A randomized comparison of patients' understanding of number needed to treat and other common risk reduction formats. The effect of alternative summary statistics for communicating risk reduction on decisions about taking statins: a randomized trial. How should the impact of different presentations of treatment effects on patient choice be evaluated? A pilot randomized trial. Health professionals' and service users' interpretation of screening test results: experimental study. Efficacy of repetitive transcranial magnetic stimulation for the treatment of refractory chronic tinnitus: a randomized, placebo controlled study. Reconciling population benefits and women's individual autonomy in mammographic screening: in-depth interviews to explore women's views about 'informed choice'. Use of comparison populations for evaluating the effectiveness of hearing loss prevention programs. A randomized clinical trial of repetitive transcranial magnetic stimulation in the treatment of major depression. Danish GPs' perception of disease risk and benefit of prevention. A study of hearing changes among military conscripts in the Swedish Army. Longer response scales improved the acceptability and performance of the Nottingham Health Profile. Neurocognition in patients with brain metastases treated with radiosurgery or radiosurgery plus whole-brain irradiation: a randomised controlled trial. An experimental evaluation of the effects of transcutaneous nerve stimulation (TNS) and applied relaxation (AR) on hearing ability, tinnitus and dizziness in patients with Menière's disease. Use of a self-help book with weekly therapist contact to reduce tinnitus distress: a randomized controlled trial. Effects of communicating social comparison information on risk perceptions for colorectal cancer. Quality of reporting of randomized controlled trials in general endocrinology literature. Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Evidence that music listening reduces preoperative patients' anxiety. The impact of different response alternatives on responders' reporting of health-related behaviour in a postal survey. A randomized trial of office-based screening for common problems in older persons. Influence of 'framing effect' on women's support for government funding of breast cancer screening. Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. GPs' and physicians' interpretation of risks, benefits and diagnostic test results. Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. Randomised controlled trial of routine individual feedback to improve rationality and reduce numbers of test requests. A randomized trial of a computerized versus an audio-booklet decision aid for women considering post-menopausal hormone replacement therapy. The role of numeracy in understanding the benefit of screening mammography. Perception of risk information. Similarities and differences between Danish and Polish general practitioners.
Commentators have suggested that patients may understand quantitative information about treatment benefits better when they are presented as numbers needed to treat (NNT) rather than as absolute or relative risk reductions.
                To determine whether NNT helps patients interpret treatment benefits better than absolute risk reduction (ARR), relative risk reduction (RRR), or a combination of all three of these risk reduction presentations (COMBO).
                Randomized cross-sectional survey.
                University internal medicine clinic.
                Three hundred fifty-seven men and women, ages 50 to 80, who presented for health care.
                Subjects were given written information about the baseline risk of a hypothetical "disease Y" and were asked (1) to compare the benefits of two drug treatments for disease Y, stating which provided more benefit; and (2) to calculate the effect of one of those drug treatments on a given baseline risk of disease. Risk information was presented to each subject in one of four randomly allocated risk formats: NNT, ARR, RRR, or COMBO.
                When asked to state which of two treatments provided more benefit, subjects who received the RRR format responded correctly most often (60% correct vs 43% for COMBO, 42% for ARR, and 30% for NNT, P =.001). Most subjects were unable to calculate the effect of drug treatment on the given baseline risk of disease, although subjects receiving the RRR and ARR formats responded correctly more often (21% and 17% compared to 7% for COMBO and 6% for NNT, P =.004).
                Patients are best able to interpret the benefits of treatment when they are presented in an RRR format with a given baseline risk of disease. ARR also is easily interpreted. NNT is often misinterpreted by patients and should not be used alone to communicate risk to patients. While different ways of presenting treatment effects can affect health care decisions, little is known about which presentations best help people make decisions consistent with their own values. We compared six summary statistics for communicating coronary heart disease (CHD) risk reduction with statins: relative risk reduction and five absolute summary measures-absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies.
                We conducted a randomized trial to determine which presentation resulted in choices most consistent with participants' values. We recruited adult volunteers who participated through an interactive Web site. Participants rated the relative importance of outcomes using visual analogue scales (VAS). We then randomized participants to one of the six summary statistics and asked them to choose whether to take statins based on this information. We calculated a relative importance score (RIS) by subtracting the VAS scores for the downsides of taking statins from the VAS score for CHD. We used logistic regression to determine the association between participants' RIS and their choice. 2,978 participants completed the study. Relative risk reduction resulted in a 21% higher probability of choosing to take statins over all values of RIS compared to the absolute summary statistics. This corresponds to a number needed to treat (NNT) of 5; i.e., for every five participants shown the relative risk reduction one additional participant chose to take statins, compared to the other summary statistics. There were no significant differences among the absolute summary statistics in the association between RIS and participants' decisions whether to take statins. Natural frequencies were best understood (86% reported they understood them well or very well), and participants were most satisfied with this information.
                Presenting the benefits of taking statins as a relative risk reduction increases the likelihood of people accepting treatment compared to presenting absolute summary statistics, independent of the relative importance they attach to the consequences. Natural frequencies may be the most suitable summary statistic for presenting treatment effects, based on self-reported preference, understanding of and satisfaction with the information, and confidence in the decision.
