Analyzing User-Generated Web-Based Posts of Adolescents' Emotional, Behavioral, and Symptom Responses to Beliefs About Depression: Qualitative Thematic Analysis.

BACKGROUND: Depression is common during adolescence. Early intervention can prevent it from developing into more progressive mental disorders. Combining information technology and clinical psychoeducation is a promising way to intervene at an earlier stage. However, data-driven research on the cognitive response to health information targeting adolescents with symptoms of depression is lacking. OBJECTIVE: This study aimed to fill this knowledge gap through a new understanding of adolescents' cognitive response to health information about depression. This knowledge can help to develop population-specific information technology, such as chatbots, in addition to clinical therapeutic tools for use in general practice. METHODS: The data set consists of 1870 depression-related questions posted by adolescents on a public web-based information service. Most of the posts contain descriptions of events that lead to depression. On a sample of 100 posts, we conducted a qualitative thematic analysis based on cognitive behavioral theory investigating behavioral, emotional, and symptom responses to beliefs associated with depression. RESULTS: Results were organized into four themes. (1) Hopelessness, appearing as a set of negative beliefs about the future, possibly results from erroneous beliefs about the causal link between risk factors and the course of depression. We found beliefs about establishing a sturdy therapy alliance as a responsibility resting on the patient. (2) Therapy hesitancy seemed to be associated with negative beliefs about therapy prognosis and doubts about confidentiality. (3) Social shame appeared as a consequence of impaired daily function when the cause is not acknowledged. (4) Failing to attain social interaction appeared to be associated with a negative symptom response. In contrast, actively obtaining social support reduces symptoms and suicidal thoughts. CONCLUSIONS: These results could be used to meet the clinical aims stated by earlier psychoeducation development, such as instilling hope through direct reattribution of beliefs about the future; challenging causal attributions, thereby lowering therapy hesitancy; reducing shame through the mechanisms of externalization by providing a tentative diagnosis despite the risk of stigmatizing; and providing initial symptom relief by giving advice on how to open up and reveal themselves to friends and family and balance the message of self-management to fit coping capabilities. An active counseling style advises the patient to approach the social environment, demonstrating an attitude toward self-action.

Finding Relevant Psychoeducation Content for Adolescents Experiencing Symptoms of Depression: Content Analysis of User-Generated Online Texts.

BACKGROUND: Symptoms of depression are frequent in youth and may develop into more severe mood disorders, suggesting interventions should take place during adolescence. However, young people tend not to share mental problems with friends, family, caregivers, or professionals. Many receive misleading information when searching the internet. Among several attempts to create mental health services for adolescents, technological information platforms based on psychoeducation show promising results. Such development rests on established theories and therapeutic models. To fulfill the therapeutic potential of psychoeducation in health technologies, we lack data-driven research on young peoples' demand for information about depression. OBJECTIVE: Our objective is to gain knowledge about what information is relevant to adolescents with symptoms of depression. From this knowledge, we can develop a population-specific psychoeducation for use in different technology platforms. METHODS: We conducted a qualitative, constructivist-oriented content analysis of questions submitted by adolescents aged 16-20 years to an online public information service. A sample of 100 posts containing questions on depression were randomly selected from a total of 870. For analysis, we developed an a priori codebook from the main information topics of existing psychoeducational programs on youth depression. The distribution of topic prevalence in the total volume of posts containing questions on depression was calculated. RESULTS: With a 95% confidence level and a ±9.2% margin of error, the distribution analysis revealed the following categories to be the most prevalent among adolescents seeking advice about depression: self-management (33%, 61/180), etiology (20%, 36/180), and therapy (20%, 36/180). Self-management concerned subcategories on coping in general and how to open to friends, family, and caregivers. The therapy topic concerned therapy options, prognosis, where to seek help, and how to open up to a professional. We also found young people dichotomizing therapy and self-management as opposite entities. The etiology topic concerned stressors and risk factors. The diagnosis category was less frequently referred to (9%, 17/180). CONCLUSIONS: Self-management, etiology, and therapy are the most prevalent categories among adolescents seeking advice about depression. Young people also dichotomize therapy and self-management as opposite entities. Future research should focus on measures to promote self-management, measures to stimulate expectations of self-efficacy, information about etiology, and information about diagnosis to improve self-monitoring skills, enhancing relapse prevention.

