Omega-3 and polyunsaturated fat for prevention of depression and anxiety symptoms: systematic review and meta-analysis of randomised trials.

BACKGROUND: There is strong public belief that polyunsaturated fats protect against and ameliorate depression and anxiety. AIMS: To assess effects of increasing omega-3, omega-6 or total polyunsaturated fat on prevention and treatment of depression and anxiety symptoms. METHOD: We searched widely (Central, Medline and EMBASE to April 2017, trial registers to September 2016, ongoing trials updated to August 2019), including trials of adults with or without depression or anxiety, randomised to increased omega-3, omega-6 or total polyunsaturated fat for ≥24 weeks, excluding multifactorial interventions. Inclusion, data extraction and risk of bias were assessed independently in duplicate, and authors contacted for further data. We used random-effects meta-analysis, sensitivity analyses, subgrouping and Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment. RESULTS: We included 31 trials assessing effects of long-chain omega-3 (n = 41 470), one of alpha-linolenic acid (n = 4837), one of total polyunsaturated fat (n = 4997) and none of omega-6. Meta-analysis suggested that increasing long-chain omega-3 probably has little or no effect on risk of depression symptoms (risk ratio 1.01, 95% CI 0.92-1.10, I2 = 0%, median dose 0.95 g/d, duration 12 months) or anxiety symptoms (standardised mean difference 0.15, 95% CI 0.05-0.26, I2 = 0%, median dose 1.1 g/d, duration 6 months; both moderate-quality evidence). Evidence of effects on depression severity and remission in existing depression were unclear (very-low-quality evidence). Results did not differ by risk of bias, omega-3 dose, duration or nutrients replaced. Increasing alpha-linolenic acid by 2 g/d may increase risk of depression symptoms very slightly over 40 months (number needed to harm, 1000). CONCLUSIONS: Long-chain omega-3 supplementation probably has little or no effect in preventing depression or anxiety symptoms. DECLARATION OF INTEREST: L.H. and A.A. were funded to attend the World Health Organization Nutrition Guidance Expert Advisory Group (NUGAG) Subgroup on Diet and Health meetings and present review results. The authors report no other conflicts of interest.

Patient-directed self-management of pain (PaDSMaP) compared to treatment as usual following total knee replacement; a randomised controlled trial.

BACKGROUND: Self-administration of medicines by patients whilst in hospital is being increasingly promoted despite little evidence to show the risks and benefits. Pain control after total knee replacement (TKR) is known to be poor. The aim of the study was to determine if patients operated on with a TKR who self-medicate their oral analgesics in the immediate post-operative period have better pain control than those who receive their pain control by nurse-led drug rounds (Treatment as Usual (TAU)). METHODS: A prospective, parallel design, open-label, randomised controlled trial comparing pain control in patient-directed self-management of pain (PaDSMaP) with nurse control of oral analgesia (TAU) after a TKR. Between July 2011 and March 2013, 144 self-medicating adults were recruited at a secondary care teaching hospital in the UK. TAU patients (n = 71) were given medications by a nurse after their TKR. PaDSMaP patients (n = 73) took oral medications for analgesia and co-morbidities after two 20 min training sessions reinforced with four booklets. Primary outcome was pain (100 mm visual analogue scale (VAS)) at 3 days following TKR surgery or at discharge (whichever came soonest). Seven patients did not undergo surgery for reasons unrelated to the study and were excluded from the intention-to-treat (ITT) analysis. RESULTS: ITT analysis did not detect any significant differences between the two groups' pain scores. A per protocol (but underpowered) analysis of the 60% of patients able to self-medicate found reduced pain compared to the TAU group at day 3/discharge, (VAS -9.9 mm, 95% CI -18.7, - 1.1). One patient in the self-medicating group over-medicated but suffered no harm. CONCLUSION: Self-medicating patients did not have better (lower) pain scores compared to the nurse-managed patients following TKR. This cohort of patients were elderly with multiple co-morbidities and may not be the ideal target group for self-medication. TRIAL REGISTRATION: ISRCTN10868989 . Registered 22 March 2012, retrospectively registered.

An investigation into the prevalence of sleep disturbances in primary Sjögren's syndrome: a systematic review of the literature.

Objectives: To identify whether sleep disturbances are more prevalent in primary SS (pSS) patients compared with the general population and to recognize which specific sleep symptoms are particularly problematic in this population. Methods: Electronic searches of the literature were conducted in PubMed, Medline (Ovid), Embase (Ovid), PsychINFO (Ovid) and Web of Science and the search strategy registered a priori . Titles and abstracts were reviewed by two authors independently against a set of prespecified inclusion/exclusion criteria, reference lists were examined and a narrative synthesis of the included articles was conducted. Results: Eight whole-text papers containing nine separate studies met the inclusion criteria and were included in the narrative analysis. Few of these studies met all of the quality assessment criteria. The studies used a range of self-reported measures and objective measures, including polysomnography. Mixed evidence was obtained for some of the individual sleep outcomes, but overall compared with controls, pSS patients reported greater subjective sleep disturbances and daytime somnolence and demonstrated more night awakenings and pre-existing obstructive sleep apnoea. Conclusions: A range of sleep disturbances are commonly reported in pSS patients. Further polysomnography studies are recommended to confirm the increased prevalence of night awakenings and obstructive sleep apnoea in this patient group. pSS patients with excessive daytime somnolence should be screened for co-morbid sleep disorders and treated appropriately. Interventions targeted at sleep difficulties in pSS, such as cognitive behavioural therapy for insomnia and nocturnal humidification devices, have the potential to improve quality of life in this patient group and warrant further investigation.

