Eva Kaltenthaler

Treatment of irritable bowel syndrome: a review of randomised controlled trials.

Irritable bowel syndrome (IBS) is a common chronic disorder that is associated with significant disability and health care costs. The purpose of this paper is to review and assess published randomised controlled trials examining the clinical effectiveness of interventions for IBS for 1987–1998. A literature search was conducted to identify randomised controlled trials of IBS treatments: 45 studies were identified that described randomised controlled trials and of these, six fulfilled all three criteria used to assess the quality of randomised controlled trials, as described by Jadad and colleagues.1 These criteria are: adequate description of randomisation, double blinding, and description of withdrawals and dropouts. It is concluded that there are few studies which offer convincing evidence of effectiveness in treating the IBS symptom complex. This review strongly suggests that future work should include well designed trials that: describe the randomisation method; use internationally approved diagnostic criteria; and are double blinded and placebo controlled. Clear well defined outcome measures are necessary. Inclusion of quality of life measures allows comparison between trials in different therapeutic areas. Conducting such studies will help to overcome some of the difficulties identified in this review.

The acceptability to patients of computerized cognitive behaviour therapy for depression: a systematic review.

BACKGROUND Cognitive behaviour therapy (CBT) is widely used to treat depression. However, CBT is not always available to patients because of a shortage of therapists and long waiting times. Computerized CBT (CCBT) is one of several alternatives currently available to treat patients with depression. Evidence of its clinical effectiveness has led to programs being used increasingly within the UK and elsewhere. However, little information is available regarding the acceptability of CCBT to patients. METHOD A systematic review of sources of information on acceptability to patients of CCBT for depression. RESULTS Sources of information on acceptability included: recruitment rates, patient drop-outs and patient-completed questionnaires. We identified 16 studies of CCBT for the treatment of depression that provided at least some information on these sources. Limited information was provided on patient take-up rates and recruitment methods. Drop-out rates were comparable to other forms of treatment. Take-up rates, when reported, were much lower. Six of the 16 studies included specific questions on patient acceptability or satisfaction although information was only provided for those who had completed treatment. Several studies have reported positive expectancies and high satisfaction in routine care CCBT services for those completing treatment. CONCLUSIONS Trials of CCBT should include more detailed information on patient recruitment methods, drop-out rates and reasons for dropping out. It is important that well-designed surveys and qualitative studies are included alongside trials to determine levels and determinants of patient acceptability.

Health-Related Quality of Life and Cost Impact of Irritable Bowel Syndrome in a UK Primary Care Setting

AbstractObjectives: To identify the impact of irritable bowel syndrome (IBS) on health-related quality of life (HR-QOL), time off work and the utilisation and cost of health services. Design: A case-control study was undertaken matching patients with IBS and controls. Quality-of-life information was collected using the Medical Outcomes Study 36-item Short Form (SF-36) health survey, EuroQOL instrument (EQ-5D) and IBS Quality-of-Life (IBS-QOL) instruments. Data on time off work was also collected. National Health Service (NHS) resource use in primary and secondary care was estimated by review of general practitioner (GP) and hospital records over a 12-month period. Setting: Recruitment was from six GPs’ surgeries in the Trent Region of the United Kingdom. Participants: 161 patients with IBS, as defined by the Rome Criteria I were recruited. These were compared with 213 controls matched for age, sex and social characteristics. Main outcome measures: SF-36 and EQ-5D scores; mean number of days off work; mean NHS costs per person during the 12-month study period. Results: Patients with IBS had considerably lower HR-QOL than controls. They scored worse in all dimensions of the SF-36 and the EQ-5D and they had more time off work. On average patients with IBS cost the NHS £123 (95% confidence interval: £35 to £221, 1999 values) more per year than individuals in the control group (p = 0.04). Conclusions: IBS affects patients through reduced quality of life, more time off work and greater healthcare utilisation than a control group of patients without IBS. The difference in quality of life was pronounced and unusual in that it was influential in every dimension of both the SF-36 and the EQ-5D.

COMPUTERIZED COGNITIVE BEHAVIOUR THERAPY: A SYSTEMATIC REVIEW

Depression, anxiety disorders and phobias are common mental health problems associated with considerable occupational and interpersonal impairment. Although there is substantial evidence to support the use of cognitive behaviour therapy (CBT) in the treatment of these disorders, access is limited. Computerized cognitive behaviour therapy (CCBT) is one of a variety of aids to self-management that offer patients the potential benefits of CBT with less therapist involvement than therapist led CBT (TCBT). In this systematic review of the efficacy of CCBT, 16 studies were identified. Of these 11 were RCTS and the remaining 5 were pilot or cohort studies. The quality of studies ranged from poor to moderate (although the criteria used precluded the highest rating). In the studies comparing CCBT with TCBT, five studies showed CCBT have equivalent outcomes to TCBT. One study of depressed inpatients found TCBT to be significantly more effective than CCBT. Four studies found CCBT to be more effective than treatment as usual (TAU). Two studies found CCBT to be no more effective than TAU. Two studies compared CCBT with bibliotherapy. Of these, one study found CCBT to be as effective as bibliotherapy and one found bibliotherapy to be significantly more effective than CCBT on some outcome measures. Although the results of this review are not conclusive, CCBT is potentially useful in the treatment of anxiety disorders, depression and phobias. From the results of this review, we make three recommendations to improve the quality of research in this field, and suggest four areas requiring further research.

