Interactive clinical supervision training added to self-education leads to small improvements in the effectiveness of clinical supervision of physiotherapists: a randomised trial.

QUESTION: Does adding an interactive clinical supervision training program to self-education improve the effectiveness of clinical supervision of physiotherapists, reduce burnout, decrease intention to leave and increase participation in clinical supervision? DESIGN: Randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. PARTICIPANTS: Physiotherapists (n = 58) working at a publicly funded health service. INTERVENTION: Participants in both groups received a self-education clinical supervision training package. In addition, participants in the experimental group received interactive clinical supervision training consisting of three 90-minute workshops. OUTCOME MEASURES: The primary outcome measure was effectiveness of clinical supervision 4 months after training measured using the Manchester Clinical Supervision Scale (MCSS-26). Secondary outcomes were the Maslach Burnout Inventory, the Intention to Leave Scale, and participation in supervision. Focus groups were also used to gauge impressions of the intervention. RESULTS: The addition of interactive clinical supervision training slightly improved effectiveness of clinical supervision, with a between-group mean difference of 6.3 units (95% CI 0.3 to 12.3) on the MCSS-26. The estimate of the effect on the proportion of physiotherapists reporting effective clinical supervision (ie, MSCC-26 score ≥ 73) was unclear (OR 1.97, 95% CI 0.50 to 7.81). Physiotherapists in the experimental group reported slightly lower levels of depersonalisation (MD -3.0 units, 95% CI -4.6 to -1.3). There were negligible or uncertain effects on the other burnout domains, intention to leave and participation in clinical supervision. Qualitatively, participants reported that the workshops made them realise that supervisees could take greater ownership of where supervision focused. CONCLUSION: Adding interactive clinical supervision training to self-education leads to small improvements in the effectiveness of clinical supervision of physiotherapists. REGISTRATION: osf.io/yz3kx.

Combined vaginal progesterone and cervical cerclage in the prevention of preterm birth: a systematic review and meta-analysis.

OBJECTIVE: Vaginal progesterone and cervical cerclage are both effective interventions for reducing preterm birth. It is currently unclear whether combined therapy offers superior effectiveness than single therapy. This study aimed to determine the efficacy of combining cervical cerclage and vaginal progesterone in the prevention of preterm birth. DATA SOURCES: We searched Medline (Ovid), EMBASE (Ovid), PsycINFO (Ovid), CINAHL (EBSCOhost), Cochrane Library (Wiley), and Scopus (from their inception to 2020). STUDY ELIGIBILITY CRITERIA: The review accepted randomized and pseudorandomized control trials, nonrandomized experimental control trials, and cohort studies. High risk patients (shortened cervical length <25mm or previous preterm birth) who were assigned cervical cerclage, vaginal progesterone, or both for the prevention of preterm birth were included. Only singleton pregnancies were assessed. METHODS: The primary outcome was birth <37 weeks. Secondary outcomes included birth <28 weeks, <32 weeks and <34 weeks, gestational age at delivery, days between intervention and delivery, preterm premature rupture of membranes, cesarean delivery, neonatal mortality, neonatal intensive care unit admission, intubation, and birthweight. Following title and full-text screening, 11 studies were included in the final analysis. Risk of bias was assessed using the Cochrane Collaboration tool for assessing the risk of bias (ROBINS-I and RoB-2). Quality of evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) tool. RESULTS: Combined therapy was associated with lower risk of preterm birth at <37 weeks than cerclage alone (risk ratio, 0.51; 95% confidence interval, 0.37-0.79) or progesterone alone (risk ratio, 0.75; 95% confidence interval, 0.58-0.96). Compared with cerclage only, combined therapy was associated with preterm birth at <34 weeks, <32 weeks, or <28 weeks, decreased neonatal mortality, increased birthweight, increased gestational age, and a longer interval between intervention and delivery. Compared with progesterone alone, combined therapy was associated with preterm birth at <32 weeks, <28 weeks, decreased neonatal mortality, increased birthweight, and increased gestational age. There were no differences in any other secondary outcomes. CONCLUSION: Combined treatment of cervical cerclage and vaginal progesterone could potentially result in a greater reduction in preterm birth than in single therapy. Further, well-conducted and adequately powered randomized controlled trials are needed to assess these promising findings.