A systematic review of non-pharmacological interventions for primary Sjögren's syndrome.

OBJECTIVE: To evaluate the effects of non-pharmacological interventions for primary SS (pSS) on outcomes falling within the World Health Organization International Classification of Functioning Disability and Health domains. METHODS: We searched the following databases from inception to September 2014: Cochrane Database of Systematic Reviews; Medline; Embase; PsychINFO; CINAHL; and clinical trials registers. We included randomized controlled trials of any non-pharmacological intervention. Two authors independently reviewed titles and abstracts against the inclusion/exclusion criteria and independently assessed trial quality and extracted data. RESULTS: A total of 1463 studies were identified, from which 17 full text articles were screened and 5 studies were included in the review; a total of 130 participants were randomized. The included studies investigated the effectiveness of an oral lubricating device for dry mouth, acupuncture for dry mouth, lacrimal punctum plugs for dry eyes and psychodynamic group therapy for coping with symptoms. Overall, the studies were of low quality and at high risk of bias. Although one study showed punctum plugs to improve dry eyes, the sample size was relatively small. CONCLUSION: Further high-quality studies to evaluate non-pharmacological interventions for PSS are needed.

Physiotherapy for Parkinson's disease: a comparison of techniques.

BACKGROUND: Despite medical therapies and surgical interventions for Parkinson's disease (PD), patients develop progressive disability. The role of physiotherapy is to maximise functional ability and minimise secondary complications through movement rehabilitation within a context of education and support for the whole person. The overall aim is to optimise independence, safety and wellbeing, thereby enhancing quality of life. Trials have shown that physiotherapy has short-term benefits in PD. However, which physiotherapy intervention is most effective remains unclear. OBJECTIVES: To assess the effectiveness of one physiotherapy intervention compared with a second approach in patients with PD. SEARCH METHODS: Relevant trials were identified by electronic searches of numerous literature databases (for example MEDLINE, EMBASE) and trial registers, plus handsearching of major journals, abstract books, conference proceedings and reference lists of retrieved publications. The literature search included trials published up to the end of January 2012. SELECTION CRITERIA: Randomised controlled trials of one physiotherapy intervention versus another physiotherapy intervention in patients with PD. DATA COLLECTION AND ANALYSIS: Data were abstracted independently from each paper by two authors. Trials were classified into the following intervention comparisons: general physiotherapy, exercise, treadmill training, cueing, dance and martial arts. MAIN RESULTS: A total of 43 trials were identified with 1673 participants. All trials used small patient numbers (average trial size of 39 participants); the methods of randomisation and concealment of allocation were poor or not stated in most trials. Blinded assessors were used in just over half of the trials and only 10 stated that they used intention-to-treat analysis.A wide variety of validated and customised outcome measures were used to assess the effectiveness of physiotherapy interventions. The most frequently reported physiotherapy outcomes were gait speed and timed up and go, in 19 and 15 trials respectively. Only five of the 43 trials reported data on falls (12%). The motor subscales of the Unified Parkinson's Disease Rating Scale and Parkinson's Disease Questionnaire-39 were the most commonly reported clinician-rated disability and patient-rated quality of life outcome measures, used in 22 and 13 trials respectively. The content and delivery of the physiotherapy interventions varied widely in the trials included within this review, so no quantitative meta-analysis could be performed. AUTHORS' CONCLUSIONS: Considering the small number of participants examined, the methodological flaws in many of the studies, the possibility of publication bias, and the variety of interventions, formal comparison of the different physiotherapy techniques could not be performed. There is insufficient evidence to support or refute the effectiveness of one physiotherapy intervention over another in PD.This review shows that a wide range of physiotherapy interventions to treat PD have been tested . There is a need for more specific trials with improved treatment strategies to underpin the most appropriate choice of physiotherapy intervention and the outcomes measured.

Physiotherapy versus placebo or no intervention in Parkinson's disease.

