Henrica C.W. de Vet

The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus.

Most systematic reviews rely substantially on the assessment of the methodological quality of the individual trials. The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of randomized clinical trials (RCTs). The invited participants were experts in the field of quality assessment of RCTs. The initial item pool contained all items from existing criteria lists. Subsequently, we reduced the number of items by using the Delphi consensus technique. Each Delphi round comprised a questionnaire, an analysis, and a feedback report. The feedback report included staff team decisions made on the basis of the analysis and their justification. A total of 33 international experts agreed to participate, of whom 21 completed all questionnaires. The initial item pool of 206 items was reduced to 9 items in three Delphi rounds. The final criteria list (the Delphi list) was satisfactory to all participants. It is a starting point on the way to a minimum reference standard for RCTs on many different research topics. This list is not intended to replace, but rather to be used alongside, existing criteria lists.

The art of quality assessment of RCTs included in systematic reviews

The best evidence on the efficacy of medical interventions is provided by high-quality trials summarized in high-quality systematic reviews or meta-analyses. The methodological quality of studies included in a systematic review can have a substantial impact on the estimates of the treatment effect and therefore on the conclusions of such a review. But what is the empirical evidence to support quality assessment of randomized clinical trials (RCTs)? We elaborate on questions such as: what is the concept of quality of individual studies (RCTs), can quality be measured validly and reliably? Plans for future research on this issue are proposed.

A patient-specific approach for measuring functional status in low back pain

BACKGROUND Activities and their importance for daily living vary widely between patients. Patient-specific measurement of functional status means that the evaluation is focused on activities that an individual patient selected as main complaints. OBJECTIVE To develop and to evaluate a patient-specific approach for measuring functional status in low back pain. STUDY DESIGN A cohort of 150 patients was measured at baseline and 12 weeks later. METHODS The feasibility of the patient-specific approach was evaluated in patients with nonspecific low back pain. We used effect size statistics to evaluate responsiveness in terms of sensitivity to change and specificity to change. RESULTS The selection procedure for the main complaint was feasible but labor intensive. The patient-specific approach was able to detect changes in complaints that were highly relevant for the patients. The patient-specific approach appeared to be more sensitive to change but less specific to change compared with other instruments. CONCLUSIONS On the basis of this study it would be valuable to apply the patient-specific approach in future studies, also with the aim of further evaluation. In the meantime a number of practical problems of the method need to be resolved.

Balneotherapy and Quality Assessment: Interobserver Reliability of the Maastricht Criteria List and the Need for Blinded Quality Assessment

This study investigates aspects of the reliability of the Maastricht criteria list for quality assessment in systematic reviews, and whether blinded reviewing is necessary to prevent review bias. We used the data set of 12 articles from a systematic review concerning the efficacy of balneotherapy in patients with arthritis. Twenty reviewers participated of which two reviewers, who have been involved in developing the Maastricht criteria list, acted as reference standard. Half of all assessments were performed blindly. A high level of agreement was found between the reviewers and a high level of correlation with the reference standard. The quality scores between the blinded and unblinded assessment did not differ much. Based on the results we conclude that the Maastricht criteria list is a reliable instrument in quality assessment of clinical trials. Within the limits of this study we found no evidence that blinding is necessary to prevent review bias.

Low-Level Laser Therapy in Ankle Sprains: A Randomized Clinical Trial

OBJECTIVE To test the efficacy of low-level laser therapy on lateral ankle sprains as an addition to a standardized treatment regimen, a trial was conducted in which high-dose laser (5J/cm2), low-dose laser (0.5J/cm2), and placebo laser therapy (0J/cm2) at skin level were compared. DESIGN Randomized, double-blind, controlled clinical trial with a follow-up of 1 year. Patients, therapists, assessors, and analysts were blinded to the assigned treatment. SETTING An ambulatory care setting. PATIENTS After informed consent and verification of exclusion criteria, 217 patients with acute lateral ankle sprains were randomized to three groups from September 1, 1993, through December 31, 1995. INTERVENTIONS Twelve treatments of 904nm laser therapy in 4 weeks as an adjunct to a standardized treatment regimen of 4 weeks of brace therapy combined with standardized home exercises and advice. The laser therapy device used was a 904nm Ga-As laser, with 25-watt peak power and 5,000 or 500Hz frequency, a pulse duration of 200nsec, and an irradiated area of 1cm2. PRIMARY OUTCOME MEASURES Pain and function as reported by the patient. RESULTS Intention-to-treat analysis of the short-term results showed no statistically significant difference on the primary outcome measure, pain (p = .41), although the placebo group showed slightly less pain. Function was significantly better in the placebo group at 10 days (p = .01) and 14 days (p = .03) after randomization. The placebo group also performed significantly better on days of sick leave (p = .02) and at some points for hindrance in activities in daily life and pressure pain, as well as subjective recovery (p = .05). Intention-to-treat analysis showed that total days of absenteeism from work and sports were remarkably lower in the placebo group than in the laser groups, ranging from 3.7 to 5.3 and 6 to 8 days, respectively. The total number of relapses at 1 year in the low-dose laser group (n = 22) was significantly higher (p = .04) than in the other two groups (high laser, n = 13; placebo, n = 13). Subgroup analysis to correct for possible confounders did not alter these findings. CONCLUSIONS Neither high- nor low-dose laser therapy is effective in the treatment of lateral ankle sprains.

