Routine Care Practice Research Articles

Tooling nurses to assess complexity in routine home care practice: Derivation of a complexity index from the interRAI-HC.

AimHome care nurses often use the Resident Assessment Instrument‐Home Care (interRAI‐HC) to assess health needs. However, this tool does not assess complexity. This study proposes to derive a complexity index (CI) from the interRAI‐HC using the operational definition of the dedicated COMID checklist (COmplexité Multidimensionnelle des prises en soins Infirmières à Domicile).DesignData were collected at the baseline assessment of the fraXity study (N = 231, aged ≥ 65), which relied on an observational longitudinal design.MethodsMeasures were the interRAI‐HC, from which the CI binary variables were computed and the COMID, used as a reference.ResultsTwenty‐six CI variables were computed from the interRAI‐HC, and all but three correlations were significant. The correlation between the CI score and the COMID score was ρ = 0.730 (p < .001).ConclusionsThe study demonstrates that complexity can be assessed directly from the interRAI‐HC by deriving a CI.

Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.

Objective Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology. Methods The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity. Results Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format. Conclusions An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.

Intravenous tocilizumab in the management of rheumatoid arthritis: Clinical practice findings from a 6-month international, multicentre, observational study in Central America and the Caribbean

Tocilizumab (TCZ), an interleukin-6 receptor-α inhibitor, is indicated in patients with moderate to severe rheumatoid arthritis with inadequate response to disease modifying drugs. ACT UP is a multinational project collecting information from several post-marketing TCZ studies. AimTo determine the proportion of patients in the routine clinical care setting receiving intravenous TCZ after 6 months treatment. Identification of TCZ treatment patterns, efficacy, and safety were also recorded. MethodThis prospective non-interventional 6-month study, collected real-world information from 169 Central American and Caribbean patients. No interventional procedures or additional visits outside routine clinical care practice were performed. Statistical analysis was essentially descriptive. ResultsAdherence rate was 74.0%, with 97% of patients receiving TCZ as first biological therapy line and there were no deviations from the local label. Almost 85% of patients started with combination therapy, and the majority remained under this scheme throughout the study. A significant decrease in disease activity assessments and acute phase reactants values were detected during TCZ treatment. The percentage of patients that achieved improvement according to the different levels of the American College of Rheumatology (ACR) increased during the study, and relevant enhancements in quality of life were also accomplished. Adverse events (AEs) occurred in 35 patients, with metabolic and nutritional disorders being the most common. Serious AEs were reported in 3% of patients, and special interest AEs occurred in 6 patients. ConclusionTreatment adherence was mainly determined by follow-up and compliance with the administration schedule. Efficacy analysis showed better results than those reported in international literature. The incidence of AEs was also lower than in previously published data.

Patient and healthcare professional experiences of the Salford Lung Studies: qualitative insights for future effectiveness trials

BackgroundRandomized controlled trials (RCTs) conducted in the routine care setting provide the opportunity to better understand the effectiveness of new medicines but can present recruitment difficulties. An improved understanding of the challenges/opportunities for patient and healthcare professional (HCP) engagement in clinical research is needed to enhance participation and trial experience. In this study, we explored patient and HCP drivers for, and experiences of, participation in the Salford Lung Studies (SLS), and their views on future trial participation and the overall value of such trials.MethodsThis was a qualitative study set in Salford, UK, comprising patient telephone interviews (N = 10) and HCP advisory boards (one with general practitioners [GPs], one with practice managers [PMs]); all individuals had participated in the SLS. Semi-structured telephone interviews were recorded, transcribed and analysed thematically. Advisory board meetings were analysed based on transcriptions of audio recordings and field notes.ResultsFor patients, key positive aspects of the SLS were the ease/convenience of study assessments and excellent relationships with study nurses. GPs and PMs considered the SLS to be well-organized and highlighted the value of research nurse support; they also described minor challenges relating to trial systems, initial financial strain on practices and staff turnover. All participants indicated that they were very likely to participate in future trials, citing a design closely aligned with routine care practice as essential. Several strategies to encourage trial participation were suggested, such as clearly communicating benefits to patients and ensuring flexible study assessments.ConclusionsPatients and HCPs had positive experiences of the SLS. The study design, closely aligned with routine care, was considered important to their high likelihood of participating in future trials. The experiences of patients and HCPs in the SLS provide valuable insights that will help inform future best practice in the design and conduct of future real-world effectiveness RCTs in primary care. The detailed first-hand experiences of HCPs will be of significant value to others considering engaging in clinical research and participating in effectiveness RCTs.

