An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer (NSCLC)

Importance It is unknown whether and to what degree trials submitted to the US FDA to support drug approval adhere to NCCN guideline-recommended care in their baseline and surveillance CNS imaging protocols. Objective We sought to characterize the frequency with which the trials cited in US FDA drug approvals for first line advanced NSCLC between 2015 and 2020 deviated from NCCN guideline-recommended care for baseline and surveillance CNS imaging. Design, setting, and participants Retrospective observational analysis using publicly available data of (1) list of trials cited by the FDA in drug approvals for first line advanced NSCLC from 2015 to 2020 (2) individual trial protocols (3) published trial data and supplementary appendices (4) archived versions of the NCCN guidelines for NSCLC from 2009 to 2018 (the years during which the trials were enrolling). Main outcomes and measures Estimated percentage of trials for first line advanced NSCLC leading to FDA approval which deviated from NCCN guideline-recommended care with regards to CNS baseline and surveillance imaging. Results A total of 14 studies that had been cited in FDA drug approvals for first line advanced NSCLC met our inclusion criteria between January 1, 2015 and September 30, 2020. Of these trials, 8 (57.1%) deviated from NCCN guidelines in their baseline CNS imaging requirement. The frequency of re-assessment of CNS disease was variable amongst trials as well, with 9 (64.3%) deviating from NCCN recommendations. Conclusions and relevance The trials supporting US FDA drug approvals in first line advanced NSCLC often have CNS imaging requirements that do not adhere to NCCN guidelines. Many trials permit alternative, substandard methods and the proportion of patients undergoing each modality is uniformly not reported. Nonstandard CNS surveillance protocols are common. To best serve patients with advanced NSCLC in the US, drug approvals by the FDA must be based on trials that mirror clinical practice and have imaging requirements consistent with current US standard of care.

Intervention usage for the management of low back pain in a chiropractic teaching clinic

Background Despite numerous low back pain (LBP) clinical practice guidelines, published studies suggest guideline nonconcordant care is still offered. However, there is limited literature evaluating the degree to which chiropractors, particularly students, follow clinical practice guidelines when managing LBP. The aim of this study was to evaluate the frequency of use of specific interventions for LBP by students at a chiropractic teaching clinic, mapping recommended, not recommend, and without recommendation interventions based on two clinical practice guidelines. Methods This was a retrospective chart review of patients presenting to the Canadian Memorial Chiropractic College teaching clinic with a new complaint of LBP from January to July 2019. Interventions provided under treatment plans for each patient were extracted. Interventions were classified as recommended, not recommended, or without recommendation according to two guidelines, the NICE and OPTIMa LBP guideline. Results 1000 patient files were identified with 377 files meeting the inclusion criteria. The most frequent interventions provided to patients were manipulation/mobilization (99%) and soft tissue therapy (91%). Exercise, localized percussion, and advice and/or education were included in just under half of the treatment plans. Patient files contained similar amounts of recommended (70%) and not recommended (80%) interventions according to the NICE guideline classification, with half the treatment plans including an intervention without recommendation. Under the OPTIMa acute guideline, patient files contained similar amounts of recommended and not recommended care, while more recommended care was provided than not recommended under the OPTIMa chronic guideline. Conclusions Despite chiropractic interns providing guideline concordant care for the majority of LBP patients, interventions classified as not recommended and without recommendation are still frequently offered. This study provides a starting point to understand the treatment interventions provided by chiropractic interns. Further research should be conducted to improve our understanding of the use of LBP guideline recommended care in the chiropractic profession. Trial registration Open Science Framework # g74e8.

Implementing asthma management guidelines in public primary care clinics in Malaysia

Implementing asthma guideline recommendations is challenging in low- and middle-income countries. We aimed to explore healthcare provider (HCP) perspectives on the provision of recommended care. Twenty-six HCPs from six public primary care clinics in a semi-urban district of Malaysia were purposively sampled based on roles and experience. Focus group discussions were guided by a semi-structured interview guide and analysed thematically. HCPs had access to guidelines and training but highlighted multiple infrastructure-related challenges to implementing recommended care. Diagnosis and review of asthma control were hampered by limited access to spirometry and limited asthma control test (ACT) use, respectively. Treatment decisions were limited by poor availability of inhaled combination therapy (ICS/LABA) and free spacer devices. Imposed Ministry of Health programmes involving other non-communicable diseases were prioritised over asthma. Ministerial policies need practical resources and organisational support if quality improvement programmes are to facilitate better management of asthma in public primary care clinics.

