Including Patient Reported Outcome Measures Research Articles

Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis

BackgroundMultiple sclerosis (MS) is a leading cause of neurological disability among young and middle-aged adults worldwide, and disability is measured using a variety of approaches, including patient reported outcome measures (PROMs) such as the Patient Determined Disease Steps (PDDS) scale. There is limited evidence for the validity of inferences from the middle-range of scores on the PDDS (i.e., 3 “gait disability” – 6 “bilateral support”), but that range of scores seemingly represents moderate disability characterized by varying levels of walking dysfunction.PurposeThe current study examined whether the middle-range of scores from the PDDS reflect varying levels of walking dysfunction among people with MS.MethodParticipants (N = 374) completed the Patient Determined Disease Steps (PDDS) scale, Multiple Sclerosis Walking Scale-12 (MSWS-12), timed 25-foot walk (T25FW), six-minute walk (6 MW), Modified Fatigue Impact Scale (MFIS), and Multiple Sclerosis Impact Scale-29 (MSIS-29), and underwent a neurological exam for generating an Expanded Disability Status Scale (EDSS) score as part of screening and baseline data collection for a clinical trial of exercise training in MS. We undertook a series of linear trend analyses that examined differences in the outcomes of EDSS, T25FW, 6 MW, MSWS-12, MFIS subscales, and MSIS-29 subscales across the 4 levels of PDDS scores (i.e., 3–6).ResultsThere were statistically significant and strong linear trends for EDSS (F1,370 = 306.1, p < .0001, η2 = 0.48), T25FW (F1,370 = 161.0, p < .0001, η2 = 0.32), 6 MW (F1,370 = 178.9, p < .0001, η2 = 0.34), and MSWS-12 (F1,370 = 97.0, p < .0001, η2 = 0.24). There was a strong correlation between PDDS and EDSS scores (rs = 0.695, 95% CI = 0.643, 0.748). Both PDDS and EDSS scores had strong correlations with walking outcomes, yet weaker correlations with measures of fatigue and QOL.ConclusionThe PDDS could serve as a simple, inexpensive, and rapidly administered PROM for remote screening and early detection of walking dysfunction for initial eligibility into clinical trials and practice for managing mobility-specific disability in MS.RegistrationThe study was registered on ClinicalTrials.gov on March 19, 2018 (NCT03468868).

Introduction and overview on autogenous Platelet concentrates.

This special issue on autologous platelet concentrates (APCs) provides clinicians with an overview on the current understanding of the use of these biomaterials for soft and hard-tissue regeneration. The included papers summarize scientific evidence and the clinical findings, presented in simple tables that outline potential benefits including Patient Reported Outcome Measures (PROMs). This approach enables clinicians to assess clinical relevance and researchers to identify significant gaps in the literature. The first part provides a comprehensive summary of the basic science surrounding APC, with particular focus on their preparation methods. Clear recommendations are outlined, which are crucial for obtaining high-quality APCs, alongside an exploration of how APCs may influence both soft and hard tissue healing processes. Part 2 delves into the clinical evidence for the potential benefits of APCs across a range of applications: alveolar ridge preservation, sinus floor elevation, periodontal plastic surgery, guided tissue regeneration, guided bone regeneration, the healing of Medication-Related Osteonecrosis of the Jaw (MRONJ), and endodontic surgery. In the part 3, the discussion turns to the effects of APCs on the healing of extra-oral wounds, including diabetic foot ulcers, venous leg ulcers, pressure injuries, burns, and more. For those clinicians persuaded by the evidence, the fourth section offers a detailed, step-by-step flowchart for each treatment modality, providing a clear guide for clinical application.

