Upper gastrointestinal endoscopy is a valuable diagnostic tool, but for an endoscopy service to be effective it is essential that it is not overloaded with inappropriately referred patients. A joint working party in Britain has considered the available literature on indications for endoscopy, assessed standard practice through a questionnaire, and audited randomly selected cases using an independent panel of experts and an American database system. They used these data to produce guidelines on the appropriate and inappropriate indications for referral for endoscopy, although they emphasise that under certain circumstances there may be reasons to deviate from the advice given. The need for endoscopy is most difficult to judge in patients with dyspepsia, and this aspect is discussed in detail. Early endoscopy will often prove more cost effective than delaying until the indications are clearer.
Sedatives and analgesics are commonly used in mechanically ventilated patients in the intensive care unit. Sedation guidelines have been shown to improve sedation management as well as various patient outcomes. The main objective was to evaluate adherence to a sedation guideline with both sedative prescribing and documentation of Richmond Agitation-Sedation Scale (RASS) scores.
In a retrospective chart review, data was collected on 111 medical intensive care unit patients mechanically ventilated via endotracheal tube for 12 hours or greater at Brigham and Women’s Hospital. Fifty-seven patients were evaluated pre-guideline implementation and 54 patients were evaluated post-guideline.
Significant increases were seen in the post-guideline group in goal-directed sedation with a patient-specific RASS goal in the sedation order: 21.3 vs 85.4% (P < 0.001), and mean number of sedation assessments per 24 hours using the RASS: 4.7 vs 11.4 (P < 0.001). Similarly, this group experienced a higher percentage of RASS scores at their sedation goal: 31.4 vs 44.1% (P < 0.001). No difference was seen in other clinical endpoints.
Implementation and routine application of a hospital pain and sedation guideline was associated with significantly improved sedation metrics, such as goal-directed sedation, as well as frequency of sedation level assessment and documentation. An increase was observed in the time that post-guideline patients spent at or near their RASS goal.
sedation; agitation; guideline; RASS; mechanically ventilated; intensive care unit
The purpose of this study was to evaluate sedation practice in UK intensive care units (ICUs), particularly the implementation of daily sedation holding, written sedation guidelines, sedation scoring tools and choice of agents.
A national postal survey was conducted in all UK ICUs.
A total of 192 responses out of 302 addressed units were received (63.5%). Of the responding ICUs, 88% used a sedation scoring tool, most frequently the Ramsey Sedation Scale score (66.4%). The majority of units have a written sedation guideline (80%), and 78% state that daily sedation holding is practiced. A wide variety of sedating agents is used, with the choice of agent largely determined by the duration of action rather than cost. The most frequently used agents were propofol and alfentanil for short-term sedation; propofol, midazolam and morphine for longer sedation; and propofol for weaning purposes.
Most UK ICUs use a sedation guideline and sedation scoring tool. The concept of sedation holding has been implemented in the majority of units, and most ICUs have a written sedation guideline.
Although guidelines advise titration of palliative sedation at the end of life, in practice the depth of sedation can range from mild to deep. We investigated physicians’ considerations about the depth of continuous sedation.
We performed a qualitative study in which 54 physicians underwent semistructured interviewing about the last patient for whom they had been responsible for providing continuous palliative sedation. We also asked about their practices and general attitudes toward sedation.
We found two approaches toward the depth of continuous sedation: starting with mild sedation and only increasing the depth if necessary, and deep sedation right from the start. Physicians described similar determinants for both approaches, including titration of sedatives to the relief of refractory symptoms, patient preferences, wishes of relatives, expert advice and esthetic consequences of the sedation. However, physicians who preferred starting with mild sedation emphasized being guided by the patient’s condition and response, and physicians who preferred starting with deep sedation emphasized ensuring that relief of suffering would be maintained. Physicians who preferred each approach also expressed different perspectives about whether patient communication was important and whether waking up after sedation is started was problematic.
Physicians who choose either mild or deep sedation appear to be guided by the same objective of delivering sedation in proportion to the relief of refractory symptoms, as well as other needs of patients and their families. This suggests that proportionality should be seen as a multidimensional notion that can result in different approaches toward the depth of sedation.
