BACKGROUND: Obesity is increasing. Previous studies have demonstrated an association between obesity and adverse events after lumbar fusion. There is limited evidence on the effect of obesity on minimally invasive SI joint fusion (SIJF) outcomes.
OBJECTIVE: The purpose of this study was to investigate the impact of obesity on patient-reported outcomes in patients undergoing SIJF surgery using triangular titanium implants (TTI).
METHODS: Retrospective cohort study based on four prospective clinical trials (INSITE [NCT01681004], SIFI [NCT01640353], iMIA [NCT01741025], and SALLY [NCT03122899]).
METHODS: Adult patients ≥18 years of age who underwent minimally invasive surgery (MIS) sacroiliac joint (SIJ) fusion between 2012 and 2021.
METHODS: Visual analog scale (VAS Pain), Oswestry Disability Index (ODI).
METHODS: Participants were classified using the National Institutes of Health body mass index (BMI). Patients with a BMI of 30 to 39 with no significant comorbidity are considered obese, patients with a BMI of 35 to 39 with a significant comorbidity or a BMI of 40 or greater are considered morbidly obese. All subjects underwent either minimally invasive SIJ fusion with TTI or nonsurgical management (INSITE and iMIA studies only). All subjects completed SIJ pain scale scores (measured with a 100-point VAS) and disability scores (measured with ODI) at baseline and at scheduled visits to 24 months. Repeated measures analysis of variance was used to examine the impact of BMI category on score changes.
RESULTS: In the SIJF group, mean SIJ pain improved at 24 months by 53.3 points (p<.0001). Over the 24-month follow-up period, BMI category did not impact mean improvement in SIJ pain scale score (repeated measures analysis of variance (ANOVA) p=.44). In the SIJF group, mean ODI at 24 months improved by 25.8 points (p<.0001). BMI category did not impact mean improvement in ODI (ANOVA p=.60). In the nonsurgical management (NSM) group, mean improvements in SIJ pain scale and ODI were clinically small (8.7 and 5.2 points, respectively) and not affected by BMI category (ANOVA p=.49 and .40).
CONCLUSIONS: This study demonstrates similar benefits and risks of minimally invasive SIJ fusion with TTI across all BMI categories. This analysis suggests that obese patients benefit from minimally invasive SIJ fusion and should not be denied this procedure based solely on elevated BMI.

This study aimed to develop a core set of patient reported outcome quality indicators (QIs) for the treatment of patients with intermittent claudication (IC), that allow a broad international implementation across different vascular registries and within trials.
A rigorous modified two stage Delphi technique was used to promote consensus building on patient reported outcome QIs among an expert panel consisting of international vascular specialists, patient representatives, and registry members of the VASCUNET and the International Consortium of Vascular Registries. Potential QIs identified through an extensive literature search or additionally proposed by the panel were validated by the experts in a preliminary survey and included for evaluation. Consensus was reached if ≥ 80% of participants agreed that an item was both clinically relevant and practical.
Participation rates in two Delphi rounds were 66% (31 participants of 47 invited) and 90% (54 of 60), respectively. Initially, 145 patient reported outcome QIs were documented. Following the two Delphi rounds, 18 quality indicators remained, all of which reached consensus regarding clinical relevance. The VascuQoL questionnaire (VascuQoL-6), currently the most common patient reported outcome measurement (PROM) used within vascular registries, includes a total of six items. Five of these six items also matched with high rated indicators identified in the Delphi study. Consequently, the panel recommends the use of the VascuQoL-6 survey as a preferred core PROM QI set as well as an optional extension of 12 additional patient reported QIs that were also identified in this study.
The current recommendation based on the Delphi consensus building approach, strengthens the international harmonisation of registry data collection in relation to patient reported outcome quality. Continuous and standardised quality assurance will ensure that registry data may be used for future quality benchmarking studies and, ultimately, positively impact the overall quality of care provided to patients with peripheral arterial occlusive disease.