BACKGROUND: Despite medical therapies and surgical interventions for Parkinson's disease (PD), patients develop progressive disability. Physiotherapy aims to maximise functional ability and minimise secondary complications through movement rehabilitation within a context of education and support for the whole person. The overall aim is to optimise independence, safety, and well-being, thereby enhancing quality of life. OBJECTIVES: To assess the effectiveness of physiotherapy intervention compared with no intervention in patients with PD. SEARCH METHODS: We identified relevant trials by conducting electronic searches of numerous literature databases (e.g. MEDLINE, EMBASE) and trial registers, and by handsearching major journals, abstract books, conference proceedings, and reference lists of retrieved publications. The literature search included trials published up to the end of January 2012. SELECTION CRITERIA: Randomised controlled trials of physiotherapy intervention versus no physiotherapy intervention in patients with PD. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from each article. We used standard meta-analysis methods to assess the effectiveness of physiotherapy intervention compared with no physiotherapy intervention. Trials were classified into the following intervention comparisons: general physiotherapy, exercise, treadmill training, cueing, dance, and martial arts. We used tests for heterogeneity to assess for differences in treatment effect across these different physiotherapy interventions. MAIN RESULTS: We identified 39 trials with 1827 participants. We considered the trials to be at a mixed risk of bias as the result of unreported allocation concealment and probable detection bias. Compared with no intervention, physiotherapy significantly improved the gait outcomes of speed (mean difference 0.04 m/s, 95% confidence interval (CI) 0.02 to 0.06, P = 0.0002); two- or six-minute walk test (13.37 m, 95% CI 0.55 to 26.20, P = 0.04) and Freezing of Gait questionnaire (-1.41, 95% CI -2.63 to -0.19, P = 0.02); functional mobility and balance outcomes of Timed Up & Go test (-0.63 s, 95% CI -1.05 to -0.21, P = 0.003), Functional Reach Test (2.16 cm, 95% CI 0.89 to 3.43, P = 0.0008), and Berg Balance Scale (3.71 points, 95% CI 2.30 to 5.11, P < 0.00001); and clinician-rated disability using the Unified Parkinson's Disease Rating Scale (UPDRS) (total -6.15 points, 95% CI-8.57 to -3.73, P < 0.00001; activities of daily living: -1.36, 95% CI -2.41 to -0.30, P = 0.01; and motor: -5.01, 95% CI -6.30 to -3.72, P < 0.00001). No difference between arms was noted in falls (Falls Efficacy Scale: -1.91 points, 95% CI -4.76 to 0.94, P = 0.19) or patient-rated quality of life (PDQ-39 Summary Index: -0.38 points, 95% CI -2.58 to 1.81, P = 0.73). One study reported that adverse events were rare; no other studies reported data on this outcome. Indirect comparisons of the different physiotherapy interventions revealed no evidence that the treatment effect differed across physiotherapy interventions for any of the outcomes assessed. AUTHORS' CONCLUSIONS: Benefit for physiotherapy was found in most outcomes over the short term (i.e. < 3 months) but was significant only for speed, two- or six-minute walk test, Freezing of Gait questionnaire, Timed Up & Go, Functional Reach Test, Berg Balance Scale, and clinician-rated UPDRS. Most of the observed differences between treatments were small. However, for some outcomes (e.g. speed, Berg Balance Scale, UPDRS), the differences observed were at, or approaching, what are considered minimal clinically important changes. These benefits should be interpreted with caution because the quality of most of the included trials was not high. Variation in measurements of outcome between studies meant that our analyses include a small proportion of the participants recruited.This review illustrates that a wide range of approaches are employed by physiotherapists to treat patients with PD. However, no evidence of differences in treatment effect was noted between the different types of physiotherapy interventions being used, although this was based on indirect comparisons. A consensus menu of 'best practice' physiotherapy is needed, as are large, well-designed randomised controlled trials undertaken to demonstrate the longer-term efficacy and cost-effectiveness of 'best practice' physiotherapy in PD.

Hypertensive patients' experience with adherence therapy for enhancing medication compliance: a qualitative exploration.

AIMS AND OBJECTIVES: To investigate the experience of non-compliant hypertensive patients who had received seven sessions of adherence therapy (AT) as part of a randomised controlled trial. BACKGROUND: AT is a patient-centred approach used to explore patient attitudes, beliefs and discrepancy toward medications that aimed to enhance patients' medication-taking behaviour. DESIGN: Qualitative analysis of semi-structured interviews with patients who had completed an AT intervention. METHODS: A convenience sample of 10 hypertensive patients who received AT as part of an exploratory randomised controlled trial (ISRCTN99494659) were included. Thematic analysis of semi-structured interviews exploring patient's views and experiences of AT was used. RESULTS: Five major themes of AT emerged; modifying attitudes and beliefs, positive impact on self efficacy, therapist motivation, positive impact on well-being and a well-designed intervention. CONCLUSIONS: patients' views about the benefit of AT were entirely consistent with our proposed mechanism of action for this intervention; that is by improving patient's beliefs and attitudes regarding taking drugs, and finding solutions to barriers that prevent adherence, patients become more complaint with their medication which in turn has a positive impact on clinical outcomes [i.e. blood pressure, hypertension complication (stroke, myocardial infarction, and recurrent hospitalisation)]. RELEVANCE TO CLINICAL PRACTICE: Exploring patients' experience with AT and recognising these five elements help in tailoring a new effective strategy according to individual needs for enhancing adherence to prescribed drugs.

Speech and language therapy versus placebo or no intervention for speech problems in Parkinson's disease.

