Systematic Reviews on the Basis of Methodological Criteria

This paper describes a method of systematic reviewing. This method puts much emphasis on the methodological quality of the randomised clinical trials involved. Various items concerning the internal validity, precision and relevance of the studies are scored in such a way that next to the methodological quality the amount of uncertainty about it also becomes visible. These quality assessments are not only useful for systematic reviews, but also have an educational function for researchers with respect to the design and publication of a clinical trial.     

A randomised controlled trial to test the feasibility of a collaborative care model for the management of depression in older people

BACKGROUND: Depression is the most common mental health disorder in people aged over 65 years. Late-life depression is associated with chronic illness and disability. AIM: To investigate the feasibility of a collaborative care model for depression in older people in a primary care setting. DESIGN OF STUDY: Randomised controlled trial with 16-weeks follow up. SETTING: A primary care trust in Manchester. METHOD: Participants were 105 people aged 60 years or older who scored 5 or more on the Geriatric Depression Scale; 53 were randomly allocated to an intervention group and 52 to a usual care group. The intervention group received care managed by a community psychiatric nurse who delivered an intervention comprising a facilitated self-help programme with close liaison with primary care professionals and old-age psychiatry according to a defined protocol. The usual care group received usual GP care. A nested qualitative study explored the views of the health professionals and patients regarding the acceptability and effectiveness of the intervention. RESULTS: The main outcome measure was recovery from depression. Patients in the intervention group were less likely to suffer from major depressive disorder at follow up compared with usual care (0.32, 95% confidence = interval = 0.11 to 0.93, P = 0.036). The qualitative component of the study demonstrated the acceptability of the intervention to patients. CONCLUSION: A model of collaborative care for older people with depression, used in a primary care setting with a facilitated self-help intervention is more effective than usual GP care. This study demonstrates that the implementation of a collaborative care model is feasible in UK primary care and that the intervention is effective and acceptable to patients.     

Assessing the Effectiveness of Front of Pack Labels: Findings from an Online Randomised-Controlled Experiment in a Representative British Sample

Front of pack food labels (FOPLs) provide accessible nutritional information to guide consumer choice. Using an online experiment with a large representative British sample, we aimed to examine whether FOPLs improve participants’ ability to identify the healthiness of foods and drinks. The primary aim was to compare ability to rank between FOPL groups and a no label control. Adults (≥18 years), recruited from the NatCen panel, were randomised to one of five experimental groups (Multiple Traffic Light, MTL; Nutri-Score, N-S; Warning Label, WL; Positive Choice tick, PC; no label control). Stratification variables were year of recruitment to panel, sex, age, government office region, and household income. Packaging images were created for three versions, varying in healthiness, of six food and drink products (pizza, drinks, cakes, crisps, yoghurts, breakfast cereals). Participants were asked to rank the three product images in order of healthiness. Ranking was completed on a single occasion and comprised a baseline measure (with no FOPL), and a follow-up measure including the FOPL as per each participant’s experimental group. The primary outcome was the ability to accurately rank product healthiness (all products ranked correctly vs. any incorrect). In 2020, 4504 participants had complete data and were included in the analysis. The probability of correct ranking at follow-up, and improving between baseline and follow-up, was significantly greater across all products for the N-S, MTL and WL groups, compared to control. This was seen for only some of the products for the PC group. The largest effects were seen for N-S, followed by MTL. These analyses were adjusted for stratification variables, ethnicity, education, household composition, food shopping responsibility, and current FOPL use. Exploratory analyses showed a tendency for participants with higher compared to lower education to rank products more accurately. Conclusions: All FOPLs were effective at improving participants’ ability to correctly rank products according to healthiness in this large representative British sample, with the largest effects seen for N-S, followed by MTL.     

Comparison of efficacy and safety of daily oral L-arginine and PDE5Is alone or combination in treating erectile dysfunction: A systematic review and meta-analysis of randomised controlled trials

The meta-analysis was performed to assess the efficacy and safety of daily oral L-arginine and phosphodiesterase type 5 inhibitors (PDE5Is) alone or combination in treating patients with erectile dysfunction (ED). We performed a search of randomised controlled trials in the following databases: PubMed, EMBASE and Cochrane Library databases. Four articles including 373 patients were studied. Erectile functions were significantly improved in three therapy groups compared with baseline. Patients who received the combination of L-arginine and PDE5Is showed significant improvement compared to those treated with L-arginine and PDE5Is alone, as assessed by sexual function index (p <0.00001 and p =0.005, respectively) and total testosterone (p <0.00001 and p =0.0007, respectively). Furthermore, patients who treated with PDE5Is alone exhibited the better efficacy than those treated with L-arginine alone in respects of sexual function index (p <0.00001) and total testosterone (p =0.0001). However, the combination of L-arginine and PDE5Is had no obvious difference relative to PDE5Is alone in terms of various adverse events (AEs). Conclusively, compared with monotherapy, the combination of L-arginine and PDE5Is showed a greater improvement of sexual function and total testosterone, and did not significantly increase the AEs. Besides, PDE5Is alone revealed a better effect than those treated with L-arginine alone for patients with ED.     