A quality indicator set for use in rehabilitation team care of people with rheumatic and musculoskeletal diseases; development and pilot testing.

BACKGROUND: Systems for monitoring effectiveness and quality of rehabilitation services across health care levels are needed. The purpose of this study was to develop and pilot test a quality indicator set for rehabilitation of rheumatic and musculoskeletal diseases. METHODS: The set was developed according to the Rand/UCLA Appropriateness Method, which integrates evidence review, in-person multidisciplinary expert panel meetings and repeated anonymous ratings for consensus building. The quality indicators were pilot-tested for overall face validity and feasibility in 15 specialist and 14 primary care rehabilitation units. Pass rates (percentages of "yes") of the indicators were recorded in telephone interviews with 29 unit managers (structure indicators), and 164 patients (process and outcome indicators). Time use and participants' numeric rating of face validity (0-10, 10 = high validity) were recorded. RESULTS: Nineteen structure, 12 process and five outcome indicators were developed and piloted. Mean (range) sum pass rates for the structure, process and outcome indicators were 59%(84%), 66%(100%) and 84%(100%), respectively. Mean (range) face validity score for managers/patients was 8.3 (8)/7.9 (9), and mean answering time was 6.0/5.5 min. The final indicator set consists of 19 structure, 11 process and three outcome indicators. CONCLUSION: To our knowledge this is the first quality indicator set developed for rehabilitation of rheumatic and musculoskeletal diseases. Good overall face validity and a feasible format indicate a set suitable for monitoring quality in rehabilitation. The variation in pass rates between centers indicates a potential for quality improvement in rheumatic and musculoskeletal rehabilitation in Norway.

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.

Clinical drug trials in general practice: how well are external validity issues reported?

BACKGROUND: When reading a report of a clinical trial, it should be possible to judge whether the results are relevant for your patients. Issues affecting the external validity or generalizability of a trial should therefore be reported. Our aim was to determine whether articles with published results from a complete cohort of drug trials conducted entirely or partly in general practice reported sufficient information about the trials to consider the external validity. METHODS: A cohort of 196 drug trials in Norwegian general practice was previously identified from the Norwegian Medicines Agency archive with year of application for approval 1998-2007. After comprehensive literature searches, 134 journal articles reporting results published from 2000 to 2015 were identified. In these articles, we considered the reporting of the following issues relevant for external validity: reporting of the clinical setting; selection of patients before inclusion in a trial; reporting of patients' co-morbidity, co-medication or ethnicity; choice of primary outcome; and reporting of adverse events. RESULTS: Of these 134 articles, only 30 (22%) reported the clinical setting of the trial. The number of patients screened before enrolment was reported in 61 articles (46%). The primary outcome of the trial was a surrogate outcome for 60 trials (45%), a clinical outcome for 39 (29%) and a patient-reported outcome for 25 (19%). Clinical details of adverse events were reported in 124 (93%) articles. Co-morbidity of included participants was reported in 54 trials (40%), co-medication in 27 (20%) and race/ethnicity in 78 (58%). CONCLUSIONS: The clinical setting of the trials, the selection of patients before enrolment, and co-morbidity or co-medication of participants was most commonly not reported, limiting the possibility to consider the generalizability of a trial. It may therefore be difficult for readers to judge whether drug trial results are applicable to clinical decision-making in general practice or when developing clinical guidelines.

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.

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

BACKGROUND: Fetal 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. METHODS: The 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. RESULTS: Eight studies were included in the final dataset and seven were included in summary analyses. The sensitivity of SF height measurement for SGA (BW < 10(th) 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. CONCLUSIONS: SF 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 ).

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

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.

Combining antidepressants and attention bias modification in primary health care (DEPTREAT): Protocol for a pragmatic randomized controlled trial.