                ISRCTN85194921. Different presentations of treatment effects can affect decisions. However, previous studies have not evaluated which presentations best help people make decisions that are consistent with their own values. We undertook a pilot study to compare different methods for doing this.
                We conducted an Internet-based randomized trial comparing summary statistics for communicating the effects of statins on the risk of coronary heart disease (CHD). Participants rated the relative importance of treatment consequences using visual analogue scales (VAS) and category rating scales (CRS) with five response options. We randomized participants to either VAS or CRS first and to one of six summary statistics: relative risk reduction (RRR) and five absolute measures of effect: absolute risk reduction, number needed to treat, event rates, tablets needed to take, and natural frequencies (whole numbers). We used logistic regression to determine the association between participants' elicited values and treatment choices. 770 participants age 18 or over and literate in English completed the study. In all, 13% in the VAS-first group failed to complete their VAS rating, while 9% of the CRS-first group failed to complete their scoring (p = 0.03). Different ways of weighting the elicited values had little impact on the analyses comparing the different presentations. Most (51%) preferred the RRR compared to the other five summary statistics (1% to 25%, p = 0.074). However, decisions in the group presented the RRR deviated substantially from those made in the other five groups. The odds of participants in the RRR group deciding to take statins were 3.1 to 5.8 times that of those in the other groups across a wide range of values (p = 0.0007). Participants with a scientific background, who were more numerate or had more years of education were more likely to decide not to take statins.
                Internet-based trials comparing different presentations of treatment effects are feasible, but recruiting participants is a major challenge. Despite a slightly higher response rate for CRS, VAS is preferable to avoid approximation of a continuous variable. Although most participants preferred the RRR, participants shown the RRR were more likely to decide to take statins regardless of their values compared with participants who were shown any of the five other summary statistics.
                Controlled-Trials.com ISRCTN85194921. To investigate the accuracy of interpretation of probabilistic screening information by different stakeholder groups and whether presentation as frequencies improves accuracy.
                Between participants experimental design; participants responded to screening information embedded in a scenario.
                Regional maternity service and national conferences and training days.
                43 pregnant women attending their first antenatal appointment in a regional maternity service; 40 companions accompanying the women to their appointments; 42 midwives; 41 obstetricians. Participation rates were 56%, 48%, 89%, and 71% respectively.
                Participants estimated the probability that a positive screening test result meant that a baby actually had Down's syndrome on the basis of all the relevant information, which was presented in a scenario. They were randomly assigned to scenarios that presented the information in percentage (n = 86) or frequency (n = 83) format. They also gave basic demographic information and rated their confidence in their estimate.
                Most responses (86%) were incorrect. Obstetricians gave significantly more correct answers (although still only 34% [corrected]) than either midwives (0%) or pregnant women (9%). Overall, the proportion of correct answers was higher for presentation as frequencies (24%) than for presentation as percentages (6%), but further analysis showed that this difference occurred only in responses from obstetricians. Many health professionals were confident in their incorrect responses.
                Most stakeholders in pregnancy screening draw incorrect inferences from probabilistic information, and health professionals need to be aware of the difficulties that both they and their patients have with such information. Moreover, they should be aware that different people make different mistakes and that ways of conveying information that help some people will not help others. The pathophysiologic mechanisms of idiopathic tinnitus remain unclear. Low frequency rTMS applied over the auditory cortex has been proposed as a new and causally oriented treatment approach for pathological conditions with abnormal, increased cortical activity including tinnitus with increased activity in the auditory cortex. However available studies are characterized by a positive reports on the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) for treatment of tinnitus, there are few details about the duration of specific treatment effects.
                The design of the study was randomized, prospective, placebo-controlled. Right-handed patients were treated with either real or sham 1 Hz frequency rTMS over a period of two weeks. Fifty-two patients with chronic, treatment resistant tinnitus and stable medication were enrolled in the study after giving written informed consent and forty-two patients completed the study and were included in data analysis.
                The ability to reduce the symptoms of tinnitus appeared in both randomized groups immediately after the 1 Hz rTMS and sham stimulation phase. There was a significant reduction in both groups of the tinnitus total score on the Tinnitus Handicap Inventory (THI) (real rTMS p=0.005; sham rTMS p=0.049) and Tinnitus Questionnaire (TQ) total score (real rTMS p=0.003; sham rTMS p=0.049). On the THI evaluation scale, in the real rTMS a mild worsening was noted during week 6 in comparison with the state attained in week 2. During the subsequent course of the study a significant reduction of the total score persisted in the case of THI (real rTMS week 14 p=0.033 and borderline week 26 p=0.058). The reduction of symptoms as evaluated using the TQ was significant compared to baseline in the real rTMS group at week 2, 6 and 14 (p=0.003; p=0.024; p=0.022). The group treated with sham stimulation reached significant reduction of symptoms only at week 2 (p=0.049). A comparison of the difference in the recorded values of the total score during follow-up in relation to baseline expressed as a percentage demonstrates the difference in the effect of rTMS and sham stimulation as evaluated by both the basic scales. Graphical analysis of mean patterns of treatment response according to stimulation type shows a similarity between treatment response patterns evaluated by reduction of the total scores using THI and TQ.
