Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial.

OBJECTIVE: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). METHODS: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. RESULTS: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD -568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. CONCLUSION: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. TRIAL REGISTRATION NUMBER: NCT01439412 (ClinicalTrials.gov).

Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study.

OBJECTIVES: The aim of this study was to evaluate whether a single treatment session of acupuncture, when applied in addition to standard treatment for acute low back pain (ALBP), reduces the time to recovery compared with standard treatment alone. DESIGN: A multicentre, randomised, controlled trial. SETTING: Conducted at 11 Norwegian general practitioners' (GPs') offices. PARTICIPANTS: 171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017. Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded. INTERVENTIONS: The participants were randomised to either the control group (CG) or the acupuncture group (AG) by online software. The CG received standard treatment according to the Norwegian guidelines, while the AG received one session of Western medical acupuncture treatment in addition to standard treatment. The statistician was blinded to group status. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was median days to recovery. Secondary outcomes were pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects. RESULTS: 185 participants were randomised, 95 in the CG and 90 in the AG. 14 participants did not receive the allocated intervention and 4 were excluded from the analysis. Thus, 167 participants were included in the analysis, 86 in the CG and 81 in the AG. The groups were similar according to baseline characteristics. The median time to recovery was 14 days for the CG and 9 days for the AG, HR 1.37 (95% CI 0.95 to 1.96), (p=0.089). No serious adverse effects were reported. CONCLUSIONS: We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care. TRIAL REGISTRATION NUMBER: NCT01439412.

Characteristics of GPs responding to an educational intervention to minimise inappropriate prescriptions: subgroup analyses of the Rx-PAD study.

BACKGROUND: Interventions aimed at improving GPs' prescribing practice usually apply a 'one size fits all' when analysing intervention effects. Few studies explore intervention effects by variables related to the GPs' age, sex, specialist status, practice type (single-handed versus group), practice setting (urban versus rural), and baseline performance regarding the target of an intervention. AIM: To explore the characteristics of the GPs responding to a comprehensive educational intervention. DESIGN & SETTING: A secondary analysis of a cluster, randomised educational intervention in Norwegian general practice. Pre-intervention data were captured from January 2005 to December 2005, and post-intervention data from June 2006 to June 2007. The intervention was carried out from January to June 2006. METHOD: Eighty continuing medical education (CME) groups, including 449 GPs aged 27-68 years, were randomly allocated to either an education intervention arm (41 groups, 250 GPs) or a control arm (39 groups, 199 GPs). The primary outcome was GPs' change in potentially inappropriate prescriptions (PIPs) per 100 prescriptions issued to patients aged ≥70 years. The interaction between intervention outcome and variables related to the GPs and their practices were tested. RESULTS: Improvements in prescribing were highest among GPs aged 57-68 years (incidence rate ratio [IRR] = 0.77 [95% confidence interval {CI} = 0.73 to 0.81]), those who were specialists (IRR = 0.80 [95% CI = 0.78 to 0.82]), and those who worked in single-handed practices (IRR = 0.75 [95% CI = 0.68 to 0.83]), among GPs with 2.4 to 2.9 PIPs per 100 prescriptions at baseline (IRR = 0.74 [95% CI = 0.70 to 0.78]), and GPs with ≥15 prescriptions per patient per year at baseline (IRR = 0.77 [95% CI = 0.73 to 0.80]). CONCLUSION: The GPs with the lowest adherence to recommended practice at baseline improved their practice most.

Potentially Inappropriate Prescribing to Older Patients: Criteria, Prevalence and an Intervention to Reduce It: The Prescription Peer Academic Detailing (Rx-PAD) Study - A Cluster-Randomized, Educational Intervention in Norwegian General Practice.

Potentially inappropriate prescriptions (PIP) is drug treatment, which in general, at the group level for a median/mean patient, can be considered unfavourable meaning that the risks commonly may outweigh the benefits. This MiniReview reports and discusses the main findings in a large cluster-randomized educational intervention in Norwegian general practice, aimed at reducing the prevalence of PIPs to patients ≥70 years (The Rx-PAD study). Targets for the intervention were general practitioners (GPs) in continuing medical education (CME) groups receiving educational outreach visits (i.e. peer academic detailing). A Delphi consensus process, with a panel of medical experts, was undertaken to elaborate a list of explicit criteria defining PIPs for patients ≥70 years in general practice. Agreement was achieved for 36 explicit PIP criteria, the so-called Norwegian General Practice (NorGeP) criteria. Using a selection (n = 24) of these criteria during a 1-year baseline period on the prescribing practice of 454 GPs (i.e. those enrolled to participate in the intervention trial), we found a prevalence rate of 24.7 PIPs per 100 patients ≥70 years per year. In the Rx-PAD study, 449 GPs completed an educational intervention (96.6% of the included GPs), 250 in the intervention group and 199 in the control arm. Following the intervention, PIPs were reduced by 13% (95% CI 8.6-17.3), and the number of patients who were no longer exposed to one or more PIPs was reduced by 1173 (8.1%). The GPs who responded most strongly to the educational intervention were the oldest GPs (57-68 years), and these were the GPs with the highest prevalence of PIPs at baseline before the intervention.

