Usage evaluation of a resource to support evidence-based physiotherapy: the Physiotherapy Evidence Database (PEDro)

Objectives

The Physiotherapy Evidence Database (PEDro) is a free, web-based database of reports of randomised controlled trials, systematic reviews and evidence-based clinical practice guidelines in physiotherapy. The objective of this study was to describe the usage of PEDro over a 2-year period, including the number of visits and searches performed, the number of countries and territories from which users accessed PEDro, and amount of usage from each country.

Design

Survey of web-site and database log files.

Main outcome measures

Usage of the PEDro home-page (www.pedro.org.au) and the search function were logged for a 2-year period. Visit and search data were used to calculate the number of visits and searches each month. Domain data were used to calculate the total number of countries accessing PEDro and the amount of usage from each country and territory.

Results

The PEDro home-page received 921,181 visits from 205 countries and territories in 2010 and 2011, with 3,350,740 new searches performed. On average, a new search was initiated every 19 seconds. The highest usage was from the United States of America (15%), Australia (13%) and Brasil (8%). Highest normalised usage was from Peru (255 searches/physiotherapist), Chile (154) and Columbia (90), and from Australia (19,883 searches/million-population), New Zealand (13,267) and Switzerland (11,361).

Conclusions

There was substantial use of the PEDro resource by the global physiotherapy community during 2010 and 2011. The provision of the PEDro search function in languages other than English may enhance accessibility.     

Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial

Objectives

Rotator cuff tendinopathy is a common source of shoulder pain characterised by persistent and/or recurrent problems for a proportion of sufferers. The aim of this study was to pilot the methods proposed to conduct a substantive study to evaluate the effectiveness of a self-managed loaded exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy.

Design

A single-centre pragmatic unblinded parallel group pilot randomised controlled trial.

Setting

One private physiotherapy clinic, northern England.

Participants

Twenty-four participants with rotator cuff tendinopathy.

Interventions

The intervention was a programme of self-managed loaded exercise. The control group received usual physiotherapy treatment.

Main outcomes

Baseline assessment comprised the Shoulder Pain and Disability Index (SPADI) and the Short-Form 36, repeated three months post randomisation.

Results

The recruitment target was met and the majority of participants (98%) were willing to be randomised. 100% retention was attained with all participants completing the SPADI at three months. Exercise adherence rates were excellent (90%). The mean change in SPADI score was −23.7 (95% CI −14.4 to −33.3) points for the self-managed exercise group and −19.0 (95% CI −6.0 to −31.9) points for the usual physiotherapy treatment group. The difference in three month SPADI scores was 0.1 (95% CI −16.6 to 16.9) points in favour of the usual physiotherapy treatment group.

Conclusions

In keeping with previous research which indicates the need for further evaluation of self-managed loaded exercise for rotator cuff tendinopathy, these methods and the preliminary evaluation of outcome offer a foundation and stimulus to conduct a substantive study.     

Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine

BackgroundRandomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking.ObjectivesThis paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy.MethodsIdentification of the homeopathy-specific requirements for RCTs by reviewing literature and experts’ communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy.ResultsRecommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented.ConclusionsThe formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.     

Efficacy of memantine in the treatment of fibromyalgia: A double-blind,randomised, controlled trial with 6-month follow-up

Fibromyalgia (FM) is a prevalent and disabling chronic disease. Recent studies have found elevated levels of glutamate in several brain regions, leading to hypotheses about the usefulness of glutamate-blocking drugs such as memantine in the treatment of FM. The aim of this study was to evaluate the efficacy of memantine in the treatment of pain and other clinical variables (global function, clinical impression, depression, anxiety, quality of life) in FM patients. A double-blind, parallel randomised controlled trial was developed. A total of 63 patients diagnosed with FM were recruited from primary health care centres in Zaragoza, Spain. Memantine was administered at doses of 20 mg/d after 1 month of titration. Assessments were carried out at baseline, posttreatment, and 3- and 6-month follow-up. Compared with a placebo group, memantine significantly decreased ratings on a pain visual analogue scale (Cohen’s d = 1.43 at 6 months) and pain measured with a sphygmomanometer (d = 1.05). All other secondary outcomes except anxiety also improved, with moderate-to-large effect sizes at 6 months. Compared with placebo, the absolute risk reduction obtained with memantine was 16.13% (95% confidence interval = 2.0% to 32.6%), and the number needed to treat was 6.2 (95% confidence interval = 3 to 47). Tolerance was good, with dizziness (8 patients) and headache (4 patients) being the most frequent side effects of memantine. Although additional studies with larger sample sizes and longer follow-up times are needed, this study provides preliminary evidence of the utility of memantine for the treatment of FM.     

