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Sample size calculation | OA knee | OA KNEE, OSTEOARTHRITIS | The exercise effect on OA knee patients was investigated using the G power software, which detected a difference in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index stiffness from 3.66 ± 2.64 to 2.10 ± 2.26 [The formula used for sample size calculation is | PMC10522526 |
Outcome measurement tools | PMC10522526 | |||
Numerical pain rating scale (NRS) | pain | The average pain intensity was measured during the past week, with zero representing no pain and ten representing the worst pain [ | PMC10522526 | |
Goniometric measurement for ROM | knee flexion and extension ROM | Both the knee flexion and extension ROM were measured while the subject was in a prone position. The measurement was done three times and the average result was obtained. | PMC10522526 | |
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | lower extremity osteoarthritis, pain | KNEE OSTEOARTHRITIS | The questionnaire was developed to measure treatment outcomes in patients with lower extremity osteoarthritis, such as pain, stiffness, and difficulty, and it employs a scale to categorize the difficulties in activities of daily living. For individuals with hip and knee osteoarthritis, the WOMAC scale is a valid and reliable outcome measurement [ | PMC10522526 |
Timed Up and Go (TUG) test | The test combines static and dynamic balance to assess a person’s mobility. Getting out of a chair, walking three meters, turning around, and returning to the chair to sit. The international research OA society recommends a series of physical function measures (five performance-based) for individuals with hip or knee OA, including the TUG test [ | PMC10522526 | ||
Interventions | HEAT | All patients received 15 min of moist heat from a hydro collator pack wrapped in a soft towel put around the afflicted knee before beginning the main treatment. In one experimental group, KT followed by TENS was applied. After that, an exercise program was started. The other experimental group was followed by TENS and an exercise program. The purpose of this exercise program was to strengthen the muscles of the hip, knee, and ankle [ | PMC10522526 | |
Kinesio taping — 2 times per week for 6 weeks | knee joint effusion | The professionally trained physical therapist applied Kinesio taping twice a week for the entire 6-week study period. The patient is in a supine position with full knee flexion. Before application, the skin surface was cleaned. This technique involved the use of two Y-cut strips and two I-cut strips. On the two Y-cut strips, the following effects and procedures were used: one to increase anterior thigh muscle function (“paper off” tension), and the other to lower the risk of knee joint effusion. The initial Y-cut strip of one end was placed on the rectus femoris muscle following the split ends passed through the medial and lateral sides of the patella and ended in the tibial tuberosity. The other Y-cut strip was placed just below the tibial tuberosity following the split ends, which passed through the medial and lateral sides of the patella and ended in the vastus medialis and lateralis muscles. The two Y-cut strips were tensioned at 0% for the first 5 cm, 10–15% for the middle area, and 0% for the last 2 cm. The adhesive is activated using the KT technique after each application. Two I-cut strips were applied one over the other on the patellar tendon toward the medial and lateral collateral ligaments to increase the mechanoreceptor stimulation, improve proprioception, and stabilize the knee. The subject was positioned in the supine position with the knee completely flexed. The first I-cut strip was applied directly to the inferior border of the patellar tendon with 100% tension following the adhesive tape was activated. Then the knee was extended to 20–30 degrees, with 75% of the tension applied until the tape reached the medial and lateral collateral ligaments, which was followed by adhesive activation. Finally, the subject was then instructed to extend the knee completely and direct the I-cut strip (about 10 cm) ends toward the posterolateral sides of the thigh with 0% tension and adhesive activation. Following that, the second strip was applied in the same method of application as the first, but it was applied lower and only covered half of the first (Fig. A view of the completed Kinesio taping (KT) application on the right knee | PMC10522526 | |
Transcutaneous electrical nerve stimulation (TENS) — 2 times per week for 6 weeks | tingling sensation | In our study, we used the following TENS device settings, such as the frequency of 32–50 Hz, the pulse width of 80 ms, and symmetrical biphasic waveform. The surface electrodes were placed on the medial and lateral superior borders of the patella, as well as the medial and lateral inferior borders of the patella. The electrodes were not placed on the quadriceps or the anterior leg muscles. The pairs of electrodes kept crossing to cover the large surface area. The device intensity was regulated by the attending physical therapist until subjects reported a bearable tingling sensation. | PMC10522526 | |
Exercise therapy program | The exercise therapy training program continued for six weeks, two days every week. The recommended American Geriatrics Society exercise program was used in this study [ | PMC10522526 | ||
Statistical methods | To reveal the patients’ demographic profile concerning the outcome parameters, a descriptive statistic was applied. Furthermore, two-way mixed ANOVA and Tukey HSD post hoc tests were used to analyze within-group and between-group comparisons in SPSS 20.0. | PMC10522526 | ||
Discussion | knee flexion ROM, a loss of muscle strength [The TUG test, pain | ADVERSE EFFECTS, OSTEOARTHRITIS | Our research results showed the majority of knee OA patients tolerated the 6-week course of Kinesio Tex Gold FP (5 cm × 5 m) knee taping very well. There were no significant adverse effects or functional deterioration that would force the intervention to be discontinued. Clinically relevant improvements in pain, knee flexion ROM, and the functional activities of WOMAC and Timed Up and Go tests were seen in the KT with CPT group. However, although we found the CPT group alone showed significant improvement in pain reduction and knee flexion ROM, at the same time, this group did not produce any detectable benefit in knee functioning as assessed by WOMAC and TUG tests.Within the scope of these principles, two different therapy approaches (KT plus CPT and CPT alone) were chosen for management in this study. Baseline demographic and clinical outcome variables demonstrate a homogenous presentation among the study groups (Patients with knee OA may have joint stiffness, which can lead to a reduction in range of motion. The evidence for the positive effects of exercise on knee OA was determined to be of high to moderate quality in a Cochrane comprehensive review [As knee OA progresses, a vicious circle of pain–weakness–pain develops, resulting in functional deficits, decreased ROM, and a loss of muscle strength [The TUG test is recommended by the International Osteoarthritis Research Society as a performance-based measure of physical function in subjects with hip and knee OA [ | PMC10522526 |
Recommendations | Large sampling, well-structured study design, and randomized controlled trials in multiple centers are needed to assess the long-term effects of Kinesio taping combined with conventional physical therapy versus conventional physical therapy alone for knee OA. | PMC10522526 | ||
Study limitations | The study sample was limited to the male gender only. There was also no control group, so the improvement in the usual care group could be attributed to normal resolution. | PMC10522526 | ||
Conclusions | knee osteoarthritis, pain | KNEE OSTEOARTHRITIS | Kinesio taping plus conventional physical therapy showed statistically significant effects on pain reduction, increased range of motion, and improved functional activity in the third week and was similarly effective in the sixth week of treatment in patients with knee osteoarthritis. TENS and exercise programs for knee osteoarthritis patients have also been proven to be safe and effective, mainly reducing pain, and improving ROM. Kinesio taping could be an alternate therapy option for knee OA, particularly if an immediate effect is desired.
