Interventions for perceptual disorders following stroke.

BACKGROUND: Perception is the ability to understand information from our senses. It allows us to experience and meaningfully interact with our environment. A stroke may impair perception in up to 70% of stroke survivors, leading to distress, increased dependence on others, and poorer quality of life. Interventions to address perceptual disorders may include assessment and screening, rehabilitation, non-invasive brain stimulation, pharmacological and surgical approaches. OBJECTIVES: To assess the effectiveness of interventions aimed at perceptual disorders after stroke compared to no intervention or control (placebo, standard care, attention control), on measures of performance in activities of daily living.  SEARCH METHODS: We searched the trials registers of the Cochrane Stroke Group, CENTRAL, MEDLINE, Embase, and three other databases to August 2021. We also searched trials and research registers, reference lists of studies, handsearched journals, and contacted authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of adult stroke survivors with perceptual disorders. We defined perception as the specific mental functions of recognising and interpreting sensory stimuli and included hearing, taste, touch, smell, somatosensation, and vision. Our definition of perception excluded visual field deficits, neglect/inattention, and pain. DATA COLLECTION AND ANALYSIS: One review author assessed titles, with two review authors independently screening abstracts and full-text articles for eligibility. One review author extracted, appraised, and entered data, which were checked by a second author. We assessed risk of bias (ROB) using the ROB-1 tool, and quality of evidence using GRADE.  A stakeholder group, comprising stroke survivors, carers, and healthcare professionals, was involved in this review update. MAIN RESULTS: We identified 18 eligible RCTs involving 541 participants. The trials addressed touch (three trials, 70 participants), somatosensory (seven trials, 196 participants) and visual perception disorders (seven trials, 225 participants), with one (50 participants) exploring mixed touch-somatosensory disorders. None addressed stroke-related hearing, taste, or smell perception disorders. All but one examined the effectiveness of rehabilitation interventions; the exception evaluated non-invasive brain stimulation. For our main comparison of active intervention versus no treatment or control, one trial reported our primary outcome of performance in activities of daily living (ADL):  Somatosensory disorders: one trial (24 participants) compared an intervention with a control intervention and reported an ADL measure.  Touch perception disorder: no trials measuring ADL compared an intervention with no treatment or with a control intervention.  Visual perception disorders: no trials measuring ADL compared an intervention with no treatment or control.  In addition, six trials reported ADL outcomes in a comparison of active intervention versus active intervention, relating to somatosensation (three trials), touch (one trial) and vision (two trials).   AUTHORS' CONCLUSIONS: Following a detailed, systematic search, we identified limited RCT evidence of the effectiveness of interventions for perceptual disorders following stroke. There is insufficient evidence to support or refute the suggestion that perceptual interventions are effective. More high-quality trials of interventions for perceptual disorders in stroke are needed. They should recruit sufficient participant numbers, include a 'usual care' comparison, and measure longer-term functional outcomes, at time points beyond the initial intervention period. People with impaired perception following a stroke should continue to receive neurorehabilitation according to clinical guidelines.

Reliability of the evidence to guide decision-making in foot ulcer prevention in diabetes: an overview of systematic reviews.

BACKGROUND: Reliable evidence on the effectiveness of interventions to prevent diabetes-related foot ulceration is essential to inform clinical practice. Well-conducted systematic reviews that synthesise evidence from all relevant trials offer the most robust evidence for decision-making. We conducted an overview to assess the comprehensiveness and utility of the available secondary evidence as a reliable source of robust estimates of effect with the aim of informing a cost-effective care pathway using an economic model. Here we report the details of the overview. [PROSPERO Database (CRD42016052324)]. METHODS: Medline (Ovid), Embase (Ovid), Epistomonikos, Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effectiveness (DARE), and the Health Technology Assessment Journals Library were searched to 17th May 2021, without restrictions, for systematic reviews of randomised controlled trials (RCTs) of preventive interventions in people with diabetes. The primary outcomes of interest were new primary or recurrent foot ulcers. Two reviewers independently extracted data and assessed the risk of bias in the included reviews. FINDINGS: The overview identified 30 systematic reviews of patient education, footwear and off-loading, complex and other interventions. Many are poorly reported and have fundamental methodological shortcomings associated with increased risk of bias. Most concerns relate to vague inclusion criteria (60%), weak search or selection strategies (70%) and quality appraisal methods (53%) and inexpert conduct and interpretation of quantitative and narrative evidence syntheses (57%). The 30 reviews have collectively assessed 26 largely poor-quality RCTs with substantial overlap. INTERPRETATION: The majority of these systematic reviews of the effectiveness of interventions to prevent diabetic foot ulceration are at high risk of bias and fail to provide reliable evidence for decision-making. Adherence to the core principles of conducting and reporting systematic reviews is needed to improve the reliability of the evidence generated to inform clinical practice.

