Development and evaluation of the Family Needs Questionnaire for Pediatric Rehabilitation.

PURPOSE: To develop the Family Needs Questionnaire-Pediatric Rehabilitation (FNQ-PR) version and evaluate the reliability and concurrent validity of this self-report measure for caregivers of children with disabilities who receive pediatric rehabilitation services. MATERIALS/METHODS: The 39-item FNQ-PR was developed through a modified Delphi Technique. For test-retest evaluation, parents completed the FNQ-PR twice through an online REDCap survey, 1-3 weeks apart. Concurrent validity data (parent-report Impact on Family Scale [IFS-15] and Measure of Processes of Care [MPOC-20]) were collected at baseline. Reliability analyses included ICCs (95%CI) and internal consistency evaluation. RESULTS: Twenty-five caregivers of children ages 2-18 years (mean age 12.2 years) with a disability completed the FNQ-PR at baseline, and 21 completed the retest. FNQ-PR total score demonstrated excellent test-retest reliability (ICC = 0.84); internal consistency was high. The FNQ-PR total score was strongly negatively associated with IFS-15 total score (r = -0.62) and showed fair to strong association with MPOC subscale scores (0.45 ≤ r ≤ 0.70). Participants did not identify issues with the online format or FNQ-PR item rating. CONCLUSIONS: The FNQ-PR demonstrated excellent overall reliability and strong evidence of validity. It fills a gap in clinical care of families of children with disabilities, providing a systematic way for families to identify the extent to which their needs are perceived to have been met. Clinicians can use this tool to target unmet needs that are most important to families. FNQ-PR use in future research will support exploration of the impact of specific child and family factors on family needs.

When dispatcher assistance is not saving lives: assessment of process compliance, barriers and outcomes in out-of-hospital cardiac arrest in a metropolitan city in China.

BACKGROUND: Several Chinese cities have implemented dispatcher-assisted cardiopulmonary resuscitation (DA-CPR), although out-of-hospital cardiac arrest (OHCA) survival rates remain low. We aimed to assess the process compliance, barriers and outcomes of OHCA in one of the earliest implemented (DA-CPR) programmes in China. METHODS: We retrospectively reviewed OHCA emergency dispatch records of Suzhou emergency medical service from 2014 to 2015 and included adult OHCA victims (>18 years) with a bystander-witnessed atraumatic OHCA that was subsequently confirmed by on-site emergency physician. The circumstances and DA-CPR process related to the OHCA event were analysed. Dispatch audio records were reviewed to identify potential barriers to implementation during the DA-CPR process. RESULTS: Of the 151 OHCA victims, none survived. The median time from patient collapse to call for emergency services and that from call to provision of cardiopulmonary resuscitation instructions was 30 (IQR 20-60) min and 115 (IQR 90-153) s, respectively. Only 110 (80.3%) bystanders/rescuers followed the dispatcher instructions; of these, 51 (46.3%) undertook persistent chest compressions. Major barriers to following the DA-CPR instructions were present in 104 (68.9%) cases, including caller disconnection of the call, distraught mood or refusal to carry out either compressions or ventilations. CONCLUSIONS: The OHCA survival rate and the DA-CPR process were far from optimal. The zero survival rate is disproportionally low compared with survival statistics in high-income countries. The prolonged delay in calling the emergency services negated and rendered futile any DA-CPR efforts. Thus, efforts targeted at developing public awareness of OHCA, calling for help and competency in DA-CPR should be increased.