BACKGROUND: Parkinson's disease patients commonly suffer from speech and vocal problems including dysarthric speech, reduced loudness and loss of articulation. These symptoms increase in frequency and intensity with progression of the disease). Speech and language therapy (SLT) aims to improve the intelligibility of speech with behavioural treatment techniques or instrumental aids. OBJECTIVES: To compare the efficacy of speech and language therapy versus placebo or no intervention for speech and voice problems in patients with Parkinson's disease. SEARCH METHODS: Relevant trials were identified by electronic searches of numerous literature databases including MEDLINE, EMBASE, and CINAHL, as well as handsearching of relevant conference abstracts and examination of reference lists in identified studies and other reviews. The literature search included trials published prior to 11(th) April 2011. SELECTION CRITERIA: Only randomised controlled trials (RCT) of speech and language therapy versus placebo or no intervention were included. DATA COLLECTION AND ANALYSIS: Data were abstracted independently by CH and CT and differences settled by discussion. MAIN RESULTS: Three randomised controlled trials with a total of 63 participants were found comparing SLT with placebo for speech disorders in Parkinson's disease. Data were available from 41 participants in two trials. Vocal loudness for reading a passage increased by 6.3 dB (P = 0.0007) in one trial, and 11.0 dB (P = 0.0002) in another trial. An increase was also seen in both of these trials for monologue speaking of 5.4 dB (P = 0.002) and 11.0 dB (P = 0.0002), respectively. It is likely that these are clinically significant improvements. After six months, patients from the first trial were still showing a statistically significant increase of 4.5 dB (P = 0.0007) for reading and 3.5 dB for monologue speaking. Some measures of speech monotoni city and articulation were investigated; however, all these results were non-significant. AUTHORS' CONCLUSIONS: Although improvements in speech impairments were noted in these studies, due to the small number of patients examined, methodological flaws, and the possibility of publication bias, there is insufficient evidence to conclusively support or refute the efficacy of SLT for speech problems in Parkinson's disease. A large well designed placebo-controlled RCT is needed to demonstrate SLT's effectiveness in Parkinson's disease. The trial should conform to CONSORT guidelines. Outcome measures with particular relevance to patients with Parkinson's disease should be chosen and patients followed for at least six months to determine the duration of any improvement.

Comparison of speech and language therapy techniques for speech problems in Parkinson's disease.

BACKGROUND: Patients with Parkinson's disease commonly suffer from speech and voice difficulties such as impaired articulation and reduced loudness. Speech and language therapy (SLT) aims to improve the intelligibility of speech with behavioural treatment techniques or instrumental aids. OBJECTIVES: To compare the efficacy and effectiveness of novel SLT techniques versus a standard SLT approach to treat Parkinsonian speech problems. SEARCH METHODS: We identified relevant, published prior to 11(th) April 2011, by electronic searches of numerous literature databases including CENTRAL, MEDLINE and CINAHL, as well as handsearching relevant conference abstracts and examining reference lists in identified studies and other reviews. SELECTION CRITERIA: Only randomised controlled trials (RCT) of one type of speech and language therapy versus another were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and resolved differences by discussion. MAIN RESULTS: Six trials involving 159 patients satisfied the inclusion criteria. Data could not be analysed from one trial due to changes in patient numbers and from a second because the data provided were not in a usable format. All trials reported intelligibility measures but a statistically significant result was only reported for the diagnostic rhyme test used in the study of Lee Silverman Voice Treatment -LOUD (LSVT-LOUD) versus a modified version of this therapy (LSVT-ARTIC). In this case a difference of 12.5 points (95% confidence interval (CI) -22.2 to -2.8; P = 0.01) between the mean changes in favour of the LSVT-LOUD group was reported for a speech sample overlaid with Babble noise; this difference was not reproduced for the two additional noise conditions under which the speech samples were assessed. LSVT-LOUD also outperformed LSVT-ARTIC and Respiration therapy (RT) in improving loudness, with a difference in reading a sample text of 5.0 dB (95%CI -8.3 to -1.7; P = 0.003) and 5.5 dB (95% CI 3.4 to 7.7; P < 0.00001) respectively, and a difference in monologue speech of 2.9 dB (95% CI 0.6 to 5.2; P = 0.01) versus RT. AUTHORS' CONCLUSIONS: Considering the small patient numbers in these trials, there is insufficient evidence to support or refute the efficacy of any form of SLT over another to treat speech problems in patients with Parkinson's disease.

Physiotherapy versus placebo or no intervention in Parkinson's disease.