"No Mr Bond, we expected you to die": a medical and psychotherapeutic analysis of trauma depiction in the James Bond films.

The death of James Bond in No Time to Die draws attention to his constant exposure to life-threatening danger, and raises the question: should he have died earlier in the franchise? To answer this, we examined Bond's exposure to physical and psychological trauma in the 25 official Bond films, noting if portrayal was realistic, and if there were temporal trends in depiction of injuries. The frequency of trauma has increased over time with Craig's Bond suffering the most trauma, both physical and psychological. Environmental factors and falls were the most common cause of trauma; psychological distress tended to involve death, either of someone close, or at his own hands. He evaded death a mean of five times per film. Our analysis highlights a misrepresentation of trauma across the Bond films from 1962 to present date. The more recent Bond films, especially those of Craig, have revealed the physical and psychological vulnerability of Bond. James Bond has been exposed to an overwhelming level of physical trauma and psychological distress, yet improbably suffered few significant injuries, despite enduring repeated brushes with death. This contradicts Bond's own acknowledgement in Casino Royale that Double 0's have a very short life expectancy.

Restorative Retelling for Processing Psychedelic Experiences: Rationale and Case Study of Complicated Grief.

Rationale: Many psychedelic experiences are meaningful, but ineffable. Engaging in meaning-making regarding emerging symbolic content and changing previous schemas have been proposed as mechanisms of change in psychedelic therapy. Objective: Firstly, we suggest the implementation of a Restorative Retelling (RR) technique to process and integrate the psychedelic experience into autobiographical memory, in a way that fosters meaning-making. We also show how ayahuasca has the potential to evoke key psychological content in survivors, during the process of grief adjustment following the death of a loved one. Methods: The rationale for the implementation of RR to process psychedelic experiences and a case study of a woman suffering from Complicated Grief (CG) after her mother's suicide are presented. Results: Evaluations conducted before the ayahuasca experience and after RR suggest the effectiveness of ayahuasca and RR in reducing symptoms of CG and psychopathology. Conclusion: This case report illustrates an effective adaptation of the RR technique for processing the psychedelic experience. The significance of the study and its limitations are discussed.

Perceptual Disorders After Stroke: A Scoping Review of Interventions.

Perceptual disorders relating to hearing, smell, somatosensation, taste, touch, and vision commonly impair stroke survivors' ability to interpret sensory information, impacting on their ability to interact with the world. We aimed to identify and summarize the existing evidence for perceptual disorder interventions poststroke and identify evidence gaps. We searched 13 electronic databases including MEDLINE and Embase and Grey literature and performed citation tracking. Two authors independently applied a priori-defined selection criteria; studies involving stroke survivors with perceptual impairments and interventions addressing those impairments were included. We extracted data on study design, population, perceptual disorders, interventions, and outcomes. Data were tabulated and synthesized narratively. Stroke survivors, carers, and clinicians were involved in agreeing definitions and organizing and interpreting data. From 91 869 records, 80 studies were identified (888 adults and 5 children); participant numbers were small (median, 3.5; range, 1-80), with a broad range of stroke types and time points. Primarily focused on vision (34/80, 42.5%) and somatosensation (28/80; 35.0%), included studies were often case reports (36/80; 45.0%) or randomized controlled trials (22/80; 27.5%). Rehabilitation approaches (78/93; 83.9%), primarily aimed to restore function, and were delivered by clinicians (30/78; 38.5%) or technology (28/78; 35.9%; including robotic interventions for somatosensory disorders). Pharmacological (6/93; 6.5%) and noninvasive brain stimulation (7/93; 7.5%) approaches were also evident. Intervention delivery was poorly reported, but most were delivered in hospital settings (56/93; 60.2%). Study outcomes failed to assess the transfer of training to daily life. Interventions for stroke-related perceptual disorders are underresearched, particularly for pediatric populations. Evidence gaps include interventions for disorders of hearing, taste, touch, and smell perception. Future studies must involve key stakeholders and report this fully. Optimization of intervention design, evaluation, and reporting is required, to support the development of effective, acceptable, and implementable interventions. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019160270.