Family-centeredness of services for young children with Down syndrome: an observational study from Turkey

Background/aim: Physicians require information on the family centeredness of services for children with Down syndrome, one of the most frequently encountered disabilities in childhood. We aimed to determine the family-centeredness of services for young children with Down syndrome and using a bioecological theory framework we hypothesized that child, family and service-related factors would be associated with such services. Materials and methods: In a crosssectional design, children with Down syndrome seen at Ankara University Developmental Pediatrics Division (AUDPD) between February 2020 and June 2020 were included if they had received services in the community for at least 12 months. Mothers responded to the measure of process of care-20 (MPOC-20) used to measure family centeredness. Results: All 65 eligible children were included; 57% were boys and median age was 25.0 (IQR: 18.5­38.0) months. The MPOC-20 subscale scores were highest for the "respectful and supportive care (RSC)" (median 6.0; IQR: 4.8­6.8) and lowest for the "providing specific information" (median 3.0; IQR: 4.4­6.5) subscales. On univariate analyses, maternal education

Validating the New Primary Care Measure in the Medical Expenditure Panel Survey.

BACKGROUND: The advancement of primary care research requires reliable and validated measures that capture primary care processes embedded within nationally representative datasets. OBJECTIVE: The objective of this study was to assess the validity of a newly developed measure of primary care processes [Medical Expenditure Panel Survey (MEPS)-PC] with preliminary evidence of moderate to excellent reliability. STUDY DESIGN: A retrospective cohort study of community-dwelling adults with history of office-based provider visit/s using the MEPS (2013-2014). METHODS: The 3 MEPS-PC subscales (Relationship, Comprehensiveness, and Health Promotion) were tested for construct validity against known measures of primary care: Usual Source of Care, Known Provider, and Family-Usual Source of Care. Concurrent and predictive logistic regression analyses were calculated and compared with a priori hypotheses for direction and strength of association. RESULTS: For concurrent validity, all odds ratio estimates conformed with hypotheses, with 91% displaying statistical significance. For predictive validity, all estimates were in the direction of hypotheses, with 92% displaying statistically significant results. Although Relationship and Health Promotion subscales conformed uniformly with hypotheses, the Comprehensiveness subscale yielded significant results in 60% of bivariate odds ratio estimates (P<0.05). CONCLUSION: The MEPS-PC composite measures display modest to strong preliminary evidence of concurrent and predictive validity relative to known indicators of primary care. IMPLICATIONS FOR POLICY AND PRACTICE: The MEPS-PC composite measures display preliminary evidence of concurrent and predictive construct validity, and it may be useful to researchers investigating primary care processes and complexities in the health care environment.

What Is Slowing Us Down? Six Challenges to Accelerating Advances in Health Behavior Change.

BACKGROUND: Accelerating advances in health behavior change requires releasing the brake, as well as applying the throttle. This paper discusses six challenges or "brakes" that have slowed progress. PURPOSE/METHODS/RESULTS: We engage with six issues that limit investigators' ability to delineate and test the strategy-target and target-behavior relations that underlie effective interventions according to the experimental medicine approach. We discuss the need for guidance on how to identify the relevant mechanism of action (target) in an intervention and whether a periodic table of health behavior constructs might aid investigators. Experimental and correlational analyses (prospective surveys and behavior change techniques) have been used to test the validity of targets, and we present evidence that there is little agreement among the findings from different research designs. Whereas target engagement is typically analyzed in terms of increasing scores on constructs that impel behavior change, we discuss the role of impeding targets and the benefits of adopting a broader construal of potential targets and approaches to engagement. There is presently a paucity of competitive tests regarding which strategies best engage targets and we discuss empirical criteria and conceptual developments that could enhance the evidence base. Finally, we highlight the need to take "context" or conditional intervention effects more seriously by leveraging the interplay between questions about why interventions work and questions about when and for whom they work. CONCLUSION: Candid appraisal of the challenges facing research on health behavior change can generate new opportunities for theoretical development and offer direction and cumulative impetus for empirical work.

The System for Patient Assessment of Cancer Experiences (SPACE): a cross-sectional study examining feasibility and acceptability.