| PMC10522526 |
Acknowledgements | I would like to thank all of the patients who participated in the study, as well as physical therapist Mr. Mohammed Alobaid of King Fahd Specialist Hospital in Tabuk, who helped with data collection. Physical therapists Mr. Sohail Mohammed Albalawi and Mr. Ali Mohammed Altdlawi arranged facilities in the hospital setting. | PMC10522526 | ||
Funding | This study was supported by grants from the Deanship of Scientific Research (S-1440–0070), University of Tabuk, Ministry of Higher Education, Kingdom of Saudi Arabia. | PMC10522526 | ||
Declarations | PMC10522526 | |||
Conflict of interest | The authors declare no competing interests. | PMC10522526 | ||
References | PMC10522526 | |||
Background | UCDs | URINARY TRACT INFECTION (UTI), MSU | Up to 30% of urine samples from women with suspected urinary tract infection (UTI) are contaminated and need to be repeated, burdening health services and delaying antibiotic prescription. To prevent contamination, midstream urine (MSU) sampling, which can be difficult to achieve, is recommended. Urine collection devices (UCDs) that automatically capture MSU have been proposed as a solution. There are few studies exploring women’s experiences of using such devices. | PMC10170521 |
Aim | UCDs | UTI | To explore women’s experiences of urine collection and the use of UCDs during a suspected UTI. | PMC10170521 |
Design and setting | UCDs | UTI | An embedded qualitative study in a UK randomised controlled trial (RCT) of UCDs among women attending primary care for UTI symptoms. | PMC10170521 |
Method | Semi-structured telephone interviews with 29 women who had participated in the RCT were conducted. The transcribed interviews were then thematically analysed. | PMC10170521 | ||
Results | UCDs | UTI | Most of the women were dissatisfied with how they normally produced urine samples. Many were able to use the devices, found them hygienic, and would use them again, even if they had initially experienced problems. Women who had not used the devices expressed interest in trying them. Potential barriers to UCD use included positioning for the sample, UTI symptoms making urine collection difficult, and waste disposal because of the single-use plastic in the UCDs. | PMC10170521 |
Conclusion | UCDs | UTI | Most women agreed there was a need for a user- and environmentally-friendly device to improve urine collection. Although using UCDs can be difficult for women experiencing UTI symptoms, they may be appropriate for asymptomatic sampling in other clinical populations. | PMC10170521 |
INTRODUCTION | fits, bacterial infections | URINARY TRACT INFECTION (UTI), BACTERIAL INFECTIONS | Among the bacterial infections managed in primary care, urinary tract infection (UTI) is one of the most common and accounts for 1%–3% of GP consultations.To avoid contamination, patients are often advised to discard the first portion of the urine stream, in which the majority of any contaminants may be present, and to collect the midstream portion for the sample;A proposed solution to the problem of contamination is the use of a urine collection device (UCD) that is designed to automatically capture the midstream portion of a urine stream. There have been three previous studies of these devices,The Whiz Midstream device employs a pressure valve system, designed to let the initial urine stream flow into the toilet and the midstream sample to then flow into a sample bottle.A qualitative study was embedded in the current authors’ RCTHow this fits in | PMC10170521 |
METHOD | PMC10170521 | |||
Design | Investigation of these issues using qualitative research methods was chosen given the lack of relevant literature and the suitability of qualitative research for investigating individuals’ experiences and perceptions of actions and processes. Semi- structured individual interviews enable researchers to explore topics of interest to them but also to enable participants to spontaneously raise issues they consider important. | PMC10170521 | ||
Setting and participants | pain | BLOOD IN THE URINE, RECRUITMENT, UTI | The RCT recruited adult women (aged 20 years–88 years) presenting to UK general practice with symptoms of UTI, experiencing at least one of: pain on urination; blood in the urine; or frequency of urination; and who were able to give informed consent to take part in the RCT. All RCT participants were asked if they were willing to be contacted about participation in an interview study. In those who agreed to be interviewed, purposive sampling was used to ensure there was a range of ages within each arm of the RCT, and across a range of the GP practices where recruitment was taking place. The authors chose to interview a small number of women who had been randomised to standardised practice to learn about their experiences of producing urine samples and whether they might use a UCD in the future. Women were given written information about the interview study and the opportunity to ask questions.The women who gave consent were interviewed by telephone as soon as possible after their participation in the RCT had finished, ensuring that their experiences of urine collection were recent. The informed consent process was recorded. | PMC10170521 |
Data collection | UTIs, UCDs | MSU | An interview topic guide was developed, taking into account the available literature, which covered issues of interest relating to the UCDs and the women’s wider experiences of providing urine samples at times of suspected UTIs, such as their usual methods of collecting urine, their awareness of the need for MSU sampling, and their awareness of how samples could be contaminated. The topic guide was modified as the study progressed (see Supplementary Information S1). Two experienced female qualitative researchers (a health services researcher and a social sciences researcher, the first two authors) carried out the interviews between December 2016 and March 2018, across the time period when women were being recruited to the RCT. They regularly discussed the interviews to ensure consistency. Data collection finished when the researchers were satisfied that no new issues were emerging from the interviews and agreed that there was the necessary understanding of the emerging categories and themes. The average length of the interviews was 30 min. | PMC10170521 |