Intravenous tocilizumab in the management of rheumatoid arthritis: Clinical practice findings from a 6-month international, multicentre, observational study in Central America and the Caribbean

Tocilizumab (TCZ), an interleukin-6 receptor-α inhibitor, is indicated in patients with moderate to severe rheumatoid arthritis with inadequate response to disease modifying drugs. ACT UP is a multinational project collecting information from several post-marketing TCZ studies. AimTo determine the proportion of patients in the routine clinical care setting receiving intravenous TCZ after 6 months treatment. Identification of TCZ treatment patterns, efficacy, and safety were also recorded. MethodThis prospective non-interventional 6-month study, collected real-world information from 169 Central American and Caribbean patients. No interventional procedures or additional visits outside routine clinical care practice were performed. Statistical analysis was essentially descriptive. ResultsAdherence rate was 74.0%, with 97% of patients receiving TCZ as first biological therapy line and there were no deviations from the local label. Almost 85% of patients started with combination therapy, and the majority remained under this scheme throughout the study. A significant decrease in disease activity assessments and acute phase reactants values were detected during TCZ treatment. The percentage of patients that achieved improvement according to the different levels of the American College of Rheumatology (ACR) increased during the study, and relevant enhancements in quality of life were also accomplished. Adverse events (AEs) occurred in 35 patients, with metabolic and nutritional disorders being the most common. Serious AEs were reported in 3% of patients, and special interest AEs occurred in 6 patients. ConclusionTreatment adherence was mainly determined by follow-up and compliance with the administration schedule. Efficacy analysis showed better results than those reported in international literature. The incidence of AEs was also lower than in previously published data.

Management of prepregnancy, pregnancy, and postpartum obesity from the FIGO Pregnancy and Non‐Communicable Diseases Committee: A FIGO (International Federation of Gynecology and Obstetrics) guideline

Management of prepregnancy, pregnancy, and postpartum obesity from the FIGO Pregnancy and Non‐Communicable Diseases Committee: A FIGO (International Federation of Gynecology and Obstetrics) guideline

The COVID-19 pandemic: is our medicine still evidence-based?

There is no randomized controlled trial that demonstrated the efficacy of antiviral therapy against COVID-19 yet. However, physicians are prescribing different drugs to a large part of COVID-19 population in the hope they will cure them. This does not reflect the evidence-based medicine approach. What we need is more evidence-based knowledge about what routine care practices we should to apply to ameliorate symptoms of patients and fight COVID-19 pathology.

FACT physical wellbeing to independently predict overall survival in patients with acute myeloid leukemia.

7532 Background: Patient-reported outcomes (PROs) predict overall survival (OS) in solid cancer populations, but little evidence exists around the prognostic value of PROs in patients with hematologic malignancies. We investigated whether scales from the Functional Assessment of Cancer Therapy – Leukemia (FACT-Leu) predicted OS beyond established prognostic factors. Methods: Data were from 317 AML patients unfit for intensive therapy from a clinical trial comparing Dacogen (decitabine) plus Talacotuzumab versus Dacogen (decitabine) alone (AML2002; NCT02472145). We used ridge-penalized Cox models to determine whether baseline (1st cycle) FACT-Leu scales predicted OS. FACT-Leu scales significant in these models and factors from a validated prognostic model, the AML composite model (AML-CL; covariates listed in Table), were entered into Cox proportional hazard models. Lastly, model selection procedures were run with 1000 bootstrapped samples using all variables. The inclusion frequency of each FACT-Leu scale in the final models was examined to evaluate prognostic value for OS (i.e., higher the % of inclusion, higher importance of the variable). Results: In the ridge-penalized Cox models, the Physical Wellbeing Scale (PWB), Trial Outcome Index (TOI), and FACT-Leu Total scales were significant predictors of OS. After adjusting for the AML-CL factors, an important difference (2 pts) in PWB score was associated with a 9% decline in OS. (Table) Model validity was evidenced as the PWB scale appeared in a large majority of selected models (90%-97%), while the TOI (45%-73%) and FACT-Leu Total (41%-71%) appeared less often. Conclusions: FACT-Leu scales, especially the PWB, were significant prognostic factors for OS among AML patients not suitable for intensive therapy. These results may indicate PROs' value as stratification factors in trials with AML patients and underscore the need to more systematically collect PRO data in routine care practice with AML patients. Clinical trial information: NCT02472145 . [Table: see text]

Using information and communication technologies to improve the management of pain from advanced cancer in the community: Qualitative study of the experience of implementation for patients and health professionals in a trial

