Appraisal of National Institute for Health and Care Research activity in primary care in England: cross-sectional study.

BACKGROUND: The National Institute for Health and Care Research (NIHR) was set up to enhance clinical and health research activity in a variety of National Health Service (NHS) healthcare settings, including primary care. OBJECTIVE: To appraise how overall General Practitioner (GP) practice performance, location, and staffing levels may interact with NIHR Portfolio activity in primary care in England. METHODS: Cross-sectional summary of GP practice research activity and practice descriptors; complete data from 6,171 GP practices was collated from NIHR (using data for 2013-2023 for Portfolio studies), Public Health England, Care Quality Commission, and NHS Digital sources, respectively. RESULTS: In primary care, 1 million patients have been recruited into NIHR Portfolio studies in the last decade. The top 10% of practices-measured by different studies recruited to-contributed over 50% of that accrual. When the top decile of GP practices is compared to the 20% least active GP practices, research activity is significantly and individually linked with larger GP practices. Furthermore, it is significantly yet modestly associated with GP practice performance (positive patient feedback, Care Quality Commission rating), lower locality deprivation levels, and lower patient to GP ratios. CONCLUSIONS: Research activity in GP practices is-as seen previously with hospitals-significantly linked with better GP practice performance and patient feedback. Practice list size and staffing levels in particular interact with the aforementioned. This should be taken into account when determining strategies to increase patient and GP practice participation in NIHR Portfolio research studies.

Patient referral from primary care to psychological therapy services: a cohort study.

BACKGROUND: Improving Access to Psychological Therapy (IAPT) services in England offer psychological therapy for patients with mental health issues such as depression and anxiety disorders. OBJECTIVE: How are primary care patients referred to IAPT, to what degree does this correlate with subsequent attendance, and how is the referral process perceived by patients? METHODS: Retrospective analysis of medical records covering June 2018-June 2019 in seven general practices servicing 96 000 patients, to identify and survey patients with anxiety and/or depression. RESULTS: Records of 6545 patients were appraised; 2612 patients were deemed suitable for IAPT intervention by the GP. Of those, 1424 (55%) attended at least one IAPT appointment whereas 1188 (45%) did not. These 'attender' and 'non-attender' cohorts did not differ in age, gender or level of deprivation; neither did GP advice to self-refer rather than making a direct GP referral influence the attendance rate. The most common reasons for IAPT non-attendance include symptom improvement (22%), lack of belief in psychotherapy effectiveness (16%) or a patient feeling too unwell to either refer themselves or attend (12%). CONCLUSIONS: Neither certain age or gender, nor the mode of patient referral to IAPT is associated with eventual attendance. Future research is indicated to identify in more detail if any specific mental health conditions are more likely to lead to non-attendance. Furthermore, there may be scope for a targeted approach for subgroups of patients, e.g. those who indicate they are feeling mentally too unwell, to enable them to attend IAPT screening and therapy appointments.

Development and cohort study of an audit approach to evaluate patient management in family practice in the UK: the 7S tool.

BACKGROUND: In the UK, there is increased pressure on general practitioners' time due to an increase in (elderly) population and a shortage of general practitioners. This means that time has to be used efficiently, whilst optimizing adherence to consistent, appropriate and timely provision of care. OBJECTIVE(S): Create an audit tool that assists general practitioners and family practice staff to evaluate if patients are managed as effectively as possible, and to test the usefulness of this tool in a family practice. METHODS: The '7S' audit tool has seven outcome elements; these broadly stand for what the actual and desired patient contact outcome was, or should have been. Terms include 'surgery', 'speak' and 'specific other' for an appointment at the practice, by telephone or with a dedicated specialist such as a practice nurse or phlebotomist, respectively. RESULTS: A very small, rural, general practice in the UK was audited using the 7S tool. Five hundred patient contacts were reviewed by an independent general practitioner and the decision made if the mode of contact was appropriate or not for each case; in one of the three cases, the choice of care provision was inappropriate and chronic disease cases contributed most to this. General practitioners instigated the majority of poor patient management choices, and chronic disease patients were frequently seen in suboptimal settings. CONCLUSIONS: Inefficiencies in the management of patients in family practice can be identified with the 7S audit tool, thereby producing evidence for staff education and service reconfiguration.

