Preventing depression and anxiety in young people: a review of the joint efficacy of universal, selective and indicated prevention.

Depression and anxiety (internalizing disorders) are the largest contributors to the non-fatal health burden among young people. This is the first meta-analysis to examine the joint efficacy of universal, selective, and indicated preventive interventions upon both depression and anxiety among children and adolescents (5-18 years) while accounting for their co-morbidity. We conducted a systematic review of reviews in Medline, PsycINFO and the Cochrane Library of Systematic Reviews, from 1980 to August 2014. Multivariate meta-analysis examined the efficacy of preventive interventions on depression and anxiety outcomes separately, and the joint efficacy on both disorders combined. Meta-regressions examined heterogeneity of effect according to a range of study variables. Outcomes were relative risks (RR) for disorder, and standardized mean differences (Cohen's d) for symptoms. One hundred and forty-six randomized controlled trials (46 072 participants) evaluated universal (children with no identified risk, n = 54) selective (population subgroups of children who have an increased risk of developing internalizing disorders due to shared risk factors, n = 45) and indicated prevention (children with minimal but detectable symptoms of an internalizing disorder, n = 47), mostly using psychological-only strategies (n = 105). Reductions in internalizing disorder onset occurred up to 9 months post-intervention, whether universal [RR 0.47, 95% confidence interval (CI) 0.37-0.60], selective (RR 0.61, 95% CI 0.43-0.85) or indicated (RR 0.48, 95% CI 0.29-0.78). Reductions in internalizing symptoms occurred up to 12 months post-intervention for universal prevention; however, reductions only occurred in the shorter term for selective and indicated prevention. Universal, selective and indicated prevention interventions are efficacious in reducing internalizing disorders and symptoms in the short term. They might be considered as repeated exposures in school settings across childhood and adolescence. (PROSPERO registration: CRD42014013990.).

Healthcare utilization and lost productivity due to infectious gastroenteritis, results from a national cross-sectional survey Australia 2008-2009.

The aim of this study was to estimate the healthcare usage and loss of productivity due to gastroenteritis in Australia using the National Gastroenteritis Survey II. In 2008-2009, 7578 participants across Australia were surveyed about infectious gastroenteritis by telephone interview. A gastroenteritis case was defined as a person experiencing ⩾ 3 loose stools and/or ⩾ 2 vomits in a 24-h period, excluding cases with a non-infectious cause for their symptoms, such as pregnancy or consumption of alcohol. Lost productivity was considered any lost time from full- or part-time paid work due to having gastroenteritis or caring for someone with the illness. Interference with other daily activities was also examined along with predictors of healthcare-seeking practices using multivariable regression. Results were weighted to obtain nationally representative estimates using Stata v. 13·1. Of the 341 cases, 52 visited a doctor due to gastroenteritis, 126 reported taking at least one medication for their symptoms and 79 cases reported missing ⩾ 1 days' paid work due to gastroenteritis. Gastroenteritis results in a total of 13·1 million (95% confidence interval 6·7-19·5) days of missed paid work each year in Australia. The indirect costs of gastroenteritis are significant, particularly from lost productivity.

A mortality risk prediction model for older adults with lymph node-positive colon cancer.

Clinicians are less likely to recommend adjuvant chemotherapy for older adults based on their age alone. This study aimed to develop a mortality risk model to assist treatment decision making by identifying patients who are unlikely to live to benefit from chemotherapy. All lymph node-positive colon cancer patients ≥65 years who received surgery in New South Wales, Australia in 2007/2008 were identified using a linked population-based dataset (n = 1550). A model predicting 1-year all-cause mortality was built using multilevel logistic regression. Risk scores derived from model factors were summed for each patient. One-year mortality was 11.5%. The risk model consisted of 14 factors, including comorbidities, hospital admission factors and other markers of frailty or health status. People with a total score of 0, 1 or 2 were considered at low risk (predicted 1-year mortality of 2.9%), those scoring 3 to 8 at medium risk (7.4% mortality) and those scoring 9 or above at high risk (24.7% mortality). The model had good discrimination (area under the receiver operating characteristic curve = 0.788, 95% confidence interval: 0.752-0.825) and calibration (P = 0.46). The risk model accurately predicts mortality for this cohort and could be useful in shifting the emphasis in chemotherapy decision making from chronological age to the identification of those of any age who will benefit.

