Research participation effects: a skeleton in the methodological cupboard

ObjectiveThere have been concerns about impacts of various aspects of taking part in research studies for a century. The concerns have not, however, been sufficiently well conceptualized to form traditions of study capable of defining and elaborating the nature of these problems. In this article we present a new way of thinking about a set of issues attracting long-standing attention.Study Design and SettingWe briefly review existing concepts and empirical work on well-known biases in surveys and cohort studies and propose that they are connected.ResultsWe offer the construct of “research participation effects” (RPE) as a vehicle for advancing multi-disciplinary understanding of biases. Empirical studies are needed to identify conditions in which RPE may be sufficiently large to warrant modifications of study design, analytic methods, or interpretation. We consider the value of adopting a more participant-centred view of the research process as a way of thinking about these issues, which may also have benefits in relation to research methodology more broadly.ConclusionResearchers may too readily overlook the extent to which research studies are unusual contexts, and that people may react in unexpected ways to what we invite them to do, introducing a range of biases.     

‘Teaching on the Run’ with Australian midwives in a tertiary maternity hospital

Teaching On The Run (TOTR) is an Australian program for health professionals involved in clinical supervision. An amended TOTR program was evaluated with midwives acting as preceptors assisting learners integrate theory with clinical practice. A mixed method study was employed to compare midwives' perceived skills and confidence before and after completion of TOTR workshops. A secondary aim explored midwifery learners' (students and new graduates) perceptions of support from preceptors during the implementation of TOTR. Sixty five midwives completed the TOTR workshops with 46 providing data before program enrolment and 1–3 months after completion of the final TOTR workshop. Significant improvements were found for midwifery preceptors with before and after comparisons using Preceptor Self-Efficacy and Self-Evaluation Questionnaires. Using the Nursing Facilitator Clinical Questionnaire, preceptees or midwifery learners (n = 49) scored the ‘qualities of their preceptors’, ‘their clinical practice’, ‘clinical learning’ and ‘how feedback was provided’ highly with no changes between 2013 and 2014. Nineteen students then participated in three focus group interviews, analyzed using a six step systematic process. One overarching theme, ‘Guiding me through’ emerged with four themes: ‘Getting to know each other’; ‘Willingness to share knowledge’; ‘Leading by example’; and ‘The system acknowledging and valuing the preceptor role’.     

Health survey and assessment of the polymorphisms BRCA1/P871L,BRCA1/Q356R,and BRCA2/N372H in female gas station workers in Rio de Janeiro

Gas station workers are exposed to chemicals known to be carcinogenic, especially benzene. The objective was to analyze the health problems of female gas station workers by means of sociodemographic and clinical questionnaires, and laboratorial exams. We performed the genotyping of the polymorphisms BRCA1/P871L and BRCA1/Q356R by Polymerase Chain Reaction‐Restriction Fragment Length Polymorphism, and of variant allele BRCA2/N372H through direct sequencing. The female workers showed a higher concentration of monocytes (P = 0.039); a greater number of spontaneous abortions (P = 0.025, OR = 4.977, 95% CI = 1.135–30.669); higher tobacco consumption (P = 0.013); and higher alcohol consumption (P = 0.05). The statistical analysis of the polymorphisms associated with the variables monocyte concentration and miscarriage number did not reveal a significant relationship, and smoking and spontaneous abortion were not statistically associated either. Environ. Mol. Mutagen. 58:730–734, 2017. © 2017 Wiley Periodicals, Inc.     

改良混合痔切除术的临床研究

为探讨改良混合痔切除术的临床疗效，本研究将40例重度混合痔患者随机分为两组，一组予改良混合痔切除术（治疗组）治疗，一组予传统外剥内扎术（对照组）治疗，对比分析两组患者疗效、术后并发症、创面愈合时间、药比、住院费用、住院时问及患者满意度。结果显示，两组疗效、创面愈合时间、药比及肛门狭窄和尿潴留方面差异均无统计学意义，P〉0．05；但在住院费用、住院时间、患者满意度及后遗皮赘、肛缘水肿、创面出血、术区疼痛方面差异有均统计学意义，P〈0．05，且治疗组优于对照组。结果表明，改良混合痔切除术治疗重度混合痔疗效确切，术后并发症少，不影响肛门功能和外观，患者满意度高，值得临床推广。     

Mixed cryoglobulinemia: demographic, clinical, and serologic features and survival in 231 patients