Point-of-care testing for bacterial infection in diabetic foot ulcers: a prospective cohort study.

OBJECTIVE: To appraise the performance of a new point-of-care wound infection detection kit in diabetic foot ulcers (DFUs), using clinician opinion as the primary comparator. The proprietary swab-based chromatic Glycologic (Glycologic Ltd., UK) detection kit used in this study is designed to detect host response to pathogenic levels of bacteria in wounds. METHOD: In high-risk podiatry clinics, patients with DFUs were recruited and infection detection kit test results compared with initial clinician opinion. Chi-squared tests, principal component analysis (PCA) and multiple regression analysis were performed to determine which variables were possibly associated with infection. The variables considered were patients' wound parameters, wider vascular comorbidity and demographics. RESULTS: A total of 136 patients, providing 383 wound swabs, were included in the study. Total agreement in terms of DFU wound assessment for infection-between podiatrists' clinical opinion and Glycologic kit test result-was observed in 79% of cases (301/383). For 56 of the 349 negative infection detection kit test results (16%), podiatrists identified a 'possible' or 'definite' infection. Conversely, in 14 of the 307 cases (4.6%) where podiatrists deemed the wound 'not infected', the infection detection kit test showed a colour change. Regression analysis and PCA showed that clinical signs of wound infection, namely erythema, purulence and odour, were all significantly associated with both a positive clinical opinion and infection detection kit test result. However, in the case of the infection detection kit, a patient's number of lesions and vascular comorbidities were also significantly correlated with a positive test result. CONCLUSION: A host response to critical pathological levels of bioburden in a wound-as detected with the infection detection kit-may partly be determined by an individual patient's (vascular) health and therefore be person-specific. Further research is indicated to determine the relationship between an infection detection kit test result and the microbiological status of the wound.

Open-label, randomised, multicentre crossover trial assessing two-layer compression bandaging for chronic venous insufficiency: results of the APRICOT trial.

Compression bandaging is the mainstay therapy for chronic venous insufficiency and venous leg ulcers, but patient compliance can be challenging due to associated discomfort. The study discussed here aimed to compare AndoFlex TLC Calamine and Coban2 compression bandaging in relation to patient comfort and pruritus symptomology, with severity of pruritus as the primary outcome. This was a multi-centre, prospective, non-blinded, randomised controlled crossover trial involving 39 randomised patients with chronic venous insufficiency patients. In two periods, the patients wore AndoFlex TLC Calamine or Coban2 for 3 weeks each. No significant differences in validated pruritus outcome measures were observed, including a non-significant treatment effect for the severity of pruritus scale (n=35 trial completers; p-value=0.24, Wilcoxon test). However, after trying both bandages, 21 of the 35 patients (60%) definitely preferred AndoFlex TLC Calamine, whereas 4 patients (11%) definitely preferred Coban2. Thus, AndoFlex TLC Calamine compression bandage therapy was preferred by most patients, although this observation could not be confirmed using validated patient-reported outcome measures for pruritus. Further research is indicated to establish if patient preference translates into favourable clinical outcomes. ISRCTN number: ISRCTN95282887.

TGF-ß & BMP receptors endoglin and ALK1: overview of their functional role and status as antiangiogenic targets.