A double blind randomised controlled clinical trial on the effect of transcutaneous spinal electroanalgesia (TSE) on low back pain

A double blind randomised controlled clinical trial on the effect of transcutaneous spinal electroanalgesia (TSE) on low back pain was carried out in 58 patients attending a Pain Management Unit. Four TSE instruments, two active and two sham, were used and each patient was assigned randomly to one of these. Low back pain was rated by each patient using a visual analogue scale (VAS) immediately before and immediately after a single 20min treatment of TSE and also daily for the week prior to, and the week following, the treatment. No significant difference in mean pain score was detected between the active and sham treated groups immediately after treatment or during the subsequent week. The Hospital, Anxiety and Depression scale (HAD) and the General Health Questionnaire (GHQ) were completed by each patient and there was a positive correlation between the scores achieved on these scales and the mean pain scores in both the active and sham treated groups. A post‐trial problem was the discovery that the specification of the two active TSE machines differed from the manufacturer's specification. Thus, the output frequencies were either more (+10%) or less (?17%) while the maximum output voltages were both less (?40% and ?20%), respectively. However, additional statistical analysis revealed no significant differences between the results obtained with the two active machines.     

The effects of a sensory stimulation intervention on psychosocial and clinical outcomes of critically ill patients and their families: A randomised controlled trial

ObjectivesTo explore the effectiveness of a sensory stimulation intervention on intensive care unit patients' psychosocial, clinical, and family outcomes.DesignA prospective, assessor-blind, parallel-group randomised controlled trial.SettingA surgical intensive care unit of one tertiary hospital in Guangzhou, mainland China.InterventionParticipants in the intervention group received a daily 30-minute auditory and visual stimulation session starting from recruitment and for a maximum of seven days while in the intensive care unit.Measurement and main resultsOne hundred fifty-two patients and family caregiver dyads were recruited. Patients in the intervention group showed lower total scores of post-traumatic stress disorder (21.92 ± 6.34 vs 27.62 ± 10.35, p = 0.001), depressive symptoms (3.76 ± 3.99 vs 6.78 ± 4.75, p = 0.001) and delusional memories (0.47 ± 0.92 vs 0.82 ± 1.23, p = 0.001) collected immediately post-intervention than those in the control group, while not on depressive symptoms at one-month post-intervention (3.32 ± 4.03 vs 3.28 ± 3.77, p = 0.800). Sensory stimulation did not significantly impact patients' unit length of stay and 30-day mortality (all p > 0.05). For family outcomes, family caregivers in the intervention group had greater satisfaction with care (127.12 ± 14.14 vs 114.38 ± 21.97, p = 0.001) and a lower level of anxiety (28.49 ± 6.48 vs 34.64 ± 7.68, p = 0.001) than family caregivers in the control group.ConclusionsSensory stimulation may benefit patients' and family caregivers' psychological well-being, and further well-designed multi-centre clustered randomized controlled trials could be considered to strengthen the evidence.     

Effectiveness of the new 'Mobile AED Map' to find and retrieve an AED: A randomised controlled trial

Background

Although early shock with an automated external defibrillator (AED) is one of the several key elements to save out-of-hospital cardiac arrest (OHCA) victims, it is not always easy to find and retrieve a nearby AED in emergency settings. We developed a cell phone web system, the Mobile AED Map, displaying nearby AEDs located anywhere. The simulation trial in the present study aims to compare the time and travel distance required to access an AED and retrieve it with and without the Mobile AED Map.

