Conducting Process Evaluations Research Articles

Process evaluation of a breastfeeding support intervention to promote exclusive breastfeeding and reduce social inequity: a mixed-methods study in a cluster-randomised trial

BackgroundBreastfeeding is a powerful public health intervention that produces long-term health benefits. However, in high-income countries such as Denmark, breastfeeding rates are suboptimal and unequally distributed across socio-economic positions. The ‘Breastfeeding – a good start together’ intervention, to promote longer duration of exclusive breastfeeding and reduce social inequity, was implemented in a cluster-randomised trial during 2022–2023 across 21 municipalities in two Danish regions. A process evaluation was conducted to assess the implementation, mechanisms of impact, and possible contextual factors affecting the intervention.MethodsThe study was guided by the Medical Research Council’s guidance for conducting process evaluations and employed a mixed-methods approach in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8).ResultsOverall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors responded positively to the intervention, noting that it fitted well within their usual practice and enhanced families’ chances of breastfeeding. Mothers expressed having received the intervention with few exceptions, and reacted positively to the intervention. Although health visitors were concerned about the potential stigmatisation of mothers receiving the intensified intervention, none of the interviewed mothers felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms included staff and management turnover, project infrastructure and mothers’ context, such as resources, social networks and previous experiences. The overall fidelity of the intervention delivery was high.ConclusionsHealth visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in alignment with support provided in other sectors of the health care system, may increase breastfeeding rates and reduce social inequity in breastfeeding, even in international contexts.Trial registrationClinical Trials: NCT05311631. First posted April 5, 2022.

Experiences with telemedicine-based follow-up of chronic conditions: the views of patients and health personnel enrolled in a pragmatic randomized controlled trial

BackgroundTelemedicine is often promoted as a possible solution to some of the challenges healthcare systems in many countries face, and an increasing number of studies evaluate the clinical effects. So far, the studies show varying results. Less attention has been paid to systemic factors, such as the context, implementation, and mechanisms of these interventions.MethodsThis study evaluates the experiences of patients and health personnel enrolled in a pragmatic randomized controlled trial comparing telemedicine-based follow-up of chronic conditions with usual care. Patients in the intervention group received an individual treatment plan together with computer tablets and home telemonitoring devices to report point-of-care measurements, e.g., blood pressure, blood glucose or oxygen saturation, and to respond to health related questions reported to a follow-up service. In response to abnormal measurement results, a follow-up service nurse would contact the patient and consider relevant actions. We conducted 49 interviews with patients and 77 interviews with health personnel and managers at the local centers. The interview data were analyzed using thematic analysis and based on recommendations for conducting process evaluation, considering three core aspects within the process of delivering a complex intervention: (1) context, (2) implementation, and (3) mechanisms of impact.ResultsPatients were mainly satisfied with the telemedicine-based service, and experienced increased safety and understanding of their symptoms and illness. Implementation of the service does, however, require dedicated resources over time. Slow adjustment of other healthcare providers may have contributed to the absence of reductions in the use of specialized healthcare and general practitioner (GP) services. An evident advantage of the service is its flexibility, yet this may also challenge cost-efficiency of the intervention.ConclusionsThe implementation of a telemedicine-based service in primary healthcare is a complex process that is sensitive to contextual factors and that requires time and dedicated resources to ensure successful implementation.Trial registrationThe trial was registered in www.clinicaltrials.gov (NCT04142710). Study start: 2019-02-09, Study completion: 2021-06-30, Study type: Interventional, Intervention/treatment: Telemedicine tablet and tools to perform measurements. Informed and documented consent was obtained from all subjects and next of kin participating in the study.

