For cluster randomized trials (CRTs) with a small number of clusters, the matched‐pair (MP) design, where clusters are paired before randomizing one to each trial arm, is often recommended to ...minimize imbalance on known prognostic factors, add face‐validity to the study, and increase efficiency, provided the analysis recognizes the matching. Little evidence exists to guide decisions on when to use matching. We used simulation to compare the efficiency of the MP design with the stratified and simple designs, based on the mean confidence interval width of the estimated intervention effect. Matched and unmatched analyses were used for the MP design; a stratified analysis was used for the stratified design; and analyses without and with post‐stratification adjustment for factors that would otherwise have been used for restricted allocation were used for the simple design. Results showed the MP design was generally the most efficient for CRTs with 10 or more pairs when the correlation between cluster‐level outcomes within pairs (matching correlation) was moderate to strong (0.3‐0.5). There was little gain in efficiency for the MP or stratified designs compared to simple randomization when the matching correlation was weak (0.05‐0.1). For trials with four pairs of clusters, the simple and stratified designs were more efficient than the MP design because greater degrees of freedom were available for the analysis, although an unmatched analysis of the MP design recovered precision for weak matching correlations. Practical guidance on choosing between the MP, stratified, and simple designs is provided.
Objective: To compare the rate of provision of longer consultations per head of population across practice locations categorised by socioeconomic status.
Design: Retrospective analysis of Medicare ...data for all consultations for all general practitioners in Australia for the 1998–99 and 1999–2000 financial years, grouped by postcode of practice location. Postcodes were categorised by the Socio‐Economic Indexes for Areas, Index of Relative Socio‐Economic Disadvantage score.
Main outcome measures: Number of consultations and number of brief, standard, long and prolonged consultations per capita in each postcode grouping.
Results: The absolute number of long plus prolonged consultations showed no trend across postcode groups, but the rate ratio per person was significantly higher in more advantaged postcode areas. This represents an example of care provision in inverse relationship to need.
Discussion: Despite higher rates of chronic disease and lower rates of preventive care uptake, patients in low socioeconomic status areas receive longer GP consultations at a lower rate than patients in more advantaged areas. Possible strategies to overcome this inverse care provision include increased numbers of GPs in disadvantaged communities, removal of financial disincentives to longer consultations, and strengthening health promotion and community health services in disadvantaged areas.
Background
Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health ...problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence‐based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm.
Objectives
To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self‐efficacy and an indicator of harm (dropouts) at six‐ to 12‐months' follow‐up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re‐exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support.
Search methods
We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature.
Selection criteria
We included randomised controlled trials (RCTs), quasi‐RCTs, cluster‐RCTs and cross‐over trials of psychological therapies with women aged 16 years and older who self‐reported recent or lifetime experience of IPV. We included trials if women also experienced co‐existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders’s psychological therapies list.
Data collection and analysis
Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short‐term (up to six months post‐baseline), medium‐term (six to under 12 months, primary outcome time point), and long‐term follow‐up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random‐effects meta‐analysis, due to high heterogeneity across trials.
Main results
We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third‐wave cognitive behavioural therapies and three other psychologically‐orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high‐income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face‐to‐face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials).
Whilst 20 trials (61%) described reliable low‐risk random‐sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status.
While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium‐term follow‐up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD −0.24, 95% CI −0.47 to −0.01; four trials, 600 women; moderate‐certainty evidence). However, for self‐efficacy, there may be no evidence of a difference between groups (SMD −0.12, 95% CI −0.33 to 0.09; one trial with medium‐term follow‐up data, 346 women; low‐certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium‐term follow‐up data, 840 women; low‐certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale.
For secondary outcomes, trials measured anxiety only at short‐term follow‐up, showing that psychological therapies may reduce anxiety symptoms (SMD −0.96, 95% CI −1.29 to −0.63; four trials, 158 women; low‐certainty evidence). However, within medium‐term follow‐up, low‐certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI −0.18 to 0.25; one trial, 337 women), post‐traumatic stress disorder (SMD −0.24, 95% CI −0.54 to 0.06; four trials, 484 women) or re‐exposure to any form of IPV (SMD 0.03, 95% CI −0.14 to 0.2; two trials, 547 women).
Authors' conclusions
There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self‐efficacy, post‐traumatic stress disorder, re‐exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow‐up time points), as we were unable to synthesise much of the research.
Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting.
To assess the efficacy ...of Chinese medicine acupuncture against sham acupuncture for menopausal HFs.
Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954).
Community in Australia.
Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency.
10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture.
The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models.
327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 95% CI, -1.87 to 2.52; P = 0.77). No serious adverse events were reported.
Participants were predominantly Caucasian and did not have breast cancer or surgical menopause.
Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs.
National Health and Medical Research Council.
Background:
In light of emerging evidence questioning the safety of antidepressants, it is timely to investigate the appropriateness of antidepressant prescribing. This study estimated the prevalence ...of possible over- and under-treatment with antidepressants among primary care attendees and investigated the factors associated with potentially inappropriate antidepressant use.
Methods:
In all, 789 adult primary care patients with depressive symptoms were recruited from 30 general practices in Victoria, Australia, in 2005 and followed up every 3 months in 2006 and annually from 2007 to 2011. For this study, we first assessed appropriateness of antidepressant use in 2007 at the 2-year follow-up to enable history of depression to be taken into account, providing 574 (73%) patients with five yearly assessments, resulting in a total of 2870 assessments. We estimated the prevalence of use of antidepressants according to the adapted National Institute for Health and Care Excellence guidelines and used regression analysis to identify factors associated with possible over- and under-treatment.