McDonald versus Shirodkar cerclage technique in the prevention of preterm birth: A systematic review and meta-analysis.

BACKGROUND: Cervical cerclage has been used for decades to reduce preterm birth. The Shirodkar and McDonald cerclage are the most commonly used techniques with no current consensus on the preferred technique. OBJECTIVE: To compare the efficacy of the Shirodkar and McDonald cerclage techniques in preventing preterm birth. SEARCH STRATEGY: Studies were sourced from six electronic databases and reference lists. SELECTION CRITERIA: Studies including women with a singleton pregnancy, requiring a cervical cerclage, using either the Shirodkar or McDonald technique that ran comparative analyses between the two techniques. DATA COLLECTION AND ANALYSIS: The primary outcome was preterm birth before 37 weeks, with analyses at 28, 32, 34 and 35 weeks. Secondary data were also collected on neonatal, maternal and obstetric outcomes. MAIN RESULTS: Seventeen papers were included: 16 were retrospective cohort studies and one was a randomised controlled trial. The Shirodkar technique was significantly less likely to result in preterm birth before 37 weeks than the McDonald technique (relative risk [RR] 0.91, 95% CI 0.85-0.98). This finding was supported by a statistically significant reduction in rates of preterm birth before 35, 34 and 32 weeks, PPROM, difference in cervical length, cerclage to delivery interval, and an increase in birthweight in the Shirodkar group. No difference was seen in preterm birth rates <28 weeks, neonatal mortality, chorioamnionitis, cervical laceration or caesarean section rates. The RR for preterm birth prior to 37 weeks was no longer significant when sensitivity analyses were performed removing studies with a serious risk of bias. However, similar analyses removing studies that utilised adjunctive progesterone strengthened the primary outcome (RR 0.83, 95% CI 0.74-0.93). CONCLUSION: Shirodkar cerclage reduces the rate of preterm birth prior to 35, 34 and 32 weeks' gestation when compared with McDonald cerclage; however, the overall quality of the studies in this review is low. Further, large, well-designed randomised controlled trials are required to address this important question to optimise care for women who may benefit from cervical cerclage.

Consumer perspectives of telehealth in ambulatory care in an Australian health network.

We aimed to explore consumer experiences of ambulatory telehealth services and whether consumer experiences differed according to whether they received their consultation using telephone or video technology. We conducted structured telephone interviews with patient consumers who had received a recent remote consultation by telephone or video call, at local ambulatory allied health or multidisciplinary services within a large public metropolitan public health network. Respondents were asked about their recent experience and future choices in relation to telehealth. Responses from consumers who received telephone and video consultations were compared. Consumers from community rehabilitation, community health, allied health outpatients, multidisciplinary specialist clinics and mental health services participated (n = 379), of whom 245 received a telephone consultation (65%) and 134 a video consultation (35%). Almost half of respondents (49%) expressed preference for future face-to-face care and 29% reported they would choose to use telehealth over face-to-face consultation for a similar appointment again. Many commented that they would be influenced by the type of consultation required and expressed a desire to have a choice. Approximately 80% of both groups reported they had achieved the desired outcome from their telehealth consultation. Consumers using video were more likely to experience technical issues. Telehealth met the needs of most consumers, and responses were similar for telephone and video consultations.

Effectiveness of combined vaginal progesterone and cervical cerclage in preventing preterm birth: a systematic review and meta-analysis protocol.

INTRODUCTION: Preterm birth (PTB) is the leading cause of death in children under 5 years. Preventive therapies targeted towards women with risk factors such as a prior PTB or a short cervix reduce the rate of PTB. Cervical cerclage, vaginal progesterone and a combination of the two have been used with no consensus as to whether combined treatment is more effective than any single treatment alone. The objective of this review is to determine the efficacy of combined treatment compared with cerclage alone and combined treatment compared with progesterone alone. METHODS AND ANALYSIS: Studies will be sourced from the electronic databases Medline (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Scopus, CINAHL (EBSCOhost) and Cochrane Library (Wiley) and reference lists. We will not exclude any papers due to publication date. Randomised control trials (RCTs), non-RCTs and cohort studies assessing single therapy (either progesterone or cerclage) versus combined therapy in women with a singleton pregnancy will be included. Two independent reviewers will conduct study screening (at abstract and full-text level), data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. Random or fixed effects models will be used depending on data heterogeneity and data will be presented as risk ratio for dichotomous data or mean difference for continuous data with a CI of 95% used for all outcomes. ETHICS AND DISSEMINATION: Not applicable due to nature of the study type. PROSPERO REGISTRATION NUMBER: CRD42020195975.

