Summary
Background
Cross‐cultural, multinational research can advance the field of functional gastrointestinal disorders (FGIDs). Cross‐cultural comparative research can make a significant ...contribution in areas such as epidemiology, genetics, psychosocial modulators, symptom reporting and interpretation, extra‐intestinal co‐morbidity, diagnosis and treatment, determinants of disease severity, health care utilisation, and health‐related quality of life, all issues that can be affected by geographical region, culture, ethnicity and race.
Aims
To identify methodological challenges for cross‐cultural, multinational research, and suggest possible solutions.
Methods
This report, which summarises the full report of a working team established by the Rome Foundation that is available on the Internet, reflects an effort by an international committee of FGID clinicians and researchers. It is based on comprehensive literature reviews and expert opinion.
Results
Cross‐cultural, multinational research is important and feasible, but has barriers to successful implementation. This report contains recommendations for future research relating to study design, subject recruitment, availability of appropriate study instruments, translation and validation of study instruments, documenting confounders, statistical analyses and reporting of results.
Conclusions
Advances in study design and methodology, as well as cross‐cultural research competence, have not matched technological advancements. The development of multinational research networks and cross‐cultural research collaboration is still in its early stages. This report is intended to be aspirational rather than prescriptive, so we present recommendations, not guidelines. We aim to raise awareness of these issues and to pose higher standards, but not to discourage investigators from doing what is feasible in any particular setting.
Background
Little information exists regarding whether psychosocial variables in irritable bowel syndrome (IBS) vary by geographic location. Adult attachment is an important psychological concept ...rooted in childhood relationship experience that has not been previously studied in IBS. Catastrophizing and negative pain beliefs have been described in IBS and may be affected by attachment. Aims: In this cross‐cultural study, we determined: (i) whether attachment differs between IBS patients and controls, (ii) whether geographic location has a significant effect on attachment style, catastrophizing and negative pain beliefs, and (iii) how all three variables correlate with IBS symptom severity.
Methods
463 IBS patients, with moderate to severe symptom scores, and 192 healthy controls completed validated questionnaires about attachment, catastrophizing, negative pain beliefs and IBS‐SSS in nine locations, USA (New York, Los Angeles), Mexico, Italy (Rome, Bari), Romania, Iran, India, and China.
Key Results
Attachment anxiety and avoidance scores were significantly higher in IBS patients than in controls (p < 0.001). This was particularly true for the fearful‐avoidant attachment category, especially in China and Romania. Path analysis showed that attachment anxiety and avoidance had indirect effects on IBS‐SSS through catastrophizing (p < 0.0001) and negative pain beliefs (p = 0.005). All three psychosocial measures varied significantly depending on location.
Conclusions & Inferences
In the IBS population studied, attachment style was significantly different in IBS compared to a control population. Geographic differences in attachment, catastrophizing and negative pain beliefs were documented and their correlation with symptom severity and thus, research of psychosocial variables in IBS should take into account the location of the population studied.
This cross‐cultural study compares three psychological factors, attachment, catastrophizing, and negative pain beliefs in IBS patients living in nine geographic sites. Attachment, never studied before in IBS, was significantly different in patients vs controls and all three variables showed significant differences among sites, including their relationships with IBS symptom severity.
Umbilical-cord blood from unrelated donors can restore hematopoiesis in adults who receive myeloablative therapy.
Transplantation of allogeneic hematopoietic stem cells, an effective treatment for ...hematologic cancers,
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is limited by the availability of HLA-matched donors. The risk of severe graft-versus-host disease (GVHD) after the transplantation of bone marrow from unrelated donors or partially HLA-mismatched related donors is another drawback of the procedure.
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Umbilical-cord blood is a source of hematopoietic stem cells that has been successfully used for transplantation, primarily in children.
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Grafts of umbilical-cord blood reconstitute hematopoiesis more slowly than does HLA-matched marrow from a sibling or an unrelated adult donor,
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but the incidence and severity of GVHD are lower with transplantation . . .
