Interventions for the treatment and management of chronic fatigue syndrome: a systematic review

CONTEXT A variety of interventions have been used in the treatment and management of chronic fatigue syndrome (CFS). Currently, debate exists among health care professionals and patients about appropriate strategies for management. OBJECTIVE To assess the effectiveness of all interventions that have been evaluated for use in the treatment or management of CFS in adults or children. DATA SOURCES Nineteen specialist databases were searched from inception to either January or July 2000 for published or unpublished studies in any language. The search was updated through October 2000 using PubMed. Other sources included scanning citations, Internet searching, contacting experts, and online requests for articles. STUDY SELECTION Controlled trials (randomized or nonrandomized) that evaluated interventions in patients diagnosed as having CFS according to any criteria were included. Study inclusion was assessed independently by 2 reviewers. Of 350 studies initially identified, 44 met inclusion criteria, including 36 randomized controlled trials and 8 controlled trials. DATA EXTRACTION Data extraction was conducted by 1 reviewer and checked by a second. Validity assessment was carried out by 2 reviewers with disagreements resolved by consensus. A qualitative synthesis was carried out and studies were grouped according to type of intervention and outcomes assessed. DATA SYNTHESIS The number of participants included in each trial ranged from 12 to 326, with a total of 2801 participants included in the 44 trials combined. Across the studies, 38 different outcomes were evaluated using about 130 different scales or types of measurement. Studies were grouped into 6 different categories. In the behavioral category, graded exercise therapy and cognitive behavioral therapy showed positive results and also scored highly on the validity assessment. In the immunological category, both immunoglobulin and hydrocortisone showed some limited effects but, overall, the evidence was inconclusive. There was insufficient evidence about effectiveness in the other 4 categories (pharmacological, supplements, complementary/alternative, and other interventions). CONCLUSIONS Overall, the interventions demonstrated mixed results in terms of effectiveness. All conclusions about effectiveness should be considered together with the methodological inadequacies of the studies. Interventions which have shown promising results include cognitive behavioral therapy and graded exercise therapy. Further research into these and other treatments is required using standardized outcome measures

Dieting to reduce body weight for controlling hypertension in adults

OBJECTIVES: Evaluate whether weight-loss diets are more effective than regular diets or other antihypertensive therapies in controlling blood pressure and preventing morbidity and mortality in hypertensive adults. SEARCH STRATEGY: MEDLINE and The Cochrane Library were searched through November 1997. Trials known to experts in the field were included through June 1998. SELECTION CRITERIA: For inclusion in the review, trials were required to meet each of the following criteria: 1) randomized controlled trials with one group assigned to a weight-loss diet and the other group assigned to either normal diet or antihypertensive therapy; 2) ambulatory adults with a mean blood pressure of at least 140 mm Hg systolic and/or 90 mm Hg diastolic; 3) active intervention consisting of a calorie-restricted diet intended to produce weight loss (excluded studies simultaneously implementing multiple lifestyle interventions where the effects of weight loss could not be disaggregated); and 4) outcome measures included weight loss and blood pressure. DATA COLLECTION AND ANALYSIS: Studies were dual abstracted by two independent reviewers using a standardized form designed specifically for this review. The primary mode of analysis was qualitative; graphs of effect sizes for individual studies were also used. MAIN RESULTS: Eighteen trials were found. Only one small study of inadequate power reported morbidity and mortality outcomes. None addressed quality of life or general well being issues. In general, participants assigned to weight-reduction groups lost weight compared to control groups. Six trials involving 361 participants assessed a weight-reducing diet versus a normal diet. The data suggested weight loss in the range of 4% to 8% of body weight was associated with a decrease in blood pressure in the range of 3 mm Hg systolic and diastolic. Three trials involving 363 participants assessed a weight-reducing diet versus treatment with antihypertensive medications. These suggested that a stepped-care approach with antihypertensive medications produced greater decreases in blood pressure (in the range of 6/5 mm Hg systolic/diastolic) than did a weight-loss diet. Trials that allowed adjustment of participants' antihypertensive regimens suggested that patients required less intensive antihypertensive drug therapy if they followed a weight-reducing diet. Data was insufficient to determine the relative efficacy of weight-reduction versus changes in sodium or potassium intake or exercise. REVIEWER'S CONCLUSIONS: Weight-reducing diets in overweight hypertensive persons can affect modest weight loss in the range of 3-9% of body weight and are probably associated with modest blood pressure decreases of roughly 3 mm Hg systolic and diastolic. Weight-reducing diets may decrease dosage requirements of persons taking antihypertensive medications

Bone-anchored hearing aids for people who are bilaterally deaf: a systematic review and economic evaluation