In cancer care, there are emerging information and communication technology systems being developed, enabling real-time information sharing between patients and health professionals. This study explored health professionals' and patients' perceptions of their engagement with an information and communication technology system for pain management to understand the mechanisms that could support implementation into routine palliative care practice. This was a qualitative study, embedded within a randomised control trial, using semi-structured face-to-face interviews. Data were analysed using thematic analysis. The role of health professionals was a key component to patient engagement with the information and communication technology system. Where patients engaged with the information and communication technology system, both patients and health professionals reported benefits to system use in addition to usual care. Implementation issues were identified that can be used to guide future system development to support pain management in the context of routine clinical care in palliative care services. Where interventions are dependent on multiple providers, collaborative working and consideration of the context within which they are set are needed.

Differences in foot care practice between participants at risk for and with diabetic foot ulcers (DFUs) in community

The research aimed to investigate differences in foot care practice between participants at risk for and with diabetic foot ulcers (DFUs). The study design was quantitative with a cross-sectional approach. A total of 150 participants included in this study. Participants at risks for DFUs were measured using the 10g Semmes-Weinstein monofilaments for detecting neuropathy and the Ankle Brachial Index (ABI) Doppler for diabetic angiopathy. Data analyzed using chi-squared and Fisher's exact tests. There were significant differences in foot care between the risk for DFUs and DFUs groups, especially for foot washing, footwear inspection, and footwear usage domains (p<0.01). Those in the risk for DFUs group were more frequent and better in conducting foot care than those in the DFUs group. Performing routine foot care practices among people diagnosed with diabetes are essential for preventing the development and infection of DFUs.

Ambulatory screening and decontamination to prevent Staphylococcus aureus complications in patients undergoing elective surgery (STAUfrei): study protocol for a controlled intervention study

BackgroundSurgical site infections (SSI) are the most common health care associated infections in German acute hospitals and can result in prolonged hospital stays, increased use of antibiotics and utilisation of care. Staphylococcus aureus bacteria (methicillin-resistant S Aureus (MRSA) and methicillin-susceptible S Aureus (MSSA)) are amongst the most prominent causes of SSI. While up to 90% of documented S Aureus colonization is already detectable prior to hospital admission, the majority of hygiene measures in Germany is focused on the hospital setting. It is hypothesized that early detection and decontamination of S Aureus colonization in primary care can prevent health care associated infections and reduce the number of S Aureus isolates in the hospital setting.MethodsThis study is a controlled interventional study (N = 13,260) with a pre-post comparison. The intersectoral intervention (over 2 years) will encompass the following elements: ambulatory detection and decontamination of MRSA and MSSA prior to elective surgery combined with a structured follow-up care. Patients from the control group will be screened in the hospital setting, in accordance with the standard operating procedure (SOP) in routine care. The primary endpoint is the reduction of MRSA and MSSA colonization upon hospital admission. Secondary endpoints are complication rate (SSI), length of stay, recolonization of patients (3 and 6 months after release), patient and provider satisfaction, patient compliance and cost development.DiscussionIn case of positive results, the chance of a widespread uptake and implementation in routine care are considered high. The active involvement of primary care providers in the implementation of screening and decontamination as well as follow-up care is a unique feature of this study. The positive resonance of primary care providers during the recruitment phase highlights the relevance of the topic to the participating actors. These efforts are coupled with patient education and specifically trained medical staff, promising a sustained impact. The STAUfrei care pathway can homogenize current practices in routine care and provide a template for further intersectoral cooperation.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00016615. Registered on April 1st, 2019.

1158: The association between sexual violence history and gynecological and obstetrical behaviors, pregnancy, and delivery outcome

Sexual violence is a global public health problem. We aimed to evaluate the association between self-reported history of sexual violence and women's health behaviors, with a focus on routine gynecological and prenatal care practices and outcomes. This was a retrospective questionnaire-based study, including mothers of live singleton newborns delivered at a regional tertiary medical center from October 2018 to February 2019. Participants were asked to answer 4 questionnaires, including screening for sexual violence history (SES), posttraumatic stress disorder (PDS), and postpartum depression (EPDS), as well as demographic and medical history data. Computerized perinatal records were reviewed. Multiple analyses were performed, comparing background and outcome variables across all levels of SES severity. Multivariable regression models were constructed while adjusting for confounders. During the study period, 210 women met the inclusion criteria. Of them, 26.3% (57) reported unwanted sexual encounter victimization, 23% (50) reported coercion, 1.8% (4) assault and attempted rape, and 1.4% (3) reported they were raped. Several multivariate regression models were constructed, to assess the independent association between sexual violence history and delivery mode, perineal damage and EPDS score (Table 1). Sexual violence history was found to be independently and significantly associated with the risk of postpartum depression while adjusting for maternal age, education, and ethnicity (adjusted OR=4.46; 95%CI 2.03-9.81). Exposed women were also more likely to report a negative relationship with their gynecologist and avoid gynecological care (33.9% versus 16.7%, p=0.012). A significant association was found between both positive EPDS screening as well as post trauma and sexual violence history (Table 2). No significant association was found between sexual violence history and pregnancy outcomes. Sexual violence history is extremely common among post-partum women. It is independently associated with post-partum depression, neglected gynecological care, and post trauma.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Synthesis of qualitative research studies regarding the factors surrounding UK critical care trial infrastructure

