According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal’s instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent.
Methods and Findings
The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author’s instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard.
Only every second psychiatry journal adheres to the ICMJE’s recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE’s recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research.
Background and aims
The French Pain Society published guidelines for neuropathic pain management in 2010. Our aim was to evaluate the compliance of GPs with these guidelines three years later.
We used “e” case vignette methodology for this non interventional study. A national panel of randomly selected GPs was included. We used eight “e” case-vignettes relating to chronic pain, differing in terms of the type of pain (neuropathic/non neuropathic), etiology (cancer, postoperative pain, low back pain with or without radicular pain, diabetes) and symptoms. GPs received two randomly selected consecutive “e” case vignettes (with/without neuropathic pain). We analyzed their ability to recognize neuropathic pain and to prescribe appropriate first-line treatment.
From the 1265 GPs in the database, we recruited 443 (35.0%), 334 of whom logged onto the web site (26.4%) and 319 (25.2%) of whom completed the survey. Among these GPs, 170 (53.3%) were aware of the guidelines, 136 (42.6%) were able to follow them, and 110 (34.5%) used the DN4 diagnostic tool. Sensitivity for neuropathic pain recognition was 87.8% (CI: 84.2%; 91.4%). However, postoperative neuropathic pain was less well diagnosed (77.9%; CI: 69.6%; 86.2%) than diabetic pain (95.2%; CI: 90.0%; 100.0%), cancer pain (90.6%; CI: 83.5%; 97.8%) and typical radicular pain (90.7%; CI: 84.9%; 96.5%). When neuropathic pain was correctly recognized, the likelihood of appropriate first-line treatment prescription was 90.6% (CI: 87.4%; 93.8%). The treatments proposed were pregabaline (71.8%), gabapentine (43.9%), amiptriptylline (23.2%) and duloxetine (18.2%). However, ibuprofen (11%), acetaminophen-codeine (29.5%) and clonazepam (10%) were still prescribed.
The compliance of GPs with clinical practice guidelines appeared to be satisfactory, but differed between etiologies.
Two-year, prospective cohort data from the Japan epidemiological research of occupation-related back pain study in urban settings were used for this analysis.
To examine the association between aggravated low back pain and psychosocial factors among Japanese workers with mild low back pain.
Summary of Background Data
Although psychosocial factors are strongly indicated as yellow flags of low back pain (LBP) leading to disability, the association between aggravated LBP and psychosocial factors has not been well assessed in Japanese workers.
At baseline, 5,310 participants responded to a self-administered questionnaire including questions about individual characteristics, ergonomic work demands, and work-related psychosocial factors (response rate: 86.5%), with 3,811 respondents completing the 1-year follow-up questionnaire. The target outcome was aggravation of mild LBP into persistent LBP during the follow-up period. Incidence was calculated for the participants with mild LBP during the past year at baseline. Logistic regression was used to explore risk factors associated with persistent LBP.
Of 1,675 participants who had mild LBP during the preceding year, 43 (2.6%) developed persistent LBP during the follow-up year. Multivariate analyses adjusted for individual factors and an ergonomic factor found statistically significant or almost significant associations of the following psychosocial factors with persistent LBP: interpersonal stress at work [adjusted odds ratio (OR): 1.96 and 95% confidence interval (95%CI): 1.00–3.82], job satisfaction (OR: 2.34, 95%CI: 1.21–4.54), depression (OR: 1.92, 95%CI: 1.00–3.69), somatic symptoms (OR: 2.78, 95%CI: 1.44–5.40), support from supervisors (OR: 2.01, 95%CI: 1.05–3.85), previous sick-leave due to LBP (OR: 1.94, 95%CI: 0.98–3.86) and family history of LBP with disability (OR: 1.98, 95%CI: 1.04–3.78).
Psychosocial factors are important risk factors for persistent LBP in urban Japanese workers. It may be necessary to take psychosocial factors into account, along with physical work demands, to reduce LBP related disability.
Health information on the Internet is ubiquitous, and its use by health consumers prevalent. Finding and understanding relevant online health information, and determining content reliability, pose real challenges for many health consumers.
To identify the types of interventions that have been implemented to assist health consumers to find reliable online health information, and where possible, describe and compare the types of outcomes studied.
