OBJECTIVES To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped. DESIGN, SETTING, AND PATIENTS A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14 692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up.

https://jamanetwork.com/journals/jama/articlepdf/1707720/joi130010.pdf

Effect of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Control: A Cluster Randomized Clinical Trial

https://link.springer.com/content/pdf/10.1007%2Fs13311-012-0145-6.pdf

Classification of Sleep Disorders

Despite the growing demand for research that engages stakeholders, there is limited evidence in the literature to demonstrate its value - or return on investment. This gap indicates a general lack of evaluation of engagement activities. To adequately inform engagement activities, we need to further investigate the dividends of engaged research, and how to evaluate these effects. This paper synthesizes the literature on hypothesized impacts of engagement, shares what has been evaluated and identifies steps needed to reduce the gap between engagement's promises and the underlying evidence supporting its practice. This assessment provides explicit guidance for better alignment of engagement's promised benefits with evaluation efforts and identifies specific areas for development of evaluative measures and better reporting processes.

Evaluating patient and stakeholder engagement in research: moving from theory to practice

Since its introduction in the early nineties as a promising functional imaging technique in the management of neoplastic disorders, FDG-PET, and subsequently FDG-PET/CT, has become a cornerstone in several oncologic procedures such as tumor staging and restaging, treatment efficacy assessment during or after treatment end and radiotherapy planning. Moreover, the continuous technological progress of image generation and the introduction of sophisticated software to use PET scan as a biomarker paved the way to calculate new prognostic markers such as the metabolic tumor volume (MTV) and the total amount of tumor glycolysis (TLG). FDG-PET/CT proved more sensitive than contrast-enhanced CT scan in staging of several type of lymphoma or in detecting widespread tumor dissemination in several solid cancers, such as breast, lung, colon, ovary and head and neck carcinoma. As a consequence the stage of patients was upgraded, with a change of treatment in 10%–15% of them. One of the most evident advantages of FDG-PET was its ability to detect, very early during treatment, significant changes in glucose metabolism or even complete shutoff of the neoplastic cell metabolism as a surrogate of tumor chemosensitivity assessment. This could enable clinicians to detect much earlier the effectiveness of a given antineoplastic treatment, as compared to the traditional radiological detection of tumor shrinkage, which usually takes time and occurs much later.

https://www.mdpi.com/2072-6694/6/4/1821/pdf

Positron Emission Tomography (PET) in Oncology

BACKGROUND
Patients and healthcare stakeholders are increasingly becoming engaged in the planning and conduct of biomedical research. However, limited research characterizes this process or its impact.

/pdf/patient-and-stakeholder-engagement-in-the-pcori-pilot-3y8v7pzi8y.pdf

Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned.

OBJECTIVES
We conducted a review of the peer-reviewed literature since 2003 to catalogue reported methods of stakeholder engagement in comparative effectiveness research and patient-centered outcomes research.

A systematic review of stakeholder engagement in comparative effectiveness and patient-centered outcomes research.

PET and PET/CT are widely used for surveillance of patients after cancer treatments. We conducted a systematic review to assess the diagnostic accuracy and clinical impact of PET and PET/CT used for surveillance in several cancers. Methods: We searched MEDLINE and Cochrane Library databases from 1996 to March 2012 for English-language studies of PET or PET/CT used for surveillance of patients with lymphoma, colorectal cancer, or head and neck cancer. We included prospective or retrospective studies that reported test accuracy and comparative studies that assessed clinical impact. Results: Twelve studies met our inclusion criteria: 6 lymphoma (n = 767 patients), 2 colorectal cancer (n = 96), and 4 head and neck cancer (n = 194). All studies lacked a uniform definition of surveillance and scan protocols. Half the studies were retrospective, and a third were rated as low quality. The majority reported sensitivities and specificities in the range of 90%–100%, although several studies reported lower results. The only randomized controlled trial, a colorectal cancer study with 65 patients in the surveillance arm, reported earlier detection of recurrences with PET and suggested improved clinical outcomes. Conclusion: There is insufficient evidence to draw conclusions on the clinical impact of PET or PET/CT surveillance for these cancers. The lack of standard definitions for surveillance, heterogeneous scanning protocols, and inconsistencies in reporting test accuracy preclude making an informed judgment on the value of PET for this potential indication.

https://jnm.snmjournals.org/content/54/9/1518.full.pdf

The Lack of Evidence for PET or PET/CT Surveillance of Patients with Treated Lymphoma, Colorectal Cancer, and Head and Neck Cancer: A Systematic Review

Objectives To better understand how to impute within-arm correlation for meta-analyses of continuous outcomes when data are missing, this study describes the range of correlation values in a representative set of studies with sufficient data reported, and simulates the effect of using different correlation values on meta-analysis summary estimates when imputing missing data. Background It is common that studies do not report sufficient data to allow meta-analysis of continuous outcomes. The standard error (SE) of the within-group differences is often not reported and cannot be calculated because the within-group correlation is unknown. For meta-analysis of net-changes, one must thus estimate the SE based on an arbitrarily chosen correlation. Methods From articles available to us from previous systematic reviews and from trials registered at ClinicalTrials.gov , we selected those that prospectively compared two or more interventions for continuous outcomes and reported all three of: baseline means and SEs (or equivalent), final means and SEs, and within-group changes and SEs. From these data we back-calculated correlation values for each study group. We described these data and tested for patterns based on study characteristics. We assessed the bias on estimates of within-group change SEs by comparing reported SEs with imputed SEs using arbitrarily chosen correlation values. We simulated meta-analyses, assessing the bias, coverage, and accuracy of the summary estimates derived from studies with missing correlation data. Results We analyzed 811 within-group correlation values from 123 studies with 281 study groups. The median (interquartile range) within-group correlation values across all studies was 0.59 (0.40, 0.81). Active treatment groups had lower correlation values (median 0.54) than no treatment groups (median 0.73, P Conclusions Negative within-group correlation values are very uncommon in clinical studies. Imputing values in meta-analyses where some or all within-group correlation estimates are not reported does not introduce bias in the summary estimate of the treatment effect. However, imputation can affect the SE of the summary estimate when the imputed value is different from the “true.” In such cases, sensitivity analyses using alternative imputation values, possibly informed by studies reporting relevant information, are recommended.

Empirical Assessment of Within-Arm Correlation Imputation in Trials of Continuous Outcomes

Plasma cell dyscrasias (PCDs) are a group of neoplastic disorders characterized by the uninhibited expansion of a monoclonal population of malignant plasma cells.1 Multiple myeloma (MM) is the most common malignant plasma cell tumor, accounting for about 1 percent of all cancer types,1 and the second most common hematologic malignancy in the United States. With an age-adjusted incidence rate of 5.5 cases per 100,000 population,2 an estimated 19,900 new diagnoses and 10,790 deaths due to myeloma occurred in 2007, according to the American Cancer Society.3 Although the median survival has improved to 5 years with current standards of treatment,4 the annual costs of modern therapies can range from $50,000 to $125,000 per patient.5,6

Kamal Patel

Papers

A systematic review of stakeholder engagement in comparative effectiveness and patient-centered outcomes research.

The Lack of Evidence for PET or PET/CT Surveillance of Patients with Treated Lymphoma, Colorectal Cancer, and Head and Neck Cancer: A Systematic Review

Empirical Assessment of Within-Arm Correlation Imputation in Trials of Continuous Outcomes

Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias

Self-Measured Blood Pressure: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 45