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

The association between body mass index and patients' experiences with inpatient care

Objective To explore the association between patients' body mass index (BMI) and their experiences with inpatient care. Design Cross-sectional. Mail survey. Setting University Hospital of Geneva. Participants Questionnaires were mailed to 2385 eligible adult patients, 6 weeks after discharge (response rate = 69%). Main Outcome Measures Patients' experiences with care were measured using the Picker inpatient survey questionnaire. BMI was calculated using self-reported height and weight. Main dependent variables were the global Picker patient experience (PPE-15) score and nine dimension-specific problem scores, scored from 0 (no reported problems) to 1 (all items coded as problems). We used linear regressions, adjusting for age, gender, education, subjective health, smoking and hospitalization, to assess the association between patients' BMI and their experiences with inpatient care. Results Of the patients, 4.8% were underweight, 50.8% had normal weight, 30.3% were overweight and 14.1% were obese. Adjusted analysis shows that compared with normal weight, obesity was significantly associated with fewer problematic items in the surgery-related information domain, and being underweight or overweight was associated with more problematic items in the involvement of family/friends domain. The global PPE-15 score was significantly higher (more problems) for underweight patients. Conclusions Underweight patients, but not obese patients, reported more problems during hospitalizatio

Patient satisfaction and survey response in 717 hospital surveys in Switzerland: a cross-sectional study.

The association between patient satisfaction and survey response is only partly understood. In this study, we describe the association between average satisfaction and survey response rate across hospital surveys, and model the association between satisfaction and propensity to respond for individual patients. Secondary analysis of patient responses (166'014 respondents) and of average satisfaction scores and response rates obtained in 717 annual patient satisfaction surveys conducted between 2011 and 2015 at 164 Swiss hospitals. The satisfaction score was the average of 5 items scored between 0 and 10. The association between satisfaction and response propensity in individuals was modeled as the function that predicted best the observed response rates across surveys. Among the 717 surveys, response rates ranged from 16.1 to 80.0% (pooled average 49.8%), and average satisfaction scores ranged from 8.36 to 9.79 (pooled mean 9.15). At the survey level, the mean satisfaction score and response rate were correlated (r = 0.61). This correlation held for all subgroups of surveys, except for the 5 large university hospitals. The estimated individual response propensity function was "J-shaped": the probability of responding was lowest (around 20%) for satisfaction scores between 3 and 7, increased sharply to about 70% for those maximally satisfied, and increased slightly for the least satisfied. Average satisfaction scores projected for 100% participation were lower than observed average scores. The most satisfied patients were the most likely to participate in a post-hospitalization satisfaction survey. This tendency produces an upward bias in observed satisfaction scores, and a positive correlation between average satisfaction and response rate across surveys

Rate of undesirable events at beginning of academic year: retrospective cohort study.

OBJECTIVE: To determine whether an increase in the rate of undesirable events occurs after care provided by trainees at the beginning of the academic year. DESIGN: Retrospective cohort study using administrative and patient record data. SETTING: University affiliated hospital in Melbourne, Australia. PARTICIPANTS: 19,560 patients having an anaesthetic procedure carried out by first to fifth year trainees starting work for the first time at the hospital over a period of five years (1995-2000). MAIN OUTCOME MEASURES: Absolute event rates, absolute rate reduction, and rate ratios of undesirable events. RESULTS: The rate of undesirable events was higher at the beginning of the academic year compared with the rest of the year (absolute event rate 137 v 107 per 1000 patient hours, relative rate reduction 28%, P&lt;0.001). The overall adjusted rate ratio for undesirable events was 1.40, 95% confidence interval 1.24 to 1.58. This excess risk was seen for all residents, regardless of their level of seniority. The excess risk decreased progressively after the first month, and the trend disappeared fully after the fourth month of the year (rate ratio for fourth month 1.21, 0.93 to 1.57). The most important decreases were for central and peripheral nerve injuries (relative difference 82%), inadequate oxygenation of the patient (66%), vomiting/aspiration in theatre (53%), and technical failures of tracheal tube placement (49%). CONCLUSIONS: The rate of undesirable events was greater among trainees at the beginning of the academic year regardless of their level of clinical experience. This suggests that several additional factors, such as knowledge of the working environment, teamwork, and communication, may contribute to the increase

Health utility indexes in patients with acute coronary syndromes.

BACKGROUND: Acute coronary syndromes (ACS) have been associated with lower health utilities (HUs) compared with the general population. Given the prognostic improvements after ACS with the implementation of coronary angiography (eg, percutaneous coronary intervention (PCI)), contemporary HU values derived from patient-reported outcomes are needed. METHODS: We analysed data of 1882 patients with ACS 1 year after coronary angiography in a Swiss prospective cohort. We used the EuroQol five-dimensional questionnaire (EQ-5D) and visual analogue scale (VAS) to derive HU indexes. We estimated the effects of clinical factors on HU using a linear regression model and compared the observed HU with the average values of individuals of the same sex and age in the general population. RESULTS: Mean EQ-5D HU 1-year after coronary angiography for ACS was 0.82 (±0.16) and mean VAS was 0.77 (±0.18); 40.9% of participants exhibited the highest utility values. Compared with population controls, the mean EQ-5D HU was similar (expected mean 0.82, p=0.58) in patients with ACS, but the mean VAS was slightly lower (expected mean 0.79, p&lt;0.001). Patients with ACS who are younger than 60 years had lower HU than the general population (&lt;0.001). In patients with ACS, significant differences were found according to the gender, education and employment status, diabetes, obesity, heart failure, recurrent ischaemic or incident bleeding event and participation in cardiac rehabilitation (p&lt;0.01). CONCLUSIONS: At 1 year, patients with ACS with coronary angiography had HU indexes similar to a control population. Subgroup analyses based on patients' characteristics and further disease-specific instruments could provide better sensitivity for detecting smaller variations in health-related quality of life

Saliva cotinine levels in smokers and nonsmokers.

The authors collected by mail self-reported data on smoking habits and saliva samples that were analyzed for cotinine concentration in 222 smokers and 97 nonsmokers. Participants were members of the University of Geneva (Switzerland) in 1995. The 207 cigarette-only smokers smoked on average 10.7 cigarettes/day and had a median concentration of cotinine of 113 ng/ml. The cotinine concentration was moderately associated with the number of cigarettes smoked per day (+14 ng/ml per additional cigarette, p &amp;lt; 0.001, R2 = 0.45) and was 54 ng/ml higher in men than in women after adjustment for cigarettes per day and for the Fagerström Test for Nicotine Dependence. The cotinine level was not associated with the nicotine yield of cigarettes (r= 0.08). In nonsmokers, the median concentration of cotinine was 2.4 ng/ml. The cotinine concentration was 1.5 times higher in nonsmokers whose close friends/spouses were smokers than in nonsmokers whose close friends/spouses were nonsmokers (p = 0.05). A cutoff of 7 ng/ml of cotinine distinguished smokers from nonsmokers with a sensitivity of 92.3% and a specificity of 89.7%; a cutoff of 13 ng/ml provided equally satisfactory results (sensitivity, 86.5%; specificity, 95.9%). This study provides evidence for the construct validity of both questionnaires and saliva cotinine for the assessment of active and passive exposure to tobacco smoke