Patient-reported conformity of informed consent procedures and participation in clinical research

Background: There is growing evidence that the quality of informed consent in clinical research is often sub-optimal. Aims: To explore the conformity of patient recruitment with recommended informed consent procedures among patients who were invited to participate in a clinical study at a general teaching hospital, and to examine the association between consent procedures and the patients' decision to participate. Design and Methods: All inpatients discharged during a 1-month period were invited to complete a mailed survey in which they reported whether they were invited to participate in a study and whether 13 recommended elements of informed consent actually occurred. Results: Among 1303 respondents, 265 (20.3%) reported that they had been invited to participate in a study, and 191 (72.1%) accepted. While the majority of potential participants were fully informed about practical issues related to the study (e.g. what their participation would consist in), <50% were informed of possible risks or benefits, and only 20% about the origin of the study funds. Only 60% reported satisfactory answers to items assessing the overall information process (e.g. explanations were easy to understand). Older and sicker patients reported lower levels of conformity with informed consent procedures, as did patients who refused to participate in a study. Conclusions: Our results confirm that informed consent procedures fail to meet standards for many patients. In particular, consent information should be adapted to the needs of older and sicker patients. Improving the quality of informed consent may increase patients' participation in clinical researc

COOP Charts in French: translation and preliminary data on instrument properties

This paper describes the procedure used to translate the COOP Charts into French and provides preliminary information on the instrument's acceptability, reliability and validity. The charts were translated in several steps: seven initial translations were combined into a first pilot version, which was then tested for acceptability, clarity and alternate wordings in two convenience samples taken from the general population (n=53). The modified version was then reviewed by a lay panel and another translator and submitted by mail to 209 congress participants to test several construct validity hypotheses through known-groups comparisons. A panel of public health professionals discussed the content validity of the charts. Finally, test-retest reliability and concurrent validity with SF-36 Health Survey scores were examined among 65 patients with end-stage renal disease. The translation process identified a wide variability in translation options for several items. The acceptability of the charts was excellent. The test-retest correlations ranged from 0.60 to 0.87. Content validity appeared to be appropriate, except for the chart on ‘social support', which combines the questions of need and availability of social support. The utility of illustrations was questioned by some respondents: many claimed not to have used the illustrations in selecting their response, while others found them to be not expressive enough. Most preliminary tests of construct validity were consistent with theory. This French translation of the COOP Charts appears to be ready for more extensive testing in the intended target population of ambulatory patient

Measuring human-error probabilities in drug preparation: a pilot simulation study

Objectives: Designing a safe medication process requires the ability to model its reliability using methods such as probabilistic risk assessment (PRA). However, lack of data, especially on human-error probabilities (HEPs), limits its use. To assess whether small-scale simulations could help generate HEP data, a pilot study was conducted among nurses and anaesthetists. It focused on two core activities, namely, the manual preparation of medications and the arithmetic necessary to prepare drugs. Its specific objectives were to evaluate whether HEPs could be high enough to be measurable and to determine whether these HEPs could be sensitive to individuals and task details. These would give some insight into the level of detail required by PRA analysis. Methods: Thirty nurse and 28 anaesthetist volunteers were involved in the experiment. Nurses and anaesthetists had to prepare medications for 20 patients and 22 syringes of various drugs, respectively. Both groups had to perform 22 calculations relating to the preparation of drugs. HEPs, distribution of HEPs and dependency of HEPs on individuals and task details were assessed. Results: In the preparation tasks, overall HEP was 3.0% for nurses and 6.5% for anaesthetists. In the arithmetic tasks, overall HEP was 23.8% for nurses and 8.9% for anaesthetists. A statistically significant difference was noted between the two groups. In both preparation and arithmetic tasks, HEPs were dependent on individual nurses but not on individual anaesthetists. In every instance, HEPs were dependent on task details. Conclusion: Our study illustrates that small-scale simulations represent an interesting way of generating HEPs. HEPs are, indeed, in the range of 10−2 and 10−1. But in most cases, HEPs depend heavily on operators and task details. This dependency means that the influence of these parameters must be determined before advanced PRA analysis. There is therefore an urgent need to develop experimental research into assessing this influence by means of randomised controlled trial

Serum NGAL, BNP, PTH, and albumin do not improve glomerular filtration rate estimating formulas in children.

