First aid in acute stroke

Objective First aid training is well established to teach the public how to recognize a medical emergency and take appropriate action. Though it is now handled as a high priority emergency stroke is not among the main topics of first aid. We investigated if first aid training may be useful for enhancing stroke awareness.
Introduction
First aid is a concept of first hands-on measures performed in a medical emergency by laypersons. The goal is to teach people how to recognize a medical emergency and start qualified action by providing measures of basic life support such as performing cardiopulmonary resuscitation. Other topics are injuries and burns, shock, unconsciousness or heart attack.
In Germany first aid training is mainly offered by charity organizations like the German Red Cross, or the St. John Ambulance. There are various training programmess differing in length and depth of information. First aid training was effectively used to teach the public in new methods of life-saving therapy like automated external defibrillation [1].
Stroke or brain attack is not or only marginally included in first aid training. This is in contrast to the fact that management of acute stroke changed as it is now handled as a high priority emergency [2]. Limited knowledge of signs, symptoms and risk factors for stroke was noted as an important factor associated with delay of admission [3–5]. To enhance awareness on stroke, various educational programmess have been initiated [3, 6–8
]. The American Stroke Association’s Operation Stroke, a huge awareness campaign on stroke, the Coordinated Stroke Programme of Southwestern Ontario and King County’s Medic One at seattle are examples of continuous health education programmes using internet, designated courses and mass media. Regular first aid training was never used in a stroke information campaign though it is widely available and well accepted in many countries.
In a prospective study we tried to test the hypothesis that stroke information integrated in first aid training will improve knowledge of laypersons. Additionally a concept of first action will increase motivation and acceptance will be quite high with participants.
Methods
Educational procedure
A teaching sequence was created by stroke neurologists of the University of Erlangen together with senior instructors of the St. John Ambulance (Johanniter-Unfall-Hilfe) in Bavaria. Educational objectives of the session were clearly defined. The sequence was designed for a 15 to 20 minutes audiovisual presentation and provided information basically what stroke means and about stroke risk factors, warning signs and symptoms. Warning signs presented included sudden uni- or bilateral weakness or numbness, facial paresis, speech disturbance, blurred vision, trouble in walking, vertigo/ dizziness, diplopia. Then a concept of first action to be taken in case of stroke was presented (Figure 1 shows a one-slide overview). including check of vital signs and immediate activation of EMS.
Fig. 1Concept of first action presented in the stroke lesson (originally presented in German)
The teaching session was presented by first aid instructors integrated in regular first aid training programmes of 8 to 16 hours duration of the St. John Ambulance all over Bavaria. A small booklet was made for the first aid instructors to provide more detailed information about stroke.
Data collection and analysis
To investigate the effect of the teaching, all participants of designated courses were asked to fill out a questionnaire before the stroke lesson. At the end of the training program a similar questionnaire was presented slightly altered in structure and some questions. The overall length of the training courses differed as some courses were presented on a whole day schedule within one weekend while others offered one 90-minute teaching unit once weekly and were therefore scattered over a period of up to 6 weeks. Accordingly the time delay between the stroke lesson and the post-teaching questionnaire varied as well ranging from 1 to 28 days (mean 8.6 d).
Before teaching participants were asked to note in free text and explain what they think that a stroke is, to name signs and symptoms of stroke and to describe how they would act in case of witnessing stroke. Additionally sex, age and profession of participants was recorded as well as their previous information about stroke After the lesson we asked again for a definition of stroke and to list symptoms of stroke. Furthermore we asked how urgent they think that a stroke needs to get therapy. After all subjects were asked for their satisfaction with the training session, how they would rate their own interest in stroke and how they would rate the importance of stroke as a topic in first aid. Therefore a rating scale from 1 to 6 was given with 1 being the best, 6 the worst.
Participants with any profession within health care were excluded from the analysis. The questionnaire was not offered in trainings for special groups such as in schools or nursing homes.
Mean values were compared using paired t-tests while χ²- statistics were used for proportions of nominal data.
Results
In 38 first aid training courses 532 participants (86.6% of 614 subjects attending the training) completed the questionnaire before and after training, 53.6% of those were male, mean age was 28.6 years (+/− 11.1 y, range 15–61 y).
Before training 28.4% of all participants stated a correct description of stroke, another 32.7% gave at least the brain as the location of the disease. The mean number of stroke symptoms named was 1.52 (± 1.1), descriptions listed were mainly “weakness”, “motor problems” “disturbance of consciousness” or “speech problems”, 12.8% of all respondents did not list at least one correct stroke symptom or warning sign, 40.7% listed symptoms that are not typically suggestive of stroke (coded as incorrect). The mean number of first aid measures named was 1.22 (± 1.0). 78.7% of respondents stated that they had any kind of information about stroke before the training.
After the stroke lesson 69.9% of the participants stated a correct description of stroke, and 20.3% gave at least the brain as the location of the disease. Now the mean number of stroke symptoms named was 3.35 (± 1.4). 58.5 % declared that in case of stroke urgent treatment is needed . See table 1 for an overview of key results.
Table 1Key results from the questionnaire before and after receiving the stroke lessonn = 532before stroke lessonafter stroke lessonmean numberno. of stroke signs1.523.35p < 0.001no. of first measures1.22not asked% of participantscorrect explanation what stroke means 28.469.9p < 0.001brain affected organ32.720.3p < 0.01no/incorrect explanation38.9 9.8p < 0.01> 4 symptoms listed 2.628.4p < 0.001 no symptom listed12.8 3.6p < 0.001“immediate medical help required”not asked58.5prior information about stroke78.7
Most participants were satisfied with the stroke lesson as the mean value in the score (1 = best to 6 = worst) was 1.76 (± 0.6), interest in topics of stroke was rated high (mean 1.56, ± 0,8). Stroke was regarded as an important topic for first aid training. (mean 1.57, ± 0,9). The difference in mean number of symptoms named before and after the lesson was highly significant (p < 0.001), as well as the difference in percentage of participants giving a correct definition of stroke (p < 0.001) and those naming more than 4 symptoms. In contrast the number of participants not listing at least one symptom and giving none or an incorrect definition of stroke was significantly reduced after the training.
Discussion
To our knowledge this is the first study published reporting about first aid training for public education on stroke. A teaching session was integrated in regular first aid training offered to the public by the St John Ambulance.
From data of this pilot study the teaching session was very effective: Mean number of stroke symptoms and number of participants giving a correct description of stroke more than doubled.
The difference in number of symptoms and portion of participants describing stroke symptoms correctly was highly significant. Nevertheless with a mean delay between teaching and retention test below 10 days these results show only the short-term effect and durability of the information remains unclear. From other studies in teaching medical skills to laypeople we know that knowledge is reduced by about 25% over the first three months and may remain stable thereafter [9]. One year may be critical period for repetition of training [10]. However, participants showed also a high grade of satisfaction with the lesson and its presentation, and ranked importance of stroke as a topic quite high. As a consequence of these results the lesson is now integrated in every first aid training of the St. John Ambulance in Bavaria.
Before this study there was no clear cut concept existing for first action in acute stroke. Despite the fact that calling EMS accelerates admission [11] the effect of all these actions performed by medical laypersons on stroke progression or outcome is not yet proven.
However, it takes about 15 minutes from starting the call to arrival of EMS on scene [12]. During this time a bystander should be able to offer help to the patient. By presenting simple hands-on measures it is also emphasized that something can and must be done in case of acute stroke.
The effect of various educational interventions was already demonstrated in previous studies [3, 6–8].
None of these studies handled information on stroke integrated in general health education campaigns such as routine first aid training. From our viewpoint integrating a stroke lesson in first aid training is not only effective but provides a number of advantages. First an integration makes it clear that stroke or brain attack is an important medical emergency as important as heart attack or trauma.
Connecting brain attack with other medical emergencies also facilitates the demonstration of measures as they could be used for other situations as well and it might help to create a better understanding to stroke and its differences from other related diseases. We linked stroke to other related topics (e.g. “head trauma”) and formed a cluster of measures for “all problems in the head” as an effort towards integrative problem-based teaching which was shown to be superior to conventional lessons also in medical education [13].
Second, by using first aid training information on stroke this will reach large numbers of subjects not particularly interested in stroke or sometimes health education at all. According to their annual review the St. John Ambulance, England, issued a first aid training certificate to more than 500000 people in the year 2003 [14], while the American Red Cross trained more than 11 million people in first aid [15]. In Germany within one year a driving license is issued to more than 800000 people mainly in the age of 16 to 21. By legal regulations every one of them must have completed at least an 8 hour first aid training. So first aid training may especially reach younger people that are not interested in stroke awareness campaigns. Furthermore, given the large numbers of people reached, this method of education is extremely cheap.
To summarize we found that a 15 minute presentation on stroke as a medical emergency improves stroke knowledge of participants in first aid training. Furthermore participants seem to appreciate getting information about stroke. Accordingly information on stroke or brain attack should be included in every first aid training thus reaching large numbers of subjects in many countries all over the world. Means of information may differ in their effectiveness [8, 16] but the question is not whether education integrated in training programs may be more effective than mass media campaigns. Both methods of information will rather be complementary as they use different approaches and may reach different target groups. The goal is not to miss any single opportunity to send out the message about stroke as a medical emergency that needs immediate reaction by anyone who is next.