Clinic-based headache registries collect data for a wide variety of purposes including delineating disease characteristics, longitudinal natural disease courses, headache management approaches, quality of care, treatment safety and effectiveness, factors that predict treatment response, health care resource utilization, clinician adherence to guidelines, and cost-effectiveness. Registry data are valuable for numerous stakeholders, including individuals with headache disorders and their caregivers, healthcare providers, scientists, healthcare systems, regulatory authorities, pharmaceutical companies, employers, and policymakers. This International Headache Society document may serve as guidance for developing clinic-based headache registries. Use of registry data requires a formal research protocol that includes: 1) research aims; 2) methods for data collection, harmonization, analysis, privacy, and protection; 3) methods for human subject protection; and 4) publication and dissemination plans. Depending upon their objectives, headache registries should include validated headache-specific questionnaires, patient reported outcome measures, data elements that are used consistently across studies (i.e., \"common data elements\"), and medical record data. Amongst other data types, registries may be linked to healthcare and pharmacy claims data, biospecimens, and neuroimaging data. Headache diagnoses should be made according to the International Classification of Headache Disorders diagnostic criteria. The data from well-designed headache registries can provide wide-ranging and novel insights into the characteristics, burden, and treatment of headache disorders and ultimately lead to improvements in the management of patients with headache.

Data collected during routine clinic visits are key to driving successful quality improvement in clinical services and enabling integration of research into routine care. The purpose of this study was to develop a standardized core dataset for juvenile idiopathic arthritis (JIA) (termed CAPTURE-JIA), enabling routine clinical collection of research-quality patient data useful to all relevant stakeholder groups (clinicians, service-providers, researchers, health service planners and patients/families) and including outcomes of relevance to patients/families.
Collaborative consensus-based approaches (including Delphi and World Café methodologies) were employed. The study was divided into discrete phases, including collaborative working with other groups developing relevant core datasets and a two-stage Delphi process, with the aim of rationalizing the initially long data item list to a clinically feasible size.
The initial stage of the process identified collection of 297 discrete data items by one or more of fifteen NHS paediatric rheumatology centres. Following the two-stage Delphi process, culminating in a consensus workshop (May 2015), the final approved CAPTURE-JIA dataset consists of 62 discrete and defined clinical data items including novel JIA-specific patient-reported outcome and experience measures.
CAPTURE-JIA is the first \'JIA core dataset\' to include data items considered essential by key stakeholder groups engaged with leading and improving the clinical care of children and young people with JIA. Collecting essential patient information in a standard way is a major step towards improving the quality and consistency of clinical services, facilitating collaborative and effective working, benchmarking clinical services against quality indicators and aligning treatment strategies and clinical research opportunities.

BACKGROUND: Lateral ankle sprains (LAS) have one of the highest recurrence rates of all musculoskeletal injuries. An emphasis on rapid return to sport (RTS) following LAS likely increases reinjury risk. Unfortunately, no set of objective RTS criteria exist for LAS, forcing practitioners to rely on their own opinion of when a patient is ready to RTS.
OBJECTIVE: To determine if there was consensus among published expert opinions that could help inform an initial set of RTS criteria for LAS that could be investigated in future research.
METHODS: PubMed, CINHL, and SPORTDiscus databases were searched from inception until October 2018 using a combination of keywords. Studies were included if they listed specific RTS criteria for LAS. No assessment of methodological quality was conducted because all included papers were expert opinion papers (level 5 evidence). Extracted data included the recommended domains (eg, range of motion, balance, sport-specific movement, etc) to be assessed, specific assessments for each listed domain, and thresholds (eg, 80% of the uninjured limb) to be used to determine RTS. Consensus and partial agreement were defined, a priori, as ≥75% and 50% to 75% agreement, respectively.
RESULTS: Eight domains were identified within 11 included studies. Consensus was reached regarding the need to assess sport-specific movement (n = 9, 90.9%). Partial agreement was reached for the need to assess static balance (n = 7, 63.6%). The domains of pain and swelling, patient reported outcomes, range of motion, and strength were also partially agreed on (n = 6, 54.5%). No agreement was reached on specific assessments of cutoff thresholds.
CONCLUSIONS: Given consensus and partial agreement results, RTS decisions following LAS should be based on sport-specific movement, static balance, patient reported outcomes, range of motion, and strength. Future research needs to determine assessments and cutoff thresholds within these domains to minimize recurrent LAS risk.