Analysis | The interviews were audiorecorded, transcribed verbatim by a transcription company, and the transcripts checked and anonymised. The data was analysed thematically using NVivo (version 11) to retrieve and organise the data. The researchers read and re-read the transcripts, undertook systematic coding of the data, and established a coding framework. They explored the relationships between codes, leading to the development of categories (provisional groups of codes) and eventually themes, sharing and discussing these with the wider research team to ensure their trustworthiness. | PMC10170521 | ||
RESULTS | anddifficulties, UCDs | RECRUITMENT, UTI | In total, 29 women participated in interviews; 13 from the Peezy arm, 13 from the Whiz Midstream arm, and three from the standardised practice arm. Three women declined to take part in the interview study when they were contacted after their participation in the trial ended. The focus was on recruitment among women who had used the devices but a small number of women were also interviewed who were randomised to standardised practice to explore their perceptions of urine sample collection, as well as UCDs and their potential place in UTI care. Participants were aged between 20 years and 88 years. Summaries of their experiences are presented in Supplementary Table S1.The results of the interviews are presented under the following main themes:
Initial impressions of UCDs.Experiences of using a UCD:
learning to use the devices;ease of use; anddifficulties experienced.Acceptability of UCDs:
hygiene;environmental concerns; andcost.Willingness to use a device in the future. | PMC10170521 |
Experiences of using a UCD | PMC10170521 | |||
Acceptability of UCDs | UCDs | Participants also expressed more general views about the acceptability of UCDs. These were related to hygiene, disposal, and cost. | PMC10170521 | |
DISCUSSION | PMC10170521 | |||
Summary | confusion, UCDs, pain, reduced vision, UTIs | MSU, MOVEMENT DISORDERS, UTI | For many of the women, their motivation for trying out the UCDs was rooted in their dissatisfaction with how they normally produced urine samples at times of a suspected UTI. The study found that most of the women were not aware of the need for MSU samples and the problem of contamination of the samples until these were mentioned to them as part of enrolment in the trial. Instead, they were eager to take part in the trial as a way of helping to find an easier, ‘less messy’ way of providing a urine sample. When they tried the devices, a large proportion of the women, across all age groups, were able to use them to produce a urine sample in the GP surgery or health centre and would feel happy to use the same device on further occasions, even when they had experienced problems on initial use. Women who had not used the devices in the trial reported that they would like to try them in the future. Thus, both devices were considered acceptable for use at times when the women were presenting to general practice with UTI symptoms and more hygienic than their usual method. The women also suggested that certain groups, for example, pregnant women and those with movement disorders, might particularly benefit from using them.The use of the UCDs in the trial was facilitated by verbal instructions and support received by the women from the HCP present. Although this helped them to use the devices, it also raises questions about the sustainability of their use in busy and pressured clinical settings, and therefore the feasibility of their introduction into these environments. An important barrier to the use of UCDs relates to the nature of the UTI symptoms themselves and issues around collecting midstream samples, such as producing sufficient quantities of urine and pain on urination. Finding a suitable position in which to collect urine via the UCD was also problematic for some women, especially those who were less mobile. The women also felt that the UCDs would be less usable among women with reduced vision, women who are overweight, or among women with confusion.The interviews highlighted that it had become common practice for some of the women to collect their urine sample at home before attending an appointment at their GP surgery. Women who experienced recurrent UTIs were often provided with the containers to keep at home ready for use when they suspected a UTI. However, there was uncertainty about whether the UCDs could be made available for home use. Thus, how UCDs could be incorporated into patients’ usual involvement in management of UTIs in the community would need to be carefully considered.An unanticipated concern that represents a major barrier to use are the issues of the quantity of single-use plastic in the devices and that of waste disposal. These issues, together with the cost of the devices, were considered prohibitive by some women. Among women who experienced recurrent UTIs, they commonly found other solutions to improve their ability to collect samples, such as storing sample pots at home to collect a sample before coming to the GP and using receptacles that worked better for them before transferring their sample to a pot. | PMC10170521 |
Strengths and limitations | UTIs | A strength of this study is the range of participants interviewed, particularly across the age groups. The authors found qualitative interviews a very useful method for collecting data about a highly personal issue such as UTIs, and the women felt able to speak with candour and in detail about their experiences.The women interviewed in this study had participated in an RCT because they were positive about trying out a UCD. This might not be the case among a wider general practice population. | PMC10170521 | |