BACKGROUND: Continuous quality improvement in cancer care relies on the collection of accurate data on the quality of care provided. It is suggested that such an approach should: (i) measure the patient's care experience throughout the cancer trajectory; (ii) use items and response scales that measure concrete and specific aspects of care; (iii) minimise recall bias; (iv) minimise the burden placed on patients for providing data; (v) minimise administrative burden; and (vi) collect actionable data. The System for Patient Assessment of Cancer Experiences (SPACE) was developed to meet these objectives. This study describes the feasibility and acceptability of the SPACE in a sample of oncology outpatients. METHODS: The SPACE was examined in four medical oncology centres. Adult patients were approached by a research assistant prior to their scheduled consultation. Consenting participants completed the SPACE on a computer tablet. Items were tailored to the patient's cancer treatment phase. RESULTS: Of the eligible participants, 1143 consented (83%) and 1056 completed the survey (92%). The average time taken to complete the survey was 6 min 28 s. A large proportion of the sample indicated that the survey was acceptable (88-93% across three acceptability items). CONCLUSION: This study demonstrates that the SPACE can be feasibly administered each time a patient comes to the oncology unit and is acceptable to patients. The SPACE could be used to quantify the care experiences which patients receive during their cancer care. The resulting data could be used to set benchmarks and improve the performance of cancer clinics.

Population segments as a tool for health care performance reporting: an exploratory study in the Canadian province of British Columbia.

BACKGROUND: Primary care serves all age groups and individuals with health states ranging from those with no chronic conditions to those who are medically complex, or frail and approaching the end of life. For information to be actionable and guide planning, there must be some population disaggregation based on differences in expected needs for care. Promising approaches to segmentation in primary care reflect both the breadth and severity of health states, the types and amounts of health care utilization that are expected, and the roles of the primary care provider. The purpose of this study was to assess population segmentation as a tool to create distinct patient groups for use in primary care performance reporting. METHODS: This cross-sectional study used administrative data (patient characteristics, physician and hospital billings, prescription medicines data, emergency department visits) to classify the population of British Columbia (BC), Canada into one of four population segments: low need, multiple morbidities, medically complex, and frail. Each segment was further classified using socioeconomic status (SES) as a proxy for patient vulnerability. Regression analyses were used to examine predictors of health care use, costs and selected measures of primary care attributes (access, continuity, coordination) by segment. RESULTS: Average annual health care costs increased from the low need ($ 1460) to frail segment ($10,798). Differences in primary care cost by segment only emerged when attributes of primary care were included in regression models: accessing primary care outside business hours and discontinuous primary care (≥5 different GP's in a given year) were associated with higher health care costs across all segments and higher continuity of care was associated with lower costs in the frail segment (cost ratio = 0.61). Additionally, low SES was associated with higher costs across all segments, but the difference was largest in the medically complex group (cost ratio = 1.11). CONCLUSIONS: Population segments based on expected need for care can support primary care measurement and reporting by identifying nuances which may be lost when all patients are grouped together. Our findings demonstrate that variables such as SES and use of regression analyses can further enhance the usefulness of segments for performance measurement and reporting.

Serious Gaming During Multidisciplinary Rehabilitation for Patients With Chronic Pain or Fatigue Symptoms: Mixed Methods Design of a Realist Process Evaluation.