USING PROCESS EVALUATION TO IMPROVE DOCUMENTATION OF LIFE-SUSTAINING TREATMENTS FOR VETERANS

Abstract The Preferences Elicited and Respected for Seriously Ill Veterans through Enhanced Decision-Making (PERSIVED) intervention began in 2021 to support United States Department of Veterans Affairs (VA) Home Based Primary Care (HBPC) clinicians in completing life-sustaining treatment (LST) templates for Veterans. In PERSIVED, HBPC clinicians partner with the PERSIVED team for 15 months, with clinicians routinely receiving coaching from the PERSIVED team. To assess participation in PERSIVED and to inform coaching sessions, the PERSIVED team conducted process evaluation interviews from August-November 2022 with N=24 clinicians across the country from seven HBPC sites. Interviews were conducted between months six-seven of PERSIVED implementation. Two PERSIVED team members conducted interviews, one acting as interviewer and the other as notetaker. Following interviews, the notetaker cleaned up the notes and the interviewer reviewed them, with the two reaching consensus on summaries on individual interviews and ultimately summarizing interview data by site. Two PERSIVED coaches then reviewed the summaries to brainstorm how to adapt coaching based on process evaluation findings. Coaches noted site-specific barriers and facilitators to improving LST template completion rates; positives of PERSIVED coaching; suggestions to improve PERSIVED; and goals for the remaining nine months of the PERSIVED intervention. Strategies suggested based on the process evaluation analyses included how to integrate checking for the LST template into existing processes, adapting note templates, discussing LST templates during team meetings, and improving education around LST template completion. The rapid integration of process evaluation findings into PERSIVED coaching sessions proved beneficial for participating HBPC teams.

Implementing a tailored, co-designed goal-setting implementation package in rehabilitation services: a process evaluation

Purpose This study aims to evaluate the process of implementing an evidence-based goal-setting package into five rehabilitation services across the continuum of rehabilitation. Materials and methods This study used a mixed methods approach guided by Medical Research Council (MRC) recommendations for conducting process evaluations, the RE-AIM framework, and the Theoretical Domains Framework (TDF). This study will evaluate the reach, adoption, implementation, and maintenance of the goal-setting package over six months. Results Environmental context and resources, the clinician’s social and professional role and identity, social influences and clinician beliefs about goal-setting consequences and individuals’ capabilities were all identified as barriers or enablers throughout the implementation process. Community rehabilitation services faced challenges implementing paper-based resources, whilst inpatient rehabilitation sites faced challenges engaging nursing staff in the interdisciplinary approach to goal-setting. Social influences were an enabler in two sites that used the case conference format to facilitate setting common goals. Clinicians in all sites continued to express difficulties implementing shared decision-making with people who had cognitive impairments or were no longer progressing in their rehabilitation. Conclusions A team-based approach to implementing the goal-setting interventions centred around the case conference format appeared to be the most successful mode for implementing interdisciplinary person-centred goal-setting.

Implementation of dementia care management in routine care (RoutineDeCM): a study protocol for process evaluation

IntroductionDementia care management is a complex intervention intended to support persons with dementia and their (caring) relatives in home-based care arrangements. Dementia care management was developed in the federal state...

The community engagement course and action network: strengthening community and academic research partnerships to advance health equity.

Historically Black Colleges and Universities and Minority Serving Institutions are uniquely positioned to implement community-campus research partnerships based on a history of service, the pursuit of community trustworthiness and student demographics often similar to surrounding marginalized communities. The Morehouse School of Medicine Prevention Research Center collaborates with members of Historically Black Colleges and Universities, Minority Serving Institutes, and community organizations on the Community Engaged Course and Action Network. This network is the first of its kind and aims to strengthen members' ability to implement Community-Based Participatory Research (CBPR) principles and partnerships. Projects address public health priorities including mental health among communities of color, zoonotic disease prevention, and urban food deserts. To assess the effectiveness of the network, a Participatory Evaluation framework was implemented to conduct process evaluation which included review of partnership structures, operations, project implementation processes, and preliminary outcomes of the research collaborations. A focus group of Community Engagement Course and Action Network members (community and academic) was also conducted to identify benefits and challenges of the network with emphasis on key areas for improvement to further enhance the relationships between partners and to facilitate their subsequent community-campus research. Network improvements were tied to themes strengthening community-academic partnerships including sharing and fellowship, coalition building and collaboration, and greater connections and awareness of community needs through their current community-academic partnerships. The need to conduct ongoing evaluation during and after implementation, for determining the early adoption of CBPR approaches was also identified. Evaluation of the network's processes, infrastructure, and operation provides early lessons learned to strengthen the network. Ongoing assessment is also essential for ensuring continuous quality improvement across partnerships such as determining CBPR fidelity, assessing partnership synergy, and dynamics, and for quality improvement of research protocol. The implications and potential for advancing implementation science through this and similar networks are great towards advancing leadership in modeling how foundations in community service can advance to CBPR partnership formation and ultimately, health equity approaches, that are local defined and assessed.