Health-related quality of life in chronic refractory reflex sympathetic dystrophy (complex regional pain syndrome type I)

The aim of this study was to find out which aspects of health-related quality of life (HRQL), measured with generic instruments, are important to patients with reflex sympathetic dystrophy (RSD) affecting the arm or leg. The Sickness Impact Profile 68 (SIP68), the Nottingham Health Profile (NHP), and the EuroQol-5D (EQ-5D) were completed by 54 patients suffering from RSD (33 arm, 21 leg). The scores of the three questionnaires for patients with an affected arm or leg are presented. Aspects relevant to patients with RSD of the arm include the NHP1 dimensions of pain (mean score: 63%), sleep (58%), and energy (45%), and the EQ-5D dimensions of pain (67% extreme), usual activities (76% some problems), and self care (76% some problems). Aspects relevant to patients with RSD of the leg include the SIP68 dimensions of social behavior (51%) and mobility control (46%), the NHP 1 dimensions of pain (mean score: 86%), mobility (54%), energy (53%), and sleep (52%), and the EQ-5D dimensions of mobility (81% some problems), pain (71% extreme), and usual activities (71% some problems). The study showed that applying generic HRQL instruments and measuring treatment effect with the dimensions scoring high provides a responsive instrument which at the same time gains information concerning dimensions not maximally responsive to a specific disease. Some dimensions which, on the basis of their label, might be expected to be important were found not to be so. After using this approach, clinicians can more directly focus treatment on specific areas that have been shown to affect a patients HRQL.

A METHOD FOR RESEARCH PROGRAMMING IN THE FIELD OF EVIDENCE-BASED MEDICINE

OBJECTIVE This paper presents the method we used in programming research on the efficacy of therapeutic interventions for nine chronic benign pain disorders. METHODS We started with an inventory to identify commonly applied interventions. For these interventions we searched the literature to identify gaps in evidence. First, we searched for recent reviews, of which we assessed the methodologic quality. If only reviews of poor or moderate quality were found, a new systematic review was recommended. When we found no recent reviews, we searched for randomized controlled trials (RCTs). If there was insufficient or inconsistent evidence, the performance of a new RCT was advised. This structured procedure resulted in a list with topics for which new systematic reviews were recommended and topics for which new RCTs were needed. These lists were the starting points for priority setting by four Centers for Pain Management and Research. All members of the centers were asked to state the priority of each topic. The resulting hierarchy of topics for their own center was discussed in a meeting in each center, giving participants the opportunity to elucidate their views and considerations. RESULTS The final result was a robust priority list for the need of research (systematic reviews and RCTs) on chronic benign pain syndromes. DISCUSSION The strength and weaknesses of this approach are discussed. This method of priority setting is by no means restricted to treatments for chronic pain; it is also a useful approach for programming research to enable evidence-based medicine in other fields of interest.

Noninvasive measurement of burn wound depth applying infrared thermal imaging (Conference Presentation)

In burn wounds early discrimination between the different depths plays an important role in the treatment strategy. The remaining vasculature in the wound determines its healing potential. Non-invasive measurement tools that can identify the vascularization are therefore considered to be of high diagnostic importance. Thermography is a non-invasive technique that can accurately measure the temperature distribution over a large skin or tissue area, the temperature is a measure of the perfusion of that area. The aim of this study was to investigate the clinimetric properties (i.e. reliability and validity) of thermography for measuring burn wound depth. In a cross-sectional study with 50 burn wounds of 35 patients, the inter-observer reliability and the validity between thermography and Laser Doppler Imaging were studied. With ROC curve analyses the ΔT cut-off point for different burn wound depths were determined. The inter-observer reliability, expressed by an intra-class correlation coefficient of 0.99, was found to be excellent. In terms of validity, a ΔT cut-off point of 0.96°C (sensitivity 71%; specificity 79%) differentiates between a superficial partial-thickness and deep partial-thickness burn. A ΔT cut-off point of -0.80°C (sensitivity 70%; specificity 74%) could differentiate between a deep partial-thickness and a full-thickness burn wound. This study demonstrates that thermography is a reliable method in the assessment of burn wound depths. In addition, thermography was reasonably able to discriminate among different burn wound depths, indicating its potential use as a diagnostic tool in clinical burn practice.