The formation of new blood vessels from existing vasculature, angiogenesis, is facilitated through a host of different signaling processes. Members of the TGF-ß superfamily, TGF-ß1, TGF-ß3, and BMP9, are key propagators of both inhibition and initiation of angiogenesis. HHT, characterized by AVM and capillary bed defects, is caused by germline mutations in the ENG and ACVRL1/ALK1 genes, respectively. Clinical symptoms include epistaxis and GI hemorrhage. The membranous receptors endoglin and ALK1 activate proliferation and migration of endothelial cells during the angiogenic process via the downstream intracellular SMAD signaling pathway. Endothelial cell senescence or activation is dependent on the type of cytokine, ligand concentration, cell-cell interaction, and a multitude of other signaling molecules. Endoglin and ALK1 receptor levels in tumor vasculature correlate inversely with prognosis in humans, whereas in mice, endoglin deficiency decelerates tumor progression. Therefore, endoglin and ALK1 have been identified as potential therapeutic targets for antibody treatment in various cancers. Early phase clinical trials in humans are currently underway to evaluate the efficacy and safety of biological therapy targeting endoglin/ALK1-mediated cells signaling.

Early MRI diagnostics for suspected scaphoid fractures subsequent to initial plain radiography.

AIM: In the United Kingdom, diagnostic management of patients presenting to emergency department with a scaphoid injury varies. Follow-up plain radiographs, after an initial inconclusive X-ray, are common practice. We optimised the diagnostic pathway for these patients by focusing on the most appropriate diagnostic modality and on minimising the time to follow-up diagnostics. MATERIALS AND METHODS: A baseline audit in the period 2008-2009 involving a total of 184 patients was conducted, and after the introduction of new local guidelines for scaphoid injury diagnostics, a follow-up audit involving 79 patients was undertaken in 2010-2012. RESULTS: In the original audit, 130 patients had only scaphoid radiographs, of which 23 underwent initial and follow-up X-rays, and 107 initial-only radiographs. Of those 23, just one single patient (4%) displayed a scaphoid fracture. Others underwent three imaging procedures: initial radiographs, follow-up radiographs and either bone scan (41 patients) or MRI (13 patients). A further 6/41 (15%) and 4/13 (31%) fractures were detected by bone scan and MRI, respectively. In the re-audit, when MRI replaced follow-up X-rays and bone scans, 7 out of 77 (9%) patients were diagnosed with scaphoid fracture. Time from initial plain radiograph to follow-up MRI was reduced from an original mean of 36 to 14 days during the re-audit period. CONCLUSION: The introduction of early MRI enhances scaphoid injury diagnostics and accelerates patient management. We therefore endorse the introduction of this approach on a wider scale through an update of the clinical guidelines for scaphoid injuries.

Efficacy of greater occipital nerve block treatment for migraine and potential impact of patient positioning during procedure: Results of randomised controlled trial.

PURPOSE: Assess the efficacy, and potential impact of patient positioning for 10 minutes immediately post-procedure, of greater occipital nerve (GON) block for treatment of migraine. METHODS: Prospective multicentre non-blinded randomised controlled trial, randomisation and treatment of 60 neurology clinic patients with poorly controlled migraine. Outcomes measured with Headache Impact Test-6 (HIT-6), modified MIgraine Disability Assessment Scale (M-MIDAS), and RELIEF scores. RESULTS: Patient positioning did not lead to significant difference in RELIEF score (34% vs 11%, p-value 0.10, Chi-squared test) at day 90. When considered in a multiple regression analysis, the sitting position outperformed supine position significantly (p-value 0.04). However, no significant difference in HIT-6 score between the supine (n = 27) and sitting position groups (n = 33) was detected at baseline (p-value 0.76), day 30 (p-value 0.69) or day 90 (p-value 0.54, Mann-Whitney U-test). The HIT-6 score significantly improved post-GON block, from median 67 (baseline pre-GON) to 59 (day 30) and 62 (day 90) for the supine group and a score of 66, 61-62 for the sitting group (all p-value ≤ 0.001, intra-group comparison using Wilcoxon test); M-MIDAS achieved similar outcomes. Overall, a significant minimal clinically important improvement was obtained with GON block, and the GON injections were deemed very tolerable by patients (median score of 2 on 10 cm pain scale). CONCLUSION: Regardless of patient positioning, GON block is an effective and near-painless procedure for migraine symptom control. Unlike earlier published observational study data, this trial concludes that a sitting patient position immediately post-GON is preferred.