PubMed, PsycINFO, CINAHL Plus and Cochrane Library databases; WorldCat and Scirus ‘gray literature’ search engines; and manual review of reference lists of selected publications.
Publications were selected by firstly screening title, abstract, and then full text.
Seven publications met the inclusion criteria, and were summarized in a data extraction form. The form incorporated the PICOS (Population Intervention Comparators Outcomes and Study Design) Model. Two eligible gray literature papers were also reported.
Relevant data from included studies were tabulated to enable descriptive comparison. A brief critique of each study was included in the tables. This review was unable to follow systematic review methods due to the paucity of research and humanistic interventions reported.
While extensive, the gray literature search may have had limited reach in some countries. The paucity of research on this topic limits conclusions that may be drawn.
The few eligible studies predominantly adopted a didactic approach to assisting health consumers, whereby consumers were either taught how to find credible websites, or how to use the Internet. Common types of outcomes studied include knowledge and skills pertaining to Internet use and searching for reliable health information. These outcomes were predominantly self-assessed by participants. There is potential for further research to explore other avenues for assisting health consumers to find reliable online health information, and to assess outcomes via objective measures.
We aimed to investigate the use of placebos (e.g. saline injections) and non-specific treatments (e.g. vitamin supplements in individuals without a relevant deficiency) among physicians working in private practices in Germany, and how such use is associated with the belief in and the use of complementary and alternative treatments, and basic professional attitudes. A four-page questionnaire was sent to nationwide random samples of general practitioners (GP), internists and orthopaedists working in private practices. The response rate was 46% (935 of 2018). 24% of GPs, 44% of internists and 57% of orthopaedists had neither used pure placebos nor non-specific therapies in the previous 12 months. 11% percent of GPs, 12% of internists and 7% of orthopaedists had exclusively used pure placebos; 30%, 33% and 26%, respectively, had exclusively used non-specific therapies; 35%, 12% and 9% had used both. Age, sex and agreement to the statement that physicians should harness placebo effects were not significantly associated with any pattern of use. Exclusive use of pure placebos was associated with being a GP, being an internist, and having unorthodox professional views. In addition to these three factors, a lower use of CAM therapies and a wish for having more time was associated with the exclusive use of non-specific therapies. Among physicians using both pure placebo and non-specific therapies, heterodox views were also somewhat more pronounced. However, associations were particularly strong for being a GP (Odds ratio 11.6 (95%CI 6.41; 21.3)) and having orthodox views (Odds ratio 0.10 (95%CI 0.06; 0.18)) among this group. In conclusion, the use of placebos and non-specific treatments varies strongly between medical specialties and is associated with basic professional attitudes. The findings support the view that the use of placebos and, in particular, of non-specific therapies is primarily a coping behaviour for difficult and uncertain situations.
Promoting physical activity is key to the management of chronic pain, but little is understood about the factors facilitating an individual’s engagement in physical activity on a day-to-day basis. This study examined the within-person effect of sleep on next day physical activity in patients with chronic pain and insomnia.
119 chronic pain patients monitored their sleep and physical activity for a week in their usual sleeping and living environment. Physical activity was measured using actigraphy to provide a mean activity score each hour. Sleep was estimated with actigraphy and an electronic diary, providing an objective and subjective index of sleep efficiency (A-SE, SE) and a sleep quality rating (SQ). The individual and relative roles of these sleep parameters, as well as morning ratings of pain and mood, in predicting subsequent physical activity were examined in multilevel models that took into account variations in relationships at the ‘Day’ and ‘Participant’ levels.
Of the 5 plausible predictors SQ was the only significant within-person predictor of subsequent physical activity, such that nights of higher sleep quality were followed by days of more physical activity, from noon to 11pm. The temporal association was not explained by potential confounders such as morning pain, mood or effects of the circadian rhythm.
In the absence of interventions, chronic pain patients spontaneously engaged in more physical activity following a better night of sleep. Improving nighttime sleep may well be a novel avenue for promoting daytime physical activity in patients with chronic pain.
Patients with sciatica frequently complain about associated back pain. It is not known whether there are prognostic relevant differences in Magnetic Resonance Imaging (MRI) findings between sciatica patients with and without disabling back pain.
