethical concerns are raised. A sequential mixed-methods design was applied. In Phase one (mapping) we used KIDSCREEN-27 to study how disabled children evaluate their QoL compared with the perspectives of their parents and those of non-disabled children and their parents. Using the Participation and environment measure we also studied parents’ perspectives of their children’s participation in different social contexts. Altogether 209 disabled children and their parents, and 335 children in a control group and their parents (paired reports) participated in phase one. Phase two (unpacking) consisted of 14 case studies with disabled children aged 8–18 years and focus groups with 21 disabled people aged 19–35 years. The initial analysis was inductive and data-oriented. We then used critical and transformative lenses to shed light on how meaning was made of life quality and participation in relation to the context in which study participants found themselves. The LIFE-DCY research promotes an understanding of how important aspects of life quality and participation may intersect within different contexts and at different times. The theoretical understandings from this study may also help unpack various aspects of childhood disability in terms of knowledge and power and enhance understandings of how ideas about normality and childhood disability are constructed.


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