A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol.

Background: Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person's life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations.Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods: The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion: The iFraP trial will answer important questions about the effectiveness of the new 'iFraP' osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.

Background: For people with osteoporosis, broken bones (called 'fragility fractures') can occur from low or no trauma and cause significant disability. Medicines can strengthen bone and lower the chance of fragility fractures. However, many people who experience a fragility fracture do not start or continue taking osteoporosis medicines. People commonly choose not to take osteoporosis medicines because they are unsure what medicines are for, confused about fracture 'risk' and/or worried about side-effects. To address this, we developed the 'iFraP intervention': 1. The iFraP 'decision-support tool': to support patients and healthcare professionals talk together to make decisions about medicines2. iFraP training for healthcare professionals to:a. use the tool in appointments with patientsb. give understandable, clear and consistent information c. listen to and address patient concerns This trial investigates whether the iFraP intervention makes decision-making about osteoporosis medicines easier, and whether it is cost-effective, acceptable and practical to deliver. Methods: 380 patients will take part who will be 50 years and older and referred to a fracture prevention service, because they have broken a bone. Patients taking part will be allocated to receive either a usual NHS appointment or an appointment using the iFraP intervention. Patients will complete a questionnaire before their appointment, and 2 weeks and 3 months afterwards. Some patients will be asked if they consent to have their appointment recorded and/or be interviewed, to understand how the decision-support tool is being used, and patient's views of the iFraP intervention. Outputs: If successful, the iFraP intervention will benefit patients and the NHS by helping patients make decisions about osteoporosis medicine. If the iFraP intervention increases the number of people with osteoporosis that start and continue taking osteoporosis medicines, iFraP will lower the number of future fractures, and reduce the negative outcomes that result from fractures (e.g. significant disability).

Transurethral water vapor therapy for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a cost-minimization and budget impact analysis from an Italian healthcare perspective.

BACKGROUND: The aim of this study was to compare the costs and budget impact of adopting water vapor thermal therapy with the Rezum™ System, for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) to transurethral resection of the prostate (TURP), from an Italian hospital healthcare perspective. METHODS: A Markov model (4-year time horizon, 3-month cycle length), developed to support a submission to the National Institute of Health and Care Excellence (NICE) in England, was adapted to an Italian payer perspective. A cost minimization analysis was conducted, assuming equal efficacy between both therapies. Net difference in costs per patient was reported, considering procedure, adverse events and retreatment costs. Probabilistic and deterministic sensitivity analyses considered the uncertainty of the results. Population data and market share distribution assumptions were applied to a cohort of Italian patients treated in one year to report the budget and capacity impact of increased use of Rezum. RESULTS: Over 4 years, the costs per patient with Rezum were €2072 compared to €2836 with TURP, resulting in net savings of €764. Sensitivity analyses showed that this conclusion was robust. Replacing 10% of TURP procedures with Rezum generates cost-savings of € 7,139,549 over 4 years and saves 4671 theatre hours and 26,856 bed days in one year. Replacing 30% of BPH surgical procedures with Rezum generates cost-savings to € 21,418,647 over 4 years, saves 14,012 theatre hours and 80,567 bed-days in one year. CONCLUSIONS: This analysis demonstrates that Rezum is highly likely to be cost-saving compared to TURP from an Italian hospital healthcare perspective.

The role of rapid on site evaluation on touch imprint cytology and brushing during conventional bronchoscopy.

BACKGROUND: The increase in immunohistochemical and molecular predictive tests in lung cancer requires new strategies for managing small samples taken during bronchoscopic procedures. The value of Rapid On Site Evaluation (ROSE) during conventional bronchoscopic procedures on endobronchial neoplasms in optimizing small biopsies and cytologlogical tissue specimens for diagnostic testing, and ancillary studies was evaluated. METHOD: ROSE on touch imprint cytology (TIC) and brushing was performed on 690 consecutive cases of patients undergoing biopsies, using fiber optic bronchoscopy. Immunohistochemical assay for PD-L1, ALK, and ROS1 and molecular testing, via next generation technique for EGFR, KRAS, and BRAF, were performed. RESULTS: The concordance between ROSE and final diagnoses was almost perfect for brushing (sensitivity: 0.84; specificity: 0.96), and less so for touch preparations (sensitivity: 0.77; specificity: 0.89). Immunohistochemical assay for PD-L1 was evaluated on 256 bioptic cases with only six unsuitable samples. Material available for immunohistochemistry for ALK was sufficient in 151 biopsies with no inadequate cases. ROS1 was evaluated in 132 biopsies, with only two unsuitable samples. Molecular analysis was performed on 128 biopsies, 29 TIC, and 17 brushing. Out of these, only ten were considered to be unsuitable. CONCLUSIONS: ROSE is an effective procedure for monitoring the quality and quantity of material taken during conventional bronchoscopic procedures for evaluating the suitability of small samples that must undergo immunohistochemical and molecular assay.