BACKGROUND: Serious gaming could support patients in learning to cope with chronic pain or functional somatic syndromes and reduce symptom burdens. OBJECTIVE: To realize this potential, insight is needed into how, why, for whom, and when it works in actual treatment circumstances. METHODS: Following a realist approach, process evaluations were performed before, during, and after a two-armed, natural quasi-experiment (n=275). A group of patients with interfering chronic pain or fatigue symptoms received a short additional blended mindfulness-based serious gaming intervention during a multidisciplinary rehabilitation program. A control group only received the regular rehabilitation program. During two sessions before and one session after the experiment, expectations about serious gaming processes were discussed in focus groups with local care providers, implementers, and experts. Patients participated in a survey (n=114) and in semistructured interviews (n=10). The qualitative data were used to develop tentative expectations about aspects of serious gaming that, in certain patients and circumstances, trigger mechanisms of learning and health outcome change. Hypotheses about indicative quantitative data patterns for tentative expectations were formulated before inspecting, describing, and analyzing-with regression models-routinely collected clinical outcome data. An updated program theory was formulated after mixing the qualitative and quantitative results. RESULTS: Qualitative data showed that a subset of patients perceived improvement of their self-awareness in moments of daily social interactions. These results were explained by patients, who played the serious game LAKA, as a "confrontation with yourself," which reflected self-discrepancies. Important characteristics of serious gaming in the study's context included innovation factors of relative advantage with experiential learning opportunity, compatibility with the treatment approach, and the limited flexibility in regard to patient preferences. Perceived patient factors included age and style of coping with stress or pain. Learning perceptions could also depend on care provider role-taking and the planning and facilitating (ie, local organization) of serious gaming introduction and feedback sessions in small groups of patients. Quantitative data showed very small average differences between the study groups in self-reported depression, pain, and fatigue changes (-.07

Reducing the length of clinic visits: A process analysis case report.

Because the University of Houston Student Health Center often had more demand for services than available appointments, the aim of this study was to streamline their clinic visit process. While appointments were scheduled for 20 minutes, the clinic's patient visit cycle time (from check-in to check-out) averaged 70 minutes. This report demonstrats how to perform process analysis using failure modes and effects analysis in order to identify the highest priority cause of waste and how to conduct a detailed evaluation of ideas using a prioritization matrix in order to select the best solution to help streamline a process. Analysis of this clinic's visit process identified that patients (mostly international students) asking many questions during their appointment regarding issues not directly related to their care led to long clinic visits. To address this issue, the clinic recruited a team of international students to create a frequently asked questions video with answers, and the final video was then uploaded to the clinic's Facebook page. Comparing before and after the video was posted showed the clinic's average time for a clinic visit was reduced by more than 15%, and it was able to accommodate nearly 100 additional patient visits per month.

Conversation Analysis and Family Therapy: A Critical Review of Methodology.

This article critiques the use of conversation analysis (CA) as applied to the study of family therapy. Searches of relevant databases and journals as well as citation searches were conducted in April 2018 for relevant articles. Inclusion criteria included the explicit use of CA either solely or in combination with discourse analysis and discursive psychology. This resulted in the inclusion of 25 articles that were reviewed against a guideline for the evaluation of qualitative research to which five items specific to CA were added to ensure a specific and balanced evaluation of the studies. Articles generally had a good application of quality criteria although there was a variation in detail of transcription, application of sequence analysis, and a limited use of validity testing. CA has the potential to complement existing research on family therapy but requires a rigorous application of process and quality criteria. The article provides recommendations for future CA research into family therapy.

Este artículo analiza el uso del análisis de la conversación (CA) según se aplica al estudio de la terapia familiar. En abril de 2018 se realizaron búsquedas en bases de datos y revistas relevantes así como búsquedas de citas para artículos relevantes. Los criterios de inclusión incluyeron el uso explícito del análisis de la conversación, ya sea exclusivamente o combinado con el análisis del discurso y la psicología discursiva. Esto resultó en la inclusión de 25 artículos que se revisaron según una guía para la evaluación de la investigación cualitativa a la cual se agregaron cinco puntos específicos del análisis de la conversación para garantizar una evaluación específica y equilibrada de los estudios. Los artículos generalmente tuvieron una buena aplicación de los criterios de calidad, aunque hubo una variación en el detalle de la transcripción, la aplicación del análisis de secuencias y un uso limitado de la evaluación de la validez. El análisis de la conversación tiene el potencial de complementar las investigaciones existentes sobre terapia familiar, pero exige una aplicación rigurosa de los criterios de procesamiento y calidad. El artículo ofrece recomendaciones para futuras investigaciones sobre el análisis de la conversación en la terapia familiar.