Pediatric sedation is a challenge which spans all continents and has grown to encompass specialties outside of anesthesia, radiology and emergency medicine. All sedatives are not universally available and local and national regulations often limit the sedation practice to specific agents and those with specific credentials. Some specialties have established certification and credentials for sedation delivery whereas most have not. Some of the relevant sedation guidelines and recommendations of specialty organizations worldwide will be explored. The challenge facing sedation care providers moving forward in the 21st century will be to determine how to apply the local, regional and national guidelines to the individual sedation practices. A greater challenge, perhaps impossible, will be to determine whether the sedation community can come together worldwide to develop standards, guidelines and recommendations for safe sedation practice.
OBJECTIVE--To assess the effect of a preprinted form on the documentation of clinical data and compliance with the national guidelines for the management of asthma. METHODS--Prospective audit six months before and after introduction of the form. RESULTS--Use of the form improved the documentation of past asthma history (69% v 93%, P < 0.001), current treatment (81% v 95%, P < 0.01), predicted peak flow (23% v 75%, P < 0.001), per cent predicted peak flow (1% v 62%, P < 0.001), and respiratory rate (81% v 95%, P = 0.007). Compliance with the British recommendations for treatment improved with use of the form (50% v 89%, P < 0.001) The prescription of steroids on discharge did not improve significantly (26% v 44%, P > 0.05). CONCLUSIONS--The preprinted form resulted in enhanced documentation of data and conformity with current guidelines for the management of asthma.
Following the introduction of the Milch technique as the preferred method of reduction of anterior shoulder dislocations in an A&E department, a retrospective study of the technique was carried out. A total of 187 patients with anterior shoulder dislocations were included. The Milch technique was attempted in 142 cases with a success rate of 86%. There was no statistical difference in the success rates of junior and senior staff. In 73% of the Milch cases either no analgesia or sedation or Entonox alone was used. This study shows that the Milch technique can successfully be used by inexperienced staff to reduce dislocated shoulders with a reduction in the requirements for sedation and anaesthetics.
Protocols for the delivery of analgesia, sedation and delirium care of the critically ill, mechanically ventilated patient have been shown to improve outcomes but are not uniformly used. The extent to which elements of analgesia, sedation and delirium guidelines are incorporated into order sets at hospitals across a geographic area is not known. We hypothesized that both greater hospital volume and membership in a hospital network are associated with greater adherence of order sets to sedation guidelines.
Sedation order sets from all nonfederal hospitals without pediatric designation in Washington State that provided ongoing care to mechanically ventilated patients were collected and their content systematically abstracted. Hospital data were collected from Washington State sources and interviews with ICU leadership in each hospital. An expert-validated score of order set quality was created based on the 2002 four-society guidelines. Clustered multivariable linear regression was used to assess the relationship between hospital characteristics and the order set quality score.
Fifty-one Washington State hospitals met the inclusion criteria and all provided order sets. Based on expert consensus, 21 elements were included in the analgesia, sedation and delirium order set quality score. Each element was equally weighted and contributed one point to the score. Hospital order set quality scores ranged from 0 to 19 (median = 8, interquartile range 6 to 14). In multivariable analysis, a greater number of acute care days (P = 0.01) and membership in a larger hospital network (P = 0.01) were independently associated with a greater quality score.
Hospital volume and membership in a larger hospital network were independently associated with a higher quality score for ICU analgesia, sedation and delirium order sets. Further research is needed to determine whether greater order-set quality is associated with improved outcomes in the critically ill. The development of critical care networks might be one strategy to improve order set quality scores.
Tonsillectomy is one of the most frequently performed operations in the UK. Documentation of the indications for tonsillectomy is vital, and should fulfil evidence-based guidelines where possible. We present a completed audit, evaluating the documentation of our department's practice in meeting the recommendations made by the Scottish Intercollegiate Guideline Network (SIGN) on indications for tonsillectomy.
PATIENTS AND METHODS
A prospective audit of 100 children undergoing tonsillectomy for recurrent tonsillitis at a university hospital during two time periods: October 2007 to January 2008 and March to September 2008. Interventions including the production of posters and rubber stamps were agreed and implemented between the two audit periods.
Following the implementation of simple changes, significant improvements were seen in documentation relating to the SIGN guidelines for tonsillectomy. Overall, the number of children meeting all four SIGN criteria for tonsillectomy rose from 12% to 44% (χ2 = 57.8; P < 0.001). Furthermore, a significant reduction was seen in the number of children below the age of 5 years undergoing tonsillectomy for recurrent tonsillitis (χ2 = 14.66; P < 0.001).