first aid
acute stroke
knowledge
emergency medical service
healtheducation


Coronary fly-through or virtual angioscopy using dual-source MDCT data

Coronary fly-through or virtual angioscopy (VA) has been studied ever since its invention in 2000. However, application was limited because it requires an optimal computed tomography (CT) scan and time-consuming post-processing. Recent advances in post-processing software facilitate easy construction of VA, but until now image quality was insufficient in most patients. The introduction of dual-source multidetector CT (MDCT) could enable VA in all patients. Twenty patients were scanned using a dual-source MDCT (Definition, Siemens, Forchheim, Germany) using a standard coronary artery protocol. Post-processing was performed on an Aquarius Workstation (TeraRecon, San Mateo, Calif.). Length travelled per major branch was recorded in millimetres, together with the time required in minutes. VA could be performed in every patient for each of the major coronary arteries. The mean (range) length of the automated fly-through was 80 (32–107) mm for the left anterior descending (LAD), 75 (21–116) mm for the left circumflex artery (LCx), and 109 (21–190) mm for the right coronary artery (RCA). Calcifications and stenoses were visualised, as well as most side branches. The mean time required was 3 min for LAD, 2.5 min for LCx, and 2 min for the RCA. Dual-source MDCT allows for high quality visualisation of the coronary arteries in every patient because scanning with this machine is independent of the heart rate. This is clearly shown by the successful VA in all patients. Potential clinical value of VA should be determined in the near future.
Introduction
Coronary fly-through or virtual angioscopy (VA) using various generations of computed tomography (CT) devices has been reported in a number of publications since its first mention in 2000 [1–3]. Main reason for the minimal research on this topic was the limited application because of the requirements for an optimal CT scan and time consuming post-processing. Recent advances in post-processing software facilitate easy construction of VA, but until now image quality of coronary CT was insufficient in most patients. The introduction of dual-source multidetector CT (MDCT) has shown a more stable quality of data in all patients because of higher temporal resolutions, which could prove to enable VA in all patients and allow investigation of the clinical value of this visualisation technique [4–6].
Materials and methods
Twenty patients (13 male, mean age 60 ± 13 years old) were selected at random from patients scanned for coronary artery disease using a standard coronary artery protocol on a dual source MDCT (Definition, Siemens, Forchheim, Germany).
Post-processing was performed on an Aquarius Workstation (TeraRecon, San Mateo, Calif.). The software allows an automatic vessel fly-through, which provides inside front and rear views, together with a view of the path and location on the surface of the heart (Fig. 1). Besides this, three multiplanar reformation planes (sagittal, coronal and axial) are shown for the location of the camera. Length travelled per major branch was recorded in millimetres, together with the time required in minutes to perform the evaluation per major branch. Ostia of side branches were visualised, but no fly-through of those side branches was performed.
Fig. 1Large trajectory visualisation of the right coronary artery (RCA)
Results
VA could be performed semi-automatically with minor user interaction in every patient for each of the major coronary arteries using dual-source CT (DSCT).
The mean (range) length of the automated fly-through was 80 (32–107) mm for the left anterior descending (LAD), 75 (21–116) mm for the left circumflex artery (LCx), and 109 (21–190) mm for the RCA.
Calcifications were clearly visualised as white structures floating inside the lumen. Stenoses were visualised when present by indentations of the lumen wall (Fig. 2). Visibility of the actual size of the stent lumen was still limited, but fly-through was possible in the stents we found (Fig. 3).
Fig. 2Visibility of a stenotic lesionFig. 3Stent visibility
The major side branches of the main coronary arteries could be detected during the fly-through (Fig. 4). No fly-through was performed through those side branches.
Fig. 4Visibility of major side branches
The mean time required was 3 min for LAD, 2.5 min for LCx, and 2 min for the RCA.
Discussion
The introduction of DSCT enables 100% visualisation of all major arteries and thus demonstrates a major gain in image quality compared with electron beam CT (EBCT) and MDCT, with only 76% and 84% assessable, respectively [3].
Furthermore, the time required for processing the data decreased to about 2.5 min compared with the 6-13 min required in 2002 (Table 1). Notice that the times shown in the table for EBCT and MDCT do not include the actual computing time, which could be hours with the hard- and software at that time. Currently, all computation and visualisation is in real time and thus included in the 2.5 min required for a coronary fly-through of a major branch using DSCT data.
Table 1Results of an earlier study using EBCT and four-slice MDCT (4-MDCT) [3] in comparison with the DSCT results of the current study EBCT (2002)4-MDCT (2002)DSCT (2006)LAD Percentage assessable14/15 (93%)14/15 (93%)20/20 (100%) Mean preparation time (min)12133 Mean number of key frames1316n.a.LC Percentage assessable11/15 (73%)10/15 (67%)20/20 (100%) Mean preparation time (min)7102.5 Mean number of key frames913*n.a.RCA Percentage assessable9/15 (60%)14/15 (95%)20/20 (100%) Mean preparation time (min)6102 Mean number of key frames814n.a. Total percentage assessable34/45 (76%)38/45 (84%)60/60 (100%)The number of key frames is no longer applicable (n.a.) for the current software tools that can perform the coronary fly-through in real time
Different artefacts still hamper the fly-through. First, non-optimal reconstruction will present itself as a sudden change in the form of the vessel wall. The effects are shown in Fig. 5, and it will be clear that these artefacts can be easily recognised because of the non-natural shape of the wall. A more difficult artefact is cause by motion. Here, the artefact can be easily appreciated on the three-dimensional view, but in the fly-through it presents as a apparent stenosis (Fig. 6).
Fig. 5Problems with artefacts in non-optimal reconstructed datasetsFig. 6Problems with motion artefacts causing apparent stenoses
Finally, surgical clips in bypasses still pose a problem as already shown an earlier publication using EBCT [1] (Fig. 7).
Fig. 7Visualisation is hampered by presence of surgical clips in a bypass graft
All three articles that (to our best knowledge) are available on this topic conclude with similar remarks [1–3]. They all state that the coronary fly-through or virtual coronary angioscopy (VCA) is a promising technique that, however, requires higher quality of the datasets and better image processing software.
A shortcoming of our study was the lack of a “gold standard” to confirm the findings of the coronary fly-through.
Conclusion
Dual-source MDCT provides a high quality visualisation of the coronary artery tree, independently of the heart rate. This is clearly shown by the successful VCA in all 20 patients in this study. With recent advancements of image processing software and CT acquisition techniques, the conditions have been met for providing the technical basis for the clinical validation of VCA and the potential clinical value of VCA should be determined in the near future.

coronary fly-through
virtual angioscopy
post-processing
coronary arteries
dual-source ct


Participatory Workshops are Not Enough to Prevent Policy Implementation Failures: An Example of a Policy Development Process Concerning the Drug Interferon-beta for Multiple Sclerosis

A possible explanation for policy implementation failure is that the views of the policy’s target groups are insufficiently taken into account during policy development. It has been argued that involving these groups in an interactive process of policy development could improve this. We analysed a project in which several target populations participated in workshops aimed to optimise the utilisation of an expensive novel drug (interferon beta) for patients with Multiple Sclerosis. All participants seemed to agree on the appropriateness of establishing a central registry of Multiple Sclerosis patients and developing guidelines. Nevertheless, these policy measures were not implemented. Possible explanations include (1) the subject no longer had high priority when the costs appeared lower than expected, (2) the organisers had paid insufficient attention to the perceived problems of parties involved, and (3) changes within the socio-political context. The workshops in which representatives of the policy’s target populations participated did not provide enough interactivity to prevent policy implementation failure.
Introduction
There are numerous examples of health policy measures that have failed in their implementation. A review from the Netherlands Court of Audit indicated that no evidence of a full policy implementation can be found in previous audits [20]. For example, the applied measures for reducing greenhouse gas emissions have not met pre-determined targets, the legal rules for maintaining food safety have not been able to prevent targeted risks, and policy measures for cost control of medicines have not resulted in more structural cost control [19].
The theory of argumentative policy analysis offers a possible explanation for such policy implementation failures [8, 15]. The basic idea of this theory is that actors’ behaviours can be explained by different views on a problem and the argumentation behind these views. According to the argumentative approach to policy analysis [7, 8], action is driven by processes of problem setting [27] in which actors define coherent sets of problems and solutions that correspond to these actors’ normative and empirical background theories. The way in which problems are defined depends on the assumptions the actors make about the situation and their beliefs regarding what is good practice (normative values).
Combining these findings with those of classical implementation theory, Grin and Van de Graaf [10] have argued that a policy will only be effective if both implementers and target populations consider the proposed policy measure meaningful. (Target populations consist of persons who will experience the consequences of a policy when implemented.) This means that the proposed policy should (a) make sense in the light of problems perceived by the target populations and (b) be consistent with their normative and empirical background theories.
However, the fact that policy problems and associated solutions tend to shift over time, different actors with different background theories being involved successively, renders this rather complicated. In other words, a policy measure is not invented at a specific moment in time, but develops over time. Nevertheless, the challenge is to identify policy measures that cohere with the views of all actors involved.