Identification of High-Risk Lower Extremity Wounds Using Point-of-Care Test for Bacterial Protease Activity; A Single-Centre, Single-Blinded, Prospective Study.

Clinician observation is the mainstay to determine if wound infection is present, and focuses on presence of erythema, purulence, and odour. However, non-visible bacterial protease activity can delay wound healing and lead to complications. In this study, a point-of-care test to detect the presence of bacterial protease activity (BPA, tested with Woundchek Bacterial Status test) was appraised. A total of 130 patients with lower extremity wounds were recruited in vascular and podiatry clinics, and across two time-points 182 BPA tests were conducted subsequent to initial (blinded) clinician's wound appraisal. Clinical opinion ('no infection', 'possible' or 'definite' infection) and BPA result (negative or positive test) had a moderate Kendall's tau-c rank correlation coefficient of 0.32 (P < 0.001). Binary logistic regression analysis and principal component analysis showed that infection determined by clinical opinion was significantly associated with abovementioned clinical signs and a positive BPA test. However, a positive BPA result was also significantly linked with wound severity, such as number of lesions, chronicity and size. Throughout a 12-week follow-up period, median ulcer size was larger for wounds positive for BPA test at baseline (P 0.001) and week-12 (P 0.036; both Mann-Whitney U-test) respectively. As a pilot initiative, clinical staff were allowed to act on the BPA result if they wished; in 11 out of 71 test-positive cases (15%) this happened and antimicrobial dressing was applied instead of planned standard dressing. These results show that protease-releasing bacteria may be active in ulcers that do not (yet) exhibit hallmark signs of infection, and are associated with delayed healing. Targeted point-of-care testing for bacterial protease activity may have the potential to identify and enable pro-active (antimicrobial) management of these high-risk wounds.

Evaluation of reduced ('Lite') compression versus brief bandaging to manage post-operative pain after total knee arthroplasty surgery; a single-centre randomised controlled trial.

PURPOSE: Investigate efficacy of reduced compression bandage for the control of pain after total knee arthroplasty. PATIENTS & METHODS: Prospective, single-centre, randomised controlled trial involving data for 56 out of 94 consented patients; 29 standard care versus 27 Andoflex TLC Calamine Lite. Comparison of standard care (non-compression bandage applied for up to one day) versus Andoflex TLC Calamine Lite (25-30 mmHg) two-layer compression bandage worn for five days. Outcomes measured with validated pain (McGill, 10-cm visual scale) and functionality (KOOS) tools. RESULTS: At day 5 post-surgery, the median pain level was 3.0 cm vs 4.0 cm (p-value 0.47, Mann-Whitney U test) respectively. Generic pain levels, pain types, and knee functionality did not differ between the interventions at days 3/5/12 and week 6 post-surgery. An exception was the degree of 'tender' pain at day 12, which was significantly lower in the Andoflex TLC Calamine Lite arm (p-value 0.041, Mann-Whitney U test). Binary logistic regression analysis showed that application of Andoflex TLC Calamine Lite, administration of oxycodone, and male sex were all significantly associated with less 'tender' pain. CONCLUSION: Reduced compression bandaging does not affect overall pain levels post knee arthroplasty surgery, but may alleviate pain experienced as 'tender', highlighting the different types of pain that may be experienced. Patients' need for, and the use of, opioid medication (oxycodone) is a significant confounding variable when assessing adjuvant therapy to control pain. The applicability of reduced compression bandaging may therefore be limited and is less efficient than medical pain control.

Indirect magnetic resonance arthrography of the shoulder; a reliable diagnostic tool for investigation of suspected labral pathology.

