Improved effectiveness of partner notification for patients with sexually transmitted infections: systematic review

Objective: To examine the effectiveness of methods to improve partner notification by patient referral (index patient has responsibility for informing sex partners of their exposure to a sexually transmitted infection). Design: Systematic review of randomised trials of any intervention to supplement simple patient referral. Data sources: Seven electronic databases searched (January 1990 to December 2005) without language restriction, and reference lists of retrieved articles. Review methods: Selection of trials, data extraction, and quality assessment were done by two independent reviewers. The primary outcome was a reduction of incidence or prevalence of sexually transmitted infections in index patients. If this was not reported data were extracted according to a hierarchy of secondary outcomes: number of partners treated; number of partners tested or testing positive; and number of partners notified, located, or elicited. Random effects meta-analysis was carried out when appropriate. Results: 14 trials were included with 12 389 women and men diagnosed as having gonorrhoea, chlamydia, non-gonococcal urethritis, trichomoniasis, or a sexually transmitted infection syndrome. All studies had methodological weaknesses that could have biased their results. Three strategies were used. Six trials examined patient delivered partner therapy. Meta-analysis of five of these showed a reduced risk of persistent or recurrent infection in patients with chlamydia or gonorrhoea (summary risk ratio 0.73, 95% confidence interval 0.57 to 0.93). Supplementing patient referral with information for partners was as effective as patient delivered partner therapy. Neither strategy was effective in women with trichomoniasis. Two trials found that providing index patients with chlamydia with sampling kits for their partners increased the number of partners who got treated. Conclusions: Involving index patients in shared responsibility for the management of sexual partners improves outcomes. Health professionals should consider the following strategies for the management of individual patients: patient delivered partner therapy, home sampling for partners, and providing additional information for partners

Reporting of Randomized Controlled Trials in Hodgkin Lymphoma in Biomedical Journals

Background: Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The Consolidated Standards for Reporting Trials (CONSORT) statement was introduced in 1996 to improve reporting of RCTs. We aimed to determine the extent of ambiguity and reporting quality as assessed by adherence to the CONSORT statement in published reports of RCTs involving patients with Hodgkin lymphoma from 1966 through 2002. Methods: We analyzed 242 published full-text reports of RCTs in patients with Hodgkin lymphoma. Quality of reporting was assessed using a 14-item questionnaire based on the CONSORT checklist. Reporting was studied in two pre-CONSORT periods (1966-1988 and 1989-1995) and one post-CONSORT period (1996-2002). Results: Only six of the 14 items were addressed in 75% or more of the studies in all three time periods. Most items that are necessary to assess the methodologic quality of a study were reported by fewer than 20% of the studies. Improvements over time were seen for some items, including the description of statistics methods used, reporting of primary research outcomes, performance of power calculations, method of randomization and concealment allocation, and having performed intention-to-treat analysis. Conclusions: Despite recent improvements, reporting levels of CONSORT items in RCTs involving patients with Hodgkin lymphoma remain unsatisfactory. Further concerted action by journal editors, learned societies, and medical schools is necessary to make authors even more aware of the need to improve the reporting RCTs in medical journals to allow assessment of validity of published clinical researc

Exploratory trials in mental health: anything to learn from other disciplines?

OBJECTIVE Confirmatory randomised controlled trials require solid justifications, especially with regard to whether the experimental intervention is promising. Such evidence is generated in exploratory trials. However, empirical evidence shows that the quality of such trials is still suboptimal. More generally, the development process of healthcare interventions and especially of drugs, remains inefficient. Over the past 10-20 years, a vast amount of methodological work has been published about exploratory trials. This overview introduces some of the concepts and recent developments in the field. METHODS A narrative approach was taken for this overview. This article focuses on study designs developed outside the mental health field to introduce concepts that might not be familiar to clinical researchers in psychiatry and psychology. Non-randomised and randomised exploratory trial designs are covered. The article ends with a brief discussion on pilot studies and their difference to exploratory studies. RESULTS Classical designs for exploratory trials such as Simon's two-stage design still have a role. However, randomised exploratory trials are probably more suitable for mental health interventions. Newer, more flexible designs such as multistage, multiarm trials or platform trials have the potential to improve the efficiency of exploratory and subsequently confirmatory experiments. CONCLUSIONS Although often not directly applicable, borrowing (study) design ideas from other medical disciplines has the potential to improve exploratory trials in the mental health field. At the same time, more explicit use of study designs specifically designed for exploratory trials will help to improve the transparency of such trials

Factors determining the success of radiofrequency denervation in lumbar facet joint pain: a prospective study