                The principal finding of this study is that real 1 Hz rTMS treatment was capable of significantly reducing the total baseline score of basic scales that measure tinnitus severity. This result is important as it proves that significant reduction of symptoms can be achieved even in a group of patients with long-term symptoms resistant to pharmacological treatment. To explore women's reactions to 'informed choice' in mammographic screening.
                Telephone interviews with a convenience sample of 106 women aged 45-70 years recruited from general practices in Sydney.
                Many (42%) women preferred an active role in decision-making. Respondents had low scores for 'uncertainty' and 'factors contributing to uncertainty' in response to explicit questions about the decision to have mammographic screening. Yet respondents indicated significantly greater willingness to have a test when the benefit of a 'new' screening test for breast cancer was expressed as relative risk reduction (RRR) (88%) than either absolute risk reduction (ARR) (78%) (McNemar's test: chi(2)1=7.14, p=0.013) or all-cause mortality (53%) (McNemar's test: chi(2)1=35.1, p<0.01). Significantly more respondents considered information about ARR 'new' to them (65%) compared with RRR information (30%) (McNemar's test: chi(2)1=25.83, p<0.01).
                As mammographic screening exposes well women to potential harms for an overall population benefit, it is challenging to ensure 'informed choice'. Our results suggest women will likely appreciate individual consultations as the context in which to share complex information that women in our study agreed they need to know about mammographic screening. Our results also demonstrate that women's willingness as individuals to participate in mammographic screening is influenced by 'framing effect'. Hence, the quantitative content of decision aids to promote 'informed choice' must be comprehensive and balanced. One approach for evaluating the effectiveness of Hearing loss prevention programs (HLPPs) is to compare the rate of hearing loss in a study population with that in a reference population. This approach was used to evaluate the HLPP of a population of 14,900 employees of an industrial company with branches across the United States. Three reference populations were selected from a database of 22 industrial companies compiled under the sponsorship of the National Institute for Occupational Safety and Health. The risk of hearing loss in the study population was estimated relative to each of the three reference populations using the Cox proportional hazards model after adjustment for race, age at baseline, and hearing threshold at time of enrollment in the HLPP. In comparison with the three reference populations, hearing loss was 2.1 to 3.9 times more likely to occur in study population males and 1.8 to 5.1 times more likely in study population females. The 95% confidence interval around each risk estimate precluded unity, indicating that each risk estimate was statistically significant. These results indicate that the performance of the subject HLPP needs improvement. This study demonstrated the use of comparison populations for evaluating the effectiveness of HLPPs. Multiple groups have reported on the use of repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant major depression. The purpose of this study is to assess the efficacy of rTMS in unmedicated, treatment-resistant patients who meet criteria for major depression.
                Depressed subjects, who had failed to respond to a median of four treatment trials, were assigned in a randomized double-blind manner to receive either active (n = 10; 20 2-sec trains of 20 Hz stimulation with 58-sec intervals; delivered at 80% motor threshold with the figure-of-eight coil positioned over the left dorsolateral prefrontal cortex) or sham (n = 10; similar conditions with the coil elevated and angled 45 degrees tangentially to the scalp) rTMS. These sequences were applied during 10 consecutive weekdays. Continuous electroencephalogram sampling and daily motor threshold determinations were also obtained.
                The group mean 25-item Hamilton Depression Rating Scale (HDRS) score was 37.2 (+/- 2.0 SEM) points. Adjusted mean decreases in HDRS scores were 14.0 (+/- 3.7) and 0.2 (+/- 4.1) points for the active and control groups, respectively (p <.05). One of 10 subjects receiving active treatment demonstrated a robust response (i.e., HDRS decreased from 47 to 7 points); three other patients demonstrated 40-45% decreases in HDRS scores. No patients receiving sham treatment demonstrated partial or full responses.
                A 2-week course of active rTMS resulted in statistically significant but clinically modest reductions of depressive symptoms, as compared to sham rTMS in a population characterized by treatment resistance. Uncertainty and risk are central issues in relation to health and health care services. Healthy individuals do not necessarily fall ill, despite the presence of risk factors. It has been documented that doctors, health service administrators and patients are more inclined to choose interventions against risk factors when information about the effects is presented in terms of relative risk reductions rather than absolute risk reductions.
                The objective of the study was to gain better insight into how GPs perceive risk of disease, and how this perception is influenced by the way the risk is presented, e.g. whether changes in risk are presented in absolute or relative terms.
                Questionnaires with clinical episodes were sent to 1500 Danish GPs. The GPs were randomized into four groups of 375, who all received the same case story with information about risk reduction achieved through medical treatment phrased in terms of either relative risk reduction, absolute risk reduction, number needed to treat or all of the aforementioned terms of risk reduction. The GPs were asked whether they would recommend medical treatment as primary prevention, knowing the case story and expected risk reduction.
                The GPs' attitude towards recommending medical treatment was dependent on the phrasing of risk reductions. Seventy-two per cent of doctors who received all information on risk reductions would definitely or probably recommend medication, while 91% would recommend medication if information only about relative risk reduction was given, and 63% would recommend medication if information was given in terms of absolute risk reduction or number needed to treat.