The study population contained patients with sciatica who underwent a baseline MRI to assess eligibility for a randomized trial designed to compare the efficacy of early surgery with prolonged conservative care for sciatica. Two neuroradiologists and one neurosurgeon independently evaluated all MR images. The MRI readers were blinded to symptom status. The MRI findings were compared between sciatica patients with and without disabling back pain. The presence of disabling back pain at baseline was correlated with perceived recovery at one year.
Of 379 included sciatica patients, 158 (42%) had disabling back pain. Of the patients with both sciatica and disabling back pain 68% did reveal a herniated disc with nerve root compression on MRI, compared to 88% of patients with predominantly sciatica (P<0.001). The existence of disabling back pain in sciatica at baseline was negatively associated with perceived recovery at one year (Odds ratio [OR] 0.32, 95% Confidence Interval 0.18–0.56, P<0.001). Sciatica patients with disabling back pain in absence of nerve root compression on MRI at baseline reported less perceived recovery at one year compared to those with predominantly sciatica and nerve root compression on MRI (50% vs 91%, P<0.001).
Sciatica patients with disabling low back pain reported an unfavorable outcome at one-year follow-up compared to those with predominantly sciatica. If additionally a clear herniated disc with nerve root compression on MRI was absent, the results were even worse.
To survey surgeons on their beliefs and attitudes towards the use of placebo in surgery.
British orthopedic shoulder surgeons, attending a national conference in the United Kingdom, were asked to complete a self-report online questionnaire about their beliefs and attitudes towards the use of placebo related to surgical intervention. The survey included questions about ethical issues, the mechanism of placebo effects, and any concerns regarding its use.
100 surgeons who participated in the survey believed that placebo surgery is ethically acceptable (96%), especially as a part of a clinical trial (46%). Respondents thought that a placebo effect in surgery is real i.e. has a scientific basis (92%), that placebo can be therapeutically beneficial (77%), and that it involves psychological mechanisms (96%). Over half of the respondents (58%) have used a surgical procedure with a significant placebo component at least once in their professional career. Their main concern about placebo use in surgery was that it might involve an element of deception.
Conclusions and Implications
Surgeons generally agreed that a placebo component to surgical intervention might exist. They also supported placebo use in clinical trials and considered it ethical, providing it does not involve deception of patients. More studies are needed, particularly among other surgical specialties and with larger numbers of participants, to better understand the use of placebo in surgery.
No recent studies have analyzed the rates of or reasons for unanticipated revision surgery within 30 days of primary surgery in spinal deformity patients. Our aim was to examine the incidence, characteristics, reasons, and risk factors for unplanned revision surgery in spinal deformity patients treated at one institution. All patients with a diagnosis of spinal deformity presenting for primary instrumented spinal fusion at a single institution from 1998 to 2012 were reviewed. All unplanned reoperations performed within 30 days after primary surgery were analyzed in terms of demographics, surgical data, and complications. Statistical analyses were performed to obtain correlations and risk factors for anticipated revision. Of 2758 patients [aged 16.07 years (range, 2–71), 69.8% female] who underwent spinal fusion surgery, 59 (2.1%) required reoperation within 30 days after primary surgery. The length of follow up for each patient was more than 30 days. Of those that required reoperation, 87.0% had posterior surgery only, 5.7% had anterior surgery, and 7.3% underwent an anteroposterior approach. The reasons for reoperation included implant failure (n = 20), wound infection (n = 12), neurologic deficit (n = 9), pulmonary complications (n = 17), and coronal plane imbalance (n = 1). The risk factors for reoperation were age, diagnosis, and surgical procedure with osteotomy.
The role of surgical care in promoting global health is the subject of much debate. The Global Burden of Disease 2010 study (GBD 2010) offers a new opportunity to consider where surgery fits amongst global health priorities. The GBD 2010 reinforces the DALY as the preferred methodology for determining the relative contribution of disease categories to overall global burden of disease without reference to the likelihood of each category requiring surgery. As such, we hypothesize that the GBD framework underestimates the role of surgery in addressing the global burden of disease.
