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Background In healthcare research and practice, intervention and implementation fidelity represent the steadfast adherence to core components of research-supported interventions and the strategies employed for their implementation. Evaluating fidelity involves determining whether these core components were delivered as intended. Without fidelity data, the results of complex interventions cannot be meaningfully interpreted. Increasingly, the necessity for firmness and strict adherence by implementers and their organizations has been questioned, with calls for flexibility to accommodate contextual conditions. This shift makes contemporary fidelity a balancing act, requiring researchers to navigate various tensions. This debate paper explores these tensions, drawing on experiences from developing fidelity assessments in two ongoing effectiveness-implementation hybrid trials. Main body First , given often scarce knowledge about the core components of complex interventions and implementation strategies, decisions about fidelity requirements involve a degree of subjective reasoning. Researchers should make these decisions transparent using theory or logic models. Second , because fidelity is context-dependent and applies to both interventions and implementation strategies, researchers must rethink fidelity concepts with every study while balancing firmness and flexibility. This is particularly crucial for hybrid studies, with their differing emphasis on intervention and implementation fidelity. Third , fidelity concepts typically focus on individual behaviors. However, since organizational and system factors also influence fidelity, there is a growing need to define fidelity criteria at these levels. Finally , as contemporary fidelity concepts prioritize flexible over firm adherence, building, evaluating, and maintaining fidelity in healthcare research has become more complex. This complexity calls for intensified efforts to expand the knowledge base for pragmatic and adaptive fidelity measurement in trial and routine healthcare settings. Conclusion Contemporary conceptualizations of fidelity place greater demands on how fidelity is examined, necessitating the expansion of fidelity frameworks to include organizational and system levels, the service- and study-specific conceptualizations of intervention and implementation fidelity, and the development of pragmatic approaches for assessing fidelity in research and practice. Continuing to build knowledge on how to balance requirements for firmness and flexibility remains a crucial task within the field of implementation science.

Alliance ruptures of the withdrawal type are prevalent in adolescents with borderline personality disorder (BPD). Longer speech pauses are negatively perceived by these patients. Safran and Muran’s rupture model is promising but its application is very work intensive. This workload makes research costly and limits clinical usage. We hypothesised that pauses can be used to automatically detect one of the markers of the rupture model i.e. the minimal response marker. Additionally, the association of withdrawal ruptures with pauses was investigated. A total of 516 ruptures occurring in 242 psychotherapy sessions collected in 22 psychotherapies of adolescent patients with BPD and subthreshold BPD were investigated. Trained observers detected ruptures based on video and audio recordings. In contrast, pauses were automatically marked in the audio-recordings of the psychotherapy sessions and automatic speaker diarisation was used to determine the speaker-switching patterns in which the pauses occur. A random forest classifier detected time frames in which ruptures with the minimal response marker occurred based on the quantity of pauses. Performance was very good with an area under the ROC curve of 0.89. Pauses which were both preceded and followed by therapist speech were the most important predictors for minimal response ruptures. Research costs can be reduced by using machine learning techniques instead of manual rating for rupture detection. In combination with other video and audio derived features like movement analysis or automatic facial emotion detection, more complete rupture detection might be possible in the future. These innovative machine learning techniques help to narrow down the mechanisms of change of psychotherapy, here specifically of the therapeutic alliance. They might also be used to technologically augment psychotherapy training and supervision.