Comparison with existing literature | UCDs | UTI | Although some of the participants in the current study encountered difficulties in using the UCDs because of UTI symptoms, they suggested that the devices might be particularly suitable for pregnant women. In one other study, a UCD (the Whiz Midstream) was compared with conventional urine collection methods in women attending antenatal clinics. The device was found to be acceptable among these participants, who were not experiencing UTI symptoms. | PMC10170521 |
Implications for practice | UCDs | UTI | In this study most women confirmed there was an unmet need for a device to improve urine sample collection. The struggles described by these participants when using smaller containers that are usually used in existing practice suggest that more user-and environmentally-friendly collection devices are needed. Some women found that the UCDs tested met that need, and considered them hygienic and easy to use. Others, however, raised concerns about difficulty in using the devices, which in many cases arose because of the symptoms of UTI they were experiencing. Those concerns, however, may not be applicable to asymptomatic sampling in other clinical populations. For this reason, devices may have a role to play when collection of urine is for asymptomatic screening or other clinical purposes.The authors gratefully acknowledge the women who participated in this study. | PMC10170521 |
Funding | This project was funded by
| PMC10170521 | ||
Ethical approval | Ethical approval was received from the East of England — Cambridge East Research Ethics Committee (reference: 16/EE/0200). | PMC10170521 | ||
Provenance | Freely submitted; externally peer reviewed. | PMC10170521 | ||
Competing interests | The authors have declared no competing interests. | PMC10170521 | ||
Discuss this article | Contribute and read comments about this article: | PMC10170521 | ||
REFERENCES | PMC10170521 | |||
Background | post-phacoemulsification | To determine the effect of ketorolac tromethamine 0.5% in preventing post-phacoemulsification macular thickening. This randomized clinical trial. patients randomized 1:1 to receive either topical ketorolac three times a day or a placebo. | PMC10347851 | |
Methods | diabetic, CMT | PROLIFERATIVE DIABETIC RETINOPATHY | A total of 101 eyes of 101 diabetic patients who were scheduled for phacoemulsification and had normal macular contour and thickness enrolled consecutively. The topical ketorolac and placebo were prescribed on the day before surgery and continued up to 4 weeks after surgery. Patients with proliferative diabetic retinopathy, a history of intravitreal injection in less than three months, a history of macular photocoagulation in less than 6 months, and any other concomitant ocular pathologies were excluded. Central macular thickness (CMT) and best corrected visual acuity (BCVA) was recorded in the follow-ups of 6, 12, and 24 weeks after the surgery and compared with the controls. | PMC10347851 |
Results | CMT | 49 eyes in the case group and 52 eyes in the control group were analyzed. Mean BCVA was significantly improved in both groups at all follow-ups (P < 0.001 for all). There was no statistically significant difference regarding the BCVA in different time points except week 12 (P = 0.028) among the study group. In the case and control groups, CMT was increased at all follow-ups (P < 0.05). There was no statistically significant difference when comparing the two groups regarding the mean of CMT at any time point postoperatively (P > 0.05 for all). | PMC10347851 | |
Conclusion | diabetic, post-phacoemulsification | Based on our findings, topical ketorolac tromethamine 0.5% is not effective in the prevention of post-phacoemulsification macular thickening in diabetic patients. | PMC10347851 | |
Trail registration | The study protocol was registered into | PMC10347851 | ||
Clinical trial registration number | NCT03551808. | PMC10347851 | ||
Keywords | PMC10347851 | |||
Background | cataract, Cataract, diabetic, visual impairment | CATARACT, POSTOPERATIVE COMPLICATIONS, RETINA, CATARACT, MACULAR EDEMA | Cataract is a common cause of visual impairment in elderly individuals all around the world [In spite of the recent improvements in the surgical techniques of phacoemulsification, some postoperative complications have been reported. A higher percentage of macular edema (ME) was reported in diabetic patients (12%) compared with non-diabetic individuals (6%) undergoing cataract surgery [Although there is no agreement regarding the main pathophysiological mechanisms of postoperative ME following phacoemulsification, some studies have suggested that cataract surgery can induce inflammatory reactions in the posterior ocular segment. In a study by Xu et al., it was shown that the expression of chemokine (C-C motif) Ligand 2 and interleukin- 1β genes and protein secretion can occur in both retina and choroid after the cataract surgery [In a prospective cohort study, a significantly higher rate of ME was observed in diabetic patients compared with non-diabetic individuals [Ketorolac tromethamine is a potent non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase enzymes and thus decreases the level of ocular prostaglandins and consequently the chance of cystoid ME when applied topically [ | PMC10347851 |
Methods | cataract, diabetic | CATARACT | In this randomized clinical trial (RCT), a total of 101 eyes from 101 diabetic patients who were scheduled for cataract surgery at Torfeh Medical Center, Shahid Beheshti University of Medical Sciences were included. The study protocol was registered into The study adhered to the tenets of the Declaration of Helsinki and was approved by the Ethics Committee of the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences. All the study procedures were explained to all patients and a signed consent form was obtained from each patient before entry to the study. We used the CONSORT reporting guidelines for our trial [ | PMC10347851 |
