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Cochrane Database of Systematic Reviews Protocol - Intervention

Educational interventions for improving the communication skills of general practice trainees in the clinical consultation

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

The aim of this systematic review is to assess the effects of educational interventions to improve the communication skills of General Practice trainees during clinical consultations. The review will examine the effects of these interventions primarily on patient‐related outcomes such as satisfaction with care, patients' assessment of the quality of communication during the clinical consultation, patients' health care behaviour, including adherence to therapy and management plans, and health outcome measures such as blood pressure or glucose control. The review will also examine the effects of the interventions on trainee‐related outcomes, such as trainee performance in real patient consultations, trainee competence, such as that measured by an Objective Structured Clinical Examination (OSCE), and trainee knowledge of communication skills. Furthermore, the review will examine whether different educational strategies yield different results across these outcomes.

Background

The calibre of communication between physicians and consumers during the clinical consultation is a key component of health care quality. Various reviews of trials show that skilful communication is related to improved outcomes, including better ratings in the following areas: patient satisfaction, therapy compliance, symptom resolution and in some cases even physiological measures such as blood pressure or blood sugar control (Griffin 2004; Kaplan 1989; Stewart 1995; Stewart 1999). Studies conducted exclusively in general practice medicine also demonstrate that communication skills are especially important for improving outcomes, including adherence to physician's advice, patient satisfaction and improved health status (Beck 2002; Safran 1998). Good communication in the clinical consultation exceeds mere academic concerns; it is also significant from the perspective of health care consumers (Edwards 2001; Lansky 1998). Specifically, analysis of complaints about physicians' behaviours shows that the most common categories reported by consumers relate to communication and interpersonal skills (Wofford 2004). Furthermore, communication problems constitute a major factor in malpractice litigation (Beckman 1994; Levinson 1994). These findings represent good reasons for future general practitioners (GPs) to give special attention to acquiring competence in communication skills. However, despite specific training in communication skills, young GPs' performance of these skills remains inferior (Kramer 2004). This therefore raises the question: What are the best ways to teach good communication skills to GP trainees to benefit their patients?

An abundant body of evidence exists in medical educational research affirming that communication skills can be taught (Aspegren 1999; Hulsman 1999; Lewin 2001), and that communication skills training can result in some changes that are retained for several years (Maguire 1986; Oh 2001; Rudner 1990; Smith 1991). However, training GP trainees in communication skills has not produced uniformly positive results (Bensing 1985; Grol 1989; Hindmarsh 1998; Hulsman 1999; Ruiz 2003; van Dalen 2002). These conflicting results therefore present the challenge and opportunity of summarising, analysing and clarifying the available evidence in this area.

The scope of this review will be restricted to the discipline of general practice and to the period of vocational training. We regard GP and family doctor as synonyms intended to describe doctors who have undergone specific postgraduate training in general practice, thereby following the European definition of General Practice/Family Medicine (WONCA 2002). The differences in the ways that health care systems and medical education are organised in different countries create difficulties in uniformly defining the term 'vocational training'. We adhere to the description of Hindmarsh and colleagues, who state that the term vocational training in the general practice context is generally used to refer to postgraduate specialist training and assessment, which commonly, but not uniformly, leads to membership of a college of general practitioners (Hindmarsh 1998).

This review will focus on the vocational training interval for two reasons. First, several studies have suggested that the most effective form of communication skills training for GPs is via an experiential method (Aspegren 1999; Greco 2001; Kurtz 1998; van Dalen 2002). Experiential learning theory defines learning as "the process whereby knowledge is created through the transformation of experience. Knowledge results from the combination of grasping and transforming experience" (Kolb 1984). Applying this method to communication skills training in medicine means that trainee GPs must first perform consultations themselves and later receive feedback from a teacher. This contrasts with the traditional or instructional method of learning communication skills in medicine, where trainees are first shown how to perform an interview by a teacher (either by textbook, by lecture or by example), then asked to repeat it with or without feedback (Aspegren 1999). For the future GP, vocational training provides a potent opportunity for experiential learning. Second, if undergraduate training in effective communication is not extended into clerkship and residency, the communication skills of trainees might deteriorate over time. This premise underlies the need to reinforce and extend communication skills training as trainees expand their clinical knowledge and deal with increasingly complex situations (Kurtz 2003). We therefore expect that this review's results will be valuable for curriculum planners when searching for methods to improve the communication skills of General Practice trainees (Kurtz 1996; Kurtz 1999; Laidlaw 2002; Makoul 1999).