Vaginal progesterone for prevention of preterm birth in asymptomatic high-risk women with a normal cervical length: a systematic review and meta-analysis protocol.

BACKGROUND: Preterm birth (PTB) is estimated to affect 14.9 million babies globally every year. Global rates of PTB continue to increase from 9.8 to 10.6% over a 15-year period from 2000 to 2014. Vaginal progesterone is commonly used by clinicians as a prevention strategy, with recent evidence affirming the benefit of vaginal (micronised) progesterone to prevent PTB in women with a shortened cervix (< 25 mm). Given the low incidence of a short cervix at mid-gestation in high-risk populations further evidence is required. The objective of this review is to determine if vaginal progesterone reduces spontaneous preterm birth (sPTB) before 37 weeks in asymptomatic high-risk women with a singleton pregnancy with a normal mid-gestation cervical length. METHODS: Studies will be sourced from MEDLINE, Embase and Cochrane Register of Trials (CENTRAL) from their inception onwards with the search terms 'progesterone' and 'preterm birth'. Studies will be screened and included if they assess vaginal progesterone compared to placebo in women with a normal cervical length. The primary outcome will be sPTB < 37 weeks, with secondary outcomes of sPTB < 34 weeks. Two independent reviewers will conduct study screening at abstract and full text level, data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. The Mantel-Haenszel statistical method and random effects analysis model will be used to produce treatment effect odds ratios and corresponding 95% confidence intervals. DISCUSSION: This review will assess the current body of evidence and provide clarity regarding the potential benefits and best practice of use of vaginal progesterone in asymptomatic women with high-risk singleton pregnancies and normal cervical length. TRIAL REGISTRATION: PROSPERO CRD42020152051.

Bridging the gap: a pre-post feasibility study of embedding exercise therapy into a co-located cancer unit.

PURPOSE: To establish the feasibility of embedding a flexible, exercise-based rehabilitation program into a cancer treatment unit to allow cancer survivors early exercise support. METHOD: A pre-post study was conducted using Bowen's Framework to describe key domains of feasibility: demand (referrals), acceptability (uptake, attendance, satisfaction), implementation (resources), practicality (adverse events, costs) and limited-efficacy (function, quality of life, self-efficacy). Participants were medically stable, adult cancer survivors receiving curative or palliative treatment for cancer at the health service. Participants completed an 8-week home or hospital-based exercise program. Data were analysed descriptively. Standardised mean differences (Hedge's g) and mean differences were calculated to determine effect size and clinical significance. RESULTS: The exercise-based rehabilitation service received 155 referrals over 6 months. Of those eligible, 73/119 (61%) commenced. Participants opting for twice-weekly, hospital-based exercise attended 9/16 (56%) sessions. Participants reported high satisfaction and there were no major adverse events. The program utilised existing resources, with the predominant cost being staff. The average health service cost per participant was AUD $1,104. Participants made clinically significant gains in function (6-min walk distance; + 73 m, 95% confidence interval 49 to 96) and quality of life (EORTC QLQ-C30 Global quality of life; + 8 units, 95% confidence interval 3 to 13). CONCLUSION: Implementation of exercise-based rehabilitation in a co-located cancer unit was safe and feasible. Access, patient and staff education and establishing funding streams are important implementation considerations. Implications for cancer survivors Access to exercise in a cancer unit provides opportunity for early intervention to optimise function during treatment.

McDonald versus Shirodkar cerclage technique in women requiring a prophylactic cerclage: a systematic review and meta-analysis protocol.