Participants | diabetic retinopathy, Comprehensive visual and ocular examinations, 78D, inflammation, uveitis, hazy, cataract, Diabetic, glaucoma, CMT, diabetes with fasting blood sugar, diopter | DIABETIC RETINOPATHY, INTRAOPERATIVE COMPLICATIONS, IOL, INFLAMMATION, UVEITIS, RECRUITMENT, CATARACT, PROLIFERATIVE DIABETIC RETINOPATHY (PDR), LENS, MACULAR DISEASE, GLAUCOMA, REFRACTIVE ERROR | Diabetic patients who were scheduled to undergo cataract surgery were included. All patients had controlled diabetes with fasting blood sugar (FBS) of 126 mg/dl or less and glycated hemoglobin A1c (HbA1c) of less than 7% at the time of study entry. Patients with glaucoma, uveitis, any previous intraocular surgery, any intravitreal injection in less than three months, macular laser photocoagulation in less than 6 months, presence of proliferative diabetic retinopathy (PDR) or any macular disease, cyclo-refraction of ≥ ± 6 diopter (D), hazy media to obtain the high-quality images of the optical coherence tomography (OCT), baseline central macular thickness (CMT) ≥ 280 μm excluded. Also, patients with any kind of intraoperative complications and those who lost to follow-up were excluded.All the study subjects were interviewed to obtain demographic data as well as the patients’ health and ocular history by an expert technician. All patients were ordered to perform the laboratory tests including FBS, creatinine, urea, and HbA1c at the time of study recruitment.Participants were randomized using the permuted block randomization method in two groups. In multiple studies and a meta-analysis, it was shown that starting NSAID eye drops are more effective in decreasing inflammation and ME, if started 1 to 3 days prior to cataract surgery [Comprehensive visual and ocular examinations were performed on all study subjects. Refractive error measurement was performed either by auto-refractometer (RM-8800; Topcon Medical, Oakland, NJ, USA) or retinoscope (HEINE BETA®200; Germany). BCVA was assessed using a Snellen E-chart at a distance of 6 m by a trained optometrist. In addition, a biomicroscopic examination was performed to evaluate the anterior segment. Intraocular pressure was measured using the applanation tonometer (Goldmann applanation tonometer, Haag-Streit, USA). Fundus examination was conducted using an indirect ophthalmoscope through dilated pupil by a 78D lens to determine the stage of diabetic retinopathy according to international classification [Spectral-domain OCT (SD-OCT, Heidelberg Engineering OCT Spectralis, USA) was performed for all study subjects to measure the CMT. IOL power calculation was conducted using A-scan (ZEISS IOL Master 500; Germany) at the baseline examination. All ophthalmic examinations and cataract surgery were performed by an expert anterior segment ophthalmologist (HMR). | PMC10347851 |
Surgical technique | IOL, LEAKAGE | The procedure was performed under topical or general anesthesia, according to the patient’s condition, by a single anterior segment surgeon (HMR). After a 2.8 mm clear corneal incision, phacoemulsification was performed using the divide and conquer technique, and the IOL was inserted in the capsular bag using the Monarch II injector and a C cartridge (Alcon Laboratories Inc., Fort Worth, TX, USA). After irrigation and aspiration, the anterior chamber was formed with the balanced salt solution. There was no wound leakage. Subconjunctival betamethasone (4 mg) and ceftazidime (100 mg) were injected, and the eyes were patched. | PMC10347851 | |
Follow-up examinations | SURGICAL COMPLICATIONS | All patients were routinely examined the next day, one week, and one month after the surgery for possible surgical complications. Follow-up examinations including OCT imaging and BCVA measurement were conducted at the three-time points of 6, 12, and 24 weeks following the surgery for both cases and controls. | PMC10347851 | |
Randomization | All participants were randomly assigned into study groups of cases and controls using the permuted block randomization method with a random block length of 2, 4, 6, and 8. The randomization list was generated by a computer-based program and the details of the random sequence were concealed from researchers. Whenever a new patient entered the study a new envelope (which contained the group for the order sequence of the patient) was opened and the group was revealed. Participant enrollment and intervention assignment were carried out (HM, HE, and AR). | PMC10347851 | ||
Blinding | Evaluation of outcomes was performed by a researcher who was uninformed about the group assignment. The study protocol and the type of treatment were concealed from our participants. | PMC10347851 | ||
Sample size | diabetic, CMT | To have a power of 90% to detect a 30 μm difference of CMT in 12 weeks, we needed 50 subjects in each group. It was based on the assumed standard deviation of 0.26 which was obtained in the pilot phase of this study. The probable attrition of up to 30% and type one error of 0.05 were also considered. Fifty-eight diabetic patients having the eligibility criteria were enrolled in each group due to overcome the possible loss of follow-up. | PMC10347851 | |
Outcome measures | The changes of CMT and BCVA at the three-time points of weeks 6, 12, and 24 compared to the baseline were considered as the primary outcome measures. | PMC10347851 | ||
Statistical analysis | The normal distribution of quantitative data was assessed by the Shapiro-Wilks test and Q-Q plot. To describe data, we used, mean and standard deviation, median and range, frequency and percentage. To compare the baseline variables between the two groups we used an independent t-test, Mann-Whitney test, chi-square test, and Fisher exact test. Evaluation of the variables’ changes in different follow-ups was performed using a linear mixed model. To compare the groups in different follow-ups we used Multivariate Analysis of Variance (MANOVA). All statistical analysis was performed using SPSS software Version 25 (IBM Corp. Armonk, NY). All tests were two-sided and P-value less than 0.05 was considered statistically significant. | PMC10347851 | ||
Results | diabetic, diopter, NPDR, CMT | DIABETIC RETINOPATHY, PROLIFERATIVE DIABETIC RETINOPATHY | This study enrolled 116 eligible patients, but the data of 15 patients were not included in the statistical analysis due to miss follow-up Finally, a total of 101 eyes out of 101 diabetic patients (mean age of 64 ± 10 and range of 45 to 95 years) were included (Fig.
