Thoracoscopic lobectomy: is a training program feasible with low postoperative morbidity?

Objective

To evaluate the feasibility of training program in video assisted thoracic surgery (VATS) lobectomy comparing intraoperative and postoperative data of patients operated on by an established consultant and trainees.

Methods

Retrospective analysis of 100 consecutive patients who underwent VATS lobectomies between May 2008 and May 2012. 66 patients were operated on by an established consultant (Group A) and 34 by trainees (Group B).

Results

The groups were comparable for clinical characteristics and pathological staging. The mean operating time in Group A was 125 ± 30 min and in Group B was 133 ± 26 min (p = 0.18). The rate of conversion was similar in both groups: 9.1 % in Group A and 8.8 % in Group B (p = 0.6). The complication rate was comparable (p = 0.4): 36.3 % in Group A and 32.3 % in Group B. Median time to drain removal and median length of hospital stay was 3 and 5.5 days in Group A and 3 and 5 days in Group B, showing no statistical differences between the two groups (p = 0.3 and 0.5). There were no differences in term of long-term complications between the two groups.

Conclusion

Our study showed that a training program in VATS lobectomy is feasible, without increasing the operative time, conversion rate, postoperative complication, time to drain removal, and length of hospital stay.     

Transvenous Biopsy in the Diagnosis of Intravascular or Perivascular Neoplasm: A Single-Center Retrospective Analysis of 36 Patients

Between September 2008 and August 2017, 36 patients (mean age 56 y; range, 30–89 y) underwent transvenous biopsy of suspected tumor thrombus or perivascular tumor. Intravascular biopsy was pursued because of inaccessible percutaneous access in 9 patients (25%) and as part of a planned revascularization procedure in 27 patients (75%). Histopathologic results showed malignancy in 26 patients (72%) and benign etiologies in 10 patients (28%). No patients required repeat biopsy. There were no complications related to the biopsy procedure. The present series suggests that transvenous biopsy is a safe and accurate method of intravascular and perivascular mass tissue sampling.     

Standards for Instrument Migration When Implementing Paper Patient-Reported Outcome Instruments Electronically: Recommendations from a Qualitative Synthesis of Cognitive Interview and Usability Studies

Objectives

To synthesize the findings of cognitive interview and usability studies performed to assess the measurement equivalence of patient-reported outcome (PRO) instruments migrated from paper to electronic formats (ePRO), and make recommendations regarding future migration validation requirements and ePRO design best practice.

Blastomycosis of bones and joints

A retrospective study of 45 patients hospitalized with blastomycosis of bones or joints revealed 41 cases of osteomyelitis and 12 cases of septic arthritis. The majority were men (35 [78%] patients) and non-Aboriginal (32 [71%] patients). Median time from the onset of symptoms to hospitalization was shorter in women than men (male, 48 d; female, 14 d; P < 0.02), and shorter for Aboriginals than non-Aboriginals (non-Aboriginal, 50 d; Aboriginal, 19 d; P < 0.04). Cutaneous disease was present in 33 (73%) patients, and lung involvement was present in 29 (64%) patients. The most common osseous sites of involvement were the lower limb and axial skeleton. Common orthopaedic symptoms of bone lesions included bone pain in 42 (78%) patients, swelling in 32 (59%) patients, and soft tissue abscesses in 21 (39%) patients. Joint infection (12 patients) manifested as a monoarticular arthropathy presenting with effusion in 9 (75%) patients, pain in 8 (67%) patients, and decreased range of motion in 5 (42%) patients. Osseous blastomycosis can mimic bacterial infection and should be included in the differential diagnosis of bone and joint infection in patients who have visited or who live in geographic regions where B dermatitidis is endemic.     

