RICERCA ITALIANA     

Research program

Sleep-debt effects on procedural learning and on clinical and cognitive performance in resident physicians: the protective function of naps

University Co-ordinator

Università degli Studi di PISA - PSICHIATRIA,NEUROBIOLOGIA, FARMACOLOGIA E BIOTECNOLOGIE - ()

Research Unit Leader

Mario Guazzelli

Description

Participants:

The aim of the research unit will be to evaluate clinical errors of resident physicians in a sleep deprivation setting. Similarly to the other research units, 200 physicians attending the 2th (n = 100, 50 males and 50 females) and 4th (n = 100, 50 males and 50 females) year of their post-graduate curriculum at the Medical School of the University of Pisa will participate in the study. Subjects will be asked to sign an informed consent approved together with the whole research project by the Ethical Committee of the University of Pisa. All subjects will be screened for a complete medical and psychological examination to exclude possible physical diseases and psychopathological condition that could interfere with the development of the study. Exclusion criteria will include current diagnosis of any kind of insomnia or hypersomina, psychotic disorders, physical disorders that might interfere with the sleep-wake cycle, and the use of drugs with possible psychotropic effects.


Experimental procedure:

The study will be carried out following a between-groups design including four main experimental groups -“wake”, “night nap”, “day nap”, “night-day nap” groups-, and a control group. Subjects in the experimental groups will be subjected to a sleep deprivation period lasting 24 hours, while subjects in the control group will not be subjected to sleep deprivation. Repeated assessment sessions for exploring procedural and diagnostic errors will be conducted during the day following the sleep deprivation period (day 2), twenty four hours after the sleep deprivation (day 3), and seven days after the sleep deprivation (day 8).

More specifically, experimental procedure will be performed as follows. After a first day of normal clinical routine (day 1) participants in the experimental groups will have a nocturnal duty (night 1). Subjects in the “wake” group will not sleep during the night 1; subjects in the “night nap” group will be allowed to take a short nap during the night 1 (lasting from 20 to 45 minutes); subjects in the “day nap” group will be allowed to take a short nap (lasting 20-45 minutes as well) during the day after the night of sleep deprivation (day 2); subjects in the “night-day nap” group will be allowed to take a nap not only during night 1 but also during day 2 (each nap always lasting 20-45 minutes). Finally, subjects in the control group will not be on call during night 1 but they will go to bed as usual.

Each group (experimental and control groups) will be further subdivided in two homogenous groups (sub-group A and sub-groups B) according to the number of assessment session to be carried out during the second day (day 2). Subjects in the sub-group A of each condition will be involved in an assessment session in the morning of the second day (from 11 A.M to noon). Subjects in the sub-group B will be involved in two assessment sessions: the first one will be carried out in the morning (always from 11 A.M to noon), and before the nap in both the “day-nap” and the “night-day nap” groups; the second one will be performed during the afternoon (from 4 P.M. to 5 P.M.), and always after the nap in both the “day-nap” and the “night-day nap” groups.

All participants will be also tested during day 3, from 11 A.M. to noon, and during day 8 from11 A.M. to noon as well. Reports by the supervisors of the residents will be collected at the end of day 2, day 3 and day 8.

10 males (5 attending the 2th and 5 attending the 4th year of residency ) and 10 females (5 attending the 2th and 5 attending the 4th year of residency ) will be randomly assigned to each group.



After night 1 subjects will not be on night call for the next seven days (i.d. till the end of the study). For subjects belonging to the control group, a night following the last nocturnal duty from at least two days will be arbitrarily chosen as night 1. Subjects in the control group will not participate in nocturnal duties for the whole eight days of duration of the study. An actigraphic measure will be collected from night 1 to the end of day 3, in order to evaluate the compliance to the experimental design and the total sleep time during the recovery night.


Materials

Following the general experimental design of the project all the subjects will be asked to fill the following scales .... to assess ....