The aim of this systematic review, using standard methodology,was to assess the clinical and cost-effectiveness of bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf. Prospective studies comparing BAHAs versus conventional hearing aids [air conduction hearing aid (ACHA) or bone conduction hearing aid (BCHA)], unaided hearing or ear surgery; and unilateral versus bilateral BAHAs were eligible. Twelve clinical effectiveness studies were included. No eligible comparisons with ear surgery were identified. Overall quality was rated as weak for all included studies.There appeared to be some audiological benefits of BAHAs compared with BCHAs and improvements in speech understanding in noise compared with ACHAs, however ACHAs may produce better audiological results for other outcomes; the limited evidence reduces certainty. Hearing is improved with BAHAs compared with unaided hearing. Improvements in QoL with BAHAs were identified by a hearing-specific instrument but not generic QoL measures. Studies comparing unilateral with bilateral BAHAs suggested benefits of bilateral BAHAs in many, but not all, situations.A decision analytic model was developed to estimate the costs and benefits of unilateral BAHAs over a ten year time horizon. The incremental cost per user receiving BAHA, compared with BCHA, was £16,344 for children and £13,281 for adults. In an exploratory analysis the incremental cost per QALY gained was between £118,898 and £55,424 for children and between £98,790 to £46,051 for adults for BAHAs compared with BCHA, depending on the assumed QoL gain and proportion of each modelled cohort using their hearing aid for eight or more hours per day. Deterministic sensitivity analysis suggested results were highly sensitive to the assumed proportion of people using BCHA for eight or more hours per day.Exploratory cost effectiveness analysis suggests that BAHAs are unlikely to be a cost effective option where the benefi ts are similar for BAHAs and their comparators. The greater the benefit from aided hearing and the greater the difference in the proportion of people using the hearing aid for eight hours or more per day, the more likely BAHAs are to be a cost effective option. The inclusion of other dimensions of QoL may also increase the likelihood of BAHAs being a cost effective option.A national audit of BAHAs is needed to provide clarity on the many areas of uncertainty surrounding BAHAs

Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions

• A number of hierarchies of evidence have been developed to enable different research methods to be ranked according to the validity of their findings. However, most have focused on evaluation of the effectiveness of interventions. When the evaluation of healthcare addresses its appropriateness or feasibility, then existing hierarchies are inadequate. • This paper reports the development of a hierarchy for ranking of evidence evaluating healthcare interventions. The aims of this hierarchy are twofold. Firstly, it is to provide a means by which the evidence from a range of methodologically different types of research can be graded. Secondly, it is to provide a logical framework that can be used during the development of systematic review protocols to help determine the study designs which can contribute valid evidence when the evaluation extends beyond effectiveness. • The proposed hierarchy was developed based on a review of literature, investigation of existing hierarchies and examination of the strengths and limitations of different research methods. • The proposed hierarchy of evidence focuses on three dimensions of the evaluation: effectiveness, appropriateness and feasibility. Research that can contribute valid evidence to each is suggested. To address the varying strengths of different research designs, four levels of evidence are proposed: excellent, good, fair and poor. • The strength of the proposed hierarchy is that it acknowledges the valid contribution of evidence generated by a range of different types of research. However, hierarchies only provide a guide to the strength of the available evidence and other issues such as the quality of research also have an important influence.David Evan

Research information in nurses' clinical decision-making: What is useful?

AIM: To examine those sources of information which nurses find useful for reducing the uncertainty associated with their clinical decisions. BACKGROUND: Nursing research has concentrated almost exclusively on the concept of research implementation. Few, if any, papers examine the use of research knowledge in the context of clinical decision-making. There is a need to establish how useful nurses perceive information sources are, for reducing the uncertainties they face when making clinical decisions. DESIGN: Cross-case analysis involving qualitative interviews, observation, documentary audit and Q methodological modelling of shared subjectivities amongst nurses. The case sites were three large acute hospitals in the north of England, United Kingdom. One hundred and eight nurses were interviewed, 61 of whom were also observed for a total of 180 hours and 122 nurses were involved in the Q modelling exercise. RESULTS: Text-based and electronic sources of research-based information yielded only small amounts of utility for practising clinicians. Despite isolating four significantly different perspectives on what sources were useful for clinical decision-making, it was human sources of information for practice that were overwhelmingly perceived as the most useful in reducing the clinical uncertainties of nurse decision-makers. CONCLUSIONS: It is not research knowledge per se that carries little weight in the clinical decisions of nurses, but rather the medium through which it is delivered. Specifically, text-based and electronic resources are not viewed as useful by nurses engaged in making decisions in real time, in real practice, but those individuals who represent a trusted and clinically credible source are. More research needs to be carried out on the qualities of people regarded as clinically important information agents (specifically, those in clinical nurse specialist and associated roles) whose messages for practice appear so useful for clinicians