Pilot randomised controlled trial of counselling in a community mental health setting: Pitfalls and learnings

The establishment of counselling and psychotherapy as “evidence‐based” interventions is contingent on the effective implementation of randomised controlled trials (RCTs) in real‐world clinical settings. This paper identifies some of the pitfalls that led to the termination of a practical RCT in a community mental health setting. It reflects upon the significance of the lessons learned by drawing on similar challenges that are documented in the wider literature. Issues surrounding staff turnover, counsellor engagement and procedural clarity are discussed, as is the conflict between the time required for research procedures and counsellors’ clinical time constraints. In our recommendations, we recognise the decisive role of collaboration and counsellor motivation in research partnerships, and the significance of clinical relevance, communication, training and research co‐production in achieving them. Time commitment is identified as the pivotal challenge in the formation and maintenance of collaborative research, but one that also must be overcome for the advancement of the counselling and psychotherapy field.     

The Use of Prayer in the Management of Pain: A Systematic Review

The availability of safe and effective non-pharmacological therapies for pain is an important unmet medical need. Prayer may be considered as an effective adjunctive therapy for pain and this systematic review aims to clarify this association. Pertinent databases were searched for English language publications, dated 2000–2019. Inclusion criteria involved prayer as an on-site or personal intervention and at least one pre-specified pain-related outcome. We evaluated 411 abstracts. Nine studies met criteria. Active prayer to God emerged as a preferred beneficial intervention for religious patients undergoing surgery or a painful procedure. Prayer effect does not seem to be opioid mediated. Improved trial design will facilitate the study of prayer as an adjuvant therapy for pain.

     

The phenotypic consequences of MECP2 mutations extend beyond Rett syndrome

Although MECP2 was initially identified as the causative gene in classic Rett syndrome (RTT), the gene has now been implicated in several phenotypes that extend well beyond the clinically defined disorder. MECP2 mutations have been found in people with various disorders, including neonatal onset encephalopathy, X-linked recessive mental retardation (MRX), classic and atypical RTT, autism, and Angelman syndrome, as well as mildly affected females and normal carrier females. To make matters more complex, in approximately 20% of classic sporadic RTT cases and more than 50% of affected sister pairs, no mutation in MECP2 has been found. X-chromosome inactivation patterns can clearly affect the phenotypic expression in females, while the effect of the type and position of the mutation is more apparent in the broader phenotype than in RTT. Both males and females are at risk, although an excess of paternally derived mutations are found in most cases of classic RTT. Thus, because of the range of disparate phenotypes, the gene may account for a relatively large portion of mental retardation in the population.     

Ground and Free-Variable Tableaux for Variants of Quantified Modal Logics

In this paper we study proof procedures for some variants of first-order modal logics, where domains may be either cumulative or freely varying and terms may be either rigid or non-rigid, local or non-local. We define both ground and free variable tableau methods, parametric with respect to the variants of the considered logics. The treatment of each variant is equally simple and is based on the annotation of functional symbols by natural numbers, conveying some semantical information on the worlds where they are meant to be interpreted.This paper is an extended version of a previous work where full proofs were not included. Proofs are in some points rather tricky and may help in understanding the reasons for some details in basic definitions.     

Managers' variance investigation decisions: an experimental examination of probabilistic and outcome ambiguity

Information ambiguity is prevalent in organizations and may influence management decisions. This study examines, given imprecise probabilities or outcomes, how managers decide which department's performance to investigate further when they are provided with performance benchmarks expressed in numerical intervals. Seventy‐nine MBA students participated in two experiments involving investigation decisions. We presented participants with interval benchmarks of a firm's expenses. Being below or above the benchmark should have been seen as equally negative. We found that, when facing outcome ambiguity, our participants consistently preferred to investigate further those departments whose performance was described as having an ambiguous outcome (when the outcome's range was centered either below or above the interval benchmark). However, when facing probabilistic ambiguity, there were two predominant choice patterns: consistently choosing to investigate the department whose performance is described with an ambiguous probability, or consistently choosing to investigate the department with unambiguous performance. To gain further insight, we conducted a follow‐up study collecting written protocols of participants' reasons for making choices involving ambiguous performance information. The results show that our participants displayed similar decision‐making processes when facing outcome ambiguity and probabilistic ambiguity. Copyright © 2001 John Wiley & Sons, Ltd.     

The suppression of reflexive visual and auditory orienting when attention is otherwise engaged

Two experiments were conducted to examine whether abrupt onsets are capable of reflexively capturing attention when they occur outside the current focus of spatial attention, as would be expected if exogenous orienting operates in a truly automatic fashion. The authors established a highly focused attentional state by means of the central presentation of a stream of visual or auditory characters, which participants sometimes had to monitor. No intramodal reflexive cuing effects were observed in either audition or vision when participants performed either an exogenous visual or auditory orthogonal cuing task together with the central focused attention task. These results suggest that reflexive unimodal orienting is not truly automatic. The fact that cuing effects were eliminated under both unimodal and cross-modal conditions is consistent with the view that auditory and visual reflexive spatial orienting are controlled by a common underlying neural substrate.     

Skull size and intelligence, and King Robert Bruce's IQ

An estimate of someone's IQ is a potentially informative personal datum. This study examines the association between external skull measurements and IQ scores, and uses the resulting regression equation to provide an estimate of the IQ of King Robert I of Scotland (Robert Bruce, 1274–1329). Participants were 48 relatively healthy Caucasian men (age 71–76 years) resident in Scotland. Using magnetic resonance imaging data, intracranial volume estimated from external skull length and width correlated greater than .5 (p < .001) with measured intracranial area, which correlates very highly with brain volume. IQ scores estimated from the National Adult Reading Test (NART) correlated .56 (p < .001) with measured intracranial area, and .49 (p < .01) with estimated intracranial volume based on external skull width and length. The partial correlation coefficient of this latter association was .25 (p = .09) after adjustment for measured intracranial area. Thus, actual intracranial area accounts for about 74% of the variance shared by NART and estimated intracranial volume. A cast of the skull of Robert Bruce was measured and its intracranial volume estimated. A regression equation between IQ and estimated intracranial volume, based on data from the 48 subjects, estimated the IQ of Robert Bruce at about 128 (95% confidence interval 106 to  130), i.e. almost two standard deviations above the mean. NART scores show a ceiling effect, so this estimated IQ might be an underestimate. Robert Bruce's estimated high IQ is congruent with his military, political and other intellectual achievements.     

Interval recording for duration events: a re‐evaluation

In two experiments, events that were recorded using continuous duration recording (CDR) were rescored using 10‐s partial interval (PIR), 10‐s momentary time sampling (MTS) and 20‐s MTS. Results of Experiment 1 showed that data paths generated by each interval method produced conclusions about functional control that were similar to those based on CDR when using reversal designs; however, for multielement designs, 10‐s PIR was prone to showing differentiation between data paths that was not evident with CDR. Results of Experiment 2 showed that both 10‐s and 20‐s MTS yielded data paths on behavior–behavior relations (e.g., covarying responses) that were consistent with CDR whereas 10‐s PIR produced some behavior–behavior patterns that were not. In both experiments, 10‐s MTS generated data paths that were nearly identical to the respective CDR data paths. The implications of these findings for researchers and clinicians are briefly discussed. Copyright © 2007 John Wiley & Sons, Ltd.     

Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.