A systematic review of reporting quality for anaesthetic interventions in randomised controlled trials

Interventions from randomised controlled trials can only be replicated if they are reported in sufficient detail. The results of trials can only be confidently interpreted if the delivery of the intervention was systematic and the protocol adhered to. We systematically reviewed trials of anaesthetic interventions published in 12 journals from January 2016 to September 2019. We assessed the detail with which interventions were reported, using the Consolidated Standards of Reporting Trials statement for non-pharmacological treatments. We analysed 162 interventions reported by 78 trials in 18,675 participants. Detail sufficiently precise to replicate the intervention was reported for 111 (69%) interventions. Intervention standardisation was reported for 135 (83%) out of the 162 interventions, and protocol adherence was reported for 20 (12%) interventions. Sixty (77%) out of the 78 trials reported the administrative context in which interventions were delivered and 36 (46%) trials detailed the expertise of the practitioners. We conclude that bespoke reporting tools should be developed for anaesthetic interventions and interventions in other areas such as critical care.     

Mother and clinician experiences of a trial of a video feedback parent–infant intervention for mothers experiencing difficulties consistent with ‘personality disorder’: A qualitative interview study

Objectives

We explored mothers' and clinicians' experiences of a video feedback intervention adapted for perinatal ‘personality disorder’ (VIPP-PMH) and the acceptability of a randomised controlled trial (RCT) examining its effectiveness.

Design

In-depth qualitative interviews with participants from a two-phase feasibility study of the VIPP-PMH intervention. Participants were mothers experiencing enduring difficulties in managing emotions and relationships, consistent with a ‘personality disorder’, and their 6- to 36-month-old children.

Methods

Forty-four qualitative interviews were conducted, including all nine mothers receiving VIPP-PMH during the pilot phase, 25 of the 34 mothers participating in the RCT (14 allocated to the VIPP-PMH arm and 9 from the control arm), 11 of the 12 clinicians delivering VIPP-PMH and one researcher. Interview data were thematically analysed.

Results

Mothers described feeling motivated to take part in the research and understood the need for randomisation. Research visits were largely experienced positively, with some suggestions for improvement in questionnaire timing and accessibility. Almost all mothers initially felt anxious about being filmed, but reported positive experiences of the intervention, particularly valuing its non-judgemental, positive and child-focussed nature, their supportive relationship with the therapist and the insights they gained on their child.

Conclusions

The findings indicate the likely feasibility and acceptability of undertaking a future definitive RCT of the VIPP-PMH intervention in this population. In designing a future trial, a positive and non-judgemental therapeutic relationship will be important to allay mothers' anxieties about being filmed, and careful consideration should be given to the timing and accessibility of questionnaires used.     

Postural post-dural puncture headache. A prospective randomised study and a meta-analysis comparing two different 0.40 mm O.D. (27 g) spinal needles

BACKGROUND: To compare the incidence of postural post-dural puncture headache (PPDPH) after spinal anaesthesia using two different 0.40 mm O.D. (27 g) spinal needles: pencil-point needle and Quincke needle. In addition, a meta-analysis of studies comparing small bore spinal needles with regard to development of PPDPH was performed. METHODS: Clinical study: A prospective randomised double-blind study was set up to investigate PPDPH after using 0.40 mm pencil-point (Pencan, B. Braun) or Quincke (Spinocan, B. Braun) spinal needle. Postoperatively on day 5 to 7 a telephone interview was conducted in order to reveal postoperative complications such as headache and backache. PPDPH was considered present when the headache was new to the patient, and demonstrated posture dependence. Meta-analysis: Electronic database search and manual search of relevant literature were performed in order to find randomised control trials comparing equal sized (outer diameter, O.D.) spinal needles with different bevel shape. Only studies with a proper method and not merely presented as an abstract were included in addition to the present clinical study. RESULTS: Out of 313 patients randomised, 301 were completely followed up, 153 in the pencil-point group and 148 in the Quincke group. The two groups were comparable regarding surgical procedures and demographic data. Of 15 patients suffering from PPDPH, 12 were found in the Quincke group, and 3 in the pencil-point group. The difference was 6.1% (95% CI from 1.2 to 12.5%). The meta-analysis of 1131 patients gave a relative risk of developing PPDPH of 0.38 (95% CI from 0.19 to 0.75) in the pencil-point group compared to the Quincke group. CONCLUSION: A pencil-point-shaped spinal needle will significantly reduce PPDPH compared with Quincke-type spinal needles, also when small bore needles (0.40 mm O.D.) are used.     

Mode of delivery in the early preterm infant (<28 weeks)

Elective caesarean section for women in labour with an immature baby might reduce the chances of fetal or neonatal death, but might also increase the risk of maternal morbidity. A review (updated in February 2004) of randomised trials comparing a policy of elective caesarean section versus expectant management with recourse to caesarean section produced six studies involving only 122 women. Differences in fetal outcome did not reach significance, but mothers undergoing elective caesarean section were more likely to have serious morbidity. Scientifically, the evidence remains inadequate. Clinically, the recommendation is that prematurity is not, in itself, an indication for caesarean section. In a survey from Israel, published in December 2004, of 2955 very low birthweight infants born at 24–34 weeks of gestation, the overall caesarean section rate was 51.7%, and the mortality rate among babies prior to discharge was lower after caesarean section (13.2 versus 21.8%). After adjustment using multiple logistic regression, caesarean section had no effect on survival except in a subgroup with amnionitis, and it was again concluded that caesarean section cannot be routinely recommended unless there are other indications. A decision model developed in the USA has compared costs and health outcomes of two options for managing labour at 24 weeks of gestation. The probabilities of both intact survival (16.8 versus 12.9%) and survival with major morbidity (39.2 versus 19.4%) are higher with willingness to perform caesarean section, but less aggressive management is the more cost-effective strategy. Large studies are few and recruitment to such studies is perceived as a major problem. For clinicians, the decision will be influenced by local circumstances.