Piloting a Student-Led Bingocize® Nutrition Workshop for Marginalized Community-Dwelling Older Adults

Upon completion, participant will be able to describe strategies and challenges in implementing and conducting process evaluation of the 10-week Bingocize® Nutrition Workshop for marginalized community-dwelling older adults.

Evaluating the effect of short-course rifapentine-based regimens with or without enhanced behaviour-targeted treatment support on adherence and completion of treatment for latent tuberculosis infection among adults in the UK (RID-TB: Treat): protocol for an open-label, multicentre, randomised controlled trial

IntroductionThe successful scale-up of a latent tuberculosis (TB) infection testing and treatment programme is essential to achieve TB elimination. However, poor adherence compromises its therapeutic effectiveness. Novel rifapentine-based regimens and...

Community mobilisation in the framework of supportive social environment to prevent family violence in Solomon Islands

• Supportive social environment is vital for effective and sustainable community mobilisation to prevent family violence. • Rigid social and gender norms and bride price in Solomon Islands can and do reinforce violence against women and girls (VAWG). • Understanding context specific factors of social environment is a vital first step in developing violence prevention interventions. • There is a dearth of evidence on response to and prevention of VAWG in the Pacific region. This paper seeks to fill some of those gaps. Community mobilisation is one of the promising approaches to prevent Violence Against Women and Girls (VAWG). Yet, there is very little research on the social contextual factors of community mobilisation for violence prevention based on broader theoretical framework. Particularly, the South Pacific remains one of the most under-researched regions in the world. This paper aims to address this and attempts to conduct process evaluation by elucidating the contexts that facilitated or hindered sustainable community mobilisation to prevent VAWG implemented by the Safe Families programme in Solomon Islands where the prevalence of violence is significantly high. This study adopted the Social Environment Framework developed by Campbell and Cornish, 2010 , Mannell and Dadswell, 2017 . They sought social contextual factors comprised of symbolic, material, relational and institutional dimensions that are of crucial importance to examine the mobilisation process, hence having influence on programme outcomes. Qualitative data were collected and analysed from 33 In-depth Interviews and 15 Focus Group Discussions with community and Oxfam staff members in 6 communities of Malaita and Temotu provinces and Honiara. A thematic analysis presented various contextual factors in the framework of Social Environment. Those include: (1) the symbolic context addressing social and gender norms that condone VAWG in the context of small and remote island communities; (2) the lack of consideration for a comprehensive programming that includes economic and material based support for sustainable interventions; (3) formation of long-term, trusting and mutually respectful relationships with communities and external stakeholders; and (4) strong demand for the institutional support through gender-responsive policy and legal systems as well as informal community by-laws that are instrumental in successful prevention interventions. Overall, the supportive Social Environment is of vital importance to achieve effective and sustainable community mobilisation, and is useful when policy makers and implementing agencies formulate community based violence prevention interventions.