In the last decade, efforts to synthesise the available evidence regarding the communication skills of physicians, as well as its teaching, learning and assessment abound (Kurtz 1998; Lewin 2001; Makoul 2001; Pendleton 2003; Silverman 1998; Stewart 2003). Such research offers a framework for understanding the meaning of the phrase 'improving the communication skills in the clinical consultation'. For the purpose of this review, we distinguish seven components within the framework. Interventions to improve communication skills can then be described by filling in each component of the framework. For each of these components, one or a mix of the possible alternatives can be applicable within an intervention, as follows:

1. Teaching content

The teaching of communication skills in the clinical consultation may focus on different content, leading to the following subdivisions. An initial distinction can be made on the basis of teaching that focuses on general communication skills compared with a focus on specific communication skills (such as conveying bad news, or skills to deal with patients with a specific problem). Second, the teaching content can focus on specific verbal or non‐verbal aspects of communication skills. Third, teaching can focus on some or on all of the different communication tasks possible in a clinical consultation. According to the Kalamazoo consensus, for example, seven essential sets of communication tasks can be identified:

  1. build the doctor‐patient relationship;

  2. open the discussion;

  3. gather information;

  4. understand the patient's perspective;

  5. share information;

  6. reach agreement on problems and plans; and

  7. provide closure (Makoul 2001).

A final distinction can be made on the basis of the teaching focussing on some or on all of the consecutive phases of the clinical consultation. For example, the Calgary‐Cambridge guide outlines five distinct phases in the consultation:

  1. initiating the session;

  2. gathering information;

  3. physical examination;

  4. explanation and planning; and

  5. closing the session (Kurtz 2003).

2. Teaching and learning method

The methods used to teach communication skills may also vary. For example, we distinguish betwen the instructional or traditional teaching method, where the skills are taught by lecture or by demonstration beforehand, and the experiential method where trainees first apply the skills and later receive feedback from the teacher (Aspegren 1999). In the context of experiential learning, the introduction of patient feedback seems to be a promising method (Greco 2001).

3. Teaching material

A distinction can be made between different teaching materials, for example, between text books and interactive media.

4. Teaching delivery format

The teaching can take place on a one to one basis, in small group or in large group settings.

5. Timing and frequency of the teaching

Teaching can have variable duration, can take place at different stages of the vocational training and may be organised for delivery at different frequencies.

6. Teachers

The teaching can be delivered by peers, medical academics, standardised patients or real patients.

7. Assessment

Following the Kalamzoo II consensus, there are three basic methods for assessing communication skills:

  1. checklists of observed behaviours in interactions;

  2. surveys of patients' experience in interactions; and

  3. examinations using oral, essay or multiple choice response questions (Duffy 2004).

According to this same consensus report, communication assessment tools can themselves be categorized in the following way:

  1. ratings of direct observation of interactions with real patients;

  2. ratings of simulated encounters with standardized patients;

  3. ratings of video‐ or audio‐taped interactions;

  4. patient questionnaire or survey; and

  5. examination of knowledge, perceptions and attitudes (Duffy 2004).

A further distinction can be made based on the intended rater. This can be:

  1. a faculty observer;

  2. a standardised patient; or

  3. a real patient (Schirmer 2005).

Finally, it is important to consider the time interval between the training session and the assessment of the learned communication skills. Improved communication skills measured at a longer time interval, for example, provides evidence of the persistence of the effects of training.

For the purpose of this review, we consider communication to include all verbal and non‐verbal interactions between General Practitioners and health care consumers during clinical consultations. In this context, we consider communication skills to represent the abilities of General Practitioners to facilitate these interactions with consumers.