As the threshold nucleated cell dose for one-unit umbilical cord blood (UCB) in adults has not to date been firmly established, we prospectively compared one- vs two-unit UCB transplantation after ...reduced intensity conditioning (RIC) in adult patients with hematological malignancies. Study design specified one-UCB unit if the cryopreserved total nucleated cell (TNC) dose was 2.5 × 10(7)/kg recipient weight, otherwise two units matched at minima of 4/6 HLA loci to the patient and 3/6 to each other were infused. A total of 27 patients received one unit; 23 patients received two units. Median time to ANC >500/μL was 24 days (95% confidence interval 22-28 days), 25 days for one unit and 23 days for two units (P=0.99). At day 100, ANC >500/μL was 88.4 and 91.3% in the one- and two-unit groups (P=0.99), respectively. Three-year EFS was 28.6% and 39.1% in the one- and two-unit groups (P=0.71), respectively. Infusion of two units was associated with a significantly lower relapse risk, 30.4% vs 59.3% (P=0.045). Infused cell doses (TNC, CD3(+), CD34(+) and CD56(+)CD3(neg)) did not impact on engraftment, OS or EFS. Taken together, one-unit UCB transplantation with a threshold cell dose 2.5 × 10(7)/kg recipient weight after RIC is a viable option for adults, although infusion of two units confers a lower relapse incidence.
Background
Patient reported outcome (PRO) is an important healthcare concept that describes patient's participation in their care by self‐evaluation, usually in the form of questionnaires. This ...report describes an unique computerized technique, electronic PRO (ePRO), for following the progress of patients with irritable bowel syndrome (IBS).
Methods
Patients first completed a series of questionnaires, including questions about their illness history, symptom severity, and, in this application, psychological and relationship issues. The symptom severity and psychological questionnaires were then completed at intervals by the patients on their own computers. The ePRO was constructed to allow scores to be automatically summed and placed on a time‐line graph for review at the time of the next office visit.
Key Results
Of the 32 patients who completed the initial set of questionnaires, 20 maintained participation in the program for a 6‐month period. Of those 20 patients, median number of submissions was 7.0; median interval between questionnaire submissions was 3.0 weeks, whereas median interval between office visits was 5.9 weeks. On average, questionnaire completion took less than 5 min and was positively experienced by the patients.
Conclusions & Inferences
The ePRO program proved to be technically feasible, clinically useful, and positively experienced by the patients. It provides a focus on a collaborative conversation between physician and patient. It has significant potential as a technique for evaluating outcome in response to various therapies.
This article describes a new method for tracking the clinical course of patients with IBS. A computerized program allows patients to complete questionnaires on their computers, with automatic scoring of questionnaires and placement of results on time‐line graphs. The graphs are then available for review by patient and physician in the office.
The time is ripe for a comprehensive mission to explore and document Earth's species. This calls for a campaign to educate and inspire the next generation of professional and citizen species ...explorers, investments in cyber-infrastructure and collections to meet the unique needs of the producers and consumers of taxonomic information, and the formation and coordination of a multi-institutional, international, transdisciplinary community of researchers, scholars and engineers with the shared objective of creating a comprehensive inventory of species and detailed map of the biosphere. We conclude that an ambitious goal to describe 10 million species in less than 50 years is attainable based on the strength of 250 years of progress, worldwide collections, existing experts, technological innovation and collaborative teamwork. Existing digitization projects are overcoming obstacles of the past, facilitating collaboration and mobilizing literature, data, images and specimens through cyber technologies. Charting the biosphere is enormously complex, yet necessary expertise can be found through partnerships with engineers, information scientists, sociologists, ecologists, climate scientists, conservation biologists, industrial project managers and taxon specialists, from agrostologists to zoophytologists. Benefits to society of the proposed mission would be profound, immediate and enduring, from detection of early responses of flora and fauna to climate change to opening access to evolutionary designs for solutions to countless practical problems. The impacts on the biodiversity, environmental and evolutionary sciences would be transformative, from ecosystem models calibrated in detail to comprehensive understanding of the origin and evolution of life over its 3.8 billion year history. The resultant cyber-enabled taxonomy, or cybertaxonomy, would open access to biodiversity data to developing nations, assure access to reliable data about species, and change how scientists and citizens alike access, use and think about biological diversity information.