Remote interpreting in primary care settings: a feasibility trial in Germany

BackgroundGlobal migration trends have led to a more diverse population in health care services everywhere, which in turn has set off a paradigm shift away from medical paternalism toward more patient autonomy. Consequently, physicians need to provide a more precise patient-centred healthcare. Professional interpreting appears to play a crucial part in tackling the challenges of language barriers adequately. The aim of this study was to conduct process evaluation through the implementing of video remote interpreting (VR) and telephone remote interpreting (TR) within primary care facilities in the northern German metropolis of Hamburg.MethodsWe conducted a three-armed exploratory pilot trial, which compared VR to TR and to a control group (CG) in different primary care settings. We assessed feasibility of implementation, as well as the acceptance of interpreting tools among their users. In addition, we compared the quality of communication as perceived by patients and physicians, as well as the enabling of patient-centred medicine over all three study groups using quantitative questionnaires.Results13 practices (7 GPs, 3 Gynaecologists, 3 Paediatricians) took part in this trial. 183 interpreting calls were documented, 178 physicians as well as 127 patients answered their respective questionnaires. The implementation of the VR- und TR-tools went smoothly and they were broadly accepted by their users. However, the tools were used significantly less often than we had anticipated. With regards to quantitative questionnaires, VR scored significantly better than the control group in terms of the perceived quality of communication by both, patients and physicians and enabled of patient-centred medicine.ConclusionOur main findings were the discrepancy between the assumed high demand of professional interpreting solutions on the one hand and the low willingness of practices to participate on the other. The rather low utilisation rates were also noteworthy. This discrepancy indicates a lack of awareness concerning the adverse effects of using informal or no interpreter in medical settings, which needs to be rectified. Due to the small sample size, all statistical results must be viewed with caution. However, our results show that remote interpreting represents a promising approach to tackling language barriers in primary care settings.

Study Protocol: IMPETUS: Implementing a Uniform Stroke Care Pathway in Medical Colleges of India: IMPETUS Stroke.

Introduction:In India, a national program for stroke (national programme for the control of cardiovascular diseases, diabetes, cancer, and stroke) and stroke management guidelines exist. Its successful implementation would need an organized system of stroke care in practice. However, many challenges exist including lack of awareness, prehospital notification systems, stroke ready hospitals, infrastructural weaknesses, and rehabilitation. We present here a protocol to investigate the feasibility and fidelity of implementing a uniform stroke care pathway in medical colleges of India.Methods and Analysis:This is a multicentric, prospective, multiphase, mixed-method, quasi-experimental implementation study intended to examine the changes in a select set of stroke care-related indicators over time within the sites exposed to the same implementation strategy. We shall conduct process evaluation of the implementation process as well as evaluate the effect of the implementation strategy using the interrupted time series design. During implementation phase, education and training about standard stroke care pathway will be provided to all stakeholders of implementing sites. Patient-level outcomes in the form of modified Rankin Scale score will be collected for all consecutive patients throughout the study. Process evaluation outcomes will be collected and reported in the form of various stroke care indicators. We will report level and trend changes in various indicators during the three study phases.Discussion:Acute stroke requires timely detection, management, and secondary prevention. Implementation of the uniform stroke care pathway is a unique opportunity to promote the requirements of homogenous stroke care in medical colleges of India.

A Process Evaluation of Social Protection Policy in the Unconditional Cash Transfer Programme for Vulnerable People

This study is a Process evaluation of the Unconditional Cash Transfer (UCT), which is implemented by the International Rescue Committee (IRC), in Chipinge District. The study assessed the program's implementation methods. The study utilized a mixed methodology approach. Semi structured interviews were utilized to interview beneficiaries and project staff. A total of 10 interviewees were interviewed and 80 questionnaires were distributed to beneficiaries. Interviewees were purposely selected, and 80 questionnaire respondents were randomly selected. The author also gathered data through document analysis and observations. The study assessed if activities were being carried out according to plan, if non-cash and cash resources utilized according to plan, and whether the skills and competencies of the personnel were adequate. The study also analyzed beneficiary satisfaction and potential changes to the UCT program’s implementation. The findings were that UCT activities are being carried out according to plan. Cash and noncash resources are always available for the implementation of the UCT Programme and there is no abuse of funds. The findings indicated that the personnel are qualified enough for the implementation of the programme and that beneficiaries are satisfied with the UCT programme services. The study recommended that it might be necessary to increase the frequency of the cash transfer payments to a monthly basis instead of bi-monthly to empower the beneficiaries to generate more income. It was recommended that there be an exit strategy to phase out eligible beneficiaries and bring in new beneficiaries. It was also recommended that the payment process may be electrified to cut costs and for easy tracking of payments Since the study was based on a single case, Chipinge, it was recommended that there is need to conduct process evaluations on the UCT programme in other parts of the country to get a broader spectrum on the implementation of the UCT programme.