Acupuncture treatments for infantile colic: a systematic review and individual patient data meta-analysis of blinding test validated randomised controlled trials.

OBJECTIVE: Needle acupuncture in small children has gained some acceptance in Western medicine. It is controversial, as infants and toddlers are unable to consent to treatment. We aimed to assess its efficacy for treating infantile colic. DESIGN: A systematic review and a blinding-test validation based on individual patient data from randomised controlled trials. Primary end-points were crying time at mid-treatment, at the end of treatment and at a 1-month follow-up. A 30-min mean difference (MD) in crying time between acupuncture and control was predefined as a clinically important difference. Pearson's chi-squared test and the James and Bang indices were used to test the success of blinding of the outcome assessors [parents]. Eligibility criteria and data sources: We included randomised controlled trials of acupuncture treatments of infantile colic. Systematic searches were conducted in Cochrane CENTRAL, MEDLINE, EMBASE, CINAHL and AMED, and in the Chinese language databases CNKI, VIP, Wang fang, SinoMed and Chinese Clinical Trial Registry. RESULTS: We included three randomised controlled trials with data from 307 participants. Only one of the included trials obtained a successful blinding of the outcome assessors in both the acupuncture and control groups. The MD in crying time between acupuncture intervention and no acupuncture control was -24.9 min [95% confidence interval, CI -46.2 to -3.6; three trials] at mid-treatment, -11.4 min [95% CI -31.8 to 9.0; three trials] at the end of treatment and -11.8 min [95% CI -62.9 to 39.2; one trial] at the 4-week follow-up. The corresponding standardised mean differences [SMDs] were -0.23 [95% CI -0.42 to -0.06], -0.10 [95% CI -0.29 to 0.08] and -0.09 [95% CI -0.48 to 0.30]. The heterogeneity was negligible in all analyses. The statistically significant result at mid-treatment was lost when excluding the apparently unblinded study in a sensitivity analysis: MD -13.8 min [95%CI -37.5 to 9.9] and SMD -0.13 [95%CI -0.35 to 0.09]. The registration of crying during treatment suggested more crying during acupuncture [odds ratio 7.7; 95% CI 2.7-20.6; one trial]. GRADE-Moderate quality evidence. CONCLUSIONS: Percutaneous needle acupuncture treatments should not be recommended for infantile colic on a general basis. Systematic review registration: PROSPERO 2015:CRD42015023253 Key points The role of acupuncture in the treatment of infantile colic is controversial. Available trials are small and present conflicting results. There were no clinically important differences between infants receiving acupuncture and no acupuncture control in this IPD meta-analysis of randomised controlled trials. The data indicate that acupuncture induces some treatment pain in many of the children. The study results indicate that percutaneous needle acupuncture should not be recommended for treatment of infantile colic on a general basis.

Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials.

BACKGROUND: Electronic questionnaires can ease data collection in randomized controlled trials (RCTs) in clinical practice. We found no existing software that could automate the sending of emails to participants enrolled into an RCT at different study participant inclusion time points. OBJECTIVE: Our aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). For the Acuback study, we determined that we would need to send a total of 5130 emails to 270 patients recruited at different centers and at 19 different time points. METHODS: The first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. We resolved these shortcomings in the next version, which we tested on the Web in February 2014. Our new version was able to schedule and send the required emails in the full-scale Acuback trial that started in March 2014. The system architecture evolved through an iterative, inductive process between the project study leader and the software programmer. The program was tested and updated when errors occurred. To evaluate the development of the software, we used a logbook, a research assistant dialogue, and Acuback trial participant queries. RESULTS: We have developed a Web-based app, Survey Email Scheduling and Monitoring in eRCTs (SESAMe), that monitors responses in electronic surveys and sends reminders by emails or text messages (short message service, SMS) to participants. The overall response rate for the 19 surveys in the Acuback study increased from 76.4% (655/857) before we introduced reminders to 93.11% (1149/1234) after the new function (P<.001). Further development will aim at securing encryption and data storage. CONCLUSIONS: The SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings.

Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice.

OBJECTIVE: Infantile colic is a painful condition in the first months of infancy. Acupuncture is used in Scandinavia as a treatment for infantile colic. A randomized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinically relevant effect for this condition. DESIGN: A prospective, blinding-validated, randomized controlled multicentre trial in general practice. Research assistants and parents were blinded. SETTING: 13 GPs' offices in Southern Norway. INTERVENTION: Three days of bilateral needling of the acupuncture point ST36, with no treatment as control. SUBJECTS: 113 patients were recruited; 23 patients were excluded, and 90 randomized; 79 diaries and 84 interviews were analysed. MAIN OUTCOME MEASURES: Difference in changes in crying time during the trial period between the intervention and control group. RESULTS: The blinding validation questions showed a random distribution with p = 0.41 and 0.60, indicating true blinding. We found no statistically significant difference in crying time reduction between acupuncture and control group at any of the measured intervals, nor in the main analysis of differences in changes over time (p = 0.26). There was a tendency in favour of the acupuncture group, with a non-significant total baseline-corrected mean of 13 minutes (95% CI -24 to + 51) difference in crying time between the groups. This was not considered clinically relevant, according to protocol. CONCLUSION: This trial of acupuncture treatment for infantile colic showed no statistically significant or clinically relevant effect. With the current evidence, the authors suggest that acupuncture for infantile colic should be restricted to clinical trials.

Prescription peer academic detailing to reduce inappropriate prescribing for older patients: a cluster randomised controlled trial.

BACKGROUND: Older patients are at particular risk for adverse drug reactions. In older people, interventions targeting potentially inappropriate prescriptions (PIPs) are considered important measures to minimise drug-related harm, especially in the general practice setting where most prescriptions for older patients are issued. AIM: To study the effects of a multifaceted educational intervention on GPs' PIPs for older patients. DESIGN AND SETTING: This was a cluster randomised, educational intervention study in Norwegian general practice. Pre-study data were captured from January 2005 to December 2005 and post-study data from June 2006 to June 2007. The educational intervention was carried out from January 2006 to June 2006. METHOD: Eighty continuing medical education (CME) groups (465 GPs) were randomised to receive the educational intervention on GPs' PIPs for older patients (41 CME groups; 256 GPs) or another educational intervention (39 CME groups; 209 GPs); these two groups acted as controls for each other. GPs' prescription data from before and after the intervention were assessed against a list of 13 explicit PIP criteria for patients aged ≥70 years. In the CME groups, trained GPs carried out an educational programme, including an audit, focusing on the 13 criteria and their rationale. RESULTS: A total of 449 GPs (96.6%) completed the study; 250 in the intervention group and 199 in the control group. After adjusting for baseline differences and clustering effects, a reduction relative to baseline of 10.3% (95% confidence interval = 5.9 to 15.0) PIPs per 100 patients aged ≥70 years was obtained. CONCLUSION: Educational outreach visits with feedback and audit, using GPs as academic detailers in GPs' CME groups, reduced PIPs for older patients aged ≥70 years in general practice.

Acupuncture for acute non-specific low back pain: a protocol for a randomised, controlled multicentre intervention study in general practice--the Acuback Study.

INTRODUCTION: Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition. The aim of this study was to evaluate whether a single treatment session with acupuncture can reduce time to recovery when applied in addition to standard LBP treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out. METHODS AND ANALYSIS: In this randomised, controlled multicentre study in general practice in Southern Norway, 270 patients will be allocated into one of two treatment groups, using a web-based application based on block randomisation. Outcome assessor will be blinded for group allocation of the patients. The control group will receive standard treatment, while the intervention group will receive standard treatment plus acupuncture treatment. There will be different GPs treating the two groups, and both groups will just have one consultation. Adults who consult their GP because of acute LBP will be included. Patients with nerve root affection, 'red flags', pregnancy, previous sick leave more than 14 days and disability pension will be excluded. The primary outcome of the study is the median time to recovery (in days). The secondary outcomes are rated global improvement, back-specific functional status, sick leave, medication, GP visits and side effects. A pilot study will be conducted. ETHICS AND DISSEMINATION: Participation is based on informed written consent. The authors will apply for an ethical approval from the Regional Committee for Medical and Health Research Ethics when the study protocol is published. Results from this study, positive or negative, will be disseminated in scientific medical journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01439412.