Wire‐guided localization (WGL) is the standard of care in the surgical treatment of nonpalpable breast tumors. In this study, we compare the use of a new magnetic marker localization (MaMaLoc) ...technique to WGL in the treatment of early‐stage breast cancer patients. Open‐label, single‐center, randomized controlled trial comparing MaMaLoc (intervention) to WGL (control) in women with early‐stage breast cancer. Primary outcome was surgical usability measured using the System Usability Scale (SUS, 0–100 score). Secondary outcomes were patient reported, clinical, and pathological outcomes such as retrieval rate, operative time, resected specimen weight, margin status, and reoperation rate. Thirty‐two patients were analyzed in the MaMaLoc group and 35 in the WGL group. Patient and tumor characteristics were comparable between groups. No in situ complications occurred. Retrieval rate was 100% in both groups. Surgical usability was higher for MaMaLoc: 70.2 ± 8.9 vs. 58.1 ± 9.1, p < 0.001. Patients reported higher overall satisfaction with MaMaLoc (median score 5/5) versus WGL (score 4/5), p < 0.001. The use of magnetic marker localization (MaMaLoc) for early‐stage breast cancer is effective and has higher surgical usability than standard WGL.
Background Patients with left ventricular assist devices (LVADs) are at increased risk of GI bleeding (GIB), primarily from GI angiodysplastic lesions (GIAD). Objective To perform meta-analysis of ...the medical literature in order to determine prevalence and risk factors for GIB. Design A literature search was performed to identify studies reporting GIB in LVAD patients. We extracted rates of prevalence, rebleeding, and overall mortality from each study. Pooled event rates and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated. Setting Meta-analysis of 17 case-control and cohort studies. Patients A total of 1839 LVAD patients of whom 1697 (92%) had continuous-flow LVADs. Results The pooled prevalence of GIB in LVAD patients was 23% (95% CI, 20.5%-27%). Subgroup analysis demonstrated that older age (standard difference in means (SDm), 0.69; 95% CI, 0.23-1.15), and elevated creatinine (SDm, 0.65; 95% CI, 0.12-1.18, P = .02) were associated with GIB. Risk factors not associated with GIB included LVAD as destination therapy (OR 1.85; 95% CI, 0.8-4.3), prior history of GIB (OR 2.22; 95% CI, 0.83-5.96), hypertension (OR 1.6; 95% CI, 0.87-2.97), and/or the presence of a continuous-flow LVAD (OR 4.5; 95% CI, 2.1-9.5). Recurrence of GIB occurred in 9.3% (95% CI, 7%-12%), with a GIB mortality rate of 23% (95% CI, 16%-32%). The pooled event rates were 48% (95% CI, 39%-57%) for upper GIB, 22% (95% CI, 16%-31%) for lower GIB, and 15% (95% CI, 8%-25%) for small-bowel bleeding. GIAD in the proximal GI tract were the most common cause of GIB (29%). Limitations Lack of information regarding endoscopic therapy and follow-up in most studies. Conclusions The prevalence of GIB is increased in patients with continuous-flow LVADs, primarily secondary to the presence of GIAD.
The present study presents a procedure to assess the property of symmetry by comparing the acquisition of conditional relations that are consistent and inconsistent with this property in a capuchin ...monkey (Sapajus spp.). One young male monkey underwent arbitrary matching-to-sample training. The experiment had four phases: Phase 1.1 (establishing A1B1 and A2B2 relations), Phase 1.2 (reinforcing B1A1 and B2A2 relations, consistent with the property of symmetry), Phase 2.1 (establishing A3B3 and A4B4 relations), and Phase 2.2 (reinforcing B3A4 and B4A3 relations, inconsistent with the property of symmetry). A comparison between Phase 1.2 (consistent) and Phase 2.2 (inconsistent) showed faster acquisition of consistent relations (B1A1 and B2A2) than inconsistent relations (B3A4 and B4A3). The results suggest that the established conditional discriminations may have the property of symmetry and confirm the potential of comparative analysis between the acquisition of conditional discriminations as a promising procedure to evaluate equivalence class formation in nonhuman subjects.
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