The Effect of Technology-Based Interventions on Pain,Depression, and Quality of Life in Patients With Cancer: A Systematic Review of Randomized Controlled Trials

BackgroundThe burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients’ health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care.ObjectiveThe aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials.MethodsWe searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool.ResultsOf the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation concealment domain. Two of the three studies focused on pain control reported significant effects of the intervention; four of the nine studies focus on depression reported significant effects, while only the studies that were focused on quality of life reported significant effects.ConclusionsThis systematic review demonstrates the potential of telehealth interventions in improving outcomes in cancer care. However, more high-quality large-sized trials are needed to demonstrate cogent evidence of its effectiveness.     

Low-dose simvastatin for the treatment of hypercholesterolaemia in recipients of cardiac transplantation.

There is increasing evidence that hypercholesterolaemia is an important contributor to the development of accelerated coronary arterial disease in the cardiac allograft. The optimal drug therapy of hypercholesterolaemia in recipients after cardiac transplantation, however, has not been defined. Simvastatin (an inhibitor of hydroxy-methyl glutaryl-coenzyme A reductase), at a dose of 10 mg/day, was administered to 12 recipients with serum total cholesterol greater than or equal to 7.8 mmol/l and serum triglyceride less than or equal to 4.5 mmol/l refractory to dietary measures during a follow-up period of 1-5 years after cardiac transplantation. All patients received maintenance doses of cyclosporin A and, in some instances, azathioprine and prednisolone. After 2 months treatment with simvastatin, serum total cholesterol was significantly reduced from 8.8 +/- 0.3 mmol/l (mean +/- SEM) to 5.5 +/- 0.5 mmol/l, P less than 0.001, low density cholesterol from 6.6 +/- 0.4 to 3.8 +/- 0.3 mmol/l, P less than 0.001 and triglycerides from 2.4 +/- 0.2 mmol/l to 1.8 +/- 0.2 mmol/l, P less than 0.005. These changes were maintained after a period of treatment of 8 months. Serum high density cholesterol, hepatic transaminase levels, serum creatinine, creatine kinase and cyclosporin A blood levels were not altered by treatment with simvastatin. It is concluded that, in this study group, low-dose simvastatin appears to be well tolerated and has favourable lipid modifying properties.     

Measuring the public-health impact of candidate HIV vaccines as part of the licensing process

The full impact of vaccines against infectious diseases is manifest at both the individual and the community levels. We argue that evaluating the community-level impact of HIV vaccine candidates should be an integral part of the licensing process. We describe a framework for the public-health evaluation of an HIV vaccine, which is based on the interactive use of mathematical models and community randomised clinical trials (C-RCTs) following completion of individual-based clinical trials (I-RCTs). Mathematical models of HIV vaccine can be used to take public-health considerations into account during the licensing process and can also help to select promising vaccine candidates for testing in C-RCTs. We also describe community and individual-based measures useful for defining public-health criteria necessary to guide the licensing process. To move forward, it is crucial to reach a consensus on what should constitute adequate public-health criteria. At the very least, a suitable vaccine would provide some individual benefit to vaccinees and not be detrimental to the population at large. In future I-RCTs and C-RCTs, quantifying each protective vaccine characteristic (eg, reductions in susceptibility or viral load) is important if regulators are to evaluate adequately the potential community-level impact of the vaccine across different settings, populations, and conditions of use.     

Gallbladder cancer in northern Jordan

BACKGROUND AND AIM: To highlight the epidemiological, clinical, and pathological features of gallbladder cancer in Jordan as a model for the Middle East. Only scattered reports are available from this region. METHODS: The histopathological reports and the hospital records for all cholecystectomies performed at Princess Basma Teaching Hospital between 1994-2000 were retrospectively reviewed to identify all patients with gallbladder carcinoma. All the histological slides for the cancer group were reviewed and reclassified by a single pathologist. RESULTS: Of 4502 cholecystectomies performed, 33 cases (0.73%) of gallbladder carcinoma were found. The mean age was 61.4 years (range 39-80 years). The male : female ratio was 1 : 3.7. Biliary colic and/or acute cholecystitis were the main presentations. Gallstones were present in 88% (29/33) of the patients. The spectrum of histological subtypes was similar to other series. Only three cases were diagnosed preoperatively, making the incidence of incidental gallbladder cancer 0.66% (30/4502). Simple cholecystectomy was performed for 13 patients. The remaining 20 patients underwent cholecystectomy and portal lymphadenectomy with (five cases) or without (15 cases) extrahepatic resection of the bile ducts. The mean follow up was 22 months (SD +/- 18.95 months; range 1-96 months). The 2-year survival rates for stages I, II, III, and IV were 100%, 42.9%, 10.8%, and 0%, respectively (P = 0.0013). CONCLUSIONS: The importance of a high index of suspicion when dealing with cholelithiasis in elderly patients, particularly with large sized stones, cannot be over-emphasized. Proper gross inspection in the theater should be a routine procedure performed by all surgeons. Routine ultrasound for suspected gallbladder stones should always be performed under the supervision of senior radiologists.     