Risk assessments and structured care interventions for prevention of foot ulceration in diabetes: development and validation of a prognostic model.

BACKGROUND: Diabetes-related foot ulcers give rise to considerable morbidity, generate a high monetary cost for health and social care services and precede the majority of diabetes-related lower extremity amputations. There are many clinical prediction rules in existence to assess risk of foot ulceration but few have been subject to validation. OBJECTIVES: Our objectives were to produce an evidence-based clinical pathway for risk assessment and management of the foot in people with diabetes mellitus to estimate cost-effective monitoring intervals and to perform cost-effectiveness analyses and a value-of-information analysis. DESIGN: We developed and validated a prognostic model using predictive modelling, calibration and discrimination techniques. An overview of systematic reviews already completed was followed by a review of randomised controlled trials of interventions to prevent foot ulceration in diabetes mellitus. A review of the health economic literature was followed by the construction of an economic model, an analysis of the transitional probability of moving from one foot risk state to another, an assessment of cost-effectiveness and a value-of-information analysis. INTERVENTIONS: The effects of simple and complex interventions and different monitoring intervals for the clinical prediction rules were evaluated. MAIN OUTCOME MEASURE: The main outcome was the incidence of foot ulceration. We compared the new clinical prediction rules in conjunction with the most effective preventative interventions at different monitoring intervals with a 'treat-all' strategy. DATA SOURCES: Data from an electronic health record for 26,154 people with diabetes mellitus in one Scottish health board were used to estimate the monitoring interval. The Prediction Of Diabetic foot UlcerationS (PODUS) data set was used to develop and validate the clinical prediction rule. REVIEW METHODS: We searched for eligible randomised controlled trials of interventions using search strategies created for Ovid® (Wolters Kluwer, Alphen aan den Rijn, the Netherlands), MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. Randomised controlled trials in progress were identified via the International Standard Randomised Controlled Trial Number Registry and systematic reviews were identified via PROSPERO. Databases were searched from inception to February 2019. RESULTS: The clinical prediction rule was found to accurately assess the risk of foot ulceration. Digital infrared thermometry, complex interventions and therapeutic footwear with offloading devices were found to be effective in preventing foot ulcers. The risk of developing a foot ulcer did not change over time for most people. We found that interventions to prevent foot ulceration may be cost-effective but there is uncertainty about this. Digital infrared thermometry and therapeutic footwear with offloading devices may be cost-effective when used to treat all people with diabetes mellitus regardless of their ulcer risk. LIMITATIONS: The threats to the validity of the results in some randomised controlled trials in the review and the large number of missing data in the electronic health record mean that there is uncertainty in our estimates. CONCLUSIONS: There is evidence that interventions to prevent foot ulceration are effective but it is not clear who would benefit most from receiving the interventions. The ulceration risk does not change over an 8-year period for most people with diabetes mellitus. A change in the monitoring interval from annually to every 2 years for those at low risk would be acceptable. FUTURE WORK RECOMMENDATIONS: Improving the completeness of electronic health records and sharing data would help improve our knowledge about the most clinically effective and cost-effective approaches to prevent foot ulceration in diabetes mellitus. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016052324. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 62. See the NIHR Journals Library website for further project information.