If the argumentative policy theory is correct, then it is advisable to identify the policy’s target populations and involve them in the process of policy development. An interactive process of policy making could thus ensure that policy coheres with and prevent that it diverges from the views of target groups.
The objective of this paper is to analyse a specific instance where target populations were involved in the process of policy development. The policy institution in this example was the Health Care Insurance Board in the Netherlands (HCIB). It is an advisory board to the Ministry of Health, particularly with respect to coverage and reimbursement issues. The Department of Policy Analysis of Medicines (PAM) is responsible for identifying developments that may jeopardise optimal medical care, analysing the nature and size of such threats and conducting further research that may provide a basis for policy decisions. The annual work programme in which topics are prioritised is submitted to the Ministry of Health for approval.
The policy objective discussed in this paper was to promote the appropriate use of a recently introduced drug for patients with multiple sclerosis. Multiple Sclerosis (MS) is a neurodegenerative disease characterised by neurological dysfunction. The drug interferon-beta (IFNβ) appeared to be a promising treatment. However, its costs were high (€ 12,000 per patient annually) and the evidence of its long-term effectiveness was limited. Therefore, policy measures to guide the prescription of this medicine were considered necessary. Representatives of prescribing physicians (neurologists), health insurance companies, and patients were invited to participate in two workshops. During these workshops, participants discussed policy measures that could promote the appropriate use of the new drug. Although two concrete policy measures had been proposed, these have never been implemented.
In this paper we evaluated whether the theory of the argumentative policy analysis could explain the proceedings in this case study. It offers a description of the process of the policy development that included the two workshops, as well as an analysis of the views of policy makers and target populations in order to assess whether the proposed policy measures fitted the perceived problems and underlying background theories.
Methods
Relevant documents were analysed and semi-structured interviews were held with the various stakeholders. These documents included correspondence, reports from the Board, internal memos on this subject, a report from Health Council on interferon-beta, reports from meetings, research proposals, and research reports. Interviews were held with three HCIB employees, two employees from the Ministry of Health, the organisers of the workshops, two neurologists, a patient, and a medical advisor from a health insurance company. Participants of the workshops were contacted and interviewed to reconstruct the proceedings of the workshops. MS patients were contacted via a Dutch MS patient organisation. Representatives of target populations were interviewed to assess their problem definitions and underlying argumentation.
Interviews were transcribed verbatim. A summary from the interview and a concept report were sent to respondents for verification and literature was used to check the findings from interviews or documents. In line with the theory of argumentative policy analysis, we used the method of reconstructing interpretative frames to analyse target populations’ argumentation [10, 11, 18]. The idea is to reconstruct (1) how problems are defined, (2) how solutions or policy measures are judged, (3) what theoretical and normative assumptions shaped them, and (4) what normative preferences underlie this all. Together, these four ‘layers’ of evaluation entail an individual’s interpretative frame.
Results
Proceedings of Project
The content of the workshops was, to a large extent, determined by two reports concerning IFNβ. These had been issued by the HCIB and by the Health Council, respectively. In July, 1995, the Ministry of Health asked both institutions to provide advice regarding the introduction of IFNβ on the Dutch market. The Ministry asked for recommendations with respect to whether or not restrictions could be imposed on the reimbursement of the drug.
In May 1996, a committee from the Health Council reported to the Ministry of Health [9]. This committee was comprised of three neurologists, a chemical technologist, and a HCIB staff member. It concluded that IFNβ could be a promising new drug, but also cautioned against unrealistic expectations. Clinical trials had shown that IFNβ could decrease the rate and severity of exacerbations, but there was no evidence of IFNβ preventing the onset of disability. The Health Council emphasised that the drug should be prescribed only to patients who meet eligibility criteria for the trials. These criteria were: (a) clinically definite Relapsing Remitting MS; (b) at least two exacerbations in the two previous years; (c) mild to moderate disability; and (d) age of 18 years or older. The Council also proposed the following policy measures: (1) develop a guideline for treatment of MS patients with IFNβ; (2) ensure that the drug is prescribed by neurologists who have sufficient experience with the diagnosis and treatment of MS patients; (3) properly instruct and guide MS patients; (4) conduct a systematic follow up of patients using IFNβ in order to evaluate side effects; (5) provide clear indications on which patients should be treated with IFNβ; (6) establish a national registry of MS patients in order to conduct further research on the effectiveness of IFNβ; and (7) conduct a re-appraisal after a number of years.
June 1996, the HCIB issued recommendations that corresponded partially with the Health Council’s report [30]. The HCIB recommended that: (a) patients fulfil the criteria described in the Health Council’s report; (b) a treatment protocol be developed; (c) health insurers approve reimbursement requests before starting treatment; (d) a prospective registration be established; and (e) the use of IFNβ be re-assessed after 3 years. Restricting prescription to a limited number of experienced neurologists was considered impossible, because IFNβ had already been included in health care packages.
In 1999, the department of Policy Analysis of Medicines (PAM) started a project on IFNβ. Initially it they considered evaluating other, less expensive interventions that could be effective, but are of no interest to the industry. Indications had been received from the field that a much cheaper drug, namely methotrexate (used in oncology and rheumatoid arthritis), could be as effective as interferon. Furthermore, PAM considered developing a national database of MS patients. PAM later decided that conducting a clinical trial was not its responsibility. PAM staff, in collaboration with neurologists, decided to initiate the development of a treatment protocol and a national registry of MS patients. They proposed the organisation of two workshops.
Workshops
In 2000, these workshops were organised by an external institute for policy research. The first workshop aimed to provide an overview of the criteria that are used for prescribing IFNβ. This workshop was preceded by an inventory study amongst health insurance companies into current reimbursement practices with respect to IFNβ. This inventory study was performed by a HCIB department. The results from the inventory study on current reimbursement practices indicated that health insurance companies did not assess reimbursement requests against medical content. Assessments were limited to an administrative review of the completeness of data [4]. Nevertheless, health insurance companies considered the pre-utilisation approval effective, because it functioned as an administrative barrier. The authors of this report recommended the following: (a) assess whether a pre-utilisation approval by a central committee could improve the assessment of reimbursement requests; (b) develop a clear protocol and design application forms.
Neurologists, medical advisors from health insurance companies, policy makers, and a representative from a patient organisation participated in the workshop. During the workshop, vignettes with patient descriptions were used to discuss which patients should be treated with IFNβ. The organisers concluded that only a few problems were perceived with respect to criteria for IFNβ use. Health insurers questioned whether the situation was indeed problematic given the small size of the patient population and IFNβ’s status as an essential medicine. Neurologists argued that problems arose incidentally. Most often, these problems were related to reimbursement requests for continued use of IFNβ. All participants agreed that subjectivity in decisions on prescription should be minimised. The participants claimed that clear distinctions should be made between the criteria for initialising treatment and the criteria for continuing treatment. The development of a guideline by neurologists was considered relevant. According to the participants, small adjustments of the current criteria would be sufficient [2].
The second workshop aimed to obtain advice on how existing databases could be improved so that the effects of IFNβ or other new drugs for MS patients could be evaluated. In preparation for this workshop, a neurologist was asked to make an inventory of available databases that contained data on IFNβ users. This inventory showed that data on MS patients were no longer being collected systematically in the Netherlands [2]. Former local databases were no longer up-to-date. The participants in the workshops agreed that a national database could be relevant and could serve the following goals: (a) policy making (such as financial surveys, planning health care capacity); (b) research (effects of treatment; monitoring for side effects); and (c) clinical practice support for neurologists (reflection on clinical practice, improvement of expertise). Participants agreed on the inclusion of general static data in the database, such as demographic details, diagnosis (type MS), the criteria used to make the diagnosis, and the initial treatment. Participants disagreed on the kinds of dynamic data, such as treatment details and information on physical functioning. A database including a broad range of data could be useful for research, but this was considered expensive. A small database that includes static data only could be used as a sample frame for selecting potential participants in further studies. In their report, the organisers concluded that additional research was needed to ascertain which variables should be included in the database.
Proposed Policy Measures
Based on the organisers’ report, the HCIB proposed the following policy measures to the Ministry of Health [5]:Have neurologists develop an evidence-based guideline for the treatment of patients with multiple sclerosis.Have reimbursement requests for IFNβ appraised on medical grounds. Possibly, implement a central pre-utilisation approval by experts (neurologists).Define clear criteria for (dis)continuing IFNβ reimbursement.Establish a national registry of MS patients. The database should enable scientific research, the improvement of treatments, monitoring, and the evaluation of efficiency and therapeutic value of new interventions.
In 2003, a medical advisor from a health insurance company mentioned that some small changes had been made to the procedures established for judging reimbursement requests (requests for continued use). A neurologist mentioned working on a guideline for diagnosis and treatment of MS patients. According to a PAM staff member, neither a central pre-utilisation approval nor a national database to prospectively register patient data had been established.
Reconstructed Interpretative Frames
In June 2003, we conducted interviews to reconstruct interpretative frames of policy makers and policy’s target populations. The actors’ views are summarised in Table 1 (IFNβ guideline) and Table 2 (national database).