The flowchart of the present studyTable
Baseline characteristics in the case and the control groupsSE, spherical equivalent; Cr, creatinine; FBS, fast blood sugar; HbA1C, hemoglobin A1C; NPDR, non- proliferative diabetic retinopathy; DR, diabetic retinopathy; P, probability; SD, standard deviation; w, week; D, diopter; yrs, years† Based on t-test‡ Based on Mann-Whitney test* Based on Chi-Square tesst** Based on Fisher exact test
The mean and changes of CMT in case and control groups in different follow upsCMT, central macular thickness; SD, standard deviation; w, weeks; Diff, difference; CI, confidence interval P, probability§Based on t-test† Based on generalized linear mixed model (GLM)
The mean and changes of BCVA (LogMAR) in case and control groups in different follow upsBCVA, best corrected visual acuity; LogMAR, logarithm of the minimum angle of resolution; SD, standard deviation; w, weeks; Diff, difference; CI, confidence interval; P, probability§Based on t-test† Based on generalized linear mixed model (GLM) | PMC10347851 |
Discussion | diabetic retinopathy, diabetic ME, inflammation, cataract, diabetic, post-phacoemulsification, diabetes | DIABETIC RETINOPATHY, INFLAMMATION, FOLLOWING CATARACT SURGERY, CATARACT, INSULIN-DEPENDENT DIABETES MELLITUS, DIABETES | In the current Randomized Clinical Trial (RCT), we investigated the prophylactic effect of ketorolac eye drop on post-phacoemulsification macular thickening in diabetic patients. We found that prophylactic ketorolac tromethamine 0.5% initiated the day before the surgery and continued up to 4 weeks in addition to topical corticosteroid was not associated with better visual outcome or lower macular thickness after the cataract surgery, compared to placebo except for follow- up in week 12, which was in favor of the ketorolac group. As well, the mean change in CMT was similar between the two study groups.There are several studies in the literature investigating the prophylactic or therapeutic effects of NSAIDs on ME following cataract surgery. Sivaprasa et al. evaluated the effects of NSAIDs on the treatment of acute and chronic ME following cataract surgery in a systematic review that included seven RCTs [Ticly et al. [Furthermore, the prophylactic effect of topical ketorolac against the development of post-cataract surgery ME in diabetic patients was evaluated by Elsawy et al. [The risk factors for the increase of macular thickness after phacoemulsification in diabetic patients are not well defined. However, some factors are diagnosed to increase the risk of macular thickening such as the presence of insulin-dependent diabetes mellitus, duration of diabetes ≥ 10 years, the severity of diabetic retinopathy, and prior treated diabetic ME. The results of the present study are in contrast to the findings of Elsawy et al., [Our study has significant limitations. A low sample size in each group may influence the statistical significance of the results. Also, we did not subgroup analysis based on diabetic retinopathy stages and normal eyes. Also maybe some confounding factors such as surgery time, cataract severity, and post-operation inflammation level influence our results and also the lack of fluorescein angiography imaging was a possible limitation of the current study. | PMC10347851 |
Conclusions | diabetes, CMT | FOLLOWING CATARACT SURGERY, DIABETES | In conclusion, the current randomized clinical trial suggests that prophylactic topical ketorolac 0.5% three times a day might not decrease CMT and improve visual acuity compared to placebo following cataract surgery in patients with diabetes. However, further studies with larger sample sizes are recommended. | PMC10347851 |
Acknowledgements | We are grateful to the Ophthalmology Research Center of Shahid Beheshti University for collaborating on classifying and reviewing patients’ clinical information, as well as monitoring database registration. | PMC10347851 | ||
Authors’ contributions | Homayoun | Hossein Mohammad-Rabei and Hamideh Sabbaghi designed the study. Saeed Karimi served as an editor. Alireza Ramezani, Homayoun Nikkhah, and Mehdi Emamverdi served as editors and data collectors, and Mehdi Emamverdi also provided consultation. Kourosh Sheibani served as a consultant. Bahareh Kheiri and Mehdi Yaseri contributed to the data analysis. Razieh Bahreini contributed as in data collection and also served as the corresponding author. | PMC10347851 | |
Funding | We confirm that none of the authors involved in this research article have any financial interest in the subject matter of the work. Additionally, we did not receive any funding for this study. | PMC10347851 | ||
Data Availability | The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. | PMC10347851 | ||
Declarations | PMC10347851 | |||
Ethics approval and consent to participate | The study adhered to the tenets of the Declaration of Helsinki and was approved by the Ethics Committee of the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Informed consent was obtained from all subjects and/or their legal guardian(s). | PMC10347851 | ||
Consent for publication | Not applicable. | PMC10347851 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10347851 | ||
References | PMC10347851 | |||
Objectives | muscle mass, ovarian cancer | OVARIAN CANCER | In ovarian cancer (OC), suboptimal muscle morphology (i.e., low muscle mass and density) is associated with poor clinical outcomes, yet little is known about the effect of interventions aimed at improving these measures. We investigated the effect of resistance exercise after first-line treatment on muscle mass and density, muscle strength and physical function, health-related quality of life (QoL), and pelvic-floor function in advanced-stage OC survivors. | PMC10132425 |
Methods | muscle mass | Fifteen OC survivors participated in supervised resistance exercise twice weekly for 12 weeks (in-clinic or by telehealth). Assessments included muscle mass and density (dual-energy X-ray absorptiometry, peripheral quantitative computed tomography), muscle strength (1-repetition maximum [1RM] chest press, 5RM leg press, handgrip strength), physical function (400-m walk, timed up-and-go [TUG]), QoL (QLQ-C30 questionnaire), and self-reported pelvic floor function (Australian Pelvic Floor Questionnaire). | PMC10132425 | |