MRCP compared to diagnostic ERCP for diagnosis when biliary obstruction is suspected: a systematic review

BackgroundMagnetic resonance cholangiopancreatography (MRCP) is an alternative to diagnostic endoscopic retrograde cholangiopancreatography (ERCP) for investigating biliary obstruction. The use of MRCP, a non-invasive procedure, may prevent the use of unnecessary invasive procedures. The aim of the study was to compare the findings of MRCP with those of ERCP by the computation of accuracy statistics.MethodsThirteen electronic bibliographic databases, covering biomedical, science, health economics and grey literature were searched. A systematic review of studies comparing MRCP to diagnostic ERCP in patients with suspected biliary obstruction was conducted. Sensitivity, specificity, likelihood ratios, acceptability and adverse events were reported.Results25 studies were identified reporting several conditions including choledocholithiasis (18 studies), malignancy (four studies), obstruction (three studies), stricture (two studies) and dilatation (five studies). Three of the 18 studies reporting choledocholithiasis were excluded from the analysis due to lack of data, or differences in study design. The sensitivity for the 15 studies of choledocholithiasis ranged from 0.50 to 1.00 while specificity ranged from 0.83 to 1.00. The positive likelihood ratio ranged: from 5.44–47.72 and the negative likelihood ratio for the 15 studies ranged from 0.00–0.51. Significant heterogeneity was found across the 15 studies so the sensitivities and specificities were summarised by a Receiver Operating Characteristic (ROC) curve. For malignancy, sensitivity ranged from 0.81 to 0.94 and specificity from 0.92 to 1.00. Positive likelihood ratios ranged from 10.12 to 43 and negative likelihood ratios ranged from 0.15 to 0.21, although these estimates were less reliable.ConclusionMRCP is a comparable diagnostic investigation in comparison to ERCP for diagnosing biliary obstruction.

Amblyopia and quality of life: a systematic review

Amblyopia is a common condition, which can affect up to 5% of the general population. Health-related quality-of-life (HRQoL) implications of amblyopia and/or its treatment have been explored in the literature. A systematic literature search was undertaken during the period of 7–14 May 2010 to identify the HRQoL implications of amblyopia and/or its treatment. A total of 35 papers were included in the literature review. The HRQoL implications of amblyopia related specifically to amblyopia treatment, rather than to the condition itself. These included impact on family life, social interactions, difficulties in undertaking daily activities, as well as feelings and behaviour. The identified studies adopted a number of methodologies. The study populations included children with the condition, parents of children with amblyopia, and adults who had undertaken amblyopia treatment as a child. Some studies developed their own measures of HRQoL, and others determined HRQoL through proxy measures. The reported findings of the HRQoL implications are of importance when considering the management of cases of amblyopia. The issues identified in the literature review are discussed with respect to how HRQoL is measured (treatment compliance vs proxy measures), and whether HRQoL is taken from a childs or a parents perspective. Changing societal views over glasses and occlusion therapy are also discussed. Further research is required to assess the immediate and long-term effects of amblyopia and/or its treatment on HRQoL using a more standardised approach.

Computerised Cognitive Behaviour Therapy for Obsessive-Compulsive Disorder: A Systematic Review

Background: Computer-guided therapy is an innovative treatment strategy that could have an important role in the future of psychological treatment. This paper summarises the available published evidence that assesses the effectiveness of a computerised cognitive behaviour therapy (CCBT) for obsessive-compulsive disorder (OCD). Methods: Fifteen electronic bibliographic databases including Medline, Embase, the Cochrane Library, Cinahl, PsycINFO, Biological Abstracts, HMIC and NHS CRD databases were comprehensively searched in March 2004: [‘obsessive compulsive disorder’ (text and indexed terms)] AND [‘cognitive therapy’ (text and indexed terms)] AND [‘computer’ (text and indexed terms)]. Reference lists of included studies, guidelines, generic research, trials registers and specialist mental health sites were hand-searched. Results: The search produced 149 citations from which we identified two RCTs and two single-arm studies with relevant data. All four studies used one software programme – BTSteps.In the large RCT, YBOCS effect sizes for BTSteps, therapist-led cognitive behaviour therapy (TCBT) and relaxation (RLX) were 0.84, 1.22, and 0.35, respectively. The smaller RCT found significantly better outcomes with brief scheduled support compared to brief on-demand phone support. Conclusions: BTSteps was as good as TCBT for reducing time spent in rituals and obsessions and for improving the Work and Social Adjustment Scale (WSA), and was superior to RLX treatment. The available evidence also showed that improvement of OCD persisted beyond the end of CCBT. TCBT was more effective than CCBT for all patients overall though not in those who went on to start self-exposure. Such a system has the potential to widen the access to CBT in general and considerably shorten clinician-guided care.