The use of hairdressing and beauty salons as health-promotion environments for the prevention and management of non-communicable diseases in ethnically diverse women

BackgroungWomen from some minoritised ethnic groups are disproportionately affected by non-communicable disease (NCDs), due to socioeconomic disadvantage, underlying health problems, health behaviours, and distrust of mainstream health services. Integrating community structures, such as hairdressing and beauty salons into existing primary care pathways can provide a sustainable process to address inequalities in access to health care. The aim of this global scoping review was to map and summarise the evidence about community salon-based interventions targeting ethnically diverse women (eg, Black African, Black Caribbean, and Asian women) for NCD prevention and management, including formative phases, theoretical approaches, and evaluation. MethodsSix databases (PubMed, Web of Science, Embase, PsycInfo, MEDLINE, and Global Health) were searched for relevant articles published from inception until July 17, 2020. Search terms included women, Black-African, Black-Caribbean, mixed ethnicity, Asian, Indian, Pakistani, nail bar, hair salon, hairdressers, intervention, and non-communicable disease. Reference lists of relevant articles (excluding letters, editorials, and protocols) were screened using a participants, concept, context framework. All authors independently screened the titles and abstracts identified and eligible full-text articles. Disagreements were discussed between authors to reach consensus, and reasons for exclusion documented. Process and outcome evaluation was assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Thematic synthesis followed previously published guidance. Risk of bias was assessed using the Quality In Prognosis Study tool. Findings525 titles and abstracts were screened, and eight met the inclusion criteria. All eight studies were US based. Two used formative phases to inform intervention development, and five referred to conceptual frameworks (Health Belief Model, Social Cognitive Theory, Chronic Care Model). Three studies described codevelopment with key community stakeholders. All studies reported outcome evaluation and the results generally showed positive changes in retention of knowledge, intention to change behaviour, changes in behaviour and in risk awareness. Five studies conducted process evaluation. Indicators included salon or participant attrition, therapists' insights of the intervention, clients' observations from the intervention, confidence of clients in their therapists to deliver the correct health messages, and the confidence and willingness of therapists to deliver health promotion messages. Sociodemographic characteristics were reported in two studies; however, their role in equity of coverage or influence on outcomes were not described. InterpretationScoped studies were largely US based and applicability to other settings is unclear. More consistent integration of formative phases, community participation, including health or social care partnerships, and process evaluation are crucial to understand the public health impact for women of ethnic minority groups. FundingNational Institute of Health Research, Research for Patient Benefit Programme (grant number NIHR202769).

Theoretical approaches to process evaluations of complex interventions in health care: a systematic scoping review protocol