With increasing scrutiny on tonsillectomy, it is important to ensure that the reasons for performing tonsillectomy are documented clearly and adhere to evidence-based guidance where possible. We have demonstrated that, with only simple and low-cost interventions, significant improvements in the documentation of tonsillectomy indications can be achieved.
Guidelines; Selection criteria; Tonsillectomy; Documentation
To assess the combination of propofol and remifentanil for sedation to reduce shoulder dislocations in an ED.
Eleven patients with anterior glenohumeral dislocation were given propofol 0.5 mg/kg and remifentanil 0.5 μg/kg iv over 90 seconds and then further doses of 0.25 mg/kg and 0.25μg/kg, respectively, if needed. Another practitioner attempted reduction using the Milch technique.
Reduction was achieved in all patients within four minutes of giving sedation (range 0.3–4; mean 1.6). Seven required one attempt at shoulder reduction, three required two attempts, and one required three attempts. Mean time to recovery of alert status was three minutes (range 1–6). The mean pain score during the reduction was 1.7 out of 10 (range 0–5). Nine patients had full recall, one had partial recall, and one had no recall at all. Eight patients were “very satisfied” with the sedation and three were “satisfied”. There were no respiratory or haemodynamic complications that required treatment.
Propofol and remifentanil provide excellent sedation and analgesia for the reduction of anterior glenohumeral dislocation, enabling rapid recovery.
propofol; remifentanil; conscious sedation; shoulder dislocation
The operative note needs to be an accurate and legible account of events occurring in the surgeon’s theatre. We set out to discover if operative notes within a British District General Oral and Maxillofacial Surgery department adhered to Royal College of Surgeons (England) guidelines.
We audited 100 consecutive Oral and Maxillofacial Surgery operations performed within general theatres. As an intervention we designed and piloted a paper based Operative Note Proforma and re-audit was undertaken.
Initial audit showed results lacking in certain areas. At re-audit all audit criteria showed improvement. The mean percentage of data point inclusion rose from 76.1 to 98.3% (0.001 < P-value < 0.005).
Previous papers have discussed various methods of improving operative note standards. We present statistical evidence for the use of an Operative Note Proforma to improve operative note standards within Oral and Maxillofacial Surgery.
Operative note; Operation note; Audit
The aim of this study, conducted in 2006, was to find out whether changes in sedation management in German intensive care units took place in comparison with our survey from 2002.
We conducted a follow-up survey with a descriptive and comparative cross-sectional multi-center design. A postal survey was sent between January and May 2006, up to four times, to the same 269 hospitals that participated in our first survey in 2002. The same questionnaire as in 2002 was used with a few additional questions.
Two hundred fourteen (82%) hospitals replied. Sixty-seven percent of the hospitals carried out changes in sedation management since the 2002 survey. Reasons for changes were published literature (46%), national guidelines (29%), and scientific lectures (32%). Sedation protocols (8% versus 52%) and a sedation scale (21% versus 46%) were used significantly more frequently. During sedation periods of up to 24 hours, significantly less midazolam was used (46% versus 35%). In comparison to 2002, sufentanil and epidural analgesia were used much more frequently in all phases of sedation, and fentanyl more rarely. For periods of greater than 72 hours, remifentanil was used more often. A daily sedation break was introduced by 34% of the hospitals, and a pain scale by 21%.
The increased implementation of protocols and scoring systems for the measurement of sedation depth and analgesia, a daily sedation break, and the use of more short-acting analgesics and sedatives account for more patient-oriented analgesia and sedation in 2006 compared with 2002.
Accurate and legible medical records are essential to good quality patient care. Guidelines from The Royal College of Surgeons of England (RCSE) state the content required to form a complete medical record, but do not address legibility. An audit of otolaryngology emergency clinic record keeping was performed using a new scoring system.
PATIENTS AND METHODS
The Adjusted Note Keeping and Legibility (ANKLe) score was developed as an objective and quantitative method to assess both the content and legibility of case notes, incorporating the RCSE guidelines. Twenty consecutive otolaryngology emergency clinic case notes from each of 7 senior house officers were audited against standards for legibility and content using the ANKLe score. A proforma was introduced to improve documentation and handwriting advice was given. A further set of 140 notes (20 notes for each of the 7 doctors) was audited in the same way to provide feedback.