We will exclude interventions occurring before the consultation from this review, as these interventions are subject to a distinct systematic review produced by the Cochrane Collaboration (Kinnersley 2006). Although potential overlap may occur between the current review and the Cochrane review by Lewin 2001, this review will focus explicitly on the vocational training phase of general practice trainees and will examine the acquisition of a broad set of communication skills. In comparison, the review by Lewin 2001 focuses specifically on the acquisition of patient‐centred skills. Similarly there may be a potential overlap between the current review and the forthcoming Cochrane review by Car 2005, which examines interventions to improve patients' trust in doctors. The most important difference between the two reviews in this case is our specific focus on the vocational training phase of general practice training and Car's specific focus on outcomes related to trust. This review also differs from the Cochrane review by Moore 2004. These authors focus on cancer patients and on outcomes related to changes in behaviour or skills measured using objective tools. In comparison, our review will focus on general practice patients and will primarily assess patient outcomes, which may make this review more relevant to consumers.

This review will also share some common ground with the review by Hulsman which focusses on clinically experienced physicians, including graduates (residents) as well as postgraduates (Hulsman 1999). Our review will differ from this earlier review, however, by systematically reviewing the literature, including the recent literature since 1999. Our review will also specifically focus on vocational trainees in general practice. In summary, although several reviews share common aspects with this review, none of these reviews specifically consider the defined question that this review seeks to address.

Objectives

The aim of this systematic review is to assess the effects of educational interventions to improve the communication skills of General Practice trainees during clinical consultations. The review will examine the effects of these interventions primarily on patient‐related outcomes such as satisfaction with care, patients' assessment of the quality of communication during the clinical consultation, patients' health care behaviour, including adherence to therapy and management plans, and health outcome measures such as blood pressure or glucose control. The review will also examine the effects of the interventions on trainee‐related outcomes, such as trainee performance in real patient consultations, trainee competence, such as that measured by an Objective Structured Clinical Examination (OSCE), and trainee knowledge of communication skills. Furthermore, the review will examine whether different educational strategies yield different results across these outcomes.

Methods

Criteria for considering studies for this review

Types of studies

Studies that will be considered eligible for inclusion in this review include the following: randomised controlled trials (RCTs), controlled (non‐randomised) clinical trials (CCTs), controlled before‐and‐after studies (CBAs) and interrupted time series (ITS).

The comparison group will in each case be composed of those not receiving specific educational interventions, or of those receiving educational interventions other than communication skills training (such as technical skills training or training in critical appraisal of the medical literature).

Trials comparing the effects of two different educational interventions to improve communication skills will also be included in this review.

Types of participants

Regarding trainees, the following will be elgibile for inclusion: vocational trainees in general practice; postgraduate residents in general practice, family practice or primary care; and postgraduate registrars in general practice, family practice or primary care. Trainees who complete the vocational training but not the other requirements needed for membership of a college of general practitioners will also be included. There will be no exclusion for trainees following a vocational program of which part is hospital based, even when the communication skills intervention takes place during the hospital years.

Regarding trainees, the following will be excluded from the review: undergraduate students and registered or clinically experienced physicians.

For those studies in which the trainees participate together with students or registered physicians, we will seek data specifically relating to the skills of the trainees. If necessary, we will retrieve additional information from the authors of the included studies. If the trainees' communication skill level cannot be established, these studies will be excluded from the review.

In terms of the patients participating in the clinical consultation there will be no restrictions for age, gender, ethnicity or health condition.

Types of interventions

Any educational intervention that aims to improve communication skills in the clinical consultation will be included. Communication skills will include all verbal and non‐verbal interactions between trainees and health care consumers during clinical consultations. Interventions that aim to improve global communication skills are included, as will those that focus on a specific skill such as patient‐centred interviewing skills, strategies to convey negative (bad) news, or skills to deal with a specific problem. Interventions focussing on one or more of the communication tasks, or on one or more of the phases of the clinical consultation will also be included.

Interventions to improve communication where the patient speaks a different first language to the GP will be excluded, as will interventions based on written patient information material and interventions occurring prior to the consultation.

To be included in this review, the timing of the intervention must occur during the vocational training period, even when a part of it is hospital based and the intervention takes place during these hospital years.

There is no limitation with respect to the learning and teaching methods used in the intervention. This means that experiential learning, as well as instructional and text‐book learning, are included. Interventions based on patient feedback will also be included.

Interventions in which the communication skills constitute one part of a broad, multifaceted intervention related to general practice training will be included in the review, but will be evaluated only for their communication skills aspect. If necessary, authors of these studies will be contacted for additional information in order to obtain the specific data with which to evaluate the communication skills training. If the data are not available, these studies will be excluded from the review.