People with diabetes sometimes have problems with their feet that can become serious and make getting around harder and life less enjoyable. We have developed a test based on a simple score to find out a person's risk of getting a foot ulcer. We also wanted to know how often the test needs to be done. People who have been tested and learn that they might go on to have foot problems rightly expect to be given treatment that stops the problem happening in the first place. In this project, we read many written reports about the best treatments to prevent foot ulcers. We found that some things can prevent foot ulcers, such as wearing special shoes and insoles, taking the temperature of the skin of the foot and resting when the temperature rises, and receiving specialist care from diabetes foot care teams. However, we also looked at the costs of the test and treatments and found that some treatments are better value for money than others. By using people's health data from NHS computers, we discovered that very few people with diabetes develop a worse risk score for foot ulcers as time goes on, and it seems that being tested every year is not necessary for everyone. New clinical trials might help to improve foot health for people with diabetes, but if all of the researchers who have collected data from people in clinical trials shared their data it would be possible to find out more about who will gain most from these treatments without spending a lot on new research. It is clear that better input of patients' health data into NHS computers will benefit diabetes research in the future.

Preventing foot ulceration in diabetes: systematic review and meta-analyses of RCT data.

AIMS/HYPOTHESIS: Foot ulceration is a serious complication for people with diabetes that results in high levels of morbidity for individuals and significant costs for health and social care systems. Nineteen systematic reviews of preventative interventions have been published, but none provides a reliable numerical summary of treatment effects. The aim of this study was to systematically review the evidence from RCTs and, where possible, conduct meta-analyses to make the best possible use of the currently available data. METHODS: We conducted a systematic review and meta-analysis of RCTs of preventative interventions for foot ulceration. OVID MEDLINE and EMBASE were searched to February 2019 and the Cochrane Central Register of Controlled Trials to October 2018. RCTs of interventions to prevent foot ulcers in people with diabetes who were free from foot ulceration at trial entry were included. Two independent reviewers read the full-text articles and extracted data. The quality of trial reporting was assessed using the Cochrane Risk of Bias tool. The primary outcome of foot ulceration was summarised using pooled relative risks in meta-analyses. RESULTS: Twenty-two RCTs of eight interventions were eligible for analysis. One trial of digital silicone devices (RR 0.07 [95% CI 0.01, 0.55]) and meta-analyses of dermal infrared thermometry (RR 0.41 [95% CI 0.19, 0.86]), complex interventions (RR 0.59 [95% CI 0.38, 0.90], and custom-made footwear and offloading insoles (RR 0.53 [95% CI 0.33, 0.85]) showed beneficial effects for these interventions. CONCLUSIONS/INTERPRETATION: Four interventions were identified as being effective in preventing foot ulcers in people with diabetes, but uncertainty remains about what works and who is most likely to benefit.

The impact of academic conferences and how to make them useful.

Academic conferences have to date largely evaded empirical examination, despite demanding a lot of time and effort from those attending. Based on my work for a forthcoming book, I consider examples of conferences, including the Cochrane Colloquium, that provide important lessons from which we can learn about the impact of conferences. Travel to the conference, the venue, and when it is held can be a barrier to delegates attending, impacting on what will be said and discussed. By sharing new knowledge and wisdom, conferences act as a signal that cuts through the noise and adds to the "Knowledge Enterprise". But if the delegates are too tired from travel or do not attend, it is not possible to meaningfully discuss issues. There is a need for the evolving discipline of Meta-research to examine research conferences, and for academics to discuss and challenge the role and value, and usefulness of academic conferences.

Does the use of specialist palliative care services modify the effect of socioeconomic status on place of death? A systematic review.