BACKGROUND: Major depressive disorder (MDD) is a highly prevalent psychiatric condition associated with significant disability, mortality and economic burden. A large proportion of MDD patients are treated in primary health care in the local community. Attentional Bias Modification (ABM) training in combination with antidepressants could be an effective treatment. Here we test the hypothesis that adding an ABM procedure to regular treatment with antidepressants in primary health care will result in further improvement of symptoms compared to treatment with antidepressants alone (treatment as usual, TAU) and as compared to an active comparison condition. METHODS: A total of 246 patients with a diagnosis of MDD will be included in this study. The study is a three-armed pragmatic randomized controlled trial comparing the efficacy of ABM as add-on to treatment with antidepressants in primary care (ABM condition) compared to standard antidepressant treatment (TAU condition). In a third group participants will complete the same schedule of intermediate assessments as the ABM condition in addition to TAU, but no ABM, thus controlling for the non-training-specific aspects of the ABM condition (Antidepressant active comparison group). DISCUSSION: The clinical outcome of this study may help develop easily accessible, low-cost treatment of depression in primary health care. Moreover, the study aims to broaden our knowledge of optimal treatment for patients with a MDD by providing adjunct treatment to facilitate recovery and long-term gain.

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.

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

AIMS: 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. METHODS: Cross-sectional, Internet-based study of 1,812 women responding to a general health questionnaire. Four severity levels for the ICIQ-UI SF scores were constructed by iteratively adjusting the ranges for these levels until maximum Kappa scores were obtained when cross-tabulated with the ISI in a random sample of half of the women with urinary incontinence. Using these intervals, weighted Kappa was calculated for the remaining women as a validation process. RESULTS: Three hundred forty-three women had urinary incontinence, and completed the ISI and the ICIQ-UI SF. A high correlation between the ISI and ICIQ-UI SF scores with versus without the QoL item was found (Spearman's rho = 0.62, P < 0.01 vs. rho = 0.71, P < 0.01, respectively). Maximum Kappa with quadratic weighting was obtained for the following scale for the ICIQ-UI SF: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21) (Kappa = 0.61), and without the QoL item: slight (1-3), moderate (4-5), severe (6-9) and very severe (10-11) (Kappa = 0.71) in the development sample. Correspondingly, for the validating sample, maximum Kappa with quadratic weighting was 0.61 and 0.74. CONCLUSIONS: A high correlation between the ICIQ-UI SF and the ISI was found. The ICIQ-UI SF may be divided into the following four severity categories: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21). Neurourol. Urodynam. 28:411-415, 2009. (c) 2009 Wiley-Liss, Inc.

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). AIM AND METHODS: To determine the short-term pain-relieving effects of seven commonly used pharmacological agents for OAK pain by performing a systematic review of randomised placebo-controlled trials. RESULTS: In total, 14,060 patients in 63 trials were evaluated. Opioids and oral NSAIDs therapy in patients with moderate to severe pain (mean baseline 64.3 and 72.8 mm on VAS respectively) had maximum efficacies compared to placebo at 2-4 weeks of 10.5 mm [95% CI: 7.4-13.7] and 10.2 mm [95% CI: 8.8-11.2] respectively. The efficacy of opioids may be inflated by high withdrawal rates (24-50%) and "best-case" scenarios reported in intention-to-treat analyses. In patients with moderate pain scores on VAS (mean range from 51 to 57 mm), intra-articular steroid injections and topical NSAIDs had maximum efficacies at 1-3 weeks of 14.5mm [95% CI: 9.7-19.2] and 11.6 mm [95% CI: 7.4-15.7], respectively. Paracetamol, glucosamin sulphate and chondroitin sulphate had maximum mean efficacies at 1-4 weeks of only 4.7 mm or lower. Heterogeneity tests revealed that best efficacy values of topical NSAIDs may be slightly deflated, while data for oral NSAIDs may be slightly inflated due to probable patient selection bias. CONCLUSION: Clinical effects from pharmacological interventions in OAK are small and limited to the first 2-3 weeks after start of treatment. The pain-relieving effects over placebo in OAK are smaller than the patient-reported thresholds for relevant improvement.

Is quality control of Cochrane reviews in controversial areas sufficient?