Glomerular filtration rate (GFR) is difficult to measure, and estimating formulas are notorious for lacking precision. This study aims to assess if the inclusion of additional biomarkers improves the performance of eGFR formulas. A hundred and sixteen children with renal diseases were enrolled. Data for age, weight, height, inulin clearance (iGFR), serum creatinine, cystatin C, neutrophil gelatinase-associated lipocalin (NGAL), parathyroid hormone (PTH), albumin, and brain natriuretic peptide (BNP) were collected. These variables were added to the revised and combined (serum creatinine and cystatin C) Schwartz formulas, and the quadratic and combined quadratic formulas. We calculated the adjusted r-square (r &lt;sup&gt;2&lt;/sup&gt; ) in relation to iGFR and tested the improvement in variance explained by means of the likelihood ratio test. The combined Schwartz and the combined quadratic formulas yielded best results with an r &lt;sup&gt;2&lt;/sup&gt; of 0.676 and 0.730, respectively. The addition of BNP and PTH to the combined Schwartz and quadratic formulas improved the variance slightly. NGAL and albumin failed to improve the prediction of GFR further. These study results also confirm that the addition of cystatin C improves the performance of estimating GFR formulas, in particular the Schwartz formula.Conclusion: The addition of serum NGAL, BNP, PTH, and albumin to the combined Schwartz and quadratic formulas for estimating GFR did not improve GFR prediction in our population. What is Known: • Estimating glomerular filtration rate (GFR) formulas include serum creatinine and/or cystatin C but lack precision when compared to measured GFR. • The serum concentrations of some biological parameters such as neutrophil gelatinase-associated lipocalin (NGAL), parathyroid hormone (PTH), albumin, and brain natriuretic peptide (BNP) vary with the level of renal function. What is New: • The addition of BNP and PTH to the combined quadratic formula improved its performance only slightly. NGAL and albumin failed to improve the prediction of GFR further

Improvement in mental health following total hip arthroplasty: the role of pain and function

BACKGROUND: Mental health has been shown to improve after total hip arthroplasty (THA). Little is known about the role of pain and function in this context. We assessed whether change in mental health was associated with improvement in pain and function 1 year post-surgery. METHODS: This prospective study included patients enrolled in a THA registry from 2010 to 2014. We examined the mental component score (MCS) before and 1 year post-surgery, and 1-year change, in association with Western Ontario McMaster Universities (WOMAC) pain and function scores. All scores were normalized, ranging from 0 to 100 (larger score indicating better outcome). Analyses were adjusted for potential confounders. RESULTS: Our study included 610 participants, of which 53% were women. Descriptive statistics are as follows: the average (SD) for age (years) was 68.5 (11.8), and for BMI was 26.9 (4.9). In addition, the MCS average (SD) at baseline was 44.7 (11.2), and at 1-year after THA was 47.5 (10.5). The average change from baseline to 1-year post-THA in MCS was 2.8 (95% CI: 1.9, 3.6), for an effect size of 0.26. As for the WOMAC pain score, the average change from baseline to 1-year post-THA was 44.2 (95%CI: 42.4, 46.0), for an effect size of 2.5. The equivalent change in WOMAC function was 38.1 (95% CI: 36.2, 40.0), for an effect size of 2.0. Results from multivariable analysis controlling for covariates showed that an improvement of 10 points in the 1-year change in pain score resulted in a 0.78 point (95%: CI 0.40, 1.26) increase in the 1-year change in MCS, whereas a 10-point improvement in the 1-year change in function was associated with a 0.94 point (95% CI: 0.56, 1.32) increase. CONCLUSIONS: Mental health significantly improved from baseline to 1-year post-THA. Greater improvement in pain and function was associated with greater improvement in mental health 1 year post-THA

Satisfaction of patients on chronic haemodialysis and peritoneal dialysis

BACKGROUND: In contrast to quality of life, patient satisfaction on chronic haemodialysis (HD) and peritoneal dialysis (PD) has only rarely been studied. PATIENTS AND METHODS: All chronic HD and PD patients of the 19 centres located in western Switzerland were asked to complete a specific questionnaire, assessing dialysis centre characteristics, treatment modalities, and information received before and during dialysis treatment. Comparison between satisfaction with PD and HD was carried out on the patients in the nine centres offering both treatment modalities. RESULTS: Of the 558 questionnaires distributed to chronic HD patients, 455 were returned (response rate 82%). Fifty of 64 PD patients (78%) returned the questionnaire. The two groups were similar in age, gender, and duration of dialysis treatment. Completion rates were &gt;90% for a majority of questions, with the lowest rate for information on sexuality (49% in HD and 54% in PD respectively). The lowest scores were recorded for information received about complications and costs of dialysis, and impact of end-stage kidney disease on sexuality. Satisfaction was lower in anonymous questionnaires. Satisfaction of PD patients was significantly better in 50% of the questions, particularly session tolerance (p&lt;0.001), information about dialysis sessions (p=0.007), and complications (p=0.006). CONCLUSIONS: PD patients were on average more satisfied with their treatment than HD patients. Satisfaction could be improved with more information about potential adverse treatment effects

Use of Treponema pallidum PCR in Testing of Ulcers for Diagnosis of Primary Syphilis(1.).

Treponema pallidum PCR (Tp-PCR) has been noted as a valid method for diagnosing syphilis. We compared Tp-PCR to a combination of darkfield microscopy (DFM), the reference method, and serologic testing in a cohort of 273 patients from France and Switzerland and found the diagnostic accuracy of Tp-PCR was higher than that for DFM