Results | lean mass | The median age was 64 (range 33–72) years, 10 women underwent neoadjuvant chemotherapy and five underwent adjuvant chemotherapy. All participants completed the intervention (median attendance = 92%; range 79–100%). Post-intervention improvements were observed for whole-body lean mass (1.0 ± 1.4 kg, | PMC10132425 | |
Conclusion | muscle mass | In this study, supervised resistance exercise effectively improved muscle mass and density, muscle strength, and physical functioning without deleterious effects on the pelvic floor. Considering the prognostic value of these outcomes, larger studies are needed to confirm the benefits of resistance exercise in OC supportive care. | PMC10132425 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00520-023-07754-y. | PMC10132425 | ||
Keywords | Open Access funding enabled and organized by CAUL and its Member Institutions | PMC10132425 | ||
Introduction | ovarian cancer, fatigue, anxiety, cancer, depressive | OVARIAN CANCER, CANCER | About 75% of ovarian cancer (OC) cases are diagnosed at an advanced stage (III or IV) [In recent years, research has highlighted the important role of skeletal muscle in cancer outcomes. Both suboptimal muscle morphology and muscle function (i.e., low muscle strength and physical function) are associated with poor treatment and survival outcomes [Exercise has a beneficial effect on cancer-related health outcomes such as anxiety, depressive symptoms, fatigue, physical function, and health-related QoL [ | PMC10132425 |
Methodology | PMC10132425 | |||
Setting and participants | illness or disorder | RECRUITMENT, BONE METASTASES | The research design was a prospective single-arm study. Women with histologically confirmed stage III or IV epithelial OC who completed first-line surgical and chemotherapy treatment between four and 12 weeks prior to participation were eligible. Participants were recruited from Sir Charles Gairdner Hospital and St John of God Hospital, Subiaco, in Perth, Western Australia. Exclusion criteria were (1) age younger than 18 years, (2) participation in a structured, progressive resistance exercise program two or more times/week in the previous 3 months, (3) inability to understand and speak English, (4) inability to obtain approval from the treating medical oncologist or general practitioner, (5) on 10 mg or more per day of prednisolone (or equivalent of other steroid medication within 4 weeks of starting the study), (6) on any experimental anti-cancer therapy during or within 8 weeks of starting the study, (7) for patients on olaparib—needing a blood transfusion within the first 8 weeks of starting olaparib, (8) existing or suspected bone metastases, and (9) any illness or disorder that could put participants at risk during exercise testing or exercise training, as determined by their specialist or general practitioner. Potentially eligible women were screened for eligibility by phone, and a recruitment pack was mailed to eligible participants. | PMC10132425 |
Exercise intervention | PERIPHERAL NEUROPATHY | The 12-week exercise intervention was delivered in an exercise clinic or by telehealth (online via the Internet) based on participants’ preferences. Participants undertook two supervised exercise sessions (either in-clinic or by telehealth) and one unsupervised home-based exercise session/week on non-consecutive days. All supervised exercise sessions were administered by the lead investigator (CS), an accredited exercise physiologist. Initial exercise prescription was based on each participant’s baseline functional and strength test results and choice of exercise delivery and adapted for limiting treatment-related side effects, such as peripheral neuropathy, and pre-existing comorbid conditions. Supervised exercise sessions consisted of a 5-min warm-up, 40–50 min of resistance training, as dictated by operational constraints, and 5 min of stretching to conclude the session. All exercise sessions included at least one multi-joint lower body exercise (e.g., leg press, sit-to-stand, and wall squat) and two multi-joint upper body exercises: a pull movement (e.g., seated row, rowing with an elastic band) and a push movement (e.g., chest press, push-ups on knees) (Supplementary Table | PMC10132425 | |
Outcome measures | Outcome measures were assessed at baseline (week 0) and post-intervention (weeks 13 or 14) at the Edith Cowan University Exercise Medicine Research Institute, Perth, Western Australia. Demographic and health history data including age, marital status, education level, employment status, comorbidities, and current medications, as well as cancer-specific information, were acquired by self-report and medical record review. Height (m) and weight (kg) were measured to calculate the body mass index (BMI; kg/m | PMC10132425 | ||
Muscle morphology | upper-limb and lower-limb bone-free lean mass | Whole-body and regional bone-free lean mass and fat mass were assessed by dual-energy X-ray absorptiometry (DXA, QDR-1500; Hologic Discovery A, Waltham, MA, USA). Appendicular lean mass was derived from the sum of upper-limb and lower-limb bone-free lean mass [ | PMC10132425 | |
Muscle strength and physical function | Upper and lower body muscle strength was assessed using a one-repetition maximum (1RM) chest press and a five-repetition maximum (5RM) leg press [ | PMC10132425 | ||
Patient-reported outcomes | nausea, dyspnea, fatigue, diarrhea, pain, constipation, insomnia, Cancer | APPETITE LOSS, CANCER | Disease-specific health-related QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. The QLQ-C30 incorporates five functional scales (physical, role, cognitive, emotional, and social), nine symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health and QoL scale [Self-reported pelvic floor function was measured with the Australian Pelvic Floor Questionnaire [ | PMC10132425 |
Statistical analysis | For a single-arm pre- and post-intervention study with alpha at 0.05 and 80% power, 15 participants provide the ability to detect an effect size of 0.8. Data were analyzed with SPSS Version 28 statistical software (IBM Corp., NY). Variables were assessed for normality using the Shapiro-Wilk test. Results for frequency data are presented as number/percentage and mean/standard deviation for normally distributed data, or median/interquartile range for non-normally distributed data. To determine differences from baseline to post-intervention, we used the paired samples | PMC10132425 | ||
Results | PMC10132425 | |||