BACKGROUND: Cancer patients in lower socioeconomic groups are significantly less likely to die at home and experience more barriers to access to palliative care. It is unclear whether receiving palliative care may mediate the effect of socioeconomic status on place of death. AIM: This review examines whether and how use of specialist palliative care may modify the effect of socioeconomic status on place of death. DESIGN: A systematic review was conducted. Eligible papers were selected and the quality appraised by two independent reviewers. Data were synthesised using a narrative approach. DATA SOURCES: MEDLINE, Embase, CINAHL, PsycINFO and Web of Knowledge were searched (1997-2013). Bibliographies were scanned and experts contacted. Papers were included if they reported the effect of both socioeconomic status and use of specialist palliative care on place of death for adult cancer patients. RESULTS: Nine studies were included. All study subjects had received specialist palliative care. With regard to place of death, socioeconomic status was found to have (1) no effect in seven studies and (2) an effect in one study. Furthermore, one study found that the effect of socioeconomic status on place of death was only significant when patients received standard specialist palliative care. When patients received more intense care adapted to their needs, the effect of socioeconomic status on place of death was no longer seen. CONCLUSION: There is some evidence to suggest that use of specialist palliative care may modify the effect of socioeconomic status on place of death.

Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE).

BACKGROUND: Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. METHODS: We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. RESULTS: The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. CONCLUSIONS: This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers.

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

BACKGROUND: Herbal 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. METHODS: Five commonly used herbal products were purchased from pharmacies, health food shops and supermarkets: St John's 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 John's wort with the contraceptive pill and warfarin) and side effects (such as ginkgo and allergic reactions). RESULTS: Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages. This included 4 of 12 St John's 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 John's wort) contained at least 85% of the safety messages. CONCLUSIONS: Most 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 John's 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.

Non-pharmacological interventions for perceptual disorders following stroke and other adult-acquired, non-progressive brain injury.

BACKGROUND: Stroke and other adult-acquired brain injury may impair perception leading to distress and increased dependence on others. Perceptual rehabilitation includes functional training, sensory stimulation, strategy training and task repetition. OBJECTIVES: To examine the evidence for improvement in activities of daily living (ADL) six months post randomisation for active intervention versus placebo or no treatment. SEARCH STRATEGY: We searched the trials registers of the Cochrane Stroke Group and the Cochrane Infectious Diseases Group (May 2009) but not the Injuries Group, the Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, Issue 3), MEDLINE (1950 to August 2009), EMBASE (1980 to August 2009), CINAHL (1982 to August 2009), PsycINFO (1974 to August 2009), REHABDATA and PsycBITE (May to June 2009). We also searched trials and research registers, handsearched journals, searched reference lists and contacted authors. SELECTION CRITERIA: Randomised controlled trials of adult stroke or acquired brain injury. Our definition of perception excluded visual field deficits, neglect/inattention and apraxia. DATA COLLECTION AND ANALYSIS: One review author assessed titles, abstracts and keywords for eligibility. At least two review authors independently extracted data. We requested unclear or missing information from corresponding authors. MAIN RESULTS: We included six single-site trials in rehabilitation settings, involving 338 participants. Four trials included people with only stroke. All studies provided sensory stimulation, sometimes with another intervention. Sensory stimulation typically involved practising tasks that required visuo-perceptual processing with occupational therapist assistance. Repetition was never used and only one study included functional training. No trials provided data on longer term improvement in ADL scores. Only three trials provided any data suitable for analysis. Two of these trials compared active to placebo intervention. There was no evidence of a difference in ADL scores at the scheduled end of intervention: mean difference (95% confidence interval (CI)) was 0.9 (-1.6 to 3.5) points on a self-care ADL scale in one study and odds ratio (95% CI) was 1.3 (0.56 to 3.1) for passing a driving test in the other, both in favour of active intervention. The trial that compared two active interventions did not find evidence of difference in any of the review outcomes. AUTHORS' CONCLUSIONS: There is insufficient evidence to support or refute the view that perceptual interventions are effective. Future studies should be sufficiently large, include a standard care comparison and measure longer term functional outcomes. People with impaired perception problems should continue to receive neurorehabilitation according to clinical guidelines.

Written information about individual medicines for consumers.