BackgroundComplex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. The process of developing, evaluating and implementing complex interventions is therefore challenging. Established guidance such as the MRC (Medical Research Council) framework for developing and evaluating complex interventions refers to process evaluations as an integral part of the development of complex evidence-based interventions. Even though the need for process evaluations is recognized, the realization of such approaches is challenging because methodological instruction is sparse, and the phenomenon of interest is complex. A number of theoretical approaches indicating how to conduct process evaluations of complex interventions in health care exist, but a systematic and comprehensive overview of these is missing. Thus, the objective of the systematic scoping review described herein is to provide an overview and analysis of theoretical approaches suitable for the planning and conducting of process evaluations.MethodsThe design and conduct of this review will follow the procedures of a systematic scoping review. The search strategy will be developed following the BeHEMoTh (Behaviour of interest; Health context; Exclusions; Models or Theories) template which has been conceptualized for structured reviews of theory. The systematic search of the MEDLINE (via PubMed), CINAHL (via EBSCO) and PsycInfo (via EBSCO) electronic databases will be complemented by “hand searching” techniques. Study selection, data extraction, and data analysis will be performed by tandems of two researchers independently of each other. Divergent decisions and judgements between the two researchers will be discussed by the whole review team.DiscussionThe findings from this scoping review will provide an overview and comparison of theoretical approaches suitable for process evaluations of complex interventions in health care. The review results will support researchers in choosing the theoretical approach that best fits the respective focus of their process evaluation study.Systematic review registrationThis study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732.

Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries\u2014a scoping review protocol

BackgroundThe use of process evaluations is a growing area of interest in research groups working on complex interventions. This methodology tries to understand how the intervention was implemented to inform policy and practice. A recent systematic review by Liu et al. on process evaluations of complex interventions addressing non-communicable diseases found few studies in low- and middle- income countries (LMIC) because it was restricted to randomized controlled trials, primary healthcare level and non-communicable diseases. Yet, LMICs face different barriers to implement interventions in comparison to high-income countries such as limited human resources, access to health care and skills of health workers to treat chronic conditions especially at primary health care level. Therefore, understanding the challenges of interventions for non-communicable diseases and neglected tropical diseases (diseases that affect poor populations and have chronic sequelae) will be important to improve how process evaluation is designed, conducted and used in research projects in LMICs. For these reasons, in comparison to the study of Liu et al., the current study will expand the search strategy to include different study designs, languages and settings.ObjectiveMap research using process evaluation in the areas of non-communicable diseases and neglected tropical diseases to inform the gaps in the design and conduct of this type of research in LMICs.MethodsScoping review of process evaluation studies of randomized controlled trials (RCTs) and non-RCTs of complex interventions implemented in LMICs including participants with non-communicable diseases or neglected tropical diseases and their health care providers (physicians, nurses, technicians and others) related to achieve better health for all through reforms in universal coverage, public policy, service delivery and leadership. The aspects that will be evaluated are as follows: (i) available evidence of process evaluation in the areas of non-communicable diseases and neglected tropical diseases such as frameworks and theories, (ii) methods applied to conduct process evaluations and (iii) gaps between the design of the intervention and its implementation that were identified through the process evaluation. Studies published from January 2008. Exclusion criteria are as follows: not peer reviewed articles, not a report based on empirical research, not reported in English or Spanish or Portuguese or French, reviews and non-human research.DiscussionThis scoping review will map the evidence of process evaluations conducted in LMICs. It will also identify the methods they used to collect and interpret data, how different theories and frameworks were used and lessons from the implementation of complex interventions. This information will allow researchers to conduct better process evaluations considering special characteristics from countries with limited human resources, scarce data available and limited access to health care.

Types of implementation of the dementia-specific case conference concept WELCOME-IdA in nursing homes: a qualitative process evaluation of the FallDem effectiveness trial