                In order to advise patients in a rational way, in addition to knowledge of the patients' preferences, doctors need to take into account all available measures of risk reductions. The aim of the study was to investigate the incidence and the relative risk of significant threshold shift (STS, >or=15 dB deterioration at any ear and audiometric frequency) during primary military service (7-9 months), and to investigate whether subjects with an initial slight hearing loss (thresholds>or=25 dB HL at any audiometric frequency and ear) were under increased risk. The investigation was made as a prospective audiometric study and included 747 men. An age-matched group of 138 individuals served as an unexposed control group, whose incidence of STS was 2.9%. In the exposed group the incidence was 7.9% and the relative risk 2.7 risk ratio (RR). In the subgroup of 95 persons, who already at reporting-for-training had a mild hearing loss, the incidence was 17%. The relative risk for STS in this group compared to the control group was 6.8 (RR), and compared to those with normal hearing at reporting was 3.1 (RR). In spite of hearing conservation efforts, hearing deterioration still occurs, above all in the artillery. Those who already at reporting-for-training had a mild hearing loss were at higher risk for STS compared to those with initially normal hearing. To test alternative response formats for the Nottingham Health Profile (NHP), in terms of acceptability, score distributions, and measurement properties.
                Randomized trial of four response formats for the NHP: original "yes/no" format, a 3-point similarity format ("applies completely/in part/not at all"), a 5-point intensity format ("completely true" to "completely false"), and a 5-point frequency format ("all the time" to "never"). Respondents were patients discharged from a hospital. We compared scores distributions, reliability coefficients, correlations with dimension-specific numerical scales, and patient ratings of the instrument.
                Response rates were similar for the four versions. The original response format had the fewest fully completed questionnaires, and the largest ceiling effects. Internal consistency and test-retest coefficients were acceptable for all versions, but were higher for the two 5-point formats. Correlations reflecting convergent and discriminant validity were higher for the longer response formats than for the original version. The frequency format received the highest ratings from patients, particularly from the sicker and older subgroups.
                The psychometric performance and patient acceptability of the NHP can be improved by using a 5-point frequency response format instead of the original dichotomous response format. It is unclear whether the benefit of adding whole-brain radiation therapy (WBRT) to stereotactic radiosurgery (SRS) for the control of brain-tumours outweighs the potential neurocognitive risks. We proposed that the learning and memory functions of patients who undergo SRS plus WBRT are worse than those of patients who undergo SRS alone. We did a randomised controlled trial to test our prediction.
                Patients with one to three newly diagnosed brain metastases were randomly assigned using a standard permutated block algorithm with random block sizes to SRS plus WBRT or SRS alone from Jan 2, 2001, to Sept 14, 2007. Patients were stratified by recursive partitioning analysis class, number of brain metastases, and radioresistant histology. The randomisation sequence was masked until assignation, at which point both clinicians and patients were made aware of the treatment allocation. The primary endpoint was neurocognitive function: objectively measured as a significant deterioration (5-point drop compared with baseline) in Hopkins Verbal Learning Test-Revised (HVLT-R) total recall at 4 months. An independent data monitoring committee monitored the trial using Bayesian statistical methods. Analysis was by intention-to-treat. This trial is registered at www.ClinicalTrials.gov, number NCT00548756.
                After 58 patients were recruited (n=30 in the SRS alone group, n=28 in the SRS plus WBRT group), the trial was stopped by the data monitoring committee according to early stopping rules on the basis that there was a high probability (96%) that patients randomly assigned to receive SRS plus WBRT were significantly more likely to show a decline in learning and memory function (mean posterior probability of decline 52%) at 4 months than patients assigned to receive SRS alone (mean posterior probability of decline 24%). At 4 months there were four deaths (13%) in the group that received SRS alone, and eight deaths (29%) in the group that received SRS plus WBRT. 73% of patients in the SRS plus WBRT group were free from CNS recurrence at 1 year, compared with 27% of patients who received SRS alone (p=0.0003). In the SRS plus WBRT group, one case of grade 3 toxicity (seizures, motor neuropathy, depressed level of consciousness) was attributed to radiation treatment. In the group that received SRS, one case of grade 3 toxicity (aphasia) was attributed to radiation treatment. Two cases of grade 4 toxicity in the group that received SRS alone were diagnosed as radiation necrosis.
                Patients treated with SRS plus WBRT were at a greater risk of a significant decline in learning and memory function by 4 months compared with the group that received SRS alone. Initial treatment with a combination of SRS and close clinical monitoring is recommended as the preferred treatment strategy to better preserve learning and memory in patients with newly diagnosed brain metastases. In 20 patients diagnosed with Menière's disease, transcutaneous nerve stimulation (TNS) and applied relaxation (AR) were used as a treatment aimed at reducing tinnitus and dizziness and increasing hearing ability. The main aim of the study was to examine whether TNS could be regarded as a more beneficial treatment regimen than AR. An experimental between-group cross-over design was used. The results from the experimental phase (group comparisons) showed a significantly increased ability to hear for the TNS group when measured on visual analogue scales. During the same period, the AR-group showed a significant hearing improvement for the ear not primarily affected by Menière's disease as measured with pure tone audiometry. The vestibular tests did not reveal any significant changes either after TNS or AR intervention. Tinnitus matching showed changes of pitch and loudness before and after both TNS and AR intervention. However, no statistically significant changes between treatment regimes were found on these measures. The results from this study did not show TNS to be superior to AR in reducing tinnitus, dizziness or increasing hearing ability. Tinnitus distress can be reduced by means of cognitive-behavior therapy (CBT). To compensate for the shortage of CBT therapists, we aimed, in this study, to investigate the effects of a CBT-based self-help book guided by brief telephone support.