A pilot randomised controlled comparison of continuous veno–venous haemofiltration and extended daily dialysis with filtration: effect on small solutes and acid–base balance

Background and aims Continuous veno–venous haemofiltration (CVVH) is an established treatment for acute renal failure (ARF). Recently, extended intermittent dialytic techniques have been proposed for the treatment of ARF. The aim of this study was to compare these two approaches. Setting Intensive care unit of tertiary hospital. Subjects Sixteen critically ill patients with ARF. Design Randomised controlled trial. Intervention We randomised sixteen patients to three consecutive days of treatment with either CVVH (8) or extended daily dialysis with filtration (EDDf) (8) and compared small-solute, electrolyte and acid–base control. Results There was no significant difference between the two therapies for urea or creatinine levels over 3 days. Of 80 electrolyte measurements taken before treatment, 19 were abnormal. All values were corrected as a result of treatment, except for one patient in the CVVH group who developed hypophosphataemia (0.54 mmol/l) at 72 h. After 3 days of treatment, there was a mild but persistent metabolic acidosis in the EDDf group compared to the CVVH group (median bicarbonate: 20 mmol/l vs. 29 mmol/l: p = 0.039; median base deficit: –4 mEq/l vs. –2.1 mEq/l, p = 0.033). Conclusions CVVH and EDDf as prescribed achieved similar control of urea, creatinine and electrolytes. Acidosis was better controlled with CVVH. Electronic supplementary material The online version of this article (doi:) contains supplementary material, which is available to authorized users.     

Engaging Patients with Digital Tools: What We Think We Know

Patients who are engaged in their own care have better outcomes and cost the health care system less money. Creating the environment that supports patient engagement has been a recent focus across the United States, and digital tools have been suggested as an important piece of patient engagement. We discuss what we think we know about digital engagement, and present data of what is actually occurring.There’s no shortage of activity within the health information technology (HIT) space. Although our positions within a university afford us the opportunity to pick and choose when and how we will engage in the advancements that are rapidly confronting US hospitals and health systems, we anticipate that many of Hospital Pharmacy’s readers do not have that opportunity. From our e-mail exchanges with you and from talking with you at conferences, it’s clear that many of you face situations in which top-down decisions directly impact what your pharmacy department does as it relates to HIT. We focus this column on bringing you relevant HIT-related information.By the time you are reading this, the ALS Ice Bucket Challenge is likely to have given way to the next social media craze. But we believe that the Ice Bucket Challenge has implications that apply to the challenges and opportunities you face in your hospital setting. If you are not familiar with the Ice Bucket Challenge, take a few moments to search for it in your favorite browser. The challenge shows how social media, specifically social networks like Facebook, can provide a medium for rapid transmission of information; depending on the topic, the outcome of this rapid spread of information can have a significant impact. By the end of August 2014, the ALS Association received nearly $80 million in donations compared to $2.5 million for the same time frame in 2013.The use of Web 2.0 tools like social networks for health-related reasons is called Health 2.0. We have advocated that hospitals and health systems begin using Health 2.0 tools to engage their patients. Patient portals are a type of Health 2.0 tool that many hospitals have implemented to engage their patients. Portals are dynamic, collaborative, allow the access and management of information (by the patient or caregiver), and are largely patient-centric. Are all of your patients using your portal? Most likely they are not. Does that mean that no patients will use your portal? Also, most likely not. What about other Health 2.0 tools and emerging technologies that you are facing in your practice?We can draw on existing data to gain insight into what engagement you can likely expect from your patients. Biesdorf and Niedermann published a list of myths related to the use of Internet-based technologies and other emerging technologies for health-related reasons.¹ Susannah Fox provided her perspective on the myths, including specific data to support her argument that the myths are not true.² We will use these myths and Fox’s data to structure our presentation of data that we believe should be brought into discussion as your institution considers its plan for engaging patients.Myth 1: People don’t want to use digital services for health care. The Pew Internet Project (www.pewinternet.org) provides numerous examples that refute this myth. For example, 87% of American adults use the Internet, 70% of American adults have high-speed access at home, and, most notably, 72% of American adults have looked for health information online. Nearly 50% of adults look online for information for someone else. These “caregivers,” as they are called, are more likely to engage in online health activities like participating in support groups and contacting their providers.Myth 2: Only young people want to use digital services. The “older crowd” can be slower to adopt new digital tools, but this does not apply to all tools. For example, 87% of American adults are online. Among those 50 to 64 years of age, 88% are online. The percentage drops to 57% when we look at those 65 and older. Although there is less online participation in the oldest segment of the population, we are still looking at nearly 6 in 10 adults. Certainly, it’s not just the younger crowd using online tools.Myth 3: Mobile health is the game changer. This myth may seem to contradict previous articles we have written describing the potential value in mobile devices as tools to gather, analyze, and share health-related information, including information that the patient manages. Our rule of thumb with mobile is the same as with any technology – you must know your audience. Eighty percent of people with 2 or more chronic conditions track a health indicator. However, only 4% use an app to do so. We believe that patients’ use of apps is influenced by many factors, including general comfort with the device, concerns over security and privacy, lack of encouragement to use apps by trusted individuals (ie, providers), and a general wait-and-see attitude. We do believe mobile will profoundly change health care, but it is not there yet.Myth 4: Patients want innovative features and apps. For those adults who track health indicators, 49% keep track in their heads, 34% use paper records, and 21% use some form of technology. The message is clear that knowing who you serve and what fits their daily routine (as well as their comfort level) is paramount in designing tools to engage your patients.Myth 5: A comprehensive platform of services is a prerequisite for creating value. As your institution starts to digitally engage patients, it will be easy to identify a wide range of tools for immediate implementation based on the expectation that “if you build it, they will come.” We believe a systematic approach to selection and implementation is best. The process should be guided by direct input from the target users (ie, patients) in terms of what tools they believe they will use. Existing data and reports suggest that patients prefer portal-based communication tools like secure messaging over apps.In discussing the myths above, we have not touched on the pharmacist’s role in these activities. We believe that pharmacy should be involved in any discussions of technologies or tools that touch the medication use process at any time in the patient’s interaction with the health system, whether that is an acute stay, an outpatient experience, or an ambulatory clinic setting. We welcome your questions and comments about the work you have before you or the work you have completed related to engaging patients with digital tools (Brent at ude.nrubua@nerbxof and Bill at ude.nrubua@gbeklef).     