Types of outcome measures

A number of outcomes might be affected by the interventions described above. We will extract all outcomes and group them by distinguishing between primary, or patient‐related outcomes, and secondary outcomes more closely related to the trainee or to the consultation process or content.

Primary outcomes

  1. Consumer satisfaction with care, including: satisfaction with the received care; and satisfaction with the care environment.

  2. Consumer assessment of the quality of the clinical consultation, including: consumer involvement or participation in discussion or decision making; consumer satisfaction with communication, e.g. with the information provided or the ways in which decisions are made; and consumer understanding of the information, options and choices provided.

  3. Patients' health care behaviour, including: adherence to management plans and therapy.

  4. Health outcome measures, including: health‐related quality of life; physiological measures of disease control, including blood pressure and blood sugar control; and psychological health of patient.

Secondary outcomes

  1. Trainee use of communication skills in clinical consultations with real patients in day‐to‐day practice.

  2. Trainee competence with communication skills, such as during Objective Structured Clinical Examination (OSCE) with standardized patients.

  3. Trainee knowledge of communication skills, such as knowledge about the skills necessary for different clinical consultations.

  4. Subjective trainee outcomes, including: satisfaction with the clinical consultation; and self‐confidence.

Search methods for identification of studies

We will use an explicit search strategy developed with the Cochrane Consumers and Communication Group to search the following databases:

  • Cochrane Consumers and Communication Review Group Specialised Register,

  • Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 4, 2005)

  • MEDLINE (1966‐present),

  • EMBASE (1985‐present),

  • ERIC (1966‐present)

  • and PsycINFO (1987‐present).

We will not exclude papers in other languages than English.

We will go through the reference lists of relevant trials and reviews in order to identify additional relevant studies. Authors will be contacted for further information about their studies, and authors of included studies will be asked if they are aware of any other published or ongoing studies meeting our inclusion criteria.

The search strategy for MEDLINE is given below, and will be adapted appropriately to search other databases.

MEDLINE (Ovid)
1. Primary Health Care/
2. (primary care or primary medical care).tw.
3. (primary health or primary healthcare).tw.
4. general practice.tw.
5. Family Practice/
6. (family practice or family medicine).tw.
7. (general practitioner$ or gp$ or general physician$).tw.
8. (family physician$ or family doctor$ or family practitioner$).tw.
9. Physicians, Family/
10. Community Health Services/
11. (communit$ adj3 health).tw.
12. or/1‐11
13. exp communication/ or communicat$.tw.
14. Physician‐Patient Relations/
15. (doctor adj1 patient$ adj1 relation$).tw.
16. (doctor adj1 client$ adj1 relatio$).tw.
17. (physician$ adj1 patient$ adj1 relation$).tw.
18. (physician$ adj1 client$ adj1 relation$).tw.
19. (general practitioner$ adj1 patient$ adj1 relation$).tw.
20. (general practitioner$ adj1 client$ adj1 relation$).tw.
21. (doctor$ adj1 consumer$ adj1 relation$).tw.
22. (physician$ adj1 consumer$ adj1 relation$).tw.
23. (general practitioner$ adj1 consumer$ adj1 relation$).tw.
24. interpersonal relation$.mp. or Interpersonal Relations/
25. exp "Referral and consultation"/
26. consultation$.tw.
27. (consultati$ adj3 skill$).tw.
28. (counsel$ adj3 skill$).tw.
29. (interview$ adj3 skill$).tw.
30. exp Medical History Taking/
31. medical interview$.tw.
32. interviews/
33. anamnesis.tw.
34. ((patient$ or client$ or consumer$) adj3 interview$).tw.
35. Patient‐Centered Care/
36. (patient centered or patient centred).tw.
37. (client centered or client centred).tw.
38. (consumer centered or consumer centred).tw.
39. (family centered or family centred).tw.
40. clinical encounter$.tw.
41. (doctor$ adj1 patient$ adj1 interaction$).tw.
42. (physician$ adj1 patient$ adj1 interaction$).tw.
43. (general practitioner$ adj1 patient$ adj1 interaction$).tw.
44. (doctor adj1 client$ adj1 interaction$).tw.
45. (physician$ adj1 client$ adj1 interaction$).tw.
46. (general physician$ adj1 client$ adj1 interaction$).tw.
47. (doctor$ adj1 consumer$ adj1 interaction$).tw.
48. (physician$ adj1 consumer$ adj1 interaction$).tw.
49. (general practitioner$ adj1 consumer$ adj1 interaction$).tw.
50. history taking.tw.
51. or/13‐50
52. Education, Medical, Graduate/
53. Education, Medical, Continuing/
54. "Internship and Residency"/
55. (resident$ or residency).tw.
56. (clinical education or graduate education).tw.
57. competency based education/
58. postgraduate$.tw.
59. (general practice registrar$ or family practice registrar$).tw.
60. (general practice resident$ or family practice resident$).tw.
61. (general practice trainee$ or family practice trainee$).tw.
62. or/52‐61
63. 12 and 51 and 62
64. randomized controlled trial.pt.
65. controlled clinical trial.pt.
66. randomized controlled trials.sh.
67. random allocation.sh.
68. double blind method.sh.
69. single blind method.sh.
70. or/64‐69
71. animals/ not (human/ and animals/)
72. 70 not 71
73. clinical trial.pt.
74. exp Clinical Trials/
75. (clin$ adj25 trial$).ti,ab.
76. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab.
77. placebos.sh.
78. placebo$.ti,ab.
79. random$.ti,ab.
80. research design.sh.
81. or/73‐80
82. 81 not 71
83. exp Evaluation Studies/
84. Follow‐Up Studies/
85. Prospective Studies/
86. (control$ or prospectiv$ or volunteer$).tw.
87. Cross‐Over Studies/
88. Comparative Study/
89. or/83‐88
90. experiment$.tw.
91. (time adj series).tw.
92. (pre test or pretest or (post test or posttest)).tw.
93. (preintervention or pre intervention or (postintervention or post intervention)).mp. [mp=title, original title, abstract, name of substance, mesh subject heading]
94. (impact$ or intervention$ or chang$).tw.
95. effect$.tw.
96. or/90‐95
97. 89 or 96
98. animals/ not (human/ and animals/)
99. 97 not 98
100. 72 or 82 or 99
101. 63 and 100