Assessment of abdominoperineal resection rate as a surrogate marker of hospital quality in rectal cancer surgery.

BACKGROUND: Rates of abdominoperineal resection (APR) have been suggested as a solitary surrogate marker for comparing overall hospital quality in rectal cancer surgery. This study investigated the value of this marker by examining the associations between hospital APR rates and other quality indicators. METHODS: Hospital-level correlations between risk-adjusted APR rates for low rectal cancer and six risk-adjusted outcomes and six care processes were performed (such as 30-day mortality, complications, timely treatment). The ability of APR rates to discriminate between hospitals' performance was examined by means of hospital variance results in multilevel regression models and funnel plots. RESULTS: A linked population-based data set identified 1703 patients diagnosed in 2007 and 2008 who underwent surgery for rectal cancer. Some 15.9 (95 per cent confidence interval (c.i.) 14.2 to 17.6) per cent of these patients had an APR. Among 707 people with low rectal cancer, 38.2 (34.6 to 41.8) per cent underwent APR. Although risk-adjusted hospital rates of APR for low rectal cancer varied by up to 100 per cent, only one hospital (1 per cent) fell outside funnel plot limits and hospital variance in multilevel models was not very large. Lower hospital rates of APR for low rectal cancer did not correlate significantly with better hospital-level outcomes or process measures, except for recording of pathological stage (r = -0.55, P = 0.019). Patients were significantly more likely to undergo APR for low rectal cancer if they attended a non-tertiary metropolitan hospital (adjusted odds ratio 2.14, 95 per cent c.i. 1.11 to 4.15). CONCLUSION: APR rates do not appear to be a useful surrogate marker of overall hospital performance in rectal cancer surgery.

Incidence and outcomes of pregnancy-associated cancer in Australia, 1994-2008: a population-based linkage study.

OBJECTIVE: To determine trends in pregnancy-associated cancer and associations between maternal cancer and pregnancy outcomes. DESIGN: Population-based cohort study. SETTING: New South Wales, Australia, 1994-2008. POPULATION: A total of 781 907 women and their 1 309 501 maternities. METHODS: Cancer and maternal information were obtained from linked cancer registry, birth and hospital records for the entire population. Generalised estimating equations with a logit link were used to examine associations between cancer risk factors and pregnancy outcomes. MAIN OUTCOME MEASURES: Incidence of pregnancy-associated cancer (diagnosis during pregnancy or within 12 months of delivery), maternal morbidities, preterm birth, and small- and large-for-gestational-age (LGA). RESULTS: A total of 1798 new cancer diagnoses were identified, including 499 during pregnancy and 1299 postpartum. From 1994 to 2007, the crude incidence rate of pregnancy-associated cancer increased from 112.3 to 191.5 per 100 000 maternities (P < 0.001), and only 14% of the increase was explained by increasing maternal age. Cancer diagnosis was more common than expected in women aged 15-44 years (observed-to-expected ratio 1.49; 95% CI 1.42-1.56). Cancers were predominantly melanoma (33.3%) and breast cancer (21.0%). Women with cancer diagnosed during pregnancy had high rates of labour induction (28.5%), caesarean section (40.0%) and planned preterm birth (19.7%). Novel findings included a cancer association with multiple pregnancies (adjusted odds ratio 1.52, 95% CI 1.13-2.05) and LGA (aOR 1.47, 95% CI 1.14-1.89). CONCLUSIONS: Pregnancy-associated cancers have increased, and this increase is only partially explained by increasing maternal age. Pregnancy increases women's interaction with health services and the possibility for diagnosis, but may also influence tumour growth.

A comparison of structural features and vulnerability between government and nongovernment alcohol and other drug (AOD) treatment providers.

