Factors That Influence Women's Decisions About Whether to Participate in Research: An Exploratory Study

Abstract: Background : Women are increasingly being asked to consider participating in medical research. We sought to investigate views of women who participated in and declined to participate in a study that was part of a program of maternity care research. Methods : An exploratory study using focus group interviews and semistructured interviews was conducted. A purposive sample of 17 postnatal women who had participated in research, from a hospital in the North West of England, were interviewed. An open coding mechanism to identify emergent themes was used for the analysis of data. Results : Of women who had not declined to participate in any research, the following themes were identified: altruism versus self‐protection, enhanced versus inferior care, professional guidance versus self‐direction, and welcome versus unacceptable methodology. Of women who had participated in some research but declined to participate in other research, the following themes were identified: feeling disempowered by the process, inability to believe equipoise existed, and practical inconvenience. Conclusions : These findings suggest that although health care researchers adopt an individualistic approach to care, they may fail to adopt a similar approach within research. What is important and acceptable to women needs to be ascertained to develop appropriate research strategies. This plan will ensure that research is carried out to the highest ethical standard, which may increase recruitment rates.     

Early postoperative voiding dysfunction after insertion of retropubic midurethral tape

Introduction and hypothesis

A significant proportion of patients develop voiding dysfunction after midurethral tape (MUT) insertion, which reduces patient satisfaction. The study’s purpose was to identify predictive factors of voiding dysfunction after a retropubic MUT procedure.

Methods

This was a retrospective study of 100 patients who underwent only a retropubic MUT procedure between January 2010 and December 2011. Early voiding dysfunction was defined when patients required a Foley catheter within 48 h. Data including demographic information, urogenital symptoms, previous surgery, preoperative uroflowmetry and urodynamic parameters were analysed using SPSS v22. Univariate analysis of all demographic variables was performed; those significant at 10 % were entered into a multivariate logistic regression.

Results

Fourteen patients required Foley catheter insertion, with a median age of 58 years (26–83 years), median BMI 28 kg/m² (20–48 kg/m2), and median parity 2 (0–4). Univariate analysis revealed peak flow rate <15 ml/s (OR 3.79; 1.07, 13.4; p?=?0.046), bladder capacity (p?=?0.044), stress incontinence versus mixed or urge incontinence (p?=?0.064) and previous surgery (OR 4.39; 1.34, 14.41; p?=?0.015) to be associated with voiding dysfunction. Multivariate analysis showed only previous pelvic floor surgery to be independently associated (OR 3.76; 1.14, 12.23, p?=?0.029).

Conclusions

Only previous pelvic-floor surgery was found to be a strong predictive factor of voiding dysfunction. The rate of voiding dysfunction was similar to those of published data. Previous studies revealed different predictive factors. A larger cohort is needed to provide a definite answer. Those with previous surgery appear to be those most at risk and pre-surgical counselling for these women could be suggested.

     

Objective assessment of urinary incontinence in women: comparison of the one-hour and 24-hour pad tests

OBJECTIVE: To compare the performance and clinical usefulness of the one-hour and 24-hour pad tests in terms of the relationship with reported symptoms and urodynamic diagnosis. METHODS: 341 women aged 40 years and over reporting lower urinary tract symptoms who were recruited to a nurse led continence service, and went on to receive urodynamics, a one-hour and a 24-hour pad test and completed a urinary diary. RESULTS: For both pad tests, there was a significant difference in the amount of urine leaked between the different urodynamic diagnoses (p<0.0001, for the one-hour and p=0.001 for the 24-hour test). Women with sphincter incompetence leaked significantly more than women with detrusor instability, or those with no abnormality. There was a significant difference between the proportion of women dry on a one-hour pad test and those dry on a 24-hour pad test (26.0% versus 38.4%, difference 12.4%; CI 5.5; 19.4). There is a positive relationship between amount of urine leakage and symptom severity expressed in terms of number of incontinent episodes for both pad tests. CONCLUSION: Both pad tests bore little relationship to the underlying urodynamic diagnosis but there was a positive relationship with symptom severity. The 24-hour pad test appears to be clinically a more useful too than the one-hour test. The two types of pad test are probably assessing incontinence in different ways. We suggest that the minimum data set should include structured questions, diaries and the 24-hour pad test.     

Computerised analysis of fetal heart rate recordings in maternal type I diabetes mellitus

Objective 1. To study computerised cardiotocograph parameters from women with type I diabetes; 2. to examine the significance of observed differences from the expected normal values.
Design Prospective observational study in the third trimester of pregnancy.
Setting The medical antenatal clinic of a tertiary referral centre.
Population Twenty-six women with type I diabetes mellitus with a singleton pregnancy.
Methods Computerised cardiotocograph recordings were made weekly from 28 to 39 weeks. Derived parameters were compared with the published figures for uncomplicated singleton pregnancies. Details of maternal blood sugar, labour and delivery and neonatal outcome were recorded. Data were compared between groups according to the computerised analysis of the antenatal CTGs.
Results One-hundred and thirty-one recordings were made with a median of five per patient (range 1–12). 11.3% showed absent episodes of high variation compared with the expected value of 0.8%, a difference of 9.5% (95% CI 4.5-15.3). Differences in short term variation, basal heart rate, frequency of fetal movements and heart rate accelerations were also found which changed with gestation. Overall these changes represented a more immature form of fetal heart rate than that which would be expected. No relationship between the changes and adverse fetal outcome could be identified.
Conclusions Significant differences exist in cardiotocographs in maternal type I diabetes compared with normal fetuses. The changes may represent a delay in fetal maturation. The analysis mode of the computer will register these as abnormal features, but there is no evidence that they are pathological. We would recommend that computerised analysis is not used to assess pregnancies complicated by maternal type I diabetes mellitus.     