Methods

Design: Randomised controlled trial. Setting: Two fields where it was estimated to take 2 min (120-170 m) to access the nearest AED. Participants were randomly assigned to either the Mobile AED Map group or the control group. We provided each participant in both groups with an OHCA scenario, and measured the time and travel distance to find and retrieve a nearby AED.

Results

Forty-three volunteers were enrolled and completed the protocol. The time to access and retrieve an AED was not significantly different between the Mobile AED Map group (400 ± 238 s) and the control group (407 ± 256 s, p = 0.92). The travel distance was significantly shorter in the Mobile AED Map group (606 m vs. 891 m, p = 0.019). Trial field conditions affected the results differently.

Conclusions

Although the new Mobile AED Map reduced the travel distance to access and retrieve the AED, it failed to shorten the time. Further technological improvements of the system are needed to increase its usefulness in emergency settings (UMIN000002043).     

Effects of family-centred care interventions on preterm infants and parents in neonatal intensive care units: A systematic review and meta-analysis of randomised controlled trials

Objective

The objective of this study was to review English and Chinese randomised controlled trials (RCTs) to determine the effects of family-centred care (FCC) interventions on preterm infants’ and parental outcomes in the neonatal intensive care units and to conduct a meta-analysis.

Efficacy and safety of Ayurvedic herbs in diarrhoea-predominant irritable bowel syndrome: A randomised controlled crossover trial

ObjectiveHerbal medicines have been used widely for the treatment of irritable bowel syndrome (IBS) patients. The aim of this study is to investigate efficacy and safety of an Ayurvedic herbal compound preparation made from: Murraya koenigii (curry), Punica granatum (pomegranate) and Curcuma longa (turmeric), compared to a placebo in patients with diarrhoea predominant IBS.Material and methodsThis trial was conducted as a randomised placebo-controlled crossover trial with randomised sequence of verum and placebo for each patient. Verum and placebo were provided as ground powders and delivered in sealed containers. Patients and outcome assessors were blinded. Patients were advised to ingest the decoction twice daily for 4 weeks. The primary outcome measure was IBS symptom intensity; secondary outcomes included: quality of life, anxiety and depression, compliance and safety.Results32 IBS patients were included in the trial (19 females, mean age 50.3 ± 11.9 years). Eleven people dropped out during the trial resulting in 37 complete verum and 35 complete placebo phases. No group differences were found between verum and placebo for IBS symptom intensity (difference 24.10; 95% CI: −17.12; 65.32, p = 0.26). The same was true for secondary outcomes. Compliance was satisfactory to good and the preparation appeared to be safe, but one third of the patients registered at least one minor adverse event that might be related to the study interventions.ConclusionAn Ayurvedic herbal preparation made from Murraya koenigii, Punica granatum and Curcuma longa appeared to be no more effective in improving diarrhoea predominant irritable bowel symptoms than placebo.     

The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial

ObjectiveTo evaluate the efficacy of Mindfulness-Based Stress Reduction (MBSR) in improving pain and physical function following total joint arthroplasty (TJA).DesignTwo-group, parallel-group, randomised controlled trial, conducted between September 2012 and May 2017.SettingSingle centre study conducted at a University-affiliated, tertiary hospital.InterventionPeople with arthritis scheduled for TJA, with a well-being score <40 (Short Form-12 Survey) were randomly allocated to a pre-surgery eight-week MBSR program or treatment as usual (TAU).Outcome MeasuresSelf-reported joint pain and function at 12 months post-surgery, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes were knee stiffness and global improvement (WOMAC); physical and psychological well-being (Veterans RAND 12-item Health Survey); self-efficacy (Arthritis Self-Efficacy Scale); and mindfulness (5-Factor Mindfulness Questionnaire).Results127 participants were randomised; 65 to MBSR and 62 to TAU, of which 45 participants allocated to the intervention and 56 participants allocated to usual care proceeded to surgery and 100 (99%) completed primary outcome measures. Greater improvements in knee pain (mean difference, -10.3 points, 95% CI -19.0 to -1.6; P = 0.021) and function (mean difference, -10.2 points, 95% CI -19.2 to -1.3; P = 0.025) at 12 months post-surgery were observed in the MBSR group compared to the TAU group. A between group difference in global scores (-9.5 points, 95% CI -17.9 to -1.1; P = 0.027) was also observed. No other differences in secondary outcomes were observed.ConclusionMBSR improves post-surgery pain and function in people with psychological distress undergoing TJA. Further research is required to examine potential barriers to broader implementation and uptake.     