Methods and Findings
We compiled International Classification of Diseases, Version 9, codes from the United States Nationwide Inpatient Sample from 2010. Using the primary diagnosis code for each hospital admission, we aggregated admissions into GBD 2010 disease sub-categories. We queried each hospitalization for a major operation to determine the frequency of admitted patients whose care required surgery. Major operation was defined according to the Agency for Healthcare Research and Quality (AHRQ). In 2010, 10 million major inpatient operations were performed in the United States, associated with 28.6% of all admissions. Major operations were performed in every GBD disease subcategory (range 0.2%–84.0%). The highest frequencies of operation were in the subcategories of Musculoskeletal (84.0%), Neoplasm (61.4%), and Transport Injuries (43.2%). There was no disease subcategory that always required an operation; nor was there any disease subcategory that never required an operation.
Surgical care cuts across the entire spectrum of GBD disease categories, challenging dichotomous traditional classifications of ‘surgical’ versus ‘nonsurgical’ diseases. Current methods of measuring global burden of disease do not reflect the fundamental role operative intervention plays in the delivery of healthcare services. Novel methodologies should be aimed at understanding the integration of surgical services into health systems to address the global burden of disease.
Although some studies evaluated the effectiveness of massage therapy for fibromyalgia (FM), the role of massage therapy in the management of FM remained controversial.
The purpose of this systematic review is to evaluate the evidence of massage therapy for patients with FM.
Electronic databases (up to June 2013) were searched to identify relevant studies. The main outcome measures were pain, anxiety, depression, and sleep disturbance. Two reviewers independently abstracted data and appraised risk of bias. The risk of bias of eligible studies was assessed based on Cochrane tools. Standardised mean difference (SMD) and 95% confidence intervals (CI) were calculated by more conservative random-effects model. And heterogeneity was assessed based on the I2 statistic.
Nine randomized controlled trials involving 404 patients met the inclusion criteria. The meta-analyses showed that massage therapy with duration ≥5 weeks significantly improved pain (SMD, 0.62; 95% CI 0.05 to 1.20; p = 0.03), anxiety (SMD, 0.44; 95% CI 0.09 to 0.78; p = 0.01), and depression (SMD, 0.49; 95% CI 0.15 to 0.84; p = 0.005) in patients with FM, but not on sleep disturbance (SMD, 0.19; 95% CI −0.38 to 0.75; p = 0.52).
Massage therapy with duration ≥5 weeks had beneficial immediate effects on improving pain, anxiety, and depression in patients with FM. Massage therapy should be one of the viable complementary and alternative treatments for FM. However, given fewer eligible studies in subgroup meta-analyses and no evidence on follow-up effects, large-scale randomized controlled trials with long follow-up are warrant to confirm the current findings.
Clinical guidelines (CGs) are popular for healthcare decision making but their acceptability and use by healthcare providers is influenced by numerous factors. Some of these factors are professional-related, such as knowledge and perceptions of and attitudes toward CGs in general. The aim of our study was to evaluate attitudes and perceptions of Spanish physicians towards CGs.
We coordinated six discussion groups with a total of 46 physicians. The participants were drawn from 12 medical specialties from both specialized and primary care. We recorded the sessions and transcribed the content verbatim. We analyzed the data using an approach based on the grounded theory.
We identified two main constructs that defined the physicians' perceptions towards guidelines: knowledge and usefulness. “Knowledge” defined the theoretical meanings of guidelines, while “Usefulness” referred to the pragmatic approach to guidelines. These constructs were interrelated through a series of categories such as confidence, usability, accessibility, dissemination and formats.
In our study, the constructs that impacted most on physician's attitudes to clinical guidelines were knowledge and usefulness. The tension between the theoretical and the pragmatic constructs determined the attitudes and how physicians use guidelines. Groups developing guidelines should ask relevant clinical questions and develop implementable and context specific recommendations. Developers should be explicit and consistent in the development and presentation of recommendations.
Cancer-related fatigue (CRF) is a common symptom affecting patients with cancer. There are an increasing number of trials examining potential treatments for CRF. Methylphenidate represents one of the most researched drugs and an up-to-date assessment of the evidence for its use is needed. Trials of methylphenidate for CRF provided inconsistent results. This meta-analysis was aimed at assessing the effect and safety of methylphenidate on CRF.
We comprehensively searched the Pubmed, EMBASE, PSYCHInfo and the Cochrane databases in order to identify published studies on the effect of methylphenidate on CRF. Primary outcomes included fatigue. Secondary outcomes included depression, cognition and adverse effects.