A systematic review of eculizumab for atypical haemolytic uraemic syndrome (aHUS)

Objective To determine the efficacy and safety of eculizumab for patients with atypical haemolytic uraemic syndrome (aHUS), compared with current treatment options. Design A systematic review was performed according to the general principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. All study designs were included, except case histories. Participants All patients diagnosed with aHUS were included; no age restrictions were used. Interventions Eculizumab compared with current treatment options. Identification of studies 12 databases were searched. Additional searches were performed through the Food and Drug Administration (FDA) and the Electronic Medicines Compendium websites, Google internet searches and contacting clinical experts. Reference lists of relevant articles were checked for additional studies. Results 2 small, uncontrolled prospective multinational, multicentre studies and one small uncontrolled multinational, multicentre retrospective study were included. No meta-analyses were performed. Compared with baseline measures, thrombotic microangiopathy event-free status was achieved in 84% of patients in the prospective studies. Adverse events, as documented by enrolling investigators were frequent, with upper-respiratory tract infection affecting a third of patients. No deaths or episodes of meningitis or meningococcal septicaemia occurred in the prospective studies. Results of the study extension phases up to 114 weeks indicate that the benefits of the treatment are sustained. Conclusions Eculizumab is clinically effective for the treatment of aHUS. Further research is needed to evaluate eculizumab, ideally using patient-related clinical outcomes. If randomised studies are not feasible, study investigators should ensure that the threat of bias is minimised in future studies of eculizumab with respect to the reporting of patient recruitment and selection.

The clinical and economic benefits of capecitabine and tegafur with uracil in metastatic colorectal cancer

Two oral fluoropyrimidine therapies have been introduced for metastatic colorectal cancer. One is a 5-fluorouracil pro-drug, capecitabine; the other is a combination of tegafur and uracil administered together with leucovorin. The purpose of this study was to compare the clinical effectiveness and cost-effectiveness of these oral therapies against standard intravenous 5-fluorouracil regimens. A systematic literature review was conducted to assess the clinical effectiveness of the therapies and costs were calculated from the UK National Health Service perspective for drug acquisition, drug administration, and the treatment of adverse events. A cost-minimisation analysis was used; this assumes that the treatments are of equal efficacy, although direct randomised controlled trial (RCT) comparisons of the oral therapies with infusional 5-fluorouracil schedules were not available. The cost-minimisation analysis showed that treatment costs for a 12-week course of capecitabine (£2132) and tegafur with uracil (£3385) were lower than costs for the intravenous Mayo regimen (£3593) and infusional regimens on the de Gramont (£6255) and Modified de Gramont (£3485) schedules over the same treatment period. Oral therapies result in lower costs to the health service than intravenous therapies. Further research is needed to determine the relative clinical effectiveness of oral therapies vs infusional regimens.

Health-related quality of life measures (HRQoL) in patients with amblyopia and strabismus: a systematic review

Background/aims Health-related quality of life (HRQoL) measures are used in healthcare to help inform clinical decision-making and policy-making decisions. A number of disease-specific or condition-specific measures have been developed and applied in ophthalmology; however, their use in the specific fields of amblyopia and strabismus are not as established. The purpose of this study is to identify and discuss specific HRQoL instruments that may be used in the investigation and management of patients with amblyopia and/or strabismus. Methods A systematic literature review was undertaken in November 2009. The electronic databases of AMED (Allied and Complementary Medicine: 1985 to November 2009), the British Nursing Index and Archive (1985 to October 2009), Ovid Medline In-Process and Other Non-Indexed Citations and Ovid Medline (1950 to present) and PsycINFO (1806 to November Week 1 2009) were searched. No language restrictions were applied to the search. Results Four instruments were identified: the Amblyopia and Strabismus Questionnaire (A&SQ), the Amblyopia Treatment Index (ATI), the Adult Strabismus Questionnaire (AS-20) and the Intermittent Exotropia Questionnaire (IXTQ). Conclusion The use of HRQoL measures in patients with amblyopia and/or strabismus is a developing area. Further research is necessary to determine the impact of issues such as diplopia and poor cosmesis upon patient groups, and to determine the influence of ethnicity and parental reporting in these patients.