Comparing the Palliative Care Needs of Patients With Hematologic and Solid Malignancies

Context

Hematologic cancer patients use palliative care services less frequently than their solid tumor counterparts. Prior work suggests that these patients have a sizable symptom burden, but comparisons between hematologic and solid tumor patients near the end of life are limited.

McMaster RARE‐Bestpractices clinical practice guideline on diagnosis and management of the catastrophic antiphospholipid syndrome

Summary

Background

The McMaster RARE‐Bestpractices project group selected the catastrophic antiphospholipid syndrome (CAPS) for a pilot exercise in guideline development for a rare disease.

Objectives

The objectives of this exercise were to provide a proof of principle that guidelines can be developed for rare diseases and assist in clinical decision making for CAPS.

Patients/Methods

The GIN‐McMaster Guideline Development checklist and GRADE methodology were followed throughout the guideline process. The CAPS guideline was coordinated by a steering committee, and the guideline panel was formed with representation from all relevant stakeholder groups. Systematic reviews were performed for the key questions. To supplement the published evidence, we piloted novel methods, including use of an expert‐based evidence elicitation process and ad hoc analysis of registry data.

Results

This paper describes the CAPS guideline recommendations, including evidence appraisal and discussion of special circumstances and implementation barriers identified by the panel. Many of these recommendations are conditional, because of subgroup considerations in this heterogeneous disease, as well as variability in patient values and preferences.

Conclusions

The CAPS clinical practice guideline initiative met the objective of the successful development of a clinical practice guideline in a rare disease using GRADE methodology. We expect that clinicians caring for patients with suspected CAPS will find the guideline useful in assisting with diagnosis and management of this rare disease.

     

Diagnosis and initial management of gastroesophageal complications

Chronic esophageal exposure to reflux of gastroduodenal contents can result in complications of GERD including esophageal stricture, Barrett's oesophagus or extraesophageal symptoms such as laryngitis, chronic cough or asthma. Endoscopy is the main diagnostic tool for patients with chronic reflux presenting with dysphagia to visualise esophageal mucosa and identify the underlying pathology. Barrett's oesophagus should be suspected in those with chronic reflux disease. Patients with Barrett's oesophagus should undergo surveillance endoscopy in order to risk stratify to dysplasia or adenocarcinoma. New endoscopic ablative therapies in patients with Barrett's oesophagus and high grade dysplasia are promising new treatment modality for those who may not be candidates for definitive intervention. Given poor sensitivity of diagnostic tests in extraesophageal reflux, empiric therapy with proton pump patients is the initial recommended approach. Diagnostic testing with esophagogastroduodenoscopy and ambulatory pH and impedance monitoring is usually reserved for those unresponsive to acid suppressive therapy. Many uncertainties remain in this group of patients including which patient subgroups might benefit from acid suppressive therapy. Future outcome studies are needed to assess the role of impedance/pH monitoring in this group of patients and to determine who might symptomatically benefit from medical or surgical intervention.     