OBJECTIVE: Both public (government-run), and not-for-profit (nongovernment) service providers provide alcohol and other drug (AOD) treatment services. Research has rarely studied the structural features of these providers, such as workforce characteristics, procurement arrangements, and funding security. The study reported here sought to document and analyze the differences between these two AOD treatment provider types in Australia. METHODS: The study administered an online survey instrument targeted at managers of AOD treatment sites. The survey comprised three sections: (1) the service (e.g., treatment types); (2) workforce (e.g., total number of staff); and (3) funding and procurement arrangements (e.g., contract length). The study completed a total of 207 site surveys. The studied compared government and nongovernment services on structural features that may create a more or less sustainable or vulnerable service (funding arrangements, payment mechanisms, and contract length). RESULTS: Government providers were more likely to provide medically oriented treatment types such as withdrawal management and pharmacotherapy, whereas nongovernment organization (NGO) providers were more likely to offer rehabilitation. Consistent with this, government services were more likely to employ medical professionals and nurses, indicative of a more medically oriented workforce, while NGO services were more likely to employ AOD workers, youth workers, peer workers, and counselors. Our data illustrate that NGO services were more likely to be subject to competitive tendering and to have shorter contract lengths, compared with government services, and overall to be more structurally vulnerable. CONCLUSION: Despite the reliance on NGOs to provide the majority of specialist care (71% of all treatment episodes in Australia), these services are more vulnerable than their government counterparts. To ensure that a comprehensive suite of treatment services is available, procurement arrangements that support stability and security in nongovernment service providers and government service providers are essential.

The efficacy of HER2-targeted agents in metastatic breast cancer: a meta-analysis.

BACKGROUND: The addition of HER2-targeted agents to standard treatment has been shown to improve outcomes for HER2 positive metastatic breast cancer patients. We undertook a meta-analysis to evaluate the efficacy of HER2-targeted therapy in addition to standard treatment in metastatic breast cancer patients. PATIENTS AND METHODS: Eligible trials were randomised controlled trials (RCTs) comparing the addition of HER2 therapy to standard treatment (hormone or chemotherapy) reporting overall survival (OS), time to progression (TTP), progression-free survival (PFS) and/or response rates. RESULTS: Eight trials comprising 1848 patients were eligible for inclusion. HER2-targeted agents were trastuzumab and lapatinib and therapeutic partners were taxanes (4 RCTs), anthracyclines (1), capecitabine (2), anastrozole (1) and letrozole (1). The addition of HER2-targeted agents improved OS [hazard ratios (HR) 0.78; 95% confidence interval (CI) 0.67-0.91], TTP (HR 0.56; 95% CI 0.48-0.64), PFS (HR 0.63; 95% CI 0.53-0.74) and overall response rate (relative risk 1.67; 95% CI 1.46-1.90). CONCLUSIONS: Our meta-analysis confirms the benefit of adding HER2-targeted therapy to standard treatment in HER2 positive metastatic breast cancer. Compared with OS, TTP, PFS and ORR overestimate treatment benefit. Trials in our meta-analysis differed in terms of partner drug or HER2 agents, yet delivered comparable outcomes.

Human papillomavirus predicts outcome in oropharyngeal cancer in patients treated primarily with surgery or radiation therapy.

OBJECTIVE: This study examines the prognostic significance of human papillomavirus (HPV) in patients with locally advanced oropharyngeal squamous cell carcinoma (SCC) treated primarily with surgery or definitive radiotherapy. METHODS: One hundred and ninety-eight patients with Stage 3/4 SCC were followed up for recurrence in any form or death from any cause for between 1 and 235 months after diagnosis. HPV status was determined using HPV E6-targeted multiplex real-time PCR/p16 immunohistochemistry. Determinants of recurrence and mortality hazards were modelled using Cox's regression with censoring at follow-up dates. RESULTS: Forty-two per cent of cancers were HPV-positive (87% type 16). HPV predicted loco-regional control, event-free survival and overall survival in multivariable analysis. Within the surgery with adjuvant radiotherapy (n=110), definitive radiotherapy-alone (n=24) and definitive radiotherapy with chemotherapy (n=47) groups, patients with HPV-positive cancers were one-third or less as likely to have loco-regional recurrence, an event or to die of any cause as those with HPV-negative cancers after adjusting for age, gender, tumour grade, AJCC stage and primary site. The 14 patients treated with surgery alone were considered too few for multivariable analysis. CONCLUSION: HPV status predicts better outcome in oropharyngeal cancer treated with surgery plus adjuvant radiotherapy as well as with definitive radiation therapy±chemotherapy.