Evidence-based assessment (EBA) in mental health is a critical aspect of improving patient outcomes and addressing the gaps in mental health care. EBA involves the use of psychometric instruments to gather data that can inform clinical decision-making, inform policymakers, and serve as a basis for research and quality management. Despite its potential, EBA is often hindered by barriers such as workload and cost, leading to its underutilization. Regarding low- and middle-income countries (LMIC), the implementation of EBA is recognized as a key strategy to address and close the prevalent mental health treatment gap. To simplify the application of EBA including in LMIC, an international team of researchers and practitioners from Tanzania, Kosovo, Chile, and Switzerland developed the Mental Health Information Reporting Assistant (MHIRA). MHIRA is an open-source electronic health record that streamlines EBA by digitising psychometric instruments and organising patient data in a user-friendly manner. It provides immediate and convenient reports to inform clinical decision-making. The current article provides a comprehensive overview of the features and technical details of MHIRA, as well as insights from four implementation scenarios. The experience gained during the implementations as well as the user-feedback suggests that MHIRA has the potential to be successfully implemented in a variety of clinical contexts and simplify the use of EBA. However, further research is necessary to establish its potential to sustainably transform healthcare services and impact patient outcomes. In conclusion, MHIRA represents an important step in promoting the widespread adoption of EBA in mental health. It offers a promising solution to the barriers that have limited the use of EBA in the past and holds the potential to improve patient outcomes and support the ongoing efforts to address gaps in mental health care.

Question Most adolescents live in low- and middle-income countries (LMIC), and about 10% of them face mental problems. The mental health provision gap in low- and middle-income countries could be addressed by evidence-based practices, however costs are implementational barriers. Digitalization can improve the accessibility of these tools and constitutes a chance for LMIC to use them more easily at a low cost. We reviewed free and brief evidence-based mental health assessment tools available for digital use to assess psychopathology across different domains in youth. Methods For the current study, instruments from a recent review on paper-based instruments were re-used. Additionally, a systematic search was conducted to add instruments for the personality disorder domain. We searched and classified the copyright and license terms available from the internet in terms of free usage and deliverability in a digital format. In the case that this information was insufficient, we contacted the authors. Results In total, we evaluated 109 instruments. Of these instruments, 53 were free and digitally usable covering 11 mental health domains. However, retrieving information on copyright and license terms was very difficult. Conclusions Free and digitally adaptable instruments are available, supporting the strategy of using instruments digitally to increase access. The instrument’s authors support this initiative, however, the lack of copyright information and the difficulties in contacting the authors and licence holders are barriers to using this strategy in LMIC. A comprehensive, online instrument repository for clinical practice would be an appropriate next step to make the instruments more accessible and reduce implementation barriers.

Background Infection prevention and control (IPC) and antibiotic stewardship (ABS) represent promising approaches for reducing the prevalence of healthcare-associated infections (HAI) and antimicrobial resistance (AMR) in different healthcare settings. However, the combined use of IPC and ABS measures and ways to optimize their integrated implementation have been insufficiently considered and assessed. The REVERSE trial, funded by the European Union’s Horizon 2020 program, involves 24 acute care hospitals from four European countries, all with high rates of AMR and HAI. REVERSE aims to investigate whether the sequential implementation of an IPC and an ABS practice bundle is feasible and sustainable and whether externally guided tailoring as an enhanced implementation strategy leads to superior clinical and implementation outcomes compared to a basic implementation condition. Methods REVERSE will be designed as a stepped wedge cluster randomized, hybrid type 2 trial, including an embedded implementation trial. Four cohorts of six acute care hospitals will sequentially enter the trial over 38 months and work to implement first IPC, and, after 1 year, add the ABS practice bundle. Simultaneously, hospitals will be provided basic implementation training and instructed to tailor their implementation, with half of the hospitals being self-guided in their tailoring, whereas hospitals in the enhanced implementation condition will receive time-limited external facilitation in practicing tailoring. Qualitative data will be collected longitudinally to investigate contextual conditions for implementing IPC and ABS locally and how they contribute to tailoring results. IPC and ABS feasibility, fidelity, and sustainability will be assessed together with tailoring fidelity using repeated measures. Retrospective, in-depth, explanatory case studies will be conducted to interpret hospital outcomes. Discussion REVERSE is an extensive and complex effectiveness-implementation trial aimed at investigating tailoring effectiveness. It will contribute to the still scarce evidence base for this adaptive approach to integrating research-supported interventions into routine healthcare settings. By identifying pathways toward strengthening the integration of IPC and ABS practices at European acute care hospitals, REVERSE also has the potential to inform much-needed concerted efforts to combat the growing challenge of antimicrobial resistance in the region. Trial registration In November 2021, the REVERSE study was registered with the “International Standard Randomised Controlled Trial Number” (ISRCTN) register under nr.12956554.