Clinical Disease Measures in Palmoplantar Pustulosis: A Scoping Review

Background Palmoplantar pustulosis (PPP) is a rare, relapsing, disease characterized by pustules, pain, and fissuring. PPP is often combined with psoriasis, most commonly palmar plantar psoriasis, in clinical trials which further complicates our understanding of treatment response. Objective The objective of this scoping review is to describe all outcome measures (clinician-reported &amp; patient-reported) used in previous PPP clinical trials. Methods A search was conducted in Medline, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for clinical trials and prospective cohort studies performed in adults with PPP, with an intervention and pre-determined outcomes collected at pre specified time points. Results The initial search identified 1839 records, of which 69 met our inclusion criteria. The studies were published between 1970–2023 and included a total of 3301 patients. The most common primary study outcome was the clinician-reported Palmoplantar Pustulosis Psoriasis Area Severity Index (ppPASI) ( n = 39, 56.5%) and an endpoint of 12 weeks ( n = 23, 33.3%). Other common clinician reported outcomes identified were pustule count ( n = 26, 37.7%) and the Physician Global Assessment ( n = 16, 23.2%) The majority of studies ( n = 43, 62.3%) did not include any patient reported outcome measures. Of those that did include patient reported outcome measures, the Dermatology Life Quality Index was most utilized ( n = 17, 24.6%), followed by symptoms-specific instruments measuring pain ( n = 11, 15.9%) and itch ( n = 6, 8.7%). Conclusions While the clinician-reported ppPASI has become the standard primary outcome in PPP clinical trials, there is still considerable heterogeneity and lack of specificity in the patient reported outcomes used.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

IntroductionNeoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high...

PP151 HTA Of Fast Track Hip And Knee Joint Replacement

IntroductionThis retrospective study was conducted, in accordance with the STROBE guidelines, (Vandenbroucke et al., 2007), considering patients receiving surgical interventions for hip and knee replacement at the IRCCS Orthopedic Institute Galeazzi, located in Milan (Italy), between 1 January 2016 and 31 December 2019 (two years of traditional procedure, and two years of new one).MethodsWe evaluated 10,922 patients treated for hip or knee joint replacement; there were 5,085 treated following the traditional procedure and 5,837 treated by fast track procedure. Excluding cases which could not satisfy the study criteria we evaluated finally 697 with traditional procedure and 1120 with the new one.ResultsWith the new fast track procedure, knee replacement mean costs were decreased by an average of EUR1,112.4 (-19.9%). Excluding the cost of prostheses from the analysis, the mean costs in the pre fast-track period for knee replacement are equal to EUR3,918.1, while the mean cost of the intervention in the fast-track period was equal to EUR3,245.8, being EUR572.3 lower (-17.2%). Considering the number of days of hospitalization, the adoption of fast-track leads to a decrease of -2.8 days (-37.6%) in knee replacement, from a mean number of days of 7.6 (± 2.8), to a mean number of days of 4.8 (± 1.8), and of – 2.9 days (-39.2%) in hip replacement, from a mean number of days of 7.3 (± 2.7) to a mean number of days of 4.4 (± 2.0).ConclusionsWe performed a study over four years, with a wide number of cases treated by various teams in the hospital having the highest workload on hip and knee joint replacements in Italy.The new fast-track procedure is efficient; the length of stay was decreased by the procedure; the direct and indirect costs were decreased; the hospital organization was improved; the increase of care intensity did not modify efficiency and costs; the effectiveness was similar to the traditional procedure as defined by outcomes collected in a registry, including patient reported outcome measures (PROMs); legal and social effects were not modified.

Functional Somatic Syndromes Are Associated With Varied Postoperative Outcomes and Increased Opioid Use After Spine Surgery: A Systematic Review.

Systematic Review. To perform a systematic review assessing the relationship between functional somatic syndromes (FSSs) and clinical outcomes after spine surgery. A systematic review of online databases (PubMed and Web of Science) through December 2021 was conducted via PRISMA guidelines to identify all studies investigating the impact of at least one FSS (fibromyalgia, irritable bowel syndrome (IBS), chronic headaches/migraines, interstitial cystitis, chronic fatigue syndrome, multiple chemical sensitivity) on outcomes after spine surgery. Outcomes of interest included patient reported outcome measures (PROMs), postoperative opioid use, cost of care, complications, and readmission rates. A total of 207 records were identified. Seven studies (n = 40,011 patients) met inclusion criteria with a mean MINORS score of 16.6 out of 24. Four studies (n = 21,086) reported postoperative opioid use; fibromyalgia was a strong risk factor for long-term opioid use after surgery whereas the association with chronic migraines remains unclear. Two studies (n = 233) reported postoperative patient reported outcome measures (PROMs) with mixed results suggesting a possible association between fibromyalgia and less favorable PROMs. One study (n = 18,692) reported higher postoperative complications in patients with fibromyalgia. Patients with fibromyalgia and possibly migraines are at higher risk for prolonged postoperative opioid use and less favorable PROMs after spine surgery. There is limited research on the relationship between other Functional somatic syndromes (FSSs) and outcomes following spine surgery. Growing evidence suggests the variation in outcomes after spine procedures may be attributed to non-identifiable organic patient factors such as FSSs.