Interstitial cystitis/bladder pain syndrome: An update

Interstitial cystitis, or painful bladder syndrome, is a condition characterized by bladder pain, urinary frequency, urgency, and nocturia. The cause of the condition remains obscure and it remains a diagnosis of exclusion. Current theories of pathogenesis include a chronic or subclinical infection, autoimmunity, neurogenic inflammation or bladder urothelial defects.     

Point mutations detected in the androgen receptor gene of three men with partial androgen insensitivity syndrome

OBJECTIVE Determine the sequence of the androgen receptor gene in men with impaired responsiveness to androgens in order to identify the molecular basis of their under-virilization. DESIGN Blood samples were used as the source of genomic DNA. Portions of the androgen receptor gene were amplified by polymerase chain reaction and sequenced. PATIENTS Samples were obtained from three patients and five normal fertile controls. Patients were all 46 XY and were undervirilized with ambiguous external genitalia, gynaecomastla and infertility. MEASUREMENTS Total cellular DNA was purified from peripheral blood leucocytes. Pairs of ollgonucleotide primers designed to flank the individual exons of the androgen receptor gene were synthesized. The specific regions of the androgen receptor were amplified from the samples of cellular DNA by polymerase chain reaction. Amplified DNA was purified, sequenced and compared to the published sequence. RESULTS In all three patients point mutations in the androgen receptor gene were detected but no defects were detected in samples from normal controls. In two of the patients, an identical single nucleotide change from G to T was detected. This nucleotide was within the codon for amino acid 866 and would change it from valine to leucine. Amino acid 866 is found within an area of the steroid binding domain thought to be involved in receptor dimerization. Within the repetitive sequence of exon I patient 1 had 21 glutamine residues and patient 2 had 25. In the third patient a single change of G to A would result in incorporation of lysine in place of a conserved arginine residue at position 607 within the second zinc finger of the DNA binding domain. The sequence of the androgen receptor gene of the mother of the third patient revealed her to be heterozygous for the same defect. CONCLUSION Patients 1 and 2 are unrelated although they have an identical point mutation in their androgen receptor gene. A patient with complete androgen insensitivity syndrome has been reported to have a defect at the same position causing the amino acid substitution of methlonine for valine. Therefore we confirm that the nature of the amino acid change in the peptide sequence of the androgen receptor as well as its location within the protein, can have a profound effect on the phenotypic severity of androgen resistance. Studies on mutated receptors from individuals with a wide range of degrees of androgen resistance may enable us to construct a map of the key amino acids in the different domains of the protein.     

The Larsson frequency/volume chart is not a substitute for cystometry in the investigation of women with urinary incontinence

The aim of the study was to assess the ability of the Larsson chart nomogram to predict the presence of detrusor instability or genuine stress incontinence without recourse to cystometry. The Larsson chart provides a probability of detrusor instability by plotting 24-hour urinary frequency against the range of void volumes. Frequency/volume chart data were obtained from the records of 216 patients who had undergone subtraction cystometry. The Larsson chart was assessed by comparing the probability of detrusor instability or of genuine stress incontinence obtained with the cystometric diagnosis. The maximum sensitivity of the Larsson chart was 52%, with a specificity of 70% for detrusor instability. For genuine stress incontinence these figures were 66% and 65% respectively. The Larsson chart provides no diagnostic information and does not remove the need for formal cystometric evaluation of patients with urinary incontinence.Editorial Comment: The authors critically assess the Larsson frequency/volume chart as a diagnostic aid in evaluating female incontinence, hoping to validate its use as a decisive test that could preclude the need for multichannel urodynamics. In a unselected cohort of females with incontinence the investigators compare the diagnosis made based on the Larsson chart to that arrived at by multichannel cystometrography. Although the Larsson chart is found to have low specificity and sensitivity in detecting DI or GSI, the voiding diary remains an important diagnostic aid in the evaluation of urinary incontinence, imparting much information regarding functional bladder capacity, urinary frequency, nocturia and daily fluid intake. This information is critical in understanding the overall function of the patient's lower urinary tract, suggests the presence of specific entities such as diabetes insipidus, contracted bladder, interstitial cystitis etc., and allows the physician to make simple adjustments in fluid intake that can minimize incontinence, nocturia and diuria. It is rather simplistic to believe that a voiding record alone could reliably distinguish between categories of incontinence, without any other evaluation.