Table 1Views towards guideline concerning IFNβ useActorJudgement of solutionaProblem definitionBackground theoriesNormative valuesMinistry of health (1996)+Clear criteria for reimbursement IFNβ neededIFNβ is an expensive medicine; uncertainty on meaning of effects Possibly inappropriate use because high expectationsOnly if evidence of effectiveness is available, a medicine can be at the expense of the community Cost control EfficiencyPAM staff+ A central pre-utilisation approval for IFNβ use A clear treatment protocol on IFNβ should be availableHealth insurance companies judged reimbursement requests differently Individual health insurer lack expertise to judge reimbursement requestsDifferences in judgement result in differences in care Situation IFNβ resembles situation growth hormones, for which a central pre-utilisation approval in combination with central registration was set up Central pre-utilisation approval prevents inappropriate useCost control; efficiency Equal accessibilityPAM staff (2003)− Central pre-utilisation approval no longer neededSituation concerning IFNβ was relatively stable; no longer problems concerning reimbursement requests Costs committee higher than possible savings IFNβ useCriteria for central pre-utilisation approval: – medicine is expensive – inappropriate use expected – decisions on treatment are complexCost control EfficiencyMedical advisor health insurance company+ Guidelines on IFNβ needed for decisions reimbursementUnclear when IFNβ is (still) meaningful Pharmaceutical companies benefit from extending criteria Expensive drugs are financed from public funds, on a solidarity baseCost control Neurologist+ Not guideline on IFNβ solely but guideline on diagnosis & treatment MSIncrease possibilities for diagnosis and therapy; variance in MS careAs in other fields increasing attention to evidence based medicine Provide clarity for neurologists on how to care patientsPatient+ National guideline might be usefulDifferences between hospitals care (IFNβ not offered in every hospital; contradictory advises on lifestyle)No common knowledge on MS Prognosis differs between individualsImprove or maintain quality of lifea‘+’ actor defines the intervention meaningful; ‘−’ intervention is not meaningfulTable 2Views towards a national registry of MS patients or IFNβ usersActorJudgement of solutionaProblem definitionBackground theoriesNormative valuesMinistry of health (1996)+ For evaluation long-term effectsUncertainty on (meaning of) effects of IFNβOnly medicines of which evidence of effectiveness is available at the expense of the community If no evidence on effectiveness, use is inappropriateEfficiencyPAM Staff + Database with only limited patient data to take samples for research or Database with all relevant data for researchFor each new medicine a study on effectiveness is inefficient Health insurance companies judged reimbursement requests differently, leading to difference in health careAim of national database to optimise IFNβ prescription: to monitor use of IFNβ in practice (which patients (indications), volume, costs) and to evaluate effectiveness IFNβ Efficiency PAM Staff (2003)− Registration without central judgement committee difficultCentral committee no longer relevant No problems perceivedCentral pre-utilisation judgement provides a minimal registration of patient data Efficiency Medical advisor of health insurance company+ Prospective database only way to assess long-term effectivenessJudgement of relative value as compared to alternative interventions not systematically but only in the neurologists headExpensive drugs are financed from public funds Pharmaceutical industry’s power is underestimatedClear vision from the ministry of health on pharmacy Quality of careNeurologist+ Meaningful for evaluating effectiveness of medicines and knowledge on MS National coverage might be difficultClinical trials have limited follow up period Distrust amongst neurologistsMS is a chronic disease, invalidating on long term MS neurologists have their own “kingdoms”Quality of care Increase knowledge on disease and treatmenta‘+’ actor defines intervention as meaningful; ‘−’ intervention is not meaningful
Ministry of Health
Initially, the Ministry contended that the long-term effectiveness of the drug was not established sufficiently, while the acquisition costs were high. Trials had shown that IFNβ decreased the number of exacerbations, but it was unknown whether IFNβ would prevent disability. The potential target population, namely patients with MS, is large and the expectations of both patients and physicians may also have been high. As a result, the risk that the drug could be used inaccurately was considered to be high. Consequently, additional policy measures to control IFNβ use in clinical practice were requested.
According to employees from the Ministry of Health, the HCIB report [5] had revealed that only health insurers perceived few problems with respect to judging reimbursement requests. The costs of a committee for a central pre-utilisation approval were considered relatively high, while the costs of the interferon-beta prescription were less than expected, namely €18 million (in 1999) versus the €90-180 million estimated by the Ministry. Therefore, both interventions were considered to be no longer relevant.
PAM Staff
According to the PAM staff, the main problem was that the use of IFNβ was expected to extend to other subgroups of patients. A central pre-utilisation approval in combination with a national registry of MS patients could provide a solution. This contention was made because the situation concerning IFNβ resembled the situation concerning other drugs for which a central pre-utilisation approval had already been established. In that case, requests for reimbursement of drug use were judged by a central committee of medical experts. For this purpose, a clear protocol including criteria for IFNβ use is needed. Simultaneously, patient data were recorded in a national registry.
At the time that PAM staff started their project, it was undesirable to evaluate why the proposed policy measures had not been implemented until then. Reason was a change in the relationship between the HCIB and the Ministry of Health. In 1999, the HCIB, an independent advisory board, was established as the successor to the Sickness Funds, which was a politically involved advisory board comprised of actors from the field.
After completion of the project, the PAM staff considered the option of having reimbursement requests judged by a central committee no longer meaningful. They considered the implementation of policy measures difficult because the drug had already been introduced several years earlier. Limiting or discontinuing the reimbursement of IFNβ would have been practically impossible. Furthermore, the scale of problems relating to the prescription and/or reimbursement of IFNβ and the costs related to IFNβ use turned out to be much smaller than expected. PAM considered the initiation of a national MS patient registry without the central pre-utilisation judgment to be unfeasible.
Medical Advisor Health Insurance Company
According to a medical advisor from a health insurance company, the problem was attributable to a lack of clarity on exactly what kind of patients benefit from IFNβ. IFNβ is an expensive drug and the costs are either carried by the community (public health insurance) or reimbursed on an individual basis (private health insurance). Preferably, physicians should develop a guideline on the relative position of IFNβ in relation to alternative interventions. At the time of IFNβ’s introduction, a central pre-utilisation approval could have been relevant. However, time had passed and the prescription of IFNβ had become common practice. Unfortunately, new drugs are often introduced and included in the health care package long before all medical specialists agree on criteria for treatment. Professionals cannot develop guidelines quickly. In contrast, the time that passes between a drug being introduced into the market and its inclusion in the health care package is regulated by law and, in most cases, quite short. As a temporary solution, the drug could be included into the health care package under certain conditions, such as the registration of patient data.
Neurologist
A neurologist mentioned working on a guideline for diagnosing and treating MS patients as part of an initiative from the Dutch Society for Neurology. A guideline for diagnosis and treatment was considered relevant as it could support evidence-based practice. As in other medical fields, knowledge and treatment options have increased. The development of a guideline is a time-consuming endeavour as, often, it has to be done alongside the professional’s usual activities. A central pre-utilisation approval was no longer relevant. Prescribing IFNβ was considered common practice, also in small general hospitals. Most neurologists were already familiar with the indications for treatment. IFNβ was proven to be effective in one type of MS that is characterised by invalidating exacerbations (relapsing remitting MS) through clinical trials that demonstrated IFNβ’s ability to decrease the severity and frequency of these exacerbations. A national database could still be useful. However, its purpose must be clear. An appropriate goal could be to evaluate the long-term effectiveness of IFNβ. The neurologist questioned whether participants would have come to agreement on specific recommendations, such as which data should be collected and who should become the owner of the database. Most neurologists do have “their own kingdoms” and do not want to share these with others.
Patient
The patient claimed that agreement amongst neurologists about MS treatment could be useful. For him, the main problem was that MS care differs between hospitals. He conveyed his experiences with receiving contradictory answers to questions from numerous health professionals and the option of using IFNβ had not been discussed in the hospital where he was initially treated. For this patient, the exacerbations are highly invalidating. Obviously, his preference is to lead a normal life, in so far as that is possible. MS has a high impact on his life.
Discussion
Although results from the workshops showed that all respondents agreed that developing a guideline and a national database could be meaningful, these policy measures have never been implemented. A number of factors can provide an explanation for the proceedings in this project.
Firstly, the costs of IFNβ appeared to be lower than expected. Perhaps the information campaign on IFNβ had had this effect [3]. It may also have been that the calculation by the Ministry of Health, which differed from calculations made by the Health Council and rested on the assumption that all MS patients are treated with IFNβ, were unrealistic. In any case, the subject of IFNβ no longer had high priority. From the point of view of policy makers, the expected high costs of IFNβ in combination with its uncertain effectiveness were the main problems behind the proposed policy measures. Apparently, however, the problem of the high costs had still higher priority than the limited knowledge on IFNβ’s effectiveness. As a result, policy makers left it to the medical profession to implement policy measures. Neurologists, however, considered cost-containment not their problem and not their responsibility.