Return to work following revision knee arthroplasty in patients under 65 years of age: A retrospective study

BackgroundLittle is known about employment following revision total knee arthroplasty (RTKA). This study aims to describe factors associated with returning to employment in patients of working age who underwent RTKA surgery. MethodsWe performed a retrospective assessment of all patients aged ≤65 who underwent RTKA at our NHS institution between 2006 and 2020. All indications and revision procedures were included. Pre-operative demographics, indication for surgery and Oxford Knee Scores (OKS) were recorded. Postal questionnaires were sent to patients including patient reported outcome measures and a departmental questionnaire asking patients about employment status pre- and post-operatively. Results132 procedures were performed in 113 patients. Median follow up was 5.5 years (2.4–9.0). Mean age was 58 (5.8) and 50% (57) were men. 62 patients undergoing 74 procedures responded to postal questionnaires and were included in the study. 53% (33) were employed prior to surgery and 61% (38) returned to work at a median of 12 weeks (3–150). Of the 24 who did not return to work, 7 reported intending to return to work. Those patients who returned to work had increased pre-operative OKS (16.9 vs 13.6) and mean improvement (16.5 vs 12.4). ConclusionThis study is limited by small numbers and its observational nature. In this population the majority of patients who wished to return to work after RTKA were able to do so. This provides some reassurance when counselling patients. Prospective studies to better understand the factors that predict return to work will be important with increasing demands from surgery.

Arthrodesis of the Second and Third Tarsometatarsal Joints: Comparison of Clinical Results Using Combined or Individual Plating Techniques

Category: Midfoot/Forefoot; Other Introduction/Purpose: Arthrodesis is an effective treatment of midfoot arthritis in reducing pain and improving function. However, there is a known risk of non-union. Our aim was to compare the outcomes of individual plating versus dual plating for combined fusion of the 2nd and 3rd tarsometatarsal joints (TMTJs). Our primary outcome was bone healing and secondary outcomes include patient reported outcome measures. Methods: All cases underwent primary arthrodesis of the 2nd and 3rd TMTJs. Arthrodesis was performed using either a single ‘H- shaped’ plate (combined plating group) or using two separate plates (individual plating group). The outcome measures were bony union and the Manchester-Oxford Foot Questionnaire score. Results: Forty-five procedures were undertaken with a mean follow-up of 527 days. The combined plating group had 28 cases and individual plating group had 17 cases. There were 10 cases (35.71%) of non-union in the combined plating group and 2 cases (11.76%) in the individual plating group. Muti-variate regression analysis showed a significant relationship of non-union with use of the combined plating group (p =.047, OR 5.822). Patients who had also undergone 1st TMTJ fusion had an increase chance of union (p=.043, OR 9.896). No other factors showed significance. MOX-FQ scores were superior in the individual group at 6 months post-surgery although this significance was lost when the non- unions were excluded. Conclusion: This study is the first to report a difference in union between combined plating and individual plating techniques in arthrodesis of the 2nd and 3rd TMTJs. We believe that individual plates permit a more anatomical reduction and greater compression at the site of arthrodesis as compared to a dual plate technique. Achieving union results in a better functional outcome.

Patient Reported Outcomes Following Revision Ankle Arthrodesis for Ankle Fusion Non-Union