Do general practitioners' consultation rates influence their prescribing patterns of antibiotics for acute respiratory tract infections?

OBJECTIVES: To examine general practitioners' (GPs') antibiotic prescribing patterns for acute respiratory tract infections (ARTIs) as compared with national guidelines. We also wanted to explore possible predictors of antibiotic prescription patterns. METHODS: Observational study based on prescription data from 440 Norwegian GPs in December 2004 through to November 2005. Outcome measures were the type and frequency of antibiotic prescriptions for various ARTI diagnoses, with patients' and GPs' characteristics as explanatory variables. RESULTS: In the study period, the 440 GPs treated a total of 142 900 ARTI episodes. In 33.5% [95% confidence interval (CI): 31.9%-35.1%] of these episodes an antibiotic was issued, of which penicillin V (pcV) accounted for 41.2% (95% CI: 37.4%-44.9%). GPs with a high number of total annual encounters had higher antibiotic prescription rates for ARTIs and used more non-pcV antibiotics compared with GPs with fewer annual patient encounters. GPs in the highest quintile with respect to the total annual encounter rate had 1.6 times the odds of prescribing antibiotics compared with GPs in the lowest quintile. Correspondingly, the odds of choosing a non-pcV antibiotic were 2.8 times higher in the top quintile of GPs compared with GPs in the bottom quintile with respect to antibiotic prescription rates. CONCLUSIONS: ARTIs are frequently treated with antibiotics and often with broader spectrum agents than pcV, which is the recommended first-line antibiotic in the Norwegian guidelines. GPs with a high practice activity are, in general, more liberal with respect to the prescription of antibiotics for ARTIs, and the higher the antibiotic prescription rate, the larger the share of non-pcV agents.

A pilot study of ST36 acupuncture for infantile colic.

OBJECTIVE: To conduct a pilot study to assess the feasibility of a proposed design of an acupuncture trial to relieve symptoms of infantile colic. METHOD: An open randomised single-blinded controlled trial, using standardised bilateral treatment of the acupuncture point ST36. Infants fulfilling Wessel's definition of infantile colic were included. PATIENTS: were randomised to active treatment or to no-treatment control. General practitioners (GPs) educated in Western medical acupuncture did the interventions. Parents and GPs' assistants were blinded. Active treatment was the bilateral insertion of 0.20×15 mm Seirin needles to 12 mm depth at ST36. The intervention consisted of daily treatments of 30 s duration for three consecutive workdays. Blinding was done with a red point mark on the skin and circular adhesive dressing covering. The parents were asked two blinding validation questions in the course of the study period. The primary end point was the effect of the intervention assessed as change in crying time per 24 h measured with a crying registration form. RESULTS: The authors improved the standardisation and changed the blinding procedure as a result of the pilot study. Blinding validation questions were considered necessary. The changes made in the main study protocol are discussed. CONCLUSION: The pilot study led to important changes that were implemented into the final trial protocol. Blinding validation is essential in no-treatment controlled trials of acupuncture on infants, where the parents are blinded assessors of symptom reduction. The authors suggest that blinding validation questions, and the answers to these questions, should be reported. Clinical Trial Registry Identifier: NCT00907621.

[Sleep disorders in the elderly]. / Søvnforstyrrelser hos eldre.

BACKGROUND: Sleep disorders are common in the elderly, and may lead to substantially impaired quality of life. Many of these disorders are not diagnosed or treated. This article covers treatment options and characteristics of common sleep disorders in the elderly. MATERIAL AND METHODS: The article is based on the authors' own research and clinical experience, and on articles identified through non-systematic searches in Pubmed. RESULTS: Many somatic and psychological complaints are associated with sleep disorders; depression is the most common comorbid diagnosis. INTERPRETATION: A thorough assessment of the patient's sleep pattern is crucial before treatment is instigated. Pharmacological intervention is the most common treatment, but serious side effects are common and there is a high risk of addiction. Effective non-pharmacological interventions are available, also for the elderly.

[Symptom patterns in chronic sleep disorders]. / Symptommønstre ved kroniske søvnsykdommer.