BACKGROUND: Preterm birth (PTB) is the leading cause of death in children under five years. Spontaneous preterm birth (SPTB) is the major cause of preterm delivery. The key risk factors for SPTB are women who have a short cervix and women who have had previous preterm birth. Cervical cerclage has been used for several decades and has shown to decrease rates of preterm birth. The most commonly used cerclage techniques were described by Shirodkar and McDonald, with no current consensus on the preferred technique. The objective of this review is to determine and compare the effectiveness of both techniques. METHODS: Studies will be sourced from six electronic databases, as well as from experts in the field, reference lists, and grey literature. Eligible studies will include pregnant women, with a singleton or twin pregnancy, requiring a cervical cerclage, using either the Shirodkar or McDonald technique and run comparative analyses between the two techniques. Randomized control trials (RCT)s, non-randomized control trials, and cohort studies will be eligible. Two independent reviewers will conduct study screening at abstract and full-text level, data extraction and risk of bias assessment. Discrepancies will be resolved by a consensus third reviewer if required. Fixed-effects or random-effects models will be used where appropriate to synthesize results. Alternative synthesis methods will be investigated in instances where a meta-analysis is not appropriate, such as summarizing effect estimates, combining P values, vote counting based on direction of effect, or synthesis in narrative form. DISCUSSION: This review will synthesize the evidence on both the Shirodkar and McDonald cerclage method, and will help clinicians and health services to determine and deliver best practice antenatal care that has the potential to make an impact on preterm birth. SYSTEMATIC REVIEW REGISTRATION: PROSPERO on 25 of May, 2020 with registration number CRD42020177386.

Physiotherapists Prefer Clinical Supervision to Focus on Professional Skill Development: A Qualitative Study.

Purpose: We explored physiotherapists' perceptions of clinical supervision. Method: Individual semi-structured interviews were conducted with a purposive sample of 21 physiotherapists from a public hospital. Qualitative analysis was undertaken using an interpretive description approach. The Manchester Clinical Supervision Scale (MCSS-26) was administered to evaluate the participants' perceptions of the effectiveness of the clinical supervision they had received and to establish trustworthiness in the qualitative data by means of triangulation. Results: The major theme was that the content of clinical supervision should focus on professional skill development, both clinical and non-clinical. Four subthemes emerged as having an influence on the effectiveness of supervision: the model of clinical supervision, clinical supervision processes, supervisor factors, and supervisee factors. All sub-themes had the potential to act as either a barrier to or a facilitator of the perception that clinical supervision was effective. Conclusions: Physiotherapists reported that clinical supervision was most effective when it focused on their professional skill development. They preferred a direct model of supervision, whereby their supervisor directly observed and guided their professional skill development. They also described the importance of informal supervision in which guidance is provided as issues arise by supervisors who value the process of supervision. Physiotherapists emphasized that supervision should be driven by their learning needs rather than health organization processes.

Objectif : explorer les perceptions des physiothérapeutes à l'égard de la supervision clinique. Méthodologie : entrevues individuelles semi-structurées réalisées auprès d'un échantillon choisi de 21 physiothérapeutes d'un hôpital public. Les chercheurs ont procédé à une analyse qualitative au moyen d'une description interprétative. Ils ont utilisé l'échelle de supervision clinique de Manchester (MCSS­26) pour évaluer les points de vue des participants à l'égard de l'efficacité de la supervision et pour établir la fiabilité des données qualitatives par triangulation. Résultats : un thème majeur est ressorti : la supervision clinique devrait être axée sur le perfectionnement d'habiletés professionnelles cliniques et non cliniques. Il a été établi que quatre sous-thèmes avaient une influence sur l'efficacité de la supervision : le modèle de supervision clinique, les processus de supervision clinique, les facteurs liés au superviseur et ceux liés au supervisé. Ces sous-thèmes avaient tous le potentiel d'être un obstacle ou un incitatif à la perception d'efficacité de la supervision clinique. Conclusion : selon les physiothérapeutes, la supervision clinique la plus efficace était axée sur le perfectionnement de leurs habiletés professionnelles. Ils préféraient un modèle de supervision directe, selon lequel leur superviseur observait directement et orientait le perfectionnement de leurs habiletés professionnelles. Ils ont également insisté sur l'importance de la supervision informelle, c'est-à-dire que les superviseurs qui adhèrent à l'importance du processus de supervision donnent des conseils à mesure que des problèmes surgissent. Ils ont souligné que la supervision devrait être dictée par leurs besoins d'apprentissage plutôt que par les processus de l'organisation hospitalière.

An in vitro functional assay to measure the biological activity of TB vaccine candidate H4-IC31.