This research Unit will explore clinical medical errors by means of a standardized method for measuring diagnostic and procedural performance during clinical reasoning, the Script Concordance Test (SCT), and using ad-hoc questionnaires for both residents and supervisors.
1) Script Concordance Test (SCT)

The SCT is a standardized method for assessing clinical reasoning skills based on the script theory. According to this theory, in specific situations clinicians tend to recover a set of learned knowledge (scripts). These scripts are used to understand situations and to act in order to achieve specifical clinical aims. Scripts can vary in the details among clinicians but are similar in their nuclear aspects (Gagnon et al., 2006; Charlin et al., 2006).

Each part of the test is based on a clinical case described through few sentences, and could concern specific aspect of clinical evaluation, diagnosis and treatment. Each test item consists of three parts. The first part includes a diagnostic hypothesis, an investigative action, or a treatment option that is relevant to the situation. The second presents new information (e.g., a
sign, condition, imaging study, or laboratory test result) that might have an effect on the diagnostic hypothesis, investigative action, or treatment option. The third part is a 5-point Likert-type scale on which each subject has to express his grade of agreement with the statement express in the first part (from +2 complete agreement to -2 complete disagreement) in light of the newer information. Each SCT evaluation will contain 50 items specific for each residency and will be fully randomized across subjects. Each item will be presented just one time to each subject. As stated in previous studies, the SCT will be scored as a measure of concordance between residents’ and supervisors’ scripts.

The SCT is frequently used to assess skills and progresses of residents (Materissian et al., 2007; Sibert et al., 2006; Marie et al., 2005; Brazeu-Lamontagne et al., 2004), and it has been validated in different countries and languages (Sibert et al., 2002) but has not been used yet to evacuate clinical reasoning impairment in sleep deprivation conditions.

In this study, specific items in the SCT for assessing diagnostic and procedural errors will be developed and standardized following the guidelines proposed by the available literature with the advisory of the supervisor physicians (Charlin et al., 2006). Specific questions will be created for each residency.

2) Ad-hoc questionnaires for residents and supervisors and direct observation

Clinical errors occurred during the real clinical practice will be assessed by a self-report questionnaire fulfilled by residents, and described in previous researches (Landrigan et al., 2004; Barger et al., 2007). In the self-report questionnaire, residents will be asked to refer any medical error defined as “any error in the delivery of medical care, whether harmful or trivial” and any adverse event occurred in their patients and possibly related to the clinical practice. Residents will have to state if they believe that the error occurred for their fatigue and sleep debt or for their inexperience. Moreover they will have to rate on a likert-type scale how much each adverse event occurred in their patients could be avoided.
Additionally, clinical errors will be assessed by clinical reports requested to residents` supervisors. Questionnaires to be fulfilled by supervisors will be developed following the guidelines proposed by Landrigan et al. (2004). Supervisors´ reports will be based on results from direct observation of residents´ performance during specific periods of time. Again, the guidelines proposed and used by Landrigan et al. (2004) will be used for conducting the data collection by means of direct observation.

In the first three-four months of the study we will develop the SCT for the different residencies and the ad-hoc questionnaires. Following the guide-lines proposed in the literature the SCT could be created starting from an interview with almost two experts in each specific fields while at least ten experts are required for the validation and standardization . The relatively small numbers of experts needed to create and validate the SCT will make the start-up period very short. In the next 17-18 months we will recruit and study subjects as we have described above while the last two months will be devoted to data analyses.

Our results will help to better understand the relationship between sleep deprivation (in controlled situations) and clinical performance. Moreover they might clarify the role of recovery strategies like naps, countermeasures that could modify the impact of sleep deprivation on clinical activities, with possible important concerns for duties scheduling. Thanks to the homogeneous experimental design shared by all the research units we will be able to correlate our results with those of the other research units. In this way we can correlate our results on clinical performances with indices of attentional and learning skills with possible profound concerning on the formative system of Italian residencies.