Background and aims: Radiofrequency denervation (RF) of the lumbar facet joints has been shown to be effective in well-selected patients. However, long-term success varies between studies. We evaluated the influence of selected psychosocial and constitutional factors on the outcome of RF, expressed as the duration of pain relief. Methods: This prospective observational study included 44 patients who received RF denervations at the University Hospital of Berne. Success was defined as at least 50% pain reduction 7-21days, 6months and 1year after RF therapy. The Cox-regression analysis was performed to evaluate the influence of the following factors on the duration of success: age, sex, depression, work inability and previous surgery. Results: Complete follow-up was available for 41 patients. The success rate 7-21days after the denervation was 76%. It decreased to 32% at 6months and to 22% at 1year. The median success duration was 17weeks (95% CI 10-26). The Cox-regression analysis showed a significant shorter duration of success for patients with depression (hazard ratio [HR] 2.97, 95% CI 1.32-6.65), previous surgery (HR 2.39, 95% CI 1.10-5.21) and number of treated joints (HR 1.95 for each increase in the number of joints, 95% CI 1.14-3.33). In bivariate analyses, only depression was kept to be significant. Conclusions: Depression seems to be related with a short duration of success. Based on these findings, a comprehensive study is warranted to evaluate whether psychosocial factors have to be considered when recruiting patients for radiofrequency denervatio

Neural evidence for age-related differences in representational quality and strategic retrieval processes.

Mounting behavioral evidence suggests that declines in both representational quality and controlled retrieval processes contribute to episodic memory decline with age. The present study sought neural evidence for age-related change in these factors by measuring neural differentiation during encoding of paired associates and changes in regional blood oxygenation level-dependent activity and functional connectivity during retrieval conditions that placed low (intact pairs) and high (recombined pairs) demands on controlled retrieval processes. Pattern similarity analysis revealed age-related declines in the differentiation of stimulus representations at encoding, manifesting as both reduced pattern similarity between closely related events and increased pattern similarity between distinct events. During retrieval, both groups increased recruitment of areas within the core recollection network when endorsing studied pairs, including the hippocampus and angular gyrus. In contrast, only younger adults increased recruitment of, and hippocampal connectivity with, lateral prefrontal regions during correct rejections of recombined pairs. These results provide evidence for age-related changes in representational quality and in the neural mechanisms supporting memory retrieval under conditions of high, but not low, control demand

Identifying age-invariant and age-limited mechanisms for enhanced memory performance: Insights from self-referential processing in younger and older adults.

Self-referential processing has been identified as a possible tool for supporting effective encoding processes in the elderly population. However, the importance of self-reference per se, relative to the increase in meaningful elaboration normally associated with self-reference instructions, remains unclear. The present study sought to explore this issue further by examining self-referential encoding strategies that inherently involve more extensive stimulus elaboration: episodic autobiographical memory (AM) retrieval and semantic AM retrieval. These were compared with an analogous task involving retrieval of general semantic knowledge, as well as traditional binary self-referential and semantic encoding judgments. We found that both AM retrieval and general semantic retrieval at encoding resulted in substantial enhancements to recall and recognition memory of concrete nouns relative to binary encoding judgments across both age groups. Furthermore, older adults exhibited larger benefits from this additional elaboration than did younger adults, leading to elimination of age-related deficits in recognition memory. However, younger adults showed an additional boost to subsequent memory following episodic, relative to semantic, AM retrieval during free recall that was not exhibited by older adults. This may be because of greater demands on frontally mediated control processes and cognitive resources associated with the use of this strategy. Taken together, the results suggest that the mnemonic benefits associated with self-referential processing vary substantially depending on the specific nature of the encoding strategy, and suggest that, under certain conditions, semantic processing and self-referential processing are equally effective in mitigating age-related deficits in memory performance.This research was supported by the BBSRC [grant number BB/L02263X/1]. A.N.T. is supported by a Cambridge Commonwealth Trust scholarship, R.N.H. by the UK Medical Research Council programme grant MC-A060-5PR10, and J.S.S. by a James S. McDonnell Foundation Scholar award.This is the author accepted manuscript. The final version is available from the American Psychological Association via http://dx.doi.org/ http://dx.doi.org/10.1037/a003911

The current prevalence of child sexual abuse worldwide: a systematic review and meta-analysis