Conducting clinical trials in critical care is integral to improving patient care. Unique practical and ethical considerations exist in this patient population that make patient recruitment challenging, including narrow recruitment...

Development of Quality Management Capacity in Child-Serving Nonprofit Agencies

Quality or performance management capabilities allow agencies to identify effective practices in routine care, implement new practices, and learn to adapt practices as contexts change. Within child-serving human service systems there is not a dominant model of quality management capabilities and how they are deployed. Quality management capabilities and their development were explored at nine different child serving agencies. Agency respondents described four emergent core quality management capabilities: generating shared goals, managing information, routinizing problem-solving, and propagating a culture of quality. None of the nine agencies we studied excelled at all four. Each capability is described and implications for research, policy and practice are discussed.

On the critical evaluation and confirmation of germline sequence variants identified using massively parallel sequencing

Although massively parallel sequencing (MPS) is becoming common practice in both research and routine clinical care, confirmation requirements of identified DNA variants using alternative methods are still topics of debate. When evaluating variants directly from MPS data, different read depth statistics, together with specialized genotype quality scores are, therefore, of high relevance. Here we report results of our validation study performed in two different ways: 1) confirmation of MPS identified variants using Sanger sequencing; and 2) simultaneous Sanger and MPS analysis of exons of selected genes. Detailed examination of false-positive and false-negative findings revealed typical error sources connected to low read depth/coverage, incomplete reference genome, indel realignment problems, as well as microsatellite associated amplification errors leading to base miss-calling. However, all these error types were identifiable with thorough manual revision of aligned reads according to specific patterns of distributions of variants and their corresponding reads. Moreover, our results point to dependence of both basic quantitative metrics (such as total read counts, alternative allele read counts and allelic balance) together with specific genotype quality scores on the used bioinformatics pipeline, stressing thus the need for establishing of specific thresholds for these metrics in each laboratory and for each involved pipeline independently.

PO 8447 ROBUST CLINICAL TRIALS ARE NOT ENOUGH: OVERCOMING OPERATIONAL CHALLENGES FOR IMPLEMENTING REMSTART INTERVENTION PACKAGE (TRIP STUDY) INTO ROUTINE PRACTICE

BackgroundThe REMSTART trial identified an effective package (cryptococcal antigen (CrAg) screening and enhanced antiretroviral therapy (ART) adherence support) that reduced all-cause mortality in advanced HIV (CD4 ≤200 cells/mm3) by 28% compared to standard of care. The introduction of this package at clinic level has been necessary to impact routine care practices in Tanzania.MethodsThe TRIP study is cluster-randomised. The intervention package was implemented in 16 routine care facilities (early arm) whilst 8 facilities continued with standard of care (deferred arm). At the end of 12 months follow-up, the intervention was implemented in the deferred facilities. The primary endpoint is all-cause mortality at 1 year.ResultsImplementation of the REMSTART intervention into routine care services has highlighted the following challenges: 1) Baseline CD4 testing: half (4/8) of rural facilities had no CD4 machines and in a further 3/8 there was a lack of reagents needed for CD4 testing. Clinical staging has replaced inclusion criterion where CD4 testing is not available; 2) Heavy staff workload in routine care; regular discussion with policymakers and workshops enhanced the take-up of the package; 3) Timing of ART: the Ministry of Health has updated national guidelines to include the package and delay ART by 2 weeks in CrAg-positives.ConclusionIt has proven essential to engage with policymakers and programme managers from the outset, i.e. during the REMSTART trial itself and the following TRIP implementation study. The Ministry of Health has now changed the national HIV guidelines to include the REMSTART package and develop training modules for CrAg screening in all regional hospitals. The TRIP study has revealed key issues that must be addressed to allow scaling up the interventions.

The Burden of Childhood Atopic Dermatitis in the Primary Care Setting: A Report from the Meta-LARC Consortium.