Category: Ankle Arthritis; Hindfoot Introduction/Purpose: Ankle arthrodesis (AA) has, for many years, been considered the gold standard procedure for the surgical treatment of end stage ankle arthritis. Non-union following AA surgery is a devastating complication which subsequently requires revision surgery. However, data on outcomes including patient reported outcome measures (PROMs) following revision ankle arthrodesis (RAA) after failed AA is lacking. The aim of this study is to assess the outcome of RAA for symptomatic non-union after AA including PROMs. Methods: Prospectively collected data from a multicenter database of ankle arthritis surgery was analyzed. Demographic data and PROMs including Ankle Osteoarthritis Scale (AOS) and Short Form-36 (SF-36) health survey were collected at regular intervals. Surgeries were performed by six fellowship-trained foot and ankle surgeons between January 2003 and July 2015. 336 primary AA cases were identified, of which 27 (8%) underwent revision for symptomatic AA non-union. Results: Mean follow-up of 27 AA non-union cases was 5.3 years (2-10). There were 16 (59%) males and 11 (41%) females, with a mean age of 62 years (44 - 81) and a mean BMI of 32 (26.5 – 45), respectively. At index AA, 12 (44%) cases were performed arthroscopically. Twenty-three (84%) AA non-union patients were actively smoking pre- and post-operatively, and 15 (56%) were diabetic. Overall union-rate following RAA was 85% (23/27). For RAA the pre-operative mean AOS score of 64.9 (38.8-81.5) improved to 49.1 (24.1-73) at latest follow-up. SF-36 PCS score improved from 27.2 (21.3 – 38.3) to 33.3 (19.1-54.2) and SF-36 MCS score improved from 41.2 (17.5-60.9) to 46.2 (29.3-65.9). Overall complication rate of RAA was 22%, with a re-operation rate of 15%. Conclusion: Revision ankle arthrodesis (RAA) for ankle fusion non-union resulted in a successful fusion of the ankle in 85% of patients with modest improvement in AOS and SF-36 scores. Indeed, even after successful RAA, patients report pain and disability levels comparable to that reported by primary AA patients pre-operatively. Additionally, complication and re-operation rates of RAA are high. This data emphasizes on the importance of achieving a primary fusion in AA. The presented patient reported outcomes may help the treating surgeon to counsel patients prior to RAA surgery to better set their expectations.

RETURN TO WORK FOLLOWING REVISION KNEE ARTHROPLASTY IN PATIENTS UNDER 65 YEARS OF AGE

AbstractIntroductionLittle is known about employment following revision total knee arthroplasty (RTKA). This study aims to describe factors associated with returning to employment in patients of working age who underwent RTKA surgery.MethodologyWe performed a retrospective assessment of all patients aged ≤65 who underwent RTKA at our NHS institution between 2006 and 2020. All indications and revision procedures were included. Pre-operative demographics, indication for surgery and Oxford Knee Scores (OKS) were recorded. Postal questionnaires were sent to patients including patient reported outcome measures and departmental questionnaire asking patients about employment status pre- and post-operatively.Results132 procedures were performed in 113 patients. Median follow up was 5.5 years (2.4–9.0). Mean age was 58 (5.8) and 50% (57) were male. 62 patients undergoing 74 procedures responded to postal questionnaires and were included in the study. 53% (33) were employed prior to surgery and 61% (38) returned to work at a median of 12 weeks (3–150). Of the 24 who did not return to work, 7 reported intending to return to work. Those patients who returned to work had increased pre-operative OKS (16.9 vs 13.6) and mean improvement (16.5 vs 12.4).ConclusionThis study is limited by small numbers and its observational nature. In this population the majority of patients who wished to return to work after RTKA were able to do so. This provides some reassurance when counselling patients. Prospective studies to better understand the factors that predict return to work will be important with increasing demands from surgery.

Poster 264: Medial Tibia Bone Marrow Edema on Preoperative MRI Predicts Inferior Patient Outcomes Following Posterior Medial Meniscus Root Repair