BACKGROUND: Despite medical therapies and surgical interventions for Parkinson's disease (PD), patients develop progressive disability. The role of physiotherapy aims to maximise functional ability and minimise secondary complications through movement rehabilitation within a context of education and support for the whole person. The overall aim is to optimise independence, safety and well-being, thereby enhancing quality of life. OBJECTIVES: To assess the effectiveness of physiotherapy intervention compared with no intervention in patients with PD. SEARCH METHODS: We identified relevant trials by electronic searches of numerous literature databases (e.g. MEDLINE, EMBASE) and trial registers, plus handsearching of major journals, abstract books, conference proceedings and reference lists of retrieved publications. The literature search included trials published up to end of December 2010. SELECTION CRITERIA: Randomised controlled trials of physiotherapy intervention versus no physiotherapy intervention in patients with PD. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from each article. We used standard meta-analysis methods to assess the effectiveness of physiotherapy intervention compared with no physiotherapy intervention. Trials were classified into the following intervention comparisons: general physiotherapy, exercise, treadmill training, cueing, dance and martial arts. We used tests for heterogeneity to assess for differences in treatment effect across these different physiotherapy interventions. MAIN RESULTS: We identified 33 trials with 1518 participants. Compared with no-intervention, physiotherapy significantly improved the gait outcomes of velocity (mean difference 0.05 m/s, 95% confidence interval (CI): 0.02 to 0.07, P = 0.0002), two- or six-minute walk test (16.40 m, CI: 1.90 to 30.90, P = 0.03) and step length (0.03 m, CI: 0 to 0.06, P = 0.04); functional mobility and balance outcomes of Timed Up & Go test (-0.61 s, CI: -1.06 to -0.17, P = 0.006), Functional Reach Test (2.16 cm, CI: 0.89 to 3.43, P = 0.0008) and Berg Balance Scale (3.36 points, CI: 1.91 to 4.81, P < 0.00001); and clinician-rated disability using the Unified Parkinson's Disease Rating Scale (UPDRS) (total: -4.46 points, CI -7.16 to -1.75, P = 0.001; activities of daily living: -1.36, CI -2.41 to -0.30, P = 0.01; and motor: -4.09, CI: -5.59 to -2.59, P < 0.00001). There was no difference between arms in falls or patient-rated quality of life. Indirect comparisons of the different physiotherapy interventions found no evidence that the treatment effect differed across the physiotherapy interventions for any of the outcomes assessed. AUTHORS' CONCLUSIONS: Benefit for physiotherapy was found in most outcomes over the short-term (i.e. < three months), but was only significant for velocity, two- or six-minute walk test, step length, Timed Up & Go, Functional Reach Test, Berg Balance Scale and clinician-rated UPDRS. Most of the observed differences between the treatments were small. However, for some outcomes (e.g. velocity, Berg Balance Scale and UPDRS), the differences observed were at, or approaching, what are considered minimally clinical important changes.The review illustrates that a wide range of approaches are employed by physiotherapists to treat PD. However, there was no evidence of differences in treatment effect between the different types of physiotherapy interventions being used, though this was based on indirect comparisons. There is a need to develop a consensus menu of 'best-practice' physiotherapy, and to perform large well-designed randomised controlled trials to demonstrate the longer-term efficacy and cost-effectiveness of 'best practice' physiotherapy in PD.

Physiotherapy versus placebo or no intervention in Parkinson's disease.

BACKGROUND: Despite medical therapies and surgical interventions for Parkinson's disease (PD), patients develop progressive disability. The role of physiotherapy aims to maximise functional ability and minimise secondary complications through movement rehabilitation within a context of education and support for the whole person. The overall aim is to optimise independence, safety and well-being, thereby enhancing quality of life. OBJECTIVES: To assess the effectiveness of physiotherapy intervention compared with no intervention in patients with PD. SEARCH METHODS: We identified relevant trials by electronic searches of numerous literature databases (e.g. MEDLINE, EMBASE) and trial registers, plus handsearching of major journals, abstract books, conference proceedings and reference lists of retrieved publications. The literature search included trials published up to end of December 2010. SELECTION CRITERIA: Randomised controlled trials of physiotherapy intervention versus no physiotherapy intervention in patients with PD. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from each article. We used standard meta-analysis methods to assess the effectiveness of physiotherapy intervention compared with no physiotherapy intervention. Trials were classified into the following intervention comparisons: general physiotherapy, exercise, treadmill training, cueing, dance and martial arts. We used tests for heterogeneity to assess for differences in treatment effect across these different physiotherapy interventions. MAIN RESULTS: We identified 33 trials with 1518 participants. Compared with no-intervention, physiotherapy significantly improved the gait outcomes of velocity (mean difference 0.05 m/s, 95% confidence interval (CI): 0.02 to 0.07, P = 0.0002), two- or six-minute walk test (16.40 m, CI: 1.90 to 30.90, P = 0.03) and step length (0.03 m, CI: 0 to 0.06, P = 0.04); functional mobility and balance outcomes of Timed Up & Go test (-0.61 s, CI: -1.06 to -0.17, P = 0.006), Functional Reach Test (2.16 cm, CI: 0.89 to 3.43, P = 0.0008) and Berg Balance Scale (3.36 points, CI: 1.91 to 4.81, P < 0.00001); and clinician-rated disability using the Unified Parkinson's Disease Rating Scale (UPDRS) (total: -4.46 points, CI -7.16 to -1.75, P = 0.001; activities of daily living: -1.36, CI -2.41 to -0.30, P = 0.01; and motor: -4.09, CI: -5.59 to -2.59, P < 0.00001). There was no difference between arms in falls or patient-rated quality of life. Indirect comparisons of the different physiotherapy interventions found no evidence that the treatment effect differed across the physiotherapy interventions for any of the outcomes assessed. AUTHORS' CONCLUSIONS: Benefit for physiotherapy was found in most outcomes over the short-term (i.e. < three months), but was only significant for velocity, two- or six-minute walk test, step length, Timed Up & Go, Functional Reach Test, Berg Balance Scale and clinician-rated UPDRS. Most of the observed differences between the treatments were small. However, for some outcomes (e.g. velocity, Berg Balance Scale and UPDRS), the differences observed were at, or approaching, what are considered minimally clinical important changes.The review illustrates that a wide range of approaches are employed by physiotherapists to treat PD. However, there was no evidence of differences in treatment effect between the different types of physiotherapy interventions being used, though this was based on indirect comparisons. There is a need to develop a consensus menu of 'best-practice' physiotherapy, and to perform large well-designed randomised controlled trials to demonstrate the longer-term efficacy and cost-effectiveness of 'best practice' physiotherapy in PD.

Public release of performance data in changing the behaviour of healthcare consumers, professionals or organisations.