A meta-analysis was conducted on five randomized controlled trials and 498 patients were enrolled. Despite a large placebo effect observed in the studies included, pooled data suggested therapeutic effect of methylphenidate on CRF. Subgroup Analyses showed that the efficacy of methylphenidate on CRF is getting better with prolonging treatment duration, with a MD of −3.70 (95% CI −7.03– −0.37, p = 0.03) for long-time group and a MD of −2.49 (95% CI −6.01–1.03, p = 0.17) for short-time group. In general, there was no impact of methylphenidate on depression and cognition associated with CRF. Adverse events were similar between methylphenidate and placebo groups except that more patients reported vertigo, anxiety, anorexia and nausea in methylphenidate group compared to placebo group.
Existing trials of methylphenidate on CRF provided limited evidence for the use of methylphenidate to treat CRF. The absolute numbers still remain small, and further confirmation is needed before firm recommendations on their usage and safety can be made in the treatment of CRF.
Study Design: A randomized, double-blind, active-controlled trial.
Objective: To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation, radiculitis, or facet joint pain.
Summary of Background Data: Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population. Once conservative management has failed and facet joint pain has been excluded, cervical epidural injections may be considered as a management tool. Despite a paucity of evidence, cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain.
Methods: One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the 2 treatment groups. Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL), whereas Group II patients received 0.5% lidocaine, 4 mL, mixed with 1 mL or 6 mg of nonparticulate betamethasone.
The primary outcome measure was ≥ 50% improvement in pain and function. Outcome assessments included numeric rating scale (NRS), Neck Disability Index (NDI), opioid intake, employment, and changes in weight.
Results: Significant pain relief and functional improvement (≥ 50%) was present at the end of 2 years in 73% of patients receiving local anesthetic only and 70% receiving local anesthetic with steroids. In the successful group of patients, however, defined as consistent relief with 2 initial injections of at least 3 weeks, significant improvement was illustrated in 78% in the local anesthetic group and 75% in the local anesthetic with steroid group at the end of 2 years. The results reported at the one-year follow-up were sustained at the 2-year follow-up.
Conclusions: Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain.
Chronic neck pain; cervical discogenic pain; cervical axial pain; cervical disc herniation; cervical epidural injections; epidural steroids; local anesthetics.
Back pain impacts on a significant proportion of the Australian population over the life course and has high prevalence rates among women, particularly in older age. Back pain care is characterised by multiple practitioner and self-prescribed treatment options, and the out-of-pocket costs associated with consultations and self-prescribed treatments have not been examined to date.
To analyse the extent of health care practitioner consultations and self-prescribed treatment for back pain care among Australian women, and to assess the self-reported costs associated with such usage.
Survey of 1,310 women (response rate 80.9%) who reported seeking help for back pain from the ‘1946-51 cohort’ of the Australian Longitudinal Study on Women’s Health. Women were asked about their use of health care practitioners and self-prescribed treatments for back pain and the costs associated with such usage.
In the past year 76.4% consulted a complementary and alternative practitioner, 56% an allied health practitioner and 59.2% a GP/medical specialist. Overall, women consulted with, on average, 3.0 (SD = 2.0) different health care practitioners, and had, on average, 12.2 (SD = 9.7) discrete health care practitioner consultations for back pain. Average self-reported out-of-pocket expenditure on practitioners and self-prescribed treatments for back pain care per annum was AU$873.10.
Multiple provider usage for various but distinct purposes (i.e. pain/mobility versus anxiety/stress) points to the need for further research into patient motivations and experiences of back pain care in order to improve and enhance access to and continuity of care. Our results suggest that the cost of back pain care represents a significant burden, and may ultimately limit women’s access to multiple providers. We extrapolate that for Australian working-age women, total out-of-pocket expenditure on back pain care per annum is in excess of AU$1.4billion, thus indicating the prominence of back pain as a major economic, social and health burden.
It remains controversial whether mini-incision (MI) benefits patients in total hip arthroplasty (THA). We performed a meta-analysis of randomized controlled trials (RCTs) to assess the effects of MI on surgical and functional outcomes in THA patients.
A systematic electronic literature search (up to May 2013) was conducted to identify RCTs comparing MI with standard incision (SI) THA. The primary outcome measures were surgical and functional outcomes. According to the surgical approach taken, MI THA patients were divided into four subgroups for sub-group meta-analysis. Standardized mean differences (SMDs) or risk differences (RDs) with accompanying 95% confidence intervals (CIs) were calculated and pooled using a fixed-effect or random-effect model according to the heterogeneity.