This also explains why the initial questions about the long-term effectiveness remained unanswered, without this being perceived as a problem. The effectiveness of IFNβ and the possible role of the industry was an issue of international debate. Clinical trials have shown that IFNβ decreased the number and severity of exacerbations in patients with relapsing-remitting MS [16, 23]. Probably, this is enough reason for neurologists to claim the right to prescribe IFNβ. That evidence of long-term effectiveness, in terms of preventing disability, and safety was still limited [26] is not of great concern to them. Neither is the possible influence of the industry on prescription practices through the financing of clinical trials that had been discussed [13, 21, 22, 28]. Some authors have even challenged the hypothesis of MS as an inflammatory auto-immune disease [1]. A national registry could have been relevant from this point of view. In the UK, the Department of Health initially refused to reimburse IFNβ use for reasons of costs [17]. In 2002, however, agreements were made with the industry concerning the funding of IFNβ. The Department of Health announced that it would reimburse IFNβ for MS patients who agreed to participate in a monitoring program on the effectiveness of IFNβ.
Secondly, the policy development process from the beginning centred around two specific policy measures, whereas it could have started with a broader scope, actors involved first eliciting the problems they perceive and adequately structuring the problem. Now, the proposed measures appeared not to be the most optimal solutions for the problems as perceived by neurologists, and therefore represented right solutions to the wrong problems. This typically concerns what Hischemuller and Dunn have coined an ‘error of the third kind’ [6, 14]. We have found that on a first order level, all actors agreed that a national guideline and a registration could be meaningful. But as it was, on a second order level they disagreed as to what goals such policy measures should serve. For example, neurologists considered a national guideline relevant, as long it was a broad guideline on the diagnosis and treatment of MS in general. All actors agreed that a national registry could be relevant, but defined different goals. Each goal came with different variables to be included in the registry.
Thirdly, during the workshops, the proposed policy measures remained rather vague and were not elaborated in detail. As a result, participants could easily consent without violating their background theories and preferences. They had not felt the urge to (re)consider these theories and preferences. This, however, was necessary, as is clearly illustrated by the respondents who questioned whether participants would have come to agreement on specific recommendations, such as which data should be collected and who should become the owner of the registry. Such an agreement requires that policy measures are made sufficiently substantive for every actor to understand what are the consequences. Moreover, it requires that background theories and normative preferences are elicited and scrutinised.
Fourthly, changes in the socio-political context affected policy development. Opinions with respect to which kind of policy measures are the responsibility of the HCIB had changed over time. The PAM staff considered conducting a clinical trial to obtain relevant information that would not be provided by the industry. Simultaneously, their position towards another Dutch institute involved with subsidising clinical research changed. Putting out clinical trials was then no longer their responsibility. Furthermore, the relationship between the HCIB and the Ministry of Health changed over the course of this project. These changes strongly affected ideas with respect to the Board’s responsibility on initiating a national registry of patient data. On this basis we conclude that the workshops failed to meet the objectives set for interactive processes in policy development, namely to prevent policy implementation problems as a result of diverging views amongst target groups. Moreover, we concede that they could not have met those objectives. From the case of IFNβ, we infer that an interactive process should meet the following criteria:The interaction should cover the whole process from problem structuring to policy implementation, in order to be able to deal with problem shifts and changes in the socio-political context. It is not enough to reduce interactivity to workshops at one or two moments in time.Actors involved should resist the temptation to think that policy problems can be understood at a first order level. That is, background theories and normative preferences should be explicated in the problem definition phase. Only if problem structuring is taken seriously in this sense can one think of developing solutions that could meet with the approval of all target groups.Developing widely endorsed solutions requires that actors involved are willing to learn from one another and adapt their views if necessary. A process of interactive policy development should include room for such learning processes [12, 24, 25, 29]. Grin and Van de Graaf [10] have argued that learning is likely to occur only if external events urge a revision of background theories and preferences, or if repeated failures show actors that their background theories are not functional.Proposed policy measures should be sufficiently elaborated, as to enable target groups to assess their consequences and constructively engage in the interactive process. As the case of IFNβ shows, actors involved are not willing to reconsider their background theories and preferences, should proposed policy measures not be sufficiently elaborated and actors involved not understand what is at stake.
In sum, this study has shown that the organisation of workshops in which target populations participate does not qualify as an appropriate process of interactive policy development. From the beginning, emphasis had been put on a limited number of interventions aimed to control the expected increase in treatment costs. Although target populations participated in policy development, perceived problems and which interventions could provide a solution had been discussed insufficiently. For policy development to be successful, interactive methods are needed, in which problem definitions and assumptions are explicated and discussed, providing an opportunity for mutual learning between actors involved.

participatory workshops
interferon-beta
multiple sclerosis
argumentative policy analysis
interactive policy development


Laparoscopic versus small-incision cholecystectomy: Health status in a blind randomised trial

Background Gallstones are a major cause of morbidity, and cholecystectomy is a commonly performed procedure. Minimal invasive procedures, laparoscopic cholecystectomy (LC) and small-incision cholecystectomy (SIC), have replaced the classical open cholecystectomy. No differences have been found in primary outcome measures between LC and SIC, therefore secondary outcome measures have to be considered to determine preferences. The aim of our study was to examine health status applying evidence-based guidelines in LC and SIC in a randomised trial.
Cholecystectomy is a commonly performed procedure in patients with symptomatic cholecystolithiasis. With an estimated incidence up to 2.17 per thousand inhabitants [1, 2], and 500,000 cholecystectomies performed annually in the USA [3] and 21,000 in The Netherlands (an incidence of 1.31 per thousand inhabitants) [4, 5], gallstones are a major cause of morbidity in the Western world. During the 1980s, the preferred surgical technique for cholecystectomy changed from the classical open procedure to a smaller incision approach [6, 7] and eventually to laparoscopic cholecystectomy. Although evidence of superiority was never delivered, the laparoscopic technique was accepted as the gold-standard procedure by consensus [3].
Multiple randomised trials comparing laparoscopic (LC) and small-incision cholecystectomy (SIC) have been performed and results are inconsistent. Some favour the SIC technique, others favour the LC technique, and many take a neutral position. All these randomised trials are included in our Cochrane review. Our review showed no differences in primary outcome measures between LC and SIC [8].
In comparing (surgical) treatments, primary outcome measures (mortality and severe complications) have to be considered prior to secondary outcome measures. As no significant differences between LC and SIC in primary outcome measures were found [8], it is justified to consider health status, an important secondary outcome measure. Frequently, quality of life is confused with health status. Quality of life measures the subjective judgment of patients about their condition, while health status refers to the impact of disease on patients’ lives in the physical, psychological and social domains.
Questionnaires, both generic and condition-specific, have been shown to be useful in measuring changes in health status after cholecystectomy [9–11]. Several studies showed that health status was improved, both after LC and open cholecystectomy in patients suffering socially disabling uncomplicated symptomatic cholecystolithiasis [12–14]. Differences between the open and laparoscopic technique are not clear [15], although some studies found superior results using the laparoscopic technique [16, 17].
To date, differences in health status between LC and SIC are not very well examined [18–20]. Moreover, as the previous studies did not use the appropriate questionnaires as advised by evidence-based guidelines, there had been no possibility to correctly find differences in health status between both operating techniques.
The gastrointestinal quality of life index (GIQLI) and the short form (SF-36) are frequently used and validated questionnaires (disease-specific and generic, respectively) and are most suitable for evaluating patients’ functional recovery after cholecystectomy [21].
Objective
The aim of our study was to examine differences in health status in patients with symptomatic cholecystolithiasis before and after LC and SIC in a blinded randomised clinical trial. We used the GIQLI and the SF-36 questionnaires, as recommended by evidence-based guidelines [21].
Methods
All patients with symptomatic cholecystolithiasis visiting the outpatients clinic of the St. Elisabeth hospital in Tilburg were considered for inclusion in a blind randomised trial comparing laparoscopic and small-incision cholecystectomy. Verbal and written informed consent was obtained from each patient, and patients were consecutively listed for elective cholecystectomy. Health status was a secondary outcome measure as part of the randomised clinical trial.
Sample size
No differences in primary outcome measures (mortality and complications) were expected between LC and SIC [8]. Consequently, a secondary outcome measure should be used to decide on preferences between both techniques. We decided to focus on costs between both techniques as the most important secondary outcome measure. Based on an anticipated difference of 10% in direct costs 120 patients had to be included in each group. However, multiple outcome measures including health status were evaluated in this randomised trial.
Based on a previous study [18], it was calculated that 128 patients were needed in each group to detect a difference of 5 points (assuming a standard deviation of 20) in the gastrointestinal quality-of-life index (GIQLI) questionnaire with a type I error of 0.05 and a power of 0.8.
Randomisation
As randomised trials with high bias risk may overestimate intervention effects [22], results of randomised trials with low bias risk are considered more reliable. Therefore, attention is warranted for correct generation of the allocation sequence, allocation concealment, blinding, and follow-up.
A random-number table was used for the generation of the allocation sequence and allocation concealment was guaranteed by using sealed envelopes. To eliminate bias caused by preoperative expectations, patients were randomised in the operation theatre after induction of anaesthesia. A telephone call to the secretary office was made and an employee opened an envelope. All patient data were recorded in a case record form, with the procedure reported as ‘trial cholecystectomy’. Wounds and port sites were dressed with identical opaque dressings, stained using iodine, regardless of the surgical procedure performed, to allow blinding for patient, nurses, and physicians during the postoperative period. The type of operation was revealed just before discharge.
No patients were lost to follow-up. Operative procedures were standardised apart from using a laparoscopic or small-incision technique. Anaesthesia, postoperative care and analgesic use were also standardised.