Barriers and considerations in the design and implementation of digital behavioral interventions: A qualitative analysis (Preprint)

BACKGROUND Digital behavioral interventions have become increasingly popular for their ability to support patient diagnosis and treatment, chronic disease self-management, behavior change, and/or adherence to recommended care. However, many research teams with interests in this area are unable to develop digital interventions due to the challenges such as lack of technical skill, limited access to developers, and cost. The purpose of this study was to elicit in-depth qualitative feedback from intervention developers who have interests in digital behavioral interventions, but lack programming skills regarding the barriers they experience and key considerations that go into the design and implementation of digital interventions. OBJECTIVE To understand barriers to the design and implementation of digital behavioral interventions, as well as to identify key considerations for researchers who are developing these interventions. METHODS We conducted semi-structured qualitative interviews with 18 researchers who had experience either designing (but not coding) digital behavioral interventions or running research studies with them. Participants were a convenience sample of users of the Computerized Intervention Authoring System (CIAS) platform, an existing no-code development platform for building digital intervention content, and were recruited through either direct email solicitation or snowball sampling. All interviews were conducted and recorded over videoconference between February and April 2020. Recordings from interviews were transcribed and thematically analyzed by multiple coders. RESULTS Interviews were completed with 18 individuals and lasted between 24-65 minutes (mean = 46.9 minutes; SD = 11.3 minutes). Interviewees were predominantly female (94.4%; 17/18) and represented different job roles ranging from researcher to project/study staff. Three key barriers to the development of digital behavior interventions were identified during interviews: lack of cross-disciplinary understanding; variability in recipients’ technology access, infrastructure, and literacy; and the idea that evidence-based in-person interactions do not translate directly to digital interactions. Interviewees identified several key considerations that interventionists learned to prioritize, which have the potential to overcome these barriers and lead to successful interventions. CONCLUSIONS Barriers to the development of digital behavioral interventions are often created by a lack of cross-disciplinary understanding, which can lead to difficulties conceptualizing interventions, unrealistic expectations in terms of cost, and confusion about the development process. Moreover, concerns about research study participant characteristics and access to technology, as well as the translation of in-person interventions to digital are apparent. Appropriate training in regards to how to work with software development teams may help future digital behavior intervention creators overcome these barriers and may lead to new, exciting innovations in this space.

The risk-treatment paradox in acute coronary syndrome patients: insights from the FORCE-ACS registry