Data collection and analysis

Two reviewers (MvN and KH) will independently assess the potential relevance of all titles and abstracts identified from electronic searches. Full text copies of all articles judged to be potentially relevant will be retrieved. At least two reviewers will then independently assess these retrieved articles for inclusion. During a meeting of all reviewers, we will verify the final list of included and excluded studies. Any disagreements about particular studies will be resolved by discussion. If the description of a study is insufficiently detailed to allow the reviewers to judge whether it meets the review's inclusion criteria, the authors will be contacted to obtain more detailed information to allow a final judgement regarding inclusion or exclusion.

For every included study at least two reviewers will independently perform the data extraction. Any discrepancies between the reviewers' data extraction sheets will be discussed and resolved by the reviewers who performed the data extraction. When necessary, we will involve another reviewer to resolve discrepancies. If data are missing we will attempt to contact the authors of the studies to obtain the information. If the authors cannot be reached, or if the studies are found to be unsatisfactory on the basis of data provided, these studies will be excluded.

Data will be extracted from all included studies using a standard form derived from the data extraction template from the Cochrane Consumers and Communication Review Group. The following data will be extracted:

  • Details of study: study design; key features of allocation; description of the comparison group; baseline measurement; contemporaneous data collection for intervention and control groups; and for interrupted time series, the number of data points collected before and after the intervention.

  • Methodological quality: allocation procedure; protection against contamination; whether baseline measurements were made; whether outcome assessors were blinded; whether an intention‐to‐treat analysis was used; whether there was potential for unit‐of‐analysis error for some outcomes and, if so, whether this was acknowledged and/or appropriate adjustments made; and for interrupted time series, whether the intervention occurred at a clearly defined point in time, and whether there were at least three data points collected before and three data points collected after the intervention delivery.

  • Participants: trainees (number, age, gender, ethnicity, year of residency); patients (number, real patient, standardized patient, age, ethnicity, specific patients' health issues); and trainers (number, graduation such as General Practitioner, Psychologist or other).

  • Geographical location: country; health care system; location of medical education and General Practitioner registration.