Potency assays for vaccine products are an important regulatory requirement, and are used to assess product quality and consistency prior to lot release for clinical testing. Ideally they measure an established correlate of efficacy or protection. In cases where there is no known correlate of protection, however, a functional assay that measures a biological response to a vaccine can be applied as a potency assay. Here we describe an in vitro assay which quantitatively measures human T cell activation as a biological response to the TB vaccine candidate H4-IC31. The Cytokine Secretion Assay (CSA) is based on the ability of peripheral blood mononuclear cells (PBMCs) from a Bacillus Calmette-Guérin (BCG)-vaccinated human donor to process and respond to H4-IC31. The ability of H4-IC31 to stimulate a cellular immune response is measured through the quantification of secreted IFNγ and is reported as relative stimulatory activity (RSA) compared to an in-house reference standard. The CSA is specific to the H4-IC31 vaccine, determines the RSA of H4-IC31 in the range of 50% to 150% of the reference standard, and is stability indicating as it detects differences in RSA between intact and heat treated H4-IC31. Although the CSA does not provide a link to clinical efficacy, it fulfills the critical requirements for a biological potency test to assess TB vaccine candidates and can be used along with biochemical and immunochemical assays to define a product profile during clinical development, while eliminating the use of animals for product testing.

A bivalent pneumococcal histidine triad protein D-choline-binding protein A vaccine elicits functional antibodies that passively protect mice from Streptococcus pneumoniae challenge.

Vaccines based on conserved pneumococcal proteins are being investigated because serotype coverage by pneumococcal polysaccharide and polysaccharide conjugate vaccines is incomplete and may eventually decrease due to serotype replacement. Here, we examined the functionality of human antibodies induced by a candidate bivalent choline-binding protein A- pneumococcal histidine triad protein D (PcpA-PhtD) vaccine. Pre- and post-immune sera from subjects who had been vaccinated with the PcpA-PhtD candidate vaccine were tested in an established passive protection model in which mice were challenged by intravenous injection with Streptococcus pneumoniae serotype 3 strain A66.1. Serum antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Bacterial surface binding by serum antibodies was determined by a flow cytometry-based assay. Sera from 20 subjects were selected based on low activity of pre-immune samples in the passive protection model. Bacterial surface binding correlated more strongly with anti-PcpA (0.87; p < 0.0001) than with anti-PhtD (0.71; p < 0.0001). The odds ratio for predicting survival in the passive protection assay was higher for the anti-PcpA concentration (470 [95% confidence interval (CI), 46.8 to >999.9]) than for the anti-PhtD concentration (3.4 [95% CI, 1.9 to 5.6]) or bacterial surface binding (9.4 [95% CI, 3.6 to 24.3]). Pooled post-immune serum also protected mice against a challenge with S. pneumoniae serotype 3 strain WU2. Both anti-PcpA and anti-PhtD antibodies induced by the bivalent candidate vaccine mediate protection against S. pneumoniae. The results also showed that the ELISA titer might be useful as a surrogate for estimating the functional activity of antibodies induced by pneumococcal protein vaccines.

Passive protection of mice against Streptococcus pneumoniae challenge by naturally occurring and vaccine-induced human anti-PhtD antibodies.

Currently marketed Streptococcus pneumoniae vaccines are based on polysaccharide capsular antigens from the most common strains. Pneumococcal histidine triad protein D (PhtD) is a conserved surface protein that is being evaluated as a candidate for a vaccine with improved serotype coverage. Here, we measured the functional activity of human anti-PhtD antibodies in a passive protection model wherein mice were challenged with a lethal dose of S. pneumoniae by intravenous injection. This functional activity was compared with anti-PhtD antibody concentrations measured by enzyme-linked immunosorbent assay (ELISA) to estimate the 50% protective dose (ED50). Anti-PhtD antibodies affinity purified from pooled normal human sera passively protected mice with an ED50 of 1679 ELISA units/ml (95% confidence interval, 1420-1946). Sera from subjects injected with aluminum-adjuvanted PhtD in a phase I trial had similar activity per unit of antibody (ED50 = 1331 ELISA units/ml [95% confidence interval, 762-2038]). Vaccine-induced activity in the passive protection model was blocked by pre-incubation with recombinant PhtD but not by a control S. pneumoniae antigen (LytB). These results show that human anti-PhtD antibodies, whether naturally acquired or induced by the PhtD candidate vaccine, are functional. This supports the development of the PhtD candidate as part of a broadly protective pneumococcal vaccine.