A total of 14 RCTs involving THA 1,174 patients met the inclusion criteria. The trials were medium risk of bias. The overall meta-analysis showed MI THA reduced total blood loss (95% CI, -201.83 to -21.18; p=.02) and length of hospital stay ( 95% CI, -0.67 to -0.08; p=.01) with significant heterogeneity. However, subgroup meta-analysis revealed posterior MI THA had perioperative advantages of reduced surgical duration ( 95% CI, -8.45 to -2.67; P<.001), less blood loss ( 95% CI, -107.20 to -1.73; P=.04) and shorter hospital stay ( 95% CI, -0.74 to -0.06; p=.002) with low heterogeneity. There were no significant differences between MI and SI THA groups in term of pain medication dose, functional outcome (HHS), radiological outcome or complications (P>.05, respectively).
Although no definite overall conclusion can be arrived at on whether MI THA is superior to SI THA, posterior MI THA clearly result in a significant decrease in surgical duration, blood loss and hospital stay. It seems to be a safe minimally invasive surgical procedure without increasing the risk of component malposition or complications.
The purpose of this study was to analyze the clinical features and prognostic factors of surgical outcome of foot drop caused by lumbar degenerative disease and put forward the clinical stage.
We retrospectively reviewed 135 patients with foot drop due to lumbar degenerative disease. The clinical features and mechanism were analyzed. Age, sex, duration of palsy, preoperative muscle strength of tibialis anterior (TA), sensation defect of affected lower limb, affected foot, diagnosis and compressed nerve roots were recorded and compared with surgical outcome.
Foot drop was observed in 8.1% of all inpatients of lumbar degenerative disease. L5 nerve root compression was observed in 126 of all 135 patients (93.3%). Single, double and triple roots compression was observed respectively in 43, 83, and 9 patients (31.9%, 61.5%, and 6.6%). But there was no significant relationship between preoperative muscle strength of TA and the number of compressed roots. The muscle strength of TA was improved in 113 (83.7%) patients after surgery, but it reached to >=4 in only 21 (15.6%) patients. Improvement of the muscle strength of TA was almost stable at the 6-month follow-up. At the last follow-up, the muscle strength of TA was 1, 2, 3, 4, 5 respectively in 28, 24, 62, 13, 8 patients. Multivariate logistic regression showed duration of palsy (p=0.0360, OR=2.543), preoperative muscle strength of TA (p=0.0064, OR=5.528) and age (p=0.0309, OR=3.208) were factors that influenced recovery following an operation.
L5 nerve root was most frequently affected. The muscle strength of TA improved in most patients after surgery, but few patients can get a good recovery from foot drop. Patients of shorter duration of palsy, better preoperative muscle strength of TA and younger age showed a better surgical outcome.
The placebo effect is an interesting phenomenon whereby a dummy treatment can produce therapeutic benefit, such as, pain relief. While evidence for the placebo effect is growing, relatively few studies have explored ways of enhancing placebo effects. To address this, the current study tested whether placebo-induced analgesia could be enhanced by providing an educational handout about the efficacy of analgesics. Fifty university students were allocated to receive placebo treatment under the guise of a new analgesic formula, either with or without an educational handout, or to a no treatment control group before undergoing electrical and cold pressor pain tests. There was a placebo effect for electrically-induced pain with those receiving placebo treatment reporting significantly less pain compared with those who received no treatment. There was also some evidence of enhancement of this placebo-induced analgesia for electrically-induced pain as a result of the educational handout. No differences were found on cold pressor-induced pain. These findings suggest that providing educational information about a treatment could enhance its efficacy via the placebo effect. Future studies should test different methods of providing educational information in order to determine which elicit the strongest effects.
The development and publication of clinical practice guidelines for acute low-back pain has resulted in evidence-based recommendations that have the potential to improve the quality and safety of care for acute low-back pain. Development and dissemination of guidelines may not, however, be sufficient to produce improvements in clinical practice; further investment in active implementation of guideline recommendations may be required. Further research is required to quantify the trade-off between the additional upfront cost of active implementation of guideline recommendations for low-back pain and any resulting improvements in clinical practice.