Objectives: Repair of posterior medial meniscus root (PMMR) tears demonstrates favorable patient outcomes and may prevent rapid progression of knee osteoarthritis, however, there is a paucity of data in literature regarding prognostic factors affecting postoperative outcomes. The medial meniscus plays an important role in the knee biomechanically by increasing tibiofemoral contact area and decreasing peak tibiofemoral contact pressures. Few studies exist that examine preoperative knee magnetic resonance imaging (MRI) findings and patient reported outcome measures (PROMs) following PMMR repair. Semi-quantitative MRI evaluation can offer improved detection of degenerative pathology. Identifying specific factors that may predict surgical outcomes is important when considering PMMR repair, as some patients with more advanced degenerative joint disease may benefit from consideration for knee arthroplasty instead of joint preservation with meniscus repair surgery. The purpose of this study was to identify factors on preoperative MRI that may predict postoperative outcomes following PMMR repair. We hypothesize that patients with worse knee overall quality would have worse postoperative PRO scores. Methods: Between 2012 and 2020, patients who underwent posterior medial meniscus root repair at a tertiary referral academic center by fellowship trained sports medicine surgeons were retrospectively identified, recruited, and enrolled in the study. Institutional review board approval and informed consent was obtained. Inclusion criteria included patients ages 18-70, posterior medial meniscus root repair through transtibial fixation technique, minimum two years postoperative follow-up, and a preoperative knee MRI. Exclusion criteria included prior ipsilateral knee meniscus or ligamentous injury, additional ipsilateral knee injury requiring surgery, and conversion to knee arthroplasty. Visual Analog Scale (VAS) pain and PRO surveys including Patient Reported Outcome Measures Information System Physical Function (PROMIS-PF) Computer Adaptive Test, Lysholm Knee Score, Knee Osteoarthritis and Injury Outcome Score (KOOS) with 5 sub-sections, were collected at minimum 2-years postoperative. Patient Acceptable State Score (PASS) values from a prior meniscus study were utilized to identify patients that met PASS for the KOOS subsections. A fellowship-trained musculoskeletal radiologist reviewed preoperative MRIs and calculated Whole Organ Magnetic Resonance Imaging Scores (WORMS) for meniscus, cartilage, bone marrow edema pattern (BMEP) in 6 knee locations as well as effusion/synovitis and meniscal extrusion. Radiographs were scored with Kellgren-Lawrence (KL) scores to assess presence and severity of osteoarthritis. Statistical analysis was performed with Stata (StataCorp) using two sample T-tests, Mann-Whitney, and Fisher’s exact test for categorical variables. Significance was defined as p&lt;0.05. Results: We evaluated 29 knees (22 female patients) with a mean age at surgery of 52.3±9.9 years, body mass index of 27.6±5.6 kg/m2, and at a mean follow-up of 59.6 months ± 26.5. median KL grade 2, and 44.8% with meniscal extrusion. Pain scores decreased significantly from before surgery to final follow-up (p&lt;0.001), and the percentage of patients meeting PASS ranged from 44.8% for KOOS-Sport subscale to 72.4% for KOOS-Pain and KOOS-Quality of Life subscales (Table 1). There were 10 patients with medial tibial BMEP on pre-operative MRI and 19 with no medial tibial BMEP (Table 2). Patients with medial tibia BMEP had significantly lower Lysholm Knee Score (p=0.037), KOOS-Symptoms (p=0.028), and KOOS-QOL (p=0.029) (Figure 1). There were no significant differences in demographics between those with and without medial tibia BMEP. There was no significant difference in PRO scores when comparing those with medial femoral condyle BMEP, cartilage quality in any of the knee regions, or presence of meniscus extrusion. Conclusions: We observed that patients with medial tibia BMEP at baseline on their preoperative MRI had inferior PROMs for Lysholm Knee Score, KOOS Symptoms, and KOOS-QOL after PMMR repair compared to those without medial tibia BMEP. The presence of medial tibial BMEP could represent underlying damage that may not be evident in the cartilage itself, given most medial tibia cartilage was normal on MRI and cartilage quality was not a significant discriminant for outcomes. The presence of meniscus extrusion did not correlate with patient outcomes either. Limitations of this study include only VAS-Pain score as a pre-operative measure. Multivariate analysis was not possible due to the sample size available. A strength of this study is the mean follow up of approximately 5 years and preoperative MRI data on all patients. Posterior medial meniscus root tears are generally treated with surgical repair due to increased risk of progression to arthritis, however, some patients continue to have symptoms after repair. Our results show that patients with medial tibial BMEP on their preoperative MRI have worse PRO scores after posterior medial meniscus root repair, which can help surgeons better counsel patients towards optimal treatment options. In conclusion, the presence of medial tibia BMEP on preoperative MRI was a marker for inferior patient outcomes for Lysholm Knee Score, KOOS Symptoms, and QOL at minimum two years postoperative following posterior medial meniscus root repair. [Table: see text][Table: see text]

THE HIPHOP STUDY: A FEASIBILITY STUDY FOR A RANDOMIZED CONTROLLED TRIAL OF HYBRID VERSUS CEMENTED TOTAL HIP ARTHROPLASTY

Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021).Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings.The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training.We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.