Sanfu acupoint herbal patching for stable asthma: A systematic review and meta-analysis of randomised controlled trials

BackgroundSanfu acupoint herbal patching (SAHP) is extensively used in people with stable asthma in China. However, the evidence available is scarce. This systematic review aims to evaluate the preventive and therapeutic effect and safety of SAHP in people with stable asthma.MethodsWe searched seven electronic databases for randomised controlled trials (RCTs). The Cochrane risk of bias tool was utilised to evaluate the methodological quality of the included studies and RevMan 5.3 and GRADEpro 3.6.1 were applied to perform data analyses.ResultsA total of 34 RCTs involving 3313 participants were included. The overall methodological quality of the trials was of high risk of bias. SAHP plus conventional therapy (CT) decreased the mean frequency (times per year) of asthma exacerbations compared with CT alone (MD: −1.42; 95% CI: −2.19 to −0.65; 7 RCTs), and similar effect was found for SAHP versus sham SAHP (MD: 0.42; 95%CI: 0.26–0.69; 1 RCT). For lung function (including PEF%, FEV₁% and FEV₁/FVC), SAHP plus CT showed better effect than CT alone, and so did SAHP versus sham SAHP on PEF and PEF%. Adverse effects in the SAHP groups were reported to be mild and well tolerated.ConclusionsSAHP alone or combined with CT appears to be more effective than sham SAHP or CT on reduction of asthma exacerbations, improving lung function, and SAHP seems to be safe. However, the findings should be interpreted with caution due to limitations in trial quality. Further, rigorously designed, large-scale trials are warranted for robust evidence.     

Intervention programme to improve knowledge,attitudes, and behaviour of nursing students towards organ donation and transplantation: A randomised controlled trial

AimTo develop and evaluate an educational programme aimed at undergraduate training to increase and improve knowledge, attitudes and behaviour towards the organ and tissue donation and transplants (OTDT).BackgroundThe request for OTDT falls on the health personnel and the reduction of family refusals depends on their attitude and competence, which is vital to increase OTDT. The evidence highlights the efficacy of starting training at early stages and the implementation of educational programmes in universities is recommended to reduce family refusals.DesignA randomised controlled trial.MethodsA randomised controlled trial with an experimental group (EG) –theory class and round table- and a control group (CG) –theory class- that transitions to a delayed experimental group. A sample of 73 students was distributed in parallel randomised groups.ResultsThe groups increased their knowledge and improved their attitude, significantly changing their behaviour in the follow-up. These changes in the experimental groups were more significant than in CG in perceived quality of information (z = −4.948; p = <0.001), level of knowledge (EG1 and CG z = −2.245; p = 0.025) (EG2 and CG z = −2.215; p = 0.027), attitude (EG1 and CG z = −2.687; p = 0.007) (EG2 and CG z = −2.198; p = 0.028) and behaviour (EG1 and CG t = 2.054; p = 0.044) (EG2 and CG z = −2.797; p = 0.005).ConclusionsThe education programme has proven effective, promoting knowledge, change and entrenchment of attitudes, facilitating conversations with families, enabling willingness to donate and increasing potential donors.     