Cost-effectiveness analysis alongside the IMPLEMENT trial from a health sector perspective to compare active implementation of guideline recommendations via the IMPLEMENT intervention (plus standard dissemination) against standard dissemination alone.
The base-case analysis suggests that delivery of the IMPLEMENT intervention dominates standard dissemination (less costly and more effective), yielding savings of $135 per x-ray referral avoided (-$462.93/3.43). However, confidence intervals around point estimates for the primary outcome suggest that – irrespective of willingness to pay (WTP) – we cannot be at least 95% confident that the IMPLEMENT intervention differs in value from standard dissemination.
Our findings demonstrate that moving beyond development and dissemination to active implementation entails a significant additional upfront investment that may not be offset by health gains and/or reductions in health service utilization of sufficient magnitude to render active implementation cost-effective.
Abuse of prescription opioid analgesics is a serious threat to public health, resulting in rising numbers of overdose deaths and admissions to emergency departments and treatment facilities. Absent adequate patient information systems, “doctor shopping” patients can obtain multiple opioid prescriptions for nonmedical use from different unknowing physicians. Our study estimates the prevalence of doctor shopping in the US and the amounts and types of opioids involved.
Methods and Findings
The sample included records for 146.1 million opioid prescriptions dispensed during 2008 by 76% of US retail pharmacies. Prescriptions were linked to unique patients and weighted to estimate all prescriptions and patients in the nation. Finite mixture models were used to estimate different latent patient populations having different patterns of using prescribers. On average, patients in the extreme outlying population (0.7% of purchasers), presumed to be doctor shoppers, obtained 32 opioid prescriptions from 10 different prescribers. They bought 1.9% of all opioid prescriptions, constituting 4% of weighed amounts dispensed.
Our data did not provide information to make a clinical diagnosis of individuals. Very few of these patients can be classified with certainty as diverting drugs for nonmedical purposes. However, even patients with legitimate medical need for opioids who use large numbers of prescribers may signal dangerously uncoordinated care. To close the information gap that makes doctor shopping and uncoordinated care possible, states have created prescription drug monitoring programs to collect records of scheduled drugs dispensed, but the majority of physicians do not access this information. To facilitate use by busy practitioners, most monitoring programs should improve access and response time, scan prescription data to flag suspicious purchasing patterns and alert physicians and pharmacists. Physicians could also prevent doctor shopping by adopting procedures to screen new patients for their risk of abuse and to monitor patients' adherence to prescribed treatments.
The concept of minimum clinically important difference (MCID) has been used to measure the threshold by which the effect of a specific treatment can be considered clinically meaningful. MCID has previously been studied in surgical patients, however few studies have assessed its role in spinal surgery. The goal of this study was to assess the role of MCID in patients undergoing anterior cervical discectomy and fusion (ACDF) for cervical spondylotic myelopathy (CSM).
Data was collected on 30 patients who underwent ACDF for CSM between 2007 and 2012. Preoperative and 1-year postoperative Neck Disability Index (NDI), Visual-Analog Scale (VAS), and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary PRO scores were collected. Five distribution- and anchor-based approaches were used to calculate MCID threshold values average change, change difference, receiver operating characteristic curve (ROC), minimum detectable change (MDC) and standard error of measurement (SEM). The Health Transition Item of the SF-36 (HTI) was used as an external anchor.
Patients had a significant improvement in all mean physical PRO scores postoperatively (p<0.01) NDI (29.24 to 14.82), VAS (5.06 to 1.72), and PCS (36.98 to 44.22). The five MCID approaches yielded a range of values for each PRO: 2.00–8.78 for PCS, 2.06–5.73 for MCS, 4.83–13.39 for NDI, and 0.36–3.11 for VAS. PCS was the most representative PRO measure, presenting the greatest area under the ROC curve (0.94). MDC values were not affected by the choice of anchor and their threshold of improvement was statistically greater than the chance of error from unimproved patients.
SF-36 PCS was the most representative PRO measure. MDC appears to be the most appropriate MCID method. When MDC was applied together with HTI anchor, the MCID thresholds were: 13.39 for NDI, 3.11 for VAS, 5.56 for PCS and 5.73 for MCS.