Background Despite the proven effectiveness of infection prevention and control (IPC) practices in reducing healthcare-associated infections and related costs, their implementation poses a challenge in neonatal care settings across high-income (HICs) and low- and middle-income countries (LMICs). While existing research has predominantly focused on assessing the clinical effectiveness of these practices in neonatal care, aspects concerning their implementation remain underexplored. This systematic review therefore aimed to analyze implementation determinants and employed strategies for implementing IPC practices in inpatient neonatal care across country income levels. Methods Following a targeted search in seven databases, titles and abstracts as well as full texts were screened in a dual review process to identify studies focusing on the implementation of IPC practices in inpatient neonatal care and reporting on implementation determinants and/or implementation strategies. Implementation determinants were synthesized using the updated Consolidated Framework for Implementation Research. Implementation strategies were coded according to the Expert Recommendations for Implementing Change taxonomy. A convergent integrated approach was used to narratively summarize results across qualitative and quantitative studies. χ 2 Tests and Fisher’s Exact Tests were performed to analyze differences in implementation determinants and strategies across IPC practices and country income levels. The quality of included studies was assessed using the Mixed Methods Appraisal Tool. Results Out of 6,426 records, a total of 156 studies were included in the systematic review. Neonatal units in LMICs and HICs showed general commonalities in reported implementation determinants, which were mainly reported at the organizational level. While educational as well as evaluative and iterative strategies were most frequently employed to support the implementation of IPC practices in both LMICs and HICs, other strategies employed showed variance across country income levels. Notably, the statistical analyses identified a significant association between country income levels and implementation determinants and strategies respectively ( <0.05). Conclusion The results of this systematic review underscore the importance of the organizational level for the implementation of IPC practices in neonatal care irrespective of country income level. However, further research is needed to understand the underlying relationships of factors and dynamics contributing to the observed practice variances in LMICs and HICs. Registration PROSPERO (CRD42022380379).

Study design Single-centre, two-parallel group, methodological randomised controlled trial to assess blinding feasibility. Background Trials of manual therapy interventions of the back face methodological challenges regarding blinding feasibility and success. We assessed the feasibility of blinding an active manual soft tissue mobilisation and control intervention of the back. We also assessed whether blinding is feasible among outcome assessors and explored factors influencing perceptions about intervention assignment. Methods On 7–8 November 2022, 24 participants were randomly allocated (1:1 ratio) to active or control manual interventions of the back. The active group (n = 11) received soft tissue mobilisation of the lumbar spine. The control group (n = 13) received light touch over the thoracic region with deep breathing exercises. The primary outcome was blinding of participants immediately after a one-time intervention session, as measured by the Bang blinding index (Bang BI). Bang BI ranges from –1 (complete opposite perceptions of intervention received) to 1 (complete correct perceptions), with 0 indicating ‘random guessing’—balanced ‘active’ and ‘control’ perceptions within an intervention arm. Secondary outcomes included blinding of outcome assessors and factors influencing perceptions about intervention assignment among both participants and outcome assessors, explored via thematic analysis. Results 24 participants were analysed following an intention-to-treat approach. 55% of participants in the active manual soft tissue mobilisation group correctly perceived their group assignment beyond chance immediately after intervention (Bang BI: 0.55 [95% confidence interval (CI), 0.25 to 0.84]), and 8% did so in the control group (0.08 [95% CI, −0.37 to 0.53]). Bang BIs in outcome assessors were 0.09 (−0.12 to 0.30) and −0.10 (−0.29 to 0.08) for active and control participants, respectively. Participants and outcome assessors reported varying factors related to their perceptions about intervention assignment. Conclusions Blinding of participants allocated to an active soft tissue mobilisation of the back was not feasible in this methodological trial, whereas blinding of participants allocated to the control intervention and outcome assessors was adequate. Findings are limited due to imprecision and suboptimal generalisability to clinical settings. Careful thinking and consideration of blinding in manual therapy trials is warranted and needed. Trial registration ClinicalTrials.gov: NCT05822947 (retrospectively registered)