BACKGROUND: Medicines are the most common intervention in most health services. As with all treatments, those taking medicines need sufficient information: to enable them to take and use the medicines effectively, to understand the potential harms and benefits, and to allow them to make an informed decision about taking them. Written medicines information, such as a leaflet or provided via the Internet, is an intervention that may meet these purposes. OBJECTIVES: To assess the effects of providing written information about individual medicines on relevant patient outcomes (knowledge, attitudes, behaviours and health outcomes) in relation to prescribed and over-the-counter medicines. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CINAHL, The Cochrane Library, PsycINFO and other databases to March 2007. We handsearched five journals' tables of contents, and the reference lists of included studies, and contacted experts in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs) of medicine users, comparing written medicines information with no written medicines information; or trials that compared two or more styles of written medicines information. We only included trials that measured a knowledge, attitudinal or behavioural outcome. There were no language restrictions. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data relating to the interventions, methods of the trials, and outcome measures; and reconciled differences by discussion. Heterogeneity of interventions and outcomes measured meant that data synthesis was not possible. The results are presented in narrative and tabular format. MAIN RESULTS: We included 25 RCTs involving 4788 participants. Six of twelve trials showed that written information significantly improved knowledge about a medicine, compared with no written information. The inability to combine results means we cannot conclude whether written information was effective for increasing knowledge. The results for attitudinal and behavioural outcomes were mixed. No studies showed an adverse effect of medicines information. AUTHORS' CONCLUSIONS: The combined evidence was not strong enough to say whether written medicines information is effective in changing knowledge, attitudes and behaviours related to medicine taking. There is some evidence that written information can improve knowledge. The trials were generally of poor quality, which reduces confidence in the results. Trials examining the effects of written information need to be better designed and use consistent and validated outcome measures. Trials should evaluate internet-based medicines information. It is imperative that written medicines information be based on best practice for its information design and content, which could improve its effectiveness in helping people to use medicines appropriately.

Relaxation therapies for the management of primary hypertension in adults.

BACKGROUND: Lifestyle interventions are often recommended as initial treatment for mild hypertension, but the efficacy of relaxation therapies is unclear. OBJECTIVES: To evaluate the effects of relaxation therapies on cardiovascular outcomes and blood pressure in people with elevated blood pressure. SEARCH STRATEGY: We searched the Cochrane Library, MEDLINE, EMBASE, Science Citation Index, ISI Proceedings, ClinicalTrials.gov, Current Controlled Trials and reference lists of systematic reviews, meta-analyses and randomised controlled trials (RCTs) included in the review. INCLUSION CRITERIA: RCTs of a parallel design comparing relaxation therapies with no active treatment, or sham therapy; follow-up >/=8 weeks; participants over 18 years, with raised systolic blood pressure (SBP) >/=140 mmHg or diastolic blood pressure (DBP) >/=85 mmHg); SBP and DBP reported at end of follow-up. EXCLUSION CRITERIA: participants were pregnant; participants received antihypertensive medication which changed during the trial. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. Disagreements were resolved by discussion or a third reviewer. Random effects meta-analyses and sensitivity analyses were conducted. MAIN RESULTS: 29 RCTs, with eight weeks to five years follow-up, met our inclusion criteria; four were excluded from the primary meta-analysis because of inadequate outcome data. The remaining 25 trials assessed 1,198 participants, but adequate randomisation was confirmed in only seven trials and concealment of allocation in only one. Only one trial reported deaths, heart attacks and strokes (one of each). Meta-analysis indicated that relaxation resulted in small, statistically significant reductions in SBP (mean difference: -5.5 mmHg, 95% CI: -8.2 to -2.8, I2 =72%) and DBP (mean difference: -3.5 mmHg, 95% CI: -5.3 to -1.6, I2 =75%) compared to control. The substantial heterogeneity between trials was not explained by duration of follow-up, type of control, type of relaxation therapy or baseline blood pressure. The nine trials that reported blinding of outcome assessors found a non-significant net reduction in blood pressure (SBP mean difference: -3.2 mmHg, 95% CI: -7.7 to 1.4, I(2) =69%) associated with relaxation. The 15 trials comparing relaxation with sham therapy likewise found a non-significant reduction in blood pressure (SBP mean difference: -3.5 mmHg, 95% CI: -7.1 to 0.2, I(2) =63%). AUTHORS' CONCLUSIONS: In view of the poor quality of included trials and unexplained variation between trials, the evidence in favour of causal association between relaxation and blood pressure reduction is weak. Some of the apparent benefit of relaxation was probably due to aspects of treatment unrelated to relaxation.

Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials.

PURPOSE: To quantify effectiveness of lifestyle interventions for hypertension. DATA SOURCES: Electronic bibliographic databases from 1998 onwards, existing guidelines, systematic reviews. STUDY SELECTION AND DATA ABSTRACTION: We included randomized, controlled trials with at least 8 weeks' follow-up, comparing lifestyle with control interventions, enrolling adults with blood pressure at least 140/85 mmHg. Primary outcome measures were systolic and diastolic blood pressure. Two independent reviewers selected trials and abstracted data; differences were resolved by discussion. RESULTS: We categorized trials by type of intervention and used random effects meta-analysis to combine mean differences between endpoint blood pressure in treatment and control groups in 105 trials randomizing 6805 participants. Robust statistically significant effects were found for improved diet, aerobic exercise, alcohol and sodium restriction, and fish oil supplements: mean reductions in systolic blood pressure of 5.0 mmHg [95% confidence interval (CI): 3.1-7.0], 4.6 mmHg (95% CI: 2.0-7.1), 3.8 mmHg (95% CI: 1.4-6.1), 3.6 mmHg (95% CI: 2.5-4.6) and 2.3 mmHg (95% CI: 0.2-4.3), respectively, with corresponding reductions in diastolic blood pressure. Relaxation significantly reduced blood pressure only when compared with non-intervention controls. We found no robust evidence of any important effect on blood pressure of potassium, magnesium or calcium supplements. CONCLUSIONS: Patients with elevated blood pressure should follow a weight-reducing diet, take regular exercise, and restrict alcohol and salt intake. Available evidence does not support relaxation therapies, calcium, magnesium or potassium supplements to reduce blood pressure.

Do themes in consumer medicines information literature reviews reflect those important to stakeholders?

OBJECTIVE: To compare the themes emerging from a stakeholder workshop on consumers' medicines information with themes in relevant published reviews. METHODS: A stakeholder workshop was held to permit consumer orientation of a systematic review of consumer medicines information. Analysis of the workshop outputs was compared to a content analysis of the identified published reviews. RESULTS: The workshop generated a range of responses inductively grouped into 12 over-arching themes. No reviews tackled all of these themes, nor addressed 'informed choice and autonomy'. More recent reviews reflected more workshop themes than older ones, suggesting a temporal trend towards a greater sensitivity to consumer issues. The most common workshop themes were covered by all reviews. Six themes in the reviews were related to traditional professional concerns including compliance, which did not arise in the workshop. CONCLUSION: The results highlight a mismatch between the themes in previous published reviews and the themes emerging from the workshop. The most commonly reflected themes in reviews conform to the 'patient education' model of discourse, while workshop themes less often echoed in reviews reflect the discourse of 'patient empowerment'. PRACTICE IMPLICATIONS: The findings suggest the importance of involving patients in the development of patient literature from the outset.

Comparing level of expenditure on HIV health promotion and incidence of HIV in Greater Glasglow and Lothian Health

Legislation through the AIDS Control Act (1987) required regional health boards in Scotland to account for their expenditure on HIV/AIDS services by æring-fencingÆ funding allocated for HIV health promotion. This aimed to ensure monies allocated for expenditure on HIV health promotion by health boards would be used for this purpose and not to finance other health board services. We analysed health board expenditure on HIV health promotion in relation to the incidence of HIV transmission for two Scottish health boards, Greater Glasgow and Lothian (the region in which the Scottish capital Edinburgh is situated). Lothian region which had a higher incidence of HIV transmission than Greater Glasgow similarly had a greater expenditure on HIV health promotion. However, for either health board there was no consistent increase in expenditure after HIV incidence increased. Likewise it was more often the exception than the norm for the incidence of HIV to decline after increased expenditure on HIV health promotion. While it is tentatively concluded that increased HIV health promotion expenditure did not apparently make a significant difference to the incidence of HIV in either health board, this ignores the effect of practical measures funded by the expenditure...