Phenylephrine infusion impact on surgical site infections after lower extremity bypass surgery.

OBJECTIVE: Lower extremity bypass (LEB) operations have high rates of surgical site infections (SSI). Phenylephrine is a commonly used vasoconstrictor which may reduce skin blood flow and increase the likelihood of SSI in these patients. We studied the potential effect of phenylephrine infusion during LEB surgery on SSI. METHODS: LEB cases and their demographic data were identified through the Vascular Quality Initiative registry. SSI in this population was identified using the hospital epidemiology surveillance database. Phenylephrine use in this population was identified through chart review. RESULTS: We identified 699 patients who underwent LEB; 82 (11.7%) developed an SSI, and 244 of 698 (35.0%) were treated with phenylephrine infusion. In bivariate analysis, higher body mass index (28.8 kg/m2 vs 27.3 kg/m2; P = .034), diabetes (14.6% vs 9.4%; P = .035), hypertension (12.6% vs 4.7%; P = .038), groin incision (13.2 vs 5.4%; P = .013) and longer procedure times (17.1% for >220 minutes and 8.9% for ≤220 minutes; P = .003) were associated with higher rates of SSI. Whereas phenylephrine infusion exhibited a trend toward a higher rate (14.8% vs 9.9%; P = .057). In the logistic regression model, diabetes (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.0-3.2; P = .032), total procedure time (OR, 1.85; 95% CI, 1.1-3.1; P = .026) and vertical groin incision (OR, 2.6; 95% CI, 1.1-6.5; P = .035) were independent predictors of increased SSI rates, whereas body mass index (OR, 1.04; 95% CI, 0.99-1.08; P = .09), hypertension (OR, 2.5; 95% CI, 0.6-10.9; P = .22), and phenylephrine infusion (OR, 1.08; 95% CI, 0.63-1.85; P = .78) were not independent predictors of increased SSI rates. CONCLUSIONS: Phenylephrine infusion did not increase the risk of SSI in patients who underwent LEB.

Chromogenic in situ hybridization to detect EGFR gene copy number in cell blocks from fine-needle aspirates of non small cell lung carcinomas and lung metastases from colo-rectal cancer.

BACKGROUND: Several studies demonstrated that epidermal growth factor receptor (EGFR) gene copy number (GCN) correlates to the response to tyrosine kinase inhibitors in non small cell lung cancer (NSCLC) and to anti-EGFR monoclonal antibodies (MoAbs) in metastatic colorectal cancer (CRC). In the presence of lung nodules, cytology is often the only possible diagnostic approach. Chromogenic in situ hybridization (CISH) is an alternative technique to fluorescence in situ hybridization (FISH), but its feasibility in detecting EGFR GCN in cell blocks from fine-needle aspiration cytology (FNAC) of lung nodules has not yet been established. METHODS: We evaluated the feasibility of CISH on 33 FNAC from 20 primary NSCLC (5 squamous carcinomas, 8 large cell carcinomas and 7 adenocarcinomas) and 13 lung metastases from CRC. RESULTS: Of the 33 FNAC analyzed by CISH, 27 (82%) presented a balanced increase in EGFR gene and chromosome 7 number: 10 cases (30%) showed a low polysomy, 15 (45%) a high polysomy and 2 (6%) NSCLC were amplified. No significant differences between NSCLC and CRC lung metastases were found in relation to disomic or polysomic status. In addition, no correlation between EGFR GCN and EGFR immunohistochemical overexpression was found. Furthermore, we compared CISH results with those obtained by FISH on the same samples and we found 97% overall agreement between the two assays (k = 0.78, p < 0.0001). Two cases were amplified with both assays, whereas 1 case of NSCLC was amplified by FISH only. CISH sensitivity was 67%, the specificity and positive predictive value (PPV) was 100%, and the negative predictive value (NPV) was 97%. CONCLUSIONS: Our study shows that CISH is a valid method to detect EGFR GCN in cell blocks from FNAC of primary NSCLC or metastatic CRC to the lung.