Andrew F. Long

Selective serotonin reuptake inhibitors: meta-analysis of efficacy and acceptability.

OBJECTIVE--To examine the evidence for using selective serotonin reuptake inhibitors instead of tricyclic antidepressants in the first line treatment of depression. DESIGN--Meta-analysis of 63 randomised controlled trials comparing the efficacy and acceptability of selective serotonin reuptake inhibitors with those of tricyclic and related antidepressants. MAIN OUTCOME MEASURES--Improvement in mean scores on Hamilton depression rating scale for 53 randomised controlled trials. Pooled drop out rates from the 58 trials which reported drop out by treatment group. RESULTS--Among the 20 studies reporting standard deviation for the Hamilton score no difference was found in efficacy between serotonin reuptake inhibitors and tricyclic and related antidepressants (standardised mean difference 0.004, 95% confidence interval -0.096 to 0.105). The difference remained insignificant when the remaining 33 studies that used the 17 item and 21 item Hamilton score were included by ascribing weighted standard deviations. The odds ratio for drop out rate in patients receiving serotonin reuptake inhibitors compared with those receiving tricyclic antidepressants was 0.95 (0.86 to 1.07). Similar proportions in both groups cited lack of efficacy as the reason for dropping out but slightly more patients in the tricyclic group cited side effects (18.8% v 15.4% in serotonin reuptake group). CONCLUSIONS--Routine use of selective serotonin reuptake inhibitors as the first line treatment of depressive illness may greatly increase cost with only questionable benefit.

Effectiveness of enhanced communication therapy in the first four months after stroke for aphasia and dysarthria: a randomised controlled trial

Objective To assess the effectiveness of enhanced communication therapy in the first four months after stroke compared with an attention control (unstructured social contact). Design Externally randomised, pragmatic, parallel, superiority trial with blinded outcome assessment. Setting Twelve UK hospital and community stroke services. Participants 170 adults (mean age 70 years) randomised within two weeks of admission to hospital with stroke (December 2006 to January 2010) whom speech and language therapists deemed eligible, and 135 carers. Interventions Enhanced, agreed best practice, communication therapy specific to aphasia or dysarthria, offered by speech and language therapists according to participants’ needs for up to four months, with continuity from hospital to community. Comparison was with similarly resourced social contact (without communication therapy) from employed visitors. Outcome measures Primary outcome was blinded, functional communicative ability at six months on the Therapy Outcome Measure (TOM) activity subscale. Secondary outcomes (unblinded, six months): participants’ perceptions on the Communication Outcomes After Stroke scale (COAST); carers’ perceptions of participants from part of the Carer COAST; carers’ wellbeing on Carers of Older People in Europe Index and quality of life items from Carer COAST; and serious adverse events. Results Therapist and visitor contact both had good uptake from service users. An average 22 contacts (intervention or control) over 13 weeks were accepted by users. Impairment focused therapy was the approach most often used by the speech and language therapists. Visitors most often provided general conversation. In total, 81/85 of the intervention group and 72/85 of the control group completed the primary outcome measure. Both groups improved on the TOM activity subscale. The estimated six months group difference was not statistically significant, with 0.25 (95% CI –0.19 to 0.69) points in favour of therapy. Sensitivity analyses that adjusted for chance baseline imbalance further reduced this difference. Per protocol analyses rejected a possible dilution of treatment effect from controls declining their allocation and receiving usual care. There was no added benefit of therapy on secondary outcome measures, subgroup analyses (such as aphasia), or serious adverse events, although the latter were less common after intervention (odds ratio 0.42 (95% CI 0.16 to 1.1)). Conclusions Communication therapy had no added benefit beyond that from everyday communication in the first four months after stroke. Future research should evaluate reorganised services that support functional communication practice early in the stroke pathway. This project was funded by the NIHR Health Technology Assessment programme (project No 02/11/04) and is published in full in Health Technology Assessment 2012;16(26):1-160. Trial registration ISRCTN78617680

Evaluating complementary medicine: methodological challenges of randomised controlled trials