BACKGROUND: Mixed cryoglobulinemia (MC) is a systemic vasculitis secondary to circulating immune complex deposition in the small vessels. In the overwhelming majority of patients, hepatitis C virus (HCV) infection represents the triggering factor of the disease. MC is characterized by multiple organ involvement, mainly skin, liver, renal, peripheral nerves, and less frequently by widespread vasculitis and cancer. OBJECTIVES: To investigate the demographic, clinical, serologic features, and survival in a large series of MC patients. METHODS: The study included 231 MC patients recruited between 1972 and 2001 at the Rheumatology Unit of the University of Pisa. All patients underwent wide clinicoserologic and virologic assessment. Cumulative survival rates were computed by the Kaplan-Meier method; moreover, the prognostic relevance of the main variables was investigated by Cox model analysis. RESULTS: In 92% of cases, the presence of HCV infection was demonstrated (anti-HCV antibody, 92%; HCV RNA, 90%), whereas hepatitis B virus (HBV) represented the possible causative agent in only 1.8% of patients (HBV DNA). Clinically, the MC syndrome followed a relatively benign clinical course in over 50% of cases, whereas a moderate-severe clinical course was observed in one third of patients whose prognosis was severely affected by renal and/or liver failure. In a limited, but significant, percentage (15%) of individuals, the disease was complicated by a malignancy, ie, B-cell lymphoma, and less frequently by hepatocellular carcinoma, or thyroid cancer. The survival study by the Kaplan-Meier method revealed a significantly lower cumulative 10th-year survival, calculated from time of diagnosis, in MC patients compared with expected death in the age- and sex-matched general population. Moreover, significantly lower survival rates were observed in males and in subjects with renal involvement. The multivariate analysis by the Cox proportional hazard regression model further supported the above findings: an increased mortality risk of 98% was observed for male gender (male/female hazard ratio, 1.978) and of 197% in patients with, compared with those without, renal involvement (hazard ratio, 2.967). At the end of the follow-up, 97 patients were deceased, and in 79 of 97 patients, the causes of death were ascertained: nephropathy (33%), malignancies (23%), liver involvement (13%), and diffuse vasculitis (13%) were the most frequent causes of death. CONCLUSIONS: Careful patient monitoring is recommended for a timely diagnosis of life-threatening MC complications, mainly nephropathy, widespread vasculitis, and B-cell lymphoma or other malignancies.     

骶神经刺激疗法治疗混合痔术后疼痛的疗效观察

目的 观察骶神经刺激疗法(SNS)治疗混合痔术后疼痛的临床疗效.方法 选取2010年1月至2012年12月在广东省中医院肛肠科住院手术治疗的患者,随机分为SNS组和氨酚曲马多组,每组40例.对比分析两组患者疼痛效果评分、止痛时间等指标差异.结果 SNS组患者治疗后的疼痛持续时间和止痛平均起效时间均显著低于氨酚曲马多组,疼痛VAS评分差值显著大于氨酚曲马多组,差异有统计学意义(P＜0.05).结论 SNS对痔术后疼痛疗效确切,实用性强,更适合于术后中、重度疼痛.     

Unmanipulated Stem Cell Boost for Mixed Chimerism in Transfusion Dependent Thalassemia

Early mixed chimerism (MC) can lead to secondary graft rejection post allogeneic hematopoietic stem cell transplantation in transfusion dependent thalassemia (TDT) patients. Reduction of immunosuppression and donor lymphocyte infusions is the mainstay for treating MC. We report our experience of administering unmanipulated stem cell boost (SCB) in reversing progressive early MC. There were 70 transplants done for 69 TDT patients at our center between September 2005 and January 2020. Mixed chimerism was defined by > 5% recipient cells and the severity was assigned according to the proportion of recipient cells as level 1 =  < 10%, level 2 = 10–25%, level 3 =  > 25%. For patients developing MC level 2 and 3, we administered unmanipulated SCB and analyzed its safety and efficacy. Out of 70 transplants 7 (10%) had MC level 2 (3/7) and 3 (4/7). These patients received unmanipulated SCB at a median CD34 cell dose of 4.5 × 10⁶/kg (range—3.5 × 10⁶/kg–5.5 × 10⁶/kg). Overall Response (stable MC and/or transfusion independency) to unmanipulated SCB was seen in 5 patients (71.4%). Five patients (71.4%) developed acute graft versus host disease (GVHD) of which 1 patient expired due to severe GVHD. SCB infusion was well tolerated by majority of our patients. The 3 year overall survival and thalassemia free survival was 85.7% (6/7) and 57.1% (4/7) respectively. Timely monitoring of chimerism is important for detecting early MC. Development of acute GVHD is common after administration of unmanipulated SCB and requires vigilance and prompt management. Unmanipulated SCB is a feasible modality for treating progressive MC and salvaging the graft especially in resource-constrained settings.     

Functional characterization of canine lymphocyte subsets

Summary Functional characterization of subsets of T lymphocytes is essential for transplantation studies in dogs, as it is in other species. We studied the function of T cells separated by two mouse monoclonal antibodies recognizing complementary subsets — an antibody directed to canine T cells (MdT-P1) with an up-regulating function, and an antibody directed to human CD 8 (MT811) that cross-reacts with down-regulating canine T cells. Immunorosetting with sheep red blood cells and Percoll gradient allowed us to study depleted and enriched fractions. Their function was tested in mixed lymphocyte culture (MLC), cell-mediated cytotoxicity (CML), and coculture with B cells in a hemolytic plaque assay (PFC). In MLC, MdT-P1-positive cells showed a high proliferative response, and MT811-positive cells responded poorly to allogeneic cells. Vice versa, MT811-negative cells responded strongly, and MdT-P1-negative cells were poor responders but strong stimulators. Effector cells of CML were separated following 8 days of culture and prior to mixing with target cells. Enriched and depleted fractions with either antibody showed low cytotoxic activity as compared with unseparated cells. When added to unseparated effector cells MT811-positive cells suppressed cytotoxicity. B cells were obtained by resetting with staphylococcal protein A (SPA). Their immunoglobulin production was studied following 6 days of culture stimulated by pokeweed mitogen in a reverse hemolytic plaque assay. Again, MT811-positive cells added to the culture suppressed, and MT811-negative cells enhanced immunoglobulin production. In conclusion, immunorosetting with two monoclonal antibodies allowed us to distinguish subpopulations of canine T cells with up-regulating (helper/inducer) from those with down-regulating (suppressor) activity.This work was supported by theWilhelm-Sander-Stiftung