BACKGROUND: It is becoming increasingly common to release information about the performance of hospitals, health professionals or providers, and healthcare organisations into the public domain. However, we do not know how this information is used and to what extent such reporting leads to quality improvement by changing the behaviour of healthcare consumers, providers and purchasers, or to what extent the performance of professionals and providers can be affected. OBJECTIVES: To determine the effectiveness of the public release of performance data in changing the behaviour of healthcare consumers, professionals and organisations. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Effective Practice and Organisation of Care (EPOC) Trials Register, MEDLINE Ovid (from 1966), EMBASE Ovid (from 1979), CINAHL, PsycINFO Ovid (from 1806) and DARE up to 2011. SELECTION CRITERIA: We searched for randomised or quasi-randomised trials, interrupted time series and controlled before-after studies of the effects of publicly releasing data regarding any aspect of the performance of healthcare organisations or individuals. The papers had to report at least one main outcome related to selecting or changing care. Other outcome measures were awareness, attitude, views and knowledge of performance data and costs. DATA COLLECTION AND ANALYSIS: Two review authors independently screened studies for eligibility and extracted data. For each study, we extracted data about the target groups (healthcare consumers, healthcare providers and healthcare purchasers), performance data, main outcomes (choice of healthcare provider and improvement by means of changes in care) and other outcomes (awareness, attitude, views, knowledge of performance data and costs). MAIN RESULTS: We included four studies containing more than 35,000 consumers, and 1560 hospitals. Three studies were conducted in the USA and examined consumer behaviour after the public release of performance data. Two studies found no effect of Consumer Assessment of Healthcare Providers and Systems information on health plan choice in a Medicaid population. One interrupted time series study found a small positive effect of the publishing of data on patient volumes for coronary bypass surgery and low-complication outliers for lumbar discectomy, but these effects did not persist longer than two months after each public release. No effects on patient volumes for acute myocardial infarction were found.One cluster-randomised controlled trial, conducted in Canada, studied improvement changes in care after the public release of performance data for patients with acute myocardial infarction and congestive heart failure. No effects for the composite process-of-care indicators for either condition were found, but there were some improvements in the individual process-of-care indicators. There was an effect on the mortality rates for acute myocardial infarction. More quality improvement activities were initiated in response to the publicly-released report cards. No secondary outcomes were reported. AUTHORS' CONCLUSIONS: The small body of evidence available provides no consistent evidence that the public release of performance data changes consumer behaviour or improves care. Evidence that the public release of performance data may have an impact on the behaviour of healthcare professionals or organisations is lacking.

Survey of speech and language therapy provision for people with Parkinson's disease in the United Kingdom: patients' and carers' perspectives.

BACKGROUND: Communication and swallowing changes are prominent in Parkinson's disease, but there remains a lack of information regarding the experiences and expectations of people with Parkinson's disease in respect of speech-language therapy (SLT) services. AIMS: To conduct a survey of people with Parkinson's disease and their carers in the United Kingdom to elicit their views concerning communication and swallowing changes in Parkinson's disease and the support they envisage in helping with these changes. METHODS & PROCEDURES: A national survey utilizing a questionnaire developed for the project, accessible by people with Parkinson's disease in web-based, e-mail or paper forms. OUTCOMES & RESULTS: A total of 168 people with Parkinson's disease (median = 7 years since diagnosis, range = 0.5-30) and 47 carers who provided their impression of the experience of the PwPD responded. Of these 215, 92 (43%) had no contact with SLT services. In general those who had seen an SLT found it a positive experience. Pointers for improvement centred around timing, intensity, duration and access to SLT as well as issues around transfer and maintenance of gains outside of clinic and (lack of) attention to psychosocial dimensions. Availability of ongoing support as the situation evolved and access to SLT when it was needed were two prominent features desired of a responsive service. CONCLUSIONS & IMPLICATIONS: Responses suggest that when SLT is available it offers positive support, but respondents felt (re)access when and where SLT is needed could improve, as well as what aspects of swallowing and communication were addressed in assessment and therapy. We reflect on possible recommendations to address the challenges for SLT services in considering organization and content of provision.

National survey of speech and language therapy provision for people with Parkinson's disease in the United Kingdom: therapists' practices.

BACKGROUND: Communication and swallowing changes feature prominently in Parkinson's disease. People with Parkinson's disease appear under-represented in speech-language therapy clinics in the United Kingdom. The nature of the speech-language therapy services in the UK to people with Parkinson's disease has not been examined. AIMS: To ascertain the number of speech-language therapists in the UK who work with people with Parkinson's disease; to establish the nature of contacts in terms of caseloads, referral stages and routes, management practices, assessments and treatments employed; and to reflect on service provision in relation to published guidelines. METHODS & PROCEDURES: A questionnaire survey of speech-language therapists. OUTCOMES & RESULTS: A total of 185 speech-language therapists responded. They were treating a median of three (inter-quartile range (IQR) = 1-6) people with Parkinson's disease with a further median of five (IQR = 1-10) on review. The majority of contacts were for assessment and advice given, especially in later and earlier stages of Parkinson's disease. Typically, respondents offered a median of six sessions (IQR = 6-8) of treatment, each session lasting a median of 45 min (IQR = 45-60), delivered over a median period of 42 days (IQR = 28-56). Speech-language therapists worked in a variety of settings, predominantly hospital. They received referrals principally from medical specialities, from whom the majority had support. Referrals were perceived in general to be later in Parkinson's disease progression than desired. Assessment focused primarily on impairment measures, in contrast to a belief that therapy focus on activity and participation issues. Speech-language therapists were relatively confident in treating people with Parkinson's disease, but 75% wanted more training. CONCLUSIONS & IMPLICATIONS: Speech-language therapist services for people with Parkinson's disease in the UK are restricted on most dimensions. Management practices often do not match guideline suggestions. Consideration needs to be given to the training for, content of and delivery of speech-language therapy services for people with Parkinson's disease.