PURPOSE: Indirect magnetic resonance arthrography (I-MRA) confers significant logistical advantages over direct MRA and does not require articular injection. In this study, we determined the diagnostic performance of I-MRA in relation to conventional MRI and arthroscopy or surgery in detecting tears of the glenoid labrum, including Bankart lesions and superior labral antero-posterior (SLAP) tears in a standard clinical setting. PATIENTS AND METHODS: Ninety-one symptomatic patients underwent conventional MRI and I-MRA of the affected shoulder, followed by either arthroscopy or open surgery. The scans were interpreted independently by two experienced radiology consultants with a special interest in musculoskeletal radiology. Using the surgical findings as the standard of reference, sensitivity, specificity, and diagnostic accuracy of conventional non-contrast MRI and I-MRA in the detection of labral tears were calculated. RESULTS: The sensitivity of I-MRA was 95 and 97 %, respectively, for two radiologists as opposed to 79 and 83 % for conventional MRI. For both radiologists, the specificity of I-MRA, as well as MRI, was 91 % for detection of labral tears of all types. Accuracy of diagnosis was 93 and 95 %, respectively, for two radiologists with indirect MRA, compared to 84 and 86 % with non-contrast MRI. CONCLUSIONS: This retrospective study shows that I-MRA is a highly accurate and sensitive method for the detection of labral tears. The data obtained supports the use of I-MRA as standard practice in patients with shoulder instability due to suspected labral pathology where further investigative imaging is indicated.

Devices for the transport and microbiological detection of Neisseria gonorrhoeae in sexual health clinic samples: a prospective comparative study.

BACKGROUND: Propagation and microbiological detection of N. gonorrhoeae can be challenging due to the fastidious nature of the bacterium outside the human host environment. Different sample transport options were evaluated in order to address this issue. METHODS: Symptomatic and high-risk patients consented to take part. Standard practice in clinics involve using a guanine and cytosine selective (GC) plate for transport and incubation. Other devices were assessed in two different studies. MWE's Sigma VCM™-a transport device for use between clinic and laboratory-was used in one study (n = 166). In the other, (n = 102), Biomed's Intray™ plates were used, which can be used for both initial transport and incubation at the destination laboratory. RESULTS: In the Sigma VCM™ study, positive results were obtained for 14% (Sigma VCM™), 21% (GC plates); the distribution of outcomes did not significantly differ between the two microbiological sampling methods (p-value 0.09, Chi-squared test). Concerning the InTray™ sub-study, N. gonorrhoeae was detected in 9% (InTray™), 13% (GC plating) of cases respectively, with again no significant difference between the microbiological sampling methods (p-value 0.25). Regression analysis identified a significant association between N. gonorrhoeae detection and male patients, absence of dysuria and previous gonorrhoea infection. CONCLUSION: No significant difference in rate of microbiological detection of N. gonorrhoeae could be detected between different transport devices in a sexual health clinic setting. Performance appraisal of transport devices for bacterial sexually transmitted infection can inform practitioners' options regarding said devices.

Management of urinary tract infections in the community: a clinical audit and patient survey.

BACKGROUND: Urinary tract infection (UTI) is a common ailment but can develop into sepsis. The outcomes related to UTI may potentially be affected by both patient and clinician management of UTI. AIM: To explore the circumstances around a single UTI episode to determine whether there are patient and clinician-related variables that may contribute to differences in management. DESIGN & SETTING: Survey and clinical audit in 12 general practices in England. METHOD: Patients (n = 504) completed a bespoke survey and their corresponding index UTI consultation was audited. The TARGET (Treat Antibiotics Responsibly, Guidance, Education and Tools) UTI audit toolkit was utilised. RESULTS: A significantly higher proportion of females compared with males used self-management measures. Increase in fluid intake was 78% for females aged <65 years and 71% for females aged >65 years compared with 53% for males (P<0.001, Χ2 test). Analgesic use was 50% for females aged <65 years and 41% for females aged >65 years compared with 36% for males (P = 0.036, Χ2 test). Males also indicated they lacked UTI knowledge when compared with females (P = 0.002, Kruskal-Wallis test). Males also claimed to have waited significantly longer for a consultation appointment (P = 0.027, Χ2 test). Antibiotics were prescribed in 98% of all cases, with adherence to clinical diagnostic guidelines lowest in females aged <65 years. Only 40% (89/221 of cases in this guideline sub-cohort [females aged >65 years]) would have been a UTI, according to TARGET criteria, following a medical record audit. CONCLUSION: UTI symptom management by clinicians is suboptimal; the presence or absence of symptoms is often insufficiently recorded in medical records. Additionally, suboptimal adherence to guidelines concerning urinalysis and microbiological investigation is common. Known increased clinical risks for males may be compounded by their more limited knowledge of (self)-managing UTI and their comparatively late presentation.