Specific unwillingness to donate eyes: the impact of disfigurement, knowledge and procurement on corneal donation.

Although willingness, attitudes and beliefs surrounding solid-organ donation have been extensively investigated, much less is known about corneal donation. Despite evidence that a substantial number of families who agree to multiorgan donation also specifically refuse corneal donation, it is unclear why this occurs and what can be done to increase rates of corneal donation. We conducted a survey of 371 Australian adults regarding their views on corneal donation. Although willingness to donate corneas generally reflected a person's willingness to donate all of one's organs, unwillingness to donate corneas appeared to be due to other factors. Specifically, decisions not to donate appear to be driven by a range of concerns surrounding disfigurement. The survey also provides eye banks with reassurance about the acceptability of whole globe procurement, and recognition that research into blindness is a highly valued part of corneal donation. Finally, the survey identifies that many individuals see benefit in having their family engaged in the decision-making process, suggesting that decisions about donation are more complex than a simple appeal to the autonomy of the deceased.

Demographic, social and lifestyle risk factors for cancer registry-notified cancer of unknown primary site (CUP).

BACKGROUND: Little is known about the risk factors for cancer of unknown primary site (CUP). We examined the demographic, social and lifestyle risk factors for CUP in a prospective cohort of 266,724 people aged 45 years and over in New South Wales, Australia. METHODS: Baseline questionnaire data were linked to cancer registration, hospitalisation, emergency department admission, and mortality data. We compared individuals with incident cancer registry-notified CUP (n = 327) to two sets of controls randomly selected (3:1) using incidence density sampling with replacement: (i) incident cancer registry-notified metastatic cancer of known primary site (n = 977) and (ii) general cohort population (n = 981). We used conditional logistic regression to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: In a fully adjusted model incorporating self-rated overall health and comorbidity, people diagnosed with CUP were more likely to be older (OR 1.05, 95% CI 1.04-1.07 per year) and more likely to have low educational attainment (OR 1.77, 95% CI 1.24-2.53) than those diagnosed with metastatic cancer of known primary. Similarly, compared to general cohort population controls, people diagnosed with CUP were older (OR 1.10, 95% CI 1.08-1.12 per year), of low educational attainment (OR 1.69, 95% CI 1.08-2.64), and current (OR 3.42, 95% CI 1.81-6.47) or former (OR 1.95, 95% CI 1.33-2.86) smokers. CONCLUSION: The consistent association with educational attainment suggests low health literacy may play a role in CUP diagnosis. These findings highlight the need to develop strategies to achieve earlier identification of diagnostically challenging malignancies in people with low health literacy.

Health-related predictors of cancer registry-notified cancer of unknown primary site (CUP).

BACKGROUND: The relationship between comorbid disease and health service use and risk of cancer of unknown primary site (CUP) is uncertain. METHODS: A prospective cohort of 266,724 people aged 45 years and over in New South Wales, Australia. Baseline questionnaire data were linked to cancer registration, health service records 4-27 months prior to diagnosis, and mortality data. We compared individuals with incident registry-notified CUP (n = 327; 90% C80) to two sets of randomly selected controls (3:1): (i) incident metastatic cancer of known primary site (n = 977) and (ii) general cohort population (n = 981). We used conditional logistic regression to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: In fully adjusted models incorporating sociodemographic and lifestyle factors, people with cancer registry-notified CUP were more likely to have fair compared with excellent self-rated overall health (OR 1.78, 95% CI 1.01-3.14) and less likely to self-report anxiety (OR 0.48, 95% CI 0.24-0.97) than those registered with metastatic cancer of known primary. Compared to general cohort population controls, people registered with CUP were more likely to have poor rather than excellent self-rated overall health (OR 6.22, 95% CI 1.35-28.6), less likely to self-report anxiety (OR 0.28, 95% CI 0.12-0.63), and more likely to have a history of diabetes (OR 1.89, 95% CI 1.15-3.10) or cancer (OR 1.62, 95% CI 1.03-2.57). Neither tertiary nor community-based health service use independently predicted CUP risk. CONCLUSION: Low self-rated health may be a flag for undiagnosed cancer, and an investigation of its clinical utility in primary care appears warranted.