                Seventy-two patients were randomized either to a self-help book and seven weekly phone calls or to a wait-list control condition, later on receiving the self-help book with less therapist support. The dropout rate was 7%. Follow-up data 1 year after completion of treatment were also collected (12% dropout). The Tinnitus Reaction Questionnaire (TRQ) was the main outcome measure, complemented with daily ratings of tinnitus and measures of insomnia, anxiety, and depression.
                On the TRQ, significant reductions were found in the treatment group both immediately following treatment and at 1-year follow-up. In the treatment group, 32% reached the criteria for clinical significance (at least 50% reduction of the TRQ) compared to 5% in the wait-list group. Directly after treatment, two out of five measures showed significant differences in favor of the treatment with more therapist support compared with the group who, after their waiting period, received little therapist support. The self-help treatment was estimated to be 2.6 (seven phone calls) and 4.8 (one phone call) times as cost-effective as regular CBT group treatment.
                Guided self-help can serve as an alternative way to administer CBT for tinnitus. Preliminary results cast some doubts on the importance of weekly therapist contact. The effect size was somewhat smaller than for regular CBT, but on the other hand, the self-help seems far more cost-effective. Future studies should compare treatment modalities directly and explore cost-effectiveness more thoroughly. People typically believe their health risks are lower than those of others (i.e., optimistic bias). We sought to increase perceptions of colorectal cancer (CRC) risk among adults aged 50-75 who were nonadherent to fecal occult screening (FOBT). 160 participants were randomized to receive information about the following: (1) general CRC risk factors (control), (2) general and tailored CRC risk factor feedback (absolute risk group), or (3) absolute CRC risk factor feedback plus CRC feedback as to how their total number of risk factors compared with that of others (absolute plus comparative risk group). Primary outcomes were perceived absolute and comparative risks, attitudinal ambivalence toward FOBT, and screening intentions; the secondary outcome was return of a completed FOBT. Participants who were told that they had more than the average number of risk factors believed their comparative CRC risk was higher than that of controls and of participants informed that they did not have more than the average number of risk factors. Perceived absolute risk did not vary by group. Participants who received social comparison risk factor feedback expressed greater intentions to screen via a FOBT than participants who received absolute risk feedback and controls; they also expressed less ambivalence about FOBT screening than controls. Although not statistically significant, participants informed they were at lower comparative risk had the highest proportion of completing an FOBT than any other group. These results suggest that providing social comparison CRC risk factor feedback can effectively reduce optimistic comparative risk perceptions. Contrary to findings of models of health behavior change, being informed that one does not have more than the average number of CRC risk factors, while resulting in lower evaluations of perceived comparative risk, did not result in higher ambivalence toward and lower intentions to screen using FOBT or the lowest rate of screening. The reporting quality of randomized controlled trials (RCTs) is poor in general medicine and several areas of specialization but unknown in endocrinology.
                Our aim was to assess the reporting quality of RCTs in general endocrinology. A secondary objective was to identify predictors for better reporting quality.
                We systematically reviewed RCTs published in three general endocrinology journals between January 2005 and December 2006.
                We included parallel-design RCTs that addressed a question of treatment or prevention. Article selection and data abstraction were conducted by two reviewers independently, and disagreements were resolved by consensus.
                There were two main outcomes: 1) a 15-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials (CONSORT); and 2) a 3-point key score, based on allocation concealment, blinding, and use of intention-to-treat analysis.
                Eighty nine RCTs were included. The median OQS was 10 (interquartile range = 2). Allocation concealment, blinding, and analysis by intention to treat were reported in 10, 20, and 16 of the 89 RCTs, respectively. A multivariable regression analysis showed that complete industrial funding [incidence rate ratio (IRR) = 1.014; 95% confidence interval (CI), 1.010-1.018], journal of publication (IRR = 1.068; 95% CI, 1.007-1.132), and sample size (IRR = 1.048; 95% CI, 1.026-1.070) were significantly associated with a slightly better OQS.
                The quality of RCT reporting in general endocrine literature is suboptimal. We discuss our results, highlight the areas where improvements are needed, and provide some recommendations. A consulting method known as 'shared decision making' (SDM) has been described and operationalized in terms of several 'competences'. One of these competences concerns the discussion of the risks and benefits of treatment or care options-'risk communication'. Few data exist on clinicians' ability to acquire skills and implement the competences of SDM or risk communication in consultations with patients.
                The aims of this study were to evaluate the effects of skill development workshops for SDM and the use of risk communication aids on the process of consultations.
                A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. Half the consultations were randomly selected for audio-taping, of which 352 patients attended and were audio-taped successfully. After baseline, participating doctors were randomized to receive training in (i) SDM skills or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were allocated randomly to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations were audio-taped from each phase. Raters (independent, trained and blinded to study phase) assessed the audio-tapes using a validated scale to assess levels of patient involvement (OPTION: observing patient involvement), and to analyse the nature of risk information discussed. Clinicians completed questionnaires after each consultation, assessing perceived clinician-patient agreement and level of patient involvement in decisions. Multilevel modelling was carried out with the OPTION score as the dependent variable, and rater, consultation and clinician levels of data, standardized by rater within clinician.