Omega-3, Omega-6, and Polyunsaturated Fat for Cognition: Systematic Review and Meta-analysis of Randomized Trials.

OBJECTIVES: Neurocognitive function may be influenced by polyunsaturated fat intake. Many older adults consume omega-3 supplements hoping to prevent cognitive decline. We assessed effects of increasing omega-3, omega-6, or total polyunsaturated fats on new neurocognitive illness and cognition. DESIGN AND INCLUSION CRITERIA: We carried out a systematic review and meta-analysis of randomized controlled trials (RCTs) in adults, with duration ≥24 weeks, assessing effects of higher vs lower omega-3, omega-6, or total polyunsaturated fats and outcomes: new neurocognitive illness, newly impaired cognition, and/or continuous measures of cognition. METHODS: We searched MEDLINE, Embase, Cochrane CENTRAL, and trials registers (final update of ongoing trials December 2018). We duplicated screening, data extraction, and risk of bias assessment. Neurocognitive measures were grouped to enable random effects meta-analysis. GRADE assessment, sensitivity analyses, and subgrouping by dose, duration, type of intervention, and replacement were used to interrogate our findings. RESULTS: Searches generated 37,810 hits, from which we included 38 RCTs (41 comparisons, 49,757 participants). Meta-analysis suggested no or very little effect of long-chain omega-3 on new neurocognitive illness [risk ratio (RR) 0.98, 95% confidence interval (CI) 0.87-1.10, 6 RCTs, 33,496 participants, I2 36%), new cognitive impairment (RR 0.99, 95% CI 0.92-1.06, 5 RCTs, 33,296 participants, I2 0%) or global cognition assessed using the Mini-Mental State Examination (MD 0.10, 95% CI 0.03-0.16, 13 RCTs, 14,851 participants, I2 0%), all moderate-quality evidence. Effects did not differ with sensitivity analyses, and we found no differential effects by dose, duration, intervention type, or replacement. Effects of increasing α-linolenic acid, omega-6, or total PUFA were unclear. CONCLUSIONS: This extensive trial data set enabled assessment of effects on neurocognitive illness and cognitive decline not previously adequately assessed. Long-chain omega-3 probably has little or no effect on new neurocognitive outcomes or cognitive impairment. IMPLICATIONS: Long-chain omega-3 supplements do not help older adults protect against cognitive decline.

Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson's disease-STARTUP.

INTRODUCTION: Parkinson's disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson's UK. OBJECTIVES: Conduct a randomised controlled trial (RCT) targeting people with Parkinson's disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS. METHODS AND ANALYSIS: An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan ETHICS AND DISSEMINATION: East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences. TRIAL REGISTRATION NUMBER: ISRCTN12437878; Pre-results.

Creation of a database to assess effects of omega-3, omega-6 and total polyunsaturated fats on health: methodology for a set of systematic reviews.

OBJECTIVE: To create a database of long-term randomised controlled trials (RCTs) comparing higher with lower omega-3, omega-6 or total polyunsaturated fatty acid (PUFA), regardless of reported outcomes, and to develop methods to assess effects of increasing omega-6, alpha-linolenic acid (ALA), long-chain omega-3 (LCn3) and total PUFA on health outcomes. DESIGN: Systematic review search, methodology and meta-analyses. DATA SOURCES: Medline, Embase, CENTRAL, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov and trials in relevant systematic reviews. ELIGIBILITY CRITERIA: RCTs of ≥24 weeks' duration assessing effects of increasing ALA, LCn3, omega-6 or total PUFAs, regardless of outcomes reported. DATA SYNTHESIS: Methods included random-effects meta-analyses and sensitivity analyses. Funnel plots were examined, and subgrouping assessed effects of intervention type, replacement, baseline diabetes risk and use of diabetic medications, trial duration and dose. Quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: Electronic searches generated 37 810 hits, de-duplicated to 19 772 titles and abstracts. We assessed 2155 full-text papers, conference abstracts and trials registry entries independently in duplicate. Included studies were grouped into 363 RCTs comparing higher with lower omega-3, omega-6 and/or total PUFA intake of at least 6 months' duration-the Database.Of these 363 included RCTs, 216 RCTs were included in at least one of our reviews of health outcomes, data extracted and risk of bias assessed in duplicate. Ninety five RCTs were included in the Database but not included in our current reviews. Of these 311 completed trials, 27 altered ALA intake, 221 altered LCn3 intake and 16 trials altered omega-3 intake without specifying whether ALA or LCn3. Forty one trials altered omega-6 and 59 total PUFA.The remaining 52 trials are ongoing though 13 (25%) appear to be outstanding, or constitute missing data. CONCLUSIONS: This extensive database of trials is available to allow assessment of further health outcomes.