The multi-dimensional matrix for consultation-liaison psychiatry (mMAX-LP).

OBJECTIVE: Consultation-liaison psychiatry (CLP) services are particularly susceptible to heterogeneity, developing haphazardly in response to local interests and perceived need. This hampers the generalisability of comparisons between services in terms of service models, resource requirements and outcome data. The objective of this paper therefore is to chronicle the development of a method to meaningfully describe, map and compare different CLP services. METHOD: A review of the literature was followed by multiple site visits in both New Zealand and England, and an extended process of consultation and feedback. RESULTS: Sixteen dimensions common to CLP services were extracted to create a multi-dimensional matrix (mMAX-LP) which had three broad clusters (structure, coverage and relationship with physical health services). The model was applied and discussed with the previously visited hospitals over the succeeding five years. Additionally, the matrix was tested, and its utility demonstrated during the planned reconfiguration of CLP services at a large teaching hospital in South Auckland, New Zealand by tracking the evolution of CLP services. CONCLUSIONS: mMAX-LP shows promise as a useful model for profiling and comparing CLP services; mapping their evolution over time; and sign-posting future service development.

Development of a measurement system for complex oral information transfer in medical consultations.

BACKGROUND: Information exchange between physician and patient is crucial to achieve patient involvement, shared decision making and treatment adherence. No reliable method exists for measuring how much information physicians provide in a complex, unscripted medical conversation, nor how much of this information patients recall. This study aims to fill this gap by developing a measurement system designed to compare complex orally provided information to patient recall. METHODS: The development of the complex information transfer measurement system required nine methodological steps. Core activities were data collection, definition of information units and the first draft of a codebook, refinement through independent coding and consensus, and reliability testing. Videotapes of physician-patient consultations based on a standardized scenario and post-consultation interviews with patients constituted the data. The codebook was developed from verbatim transcriptions of the videotapes. Inter-rater reliability was calculated using a random selection of 10% of the statements in the transcriptions. RESULTS: Thirtyfour transcriptions of visits and interviews were collected. We developed a set of rules for defining a single unit of information, defined detailed criteria for exclusion and inclusion of relevant units of information, and outlined systematic counting procedures. In the refinement phase, we established a system for comparing the information provided by the physician with what the patient recalled. While linguistic and conceptual issues arose during the process, coders still achieved good inter-rater reliability, with intra-class correlation for patient recall: 0.723, and for doctors: 0.761. A full codebook is available as an appendix. CONCLUSIONS: A measurement system specifically aimed at quantifying complex unscripted information exchange may be a useful addition to the tools for evaluating the results of health communication training and randomized controlled trials.

Adaptation and Implementation of the STarT Back Risk Stratification Strategy in a US Health Care Organization: A Process Evaluation.

OBJECTIVE: To support implementation of effective treatments for back pain that can be delivered to a range of people, we summarize learnings from our process evaluation of the MATCH trial's implementation of an adaptation of the STarT Back risk-stratified care model. DESIGN: Our logic model-driven evaluation focused primarily on qualitative data sources. SETTING: This study took place in a US-based health care delivery system that had adapted and implemented the STarT Back stratified care approach. This was the first formal test of the strategy in a US setting. METHODS: Data collection included observation of implementation activities, staff/provider interviews, and post-training evaluation questionnaires. Data were analyzed using thematic analysis of qualitative data and descriptive statistics for questionnaire data. RESULTS: We found that both primary care teams and physical therapists at intervention clinics gave the training high scores on evaluation questionnaires and reported in the interviews that they found the training engaging and useful. However, there was significant variation in the extent to which the risk stratification strategy was incorporated into care. Some primary care providers reported that the intervention changed their conversations with patients and increased their confidence in working with patients with back pain. Providers using the STarT Back tool did not change referral rates for recommended matched treatments. CONCLUSIONS: These insights provide guidance for future efforts to adapt and implement the STarT Back strategy and other complex practice change interventions. They emphasize the need for primary care-based interventions to minimize complexity and the need for ongoing monitoring and feedback.