                Following each of the interventions, the clinicians significantly increased their involvement of patients in decision making (OPTION score increased by 10.6 following risk communication training [95% confidence interval (CI) 7.9 -13.3; P < 0.001] and by 12.9 after SDM skill development (95% CI 10 -15.8, P < 0.001), a moderate effect size. The level of involvement achieved by the risk communication aids was significantly increased by the subsequent introduction of the skill development workshops (7.7 increase in OPTION score, 95% CI 3.4-12; P < 0.001). The alternative sequence (skills followed by risk communication aids) did not achieve this effect. The use of most risk information formats increased after the provision of specific risk communication aids (P < 0.001). Clinicians using the risk communication tools perceived significantly higher patient and clinician agreement on treatment (P < 0.001), patient satisfaction with information (P < 0.01), clinician satisfaction with decision (P < 0.01) and general overall satisfaction with the consultation (P < 0.001) than those who were exposed to SDM skill development workshops.
                These clinicians were able to acquire the skills to implement SDM competences and to use risk communication aids. Each intervention provided independent effects. Further progress towards greater patient involvement in health care decision making is possible, and skill development in this area should be incorporated into postgraduate professional development programmes. Patients often exhibit preoperative fear and anxiety that may influence the process of induction and recovery from anesthesia. Music is thought to be an alternative to medication for relief of fear and anxiety.
                The purpose of the present study was to explore the feasibility of using heart rate (HR) variability (HRV) for evaluating the efficacy of music listening to relieve the patients' anxiety during their stay in the operation room waiting area and to compare the HRV measures with subjective Visual Analogue Scale (VAS) scores. Methods: In total, 140 patients were randomly assigned to the experimental (n = 64) or control group (n = 76). The intervention consisted of a 10-min period of exposure to relaxing music delivered through headphones. Anxiety levels were measured by VAS (a 10-point scale) and 5 min of HRV monitoring before and after the music intervention.
                The music group demonstrated significant reductions in VAS scores, mean HR, low-frequency HRV, and low- to high-frequency ratio and an increase in high-frequency HRV, while patients in the control group showed no changes. The subjective results of patients' VAS anxiety scores were consistent with the objective results of HRV parameters.
                Listening to music can significantly lower the anxiety levels of patients before surgery. The frequency-domain parameters of HRV can be indicators for monitoring the change in anxiety level of preoperative patients. Previous experimental research in other topic areas has shown that the choice of response alternatives can influence respondents' reporting of the frequency of vaguely defined events and that the set of response alternatives is treated as information in the interpretation of the question. The aim of this study was to examine whether such affects would occur in the context of respondents reporting of health-related events using high and medium frequency closed format response categories, which might be used interchangeably by researchers. The study consisted of a postal survey of n = 518 patients aged > or = 18 years randomly selected from the patient list of a diabetes centre and who were equally and randomly allocated to one of three conditions (Condition A: high frequency response alternatives/horizontal orientation; condition B: medium frequency response alternatives/horizontal orientations; condition C: high frequency response alternatives/vertical orientation). Testing for the effect of response alternatives for the combined responses of five vaguely defined questions between conditions A and B was chi 2 = 5.5, p = 0.019, for the difference in proportions, indicating that overall, those respondents presented with response alternatives discriminating at medium frequency, reported significantly fewer target events than those presented with high frequency response alternatives. Testing for the effect of orientation of the combined question responses between conditions A and C, differences in proportions between conditions, did not reach statistical significance (p > 0.05). Findings from this and previous studies indicate that response alternatives provide information on the interpretation of vaguely defined questionnaire items and that their choice should not be left to intuition alone when designing questionnaire items. To test the effectiveness of a 10-minute office-staff administered screen to evaluate malnutrition/weight loss, visual impairment, hearing loss, cognitive impairment, urinary incontinence, depression, physical limitations, and reduced leg mobility among older persons seen in office practice. This screen was coupled with clinical summaries to assist the physician in further evaluating and managing the screen-included problems.
                Twenty-six community-based office practices of internists and family physicians in Los Angeles were randomized to intervention or control groups. Two hundred and sixty-one patients aged > or = 70 years and seeing these physicians for a new visit or a physical examination participated in the study. At the enrollment visit intervention group patients were administered the screening measure and their physicians were given the pertinent clinical summaries. Outcome measures were detection of, and intervention for conditions screened, and health status 6 months after the intervention.
                Hearing loss was both more commonly detected (40% intervention versus 28% control) and further evaluated (29% versus 16%) by physicians in the intervention group (P < 0.05). No other differences in the frequency of problem detection or intervention were noted between groups. Six months after the intervention no differences were noted in health status between groups.
                A brief measure to screen for common conditions in older persons was associated with more frequent detection and follow-up assessment of hearing loss. Although the measure was well accepted by physicians and their staffs, it did not appear to affect detection and intervention in regard to the other screen-included conditions, or health status at 6 months. To explore whether Australian women's support for government funding of mammographic screening is influenced by 'framing effect'.