Mixed-Methods Study Identifying Key Intervention Targets to Improve Participation in Daily Living Activities in Primary Sjögren's Syndrome Patients.

OBJECTIVE: Functional ability and participation in life situations are compromised in many primary Sjögren's syndrome (SS) patients. This study aimed to identify the key barriers and priorities to participation in daily living activities, in order to develop potential future interventions. METHODS: Group concept mapping, a semiquantitative, mixed-methods approach was used to identify and structure ideas from UK primary SS patients, adult household members living with a primary SS patient, and health care professionals. Brainstorming generated ideas, which were summarized into a final set of statements. Participants individually arranged these statements into themes and rated each statement for importance. Multidimensional scaling and hierarchical cluster analysis were applied to sorted and rated data to produce visual representations of the ideas (concept maps), enabling identification of agreed priority areas for interventions. RESULTS: A total of 121 patients, 43 adult household members, and 67 health care professionals took part. In sum, 463 ideas were distilled down to 94 statements. These statements were grouped into 7 clusters: Patient Empowerment, Symptoms, Wellbeing, Access and Coordination of Health Care, Knowledge and Support, Public Awareness and Support, and Friends and Family. Patient Empowerment and Symptoms were rated as priority conceptual themes. Important statements within priority clusters indicate patients should be taken seriously and supported to self-manage symptoms of oral and ocular dryness, fatigue, pain, and poor sleep. CONCLUSION: Our data highlighted the fact that in addition to managing primary SS symptoms, interventions aiming to improve patient empowerment, general wellbeing, access to health care, patient education, and social support are important to facilitate improved participation in daily living activities.

Speech and communication in Parkinson's disease: a cross-sectional exploratory study in the UK.

OBJECTIVE: To assess associations between cognitive status, intelligibility, acoustics and functional communication in PD. DESIGN: Cross-sectional exploratory study of functional communication, including a within-participants experimental design for listener assessment. SETTING: A major academic medical centre in the East of England, UK. PARTICIPANTS: Questionnaire data were assessed for 45 people with Parkinson's disease (PD), who had self-reported speech or communication difficulties and did not have clinical dementia. Acoustic and listener analyses were conducted on read and conversational speech for 20 people with PD and 20 familiar conversation partner controls without speech, language or cognitive difficulties. MAIN OUTCOME MEASURES: Functional communication assessed by the Communicative Participation Item Bank (CPIB) and Communicative Effectiveness Survey (CES). RESULTS: People with PD had lower intelligibility than controls for both the read (mean difference 13.7%, p=0.009) and conversational (mean difference 16.2%, p=0.04) sentences. Intensity and pause were statistically significant predictors of intelligibility in read sentences. Listeners were less accurate identifying the intended emotion in the speech of people with PD (14.8% point difference across conditions, p=0.02) and this was associated with worse speaker cognitive status (16.7% point difference, p=0.04). Cognitive status was a significant predictor of functional communication using CPIB (F=8.99, p=0.005, η2 = 0.15) but not CES. Intelligibility in conversation sentences was a statistically significant predictor of CPIB (F=4.96, p=0.04, η2 = 0.19) and CES (F=13.65, p=0.002, η2 = 0.43). Read sentence intelligibility was not a significant predictor of either outcome. CONCLUSIONS: Cognitive status was an important predictor of functional communication-the role of intelligibility was modest and limited to conversational and not read speech. Our results highlight the importance of focusing on functional communication as well as physical speech impairment in speech and language therapy (SLT) for PD. Our results could inform future trials of SLT techniques for PD.

Roles of Cognitive Status and Intelligibility in Everyday Communication in People with Parkinson's Disease: A Systematic Review.

BACKGROUND: Communication is fundamental to human interaction and the development and maintenance of human relationships and is frequently affected in Parkinson's disease (PD). However, research and clinical practice have both tended to focus on impairment rather than participation aspects of communicative deficit in PD. In contrast, people with PD have reported that it is these participation aspects of communication that are of greatest concern to them rather than physical speech impairment. OBJECTIVE: To systematically review the existing body of evidence regarding the association between cognitive status and/or intelligibility and everyday communication in PD. METHODS: Five online databases were systematically searched in May 2015 (Medline Ovid, EMBASE, AMED, PsycINFO and CINAHL) and supplementary searches were also conducted. Two reviewers independently evaluated retrieved records for inclusion and then performed data extraction and quality assessment using standardised forms. Articles were eligible for inclusion if they were English-language original peer-reviewed research articles, book chapters or doctoral theses investigating the associations between at least one of cognitive status and level of intelligibility impairment and an everyday communication outcome in human participants with PD. RESULTS: 4816 unique records were identified through database searches with 16 additional records identified through supplementary searches. 41 articles were suitable for full-text screening and 15 articles (12 studies) met the eligibility criteria. 10 studies assessed the role of cognitive status and 9 found that participants with greater cognitive impairment had greater everyday communication difficulties. 4 studies assessed the role of intelligibility and all found that participants with greater intelligibility impairment had greater everyday communication difficulties, although effects were often weak and not consistent. CONCLUSIONS: Both cognitive status and intelligibility may be associated with everyday communicative outcomes in PD. The contribution of intelligibility to everyday communication appears to be of small magnitude, suggesting that other factors beyond predominantly motor-driven impairment-level changes in intelligibility may play an important role in everyday communication difficulties in PD.