An evaluation of physiotherapists’ knowledge regarding the clinical assessment of an acute ankle sprain and chronic ankle instability

INTRODUCTION: Previous research has shown that 40% of people who suffer an ankle sprain will develop chronic ankle instability (CAI). Both mechanical insufficiencies and functional insufficiencies contribute to the development of CAI. In order to reduce the incidence of CAI and to provide the highest standard of care to patients, physiotherapists must be able to identify these insufficiencies in order to develop an appropriate treatment pathway. METHODS: We designed an online survey which the Irish Society of Chartered Physiotherapists sent to members within particular subgroups. The survey allowed us to determine the competencies of Chartered Physiotherapists in conducting a comprehensive clinical ankle assessment, their knowledge of CAI and their self-rated confidence in treating and assessing an ankle injury. RESULTS: From the emails distributed, 263 people chose to take part. Of those, 87 people completed the survey, yielding a response rate of 33%. Of the 87 respondents, 49% could not identify any mechanical impairments, and 40% could only identify one. 47% could not identify any functional impairments, 21% identified one and 25% identified two. 62% of participants did not include ankle joints arthrokinematics in their clinical assessments of ankle injury, and 60% did not include patient reported outcome measures. Therefore the majority of Irish physiotherapist’s are not meeting the minimally accepted standards of ankle injury assessments. Despite this, 86% of participants rated themselves as 6/10 or greater in their own clinical assessment proficiency. CONCLUSION: Our results highlight that Irish physiotherapist have a limited understanding of the mechanical and functional insufficiencies contributing to the development of CAI.

Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. 90146150 (28/03/2019).

A prospective randomised controlled trial of mechanical axis with soft tissue release balancing vs functional alignment with bony resection balancing in total knee replacement—a study using Stryker Mako robotic arm-assisted technology

BackgroundImproving the functional outcome following total knee arthroplasty (TKA) by using different alignment techniques remains controversial. The surgical techniques and technologies used so far to obtain these alignments have all suffered from inaccuracies. The use of robotic technology to plan and execute the bony resection provides increased accuracy for these various alignment techniques and may determine which will deliver superior function. Functional alignment (FA) is a newer surgical technique that aims to position the prosthesis with respect to each patients’ specific bony anatomy whilst minimising disruption to the soft tissue envelope. This trial aims to compare the patient and surgical outcomes of FA to the current gold standard surgical technique, mechanical alignment (MA), under randomised and blinded conditions.MethodsPatients with symptomatic knee osteoarthritis will be prospectively recruited. Following informed consent, 240 patients will be randomised to either a MA surgical technique (the control group) or a FA surgical technique (the intervention group) at a ratio of 4:1 using a random number generator. All patients will undergo computer tomography (CT) based robotic arm-assisted surgery to execute planned implant positioning and alignment with high levels of accuracy. The primary outcome is the forgotten joint score (FJS) at 2 years post-operation. Secondary outcome measures include patient reported outcome measures of post-operative rehabilitation, pain, function and satisfaction, as well as limb alignment, implant revisions and adverse events. Intention-to-treat and per-protocol population analysis will also be conducted. Standardisation of the surgical system and care pathways will minimise variation and assist in both patient and physiotherapist blinding. Ethical approval was obtained from the Northern B Health and Disability Ethics Committee (20/NTB/10).DiscussionCurrently, MA remains the gold standard in knee replacement due to proven outcomes and excellent long-term survivorship. There are many alternative alignment techniques in the literature, all with the goal of improving patient outcomes. This study is unique in that it leverages an advanced analytics tool to assist the surgeon in achieving balance. Both alignment techniques will be executed with high precision using the CT-based robotic arm-assisted surgery system which will minimise surgical variation. This trial design will help determine if FA delivers superior outcomes for patients.Trial registrationAustralia and New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000009910. Registered on 9 January 2020. ClinicalTrials.gov, NCT04600583. Registered on 29 September 2020.

Putting measurement on a diet: development of a core set of indicators for quality improvement in the ICU using a Delphi method

BackgroundThe number and efficacy of indicators used to monitor and improve the quality of care in Intensive Care Units (ICU) is debatable. This study aimed to select a consensus-based core set of indicators for effective quality improvement in the ICU.MethodsA Delphi study with a panel of intensivists, ICU nurses, and former ICU patients or relatives (n = 34) from general, teaching, and academic hospitals. Panelists completed a questionnaire in which they scored 69 preselected quality indicators on relevance using a nine-point Likert scale. Indicators were categorized using the rated relevance score into: ‘accepted, ‘equivocal’ and ‘excluded’. Questionnaire results were discussed in focus groups to reach consensus on the final set.ResultsResponse rates for the questionnaire and focus groups were 100 and 68%, respectively. Consensus was reached on a final set of 17 quality indicators including patient reported outcome measures (PROMs) and patient reported experience measures (PREMs). Other quality indicators relate to the organization and outcome of ICU care, including safety culture, ICU standardized mortality ratio, and the process indicator ‘learning from and improving after serious incidents’.ConclusionsICU clinicians and former patients and relatives developed a consensus-based core set of ICU quality indicators that is relatively short but comprehensive and particularly tailored to end-users needs.