Participant characteristics | Between September 2019 and September 2021, 16 of 29 eligible women were recruited (Fig. Participant flowchartPatient characteristicsAbbreviations: | PMC10132425 | ||
Exercise intervention | muscular pain, chest pain | ADVERSE EVENTS | Twelve women (80%) chose to participate in person in the exercise clinic. The three women (20%) who opted for the online intervention indicated travel distance to the exercise clinics as the reason. The median attendance of the 24 scheduled supervised sessions was 92% (range 79–100%). Participants indicated reasons for missed sessions to be “not feeling well enough to exercise” (68% of missed sessions), non-medical appointments (16%), and family-related matters (16%). The mean rating of perceived exertion across all sessions was 13 ± 1 (i.e., somewhat hard). One participant was hospitalized for one night midway through the intervention with chest pain that was diagnosed as muscular pain, likely due to the intervention. No other adverse events were reported. | PMC10132425 |
Muscle morphology | From pre- to post-intervention, body weight increased by 1.4 ± 1.7 kg (Pre- and post-intervention measures of body composition, muscle morphology, muscle strength, and physical functionMuscle strengthAbsolute strengthAbbreviations: Values are presented as mean (SD) unless otherwise specifiedpQCT values, Leg press Chest press Values in bold indicate statistically significant changesIndividual changes from pre- to post-intervention—whole-body and appendicular lean mass. Lines and dots indicate individual data, with the box-and-whisker representation of the whole group.* | PMC10132425 | ||
Muscle function | Over the 12-week intervention period, there was a significant increase in upper body absolute strength (+ 5.8 kg, 95% CI: 3.6–8.1, Individual changes from pre- to post-intervention—muscle strength and physical function. Lines and dots indicate individual data, with the box-and-whisker representation of the whole group. * | PMC10132425 | ||
Discussion | cancer, fatigue | CANCER | This study aimed to investigate the effect of supervised resistance exercise on muscle morphology and muscle function in advanced-stage OC survivors who had completed first-line treatment. There were two main findings. First, after 12 weeks of resistance exercise, there were significant increases in lean mass and muscle density, upper and lower body muscle strength, and physical function. Second, participants experienced clinically important improvements in global health and quality of life, fatigue, and social functioning, with no increase in pelvic floor symptoms.We observed statistically significant increases in lean mass from pre- to post-intervention. Our finding is consistent with that of Lee et al. [In contrast to muscle mass, information on the effect of exercise on muscle density in people with cancer is limited, with some evidence that exercise during treatment preserves muscle density [Participants in our study experienced significant increases in physical function and upper and lower body muscle strength during the 12-week resistance exercise intervention. Only a few OC exercise studies have included measures of physical function or muscle strength [We did not observe a change in handgrip strength after the 12-week resistance exercise intervention. While Moonsammy et al. also reported no improvement in handgrip strength after a 24-week multimodal exercise intervention [Health-related QoL in OC survivors who had completed treatment is often negatively affected by persistent symptoms and side effects such as fatigue [Importantly, patient-reported pelvic floor symptoms did not increase during the resistance training intervention. Although research investigating the effect of exercise on the pelvic floor is insufficient and often contradictory, current best evidence suggests that most physical activity does not harm the pelvic floor [This study investigated the effects of resistance exercise in advanced-stage OC survivors. We found that participation in a resistance exercise program shortly after the completion of first-line treatment can effectively improve muscle morphology and muscle function, both considered potentially prognostic for treatment and survival outcomes [Although larger, controlled randomized trials are needed for confirmation, our findings suggest that supervised resistance exercise is beneficial for women who have completed first-line treatment for OC. Considering the growing interest in pre-habilitation for OC patients undergoing neoadjuvant chemotherapy, our findings also provide promise for pre-habilitation programs with a resistance training component. | PMC10132425 |
Conclusion | fatigue | In this study, women with advanced-stage OC who recently completed first-line treatment experienced significant increases in lean body mass and muscle density, upper and lower body strength, and physical function after participating in resistance exercise. Clinically important improvements were also observed in fatigue, global health, and QoL, and social, cognitive, and role functioning. Importantly, participants did not experience an increase in pelvic floor symptoms. Although our findings need to be confirmed in larger trials, preliminary results show that targeted resistance exercise in a supervised setting is beneficial and should be recommended for women with advanced-stage OC. | PMC10132425 | |
Author contribution | Daniel A. | Christelle Schofield: conceptualization, methodology, investigation, formal analysis, project administration, and writing—original draft. Robert U. Newton: conceptualization, methodology, supervision, and writing—review and editing. Dennis R. Taaffe: conceptualization, methodology, formal analysis, and writing—review and editing. Daniel A. Galvão: conceptualization, methodology, and writing—review and editing. Paul A. Cohen: conceptualization, methodology, and writing—review and editing. Tarek M. Meniawy: conceptualization and methodology. Carolyn J. Peddle-McIntyre: conceptualization, methodology, project administration, supervision, and writing—review and editing. | PMC10132425 | |
Funding | Cancer | CANCER | Open Access funding enabled and organized by CAUL and its Member Institutions. CS was financially supported by an Edith Cowan University Ph.D. Scholarship, Australian Government Research Training Program Scholarship, and Western Australian Cancer Council Ph.D. Top-up Scholarship. | PMC10132425 |
Declarations | PMC10132425 |
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