Positive and cost-effectiveness effect of spa therapy on the resumption of occupational and non-occupational activities in women in breast cancer remission: A French multicentre randomised controlled trial

Purpose of the researchThe main aim was to assess the effects of a spa treatment on the resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission. A cost-effectiveness analysis (CEA) was also performed.Methods and sampleA multicentre randomised controlled trial was carried out between 2008 and 2010 in the University Hospital of Auvergne and two private hospitals in Clermont-Ferrand, France. Eligible patients were women in complete breast cancer remission without contraindication for physical activities or cognitive disorders and a body mass index between 18.5 and 40 kg/m². The intervention group underwent spa treatment combined with consultation with dietician whereas the control underwent consultations with the dietician only. Of the 181 patients randomised, 92 and 89 were included in the intervention and the control groups, respectively. The CEA involved 90 patients, 42 from the intervention group and 48 from the control group.Key resultsThe main results showed a higher rate of resumption of occupational activities in the intervention group (p = 0.0025) and a positive effect of the intervention on the women's ability to perform occupational activities 12 months after the beginning of the study (p = 0.0014), and on their ability to perform family activities (p = 0.033). The stay in a thermal centre was cost-effective at 12 months.ConclusionsSpa treatment is a cost-effective strategy to improve resumption of occupational and non-occupational activities and the abilities of women in breast cancer remission.     

The effect of a family-based participatory care program on anxiety in patients with acute coronary syndrome in coronary care units: A randomised controlled clinical trial

BackgroundAdmission to the coronary care units (CCUs) and the patient's reduced interaction with family are regarded as important sources of anxiety. Family participation in care programs is pivotal to patient outcomes.ObjectivesThe present study was conducted to determine the effect of a care program based on family participation on anxiety in patients with acute coronary syndrome.MethodsThis randomised controlled trial was conducted on 90 patients in CCUs and their families. The patients were randomly assigned to one of the following three groups: routine care, control, and intervention. Routine care measures were provided to the routine care group, increased participation of the family was ensured in the control group, and a family-based participatory care program was implemented in the intervention group with the interaction of the nurse, patient, and family based on five principles, including presence, determination of needs, communication, participation in decision-making, and cooperation in care. The patients’ anxiety was measured in the three groups on day 1 and 3 days after the admission to the CCU using the Spielberger State-Trait Anxiety Inventory.ResultsThe patients’ mean state anxiety score before the intervention was 44.4 ± 12.7, 46.6 ± 12.4, and 45.5 ± 12.1 in the routine care, control, and intervention groups, respectively, with no significant differences between them (P = 0.81). After adjusting for anxiety before the intervention and study hospital, the mean (before–after) changes in anxiety score in the three groups showed that anxiety was significantly lower in the intervention group than in the other groups (P < 0.05).ConclusionIncreased family presence alone has no effect on the patients’ anxiety, but the family’s participation and interaction with the care team can affect anxiety levels in cardiac patients in CCUs and improve the care processes.Trial registration: Iranian Registry of Clinical Trials, Trial No. IRCT201105146481N1.     

A randomised, controlled study of outcome and cost effectiveness for RA patients attending nurse-led rheumatology clinics: study protocol of an ongoing nationwide multi-centre study

Background

The rise in the number of patients with arthritis coupled with understaffing of medical services has seen the deployment of Clinical Nurse Specialists in running nurse-led clinics alongside the rheumatologist clinics. There are no systematic reviews of nurse-led care effectiveness in rheumatoid arthritis. Few published RCTs exist and they have shown positive results for nurse-led care but they have several limitations and there has been no economic assessment of rheumatology nurse-led care in the UK.

Objective

This paper outlines the study protocol and methodology currently being used to evaluate the outcomes and cost effectiveness for patients attending rheumatology nurse-led clinics.

Design and methods

A multi-centred, pragmatic randomised controlled trial with a non-inferiority design; the null hypothesis being that of ‘inferiority’ of nurse-led clinics compared to physician-led clinics. The primary outcome is rheumatoid arthritis disease activity (measured by DAS28 score) and secondary outcomes are quality of life, self-efficacy, disability, psychological well-being, satisfaction, pain, fatigue and stiffness. Cost effectiveness will be measured using the EQ-5D, DAS28 and cost profile for each centre.