Hospital workforce engagement, satisfaction, burnout and effects on patient mortality: Findings from the English national health service staff surveys.

Previous studies of healthcare organizations' workforces and their performance have focused on burnout and its impact on care. The aim of this research is to expand on this and examine the association of positive organizational states, engagement and recommendation of employer as a place to work, in comparison to burnout on Hospital performance. Methods: This was a panel study of the respondents to the 2012-2019 yearly Staff Surveys of the English National Health Service (NHS) hospital Trusts with hospital performance measured by the adjusted inpatient Summary Hospital-level Mortality Indicator (SHMI). Results: In univariable regression, all three organizational states significantly and negatively correlated with SHMI, with recommendation and engagement showing a nonlinear effect. In multivariable analysis, all three states remained significant predictors of SHMI. Engagement and recommendation showed mutual correlation, with engagement being a more prevalent state than recommendation. Conclusion: Our study indicates that organizations could benefit from monitoring multiple workforce variables to preserve or enhance workforce well-being, while optimizing organizational performance. The surprising finding that higher burnout was associated with improved short-term performance requires further investigation, as does the finding of less frequent staff recommendation of work compared to staff engagement with their work.

Digital diary App use for migraine in primary care: Prospective cohort study.

BACKGROUND: Headache diaries are recommended for migraine management in primary care. OBJECTIVE: Determine the acceptability and use of a digital headache diary App for migraine METHODS: Evaluative prospective primary care cohort study in North of England. Part 1 was a postal survey; if responders were interested, in Part 2 participants trialled the digital N1-Headache App headache diary for 90 days, followed by survey feedback on the App's usability. RESULTS: A total of 637 out of 2189 invited patients (29%) completed the initial survey, and 32% of respondents had previously used a headache diary; 437 out of 637 patients (69%) were interested in using the App. Regression analysis showed that interested patients were those with more severe migraines that limit physical/intellectual activities, and who indicate to not know enough about their migraine. Actual registration numbers and compliance with the App was very modest; 53 out of 173 participants (23%), who ultimately activated their personal N1-Headache App account, were able to generate a personalised trigger and protector map & report. Furthermore, at the end of the 90 day App trial period there was a non-significant trend towards improvements in participants' health confidence levels. CONCLUSION: Migraine patients - particularly those with more severe and frequent migraines - show an interest in using a digital headache diary App, Ultimately, consistent daily use is very modest. The challenge is to improve App usage and compliance rates to allow interpretation of more patients' migraine trigger and/or protector patterns, and wider use amongst patients.

Evaluation of Glycologic Point-of-Care Infection Test Kit for Diabetic Foot Ulcers in Relation to Bacterial Presence: A Prospective Cohort Study.