The neglected hepatitis C virus genotypes 4, 5 and 6: an international consensus report

Hepatitis C virus (HCV) genotypes 4, 5 and 6 represent >20% of all HCV cases worldwide. HCV‐4 is mainly seen in Egypt, where it represents 90% of all HCV cases. Antischistosomal therapy was the main cause of contamination there, followed by procedures performed by informal providers and traditional healers such as dental care, wound treatment, circumcision, deliveries, excision and scarification. It is also highly prevalent in sub‐Saharan Africa and in the Middle East. In Europe, its prevalence has recently increased particularly among intravenous drug users and in immigrants. HCV‐5 is mainly found in South Africa, where it represents 40% of all HCV genotypes, but four pockets of HCV‐5 were found in France, Spain, Syria and Belgium and sporadic cases were found elsewhere. The mode of transmission is mainly iatrogenic and transfusion. HCV‐6 is found in Hong Kong, Vietnam, Thailand and Myanmar and also in American and Australian from Asian origin. The response to treatment in HCV‐4 is intermediate between HCV‐1 and HCV‐2 and HCV‐3. A sustained viral response is achieved in 43–70% with pegylated interferon and ribavirin. It is higher in Egyptians than Europeans and Africans and is negatively related to insulin resistance and to the severity of fibrosis. It increases to >80% with 24 weeks of therapy only if a rapid virological response is achieved. In HCV‐5, a sustained virological response is achieved in >60% with 48 weeks of therapy. HCV‐6 is also considered an easy‐to‐treat genotype, leading to a response in 60–85% of cases.     

The colon in patients with ankylosing spondylitis and in normal controls in Bangladesh

The objective of this paper is to study the macroscopic and microscopic aspects of colonic mucosa in patients with ankylosing spondylitis (AS) and in controls without colonic symptoms in Bangladesh. This observational study was done in a tertiary care center of Dhaka. Twenty-eight consecutive cases of AS were included, fulfilling modified New York Criteria with pure axial form or combined axial and peripheral joint involvement. Ten controls were enrolled in the study from people in whom endoscopy of upper gastrointestinal tract (GI) tract was performed and who had no musculoskeletal complaints and no colonic symptoms. Short colonoscopy (up to 60 cm) and colonoscopic biopsy were done in all. Histological features were evaluated following Cuvelier grading and Rubio and Kock scoring system. Demographic data including age and sex were similar in the AS and control groups. Out of 28 patients, ten had axial and 18 combined axial and peripheral joint disease, mostly pauciarticular. In the AS group, macroscopic and microscopic lesions were found in four and 14 subjects, respectively. Out of 22 subjects without diarrhea, seven had stage II and two had stage I changes. Six subjects in the AS group gave a history of diarrhea, of them three had stage I and two had stage II changes. In the control group, no macroscopic abnormalities were found. On histological examination, the mean diameter of transversely cut rectal glands, interglandular linear distances, number of glands per area, and total digital scores varied between 45–90 μm, 4.6–27 μm, 5–25, and 17–18 respectively. In eight of the ten controls, eosinophilic infiltration was found. Subclinical inflammatory lesions in the colonic mucosa are common in patients with ankylosing spondylitis. Colonic mucosa in normal individuals does not differ from that found in western studies, except for the presence of frequent mild eosinophilic infiltration in the lamina propria.     

Exercise capacity and haemodynamics in patients with sickle cell disease with pulmonary hypertension treated with bosentan: results of the ASSET studies

Doppler‐defined pulmonary hypertension (PH) in sickle cell disease (SCD) is associated with 40% mortality at 40 months. To assess the effect of bosentan in SCD‐PH, two randomized, double‐blind, placebo‐controlled, 16‐week studies were initiated. Safety concerns are particularly relevant in SCD due to comorbid conditions. ASSET‐1 and ‐2 enrolled patients with pulmonary arterial hypertension (PAH) and pulmonary venous hypertension (PH), respectively. Haemodynamics and 6‐min walk distance (6MWD) were obtained at baseline and week 16. The studies were terminated due to slow site initiation and patient enrolment (n = 26). Bosentan appeared to be well tolerated. Although sample sizes were limited, in ASSET‐1 at baseline, 6MWD correlated with cardiac output (CO; P = 0·006) with non‐significant inverse correlations between 6MWD and pulmonary vascular resistance (PVR; P = 0·07) and between 6MWD and right atrial pressure (P = 0·08). In ASSET‐2 at baseline, there was a non‐significant correlation between 6MWD and CO (P = 0·06). Due to limited sample sizes, efficacy endpoints were not analysed. However, in both studies, non‐significant increases in CO were observed with bosentan compared to placebo. Similarly, non‐significant decreases in PVR were observed with bosentan. Limited data in SCD‐PH suggest that a low 6MWD predicts a low CO. Standard‐dose bosentan appears to be well tolerated. Further investigation is warranted. Clinicaltrials.gov registration numbers NCT00310830, NCT00313196, NCT00360087.