                Self-administered survey of 701 women in general practice to elicit their support for government funding of each of four mammographic screening programs where benefits were expressed as a relative risk reduction (RRR); absolute risk reduction (ARR); number needed to screen (NNS) and number of cases detected for additional death avoided.
                The proportion of respondents indicating they 'definitely would support funding' was significantly greater when benefits were expressed as RRR than ARR (chi 2(1) = 148.4, p < 0.0001), NNS (chi 2(1) = 126.4, p < 0.0001) or number of cases detected for additional deaths avoided (chi 2(1) = 29.0, p < 0.0001). 55.8% of women were not influenced by 'framing effect'. Younger women and those with higher educational levels were more likely to be susceptible to 'framing effect'.
                Having demonstrated its influence among these women, 'framing effect' should be acknowledged in future research. Shared decision-making (SDM) between professionals and patients is increasingly advocated from ethical principles. Some data are accruing about the effects of such approaches on health or other patient-based outcomes. These effects often vary substantially between studies.
                Our aim was to evaluate the effects of training GPs in SDM, and the use of simple risk communication aids in general practice, on patient-based outcomes.
                A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. After baseline, participating doctors were randomized to receive training in (i) SDM skills; or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were randomly allocated to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations took place in 'research clinics' to evaluate the effects of more time for consultations, compared with usual surgery time. Patient-based outcomes were assessed at exit from consultation and 1 month follow-up. These were: COMRADE instrument (principal measures; subscales of risk communication and confidence in decision), and a range of secondary measures (anxiety, patient enablement, intention to adhere to chosen treatment, satisfaction with decision, support in decision making and SF-12 health status measure). Multilevel modelling was carried out with outcome score as the dependent variable, and follow-up point (i.e. exit or 1 month later for each patient), patient and doctor levels of explanatory variables.
                No statistically significant changes in patient-based outcomes due to the training interventions were found: COMRADE risk communication score increased 0.7 [95% confidence interval (CI) -0.92 to 2.32] after risk communication training and 0.9 (95% CI -0.89 to 2.35) after SDM training; and COMRADE satisfaction with communication score increased by 1.0 (95% CI -1.1 to 3.1) after risk communication, and decreased by 0.6 (95% CI 2.7 to -1.5) after SDM training. Patients' confidence in the decision (2.1 increase, 95% CI 0.7-3.5, P < 0.01) and expectation to adhere to chosen treatments (0.7 increase, 95% CI 0.04-1.36, P < 0.05) were significantly greater among patients seen in the research clinics (when more time was available) compared with usual surgery time. Most outcomes deteriorated between exit and 1 month later. There was no interaction between intervention effects.
                Patients can be more involved in treatment decisions, and risks and benefits of treatment options can be explained in more detail, without adversely affecting patient-based outcomes. SDM and risk communication may be advocated from values and ethical principles even without evidence of health gain or improvement in patient-based outcomes, but the resources required to enhance these professional skills must also be taken into consideration. These data also indicate the benefits of extra consultation time. Understanding pre-test probability and baseline risks helps to interpret the results of diagnostic tests and the benefits of treatment, but how good is the understanding of these concepts?
                Our aim was to assess the ability of GPs and consultant physicians to make accurate estimates and understand the application of pre-test probability and baseline risk for two common clinical conditions.
                A two-stage questionnaire survey based on case scenarios of patients with angina and congestive heart failure was carried out of 202 physicians, randomly selected from the members of the Royal College of Physicians in the NW of England, 205 GPs randomly chosen from the practice list of the NW Health Authorities and 128 MRCGP examiners attending an examiners meeting. A total of 115, 106 and 81 members of these groups, respectively, responded to the first stage, and 44, 46 and 64 to the second. The main outcome measures were the stated likelihood of true ischaemic heart disease (IHD) being present and the predicted 1-year mortality; the impact of changing prevalence and baseline risk on these results; and interpretation of different methods of risk presentation.
                Estimates of pre-test probability of IHD being present ranged from 5 to 100% and of baseline risk of 1-year mortality from 0 to 86%. More GP examiners and consultant physicians understood the impact of increasing age on the test result than did the random sample of GPs. A majority of each group correctly said that increasing age would reduce the number needed to treat (NNT). Presentation of benefit as relative risk reduction was a greater stimulus to starting treatment than the NNT or measures of population impact.
                Clinicians should collect data to allow a better knowledge of the likelihood of disease and of baseline risk in their patient populations. Methods to increase the understanding of the influence of pre-test probability on diagnostic test results and of how to quantify and demonstrate the impact of the benefit of interventions should be explored. Studies investigating means of recruiting participants to randomized controlled trials (RCTs) are sparse. We investigated the effects of telephone reminders as a recruitment strategy.
                Sick-listed employees received a written invitation to participate in a study comparing standard treatments with a solution-focused follow-up and were randomly allocated to an intervention or control group (n=703). Those who did not respond within 2 weeks received either 'no reminder' (n=242) or 'attempted telephone reminder' (n=256). Outcome was enrollment to the RCT.
                An intention to recruit analysis revealed no significant differences between the groups (P=.229). An intention to phone analysis among nonresponders revealed significant differences between 'no reminder' (recruited 4.5%) and 'attempted telephone reminder' (recruited 12.1%) (P=.003, odds ratio 2.89, 95% confidence interval [CI] 1.42-5.90). An analysis of numbers needed to phone showed that to recruit one more person in this group of nonresponders, we needed to phone 13 persons (95% CI=8-33).