STructured lifestyle education for people WIth SchizophrEnia (STEPWISE): mixed methods process evaluation of a group-based lifestyle education programme to support weight loss in people with schizophrenia.

BACKGROUND: STEPWISE is a theory-informed self-management education programme that was co-produced with service users, healthcare professionals and interventionists to support weight loss for people with schizophrenia. We report the process evaluation to inform understanding about the intervention and its effectiveness in a randomised controlled trial (RCT) that evaluated its efficacy. METHODS: Following the UK Medical Research Council (MRC) Guidelines for developing and evaluating complex interventions, we explored implementation quality. We considered causal mechanisms, unanticipated consequences and contextual factors associated with variation in actual and intended outcomes, and integrated treatment fidelity, using the programme theory and a pipeline logic model. We followed a modified version of Linnan and Steckler's framework and single case design. Qualitative data from semi-structured telephone interviews with service-users (n = 24), healthcare professionals delivering the intervention (n = 20) and interventionists (n = 7) were triangulated with quantitative process and RCT outcome data and with observations by interventionists, to examine convergence within logic model components. RESULTS: Training and course materials were available although lacked co-ordination in some trusts. Healthcare professionals gained knowledge and some contemplated changing their practice to reflect the (facilitative) 'style' of delivery. They were often responsible for administrative activities increasing the burden of delivery. Healthcare professionals recognised the need to address antipsychotic-induced weight gain and reported potential value from the intervention (subject to the RCT results). However, some doubted senior management commitment and sustainability post-trial. Service-users found the intervention highly acceptable, especially being in a group of people with similar experiences. Service-users perceived weight loss and lifestyle benefits; however, session attendance varied with 23% (n = 47) attending all group-sessions and 17% (n = 36) attending none. Service-users who lost weight wanted closer monitoring and many healthcare professionals wanted to monitor outcomes (e.g. weight) but it was outside the intervention design. No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention. CONCLUSIONS: This process evaluation provides a greater understanding of why STEPWISE was unsuccessful in promoting weight loss during the clinical trial. Further research is required to evaluate whether different levels of contact and objective monitoring can support people with schizophrenia to lose weight. TRIAL REGISTRATION: ISRCTN, ISRCTN19447796. Registered 20 March 2014.

Measuring the quality of maternal and care processes at the time of delivery in sub-Saharan Africa: development and validation of a short index.

BACKGROUND: There is a growing recognition that quality of care must improve in facility-based deliveries to achieve further global reductions in maternal and newborn mortality and morbidity. Better measurement of care quality is needed, but the unpredictable length of labor and delivery hinders the feasibility of observation, the gold standard in quality assessment. This study evaluated whether a measure restricted to actions at or immediately following delivery could provide a valid assessment of the quality of the process of intrapartum and immediate postpartum care (QoPIIPC), including essential newborn care. METHODS: The study used a comprehensive QoPIIPC index developed through a modified Delphi process and validated by delivery observation data as a starting point. A subset of items from this index assessed at or immediately following delivery was identified to create a "delivery-only" index. This delivery-only index was evaluated across content and criterion validation domains using delivery observation data from Kenya, Madagascar, and Tanzania, including Zanzibar. RESULTS: The delivery-only index included 13 items and performed well on most validation criteria, including correct classification of poorly and well-performed deliveries. Relative to the comprehensive QoPIIPC index, the delivery-only index had reduced content validity, representing fewer dimensions of QoPIIPC. The delivery-only index was also less strongly associated with overall quality performance in observed deliveries than the comprehensive QoPIIPC index. CONCLUSIONS: Where supervision resources are limited, a measure of the quality of labor and delivery care targeting the time of delivery may mitigate challenges in observation-based assessment. The delivery-only index may enable increased use of observation-based quality assessment within maternal and newborn care programs in low-resource settings.