Little is known about the burden of atopic dermatitis (AD) encountered in US primary care practices and the frequency and type of skin care practices routinely used in children. To estimate the prevalence of AD in children 0 to 5 years attending primary care practices in the United States and to describe routine skin care practices used in this population. A cross-sectional survey study of a convenience sample of children under the age of 5 attending primary care practices for any reason. Ten primary care practices in 5 US states. Among 652 children attending primary care practices, the estimated prevalence of ever having AD was 24% (95% CI, 21-28) ranging from 15% among those under the age of 1 to 38% among those aged 4 to 5 years. The prevalence of comorbid asthma was higher among AD participants compared to those with no AD, namely, 12% and 4%, respectively (P < .001). Moisturizers with high water:oil ratios were most commonly used (ie, lotions) in the non-AD population, whereas moisturizers with low water:oil content (ie, ointments) were most common when AD was present. Our study found a large burden of AD in the primary care practice setting in the US. The majority of households reported skin care practices that may be detrimental to the skin barrier, such as frequent bathing and the routine use of moisturizers with high water: oil ratios. Clinical trials are needed to identify which skin care practices are optimal for reducing the significant burden of AD in the community.

Substance Use Screening in HIV Care Settings: a Review and Critique of the Literature

People living with human immunodeficiency virus/AIDS (PLWHA) experience high prevalence of substance use disorders (SUD). HIV care settings represent a unique opportunity to identify possible SUD, to provide SUD interventions, and to improve linkage to SUD treatment. The aims of this paper are to (a) review and critique the extant literature examining substance use screening approaches among PLWHA in HIV care settings and (b) provide recommendations for future clinical practice. Twenty-one peer-reviewed articles that examined substance screening approaches employed in HIV and other primary care settings were included in the review. There was limited literature reporting on the implementation and evaluation of substance use screening practices within HIV care settings, and methodological rigor varied across studies. Further, the use of validated substance use screening measures or incorporation of other substance use screening approaches (e.g., use of urine drug testing) within routine HIV care practice is limited. Strategies to implement routine substance use screening within HIV care and incorporate additional substance use assessment, brief interventions, and referral to specialty substance use treatment are discussed. Use of self-report substance use screening measures using web- or computer-delivered approaches that can be integrated within electronic health record systems is particularly promising. HIV care practices should consider potential models to optimally screen and treat SUD. Co-location of HIV and SUD treatment services may be optimal; when co-located services are not possible, strategies to consistently provide brief intervention approaches and referrals to specialty SUD treatment are needed.

MicroRNAs: Epigenetic players in cancer and aging.

MicroRNAs (miRNAs) are endogenous, small non-coding RNA molecules that play important regulatory roles in numerous biological processes, cellular pathways and networks. They do so by targeting specific mRNAs, directly degrading them and/or preventing their translation into proteins. The impaired function of miRNAs results in aberrant gene expression that promotes abnormal cell growth and differentiation. miRNAs, located at fragile sites or cancer associated regions of the genome, act as either tumor suppressor or tumor promoters. miRNAs also play significant role in aging and in various diseases. Despite the fact that profiling of miRNA expression is considered an important tool for diagnostic and therapeutic purposes, such analysis has not yet been adopted in routine clinical care practices. Here, we highlight advances and challenges in research on cancer and aging in relation to miRNAs.

Update on distress management for cancer patients

Many cancer patients experience psychological suffering during their journey from diagnosis, through treatment, to survivorship or the end of life. Their psychological distress can become severe enough to interfere with their ability to cope with cancer. Conditions such as anxiety, depression, insomnia, and delirium often occur among cancer patients. Although distress is prevalent in cancer patients, it is often under-recognized and under-treated in the oncology setting. Psychological distress may have a negative effect on patients' quality of life. The prevention, early detection, and proper management of distress are important for improving patients' quality of life during and after cancer treatment. It is therefore necessary to develop a system for assessing and managing distress. The US National Comprehensive Cancer Network developed guidelines for distress management in 1999. Korean recommendations for distress management were released in 2009. The Korean government recently designated integrated supportive care centers for survivors at the National Cancer Center and regional cancer centers. The supportive care service is provided for cancer survivors who have completed first-line anti-cancer treatment. Psycho-oncology is one of the most important components of supportive care in cancer. Distress management yields many benefits for cancer patients, but the reality is that significantly distressed patients are often not properly referred for psychosocial care. All distressed patients should be properly referred for psychosocial care, and the psychosocial care of cancer patients should be integrated into routine cancer care practice.