                Systematic use of telephone calls can increase the recruitment rate among nonresponders in RCTs. Feedback can be described as a way to provide information on doctors' performance to enable changes in future behaviour. Feedback is used with the aim of changing test-ordering behaviour. It can lead to reductions in test usage and cost savings. It is not sufficiently clear, however, whether feedback leads to more appropriate test use. Since 1985, the Diagnostic Coordinating Center Maastricht has been giving feedback on diagnostic tests as a routine health care activity to all family doctors in its region. Both quantity and quality of requests are discussed. In a randomised, controlled trial over 2.5 years, discussion of tests not included previously was added to the existing routine feedback. One group of family doctors (n = 39) received feedback on test-group A (electrocardiography, endoscopy, cervical smears, and allergy tests), the other (n = 40) on test-group B (radiographic and ultrasonographic tests). Thus, each group of doctors acted as a control group for the other. Changes in volume and rationality of requests were analysed. The number of requests decreased during the trial (p = 0.036). Request numbers decreased particularly for test-group A (p = 0.04). The proportion of requests that were non-rational decreased more in the intervention than in the control groups (p = 0.009). Rationality improved predominantly for test-group B (p = 0.043). Thus, routine feedback can change the quantity and quality of requests. Decision aids (DAs) are increasingly being developed to help patients make shared health care decisions with their practitioners. There are no formal comparisons of the efficacy of different delivery methods. Interactive computerized delivery methods have the advantage of allowing patients control over flow of information and to receive feedback on their comprehension. The purpose of this study was to compare the efficacy of an interactive computerized DA for women considering long-term hormone replacement therapy, to that of a validated audio-booklet version of the same intervention. Fifty-one peri-menopausal women were randomized to use either the computerized or the standard audio-booklet version of the DA. The computerized version presented identical information with the addition of feedback modules to reinforce the participant's understanding. The patients were interviewed with a pre- and post-intervention questionnaire. The computerized DA improved realistic expectations by 52.7% over baseline versus 27.6% with the audio-booklet (P=0.015). Knowledge (Kn) scores improved by 17.5 and 8.4% for the computer and standard DA groups, respectively (P=0.019). The results of this study have implications for future DA design, and other areas where patient Kn and understanding are important, such as in the setting of informed consent. Quantitative information about risks and benefits may be meaningful only to patients who have some facility with basic probability and numerical concepts, a construct called numeracy.
                To assess the relation between numeracy and the ability to make use of typical risk reduction expressions about the benefit of screening mammography.
                Randomized, cross-sectional survey.
                A simple random sample of 500 female veterans drawn from a New England registry.
                One of four questionnaires, which differed only in how the same information on average risk reduction with mammography was presented.
                Numeracy was scored as the total number of correct responses to three simple tasks. Participants estimated their risk for death from breast cancer with and without mammography. Accuracy was judged as each woman's ability to adjust her perceived risk in accordance with the risk reduction data presented.
                61% of eligible women completed the questionnaire. The median age of these women was 68 years (range, 27 to 88 years), and 96% were high school graduates. Both accuracy in applying risk reduction information and numeracy were poor (one third of respondents thought that 1000 flips of a fair coin would result in < 300 heads). Accuracy was strongly related to numeracy: The accuracy rate was 5.8% (95% CI, 0.8% to 10.7%) for a numeracy score of 0, 8.9% (CI, 2.5% to 15.3%) for a score of 1, 23.7% (CI, 13.9% to 33.5%) for a score of 2, and 40% (CI, 25.1% to 54.9%) for a score of 3.
                Regardless of how information was presented, numeracy was strongly related to accurately gauging the benefit of mammography. More effective formats are needed to communicate quantitative information about risks and benefits. The objective of the study was to gain better insight into how general practitioners (GPs) perceive risk reduction and the way this perception may be influenced by healthcare environment.
                Questionnaires with clinical episodes were sent to Danish and Polish GPs, who were randomised into four groups, each receiving the same case story with differently phrased information about risk reduction achieved through medical treatment. The GPs were asked whether they would recommend medical treatment, knowing the case story and expected risk reduction.
                Danish and Polish GPs.
                A greater proportion of Polish GPs than Danish GPs would definitely or probably recommend treatment (93% versus 72%; p < 0.001). Both groups of doctors were more inclined to recommend treatment when the achievable benefits were presented in terms of relative risk reduction rather than absolute risk reduction or number needed to treat.
                Neither information on number needed to treat nor relative risk reduction alone provides doctors with all the information they need to recommend treatment or prevention to their patients. The present study showed that the professional handling of risk information is affected by differences produced by healthcare cultures.
Natural frequencies are probably better understood than percentages in the context of diagnostic or screening tests. For communicating risk reductions, relative risk reduction (RRR), compared with absolute risk reduction (ARR) and number needed to treat (NNT), may be perceived to be larger and is more likely to be persuasive. However, it is uncertain whether presenting RRR is likely to help people make decisions most consistent with their own values and, in fact, it could lead to misinterpretation. More research is needed to further explore this question.