OBJECTIVES: Some conclusions from the Cochrane Database of Systematic Reviews (CDSR) seem volatile in areas of controversy and have recently changed conclusions. With this perspective in mind we decided to test the validity and sensitivity of negative conclusions in a systematic review of low-level laser therapy (LLLT) for osteoarthritis (OA) from the Cochrane Library was valid and robust. SETTINGS/LOCATION: None as this was a systematic review of literature. DESIGN: Validity was tested against a 9-item checklist for systematic reviews. Review selections were analyzed for possible discrepancies between trial and review reports and omissions of relevant trials and data. Data from discrepancies and omissions were then entered into sensitivity and subgroup analyses. OUTCOME MEASURES: Continuous and dichotomous data for pain SUBJECTS: Patients with osteoarthritis. INTERVENTIONS: LLLT. RESULTS: Only clinicians who had performed LLLT trials, and had negative results were invited into the review group. The review was oblivious to findings published after 1993 about physiologic mechanisms and dose response patterns for LLLT. We found 18 questionable selections that favored a negative review conclusion in 17 of 18 cases. These were largely omissions of relevant positive data and selective inclusion of negative data from trials with small, ineffective doses. When existing and omitted data from relevant trials were combined, results changed from negative to significantly positive for continuous and categorical data. Subgrouping trials by location and recommended doses taken from current guidelines, revealed a highly significant effect of LLLT for treating knee OA. CONCLUSIONS: The results of this CDSR was not robust and seems to be colored by questionable selections or omissions. For alternative pain therapies, it should be considered if lack of expertise on therapy mechanisms, or conflicts of interests with competing pain drug manufacturers, may bias conclusions. Review groups should recruit a balanced mix of current views and expertise and expand the use of sensitivity analyses to improve quality of CDSRs in areas of controversy.

A pilot study on the use of acupuncture or pelvic floor muscle training for mixed urinary incontinence.

OBJECTIVES: To determine the feasibility and acceptability of traditional Chinese medicine (TCM) acupuncture and pelvic floor muscle training (PFMT) in reducing symptoms and bothersomeness in women with mixed urinary incontinence (MUI); and to estimate the sample size for a full scale trial. METHODS: Thirty-four women with MUI were randomly assigned to either 12 sessions of TCM acupuncture, 12 sessions of PFMT, or to a waiting list control group. Outcome measures included an assessment of interest to participate in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with treatment. Clinical outcomes were assessed at baseline and 12 weeks, and included the International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI SF), expectations of treatment effect, and adverse events. RESULTS: Recruitment was feasible and randomisation worked adequately by means of SurveyMonkey. SurveyMonkey does not permit stratification by ICIQ-UI SF baseline score. Fourteen of 22 women found the treatment options acceptable. The dropout rate was high, especially in the control group (6/12). Outcome forms were completed by 20 of 34 women. The median (IQR) changes of the ICIQ-UI SF scores in the acupuncture, physiotherapy, and waiting list group were 5.5 (2.3 to 6.8), 1.0 (-3.0 to 4.5), and 1.5 (-1.5 to 3.0), respectively, suggesting the need for a full scale trial. CONCLUSIONS: Women with MUI were willing to participate in this study. There is a need for adjusting eligibility criteria. A sample size of 129 women, 43 in three arms, is required. No major adverse events occurred.

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 (χ(2) 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.

Can Cochrane Reviews in controversial areas be biased? A sensitivity analysis based on the protocol of a Systematic Cochrane Review on low-level laser therapy in osteoarthritis.

OBJECTIVE: The aim of this study was to test if a conclusion in a systematic review of low-level laser therapy (LLLT) for osteoarthritis from the Cochrane Library was valid and robust. BACKGROUND DATA: Health policy decisions often rely on conclusions from the Cochrane Database of Systematic Reviews for approval of new therapies, although their validity for controversial non-pharmacological treatment has been questioned. METHODS: Validity was tested against a nine-item checklist for systematic reviews. Review selections were analyzed for possible discrepancies between trial and review reports, and omissions of relevant trials and data. Alternative data from discrepancies and omissions were then imputed in a sensitivity analysis, to test if review conclusions were robust. RESULTS: Only clinicians who had performed LLLT trials with negative results were invited into the review group. Review quality was sound in areas of literature search and methodological assessments, and some of the limitations were mentioned. The statistical analysis held 18 questionable selections such as omissions of trials, data, and subgroup analyses. These selections systematically favored the negative review conclusion. Without altering the review protocol, the sensitivity analysis of combined results changed to significantly positive for continuous and categorical data when data from all included trials were combined. Further sensitivity analyses with inclusion of valid non-included trials, performance of missing follow-up, and subgroup analyses revealed consistent and highly significant results in favor of active LLLT. CONCLUSIONS: In this example, the Cochrane review conclusion was neither robust nor valid. Representation of experts and different views on efficacy in the review group and extensive use of sensitivity analyses could probably improve quality control of reviews in areas of controversy.