The introduction of a proforma and advice on handwriting significantly increased the quality of case note entries in terms of content, legibility and overall ANKLe score.
Accurate note keeping can be improved by the use of a proforma. The legibility of handwriting can be improved using simple advice. The ANKLe score is an objective assessment tool of the overall quality of medical note documentation which can be adapted for use in other specialties.
Medical audit; Medical records; Handwriting; Quality
Targeted monitoring of analgesia, sedation and delirium, as well as their appropriate management in critically ill patients is a standard of care in intensive care medicine. With the undisputed advantages of goal-oriented therapy established, there was a need to develop our own guidelines on analgesia and sedation in intensive care in Germany and these were published as 2nd Generation Guidelines in 2005. Through the dissemination of these guidelines in 2006, use of monitoring was shown to have improved from 8 to 51% and the use of protocol-based approaches increased to 46% (from 21%).
Between 2006–2009, the existing guidelines from the DGAI (Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin) and DIVI (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin) were developed into 3rd Generation Guidelines for the securing and optimization of quality of analgesia, sedation and delirium management in the intensive care unit (ICU). In collaboration with another 10 professional societies, the literature has been reviewed using the criteria of the Oxford Center of Evidence Based Medicine. Using data from 671 reference works, text, diagrams and recommendations were drawn up. In the recommendations, Grade “A” (very strong recommendation), Grade “B” (strong recommendation) and Grade “0” (open recommendation) were agreed.
As a result of this process we now have an interdisciplinary and consensus-based set of 3rd Generation Guidelines that take into account all critically illness patient populations.
The use of protocols for analgesia, sedation and treatment of delirium are repeatedly demonstrated. These guidelines offer treatment recommendations for the ICU team. The implementation of scores and protocols into routine ICU practice is necessary for their success.
guideline; evidence; analgesia; sedation; delirium; monitoring; treatment; intensive care
Point-of-care practice audits allow documentation of procedural outcomes to support quality improvement in endoscopic practice.
To evaluate a colonoscopists’ practice audit tool that provides point-of-care data collection and peer-comparator feedback.
A prospective, observational colonoscopy practice audit was conducted in academic and community endoscopy units for unselected patients undergoing colonoscopy. Anonymized colonoscopist, patient and practice data were collected using touchscreen smart-phones with automated data upload for data analysis and review by participants. The main outcome measures were the following colonoscopy quality indicators: colonoscope insertion and withdrawal times, bowel preparation quality, sedation, immediate complications and polypectomy, and biopsy rates.
Over a span of 16 months, 62 endoscopists reported on 1279 colonoscopy procedures. The mean cecal intubation rate was 94.9% (10th centile 84.2%). The mean withdrawal time was 8.8 min and, for nonpolypectomy colonoscopies, 41.9% of colonoscopists reported a mean withdrawal time of less than 6 min. Polypectomy was performed in 37% of colonoscopies. Independent predictors of polypectomy included the following: endoscopy unit type, patient age, interval since previous colonoscopy, bowel preparation quality, stable inflammatory bowel disease, previous colon polyps and withdrawal time. Withdrawal times of less than 6 min were associated with lower polyp removal rates (mean difference −11.3% [95% CI −2.8% to −19.9%]; P=0.01).
Cecal intubation rates exceeded 90% and polypectomy rates exceeded 30%, but withdrawal times were frequently shorter than recommended. There are marked practice variations consistent with previous observations.
Real-time, point-of-care practice audits with prompt, confidential access to outcome data provide a basis for targeted educational programs to improve quality in colonoscopy practice.
Colonoscopy; Health care; Practice audit; Quality assurance; Quality indicators
In the majority of dental schools there are insufficient numbers of clinical patients for all students to receive optimal experience in intravenous sedation. This investigation was carried out to assess whether the signs and symptoms for intravenous sedation taught to the undergraduates were sufficiently objective to ensure that this clinical deficiency was not detrimental to competency of the graduating student. The signs of ptosis, altered speech and blurred vision were used by both experienced dentists and novice students to assess the level of intravenous sedation. Blurred vision was found to be unreliable while altered speech was more accurate than ptosis. The more experienced the operator the earlier the signs were observed.
