Atle Klovning

Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials

Abstract Objective To estimate the analgesic efficacy of non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase-2 inhibitors (coxibs), in patients with osteoarthritis of the knee. Design Systematic review and meta-analysis of randomised placebo controlled trials. Studies reviewed 23 trials including 10 845 patients, median age of 62.5 years. 7807 patients received adequate doses of NSAIDs and 3038 received placebo. The mean weighted baseline pain score was 64.2 mm on 100 mm visual analogue scale (VAS), and average duration of symptoms was 8.2 years. Main outcome measure Change in overall intensity of pain. Results Methodological quality of trials was acceptable, but 13 trials excluded patients before randomisation if they did not respond to NSAIDs. One trial provided long term data for pain that showed no significant effect of NSAIDs compared with placebo at one to four years. The pooled difference for pain on visual analogue scale in all included trials was 10.1 mm (95% confidence interval 7.4 to 12.8) or 15.6% better than placebo after 2-13 weeks. The results were heterogeneous, and the effect size for pain reduction was 0.32 (0.24 to 0.39) in a random effects model. In 10 trials that did not exclude non-responders to NSAID treatment the results were homogeneous, with an effect size for pain reduction of 0.23 (0.15 to 0.31). Conclusion NSAIDs can reduce short term pain in osteoarthritis of the knee slightly better than placebo, but the current analysis does not support long term use of NSAIDs for this condition. As serious adverse effects are associated with oral NSAIDs, only limited use can be recommended.

Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials.

Background: Pain is the most debilitating symptom in osteoarthritis of the knee (OAK).

Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index†

To compare the International Consultation on Incontinence Questionnaire‐Urinary Incontinence Short Form (ICIQ‐UI SF) with the Incontinence Severity Index (ISI), and to propose intervals for four severity levels of ICIQ‐UI SF.

Web-based survey attracted age-biased sample with more severe illness than paper-based survey

OBJECTIVE To assess how web-based recruitment is comparable to postal surveys. STUDY DESIGN AND SETTING In 2002, we invited female users of major Norwegian websites to join a womens health study on the Internet. The results of this study on the prevalence of urinary incontinence (UI) were compared with similar data collected by post in a previous epidemiological study, EPINCONT (Epidemiology of Urinary Incontinence in Nord-Trøndelag). RESULTS Altogether 1,812 web respondents compared with 27,936 postal respondents from the EPINCONT study. The Internet sample was younger than the EPINCONT sample (37 vs. 48 years, P<0.05). The proportion of women 60 years or older was 3.3% in our study and 29.0% in the EPINCONT study. Unadjusted prevalence of UI was lower in our study (20%) than in the EPINCONT study (25%), but stratified prevalence rates were higher in all individual age groups. In the Internet sample, we found less slight UI in all age groups, and more moderate (30-39 and 50-59-year age groups) and severe UI (30-39, 40-49, and 50-59-year age groups). CONCLUSION We attracted a younger population with more severe UI than the EPINCONT study. Web-based approaches are less appropriate for studies on conditions concerning the older population than postal methods.

Prognostic value of the labour admission test and its effectiveness compared with auscultation only: a systematic review

Objective  To assess the effectiveness of the labour admission test in preventing adverse outcomes, compared with auscultation only, and to assess the tests prognostic value in predicting adverse outcomes.

Validity of a scored urological history in detecting detrusor instability in female urinary incontinence

Background. Kauppila and co‐workers published in 1982 a detrusor instability score (DIS) for women with urinary incontinence. The aim of this study was to determine the validity of the DIS in an outpatient clinic for urogynecology.

The Norwegian General Practice--Nursing Home criteria (NORGEP-NH) for potentially inappropriate medication use: A web-based Delphi study.

Abstract Objective. To develop a set of explicit criteria for pharmacologically inappropriate medication use in nursing homes. Design. In an expert panel, a three-round Delphi consensus process was conducted via survey software. Setting. Norway. Subjects. Altogether 80 participants – specialists in geriatrics or clinical pharmacology, physicians in nursing homes and experienced pharmacists – agreed to participate in the survey. Of these, 62 completed the first round, and 49 panellists completed all three rounds (75.4% of those ultimately entering the survey). Main outcome measures. The authors developed a list of 27 criteria based on the Norwegian General Practice (NORGEP) criteria, literature, and clinical experience. The main outcome measure was the panellists’ evaluation of the clinical relevance of each suggested criterion on a digital Likert scale from 1 (no clinical relevance) to 10. In the first round panellists could also suggest new criteria to be included in the process. For each criterion, degree of consensus was based on the average Likert score and corresponding standard deviation (SD). Results. A list of 34 explicit criteria for potentially inappropriate medication use in nursing homes was developed through a three-round web-based Delphi consensus process. Degree of consensus increased with each round. No criterion was voted out. Suggestions from the panel led to the inclusion of seven additional criteria in round two. Implications. The NORGEP-NH list may serve as a tool in the prescribing process and in medication list reviews and may also be used in quality assessment and for research purposes.

Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice

Objectives Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998–2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Design Cohort study of trials with systematic searches for published results. Setting Clinical drug trials in Norwegian general practice. Methods We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. Main outcome measures We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Results Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ2 test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. Conclusions We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published.

Symphysis-fundus height measurement to predict small-for-gestational-age status at birth: A systematic review

BackgroundFetal growth restriction is among the most common and complex problems in modern obstetrics. Symphysis-fundus (SF) height measurement is a non-invasive test that may help determine which women are at risk. This study is a systematic review of the literature on the accuracy of SF height measurement for the prediction of small-for-gestational-age (SGA) status at birth in unselected and low-risk pregnancies.MethodsThe Medline, Embase, Cinahl, SweMed, and Cochrane Library databases were searched with no limitation on publication date (through September 2014), which returned 722 citations. Two reviewers then developed a short list of 51 publications of possible relevance and assessed them using the following inclusion criteria: cohort study of test accuracy performed in a routine prenatal care setting; SF height measurement for all participants; classification of SGA, defined as birth weight (BW) < 10th, 5th, or 3rd percentile or ≥ one or two standard deviations below the mean; study conducted in Northern, Western, or Central Europe; USA; Canada; Australia; or New Zealand; and sufficient data for 2 × 2 table construction. Quality of the included studies was assessed in duplicate using criteria suggested by the Cochrane Collaboration. Review Manager 5.3 software was used to analyze the data, including plotting of summary receiver operating curve spaces.ResultsEight studies were included in the final dataset and seven were included in summary analyses. The sensitivity of SF height measurement for SGA (BW < 10th percentile) prediction ranged from 0.27 to 0.76 and specificity ranged from 0.79 to 0.92. Positive and negative likelihood ratios ranged from 1.91 to 9.09 and from 0.29 to 0.83, respectively.ConclusionsSF height can serve as a clinical indicator along with other clinical findings, information about medical conditions, and previous obstetric history. However, SF height has high false-negative rates for SGA. Clinicians must understand the limitations of this test.The protocol has been registered in the international prospective register of systematic reviews, PROSPERO (Registration No. CRD42014008928, http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42014008928).

Clinical drug trials in general practice: a 10-year overview of protocols

BackgroundDrugs predominantly prescribed in general practice should ideally be tested in that setting; however, little is known about drug trials in general practice. Our aim was to describe drug trials in Norwegian general practice over the period of a decade.MethodsThe present work concerns a 10-year retrospective study of protocols submitted to the Norwegian national medicines agency (1998 to 2007) identifying all studies involving general practitioners (GPs) as clinical investigator(s). We analyzed the number of trials, drug company involvement, patients, participating doctors, payment, medications tested and main diagnostic criteria for inclusion. We also analyzed one trial in greater detail.ResultsOut of 2,054 clinical drug trials, 196 (9.5%) were undertaken in general practice; 93% were multinational, 96% were industry funded and 77% included patients both from general practice and specialist care. The trials were planned to be completed in the period 1998 to 2012. A total of 23,000 patients in Norway and 340,000 patients internationally were planned to be included in the 196 trials. A median of 5 GPs participated in each trial (range 1 to 402). Only 0.7% of 831 GP investigators had general practice university affiliations. Median payment for participating investigators was €1,900 (range €0 to 13,500) per patient completing the trial. A total of 30 pharmaceutical companies were involved. The drugs most commonly studied were antidiabetics (21%), obstructive airway disease medications (12%), agents acting on the renin-angiotensin system (10%), and lipid modifying agents (10%). One trial, presented in more detail, had several characteristics of a seeding or marketing trial.ConclusionsOnly one in four drug trials involving general practice were solely general practice trials and almost all were industry initiated without input from academic general practice. There was a large variation in the number of patients, participating doctors, and economic compensation for trial investigators, with some investigators receiving substantial payments.