Complementary medicine is increasingly popular for treating many different problems. Doctors and patients need evidence about complementary treatments, but randomised controlled trials need to be carefully designed to take holism into account and avoid invalid results You think that by understanding one, you can understand two, for one and one is two. But to understand two, you must first understand “and.” Sufi saying1 Complementary medicine should be evaluated as rigorously as conventional medicine to protect the public from charlatans and unsafe practices,2–5 but many practitioners of complementary medicine are reticent about evaluation of their practice. Sceptics maintain that this is because of fear that investigations will find treatments ineffective and threaten livelihoods. In defence, many practitioners argue that research methods dissect their practice in a reductionist manner and fail to take into account complementary medicines holistic nature leading to invalid evaluation. #### Summary points Complementary medicine comprises many different disciplines, a wide spectrum of practices and philosophies which differ from conventional medicine. Conventional medicine traditionally aims to diagnose illness and treat, cure, or alleviate symptoms. Many complementary disciplines aim not only to relieve symptoms and restore wellness but also to help individuals in a process of self healing within a holistic view of health. In this view, individuals are more than just mind, body, and spirit in a social—family …

An evaluation tool to assess the quality of qualitative research studies

Critical appraisal of research studies forms a central role within the application and uptake of evidence‐based approaches within health and social care. While there are established checklists for evaluating quantitative research, this is not the case for qualitative research. This article outlines the process of developing an evaluative tool for qualitative studies, reflecting the uniqueness of the associated paradigm, and illustrates its use by reference to three qualitative research papers appraised within a systematic review of community‐based rehabilitation services. At its centre are concerns with the context of the study and the way the data are collected and analysed. Use of such an evaluative template opens the way for the quality of qualitative research to be judged in a systematic manner and for qualitative research to take its rightful place within debates over what works, where, when and how within health and social care policy and practice.

Workplace physical activity interventions: a systematic review

Purpose – This paper aims to report a synopsis of a recent systematic review of the literature regarding the effectiveness of workplace physical activity interventions, commissioned by the National Institute for Health and Clinical Excellence (NICE).Design/methodology/approach – A search for English‐language papers published between 1996 and 2007 was conducted using 12 relevant databases and associated grey literature. Search protocols and analysis regarding study quality as recommended by NICE were utilised. Key inclusion criteria were, workplace intervention aiming to increase physical activity, intervention aimed at working adults, intervention initiated/endorsed by the employer, physical activity outcome. Thirty‐three studies (38 papers) met the inclusion criteria and were independently reviewed (checked by two reviewers) with a narrative synthesis of findings.Findings – Fourteen studies were graded as high quality or good quality. Evidence from previous systematic reviews was inconclusive. Data regar...

Pain assessment for people with dementia: a systematic review of systematic reviews of pain assessment tools

BackgroundThere is evidence of under-detection and poor management of pain in patients with dementia, in both long-term and acute care. Accurate assessment of pain in people with dementia is challenging and pain assessment tools have received considerable attention over the years, with an increasing number of tools made available. Systematic reviews on the evidence of their validity and utility mostly compare different sets of tools. This review of systematic reviews analyses and summarises evidence concerning the psychometric properties and clinical utility of pain assessment tools in adults with dementia or cognitive impairment.MethodsWe searched for systematic reviews of pain assessment tools providing evidence of reliability, validity and clinical utility. Two reviewers independently assessed each review and extracted data from them, with a third reviewer mediating when consensus was not reached. Analysis of the data was carried out collaboratively. The reviews were synthesised using a narrative synthesis approach.ResultsWe retrieved 441 potentially eligible reviews, 23 met the criteria for inclusion and 8 provided data for extraction. Each review evaluated between 8 and 13 tools, in aggregate providing evidence on a total of 28 tools. The quality of the reviews varied and the reporting often lacked sufficient methodological detail for quality assessment. The 28 tools appear to have been studied in a variety of settings and with varied types of patients. The reviews identified several methodological limitations across the original studies. The lack of a ‘gold standard’ significantly hinders the evaluation of tools’ validity. Most importantly, the samples were small providing limited evidence for use of any of the tools across settings or populations.ConclusionsThere are a considerable number of pain assessment tools available for use with the elderly cognitive impaired population. However there is limited evidence about their reliability, validity and clinical utility. On the basis of this review no one tool can be recommended given the existing evidence.

The problem with measuring patient perceptions of outcome with existing outcome measures in foot and ankle surgery

Quality outcome measures are the cornerstone of clinical research. A review of outcome measures used in foot and ankle surgery research reveals that the issues of validity, reliability and responsiveness of outcome measures have not been addressed. Most reports in the literature have attempted to evaluate patient perceptions of outcome following foot surgery. Underlying the many difficulties with these outcome measures is a lack of understanding of what patients perceive to be important in terms of outcome. Consequently none of the existing outcome measures can claim to be valid measures of patient perceptions of outcome, as there has been no research uncovering these perceptions. In addition, measures of general health status and quality of life in relation to outcome of foot and ankle surgery have been largely ignored to date.

Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale

Objective: To develop and validate a clinically feasible measure of communication effectiveness for people with any type of communication problem following stroke. Design: Cross-sectional, interview-based, psychometric study, building on the development phase for construction of the Communication Outcome after Stroke (COAST) scale. Setting: A community sample from the northwest of England, UK. Subjects: One hundred and two people with communication problems (aphasia and/or dysarthria) following a stroke, within the previous 4—12 months. Interventions: Administration of the COAST scale, on two occasions, within a two-week period, and collection of demographic and other data relating to disability, degree of aphasia (where appropriate) and hospital diagnosis of aphasia/dysarthria. Main measures: Acceptability (missing values), reliability (internal consistency and test—retest reliability) and item analysis (item redundancy). Results: Ninety-seven (visit 1) and 98 (visit 2) respondents provided usable data for the psychometric analysis. The 29-item COAST scale showed good acceptability (few missing values, sample spread 28—100%), internal consistency and test—retest reliability for the scale (α = 0.95; ICC = 0.90) and its subscales (α = 0.65—0.93; ICC = 0.72—0.88), but possible item redundancy. A revised scale of 20 items was produced, demonstrating good internal consistency and test—retest reliability (α = 0.83—92; ICC = 0.72—0.88). Conclusions: The COAST is a patient-centred, practical and reliable measure that can be used to assess self-perceived communication effectiveness for people with aphasia and/or dysarthria. Further testing on construct validity and responsiveness to change is needed before the measure can be firmly recommended for use within clinical practice and research.

Buyer beware? Does the information provided with herbal products available over the counter enable safe use?

BackgroundHerbal products obtained over the counter are commonly used in Europe, North America and Australia. Although there is concern about a lack of information provided to consumers to allow the safe use of these products, there has been no published research to confirm these fears. In this study, we evaluated written information provided with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that tightened regulations for some herbal products, including requirements to provide safety information.MethodsFive commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St Johns wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key safety messages included in the monographs of the US National Center for Complementary and Alternative Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for people with diabetes), interactions with conventional medicines (such as St Johns wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions).ResultsOur analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St Johns wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21 garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new European Union regulations (for St Johns wort) contained at least 85% of the safety messages.ConclusionsMost of the herbal medicine products studied did not provide key safety information which consumers need for their safe use. The new European Union legislation should ensure that St Johns wort and echinacea products will include the previously missing information in due course. The legislation does not apply to existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products may not be covered by the legislation and can continue to be bought without the safety information. Also, consumers will still be able to buy products over the internet from locations outside European Union jurisdiction. Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products which provide the information they need for the safe use of these products.

Communication outcome after stroke: a new measure of the carer’s perspective:

Objective: To validate a measure of the carer’s perspective of a stroke survivor’s communication in everyday life. Design: Cross-sectional, interview-based, psychometric study. Setting: A community sample from the northwest of England, UK. Subjects: Fifty-eight carers and 58 stroke survivors with communication problems (aphasia and/or dysarthria) following a stroke within the previous 4—12 months. Interventions: Administration of the 20-item Carer Communication Outcome after Stroke (Carer COAST) scale, on two occasions, within a two-week period; the 15-item Carers of Older People in Europe (COPE) Index, the patient Communication Outcome after Stroke (COAST) Scale, and collection of demographic and other data relating to the stroke survivor’s disability (Barthel Index), degree of aphasia (Frenchay Aphasia Screening Test) and hospital diagnosis of aphasia/dysarthria. Main measures: Acceptability (missing values), reliability (internal consistency and test—retest reliability) and construct validity. Results: Carer COAST showed good acceptability (no incomplete items, sample spread 24—100%), internal consistency and test—retest reliability for the scale (a = 0.94; intraclass correlation (ICC) = 0.91) and its subscales (a = 0.78—0.90; ICC = 0.75—0.87), and indicative evidence on construct validity (Carer COAST, COPE subscales and COAST). There were statistically significant correlations between the communication items of Carer COAST and the negative impact of caregiving (rs = —0.29) and the financial difficulties of caregiving (rs = —0.38). Conclusions: The Carer COAST scale has considerable potential as a reliable and valid measure of the carer’s perspective on the communication effectiveness of stroke survivors. Intercorrelations with COPE provide specific evidence of the impact of caring for a person with communication difficulties following a stroke.