The “Guidelines for the Teaching of Pain and Anxiety Control in Dentistry” were initially formulated by the American Dental Association in 1971 and revised in 19781 while similar guidelines were accepted by the House of Delegates of the Association of the Canadian Faculties of Dentistry in 19752 Both of these documents outlined the course of instructions necessary for the teaching of all modalities of pain and apprehension control at the undergraduate, postgraduate and continuing education level. Implementation of these guidelines at the undergraduate level has proven to be particularly difficult in the area of intravenous sedation because of the lack of suitable patients. This has resulted in many students graduating, having had little practical experience in sedating a patient with an intravenous drug. It is the hope of educators in this field that lectures, seminars, and demonstrations given to dental students are sufficient to overcome this deficiency.
Since the most critical clinical aspect of intravenous sedation is titrating the amount of drug required without overdosing or underdosing the patient, it was decided to investigate this ability in students with no clinical experience with intravenous diazepam. Although many drugs and techniques are advocated3,4,5 it was decided to limit the study to intravenous diazepam as it may be used alone and has a high therapeutic index.
With the introduction of diazepam to clinical practice the symptomatology of the drug was established and described by clinicians.6,7 Objective methods of measuring recovery from diazepam have been described by several authors8,9,10 but the signs and symptoms used to assess the initial level of sedation have been subjective. This can be attributed to the fact that sedation is an ill-defined clinical effect and can, therefore, only be calibrated by individual arbitary signs. The most frequently used signs for intravenous diazepam sedation are ptosis, also referred to as “the Verrill sign,”11 altered speech and blurred vision.7 This investigation was designed to test the reliability of these signs and to examine the variability of observations between clinicians and students.
The functions of an outpatient anaesthetic clinic are discussed in relation to the first 100 patients who attended. Preoperative assessment excluded 11 patients who would have been refused anaesthesia for elective operations without further treatment. Six of these required preoperative physiotherapy, 4 antihypertensive therapy, and 1 hospital admission for incipient myocardial infarction. The clinic also played an important role with regard to advice and reassurance of the patient from an experienced anaesthetist, organising suitable admission dates, and detecting anaesthetic and surgical hazards, especially dental caries and obesity, which could be corrected before operation. Two patients developed postoperative complications which could not have been foreseen.
A prospective study was carried out in one District Health Authority over a twelve month period to investigate the principal reasons for the postponement of operations on the advice of anaesthetic staff. A mean of 1.4% of all cases listed for general anaesthesia were postponed. The clinical indications for this are described and possible methods for reducing this figure are discussed.
Inpatient medical notes often fail to record important details of patient history and findings on clinical examination. To overcome problems with content and legibility of notes we introduced preprinted notes for the admission of children to this hospital. The quality of the information recorded for 100 children whose admissions were clerked with the preprinted notes was compared with that recorded for 100 whose admissions were recorded with the traditional notes. All case notes were selected randomly and retrospectively from traditional notes written from April to October 1993 and from preprinted notes written from October 1993 to April 1994. The quality of information was assessed according to the presence or absence of 25 agreed core clinical details and the number of words per clerking. In admissions recorded with the preprinted notes the mean number of core clinical details present was significantly higher than those recorded with traditional notes (24.0 v 17.6, p < 0.00001). Admissions recorded with the preprinted notes were also significantly shorter (mean 144 words v 184 words, p < 0.0001). The authors conclude that information about children admitted to hospital is both more complete and more succinct when recorded using preprinted admission sheets.
Clinical laboratories should be able to offer interpretation of the results they produce.At a minimum, contact details for interpretative advice should be available on laboratory reports.Interpretative comments may be verbal or written and printed.Printed comments on reports should be offered judiciously, only where they would add value; no comment preferred to inappropriate or dangerous comment.Interpretation should be based on locally agreed or nationally recognised clinical guidelines where available.Standard tied comments (“canned” comments) can have some limited use.Individualised narrative comments may be particularly useful in the case of tests that are new, complex or unfamiliar to the requesting clinicians and where clinical details are available.Interpretative commenting should only be provided by appropriately trained and credentialed personnel.Audit of comments and continued professional development of personnel providing them are important for quality assurance.