Inclusion and exclusion criteria
Inclusion criteria were: male or female patients with symptomatic cholecystolithiasis, age 18 years or older at recruitment, with reasonable to good health according to American Society of Anaesthesiologists (ASA) classification (ASA I or II) [23], no known relevant allergies and a signed letter of informed consent.
Exclusion criteria were: age younger than 18 years, choledocholithiasis (icterus, acholic faeces and/or bilirubine twice normal range), cholangitis, known pregnancy, moderate to severe systemic disease (ASA III and higher), known cirrhosis of the liver, history of abdominal malignancy, previous upper abdominal surgery (precluding laparoscopic approach), psychiatric disease, or another reason (e.g. lack of knowledge of the Dutch language) for making follow-up or completion of questionnaires unreliable.
Obesity was indexed but not considered an exclusion criterion [24]. Recovery after successful endoscopic treatment of choledocholithiasis was not a contraindication. Acute cholecystitis is a different disease with other complication rates, morbidity, and conversion rates, and patients suffering acute cholecystitis were, therefore, not included.
Surgical procedures
The policy in our hospital was not to perform operative cholangiography in any patient in elective cholecystectomy. All patients had nasogastric intubations during the operation that were removed immediately afterwards. Bladder drainage was not performed. Abdominal wall and skin closure were standardised. In case of technical difficulties or for safety reasons, both laparoscopic and small-incision cholecystectomies were converted to open cholecystectomy by a subcostal incision (>8 cm). Reasons for conversion were registered. The wounds were covered with standard wound dressings as described by Majeed [24] to blind patient and ward personnel postoperatively. We did not use any local anaesthetic technique into the wounds nor intercostal nerve blocks.
Laparoscopic cholecystectomy
Open introduction of trocars was performed in all patients, regardless of previous abdominal surgery. Pneumoperitoneum was created using the subumbilical trocar with an intra-abdominal pressure up to 12 mmHg. Three trocars for instruments were inserted. The dissection of the cystic artery and cystic duct, identifying Calot’s triangle, was performed using a three-point ‘flag’ technique [25]. The cystic duct and artery were clipped and transsected. After complete dissection of the gallbladder, it was removed either through the subumbilical or the subxyphoidal trocar. Fascia defects as a result of the insertion of 10mm trocar and the open introduction of the subumbilical trocar were closed with UR6 vicryl 1.0/2.0® sutures. All instruments, except for the subumbilical trocar, were reusable. No suction drains were left in the subhepatic space at the end of the procedure.
Small-incision cholecystectomy
In the literature most authors used 8 cm (or less) as a cut-off point to differentiate between small-incision and open cholecystectomy [24, 26–32]. Therefore, we performed small-incision cholecystectomy principally through an incision of 6 cm, maximally extended to 8 cm. As part of a separate research question, all patients had a preoperative ultrasound scan and the location of the fundus of the gallbladder was marked on the skin. We used the craniocaudal position of the mark for incision. The mediolateral position of the mark was not used, because in the pilot phase we found that the incision would be too lateral for adequate view of the hilus. The incision was placed over the musculus rectus abdominis. Only standard instruments were used and no special equipment. Access to the peritoneum was obtained by a muscle splitting (and not transsection) technique of the musculus rectus abdominis (like in an open appendectomy). The gallbladder was dissected by a fundus-first technique. If necessary the gallbladder was punctured to remove its liquid contents. The cystic duct and artery were ligated and the gallbladder was removed. No suction drains were left in the subhepatic space at the end of the procedure. Posterior and anterior fascias were closed separately with PDS 3.0® running suture. After wound closure, the length of the incision was measured. When the length exceeded 8 cm, the operation was considered to be a conversion to open cholecystectomy.
Postoperative protocol
Early oral intake and mobilization were encouraged. Patients left the hospital as soon as they felt capable. As patients were admitted at the day of operation, hospital stay was defined as the number of nights (postoperative) in hospital. Shortly before discharge, wound dressings were removed for wound inspection. For logistic reasons, we were not able to blind the surgeon at the patients’ follow-up. Follow-up took place according to a standardised scheme after 2 weeks, 6 weeks, and 3 months. Patients were encouraged to resume work and normal daily activity as soon as they felt capable to do so.
Measurements
In accordance with evidence-based guidelines [21], we decided to use the generic short form (SF-36) and the disease-specific gastrointestinal quality-of-life index (GIQLI) questionnaires. These questionnaires were completed preoperatively, on the first day postoperative and at each follow-up visit after 2 and 6 weeks and after 3 months. In addition, the body image questionnaire (BIQ) was completed preoperatively and at 6 weeks postoperatively in order to estimate differences in the patients’ perception of their body image and cosmetics [33].
The SF-36 is a generic health status questionnaire that has 36 questions to assess eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) [34]. Internal consistency measured by Cronbach’s alpha was shown to be high (above 0.80 in all subscales) [34]. The Dutch version has been validated [35].
The GIQLI is a disease-specific health status measure. It includes both specific questions on gastrointestinal symptoms, for both the upper and the lower gastrointestinal tract, as well as questions on physical, emotional and social capabilities [36]. It is a mixed questionnaire that includes both generic and specific questions. Based on face validity, five subscales are distinguished in addition to a total score. Internal consistency measured by Cronbach’s alpha was shown to be high (above 0.90 in all subscales) [36]. The Dutch version has been validated [37].
The body image questionnaire (BIQ) consists of nine questions evaluating three subscales: body image, cosmetic, and self-confidence. The BIQ has shown to consist of two factors, a body image and a cosmetic factor [33]. The body image scale measures patients’ perception of and satisfaction with their own body and explores patients’ attitudes toward their bodily appearance. The cosmetic scale assesses the degree of satisfaction of patients with respect to the physical appearance of the scar. Additionally, a question is added to assess patients’ self-confidence before and after surgery. Internal validity (measured by Crohnbach’s alpha) reliability coefficients were shown to be high for both the body image (0.80) and cosmetic scales (0.83) [33].
Statistical analysis
Analyses were performed according to the type of operative procedure used, based on the intention to treat principle. Apart from this main analysis, one subgroup analysis was performed: converted procedures (LC and SIC) were compared with minimal invasive procedures (LC and SIC). This subgroup analysis was performed in order to illustrate the sensitivity of the questionnaires. Calculations were made using SPSS version 11.0®.
Repeated measures analysis of variance (ANOVA) was used to evaluate health status differences over time between the two operative techniques.
Additional independent t-tests were performed to test for time-specific differences in scores at the preoperative measurements between two groups in order to check for a correct randomisation procedure. If appropriate, additional independent t-tests were performed to test for other time-specific differences in measurements.
Results
All trial patients were included and operated between January 2001 and March 2004. Leaving unwilling and excluded patients out of consideration, 366 patients initially fulfilled the inclusion criteria and were initially included in the trial. A total of 102 patients were not randomised for a variety of reasons (Fig. 1). After randomizing 264 patients, another seven patients were excluded (after their cholecystectomy) for the following reasons: unwillingness for further participation in the trial (2), intraoperative suspicion of malignancy (2), transfer to another ward not participating in the trial (1), participation in two trials (not in line with the Helsinki declaration) (1), and insufficient knowledge of the Dutch language (1). Excluding the data of these seven patients from our analyses did not affect the results of our questionnaires in any way. A total of 257 patients were left for analysis (LC:120 and SIC:137).
Fig. 1Revised consort statement diagram showing the flow of participants through each stage of the randomised trial [38]
Baseline characteristics and operative results
The groups (LC and SIC) did not differ regarding age, sex, body mass index (BMI) and ASA classification (Table 1). The classical diagnostic symptoms of cholecystolithiasis as well as the duration of these symptoms were also equally distributed in both groups. In addition, the number of patients presenting with complicated gallstone disease who had received treatment by endoscopic retrograde cholangiopancreaticography (ERCP) (and papillotomy) were equally distributed and operated on in a later stage (Table 2).
Table 1Patient characteristicsLaparoscopic cholecystectomy (n = 120)Small-incision cholecystectomy (n = 137)P valueMale31 (25.8%)30 (21.9%)0.459Female89 (74.2%)107 (78.1%)Age (years)  Mean (SD)48.4 (14.1)48.5 (14.0)0.974  Median (range)49 (17–77)48 (18–80)BMI  Mean (SD)27.5 (4.8)27.9 (4.6)0.500  Median (range)26.8 (18.5–45.9)27,2 (18.0–43.3)ASA stage  I81 (67.5%)91 (66.4%)0.855  II39 (32.5%)46 (33.6%)BMI body mass index; ASA american society of anaesthesiologists classificationTable 2Operative features and difficulties of laparoscopic and small-incision cholecystectomyLaparoscopic cholecystectomy (n = 120)Small-incision cholecystectomy (n = 137)P valuePatients with complicated gallstone diseases before cholecystectomy18180.668Endoscopic retrograde cholangiopancreaticography12130.890Duration of symptoms (weeks)n = 107 (89.2%)n = 130 (94.9%)0.443  mean (SD)61.1 (108.8)70.3 (147.2)  median (range)26 (2–884)17.5 (1–1040)Incision length (mm) #n = 95 (12 conversions)n = 134 (20 conversions)0.196  mean (SD)76.1 (33.8)76.0 (24.0)  median (range)65 (40–200)66 (49–165)Inflammation21250.876Operative team:  surgeon–resident15 (12.5%)21 (15.3%)0.515  resident–surgeon84 (70.0%)100 (73.0%)0.596  resident–resident21 (17.5%)18 (13.1%)0.331Hospital stay *  mean (SD)2.4 (4.6)3.1 (12.4)0.560  median (range)1 (1–36)2 (1–144)Hospital stay * (without one extreme value)  mean (SD)2.1 (3.38)2.04 (2.42)0.877Employed (n)5051Return to work (weeks)  mean (SD)4.1 (2.3)3.7 (2.0)0.298  median (range)4 (1–12)3 (0.5–12)# conversions were included in incision length measurements* hospital stay in postoperative nights
There was no mortality. There were five intraoperative complications in the LC group compared with three in the SIC group. There were 16 postoperative complications in the LC group and 13 in the SIC group. There were 21 and 16 total complications (intra- and postoperative) in the LC and SIC group, respectively. Of these, 11 and 7 complications were serious in the LC and the SIC group, respectively (Table 3). We did not find a difference in the number or severity of the complications.