POS0850 A PHASE II RANDOMISED CONTROLLED TRIAL OF ORAL PREDNISOLONE IN EARLY DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS (PRedSS)

BackgroundA highly controversial question is whether or not corticosteroids should be prescribed for patients with early diffuse cutaneous systemic sclerosis (dcSSc). Although the painful and disabling features of early dcSSc (including tight itchy skin, contractures, fatigue) have an inflammatory basis and are likely to respond to corticosteroids, corticosteroids are a risk factor for potentially life-threatening scleroderma renal crisis.ObjectivesOur aim was to examine safety and efficacy of moderate dose prednisolone in patients with early dcSSc. Specific objectives were to evaluate whether moderate dose prednisolone reduced pain and disability, and improved skin score, and whether prednisolone was safe with particular reference to renal functionMethodsPRedSS set out as a Phase II, multicentre, double-blind randomised controlled trial, converted to open-label because of the Covid-19 pandemic. Patients were randomised to receive either moderate dose prednisolone (approximately 0.3 mg/kg) or matching placebo (or no treatment during open-label) for 6 months. The co-primary endpoints were the Health Assessment Questionnaire Disability Index (HAQ-DI) and modified Rodnan skin core (mRSS) at 3 months. Over 20 secondary endpoints included patient reported outcome measures reflecting pain, itch, anxiety and depression, fatigue and helplessness. 72 participants randomised 1:1 were planned and anticipated to yield 60 evaluable, giving over 80% power for each co-primary outcome in ANCOVA analyses [assumptions; HAQ-DI (α = 0.025, δ = -0.6, σ = 0.9, ρ = 0.6), mRSS (α = 0.025, δ = -5.5, σ = 8.2, ρ = 0.6)]. Mixed Models for Repeated Measures (week 6, month 3, month 6) were fitted with covariates trial arm, baseline score, anti-Scl-70 and their interactions with time point. An unstructured covariance matrix was assumed with the primary focus being the trial arm effect at 3 months.ResultsThe study terminated early due to the Covid-19 pandemic and consequently did not meet the recruitment target of 72 patients. Thirty-five patients (Table 1) were randomised (17 to prednisolone and 18 to placebo/control, 25 during the double-blind phase), of whom 34 completed the 3 month assessment. The adjusted mean difference between treatment groups at 3 months in HAQ-DI score was -0.10 (97.5% CI -0.29 to 0.10), p=0.25, and in mRSS -3.90 (97.5% CI -8.83 to 1.03), p=0.070, both favouring prednisolone but not significantly. Patients in the prednisolone group experienced less pain, helplessness and anxiety than control patients at 3 months: mean difference in pain scores -0.49, 95%CI (-0.93 to -0.06), p=0.027, in Hospital Anxiety and Depression (HADS) anxiety scores -2.05, 95%CI (-3.73 to -0.37), p=0.018, and in helplessness scores -1.54, 95%CI (-3.01 to -0.07), p=0.040. There were no renal crises.Table 1.Baseline characteristics of patients by treatment allocationCharacteristicPrednisolone (n=17)Control (n=18)Age (years)52.7 (14.0)55.3 (12.7)Female n (%)10 (59)9 (50)Duration of skin thickening (years)1.6 (0.8)1.7 (0.8)Anti-topoisomerase-1 n (%)5 (29)6 (33)Anti-RNA polymerase III n (%)6 (35)8 (44)HAQ-DI1.6 (0.8)1.7 (0.7)mRSS18.8 (7.9)23.5 (8.6)Values are mean (standard deviation) unless stated otherwiseConclusionPRedSS exemplified the challenges of running a clinical trial of an investigational medicinal product potentially associated with increased infection risk during the Covid-19 pandemic. Because PRedSS was terminated prior to target recruitment, it was underpowered, and any conclusions have to be extremely cautious. Although PRedSS suggested some benefit from moderate dose prednisolone, the small sample indicates the need for a further randomised trial.

