Patient satisfaction with different interpreting methods: a randomized controlled trial.
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ABSTRACT: Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction.1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants.541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (beta 0.10, 95% CI 0.02-0.18, scale 0-1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters.While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health care.
Project description:Language barriers may contribute to the under-detection of depression in Latinos and Asians. A total of 782 English, Spanish, and Chinese-speaking primary care patients were enrolled in a randomized controlled trial. Language discordant patients were randomized to Remote Simultaneous Medical Interpreting (RSMI) or usual and customary (U&C) interpreting. The Beck Depression Inventory-Fast Screen (BDI-FS) was administered. Patients were tracked for 1 year. A total of 462 patients completed the BDI-FS. Thirty-three percent had a positive (> or = 4) screen. Twenty-seven percent of BDI-FS positive patients were diagnosed with depression. Among BDI-FS positive patients, Chinese-speakers were less likely to be diagnosed compared with English speakers (31% vs. 10%, P < 0.05). There was a trend towards greater diagnosis with RSMI (27% detection with RSMI vs. 20% U&C, P = 0.41). The diagnosis of depression among BDI-FS positive patients in our population was low, particularly among Chinese-speakers. RSMI could be an important part of a multi-faceted approach to improving the detection of depression.
Project description:Objective The aim of the study was patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment-retained maxillary obturators with metal framework versus milled polyetheretherketone (PEEK) framework in the management of maxillectomy cases.Materials and methods Eighteen participants were randomly divided into three parallel groups (n = 6). Participants of the PEEK group received attachment-retained obturators with milled PEEK framework, the metal group received an attachment-retained obturator with a metallic framework, and the conventional group received conventional clasp-retained obturators with a metallic framework (Control group). The evaluation included was radiographic evaluation and patients' satisfaction in this study included two scales-"The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one-way ANOVA test.Results Both PEEK and metal groups showed a statistically significant lower mean bone loss (p <0.050) compared with the conventional group during all follow-up periods. There is no statistically significant difference between the PEEK and metal groups during all follow-up periods. Regarding patient satisfaction, both the PEEK and metal groups showed a statistically significant decrease score (p <0.050) compared with the conventional group in various aspects of patients' satisfaction scales as satisfaction with the look and difficulty of talking to the public, and noticeable clasps. In comparison, the PEEK group showed a statistically significant decrease score (p <0.050) than the metal group with respect to satisfaction with the look along all follow-up periods.Conclusions PEEK attachment-retained maxillary definitive obturators could be considered a promising treatment modality for patients with acquired maxillary defects with regard to esthetics and satisfaction.
Project description:This article describes rationales and limitations for making inferences based on data from randomized controlled trials (RCTs). We argue that obtaining a representative random sample from a patient population is impossible for a clinical trial because patients are accrued sequentially over time and thus comprise a convenience sample, subject only to protocol entry criteria. Consequently, the trial's sample is unlikely to represent a definable patient population. We use causal diagrams to illustrate the difference between random allocation of interventions within a clinical trial sample and true simple or stratified random sampling, as executed in surveys. We argue that group-specific statistics, such as a median survival time estimate for a treatment arm in an RCT, have limited meaning as estimates of larger patient population parameters. In contrast, random allocation between interventions facilitates comparative causal inferences about between-treatment effects, such as hazard ratios or differences between probabilities of response. Comparative inferences also require the assumption of transportability from a clinical trial's convenience sample to a targeted patient population. We focus on the consequences and limitations of randomization procedures in order to clarify the distinctions between pairs of complementary concepts of fundamental importance to data science and RCT interpretation. These include internal and external validity, generalizability and transportability, uncertainty and variability, representativeness and inclusiveness, blocking and stratification, relevance and robustness, forward and reverse causal inference, intention to treat and per protocol analyses, and potential outcomes and counterfactuals.
Project description:There are no universally accepted guidelines for the follow-up of individuals with cutaneous melanoma. Furthermore, to date, there have been no randomised controlled trials of different models of melanoma follow-up care. This randomised controlled trial was conducted to evaluate the effects of GP-led melanoma follow-up on patient satisfaction, follow-up guideline compliance, anxiety and depression, as well as health status.A randomised controlled trial of GP-led follow-up of cutaneous melanoma was conducted over a period of 1 year with assessment by self-completed questionnaires and review of general practice-held medical records at baseline and 12 months later. It took place in 35 general practices in North-east Scotland. Subjects were 142 individuals (51.4% women 48.6% men; mean (s.d.) age 59.2 (15.2) years previously treated for cutaneous melanoma and free of recurrent disease. The intervention consisted of protocol-driven melanoma reviews in primary care, conducted by trained GPs and supported by centralised recall, rapid access pathway to secondary care and a patient information booklet. The main outcome measure was patient satisfaction measured by questionnaire. Secondary outcomes were adherence to guidelines, health status measured by Short Form-36 and the Hospital Anxiety and Depression Scale.There were significant improvements in 5 out of 15 aspects of patient satisfaction during the study year in those receiving GP-led melanoma follow-up (all P<or=0.01). The intervention group was significantly more satisfied with 7 out of 15 aspects of care at follow-up after adjustment for potential confounders. There was significantly greater adherence to guidelines in the intervention group during the study year. There was no significant difference in health status or anxiety and depression between intervention and control groups at either baseline or outcome.GP-led follow-up is feasible, engenders greater satisfaction in those patients who receive it, permits closer adherence to guidelines and does not result in adverse effects on health status or anxiety and depression when compared with traditional hospital-based follow-up for melanoma.