Population pharmacokinetic analysis of axitinib in healthy volunteers

AIMS

Axitinib is a potent and selective second generation inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 approved for second line treatment of advanced renal cell carcinoma. The objectives of this analysis were to assess plasma pharmacokinetics and identify covariates that may explain variability in axitinib disposition following single dose administration in healthy volunteers.

METHODS

Plasma concentration–time data from 337 healthy volunteers in 10 phase I studies were analyzed, using non-linear mixed effects modelling (nonmem) to estimate population pharmacokinetic parameters and evaluate relationships between parameters and food, formulation, demographic factors, measures of renal and hepatic function and metabolic genotypes (UGT1A1*28 and CYP2C19).

RESULTS

A two compartment structural model with first order absorption and lag time best described axitinib pharmacokinetics. Population estimates for systemic clearance (CL), central volume of distribution (V_c), absorption rate constant (k_a) and absolute bioavailability (F) were 17.0 l h⁻¹, 45.3 l, 0.523 h⁻¹ and 46.5%, respectively. With axitinib Form IV, k_a and F increased in the fasted state by 207% and 33.8%, respectively. For Form XLI (marketed formulation), F was 15% lower compared with Form IV. CL was not significantly influenced by any of the covariates studied. Body weight significantly affected V_c, but the effect was within the estimated interindividual variability for V_c.

CONCLUSIONS

The analysis established a model that adequately characterizes axitinib pharmacokinetics in healthy volunteers. V_c was found to increase with body weight. However, no change in plasma exposures is expected with change in body weight; hence no dose adjustment is warranted.     

Development and preliminary validation of the First Episode Social Functioning Scale for early psychosis

The current study aimed at developing and conducting a preliminary validation a novel social functioning measure for people with early psychosis. The First Episode Social Functioning Scale (FESFS) was developed to cover many domains specific to this population in their contemporary reality. The self-report version of the FESFS was administered to 203 individuals receiving services in first episode clinics. Scores of the GAF, SOFAS, Social Functioning Scale and BPRS were also obtained for parts of the sample to calculate convergent and discriminant validity. A subgroup also answered the FESFS at several time points during treatment in order to determine sensibility to change. Principal component factor analyses and internal consistency analyses revealed the following nine factors with alphas ranging from 0.63 to 0.80: Friendships and social activities, Independent living skills, Interacting with people, Family, Intimacy, Relationships and social activities at work, Work abilities, Relationships and social activities at school, Educational abilities. Convergent and discriminant validity were demonstrated, as well as sensitivity to change. Clinical and research utility of the FESFS are discussed.