Ethnicity, equity and public benefit: a critical evaluation of public umbilical cord blood banking in Australia.

Over the past decade umbilical cord blood (UCB) has been increasingly used as a source of haematopoietic stem cells (HSCs) for patients who require a HSC transplant but do not have an HLA-matched donor. It was anticipated that using UCB as an alternative source of HSCs would increase the chance of finding a donor, particularly for the otherwise underrepresented ethnic minority groups. To evaluate the effectiveness of the Australian public UCB banks to increase the ethnic diversity of available HSC donations, this paper analyses the ethnic diversity of the Sydney Cord Blood Bank (SCBB), comparing this diversity to that of the Australian Bone Marrow Donor Registry (ABMDR). It also examines the ethnic diversity of those patients who, after requesting a haematopoietic stem cell transplantation in the 2-year period between 2003 and 2005, managed to find a suitably matched bone marrow or UCB donor. We show that the ethnic mix of donors to the SCBB has remained generally broad in source, is comparative to the Australian population, and is more diverse than the ABMDR. This, however, may still not be sufficient to substantially increase the likelihood of finding a donor for some ethnic minority groups.

A motional Stark effect diagnostic analysis routine for improved resolution of iota in the core of the large helical device.

A new Motional Stark Effect (MSE) analysis routine has been developed for improved spatial resolution in the core of the Large Helical Device (LHD). The routine was developed to reduce the dependency of the analysis on the Pfirsch-Schlüter (PS) current in the core. The technique used the change in the polarization angle as a function of flux in order to find the value of diota/dflux at each measurement location. By integrating inwards from the edge, the iota profile can be recovered from this method. This reduces the results' dependency on the PS current because the effect of the PS current on the MSE measurement is almost constant as a function of flux in the core; therefore, the uncertainty in the PS current has a minimal effect on the calculation of the iota profile. In addition, the VMEC database was remapped from flux into r/a space by interpolating in mode space in order to improve the database core resolution. These changes resulted in a much smoother iota profile, conforming more to the physics expectations of standard discharge scenarios in the core of the LHD.

Consent for corneal donation: the effect of age of the deceased, registered intent and which family member is asked about donation.

AIM: To determine whether consent to corneal donation is related to which next of kin is asked to consent, the age of the potential donor and the indication about donation made by the deceased on their driving licence. METHOD: The Lions New South Wales Eye Bank (Sydney, New South Wales, Australia) provides the corneal transplantation service for Australia's most populous state. Over the 18-month period from 1 July 2004 to 31 December 2005 for all requests for donation, records were kept of which next of kin was asked for consent, the age of the deceased and the indication about donation by the deceased on their driving licence. RESULTS: Over the 18-month study period, 841 people were approached about corneal donation. 63.2% of those people approached gave their consent to donation. Increasing age of the deceased was significantly positively associated with consent to donation (p = 0.006). Multivariable univariate analysis adjusting for age of deceased showed that relative type was strongly associated with consent (p<0.001), with mothers and fathers more likely to donate than siblings, and siblings more likely to donate than children and spouses. An indication of willingness to donate on a driving licence was strongly associated with consent (p<0.001). CONCLUSIONS: Higher consent rates from older donors have implications for policies to maximise corneal procurement. The decision to donate on behalf of a deceased family member is complex and influenced by social context. Research should investigate individualised strategies to be used when seeking consent from particular categories of next of kin.

A synthetic diagnostic for beam emission spectroscopy in the helically symmetric experiment stellarator.