The Heart Manual (HM) is the UK\'s leading facilitated home-based cardiac rehabilitation (CR) programme for individuals recovering from myocardial infarction and revascularisation. This audit explored patient-reported outcomes of home-based CR in relation to current Scottish, UK and European guidelines.
Patients across the UK returned their questionnaire after completing the HM programme to the HM Department (NHS Lothian).
Qualitative data from 457 questionnaires returned between 2011 and 2018 were included for thematic analysis. Seven themes were identified from the guidelines. This guided initial deductive coding and provided the basis for inductive subthemes to emerge.
Themes included: (1) health behaviour change and modifiable risk reduction, (2) psychosocial support, (3) education, (4) social support, (5) medical risk management, (6) vocational rehabilitation and (7) long-term strategies and maintenance. Both (1) and (2) were reported as having the greatest impact on patients\' daily lives. Subthemes for (1) included: guidance, engagement, awareness, consequences, attitude, no change and motivation. Psychosocial support comprised: stress management, pacing, relaxation, increased self-efficacy, validation, mental health and self-perception. This was followed by (3) and (4). Patients less frequently referred to (5), (6) and (7). Additional themes highlighted the impact of the HM programme and that patients attributed the greatest impact to a combination of all the above themes.
This audit highlighted the HM as comprehensive and inclusive of key elements proposed by Scottish, UK and EU guidelines. Patients reported this had a profound impact on their daily lives and proved advantageous for CR.

Literature on the health-related quality of life (HRQoL) for men with localized prostate cancer (PCa) on active surveillance (AS) shows a need for methodological guidance regarding HRQoL issues and how to address them.
The European School of Oncology Task Force (ESO TF) aimed to identify a core set of research questions and related measures to include in AS HRQoL studies.
A modified Delphi study was used to reach consensus on AS HRQoL research topics and tools between 2014 and 2015. Data were collected by engaging a multidisciplinary team of 15 experts.
An open-ended questionnaire was used to collect information from ESO TF members regarding issues in AS HRQoL research. Then a structured questionnaire was used to collect ratings on the usefulness/importance of different AS HRQoL aspects. Items that ≥80% of ESO TF members rated as useful/important were retained. Items with a 50-80% rating were discussed to reach final agreement.
Six main research questions concerning the selection of outcome measures, measurement tools, and comparison groups were identified as relevant. The core set of measures identified were related to individual characteristics, psychological dimensions; decision-making-related issues, and physical functioning. The multidisciplinary expertise of ESO TF members was a significant asset, even if bringing different backgrounds to the discussion table represented a challenge.
HRQoL measures have to be sensitive to the specific needs of men on AS. The definition of HRQoL outcomes will enhance a broader understanding of the HRQoL of men on AS and sustain patient-centered medicine.
An international panel agreed on a set of health-related quality-of-life aspects to be assessed among men on active surveillance for prostate cancer. Valid relevant questionnaires were identified. The experts\' indications lay a foundation for future research and clinical practice.

OBJECTIVE: The emerging model of US health-care delivery is aimed at reducing costs, standardizing care, and improving outcomes. Although it is necessary for health-care providers and insurance carriers to work together to achieve those goals, insurers have the added duty of assuring physicians and patients that they comprehend the medical evidence and, based on that understanding, construct policies. Are US insurers meeting that responsibility or are they simply creating policies to serve their own needs?
METHODS: The medical policies of several US health insurers were analysed. The goal was to see whether it could readily be determined if these carriers used evidence-based medicine consistently to create uniform policies for the treatment of patients with symptomatic varicose veins. The literature was also reviewed to determine whether increased insurance documentation requirements have affected cost reduction, standardization of care and/or improvement of outcomes related to chronic vein disease management.
RESULTS: There is a dramatic lack of uniformity among the insurance policies reviewed. Insurers appear to not choose important papers to create policy but use carefully chosen articles to reinforce what they want their policies to say. In so doing, conflicting policy criteria are being created. Complicating this inconsistency, rules for medical necessity are modified frequently, raising frustration levels among vein providers and their patients. What is clear is that costs are not being lowered, care is not being standardized and little is being done to prevent potential complications resulting from chronic vein disease.
CONCLUSIONS: Patients and physicians are increasingly ill-served by, and frustrated with, the clear lack of consistency in the medical policy criteria being created by US insurance carriers in covering the treatment of patients with symptomatic varicose veins. The contradictory coverage requirements, seemingly based on no understanding of evidence-based medicine guidelines, and total variability in reimbursement for various types of treatment options is particularly worrisome. Collaboration between venous treatment providers and insurance carriers, to create evidence-based standards of care, would be timely and beneficial in creating guidelines for optimal patient care.