  • Clinical setting: mixed General Practice consultations; or consultations focused on a particular subject, such as smoking cessation, alcohol abuse, preventive care, psychological distress, or counselling.

  • Intervention: full description; stated theoretical/conceptual basis; training strategies used; how delivered/ where delivered/ who delivered by; duration and timing (frequency, first or second years' residency); focus on a specific skill (such as patient‐centered interviewing, counseling skills, consultations skills in the psychosocial domain, etc).

  • Outcomes: primary and secondary outcome measures; assessment tools; training of the assessors; patient participation in the assessment; and timing of the outcome assessment.

  • Study's conclusions: conclusions made by the study authors.

Methodological quality

Two reviewers will independently asses the quality of each eligible study. The criteria included in the data collection checklist of the Cochrane Effective Practice and Organisation of Care Review Group (EPOC) (http://www.epoc.uottawa.ca/checklist2002.doc) will be used to assess the quality of each of the four study designs that are eligible for inclusion (RCT, CCT, CBA, ITS). For each criterion, the reviewers will indicate whether it was 'done', 'not done' or 'unclear'. Disagreements will be resolved by discussion, and when necessary will include another reviewer to resolve any discrepancies. Studies with a 'not done' criterion or with two or more 'unclear' criteria will be considered as studies compromised by flaws in their design or execution that render them unlikely to provide reliable data. These studies will be presented to all reviewers for assessment of quality using the same EPOC checklist. Whether or not these studies are excluded will then be decided in a meeting of all reviewers. The reason for exclusion for each disallowed study will be based on at least one 'not done' criterion, or on at least two 'unclear' criteria on the EPOC checklist, and will be listed in the table of excluded trials.

Consumer participation

The protocol and the draft review will be circulated for Cochrane Collaboration consumer peer review. We will examine whether consumers were involved in the design and implementation of each included study. In addition, we plan a systematic review of the literature on General Practice consumers' needs and preferences concerning communication in the clinical consultation. We will check to what extent the included studies of the current Cochrane review address the issues that emerge from the consumers' needs and preferences literature review. This will be presented in the discussion section of the current Cochrane review.

Analysis

Once we have completed all previous steps, we will look for studies sufficiently similar in terms of study design, setting, intervention, follow‐up and outcome measures in order to combine the study data in a meta‐analysis. A meeting of all reviewers will decide whether or not it is appropriate to carry out such a meta‐analysis. If such a meta‐analysis is found to be appropriate, we will compare the effects of different teaching tactics on the outcome measures. For continuous data, where outcomes have been measured in a standard way across studies, the weighted mean difference and confidence intervals will be reported. For dichotomous data, when outcomes have been measured in a standard way the odds ratio and confidence intervals will be reported. A cautious approach to combining results will be taken at every stage, and the rationale will be clearly detailed.

Considering the complexity of the subject of this review, we anticipate that meta‐analysis will only be feasible for some subgroups. The identifiaction of subgroups will be based on differences relating to the outcome measures, as follows: subgroups of interventions focussing on particular patient‐related outcomes; subgroups of interventions focussing on a specific communication task or skill; and subgroups of interventions focussing on improving communication skills more broadly. Because we expect to find heterogeneity in study design, interventions and outcome measures, we will conduct a descriptive review of the included studies, presenting both a narrative summary and summaries of the extracted data in appropriate tables and figures.

We will classify the studies based on the following issues:

  • Study design: RCTs, CCTs, CBAs, ITS.

  • Outcome measures used: consumer satisfaction with care; consumer assessment of the quality of the clinical consultation; patient health behaviour; patient health outcome measures; and trainees' performance, competence or knowledge about communication skills in the clinical consultation.

  • Focus of the intervention on different teaching contents: improving global communication skills; or improving a specific communication task or a specific skill, such as sexual history taking, finding common ground, conveying bad news, etc.

  • The teaching and learning method used within the intervention: traditional, experiential or a mix.

  • The teaching material used within the interventions: such as text books or interactive media.

  • The teaching delivery format: one to one, small groups or large group settings.

  • Timing and frequency of the teaching: stage of the vocational training (first year, second year or third year; hospital years versus general practice years); duration of the teaching and frequency of the teaching.

  • Delivery of the teaching: delivered by peers, medical academics, standardised patients or real patients.