BackgroundDementia is regularly associated with behavioral and psychological symptoms of dementia (BPSD, also referred to as challenging behavior). Structured dementia-specific case conferences (DSCCs) enable nursing staff in nursing homes (NHs) to analyze and handle the BPSD of residents with dementia. The FallDem trial estimated the effectiveness of the structured DSCC intervention WELCOME-IdA (Wittener model of case conferences for people with dementia – the Innovative dementia-oriented Assessment tool) in NHs in Germany. No significant change in the overall prevalence of challenging behavior was found. A multipart process evaluation was conducted to explain this result.MethodsThis qualitative process evaluation of the response of individuals, perceived maintenance, effectiveness, and unintended consequences was part of the multipart process evaluation that followed the framework by Grant et al. (Trials 14: 15, 2013). It used the data from semi-structured telephone interviews and focus group interviews with nurses and managers as secondary data. Selected domains of the Consolidated Framework for Implementation Research (CFIR) were used as deductive categories for a directed content analysis.ResultsThe interviewees in all NHs appraised WELCOME-IdA as generating positive change, although it proved important that some adjustments were made to the intervention and the organization. Thirteen CFIR constructs out of the domains intervention characteristics, inner setting, and process proved to be essential for understanding the different course that the implementation of WELCOME-IdA took in each of the four NHs. This is reflected in three types of WELCOME-IdA implementation: (1) priority on adjusting the intervention to fit the organization, (2) priority on adjusting the organization to fit the intervention, and (3) no setting of priorities in adjusting either the organization or the intervention.ConclusionThe unsatisfying results of the FallDem effectiveness trial can in part be explained with regard to the interplay between the intervention and the implementation which was revealed in the processes that occurred in the organizations during the implementation of the WELCOME-IdA intervention. Future implementation of WELCOME-IdA should be tailored based on an analysis of the organization’s readiness, resources, and capacities and should also define custom-made intervention and implementation outcomes to measure success. Furthermore, our results confirm that the CFIR can be used beneficially to conduct process evaluations.

Development and implementation of a process evaluation for intervention quality improvement of a community-based behavioral HIV intervention trial in Tanzania.

Process evaluations for social and behavioral interventions are increasingly important as interventions become more complex and multi-faceted. Conducting process evaluations in low-resource international settings can be challenging. Process evaluations in low-resource international settings can help inform and improve quality of ongoing intervention implementation. We conducted a process evaluation of a cluster-randomized controlled trial to assess the efficacy of a microfinance and health leadership program on sexually transmitted infections and intimate partner violence perpetration among young men in Tanzania. Our trial included 1,491 participants and the intervention lasted two years. We collected process data on microfinance loan uptake and repayment, and health leaders' health conversations with peers to monitor intervention reach and dose received. We developed a database system that allowed offline data collection and synced to a central database when internet was accessible. Research staff in the U.S. accessed data from the central database to analyze and create regular implementation reports. Process graphical reports facilitated identification of implementation challenges and enabled us to resolve issues before they worsened. For example, from a group with low microfinance loan repayment we learned area participants perceived the loan to be a grant, and then we clarified the misinformation with participants. The process evaluation helped inform ongoing intervention implementation, including approaches to improve reach and uptake of interventions. Field staff time was protected by systemizing the sharing of data processing and analyses across the global team.

Implementation of Self-Management Interventions in Cancer Survivors: Why Are We Not There Yet?

Despite the growing evidence base for supported self-management for the improvement of quality of life, there is a lack of widespread implementation of self-management interventions for cancer survivors. We propose five key areas that, if addressed, would optimise the development and evaluation of these interventions, namely: (1) improving intervention adaptability to different survivor populations; (2) establishing intervention acceptability (and feasibility); (3) ensuring systematic description of interventions, their content, and active ingredients; (4) conducting process evaluations; and (5) assessing cost-effectiveness. These areas are an essential prerequisite for translation of self-management interventions from research into routine cancer care.

Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol

BackgroundThe consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes.We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials.MethodsWe will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living.DiscussionThe present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.

Big data based research on the management system framework of ideological and political education in colleges and universities

Artificial intelligence model combined with data mining technology can mine useful data from college ideological and political education management, and conduct process evaluation and teaching management. Therefore, based on the superiority of data mining technology and artificial intelligence system, this paper improves the traditional algorithm and constructs a university ideological and political education management model based on big data artificial intelligence. Moreover, this study uses a local sensitive hash function to generate representative point sets and uses the generated representative point sets for clustering operations. In order to verify the performance of the algorithm model, a control experiment is designed to compare the algorithm of this paper with traditional data mining methods. It can be seen from the research results that the algorithm model constructed in this paper has good performance and can be applied to practice.