Project description:Background and objectivesThis study aimed to (1) identify patient-controlled analgesia (PCA) attributes that negatively impact patient satisfaction and ability to control pain while using PCA and (2) obtain data on patient perceptions of new PCA design features.MethodsWe conducted a prospective survey study of postoperative pain control among patients using a PCA device. The survey was designed to evaluate patient satisfaction with pain control, understanding of PCA, difficulties using PCA, lockout-period management, and evaluation of new PCA design features.ResultsA total of 350 eligible patients completed the survey (91%). Patients who had difficulties using PCA were less satisfied (P < 0.001) and were more likely to feel unable to control their pain (P < 0.001). Satisfaction and self-reported ability to control pain were not affected by patient education about the PCA. Forty-nine percent of patients reported not knowing if they would receive medicine when they pushed the PCA button, and of these, 22% believed that this uncertainty made their pain worse. The majority of patients preferred the proposed PCA design features for easier use, including a light on the button, making it easier to find (57%), and a PCA button that vibrates (55%) or lights up (70%), alerting the patient that the PCA pump is able to deliver more medicine.ConclusionsA majority of patients, irrespective of their satisfaction with PCA, preferred a new PCA design. Certain attributes of current PCA technology may negatively impact patient experience, and modifications could potentially address these concerns and improve patient outcomes.
Project description:BackgroundAcupressure therapy may be potentially beneficial in improving postoperative symptoms like postoperative nausea and vomiting (PONV), pain and sleep disorder and improving postoperative quality of recovery. The primary aim of this study is to investigate the efficacy of acupressure therapy on postoperative patient satisfaction and quality of recovery in hospitalized patients after surgical treatment.Methods/designThis three-group, parallel, superiority, blinded, randomized controlled trial will test the hypothesis that a combination of PC6, LI4 and HT7 acupressure is superior to sham or no intervention for improving postoperative quality of recovery in hospitalized patients. A minimum of 150 patients will be randomly allocated to one of the three experimental groups: control (no visit), light touch (sham acupressure) or active acupressure therapy in a 1:1:1 ratio. Interventions will be performed three times a day for 2 days. Patient satisfaction, quality of recovery, PONV and pain will be measured during the 3 days following randomization. The study protocol was approved by the Stony Brook University Institutional Review Board on 21 March 2016. Written informed consent will be recorded from every consented patient.DiscussionThis study has the potential to improve the recovery of hospitalized patients by adding knowledge on the efficacy of acupressure therapy in this setting. A multipoint acupressure protocol will be compared to both a no intervention group and a light touch group, providing insight into different aspects of the placebo effect.Trial registrationClinicalTrial.gov, NCT02762435 . Registered on 14 April 2016.
Project description:Rationale: Sepsis patients suffer from severe metabolic and immunologic dysfunction that may be amplified by standard carbohydrate-based nutritional regimes. We therefore hypothesize that a ketogenic diet improves sepsis treatment. Objectives: We investigated the safety and feasibility of a ketogenic diet in sepsis patients. Methods: We conducted a monocentric open-labeled randomized controlled trial (DRKS00017710) enrolling adult sepsis patients randomly assigned to either ketogenic or standard high-carbohydrate diet for 14 days with follow-up until day 30. The primary outcome measure was β-hydroxybutyrate serum concentration on day 14. Secondary outcomes included safety, clinical and immunological changes. Measurements and Main Results: 40 critically ill septic patients were assigned to the study groups. Increase in β-hydroxybutyrate concentrations from baseline to day 14 was markedly greater under ketogenic diet (1.2 ±0.9) compared to controls (-0.3 ±0.4); estimated mean difference 1.4 (95%-CI 1.0-1.8; p<0.0001). During ketogenic diet, no patient required insulin treatment beyond day 4, whereas 35% to 60% of control patients did (p=0.0095). Metabolic side effects were not observed under ketogenic diet. Ventilation-free (IRR 1.7; 95%-CI: 1.5 to 2.1; p<0.0001), vasopressor-free (IRR 1.7; 95%-CI: 1.5 to 2.0; p<0.0001), dialysis-free (IRR 1.5; 95%-CI: 1.3 to 1.8; p<0.0001), and ICU-free days (IRR 1.7; 95%-CI: 1.4 to 2.1; p<0.0001) significantly increased in patients under ketogenic diet. There was no difference in 30-day mortality. Analyses indicated favorable changes towards immune homeostasis. Conclusions: Ketogenic diet is a feasible and safe nutritional regimen in septic patients promoting recovery from sepsis-related organ dysfunction and could become a new tool in modern treatment concepts.