Modifying the Environment and Policy Assessment and Observation (EPAO) to better capture feeding practices of family childcare home providers.

OBJECTIVE: To describe the modification and validation of an existing instrument, the Environment and Policy Assessment and Observation (EPAO), to better capture provider feeding practices. DESIGN: Modifications to the EPAO were made, validity assessed through expert review, pilot tested and then used to collect follow-up data during a two-day home visit from an ongoing cluster-randomized trial. Exploratory factor analysis investigated the underlying factor structure of the feeding practices. To test predictive validity of the factors, multilevel mixed models examined associations between factors and child's diet quality as captured by the Healthy Eating Index-2010 (HEI-2010) score (measured via the Dietary Observation in Childcare Protocol). SETTING: Family childcare homes (FCCH) in Rhode Island and North Carolina, USA.ParticipantsThe modified EPAO was pilot tested with fifty-three FCCH and then used to collect data in 133 FCCH. RESULTS: The final three-factor solution ('coercive control and indulgent feeding practices', 'autonomy support practices', 'negative role modelling') captured 43 % of total variance. In multilevel mixed models adjusted for covariates, 'autonomy support practices' was positively associated with children's diet quality. A 1-unit increase in the use of 'autonomy support practices' was associated with a 9·4-unit increase in child HEI-2010 score (P=0·001). CONCLUSIONS: Similar to the parenting literature, constructs which describe coercive controlling practices and those which describe autonomy-supportive practices emerged. Given that diets of pre-schoolers in the USA remain suboptimal, teaching childcare providers about supportive feeding practices may help improve children's diet quality.

Barriers and facilitators to implementing dementia care mapping in care homes: results from the DCM™ EPIC trial process evaluation.

BACKGROUND: Psychosocial person-centred interventions are considered best practice for addressing complex behaviours and care needs such as agitation and anxiety, and for improving the quality of life of people with dementia in care homes. Dementia Care Mapping (DCM™) is an established practice development tool and process aimed to help care home staff deliver more person-centred care. To date, few studies have evaluated the efficacy of DCM™ and have found mixed results. These results are suggested to be the outcome of intervention implementation, which may be impacted by a range of factors. This study reports the barriers and facilitators to DCM™ implementation in care homes found during the process evaluation conducted as part of a randomized controlled trial. METHODS: Eighteen of the 31 DCM™ intervention care homes were recruited to participate in the embedded process evaluation. Semi-structured interviews were conducted with 83 participants, comprising care home managers, trained DCM™ users (mappers), expert external mappers, staff members, relatives, and residents. RESULTS: Barriers and facilitators to DCM™ implementation were found at the mapper level (e.g. motivation and confidence), the DCM™ intervention level (e.g. understanding of DCM™) and the care home level (e.g. staffing issues, manager support). Further barriers caused by the burden of trial participation were also identified (e.g. additional paperwork). CONCLUSIONS: Implementing DCM™ is complex and a greater consideration of potential barriers and facilitators in planning future studies and in practice could help improve implementation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82288852 , registered 16/01/2014.

Process evaluation in the field: global learnings from seven implementation research hypertension projects in low-and middle-income countries.

