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Objectives: Ensuring implementation fidelity of patient-reported outcome measures (PROMs) in the complex clinical setting remains exigent. We aimed to integrate the routine use of PROM reports in day-to-day patient care and assess the implementation outcomes using statistical process control (SPC) methods. Study Design and Setting: This prospective pilot study used an implementation science framework to integrate PROMs. SPC analysis was applied to track patient completion rates and staff acknowledgment rates over time. Daily observational data across clinical areas were collected to assess potential variations. Results: Data were available from 324 patient encounters over 14 weeks. On average, 78% (52% to 100%) of eligible patients entering the clinic completed the PROMs; staff acknowledged 78% (50–100%) of these patient reports. Most patterns of fluctuation were inside the control frame. Dips in compliance relating to changes in clinic daily routine, including the introduction of the second randomized clinic, were quickly resolved with a structured response. Conclusion: Implementation of PROMs was feasible with reasonable patient completion and staff acknowledgment rates. Fidelity was vulnerable to barriers impacting the daily routine or unusual events in the clinics, suggesting that greater standardization and integration into clinic processes may yet further improve compliance and consistency of reporting.

Background Active warming reduces risk of surgical complications. Implementation of a perioperative thermal care bundle increased use of active warming for surgical patients. Objective This study aimed to determine if implementing a thermal care bundle to prevent inadvertent perioperative hypothermia is cost-effective. Design A model-based cost-effectiveness analysis was undertaken using Monte Carlo simulations from input distributions to estimate costs and effects. Setting Hospitals undertaking between 5,000 and 40,000 surgeries per year, which either implemented or did not implement the thermal care bundle, were modelled. Participants The decision tree guiding the structure of the model was populated with clinical outcomes (surgical site infection, blood transfusion requirement and morbid cardiac events) of a hypothetical cohort of surgical patients. Interventions Implementation or non-implementation of the thermal care bundle. Main outcome measures Net monetary benefit was calculated by multiplying the health benefits (quality-adjusted life years) by the willingness-to-pay threshold minus the cost. We tested a range of values for willingness to pay per quality-adjusted life year thresholds and plotted results for expected incremental benefits and probability of cost-effectiveness. The incremental cost-effectiveness ratio was also calculated. Results Thermal care bundle implementation simultaneously reduced costs and increased quality-adjusted life years in the majority of simulations (88.1%). The average cost reduction was $689,659 (95% credible intervals spanned from a $2,718,364 decrease in costs to $379,826 increase in costs) and average difference in quality-adjusted life years was 54 (95% CI = 0.4 less to 176 more). This equated to an incremental cost-effectiveness ratio of $12747 saved per quality-adjusted life year gained. Conclusions It is likely that increasing use of active warming by implementing the thermal care bundle would generate cost-savings and improve the quality of life for surgical patients. It would be good value for hospitals with similar characteristics to those included in our model to allocate the extra resources required for implementation.

Objectives To assess the feasibility of conducting a trial of a psycho-educational intervention involving the provision of tailored information and coaching to improve management of a cancer-related symptom cluster (fatigue, pain and sleep disturbance) and reduce symptom cluster impacts on patient health outcomes in the Vietnamese context, and to undertake a preliminary evaluation of the intervention. Methods A parallel-group single blind pilot quasi-experimental trial was conducted with 102 cancer patients in one Vietnamese hospital. The intervention group received one face-to-face session and two phone sessions delivered by a nurse one week apart and the comparison group received usual care. Patient outcomes were measured at baseline prior to the chemotherapy cycle and immediately preceding the next chemotherapy cycle. Separate linear mixed models were used to evaluate the impact of the intervention on total symptom cluster severity, symptom scores, functional status, depressive symptoms and health-related quality of life. Results The study design was feasible with a recruitment rate of 22.6% and attrition rate of 9.8%. Compared to the control group, the intervention group showed a significant reduction in symptom cluster severity, fatigue severity, fatigue interference, sleep disturbance, depression and anxiety. Significant differences were not observed for pain severity, pain interference, functional status and health-related quality of life. The intervention was acceptable to the study population, with a high attendance rate of 78% and adherence rate of 95.7%. Conclusion On the basis of the present study findings, future randomized controlled trials are needed to test the effectiveness of a symptom cluster psycho-educational intervention in Vietnam.

Objective This study compared the incidence and hazard of ICD-9-CM-coded infections and severe infections in rheumatoid arthritis (RA) patients treated with subsequent-line (SL) BIOs (BIO) after switching from first-line (FL) anti-TNF therapy (anti-TNF). Methods Retrospective analysis of a large U.S. claims database. RA patients initiating an FL anti-TNF between 1/1/2004 and 3/31/2010 were identified and followed forward in time to capture all SL BIO episodes through 3/31/2010. SL BIO episodes were classified into: abatacept, adalimumab, etanercept, infliximab, or rituximab. Multivariate mixed-effects survival models compared the hazard of infections and severe infections across the SL BIO episodes with adjustment for demographic and clinical confounders. Results In total, 4332 SL BIO episodes were identified: mean age 55 years; 80% female. In adjusted analyses: when compared to rituximab, the hazard of all infections was significantly higher for adalimumab (hazard ratio [HR] = 1.31, 95% confidence interval [CI] = 1.09–1.55), etanercept (HR = 1.44, 95% CI = 1.20–1.72), and infliximab (HR = 1.30, 95% CI = 1.07–1.57), and insignificantly different for abatacept (HR = 1.18, 95% CI = 0.98–1.41); when compared to rituximab, the hazard of severe infection was significantly higher for infliximab (HR = 1.62, 95% CI = 1.03–2.55), and insignificantly different for abatacept (HR = 1.21, 95% CI = 0.78–1.88), adalimumab (HR = 1.10, 95% CI = 0.72–1.68), and etanercept (HR = 1.27, 95% CI = 0.83–1.95). Conclusions In RA patients treated with SL BIO, a 30–44% higher hazard of all infection was observed in anti-TNFs versus rituximab with a 62% higher hazard of severe infection observed in infliximab versus rituximab. This study used a non-randomized, observational design and is therefore subject to confounding from unmeasured factors that influence both treatment choice and infection risk.

Context Little is known about the phenotypic and molecular characteristics associated with various domains of quality of life (QOL) in women following breast cancer surgery. Objectives In a sample of women with breast cancer (n= 398), purposes were: to identify latent classes with distinct trajectories of QOL from prior to through six months following surgery and to evaluate for differences in demographic and clinical characteristics, as well as for polymorphisms in cytokine genes, between these latent classes. Methods Latent class analyses were done to identify subgroups of patients with distinct QOL outcomes. Candidate gene analyses were done to identify cytokine gene polymorphisms associated with various domains of QOL (i.e., physical, psychological, spiritual, social). Results One latent class was identified for the psychological and spiritual domains. Two latent classes were identified for the social domain and overall QOL scores. Three latent classes were identified for the physical domain. For the physical and social domains, as well as for the overall QOL scores, distinct phenotypic characteristics (i.e., younger age, poorer functional status, higher body mass index, and receipt of adjuvant chemotherapy) and a number of cytokine gene polymorphisms (CXCL8, NFKB2, TNFSF, IL1B, IL13, and NFKB1) were associated with membership in the lower QOL classes. Conclusions Findings suggest that women experience distinctly different physical well-being, social well-being, and total QOL outcomes during and following breast cancer surgery. The genetic associations identified suggest that cytokine dysregulation influences QOL outcomes. However, specific QOL domains may be impacted by different cytokines. Key words quality of life; cytokine genes; breast cancer; polymorphism; growth mixture modelling