Results:
In 41% (243/586) of assessments where antidepressants were indicated according to adapted National Institute for Health and Care Excellence guidelines, patients reported not taking them. Conversely in a third (557/1711) of assessments where guideline criteria were unlikely to be met, participants reported antidepressant use. Being female and chronic physical illness were associated with antidepressant use where guideline criteria were not met, but no factors were associated with not taking antidepressants where guideline criteria were met.
Conclusions:
Much antidepressant treatment in general practice is for people with minimal or mild symptoms, while people with moderate or severe depressive symptoms may miss out. There is considerable scope for improving depression care through better allocation of antidepressant treatment.
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects of psychological interventions in comparison to usual care, no treatment, delayed ...provision of psychological interventions and minimal interventions (such as screening, information provision and referral to community services such as women shelters) for women who experience intimate partner violence (IPV).
Australia has one of the highest incidences of colorectal cancer (CRC) worldwide. The Australian National Bowel Cancer Screening Program (NBCSP) is a best-practice, organised screening programme, but ...uptake is low (40.9%) and increasing participation could reduce morbidity and mortality associated with CRC. Endorsement by GPs is strongly associated with increasing screening uptake.
This study (SMARTscreen) aimed to test whether a multi-intervention short message service (SMS) sent by general practices to 50-60-year-old patients who were due to receive the NBCSP kit would increase NBCSP uptake, by comparing it with usual care.
A stratified cluster randomised controlled trial was undertaken, involving 21 Australian general practices in Western Victoria, Australia.
For intervention practices, people due to receive the NBCSP kit within a 6-month study period were sent an SMS just before receiving the kit. The SMS included a personalised message from the person's general practice endorsing the kit, a motivational narrative video, an instructional video, and a link to more information. Control practices continued with usual care, comprising at-home testing with a faecal immunochemical test (FIT) through the NBCSP. The primary outcome was the between-arm percentage difference in uptake of FIT screening within 12 months from randomisation, which was estimated using generalised linear model regression.
In total, 39.2% (1143/2914) of people in 11 intervention practices and 23.0% (583/2537) of people in 10 control practices had a FIT result in their electronic health records - a difference of 16.5% (95% confidence interval = 2.02 to 30.9).
The SMS intervention increased NBCSP kit return in 50-60-year-old patients in general practice. This finding informed a larger trial - SMARTERscreen - to test this intervention in a broader Australian population.
Depression trajectories among primary care patients are highly variable, making it difficult to identify patients that require intensive treatments or those that are likely to spontaneously remit. ...Currently, there are no easily implementable tools clinicians can use to stratify patients with depressive symptoms into different treatments according to their likely depression trajectory. We aimed to develop a prognostic tool to predict future depression severity among primary care patients with current depressive symptoms at three months.
Patient-reported data from the diamond study, a prospective cohort of 593 primary care patients with depressive symptoms attending 30 Australian general practices. Participants responded affirmatively to at least one of the first two PHQ-9 items. Twenty predictors were pre-selected by expert consensus based on reliability, ease of administration, likely patient acceptability, and international applicability. Multivariable mixed effects linear regression was used to build the model.
The prognostic model included eight baseline predictors: sex, depressive symptoms, anxiety, history of depression, self-rated health, chronic physical illness, living alone, and perceived ability to manage on available income. Discrimination (c-statistic =0.74; 95% CI: 0.70–0.78) and calibration (agreement between predicted and observed symptom scores) were acceptable and comparable to other prognostic models in primary care.
More complex model was not feasible because of modest sample size. Validation studies needed to confirm model performance in new primary care attendees.
A brief, easily administered algorithm predicting the severity of depressive symptoms has potential to assist clinicians to tailor treatment for adult primary care patients with current depressive symptoms.
•Model developed to predict future depression severity in primary care patients.•Prognostic model is brief and easily administered in a busy primary care setting.•Model using psychosocial items is embedded in a clinical prediction tool (CPT).•CPT tailors type and intensity of treatment to predicted depression severity.•Is a systematic approach designed to support clinician treatment decision making.
•Mental health websites are recommended as part of stepped mental health care.•The natural uptake of these websites and characteristics of users are unknown.•In this primary care sample, uptake was ...associated with more severe symptoms.•Users are female, younger, educated, educated, and help seekers.•Mental health websites have potential but must be targeted appropriately.
To describe the characteristics of primary care attendees with depressive symptoms who use mental health websites.
789 individuals with depressive symptoms recruited and followed up annually for nine years. Self-reported written surveys included mental health, professional and self-help use, e-mental health interventions or therapeutic websites. Marginal logistic regression examined association between mental health website (MHW) use and patient’s mental health, health services use, anti-depressant use and self-help strategies.
36% of participants used an MHW at least once. MHW users were more likely to be female, younger, highly educated and employed. MHW use increased with depressive symptom severity; reported in 16% of assessments when minimal symptoms were present and 28% when severe symptoms were present. MHW use was associated with: GP mental health visits, psychologist and psychiatrist visits and other self-help strategies including self-help books and telephone helplines.
Mental health websites were more likely to be used by those with severe depressive symptoms rather than those with mild depression as recommended in current guidelines.
Whilst mental health websites offer potential to support the high volume of people with mild depression new strategies may be required to ensure uptake.
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