Power calculations

In this trial, a DAS28 change of 0.6 is considered to be the threshold for clinical distinction of ‘inferiority’. A sample size of 180 participants (90 per treatment arm) is needed to reject the null hypothesis of ‘inferiority’, given 90% power. Primary analysis will focus on 2-sided 95% confidence interval evaluation of between-group differences in DAS28 change scores averaged over 4 equidistant follow up time points (13, 26, 39 and 52 weeks). Cost effectiveness will be evaluated assessing the joint parameterisation of costs and effects.

Results

The study started in July 2007 and the results are expected after July 2011.

Trial registration

The International Standard Randomised Controlled Trial Number ISRCTN29803766.     

The Pain Course: A randomised controlled trial of a clinician-guided Internet-delivered cognitive behaviour therapy program for managing chronic pain and emotional well-being

The present study evaluated the efficacy of a clinician-guided Internet-delivered cognitive behaviour therapy (iCBT) program, the Pain Course, to reduce disability, anxiety, and depression associated with chronic pain. Sixty-three adults with chronic pain were randomised to either a Treatment Group or waitlist Control Group. Treatment consisted of 5 iCBT-based lessons, homework tasks, additional resources, weekly e-mail or telephone contact from a Clinical Psychologist, and automated e-mails. Twenty-nine of 31 Treatment Group participants completed the 5 lessons during the 8-week program, and posttreatment and 3-month follow-up data were collected from 30/31 and 29/31 participants, respectively. Treatment Group participants obtained significantly greater improvements than Control Group participants in levels of disability, anxiety, depression, and average pain levels at posttreatment. These improvements corresponded to small to large between-groups effect sizes (Cohen’s d) at posttreatment for disability (d = .88), anxiety (d = .38), depression (d = .66), and average pain (d = .64), respectively. These outcomes were sustained at follow-up and participants rated the program as highly acceptable. Overall, the clinician spent a total mean time of 81.54 minutes (SD 30.91 minutes) contacting participants during the program. The results appear better than those reported in iCBT studies to date and provide support for the potential of clinician-guided iCBT in the treatment of disability, anxiety, and depression for people with chronic pain.     

Chinese herbal medicine Dengzhan Xixin injection for acute ischemic stroke: A systematic review and meta-analysis of randomised controlled trials

ObjectiveTo evaluate the effectiveness and safety of Chinese herbal medicine Dengzhan Xixin (Erigeron breviscapus) injection for acute ischemic stroke.DesignSystematic review and meta-analysis (CRD42016038413, http://www.crd.york.ac.uk/PROSPERO).MethodsSix electronic databases were searched from inception to March 2016 for randomised controlled trials (RCTs) of Dengzhan Xixin (DZXX) injection for acute ischemic stroke. The methodological quality of RCTs was assessed by the Cochrane risk of bias tool.Data synthesiswas performed using RevMan 5.3 and was presented with mean difference (MD) or relative risk (RR) and their 95% confidence interval (CI). A summary of finding table was generated by GRADEpro (version 3.6).ResultsTwenty-five RCTs with 2498 participants were included and all trials adopted conventional therapy (CT) in both arms. Most of the studies had high risk of bias. The addition of DZXX to CT showed no significant benefit on death (RR 0.27, 95% CI 0.05–1.63) within the treatment period (14–35 d), but showed higher Barthel index score (MD 10.20, 95% CI 8.16–12.25), lower neurological function deficit score (MD −3.99, 95% CI −5.68 to −2.30, by NFDS; MD −1.67, 95% CI −2.59 to −0.76, by NIHSS), and lower treatment failure (RR 0.40, 95% CI 0.31–0.52). Thirteen trials (52%) reported the outcome of adverse events, but no serious adverse events were reported.ConclusionLow quality evidence implied that DZXX injection appeared to improve neurological function in patients with acute ischemic stroke. However, this potential benefit should be further studied in large, rigorous trials.