Single-stage buried autologous breast reconstruction (BABR)

Breast reconstructive standards are increasingly high oncologically, aesthetically, and practically. Autologous breast reconstruction remains the gold standard which, buried, after nipple-sparing mastectomy (where oncologically safe) or wise pattern reduction for large or ptotic patients, with contralateral symmetrisation where required, enables single-stage reconstruction. However, previous series report prohibitively high revision rates. This series prospectively compares a series of buried and non-buried free flaps for breast reconstruction. All breast reconstructions with free autologous tissue transfer, buried or with a cutaneous paddle, conducted over 8 years by a single surgeon were included. Demographic, oncologic and reconstructive details, immediate complications and revision surgeries were recorded and compared between the two groups. A total of 182 free flaps were performed on 156 patients, 69 buried and 113 with cutaneous paddles. There were no significant demographic or complication differences between the two groups. Of the buried group, 51% did not require further surgery compared to 29% of the paddle group. Buried autologous breast reconstruction is a safe and aesthetic option for breast reconstruction, and potentially single stage. This is particularly true where it is combined with nipple-sparing mastectomy (where oncologically safe) or breast reduction mastectomy, and contralateral symmetrisation, where required. Further research could include patient reported outcome measures and cost analysis.

Spinal pathology and outcome post-THA: does segment of arthrodesis matter?

The presence of lumbar spine arthrodesis (SA) is associated with abnormal spinopelvic characteristics and inferior outcome post total hip arthroplasty (THA). However, whether patients with upper segment SA are also at increased risk of complications is unknown. This study aims to (1) determine if upper segment SA is associated with inferior THA outcomes; (2) assess spino-pelvic characteristics; and (3) test whether static or dynamic spinopelvic characteristics correlate with outcome post-THA. In this retrospective, case-matched, cohort study from a tertiary referral centre, 40 patients (59 hips) that had undergone both THA and any level of spinal arthrodesis (49 THA-Lumb and 10 THA-Cerv) were compared with 41 patients (59 hips) who had THA-only without known spinal pathology. Spino-pelvic characteristics [including severity of Degenerative-Disc-Disease (DDD); spinal balance and stiffness] and outcome, including patient reported outcome measures (PROMs), at minimum of 1-year post-THA were assessed. THA-Lumb and THA-Cerv groups had greater number of complications and inferior hip and spinal PROMs compared to THA-Only (p < 0.001). Similar spinopelvic characteristics were seen between the THA-Cerv and THA-Lumb, which were significantly different to the THA-only group. The presence of DDD and unbalanced or stiff spine was associated with increased dislocation and inferior PROMs in the whole cohort. THA in the presence of SA, regardless of level, is associated with inferior outcomes and an increased risk for dislocation. The presence of a SA is associated with increased risk of adverse spinopelvic characteristics. Such characteristics were strongly associated with increased dislocation-risk and inferior PROMs. It is likely that these adverse characteristics are the most important adverse predictor, rather than segment of SA per se.

Fluid administration during routine colonoscopy is not clinically significant: a randomized controlled trial

Retrospective studies have questioned the benefits of intravenous (IV) fluids during routine colonoscopies given they are performed on well patients who experience limited fluid loss, consume clear fluids up until 2 h prior and low IV volumes typically infused. This trial aims to assess the impact of IV fluid on hypotension and electrolyte changes amongst patients undergoing colonoscopy. Participants undergoing colonoscopies were randomized (single blinded) to IV fluid or no IV fluid. Primary outcomes were equivalence of intraoperative hypotensive episodes (>20% drop in systolic blood pressure (SBP)) and changes in serum electrolytes post procedure. Secondary outcomes included patient reported outcome measures (PROMs). Of the 470 participants enrolled, 84/235 (35.7%) from the IV fluids group and 88/230 (38.3%) from the no IV fluids group experienced a hypotensive event (difference in prevalence -2.5, 95% CI -11.3, 6.3). Fourteen participants in each group required clinical intervention to provide haemodynamic support (difference in prevalence -0.1, 95% CI -4.4, 4.2). Postoperative electrolytes changes and PROMs were similar for both groups. Whilst definitive recommendations for IV fluid use during routine colonoscopy are not possible as this trial was underpowered to show equivalence between the groups for hypotensive events, there was no clinically meaningful difference between the groups. These findings provide important data for meta-synthesis and for planning future work.