The Helically Symmetric Experiment (HSX) has a number of active spectroscopy diagnostics. Due to the relatively large beam width compared to the plasma minor radius, it is difficult to achieve good spatial resolution at the core of the HSX plasma. This is due to the fact that the optical sightline cuts through many flux surfaces with varying field vectors within the beam. In order to compare the experimental results with theoretical models it is important to accurately model the beam width effects. A synthetic diagnostic has been developed for this purpose. This synthetic diagnostic calculates the effect of spot size and beam width on the measurements of quantities of interest, including radial electric field, flow velocity, and Stark polarization.

A placebo-controlled trial of insulin-like growth factor-I in amyotrophic lateral sclerosis. European ALS/IGF-I Study Group.

To test the safety and efficacy of recombinant human insulin-like growth factor-I (rhIGF-I) in ALS, 183 patients from eight European centers were randomized to receive double-blind placebo (n = 59) or rhIGF-I 0.1 mg/kg/day (n = 124) subcutaneously for 9 months. At study completion, the primary efficacy outcome measure (change in disease progression as assessed by the Appel ALS rating scale) showed no significant difference between treatment groups. RhIGF-I appeared to be safe and well-tolerated.

Identification of an optimal subgroup for treatment evaluation of patients with brain metastases using RTOG study 7916.

The overall poor prognosis of brain metastases patients has complicated the evaluation of treatment effectiveness in previous clinical trials involving radiation therapy. Therapy has not been seen to alter survival, which is generally short in these patients. Possible benefits of the treatments tested may be better assessed using a favorable group of patients who are at lower risk of dying quickly from cancer. The determination of a patient subgroup having prolonged survival allows for improvement in the design and analysis of subsequent clinical trials. An optimal patient group was identified in an RTOG study (7916) that evaluated two fractionation schedules (30 Gy/10 fractions/2 weeks and 20 Gy/6 fractions/3 weeks) with or without the administration of misonidazole (MISO) in the treatment of brain metastases. A Cox regression model was used to identify the pretreatment characteristics associated with a favorable prognosis for survival: Karnofsky Performance Status (KPS) of 70-100, an absent/controlled primary tumor, age less than 60 years, and metastatic spread limited to the brain. A logistic model confirmed that the odds of surviving at least 200 days depend on these pretreatment characteristics. Patients with all four favorable characteristics constitute 11% of the evaluable study population and have a predicted 200 day survival of 52%. Prognostically favorable subgroups have been identified as patients having at least three of these four favorable characteristics. These patients have predicted probabilities of 200 day survival between 33 and 52%. Conversely, unfavorable subgroups are defined as patients having two or less favorable characteristics. Subsequent verification of these results by a second data set is warranted. The prognostically favorable characteristics have been used to define the patient population in a current RTOG study evaluating accelerated radiation therapy in patients with brain metastases.

Effects of modulators of the renin-angiotensin-aldosterone system on cough. Losartan Cough Study Group.

OBJECTIVE: To compare the incidence of cough in patients with a history of angiotensin converting enzyme (ACE) inhibitor-related cough who received losartan [a type 1 angiotensin II (Ang II) receptor antagonist], lisinopril (an ACE inhibitor) or hydrochlorothiazide (a diuretic). DESIGN: An international, multicentre, randomized double-blind, parallel-group controlled trial. SETTING: Outpatient clinics at 20 tertiary care medical centres in 11 countries. PATIENTS: One hundred and thirty-five patients with uncomplicated primary hypertension with a history of ACE inhibitor-related cough were randomly assigned to the double-blind treatment phase and completed the study. INTERVENTION: After confirming that the cough was ACE inhibitor-related by a single-blind rechallenge, followed by a placebo washout period, patients were randomly assigned to receive 50mg losartan, 20mg lisinopril or 25mg hydrochlorothiazide once a day for 8 weeks. MAIN OUTCOME MEASURES: Cough incidence, severity and frequency were assessed by a self-administered questionnaire and a visual analogue scale. RESULTS: The percentage of patients who complained of cough was significantly higher with lisinopril than with losartan or hydrochlorothiazide. The mean visual analogue scale scores for patients treated with lisinopril demonstrated that these patients coughed more frequently than those who received losartan or hydrochlorothiazide. CONCLUSION: The incidence of cough related to the type 1 Ang II receptor antagonist losartan is significantly lower than that observed with lisinopril, and similar to that observed with hydrochlorothiazide in patients with a rechallenged ACE inhibitor cough. Type 1 Ang II receptor antagonists represent a potential new treatment for hypertensive patients in whom ACE inhibitors are indicated, but who develop a cough with these agents.