Incorporating the patient's view on care and treatment has become increasingly important for health care. Patients describe the variety of consequences of their chronic pain conditions as significant pain intensity, depression, and anxiety. We hypothesised that intensities of common symptoms in chronic pain conditions carry important information that can be used to identify clinically relevant subgroups. This study has three aims: 1) to determine the importance of different symptoms with respect to participation and ill-health; 2) to identify subgroups based on data concerning important symptoms; and 3) to determine the secondary consequences for the identified subgroups with respect to participation and health factors.
Methods and Subjects
This study is based on a cohort of patients referred to a multidisciplinary pain centre at a university hospital (n = 4645, participation rate 88%) in Sweden. The patients answered a number of questionnaires concerning symptoms, participation, and health aspects as a part of the Swedish Quality Registry for Pain Rehabilitation (SQRP).
Common symptoms (such as pain intensity, depression, and anxiety) in patients with chronic pain showed great variability across subjects and 60% of the cohort had normal values with respect to depressive and anxiety symptoms. Pain intensity more than psychological symptoms showed stronger relationships with participation and health. It was possible to identify subgroups based on pain intensity, depression, and anxiety. With respect to participation and health, high depressive symptomatology had greater negative consequences than high anxiety.
Common symptoms (such as pain intensity and depressive and anxiety symptoms) in chronic pain conditions carry important information that can be used to identify clinically relevant subgroups.
Non-ionic radiocontrast media (RCM) is rarely associated with hypersensitivity reactions. Premedication of patients who reacted previously to RCM with systemic corticosteroids and/or antihistamines can help reduce recurrent hypersensitivity reactions. However, premedication is still not prescribed in many cases for various reasons. This study aimed to determine the effectiveness of our novel RCM hypersensitivity surveillance and automatic recommending system for premedication.
Methods and Results
Hospitalized patients with a history of RCM hypersensitivity were identified in an electronic medical record system that included a mandatory reporting system for past adverse drug reactions. In 2009, a novel automatic prescription system was added that classified index RCM reactions by severity and dispensed appropriate corticosteroid and/or antihistamine pretreatment prior to new RCM exposures. The data from 12 months under the previous system and 12 months under the current system were compared.
The two systems had similar overall premedication rates (91% and 95%) but the current system was associated with a significantly higher corticosteroid premedication rate (65% vs. 14%), which significantly reduced the breakthrough reaction rate (6.7% vs. 15.2%). The current system was also associated with increased corticosteroid and antihistamine premedication of patients with a mild index reaction (61% vs. 7%) and a reduction in their breakthrough reaction rate (6% vs. 15%).
Premedication with corticosteroid and/or antihistamine, which was increased by our novel automatic prescription system, significantly reduced breakthrough reactions in patients with a history of RCM hypersensitivity.
Placebos are widely used in clinical practice in spite of ethical restrictions. Whether such use is justified depends in part on the relative benefit of placebos compared to ‘active’ treatments. A direct test for differences between placebo and ‘active’ treatment effects has not been conducted.
We aimed to test for differences between treatment and placebo effects within similar trial populations.
A Cochrane Review compared placebos with no treatment in three-armed trials (no treatment, placebo, and treatment). We added an analysis of treatment and placebo differences within the same trials.
For continuous outcomes we compared mean differences between placebo and no treatment with mean differences between treatment and placebo. For binary outcomes we compared the risk ratio for treatment benefit (versus placebo) with the risk ratio for placebo benefit (versus no treatment). We conducted several preplanned subgroup analyses: objective versus subjective outcomes, conditions tested in three or more trials, and trials with varying degrees of bias.
In trials with continuous outcomes (n = 115) we found no difference between treatment and placebo effects (MD = −0.29, 95% CI −0.62 to 0.05, P = 0.10). In trials with binary outcomes (n = 37) treatments were significantly more effective than placebos (RRR = 0.72, 95%CI = 0.61 to 0.86, P = 0.0003). Treatment and placebo effects were not different in 22 out of 28 predefined subgroup analyses. Of the six subgroups with differences treatments were more effective than placebos in five. However when all criteria for reducing bias were ruled out (continuous outcomes) placebos were more effective than treatments (MD = 1.59, 95% CI = 0.40 to 2.77, P = 0.009).
Conclusions and Implications
Placebos and treatments often have similar effect sizes. Placebos with comparatively powerful effects can benefit patients either alone or as part of a therapeutic regime, and trials involving such placebos must be adequately blinded.