Background Acute coronary syndrome (ACS) patients at high risk might benefit most from guideline-recommended interventions. However, it is well recognized that the delivery of guideline-directed care is inversely related to the estimated mortality risk, the so called risk-treatment paradox. Purpose To assess the existence of the risk-treatment paradox in a contemporary cohort of ACS patients and its possible association with one-year mortality. Methods The study population consisted patients enrolled in the FORCE-ACS registry who survived their initial admission. All ACS patients were stratified into low, intermediate or high mortality risk based on the Global Registry of Acute Coronary Events (GRACE) risk score. Optimal guideline-recommended care was defined as undergoing coronary angiography during initial hospital admission and receiving all outpatient medications with a class I guideline recommendation (i.e. aspirin, P2Y12-inhibitor, beta-blocker, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and cholesterol-lowering drug). Aspirin and/or a P2Y12-inhibitor on top of an oral anticoagulant was also considered as optimal guideline-recommended care. The cumulative incidence of one-year mortality between optimal and suboptimal managed patients, within each GRACE risk score stratum, was estimated. Results In total, 2,524 patients who were enrolled between January 2015 and June 2018 were included. Based on the GRACE risk score, 46.9% of patients were classified as low-risk, 37.6% as intermediate-risk and 15.5% as high-risk. Overall, 49.8% of patients received optimal guideline-recommended care. Among the different risk strata, 54.9% of the low-risk, 49.1% of the intermediate-risk and 36.1% of the high-risk patients received optimal guideline-recommended care (Table 1). DAPT or DAT treatment (95.3% overall) did not differ between the risk categories. Beta-blockers were prescribed less frequently (69.6% overall), butprescription rates did not differ between the risk categories. ACE-inhibitors/ARBs were prescribed in 74.1% of all patients, but less often in high risk patients. Cholesterol lowering-drugs were prescribed in almost all patients (94.9% overall), but less frequently in high risk patients. Overall, 93.9% of patients underwent coronary angiography (CAG), high-risk patients had a statistically significant lower likelihood of undergoing CAG. In all risk categories, optimal guideline-recommended care was associated with a lower one-year mortality as compared to sub-optimal treatment (5.7% vs. 15.6% in high-risk) (Fig. 1). Conclusion Patients at higher estimated mortality risk, based on the GRACE-risk score, are less likely to receive guideline-recommended care. Although, the absolute benefit from guideline-recommended care appears to be greater in high-risk patients. Receiving guideline-recommended care was associated with a statistically significant better prognosis in intermediate- and high-risk patients. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): ZonMW Netherlands TopZorgSt. Antonius Research funds Figure 1. All-cause mortality

Using the vignette methodology to measure access

Background A vignette is a short description of a person or situation designed to simulate key features of a real- world scenario. Usually this vignette is then presented to relevant professionals to solicit their hypothetical response or behaviour. In medical literature, vignettes are mostly used to study clinical judgments, compare hospital prices, self-assess health or examine how age, sex, socioeconomic or insurance status affects chosen treatment. Methods We aimed to develop a method to utilize case vignettes to gain a better understanding of health access challenges. To this end, we studied available access indicators and frameworks and vignette applications as well as possible ways to include internationally recommended care plans to increase comparability of results across countries. Results We developed a five-step approach consisting of (1) selection of vignettes, (2) drafting of vignettes and a questionnaire based on available access framework and best practice guidelines for treatment, (3) expert validation, (4) application of vignette in country context, and (5) systematic analysis of country feedback. Four detailed pilots were carried out for dental care, stroke, depression and palliative care, in up to 12 European countries. Conclusions The vignette approach has the potential to identify gaps in coverage and access as well as differences in treatment and quality. Four detailed pilots have provided valuable insights in the challenges and limitations of the method that can be addressed in future applications. These include suggestions to improve user friendliness, scope, expert selection and complementing the survey with more specific and quantitative questions.

The association between first-time accreditation and the delivery of recommended care: a before and after study in the Faroe Islands

Background Significant resources are spent on hospital accreditation worldwide. However, documentation of the effects of accreditation on processes, quality of care and outcomes in healthcare remain scarce. This study aimed to examine changes in the delivery of patient care in accordance with clinical guidelines (recommended care) after first-time accreditation in a care setting not previously exposed to systematic quality improvement initiatives. Methods We conducted a before and after study based on medical record reviews in connection with introducing first-time accreditation. We included patients with stroke/transient ischemic attack, bleeding gastric ulcer, diabetes, chronic obstructive pulmonary disease (COPD), childbirth, heart failure and hip fracture treated at public, non-psychiatric Faroese hospitals during 2012–2013 (before accreditation) or 2017–2018 (after accreditation). The intervention was the implementation of a modified second version of The Danish Healthcare Quality Program (DDKM) from 2014 to 2016 including an on-site accreditation survey in the Faroese hospitals. Recommended care was assessed using 63 disease specific patient level process performance measures in seven clinical conditions. We calculated the fulfillment and changes in the opportunity-based composite score and the all-or-none score. Results We included 867 patient pathways (536 before and 331 after). After accreditation, the total opportunity-based composite score was marginally higher though the change did not reach statistical significance (adjusted percentage point difference (%): 4.4%; 95% CI: − 0.7 to 9.6). At disease level, patients with stroke/transient ischemic attack, bleeding gastric ulcer, COPD and childbirth received a higher proportion of recommended care after accreditation. No difference was found for heart failure and diabetes. Hip fracture received less recommended care after accreditation. The total all-or-none score, which is the probability of a patient receiving all recommended care, was significantly higher after accreditation (adjusted relative risk (RR): 2.32; 95% CI: 2.03 to 2.67). The improvement was particularly strong for patients with COPD (RR: 16.22; 95% CI: 14.54 to 18.10). Conclusion Hospitals were in general more likely to provide recommended care after first-time accreditation.