Anterior shoulder dislocation is a disabling injury affecting all ages, young and old alike. Recently, the treatment of traumatic shoulder dislocation has included immobilisation for varying periods of time followed by physiotherapy. This study is the first in this country to address the demographic data and recurrence rates of shoulder dislocation. Three hundred and eight patients (170 men and 138 women) were followed up for an average of 5.9 years. The most frequent mechanism of injury was a fall (65.66% of cases), and in 92.1% of the patients, the shoulder was reduced in the Emergency Department without the need for sedation or general anaesthesia. The overall recurrence rate in all ages was 50%, but rose to 88.9% in the 14–20-year age group. The duration of immobilisation did not affect the rate of re-dislocation of the humeral head. We believe that conventional shoulder immobilisation in a sling offers no benefits, and it would be preferable not to immobilise the shoulder at all.
Need for improved sedation strategy for adults receiving ventilator support.
Observational study of effect of introduction of guidelines to improve the doctors' and nurses' performance. The project was a prospective improvement and was part of a national quality improvement collaborative.
Background and setting
A general mixed surgical intensive care unit in a university hospital; all doctors and nurses in the unit; all adult patients (>18 years) treated by intermittent positive pressure ventilation for more than 24 hours.
Key measures for improvement
Reduction in patients' mean time on a ventilator and length of stay in intensive care over a period of 11 months; anonymous reporting of critical incidents; staff perceptions of ease and of consequences of changes.
Strategies for change
Multiple measures (protocol development, educational presentations, written guidelines, posters, flyers, emails, personal discussions, and continuous feedback) were tested, rapidly assessed, and adopted if beneficial.
Effects of change
Mean ventilator time decreased by 2.1 days (95% confidence interval 0.7 to 3.6 days) from 7.4 days before intervention to 5.3 days after. Mean stay decreased by 1.0 day (–0.9 to 2.9 days) from 9.3 days to 8.3 days. No accidental extubations or other incidents were identified.
Relatively simple changes in sedation practice had significant effects on length of ventilator support. The change process was well received by the staff and increased their interest in identifying other areas for improvement.
Problem: Need for improved sedation strategy for adults receiving ventilator support.
Design: Observational study of effect of introduction of guidelines to improve the doctors' and nurses' performance. The project was a prospective improvement and was part of a national quality improvement collaborative.
Background and setting: A general mixed surgical intensive care unit in a university hospital; all doctors and nurses in the unit; all adult patients (>18 years) treated by intermittent positive pressure ventilation for more than 24 hours.
Key measures for improvement: Reduction in patients' mean time on a ventilator and length of stay in intensive care over a period of 11 months; anonymous reporting of critical incidents; staff perceptions of ease and of consequences of changes.
Strategies for change: Multiple measures (protocol development, educational presentations, written guidelines, posters, flyers, emails, personal discussions, and continuous feedback) were tested, rapidly assessed, and adopted if beneficial.
Effects of change: Mean ventilator time decreased by 2.1 days (95% confidence interval 0.7 to 3.6 days) from 7.4 days before intervention to 5.3 days after. Mean stay decreased by 1.0 day (–0.9 to 2.9 days) from 9.3 days to 8.3 days. No accidental extubations or other incidents were identified.
Lessons learnt: Relatively simple changes in sedation practice had significant effects on length of ventilator support. The change process was well received by the staff and increased their interest in identifying other areas for improvement.
Previous studies have suggested that exposure to organic solvents, including volatile anaesthetic agents, may be a risk factor for multiple sclerosis (MS), possibly in combination with genetic and other environmental factors.
To further investigate the role of volatile anaesthetic agents having similar acute toxic effects to other organic solvents.
Female nurse anaesthetists, other female nurses, and female teachers from middle and upper compulsory school levels were identified and retrieved from the 1985 census, Statistics Sweden. By means of the unique personal identity number in Sweden, these individuals were linked with the disability pension registers at The National Social Insurance Board and also with data on hospital care 1985–2000 at The National Board of Health and Welfare.
The cumulative incidence rate ratio of MS was found to be increased in female nurse anaesthetists in relation to other nurses (statistically not significant) and teachers (statistically significant), respectively.
These findings give some support to previous findings of an increased risk for MS in nurse anaesthetists. This is interesting in the context of previous observations of organic solvents in general as a potential risk factor in MS.
exposure; volatile anaesthetic gases; organic solvents; risk
Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management.
A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited.
In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline.
Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52 weeks. Clinical endpoints will not be measured, but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year.
The combined use of risk communication, a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention.
Current Controlled Trials ISRCTN51556722