Table 3Serious complications in laparoscopic and small-incision cholecystectomy (intraoperative and postoperative)Laparoscopic cholecystectomy11Small-incision cholecystectomy7Intraoperative complicationsAsystole 1Cardiac ischemia, no elevated enzymes 1Common bile duct (CBD) injury, eventually hepatico-jejunostomy, complicated prolonged ICU stay, stenosis bile duct.1CBD injury, conversion, T-drain, ERCP and papillotomy for CBD stone1Bleeding requiring conversion (and transfusion)1Hepatic parenchyma rupture, conservative treatment (transfusion) 1Bowel injury at introduction (sutured)1Cerebrovascular accident at recovery1Total intraoperative5Total intraoperative3Postoperative complicationsPneumonia1Cystic duct leakage (ERCP + stent)1Cerebrovascular accident (6 weeks postoperative)1CBD injury, multiple relaparotomies and ICU stay 1Intra-abdominal fluid collection (haematoma); icterus (ERCP: no stones, complicated by bleeding)1CBD stone (ERCP) and abscess intra-abdominal (ultrasound drainage)1Pancreatitis (conservative treatment) 1CBD stone with pancreatitis (ERCP)1Intra-abdominal abscess (re-laparoscopy)1Epididimitis (operation by urologist)1Total postoperative6Total postoperative4CBD common bile duct; ICU intensive care unit; ERCP endoscopic retrograde cholangiopancreaticography
Operative time was shorter for SIC compared to LC (60 versus 72 min, respectively; U = 6013.0, p < 0.001). Conversion rates were similar (p = 0.312), with similar reasons for conversion. The follow-up rate between the groups was not statistically different. Follow-up was 91.4–96.3% at six weeks, 82.2–82.8% at three months and 100% at either six weeks or three months. Complaints at follow-up were comparable.
There were no differences in the preoperative measurements of the SF-36 subscales, all the GIQLI subscales, the total GIQLI score and the BIQ subscales.
Health status
The questionnaires were obtained with a response rate varying from 87.5% preoperatively to 77.4% three months postoperatively. The nonresponders did not differ from those who remained in the study with regard to complications (16%), operative time (65 minutes), hospital stay (1.5 days), return to work (3.2 weeks) or baseline scores.
When comparing LC with SIC (intention-to-treat), we found no differences in all SF-36 subscales, except for ‘perceived health change’. There were significant differences favouring the laparoscopic technique (F = 16.054, df = 1; p < 0.001) (Table 4). Performing time-specific analyses, differences were identified at two weeks (p = 0.029) and six weeks (p < 0.001) postoperatively. There were no differences between LC and SIC with regard to the four GIQLI subscales, the total GIQLI score, and the body image subscales.
Table 4Comparison of GIQLI, SF-36 and BIQ scores in laparoscopic (LC) and small-incision cholecystectomy (SIC) according to intention-to-treat (mean scores and SD)PreoperativePostoperativeP valueday 12 weeks6 weeks12 weeksSF-36PhysicalLC77.0 (23.0)57.1 (29.5)67.5 (23.2)83.2 (21.2)87.8 (17.4)0.413SIC83.0 (18.3)39.9 (29.8)63.0 (22.8)83.1 (20.8)87.5 (19.3)SocialLC43.4 (14.2)77.8 (19.9)70.7 (23.9)86.5 (19.3)91.9 (15.9)0.260SIC42.7 (17.1)74.3 (22.6)66.3 (25.8)82.3 (22.9)90.4 (19.0)Role physicalLC56.4 (43.4)52.6 (43.2)26.7 (36.4)67.4 (40.1)81.1 (34.9)0.667SIC60.8 (44.4)53.0 (45.7)29.5 (49.4)54.8 (42.6)79.2 (35.8)Role emotionLC73.7 (39.4)70.5 (38.8)68.3 (41.7)82.7 (33.6)88.6 (27.8)0.797SIC74.3 (39.7)70.3 (40.7)66.4 (54.9)80.7 (36.5)88.7 (29.4)MentalLC61.7 (11.8)75.0 (17.1)77.3 (18.3)83.3 (16.2)85.1 (16.6)0.558SIC62.0 (10.9)72.1 (18.9)74.5 (18.7)81.2 (18.4)83.4 (17.4)VitalityLC54.1 (11.0)59.6 (22.4)52.1 (21.1)67.8 (20.1)73.5 (20.4)0.767SIC53.8 (12.2)58.4 (22.9)51.8 (21.6)66.9 (22.6)72.7 (21.7)PainLC56.5 (19.5)55.6 (22.5)52.2 (21.7)74.7 (20.2)82.4 (21.5)0.429SIC54.6 (17.1)55.9 (24.6)46.4 (21.9)69.3 (23.8)83.1 (21.4)General healthLC56.1 (11.7)69.7 (17.3)71.8 (19.3)74.9 (22.0)76.3 (21.2)0.457SIC57.4 (11.3)65.1 (19.2)70.1 (20.1)72.5 (21.5)76.4 (19.2)Health changeLC57.7 (21.2)57.7 (21.2)62.0 (26.9)76.7 (23.9)77.1 (24.4)<0.001*SIC55.4 (20.4)55.4 (20.4)53.5 (27.5)64.6 (25.1)71.5 (27.2)GIQLIPhysicalLC2.79 (0.76)2.82 (0.73)2.78 (0.75)3.20 (0.62)3.31 (0.59)0.790SIC2.95 (0.74)2.67 (0.83)2.69 (0.75)3.14 (0.73)3.30 (0.63)GastrointestinalLC3.01 (0.59)3.01 (0.54)3.22 (0.48)3.46 (0.41)3.50 (0.42)0.247SIC3.12 (0.58)3.13 (0.55)3.22 (0.45)3.46 (0.46)3.52 (0.40)SocialLC2.89 (0.48)2.82 (0.42)2.81 (0.52)2.93 (0.37)2.97 (0.29)0.056SIC2.90 (0.42)2.82 (0.43)2.76 (0.56)2.85 (0.50)2.85 (0.38)MentalLC2.55 (0.55)2.59 (0.45)2.88 (0.41)3.04 (0.35)3.07 (0.37)0.561SIC2.65 (0.49)2.58 (0.55)2.74 (0.45)2.99 (0.47)3.04 (0.44)TotalLC102.4 (17.0)102.6 (14.8)108.5 (15.0)116.4 (11.9)118.3 (11.7)0.607SIC106.7 (14.9)104.5 (16.0)107.4 (14.0)116.7 (13.2)118.0 (11.1)BIQBody imageLC6.42 (1.98)––6.03 (1.90)–0.530SIC6.26 (1.89)––5.85 (1.35)–CosmeticLC–––18.38 (3.88)–0.100SIC–––17.52 (3.55)–Self-confidenceLC6.95 (1.27)––7.68 (1.21)–0.647SIC7.02 (1.28)––7.49 (1.15)–* significant difference
Subgroup analysis
In checking for differences in preoperative data in the minimal invasive procedures versus conversions comparison, we only found a significant difference in the self-confidence subscale of the body image questionnaire (t = 2.821, df = 207, p = 0.005) with higher self-confidence scores in the minimal invasive operated group (7.08 versus 6.31). No other differences were found in preoperative data.
In order to assess differences between minimal invasive procedures (both laparoscopic and small-incision) and procedures converted to the classical open cholecystectomy, we examined patients’ scores across the follow-up period (Table 5).