Project description:ObjectiveTo analyze the effects of cryolipolysis on the fat thickness of the lower abdomen of healthy women and patient's satisfaction.MethodsDesign and setting: a randomized controlled trial, with concealed allocation and blinded assessor.Participants34 healthy women between 18 and 48 years, skinfold in the lower abdomen ≥3cm, BMI between 18.5 and 27kg/m2, low level of physical activity, and no contraindication to cryolipolysis were allocated to intervention group (IG, n=17) or control group (CG, n=17).InterventionsThe IG received one session of cryolipolysis with -10°C of temperature for 50min. The CG was not submitted to any kind of intervention. Both groups did the evaluation protocols at baseline, 30, 60 and 90 days after the intervention.Main outcome measuresfat thickness was measured by ultrasonography (US), skinfold (SF) and abdominal circumference (AC1 and AC2).ResultsNo significant differences between the IG and CG were demonstrated at any evaluation at any time of follow up for the variables US (30 days: 0.05cm (95%CI: -0.12; 0.22), 60 days: 0.05cm (95%CI: -0.11; 0.20) and 90 days: 0.04cm (95%CI: -0.7; 0.25)), SF (30 days: -0.09cm (95%CI: -0.25; 0.08), 60 days: -0.14cm (95%CI: -0.36; 0.09) and 90 days: -0.001cm (95%CI: -0.237; 0.234)), AC1 (30 days: 0.42cm (95%CI: -1.1; 1.9), 60 days: -0.1cm (95%CI: -1.74; 1.54) and 90 days: -0.007cm (-1.9; 1.9)) and AC2 (30 days: 0.183cm (95%CI: -0.84; 1.20), 60 days: -0.13cm (95%CI: -1.61; 1.35) and 90 days: -0.31cm (95%CI: -1.61; 1.00)).ConclusionsThe current study showed that a single application of the utilized protocol of cryolipolysis does not produce any significant effect on fat thickness of the lower abdomen of healthy women.Clinical trial registration numberNCT03160976 (https://clinicaltrials.gov/ct2/show/NCT03160976). Contribution of the Paper: the study is one of the first studies in the literature with methodological rigor to report an unfavorable result for localized abdominal fat treatment with a single session of cryolipolysis.
Project description:PurposeTo measure the effectiveness of a 4-month interdisciplinary multifaceted intervention based on a change in care delivery for patients with multimorbidity in primary care practices.MethodsA pragmatic randomized controlled trial with a mixed-methods design in patients aged 18 to 80 years with 3 or more chronic conditions from 7 family medicine groups (FMGs) in Quebec, Canada. Health care professionals (nurses, nutritionists, kinesiologists) from the FMGs were trained to deliver the patient-centered intervention based on a motivational approach and self-management support. Primary outcomes: self-management (Health Education Impact Questionnaire); and self-efficacy.Secondary outcomeshealth status, quality of life, and health behaviors. Quantitative analyses used multi-level mixed effects and generalized linear mixed models controlling for clustering within FMGs. We also conducted in-depth interviews with patients, family members, and health care professionals.ResultsThe trial randomized 284 patients (144 in intervention group, 140 in control group). The groups were comparable. After 4 months, the intervention showed a neutral effect for the primary outcomes. There was significant improvement in 2 health behaviors (healthy eating with odds ratios [OR] 4.36; P = .006, and physical activity with OR 3.43; P = .023). The descriptive qualitative evaluation revealed that the patients reinforced their self-efficacy and improved their self-management which was divergent from the quantitative results.ConclusionsQuantitatively, this intervention showed a neutral effect on the primary outcomes and substantial improvement in 2 health behaviors as secondary outcomes. Qualitatively, the intervention was evaluated as positive. The combination of qualitative and quantitative designs proved to be a good design for evaluating this complex intervention.
Project description:We hypothesized that seminal plasma, the acellular seminal fluid component, influences the endometrium stimulating the immune system and facilitating the implantation. We designed a randomized, double-blinded, placebo-controlled trial, and we used microarray analysis to evaluate differences in the endometrial transcriptomic profile after vaginal seminal plasma application. Differential gene pathways analysis showed an upregulation of pathways associated with the immune response, cell viability, proliferation and cellular movement, implantation, embryo development, oocyte maturation and angiogenesis. We compared our results with similar studies in pigs, mice and in vitro human endometrial cells and found similar and found comparable results. Our data show that seminal plasma has a positive effect on the endometrium during the implantation window.