Distance to available services for newborns at facilities in Malawi: A secondary analysis of survey and health facility data

Background Malawi has halved the neonatal mortality rate between 1990–2018, however, is not on track to achieve the Sustainable Development Goal 12 per 1,000 live births. Despite a high facility birth rate (91%), mother-newborn dyads may not remain in facilities long enough to receive recommended care and quality of care improvements are needed to reach global targets. Physical access and distance to health facilities remain barriers to quality postnatal care. Methods Using data We used individual data from the 2015–16 Malawi Demographic and Health Survey and facility data from the 2013–14 Malawi Service Provision Assessment, linking households to all health facilities within specified distances and travel times. We calculated service readiness scores for facilities to measure their capacity to provide birth/newborn care services. We fitted multi-level regression models to evaluate the association between the service readiness and appropriate newborn care (receiving at least five of six interventions). Results Households with recent births (n = 6010) linked to a median of two birth facilities within 5–10 km and one facility within a two-hour walk. The maximum service environment scores for linked facilities median was 77.5 for facilities within 5–10 km and 75.5 for facilities within a two-hour walk. While linking to one or more facilities within 5-10km or a two-hour walk was not associated with appropriate newborn care, higher levels of service readiness in nearby facilities was associated with an increased risk of appropriate newborn care. Conclusions Women’s choice of nearby facilities and quality facilities is limited. High quality newborn care is sub-optimal despite high coverage of facility birth and some newborn care interventions. While we did not find proximity to more facilities was associated with increased risk of appropriate care, high levels of service readiness was, showing facility birth and improved access to well-prepared facilities are important for improving newborn care.

Obesity 2021: Current Clinical Management of a Chronic, Serious Disease

LEARNING OBJECTIVES At the end of the activity, participants will be able to: • Recognize obesity as a chronic, relapsing, serious disease warranting long-term management and early intervention to minimize disease burden and decrease associated morbidity and mortality. • Destigmatize obesity to initiate and enhance patient engagement. • Apply guideline-recommended care for screening, diagnosis, and individualized treatment of adults and others with obesity. • Incorporate practical practice management strategies.

From Pathways to Practice: Impact of Implementing Mobilization Recommendations in Head and Neck Cancer Surgery with Free Flap Reconstruction

One of the foundational elements of enhanced recovery after surgery (ERAS) guidelines is early postoperative mobilization. For patients undergoing head and neck cancer (HNC) surgery with free flap reconstruction, the ERAS guideline recommends patients be mobilized within 24 h postoperatively. The objective of this study was to evaluate compliance with the ERAS recommendation for early postoperative mobilization in 445 consecutive patients who underwent HNC surgery in the Calgary Head and Neck Enhanced Recovery Program. This retrospective analysis found that recommendation compliance increased by 10% despite a more aggressive target for mobilization (from 48 to 24 h). This resulted in a decrease in postoperative mobilization time and a stark increase in the proportion of patients mobilized within 24 h (from 10% to 64%). There was a significant relationship between compliance with recommended care and time to postoperative mobilization (Spearman’s rho = −0.80; p < 0.001). Hospital length of stay was reduced by a median of 2 days, from 12 (1QR = 9–16) to 10 (1QR = 8–14) days (z = 3.82; p < 0.001) in patients who received guideline-concordant care. Engaging the clinical team and changing the order set to support clinical decision-making resulted in increased adherence to guideline-recommended care for patients undergoing major HNC surgery with free flap reconstruction.