Table 5Comparison of GIQLI, SF-36 and BIQ scores in minimal invasive laparoscopic (LC) and small-incision cholecystectomy (SIC) procedures versus converted (LC and SIC) procedures (mean scores and SD)PreoperativePostoperativeP valueday 12 weeks6 weeks12 weeksSF-36Physicalmin-inv79.9 (21.3)50.1 (30.9)67.3 (22.1)83.5 (21.1)87.6 (18.9)0.046*conv82.3 (17.5)31.6 (24.9)45.5 (22.6)79.6 (19.3)87.8 (14.6)Socialmin-inv43.2 (15.5)76.7 (21.3)69.9 (24.1)85.1 (20.9)90.9 (18.1)0.214conv41.7 (18.3)70.1 (21.9)55.1 (29.0)76.1 (24.7)93.2 (13.8)Role physicalmin-inv60.2 (43.4)54.0 (44.5)27.9 (36.3)61.3 (41.7)79.9 (35.2)0.415conv46.9 (46.8)43.1 (43.9)31.0 (87.6)55.0 (44.1)81.8 (37.1)Role emotionmin-inv74.9 (39.0)72.1 (38.8)67.4 (41.5)82.1 (34.6)89.3 (28.1)0.373conv66.7 (42.8)56.5 (45.4)66.7 (93.7)76.7 (40.6)83.3 (32.1)Mentalmin-inv61.8 (11.6)73.8 (17.9)76.6 (17.5)82.7 (16.4)84.9 (15.9)0.413conv62.6 (9.1)70.8 (19.5)69.0 (25.5)77.1 (24.4)78.6 (23.8)Vitalitymin-inv54.0 (11.9)59.5 (22.8)53.1 (21.1)67.8 (21.4)73.3 (20.6)0.180conv53.2 (8.8)55.0 (21.2)41.6 (21.1)63.3 (21.6)71.1 (24.9)Painmin-inv55.6 (18.4)56.5 (23.7)50.4 (22.1)72.5 (22.3)82.9 (21.7)0.038*conv55.2 (17.7)49.6 (22.2)37.1 (17.4)65.4 (22.4)81.9 (18.5)General healthmin-inv56.8 (11.4)68.2 (18.1)72.0 (19.4)74.2 (21.3)76.9 (19.7)0.136conv56.3 (12.4)59.7 (19.6)61.0 (20.2)67.8 (25.1)72.2 (23.3)Health changemin-inv56.8 (20.8)56.8 (20.8)58.8 (27.5)71.7 (24.9)74.9 (26.3)0.066conv54.2 (20.4)54.2 (20.4)46.3 (24.7)56.3 (24.2)67.1 (23.6)GIQLIPhysicalmin-inv2.90 (0.72)2.78 (0.76)2.79 (0.71)3.19 (0.65)3.33 (0.60)0.007*conv2.67 (0.96)2.40 (0.96)2.20 (0.87)2.96 (0.91)3.10 (0.71)Gastrointestinalmin-inv3.09 (0.57)3.10 (0.54)3.23 (0.47)3.47 (0.43)3.52 (0.39)0.052conv2.89 (0.68)2.89 (0.56)3.08 (0.37)3.42 (0.50)3.46 (0.50)Socialmin-inv2.89 (0.46)2.83 (0.42)2.83 (0.51)2.90 (0.43)2.92 (0.35)0.003*conv2.90 (0.35)2.75 (0.45)2.35 (0.62)2.74 (0.58)2.85 (0.35)Mentalmin-inv2.60 (0.53)2.58 (0.50)2.84 (0.41)3.04 (0.38)3.06 (0.38)0.031*conv2.63 (0.45)2.64 (0.53)2.48 (0.57)2.81 (0.70)2.96 (0.63)Totalmin-inv104.9 (16.0)104.3 (15.0)108.9 (14.3)117.1 (11.5)118.4 (11.0)0.020*conv101.4 (17.0)97.8 (17.8)98.5 (13.3)111.2 (19.5)115.8 (14.0)BIQBody imagemin-inv6.31 (1.80)--5.75 (1.27)-<0.001*conv6.60 (2.78)--7.55 (3.04)-Cosmeticmin-inv---18.27 (3.54)-<0.001*conv---14.86 (3.97)-Self-confidencemin-inv7.08 (1.16)--7.60 (1.13)-0.064conv6.31 (1.83)--7.38 (1.60)-* significant difference; min-inv: minimal invasive procedures (LC and SIC); conv: converted procedures (LC and SIC)
There were significant differences in the SF-36 subscales ‘physical functioning’ (F = 4.057, df = 1; p = 0.046) and ‘pain’ (F = 4.391, df = 1; p = 0.038). In the GIQLI questionnaire, there were significant differences in the total score (F = 5.593, df = 1; p = 0.020), and in the ‘physical’ (p = 0.007), ‘social’ (p = 0.003), and ‘mental’ (p = 0.004) subscales. Also, in the BIQ there were significant differences in the ‘body image’ and ‘cosmetic’ subscales between both operative groups, favouring the minimal invasive procedures (F = 13.939, df = 1; p < 0.001). No other differences were found.
Discussion
We have used both generic and disease-specific health status questionnaires and a body image questionnaire to evaluate the effect of LC versus SIC in patients having cholecystectomy for symptomatic cholecystolithiasis. No differences were found between laparoscopic and small-incision cholecystectomies (applying intention-to-treat). However, with regard to minimal invasive or converted procedures, we found significant differences in the ‘physical’ subscales in both SF-36 and GIQLI as well as differences in body image in favour of minimal invasive procedures. The fact that significant differences were found in the ‘physical’ subscales in both questionnaires illustrates construct validity between both health status instruments.
Literature
A few other studies have compared health status after LC and SIC [18–20]. Two studies found that the laparoscopic technique was associated with a more rapid improvement in health status after cholecystectomy compared with the small-incision technique [18, 19]. One study found no differences at all between both techniques [20]. However, it is difficult to draw conclusions from three studies that used different questionnaires and suffer several methodological flaws. None of the mentioned studies combined the SF-36 and GIQLI as advised by evidence-based guidelines [21].
Barkun studied 35 and 23 patients in the LC and SIC groups, respectively, and used the same GIQLI as we did in addition to the Nottingham health profile (NHP) and a visual analogue scale (VAS) for health [18]. Allocation concealment was unclear, no blinding was used, and eight dropouts occurred in their rather small, preliminary stopped trial. They used cumulative totals of both GIQLI and NHP data instead of using subscales. Changes in one dimension might be offset by changes in other dimensions. Both questionnaires have more than one dimension (the cumulative total); subscales indeed provide the advantage of additional information on several dimensions. As a rather small number of patients were included (the trial was stopped preliminary), no subscales were assessed, and no considerations were given to the construct or divergent validity of both questionnaires, their conclusion that LC was associated with a significantly quicker return to ‘good health’ seems inappropriate based on their results.
McMahon compared health status in 151 and 148 laparoscopic and small-incision cholecystectomy patients respectively using the SF-36 health survey questionnaire and the hospital anxiety and depression scale (HADS) [19]. Generation of the allocation sequence in their trial was unclear and no blinding was used. They found that patients recovering from LC enjoyed significantly better health 1 and 4 weeks after the operation compared with those recovering from SIC, but no significant difference was found at 12 weeks. The absence of preoperatively baseline measurements and the absence of considerations on the construct or divergent validity of the questionnaires make conclusions about postoperative data uncertain. Differences in SF-36 and HADS correlated with differences in return to domestic and leisure activities, but were not translated in differences in paid activity.
Squirrell used the NHP in 100 patients (50 in each group) preoperatively, and 3 weeks and 6 months postoperatively [20]. This was the only study that used blinding in their methods. Generation of the allocation sequence in their trial was unclear. At no time there was a significant difference between the two groups. The study used a rather small sample size, and unfortunately they did not use a disease-specific questionnaire, but only one generic questionnaire. They concluded that it is necessary to take a broader view of health and not concentrate simply on pain when assessing postoperative recovery.
In our study, no significant differences were found between LC and SIC using both generic and disease-specific health status as well as body image with response in approximately 80% of patients. The response rate of 77.4% at 3 months follow-up may represent a possible source of bias. However, the nonresponders were comparable to those who remained in the study with regard to complications, operative time, hospital stay, return to work, and baseline scores of questionnaires. Moreover, our response rate is in line with the response rates in the studies of Barkun et al. (58%) and McMahon et al. (78%).
We conclude that there are no differences between both operative techniques regarding health status. The only exception is that in the SF-36 subscale perceived health change we found a difference between LC and SIC, which appeared to be caused by the scores at 2 and 6 weeks postoperatively and disappeared at 3 months follow-up. LC patients reported a larger health change. However, in the evaluation of 17 aspects of health status, only one difference was found. Moreover, this difference in perceived health change was not reflected in an earlier return to work in LC. In contrast, SIC patients returned to work quicker than LC patients, although this different was not significant. Therefore, our overall interpretation is that there are no differences between LC and SIC.
The comparable ‘physical’ subscales in SF-36 and GIQLI, which are supposed to measure the same effect, are both significantly different in the minimal invasive versus conversions comparison illustrating construct validity of both questionnaires. Subscales on different subjects in the questionnaires illustrate divergent validity. Significant differences between minimal invasive and converted procedures illustrate that the questionnaires used are able to measure what they are intended to do.
Conclusion
In our randomised trial with adequate generation of the allocation sequence, concealment of allocation, blinding, and follow-up we used both a generic and a disease-specific questionnaire in addition to a body image questionnaire. There is no significant difference in health status measured with SF-36, GIQLI, and BIQ between laparoscopic and small-incision cholecystectomy (applying the intention-to-treat principle). Additional calculations showed a significant difference between minimal invasive LC or SIC procedures and procedures converted to the classical open cholecystectomy.

cholecystectomy
health status
surgery
surgery
laparoscopy
laparotomy