BACKGROUND: Process evaluation is increasingly recognized as an important component of effective implementation research and yet, there has been surprisingly little work to understand what constitutes best practice. Researchers use different methodologies describing causal pathways and understanding barriers and facilitators to implementation of interventions in diverse contexts and settings. We report on challenges and lessons learned from undertaking process evaluation of seven hypertension intervention trials funded through the Global Alliance of Chronic Diseases (GACD). METHODS: Preliminary data collected from the GACD hypertension teams in 2015 were used to inform a template for data collection. Case study themes included: (1) description of the intervention, (2) objectives of the process evaluation, (3) methods including theoretical basis, (4) main findings of the study and the process evaluation, (5) implications for the project, policy and research practice and (6) lessons for future process evaluations. The information was summarized and reported descriptively and narratively and key lessons were identified. RESULTS: The case studies were from low- and middle-income countries and Indigenous communities in Canada. They were implementation research projects with intervention arm. Six theoretical approaches were used but most comprised of mixed-methods approaches. Each of the process evaluations generated findings on whether interventions were implemented with fidelity, the extent of capacity building, contextual factors and the extent to which relationships between researchers and community impacted on intervention implementation. The most important learning was that although process evaluation is time consuming, it enhances understanding of factors affecting implementation of complex interventions. The research highlighted the need to initiate process evaluations early on in the project, to help guide design of the intervention; and the importance of effective communication between researchers responsible for trial implementation, process evaluation and outcome evaluation. CONCLUSION: This research demonstrates the important role of process evaluation in understanding implementation process of complex interventions. This can help to highlight a broad range of system requirements such as new policies and capacity building to support implementation. Process evaluation is crucial in understanding contextual factors that may impact intervention implementation which is important in considering whether or not the intervention can be translated to other contexts.

Measuring implementation: development of the implementation process assessment tool (IPAT).

BACKGROUND: Implementation science comprises a large set of theories suggesting interacting factors at different organisational levels. Development of literature syntheses and frameworks for implementation have contributed to comprehensive descriptions of implementation. However, corresponding instruments for measuring these comprehensive descriptions are currently lacking. The present study aimed to develop an instrument measuring care providers' perceptions of an implementation effort, and to explore the instrument's psychometric properties. METHODS: Based on existing implementation literature, a questionnaire was designed with items on individual and team factors and on stages of change in an implementation process. The instrument was tested in a Norwegian study on implementation of evidence based practices for psychosis. Item analysis, factor structure, and internal consistency at baseline were examined. RESULTS: The 27-item Implementation Process Assessment Tool (IPAT) revealed large variation between mean score of the items. The total scale scores were widely dispersed across respondents. Internal consistency for the total scale was high (Cronbach's alpha: .962), and all but one item contributed positively to the construct. The results indicated four underlying constructs: individual stages for behavioural change, individual activities and perceived support, collective readiness and support, and individual perceptions of the intervention. CONCLUSIONS: The IPAT appears to be a feasible instrument for investigating the implementation process from the perspective of those making the change. It can enable examination of the relative importance of factors thought to be essential for implementation outcomes. It may also provide ongoing feedback for leaders tailoring support for teams to improve implementation. However, further research is needed to detect the instrument's properties later in the implementation process and in different contexts. TRIAL REGISTRATION: ClinicalTrials.gov code NCT03271242 (retrospective registered September 5, 2017).

Process evaluation of the effects of patient safety auditing in hospital care (part 2).

OBJECTIVE: To identify factors that explain the observed effects of internal auditing on improving patient safety. DESIGN SETTING AND PARTICIPANTS: A process evaluation study within eight departments of a university medical centre in the Netherlands. INTERVENTION(S): Internal auditing and feedback for improving patient safety in hospital care. MAIN OUTCOME MEASURE(S): Experiences with patient safety auditing, percentage implemented improvement actions tailored to the audit results and perceived factors that hindered or facilitated the implementation of improvement actions. RESULTS: The respondents had positive audit experiences, with the exception of the amount of preparatory work by departments. Fifteen months after the audit visit, 21% of the intended improvement actions based on the audit results were completely implemented. Factors that hindered implementation were short implementation time: 9 months (range 5-11 months) instead of the 15 months' planned implementation time; time-consuming and labour-intensive implementation of improvement actions; and limited organizational support for quality improvement (e.g. insufficient staff capacity and time, no available quality improvement data and information and communication technological (ICT) support). CONCLUSIONS: A well-constructed analysis and feedback of patient safety problems is insufficient to reduce the occurrence of poor patient safety outcomes. Without focus and support in the implementation of audit-based improvement actions, quality improvement by patient safety auditing will remain limited.