BACKGROUND: Sleep disorders are classified into six main categories: insomnias, circadian rhythm disorders, sleep-related movement disorders, sleep-related breathing disorders, hypersomnias and parasomnias. The aim of this article is to shed light on differences between these categories with respect to symptom patterns. MATERIAL AND METHODS: The main sources of information are the diagnosis manual published by the American Academy of Sleep Medicine in 2005 and papers identified through non-systematic searches in Pubmed. RESULTS: Long sleep onset latency is most common in patients with insomnia, delayed sleep phase syndrome and restless legs while nightly awakenings are most common in patients with insomnia, restless legs and the sleep apnoea syndrome. Excessive daytime sleepiness is most pronounced in patients with hypersomnia, sleep apnoea syndrome and delayed sleep phase syndrome, whereas patients with insomnia rarely have this problem. Fatigue is a common feature of all sleep disorders, especially insomnia. The diagnosis of insomnia, circadian rhythm disturbances, restless legs and most parasomnias is mainly based on anamnestic data. Objective sleep recordings are necessary to diagnose sleep apnoea syndrome, hypersomnia and periodic leg movement during sleep. INTERPRETATION: The six sleep disorder categories differ substantially with respect to symptom patterns. Sleep disorders can often be distinguished from each other by use of anamnestic data without resorting to further assessment, but objective sleep recordings are needed for accurate diagnosis of some patients.

Late-life insomnia: a review.

Aging is associated with substantial changes in sleep patterns, which are almost always negative in nature. Typical findings in the elderly include a reduction in the deeper stages of sleep and a profound increase in the fragmentation of nighttime sleep by periods of wakefulness. The prevalence of specific sleep disorders increases with age, such as a phase advance in the normal circadian sleep cycle, restless legs syndrome, and obstructive sleep apnea, which is increasingly seen among older individuals and is significantly associated with cardio- and cerebrovascular disease as well as cognitive impairment. Elderly patients with sleep disturbances are often considered difficult to treat; yet, they are among the groups with the greatest need of treatment. Management of sleep disturbances begins with recognition and adequate assessment. Hypnotic drugs have clearly been shown to improve subjective and objective sleep measures in short-term situations, but their role in chronic insomnia still remains to be further defined by research evidence. Non-pharmacological treatments, particularly stimulus control and sleep restriction, are effective for conditioned aspects of insomnia and are associated with a stable, long-term improvement in sleep. This review delineates the common causes of disordered sleep in older individuals, and effective diagnostic approaches and treatments for these conditions.

The Norwegian General Practice (NORGEP) criteria for assessing potentially inappropriate prescriptions to elderly patients. A modified Delphi study.

OBJECTIVE: To establish a clinically relevant list with explicit criteria for pharmacologically inappropriate prescriptions in general practice for elderly people > or =70 years. DESIGN: A three-round Delphi process for validating the clinical relevance of suggested criteria (n = 37) for inappropriate prescriptions to elderly patients. SETTING: A postal consensus process undertaken by a panel of specialists in general practice, clinical pharmacology, and geriatrics. Main outcome measures. The Norwegian General Practice (NORGEP) criteria, a relevance-validated list of drugs, drug dosages, and drug combinations to be avoided in the elderly (< or =70 years) patients. RESULTS: Of the 140 invited panellists, 57 accepted to participate and 47 completed all three rounds of the Delphi process. The panellists reached consensus that 36 of the 37 suggested criteria were clinically relevant for general practice. Relevance of three of the criteria was rated significantly higher in Round 3 than in Round 1. At the end of the Delphi process, a significant difference between the different specialist groups' scores was seen for only one of the 36 criteria. CONCLUSION: The NORGEP criteria may serve as rules of thumb for general practitioners (GPs) related to their prescribing practice for elderly patients, and as a tool for evaluating the quality of GPs' prescribing in settings where access to clinical information for individual patients is limited, e.g. in prescription databases and quality improvement interventions.

[New guidelines for antibiotic use in primary health care]. / Nye retningslinjer for antibiotikabruk i primaerhelsetjenesten.

BACKGROUND: In 2000, the first national guideline is on antibiotic use in general practice wee distributed to all general practitioners and medical students in Norway. Here we describe the development of new guidelines. MATERIAL AND METHODS: A working group of 30 people searched relevant databases for literature. We have especially used research from Norway and from general practice and nursing homes. RESULTS: The main recommendations of the 2000 guidelines are upheld. For upper respiratory tract infections there is now an even better evidence base to support strict indications for antibiotic treatment. INTERPRETATION: A good evidence base supports continuation of the Norwegian tradition of prudent antibiotic use in primary health care. In some areas there is insufficient research. After an initiative from the Directorate of Health, the Antibiotic Centre for Primary Medicine have developed the new guidelines as a part of the governmental strategy to combat antimicrobial resistance. Prudent antibiotic use is seen as an important measure. For this reason, the guidelines will also be printed in a booklet that will be sent to general practitioners, medical students and nursing homes.