Rofecoxib versus codeine/acetaminophen in postoperative dental pain: a double-blind, randomized, placebo- and active comparator-controlled clinical trial.

BACKGROUND: In recent studies of acute pain and primary dysmenorrhea, rofecoxib, a nonsteroidal anti-inflammatory drug that selectively targets the cyclooxygenase-2 enzyme, was found to be similar in efficacy to ibuprofen and naproxen sodium. OBJECTIVE: The purpose of this study was to determine the analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with the combination of codeine 60 mg/acetaminophen 600 mg in a model of postsurgical dental pain. METHODS: In this double-blind, placebo- and active comparator-controlled, parallel-group study, patients experiencing moderate or severe pain after the surgical extraction of > or = 2 third molars, at least 1 of which was a mandibular impaction, were randomized to receive placebo, rofecoxib 50 mg, or codeine 60 mg/acetaminophen 600 mg. Patient evaluations of pain intensity, pain relief, and global assessments were recorded throughout the 24-hour period after dosing. The 2-stopwatch method was used to determine time to confirmed perceptible pain relief. The primary end point assessing overall analgesic effect was total pain relief over 6 hours (TOPAR6). Secondary end points were patient global assessment of response to therapy (PGART) at 6 hours, onset of analgesia, peak analgesic effect, and duration of analgesia. RESULTS: A total of 393 patients were enrolled; 182 received rofecoxib, 180 received codeine/acetaminophen, and 31 received placebo. The overall analgesic effect of rofecoxib 50 mg was greater than that of codeine 60 mg/acetaminophen 600 mg for TOPAR6 (12.4 vs 7.0; P < 0.001) and PGART at 6 hours (P < 0.001). The onset of analgesic effect was similar for rofecoxib and codeine/acetaminophen. Peak analgesic effect as measured by peak pain relief scores during the first 6 hours was significantly greater in the rofecoxib group compared with the codeine/acetaminophen group (P < 0.001), as was the duration of analgesic effect measured by the time to rescue analgesia (9.6 hours vs 2.3 hours, P < 0.001). Adverse events were reported in 33.0%, 46.1%, and 32.3% of patients treated with rofecoxib, codeine/acetaminophen, and placebo, respectively. The most common adverse events were nausea (6.0%, 25.0%, and 9.7%, respectively) and vomiting (3.8%, 18.3%, and 6.5%, respectively). Significantly more patients in the codeine/acetaminophen group than in the rofecoxib group experienced adverse events overall (P < 0.050) and nausea in particular (P < 0.001). CONCLUSION: In this study of moderate to severe postoperative dental pain, the analgesic efficacy of rofecoxib 50 mg was greater than that of codeine/acetaminophen, with a lower incidence of adverse events and nausea.

Reproducibility of data collected by patient interview.

This study examined the reproducibility of data, not generally considered at risk for poor patient recall, obtained on two separate occasions. Our study used data collected for a register of heart attacks in the Lower Hunter Region of New South Wales, and included 1675 patients who were registered at least twice. Reporting inconsistencies between occasions were assessed for eight data items. We found that the sex of five patients had been recorded differently on the two occasions. Among patients interviewed on both occasions, between 0.5 per cent and 2.0 per cent of patients had inconsistent reports for marital status, country of birth, smoking status and height, 2.7 per cent for date of birth, 13 per cent for education level and between 1.6 per cent and 9.6 per cent for the history of various medical conditions. Patients not from an English-speaking background, over 60 years of age or without tertiary education tended to have higher rates of inconsistent reporting. Time between occasions, marital status and sex were not associated with increased rates of inconsistent reporting. We concluded that apparently straightforward data items, such as date of birth and education level, were not perfectly reproducible when obtained by patient interview on separate occasions. Our results provide a starting point for sensitivity analysis in other studies if the potential inaccuracies in reporting of such data should be of concern.