BACKGROUND: Point-of-care testing for infection might help podiatric physicians optimize management of diabetic foot ulcers (DFUs). Glycologic's proprietary GLYWD product has been developed to detect changes in a patient's immunologic/inflammatory response related to wound infection. We evaluated how bacterial presence in DFUs relates to GLYWD test outcome. METHODS: This was a single-organization, prospective, controlled cohort study of clinical opinion versus GLYWD test result for DFU infection status and the appraisal of bacterial presence in the wounds and semiquantitative microbiology swab at weeks 0, 3, 6, 12, and 18. Spearman correlation, backward elimination linear regression, and principal components analysis were applied to determine which variables, including degree of bacterial load, are associated with a positive clinical opinion or GLYWD result for DFU infection. RESULTS: Forty-eight patients were enrolled, and 142 complete wound appraisals were conducted; a consensus outcome between clinical opinion and GLYWD result was achieved in most (n = 122, 86%). Clinical opinion significantly correlated with a higher bacterial load (Spearman rho = 0.38; P < .01), whereas GLYWD did not (rho = -0.010; P = .91). This observation was corroborated with logistic regression analysis, in which a previous observation of both clinical opinion and GLYWD associating with wound purulence and erythema was also confirmed. CONCLUSIONS: Podiatric physicians are guided by hallmark signs of DFU infection, such as erythema and purulence; furthermore, we found that clinical opinion of infection correlates with increased bacterial load. GLYWD test results match clinical opinion in most cases, although the results obtained with this point-of-care method suggest that the degree of bacterial presence might not necessarily mean a higher chance of inducing an immunologic/inflammatory host response to said bacteria.

Application of compression bandaging post-osteotomy results in altered pain profile; results of a single-centre randomised controlled trial.

PURPOSE: To assess if application of dual-layer compression bandage to osteotomy patients post-surgery can positively influence levels of post-operative pain and swelling. PATIENTS & METHODS: Prospective, single-centre, randomised controlled trial comparing standard care, non-compression bandaging, versus Coban™ 2 (3M). Seven day application of the latter to index leg of osteotomy patients. RESULTS: Primary outcome data was available for 36 out of 49 study subjects (18 standard care versus 18 Coban™ 2 subjects). Median 10-cm scale pain levels showed a statistically non-significant difference at day 5 and day 12 post-surgery between standard care and Coban™ 2 respectively: 5.5 cm vs 2.5 cm (p-value 0.068) and 4.0 cm vs 2.3 cm (p-value 0.39). However, on day 12 (p-value 0.029) and week 6 (p-value 0.027), 'throbbing pain' was significantly higher for Coban™ 2 patients. Changes in limb swelling measures, comparing before and after the surgical procedure, did not differ between treatment arms. Compression led to more patients reporting bandage-related discomfort (6% standard care versus 63% Coban™ 2 patients). CONCLUSION: Compression bandaging changes the post-surgery pain profile in osteotomy patients, but does not reduce leg swelling. Any subsequent leg compression trials must take into account patient comfort and titrate intervention length and compression rates.

Longer Term Outcomes Following High Tibial Osteotomy for Osteoarthritis: A Prospective, Multi-Centre Observational Study Comparing Tomofix and OPTY-LINE Devices.

PURPOSE: Assessing surgical accuracy and patient-recorded outcome measures for patients fitted with either the OPTY-LINE intramedullary realignment system or the Tomofix plate for medial opening wedge high tibial osteotomy (HTO). PATIENTS AND METHODS: Two matched case series of patients with symptomatic medial compartment osteoarthritis without other significant knee pathology. One group comprised of 19 patients receiving the Tomofix plate, whereas another comprised of 12 patients receiving the OPTY-LINE intramedullary nail. Patella-centred long leg alignment radiographs were assessed to calculate surgical accuracy in all cases. Patients completed knee injury osteoarthritis outcome scores (KOOS) and osteotomy surgery patient satisfaction questionnaires pre-operatively and at 24 months post-surgery. RESULTS: Absolute surgical accuracy at 2 years post-surgery was a mean 4.2 [standard deviation 3.7] for OPTY-LINE versus 9.2 [SD 7.8] for Tomofix (p = 0.11, Mann-Whitney U test). On average, patients in either the OPTY-LINE or Tomofix cohort reported at least a minimal perceptible clinical improvement-minimum average improvement of 15-for all five KOOS themes. No significant difference in change of KOOS scores over time or patient satisfaction levels were observed between the two cohorts. CONCLUSION: The OPTY-LINE device for HTO performs to a similar level as the Tomofix device. Surgical accuracy data are promising for OPTY-LINE, but does not seem to readily translate into difference in patient-reported outcomes compared to Tomofix. Even longer follow-up periods, to measure survival rates, and true randomised trials on larger samples can elucidate if there is a benefit for using one device over the other.