Objectives: Systematic reviews on prevalence estimates of child sexual abuse (CSA) worldwide included studies with adult participants referring on a period of abuse of about 50years. Therefore we aimed to describe the current prevalence of CSA, taking into account geographical region, type of abuse, level of country development and research methods. Methods: We included studies published between 2002 and 2009 that reported CSA in children below 18years. We performed a random effects meta-analysis and analyzed moderator variables by meta-regression. Results: Fifty-five studies from 24 countries were included. According to four predefined types of sexual abuse, prevalence estimates ranged from 8 to 31% for girls and 3 to 17% for boys. Nine girls and 3 boys out of 100 are victims of forced intercourse. Heterogeneity between primary studies was high in all analyses. Conclusions: Our results based on most recent data confirm results from previous reviews with adults. Surveys in children offer most recent estimates of CSA. Reducing heterogeneity between studies might be possible by standardized measures to make data more meaningful in international comparison

Early versus Late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN) : Protocol for an international, multicentre, randomised-controlled, two-arm, open, assessor-blinded trial

Rationale: Direct oral anticoagulants (DOAC) are highly effective in preventing ischaemic strokes in people with atrial fibrillation (AF). However, it is unclear how soon they should be started after acute ischaemic stroke (AIS). Early initiation may reduce early risk of recurrence but might increase the risk of haemorrhagic complications. Aim: To estimate the safety and efficacy of early initiation of DOACs compared to late guideline-based initiation in people with AIS related to AF. Methods and design: An international, multicentre, randomised (1:1) controlled, two-arm, open, assessor-blinded trial is being conducted. Early treatment is defined as DOAC initiation within 48 h of a minor or moderate stroke, or at day 6-7 following major stroke. Late treatment is defined as DOAC initiation after day 3-4 following minor stroke, after day 6-7 following moderate stroke and after day 12-14 following major stroke. Severity of stroke is defined according to imaging assessment of infarct size. Sample size: ELAN will randomise 2000 participants 1:1 to early versus late initiation of DOACs. This assumes a risk difference of 0.5% favouring the early arm, allowing an upper limit of the 95% confidence interval up to 1.5% based on the Miettinen & Nurminen formula. Outcomes: The primary outcome is a composite of symptomatic intracranial haemorrhage, major extracranial bleeding, recurrent ischaemic stroke, systemic embolism or vascular death at 30 +/- 3 days after randomisation. Secondary outcomes include the individual components of the primary outcome at 30 +/- 3 and 90 +/- 7 days and functional status at 90 +/- 7 days. Discussion: ELAN will estimate whether there is a clinically important difference in safety and efficacy outcomes following early anticoagulation with a DOAC compared to late guideline-based treatment in neuroimaging-selected people with an AIS due to AF.Peer reviewe

StOP? II trial: cluster randomized clinical trial to test the implementation of a toolbox for structured communication in the operating room-study protocol.

BACKGROUND Surgical care, which is performed by intensely interacting multidisciplinary teams of surgeons, anesthetists, and nurses, remains associated with significant morbidity and mortality. Intraoperative communication has been shown to be associated with surgical outcomes, but tools ensuring efficient intraoperative communication are lacking. In a previous study, we developed the StOP?-protocol that fosters structured intraoperative communication. Before the critical phases of the operation, the responsible surgeon initiates and leads one or several StOP?s. During a StOP?, the surgeon informs about the progress of the operation (status), next steps and proximal goals (objectives), and possible problems (problems) and encourages all team members to voice their observations and ask questions (?). In a before-after study performed mainly in visceral surgery, we found effects of the StOP?-protocol on mortality, length of hospital stay, and reoperation. We intend to assess the impact of the StOP?-protocol in a cluster randomized trial, in a wider variety of surgical specialties (i.e., general, visceral, thoracic, vascular surgery, surgical urology, and gynecology). The primary hypothesis is that the consistent use of the StOP?-protocol by the main surgeon reduces patient mortality within 30 days after the operation. The secondary hypothesis is that the consistent use of the StOP?-protocol by the main surgeon reduces unplanned reoperations, length of hospital stay, and unplanned hospital readmissions. METHODS This study is designed as a multicenter, cluster-randomized parallel-group trial. Board-certified surgeons of participating clinical departments will be randomized 1:1 to the StOP? intervention group or to the standard of care (control) group. The intervention group will undergo a training to use the StOP?-protocol and receive regular feedback on their compliance with the protocol. The surgeons in the control group will communicate as usual during their operations. The unit of observation will be operations performed by cluster surgeons. Consecutive patients will be enrolled over 4 months per cluster. A total of 400 surgeons will be recruited, and we expect to collect patient outcome data for 14,000 surgical procedures. DISCUSSION The StOP?-protocol was designed as a tool to structure communication during surgical procedures. Testing its effects on patient outcomes will contribute to implementing evidenced-based interventions to reduce surgical complications. TRIAL REGISTRATION ClinicalTrials.gov NCT05356962. Registered on May 2, 2022