A Pragmatic, Single-Center, Prospective, Randomized Controlled Trial of Adjunct Hemoglobin-Mediated Granulox Topical Oxygen Therapy Twice Weekly for Foot Ulcers.

BACKGROUND: Achieving timely healing of foot ulcers can help avoid complications such as infection and amputation; topical oxygen therapy has shown promise in achieving this. We evaluated the clinical effectiveness of Granulox, a hemoglobin spray device designed to deliver oxygen to the surface of wounds, for the healing of foot ulcers. METHODS: We conducted a single-center, prospective, randomized controlled trial comparing standard of care (once-weekly podiatric medical clinic visits) versus standard care plus adjunct Granulox therapy twice weekly in adults with foot ulcers. After a 2-week screening phase, patients in whom the index wound had healed by less than 50% were randomized 1:1. Outcome measures were collated during the trial phase at 6 and 12 weeks. RESULTS: Of 79 patients enrolled, 38 were randomized. After 12 weeks, the median percentage wound size reduction compared with the size of the ulcer at the start of the trial phase was 100% for the control arm and 48% for the Granulox arm (P = .21, Mann-Whitney U test). In the former, eight of 14 foot ulcers had healed; in the latter, four of 15 (P = .14, Fisher exact test). In the control arm, two amputations and one withdrawal occurred, whereas in the Granulox arm, one unrelated death and five withdrawals were recorded. CONCLUSIONS: We could not replicate the favorable healing associated with use of Granulox as published by others. Differences in wound chronicity and frequency of Granulox application might have influenced differences in study results. Granulox might perform best when used as an adjunct for treatment of chronic wounds at least 8 weeks old.

Patients admitted to more research-active hospitals have more confidence in staff and are better informed about their condition and medication: Results from a retrospective cross-sectional study.

RATIONALE, AIMS AND OBJECTIVES: Clinical research activity in hospitals is associated with reduced mortality and improved overall care quality. In England, the latter is a compound score of several elements and both staff and inpatient feedback form part of the Care Quality Commission (CQC) ratings. The objective of this study was to determine if NHS Trusts' National Institute for Health Research (NIHR) study activity data correlates with specific outcomes from national NHS staff and patient surveys. METHOD: Retrospective cohort design involving data for 129 English NHS hospital Trusts, including scores from recent national NHS staff and inpatient surveys and NIHR data. Statistical approach involved Spearman correlation analyses, with cut-off P value ≤ 0.01 for qualification for subsequent principal component analysis (correlation coefficient cut-off value 0.20). RESULTS: Outcomes of one staff survey question (staff recommendation of the organization as a place to work or receive treatment) and multiple outcomes of inpatient survey questions were positively associated with increased NIHR-adopted clinical research activity. Better quality of information provision to patients was the dominant theme, though a higher degree of observed staff teamwork, more confidence in the treating doctors, and a better overall inpatient experience also correlated significantly. The number of different studies contributed more to positive associations with survey outcomes compared with the number of recruited participants into research. CONCLUSIONS: Survey elements of the CQC appraisal of English NHS Hospital Trusts are significantly associated with increased clinical research activity levels; it appears to drive better information provision to inpatients-particularly around medicine management-and contribute to a better inpatient experience overall, whilst staff are more likely to recommend their own organization. Despite clinical research activity forming a very small fraction of overall NHS activity, it has an indirect positive effect on staff and Trust performance that is measurable at patient level.